chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: dizziness, It only occurs when I am sitting down or still; This is a spontaneous report from a non-contactable consumer, the patient. A 20-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration on 18Mar2021 (at the age of 20-years-old) as a single dose for COVID-19 immunisation. Medical history included PCOS (Polycystic ovary syndrome), anemia (at the time of this report the condition was reported as on and off, slightly above borderline Anemic). The patient was allergic to minocycline. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. Concomitant medications included birth control, magnesium and zinc vitamin (MANUFACTURER UNKNOWN), vitamin d3(MANUFACTURER UNKNOWN) for unknown indication from unknown date. On 19Mar2021, the patient experienced dizziness only when sitting down or still. It was reported that patient was worried about receiving the second dose. The event 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 event dizziness. The clinical outcome of dizziness only when sitting down or still was unknown at the time of this report.   Information about lot/ batch number cannot be obtained. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Sensitive skin
Clinical narrative: The skin on my back got extremely sensitive to everything.; Skin sensitivity on my back - felt like Ihad been badly sunburned. There was no visibleredness or swelling but everything thattouched my back stung.; This is a spontaneous report received from a contactable consumer, the patient. A 27-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EP7534) via an unspecified route of administration in the left arm on 20Mar2021 at 1045 (at the age of 27-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had no allergies to medications, food or other products. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: 6198) via an unspecified route of administration in the left arm on 27Feb2021 at 1045 as a single dose for COVID-19 immunisation. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19.  The patient did not receive any concomitant medication within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. On 20Mar2021 at 2100, the patient reported that she had skin sensitivity on her back which felt like badly sunburned, the skin on back got extremely sensitive to everything. There was no visible redness or swelling, but everything that touched her back stung. It was reported that no treatment was taken for the events experienced. The clinical outcome of the event skin sensitivity which felt like badly sunburned and everything that touched her back stung was resolved 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: Injection site erythema, Rash
Clinical narrative: Approximately 1.5in diameter red spot at the injection site appeared 9 days after the jab; Rash; This is a spontaneous report from a non-contactable consumer, the patient. A 35-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6204) via unspecified route of administration in left arm on 12Mar2021 at 08:30 (at the age of 35-year-old) as a single dose for COVID-19 immunisation. Medical history included allergic to blackberry. Concomitant medication included centrum (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 21Mar2021, the patient experienced 1.5 in diameter red spot at the injection site which appeared 9 days after the jab. On an unknown date in Mar2021, the patient experienced no pain, itching, tenderness was associated with the rash. No therapeutic measures were taken for the events. 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 events red spot at injection site and rash was recovered at an unknown date.   No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Injection site pain; This is a spontaneous report from a contactable consumer or other non hcp (reporters father). A 60-years-old male patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number unspecified, expiration date unspecified), via an unspecified route of administration on 26Mar2021 as DOSE 1, SINGLE for covid-19 immunization (60 year at the time of vaccination). The patient medical history and concomitant medications were not reported. On 26Mar2021, the patient experienced injection site pain. And the reporter wanted to know if the patient can take Tylenol/ibuprofen. The outcome of the was reported as unknown at the time of report.  No follow-up attempts are possible. No information about lot/batch number cannot been obtained.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: pain in injection site arm; This is a spontaneous report received from a non-contactable consumer, the patient. A 67 years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ep6955) via an unspecified route of administration in the left arm on 13Mar2021 at 11:00 (at the age of 67-year-old) as a single dose for COVID-19 immunisation. Medical history included Type II diabetes mellitus. Concomitant medications were not reported. The patient did not have any allergies to medications, food, or other products. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested positive for COVID-19. On 13Mar2021 after 6 hours of vaccination, the patient experienced very slight pain in injection site arm. The patient did not receive any treatment for events. The events had not resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the pain in arm was resolved on 14Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Paraesthesia
Clinical narrative: Left leg felt heavy; left leg felt tingly; This is a spontaneous report from a non-contactable consumer, the patient. A 46-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in the left arm on 18Mar2021 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient had a history of allergy to levofloxacin (LEVAQUIN). The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Prior to vaccination, the patient had no symptoms associated for COVID-19. Since the vaccination, the patient was not tested positive for COVID-19. On 18Mar2021, the patient experienced heaviness and tingling in the left leg that corresponded to the arm where the shot was received for 5 days after the vaccine. The patient did not receive any treatment for the reported 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 heaviness and tingling in the left leg were resolving.   No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Tic, Vaccination site pain
Clinical narrative: FACIAL TIC RIGHT BELOW THE RIGHT EYE; Injection site pain; This is a spontaneous report from a contactable consumer or other non-health care professional (patient).   A 50-years-old non-pregnant female patient (not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8727), via an unspecified route of administration, administered in arm right on 25Mar2021 at 11:00 (50-year-old at the time of vaccination) as dose 1, single for COVID-19 immunization. Medical history included hypothyroidism from an unknown date and unknown if ongoing. The patient not had any allergies to medications, food, or other products. The vaccination facility type was reported as pharmacy or drug store. Concomitant medications included ethinylestradiol, norethisterone acetate (JUNEL), levothyroxine sodium (LEVOTHYROXINE SODIUM) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19, prior to vaccination and had not tested for COVID-19, since the vaccination. On 25Mar2021 at 16:00, the patient experienced injection site pain. On 26Mar2021 at 07:30, experienced facial tic right below the right eye. The treatment was not received for the event. The events were reported as non-serious. The outcome for the event injection site pain was resolving while other event facial tic right below the right eye was reported as resolved on an unspecified date in 2021.  No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Contusion, Ear pain, Herpes zoster, Lymphadenopathy
Clinical narrative: skin rash/rash; swollen lymph nodes/swollen lymph nodes on my right neck; has a bruise on the back of her neck or like her muscle got hurt; has a bruise on the back of her neck or like her muscle got hurt; asthma/allergic asthma; ear hurts; Shingles; This is a spontaneous report from a contactable consumer(patient). A 56-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8730), dose 1 via an unspecified route of administration, administered in Arm Left on 22Mar2021 08:00 (at the age of 56-years-old) as dose 1, single for COVID-19 immunisation. The patient's medical history included Allergic asthma from an unknown and was ongoing. The patient concomitant medications were not reported. The patient with a history of allergic asthma who received the first dose of the COVID19 vaccine on (Monday) on 22Mar2021 at 8 AM. About 8 hours later around 3 PM (Monday) on 22Mar2021 she started to start felling some asthma /Asthmatic, like dealing with bad allergies because she has allergic asthma. It just got like she had dealing bad allergies. Not bad, but similar to when she is exposed to a lot of dust. She took her spray as she periodically took it. On (Wednesday) on 24Mar2021 (36 hours after), she noticed a skin rash and swollen lymph nodes on the right side of her neck, which was the opposite side of where she got her shot, she got shot on the left side on her arm. It feels like she has a bruise on the back of her neck or like her muscle got hurt. Sometimes her ear hurts too. She got the vaccination on her left side. She doesn't know if this was fairly typical or not. She was uncertain if she should get the second dose because she heard second shot is worse. The patient received the treatment spray for asthma. She has rash and swollen lymph still and she was wondering is it safe for me to take second dose giving that she has have this symptom. She saw Doctor on Friday (26Mar2021) and she told her that she got shingles, the rash, it turned out to be Shingles. She asked has a lot of people reported shingles. Her second dose scheduled for 12Apr2021. The outcome of skin rash/rash and swollen lymph nodes/swollen lymph nodes on my right neck was not resolved. The outcome of asthma/allergic asthma has a bruise on the back of her neck or like her muscle got hurt, ear hurts, shingles was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Rash
Clinical narrative: skin rash/rash; swollen lymph nodes/swollen lymph nodes on my right neck; has a bruise on the back of her neck or like her muscle got hurt; has a bruise on the back of her neck or like her muscle got hurt; asthma/allergic asthma; ear hurts; Shingles; This is a spontaneous report from a contactable consumer(patient). A 56-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8730), dose 1 via an unspecified route of administration, administered in Arm Left on 22Mar2021 08:00 (at the age of 56-years-old) as dose 1, single for COVID-19 immunisation. The patient's medical history included Allergic asthma from an unknown and was ongoing. The patient concomitant medications were not reported. The patient with a history of allergic asthma who received the first dose of the COVID19 vaccine on (Monday) on 22Mar2021 at 8 AM. About 8 hours later around 3 PM (Monday) on 22Mar2021 she started to start felling some asthma /Asthmatic, like dealing with bad allergies because she has allergic asthma. It just got like she had dealing bad allergies. Not bad, but similar to when she is exposed to a lot of dust. She took her spray as she periodically took it. On (Wednesday) on 24Mar2021 (36 hours after), she noticed a skin rash and swollen lymph nodes on the right side of her neck, which was the opposite side of where she got her shot, she got shot on the left side on her arm. It feels like she has a bruise on the back of her neck or like her muscle got hurt. Sometimes her ear hurts too. She got the vaccination on her left side. She doesn't know if this was fairly typical or not. She was uncertain if she should get the second dose because she heard second shot is worse. The patient received the treatment spray for asthma. She has rash and swollen lymph still and she was wondering is it safe for me to take second dose giving that she has have this symptom. She saw Doctor on Friday (26Mar2021) and she told her that she got shingles, the rash, it turned out to be Shingles. She asked has a lot of people reported shingles. Her second dose scheduled for 12Apr2021. The outcome of skin rash/rash and swollen lymph nodes/swollen lymph nodes on my right neck was not resolved. The outcome of asthma/allergic asthma has a bruise on the back of her neck or like her muscle got hurt, ear hurts, shingles was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Parosmia
Clinical narrative: Metallic taste and smell after second dose; Metallic taste and smell after second dose; This is a spontaneous report from a contactable consumer (Pfizer colleague). A 17-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: ER8730) via an unspecified route of administration in left arm on 26Mar2021 at 09:30 (age at vaccination 17-year-old), single dose for covid-19 immunisation. The patient's relevant medical history included vasovagal syncope and Covid-19. The patient did not have any known allergies. The patient's concomitant medications included ethinylestradiol, norethisterone acetate (JUNEL). The patient previously took first dose of BNT62B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EN6203) on 05Mar2021 at 12:00 via an unspecified route of administration in left arm at single dose for covid-19 immunization. Prior to vaccination patient was diagnosed with Covid-19. Patient did not receive any other vaccines within 4 weeks prior to covid vaccine. Since the vaccination, the patient had not been tested for COVID-19. Reporter stated that patient texted her that, on 26Mar2021 at 09:30, after getting her second dose, she had metallic taste (tasted metal in her mouth) and smell. Patient did not receive any treatment for the adverse event. The outcome of event was recovering at the time of reporting.  No Follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dizziness, Nausea, Pyrexia
Clinical narrative: dizzy; nauseous; slight fever; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 22Mar2021 as single dose for COVID-19 immunization. Medical history, concomitant medications or past drug history were not reported. On 26Mar2021, patient woke up very dizzy, nauseous and had a slight fever. Patient asked that considering that it is 5 days after, should she be concerned that she contracted COVID-19 before getting vaccinated. Outcome of the events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Lip swelling, Swelling, Swelling face
Clinical narrative: my lip, face and neck is swelling up little; my lip, face and neck is swelling up little; my lip, face and neck is swelling up little; This is a spontaneous report received from a contactable consumer, the patient. This consumer reported similar event for 2 patients. This is the 1st of two reports. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported, Solution for injection), 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. On an unspecified date, patient got the first dose of the Pfizer vaccine and his lip, face and neck were swelled up little. He did not fell short of breath. He asked, what he can do for his second dose that comes next Tuesday, 31Mar2021. There were some other patients who reported some symptoms the same as this. He was afraid with the second dose that it will give him a stronger reaction. The outcome of events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021337093 Same reporter/ drug/ event for different patients
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Influenza like illness
Clinical narrative: Fatigue; Flu-like symtoms; This is a spontaneous report from a contactable consumer (patient, reported for self). A 39-year-old (non pregnant) female patient received second dose of BNT162B2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3247, Expiration date: Not reported), via an unspecified route of administration, administered in the left arm on 26Mar2021 15:00 (at 03:00 PM) (at the age of 39-years-old) as dose 2, single in left arm for COVID-19 immunization. Patient had no allergies to medications, food, or other products. The patient concomitant medications were not reported. The patient had earlier received first dose of BNT162B2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EL3247, Expiration date: Not reported), via an unspecified route of administration, administered in the left arm on 04Mar2021 (03:00 PM) as dose 1, single for COVID-19 Immunization. Prior to vaccination, patient was not diagnosed with COVID-19 prior to the COVID vaccine. No other medical history reported. Patient did not receive other vaccine within 4 weeks prior to the COVID vaccine. On 26Mar2021 at 07:00 AM patient experienced fatigue, and flu like symptoms. Adverse event did not result in Physician office visit or emergency visit. Patient had received treatment for the adverse events which included acetaminophen. Since the vaccination the patient has not been tested for COVID-19. The outcome of events was not recovered.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Nausea, Pain in extremity, Vomiting
Clinical narrative: don't feel well today; nauseous; vomiting; fatigue; sore arm; This is a spontaneous report from a contactable consumer.  A (Age: 65, Unit: Unknown) male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Lot number: unknown), dose 1 via an unspecified route of administration on 23Mar2021 (Tuesday) at 14:30 as 1st dose, single for COVID-19 immunization. No medical and concomitant medication history were reported. On 24Mar2021, the patient experienced a little bit of fatigue and a pretty sore arm. On 26Mar2021, the patient was feeling nauseous and vomiting. Caller stated that he was not really up to filing a report as he was not feeling well and he just wanted to know if this was normal and if it may be related to the vaccine. Caller stated that would be three days or 72 hours since he got the vaccine at 14:30. The outcome of the events were unknown.    No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: Fever; severe headache; body aches; exhaustion; This is a spontaneous report from a contactable Health care professional. A 50-years-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Right on 22Jan2021 11:45 (Batch/Lot Number: EL9261) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included (Since Childhood), Sessional envirmental Allergies, Casein Allergy from an unknown date and unknown if ongoing. Patient's historical vaccine included bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm left on 31Dec2021 (Batch/Lot Number: EL0142) as DOSE 1, SINGLE for covid-19 immunisation. Concomitant medication(s) included fexofenadine hydrochloride (ALLEGRA) 150 Mg orally Daily taken for hypersensitivity from an unspecified start date and ongoing; nifedipine 30 Mg orally Daily taken for hypertension from an unspecified start date and ongoing; montelukast sodium (SINGULAIR) 10 Mg orally Daily taken for asthma from an unspecified start date and ongoing; atorvastatin taken for blood cholesterol from Sep2019 and ongoing. The patient experienced fever, severe headache, body aches, exhaustion on 22Jan2021 21:00. The patient underwent lab tests and procedures which included body temperature: 103 degree F on 103 degree F. Therapeutic measures were taken as a result of fever, severe headache, body aches, exhaustion (Tylenol: 1000 mg orally (31Dec2021) and Ibuprofen). Hx of Vitiligo reaction after fw Vaccine 10 hrs ago, Vitiligo appearal where bondaid adheoine contacted skin. Bandaid first removed for approx. 24 hrs. Post vaccine vitiligo remained for 4 months then resolved. Outcome of event s was resolved on unspecified date in 2021. additional information has been requested  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: caller had a bad and painful headache; This is a spontaneous report from a contactable consumer (patient himself) and via Pfizer sponsored program. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 25Mar2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 26Mar2021, the patient experienced had a bad and painful headache. Patient had the first dose of the Pfizer COVID-19 vaccine last night, he had a bad and painful headache,woke up with a headache this morning. He wanted to know if he could take ibuprofen and what should he do for the headache.  He would like to know how to get rid of his headache. The outcome of the event was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation
Clinical narrative: A burning sensation as it went in/ got the second one and it burns; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE: solution for injection), via an unspecified route of administration on an unspecified date in 2021 (Batch/Lot number was not reported) as single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE: solution for injection), via an unspecified route of administration on about 3 and half weeks ago in 2021 (Batch/Lot number was not reported) as single for covid-19 immunization and patient was fine. Patient stated that she got the Pfizer COVID-19 vaccine a month ago. She said the first shot was fine but with the second one, she felt a burning sensation as it went in on an unspecified date in 2021. She wanted to know if the first and second dose of the vaccine are exactly the same and if not, what could have caused the burning sensation and she told her experience with each of the doses. Everything was set-up during her first dose appointment. During her second dose, the lady was running back and forth with the vaccine and it kind of struck her for being odd. She thinks something must've screwed up that's why she felt the burning sensation. Patient also stated she got the first Pfizer vaccine about 3 and half weeks ago, didn't feel the same, got the second one and it burns as it went in and she wanted to know what was the difference between the first and the second and what could have caused that. The outcome of the event was unknown.  No follow-up attempts are possible; Information about Lot/batch number cannot been obtained.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Lymphadenopathy, Vaccination site pain
Clinical narrative: swollen lymph node under his left arm; tenderness at the injection site/his arm was tender; felt like he got light-headed was going to pass out; This is a spontaneous report from a contactable consumer or other non-healthcare professional (Patient). A 50-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: GR2613, expiration date: not reported), via an unspecified route of administration, administered in arm left (left upper arm, around his shoulder area) on 24Mar2021 19:00 as dose 1, single for COVID-19 immunisation (reason for vaccination: at his age, he had elder parents and grandkids and he wanted to protect himself and protect others). The patient's medical history was none and concomitant medications were not reported. No history of all previous immunization with the Pfizer vaccine, no additional vaccines administered on same date of the Pfizer Suspect. No prior vaccinations within 4 weeks. No family medical history relevant to adverse events. On 25Mar2021 (yesterday) he felt fine, but he felt a tenderness around the injection site. The patient stated that he had tenderness at the injection site on 25Mar2021 (yesterday). On 26Mar2021 (this morning) his arm was tender, and he noticed a swollen lymph node under his left arm, in which the node was the reported as the size of a baseball. He had received the vaccine in the left arm. On 26Mar2021 (this morning) whenever he got out of the shower, he noticed his lymph node underneath his arm was swollen and tender. He started rubbing it and then he felt like he got light-headed was going to pass out (start: unspecified date in 2021). Tenderness around the injection site felt a lot better on 26Mar2021 (today) than it did yesterday, and it was just a little tender today. His lymph node was very tender, and it was not that bad, until he started rubbing on it, then it went down-hill after that. No physician office, no emergency room visit. He was asking if this was normal and if this was something that should go back down in 2 or 3 days and if he should get this looked at by a doctor and will the swollen lymph node go down. The outcome of tenderness at the injection site was recovering, light-headed was unknown, swollen lymph node under his left arm was not recovered. No follow-up attempts are possible. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Post procedural infection, Surgery
Clinical narrative: have got a little bit of infection on it.; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6202), via an unspecified route of administration on 08Mar2021 as dose 1, single (age at vaccination 75 year old) for covid-19 immunization. Medical history included chronic obstructive pulmonary disease (COPD), atrial fibrillation, emphysema from an unknown date (Emphysema and AFib. Yes, I have COPD or Emphysema and AFib with my heart, Atrial fibrillation). Concomitant medication included CEFALEXIN [CEFALEXIN SODIUM] 500mg twice daily, rivaroxaban (XARELTO) 50mg once daily, tiotropium bromide (SPIRIVA) 18ug, once daily, ciprofloxacin hydrochloride (CIPROWIN [CIPROFLOXACIN HYDROCHLORIDE]) 75 mgs 2 tablets a day. The patient have got a little bit of infection on it on an unspecified date. She was scheduled to receive the second dose of Pfizer BioNtech Covid 19 vaccine this Monday (confirmed as 29Mar2021) coming up and she reports that she had been on Cefalexin for a week now this entire week and her dose was going to be this Sunday and she was just calling to see if it was okay to get second dose of the vaccine but patient got her over here to report it the use of that medication. patient did not want to go if the antibiotic was going to interfere with the potency of the shot. The patient underwent lab tests and procedures which included minor surgery resulted to infection on an unknown date. Therapeutic measures were taken as a result of have got a little bit of infection on it which includes CEFALEXIN. The clinical outcome for the event was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Dyspnoea, Fatigue
Clinical narrative: arm soreness; joint pain; Malaise; 19 to 20 days post 1st vaccine fever; chills; extreme fatigue; shortness of breath; pain when taking a deep breath; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 66-years-old female patient received BNT162B2 (BNT162B2, solution for injection, Batch/Lot Number: EN6204; Expiration Date: 03Jun2021), via an unspecified route of administration, administered in Arm Left on 06Mar2021 12:00 (at the age of 66-year-old) as 1st dose, single for covid-19 immunisation. Medical history included chronic obstructive pulmonary disease, polymyalgia rheumatica. Patient is allergic to clindamycin, fortaz, sulfa. The patient's concomitant medications were not reported. Prior to vaccination, patient was not diagnosed with COVID-19. Patient was not tested positive since vaccination. Patient did not receive any other vaccines within four weeks prior to the vaccination. Other medications received in two weeks was reported as too many to list. On 25Mar2021 06:00, 19 to 20 days post 1st vaccine, the patient experienced fever, chills, extreme fatigue, shortness of breath, pain when taking a deep breath. On an unknown date patient experienced arm soreness, joint pain, malaise. Consumer stated that she was not sure if she was experiencing side effects from her vaccine or not which is why she didn't go to the website. she was wondering if you are seeing any cases of 3 weeks out 24 hours of fever, malaise, fatigue. she was supposed to get her second one tomorrow and she was feeling better now, but yesterday she was running a 100 temperature, she had joint pain and it just knocked out, it was about 24 hours and now its over. When confirmed that the consumer wanted to know about the side effects from the COVID 19 Vaccine, consumer stated that Yeah, have you heard about that. When confirmed if the consumer had any side effects from the first shot, consumer stated that she was not sure if this is or not, all she had was some arm soreness and fatigue directly from the first vaccination. This is almost 3 weeks and she had this almost 24 hour thing just out of nowhere. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 26Mar2021, fever: 100 on 25Mar2021. Therapeutic measures were taken as a result of events included antibiotics and steroids. The outcome of the events were recovered on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pain in extremity, Painful respiration, Pyrexia, SARS-CoV-2 test
Clinical narrative: arm soreness; joint pain; Malaise; 19 to 20 days post 1st vaccine fever; chills; extreme fatigue; shortness of breath; pain when taking a deep breath; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 66-years-old female patient received BNT162B2 (BNT162B2, solution for injection, Batch/Lot Number: EN6204; Expiration Date: 03Jun2021), via an unspecified route of administration, administered in Arm Left on 06Mar2021 12:00 (at the age of 66-year-old) as 1st dose, single for covid-19 immunisation. Medical history included chronic obstructive pulmonary disease, polymyalgia rheumatica. Patient is allergic to clindamycin, fortaz, sulfa. The patient's concomitant medications were not reported. Prior to vaccination, patient was not diagnosed with COVID-19. Patient was not tested positive since vaccination. Patient did not receive any other vaccines within four weeks prior to the vaccination. Other medications received in two weeks was reported as too many to list. On 25Mar2021 06:00, 19 to 20 days post 1st vaccine, the patient experienced fever, chills, extreme fatigue, shortness of breath, pain when taking a deep breath. On an unknown date patient experienced arm soreness, joint pain, malaise. Consumer stated that she was not sure if she was experiencing side effects from her vaccine or not which is why she didn't go to the website. she was wondering if you are seeing any cases of 3 weeks out 24 hours of fever, malaise, fatigue. she was supposed to get her second one tomorrow and she was feeling better now, but yesterday she was running a 100 temperature, she had joint pain and it just knocked out, it was about 24 hours and now its over. When confirmed that the consumer wanted to know about the side effects from the COVID 19 Vaccine, consumer stated that Yeah, have you heard about that. When confirmed if the consumer had any side effects from the first shot, consumer stated that she was not sure if this is or not, all she had was some arm soreness and fatigue directly from the first vaccination. This is almost 3 weeks and she had this almost 24 hour thing just out of nowhere. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 26Mar2021, fever: 100 on 25Mar2021. Therapeutic measures were taken as a result of events included antibiotics and steroids. The outcome of the events were recovered on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Head discomfort, Hyperhidrosis
Clinical narrative: Fever 104 solid; extreme exhaustion / body fatigue; Chills/sweats; Point of injection is sore with some bruising; armpit muscle extremly sore; Point of injection is sore with some bruising; Fever 104 solid with constant intense ringing in the head; Chills/sweats; This is a spontaneous report received from contactable consumer (patient).  A 47-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EK5730), via an unspecified route of administration, administered in Arm Left on 23Mar2021 at 03:45 PM (at the age of 47-year-old) as single dose for covid-19 immunisation at clinic. Medical history included allergy to sulfa drug from an unknown date and unknown if ongoing and other medical history reported as none. The patient's concomitant medications were not reported. Patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EJ1685), via an unspecified route of administration, administered in Arm Left on 04Mar2021 at 01:15PM as single dose for covid-19 immunisation at clinic. Prior to vaccination, patient was not diagnosed with covid-19. Since the vaccination, patient was not tested for covid-19. Patient did not receive any other vaccine four weeks prior of vaccination and any other medication two weeks of vaccination. On 23Mar2021 at 09:00 PM, the patient experienced fever 104 solid with constant intense ringing in the head, chills/sweats, extreme exhaustion/body fatigue, point of injection is sore with some bruising and armpit muscle extremely sore. Patient visited to healthcare professional office/clinic for the events. No therapeutic measures were taken because of the events. The outcome of the events was reported as recovering.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia, Vaccination site bruising, Vaccination site pain
Clinical narrative: Fever 104 solid; extreme exhaustion / body fatigue; Chills/sweats; Point of injection is sore with some bruising; armpit muscle extremly sore; Point of injection is sore with some bruising; Fever 104 solid with constant intense ringing in the head; Chills/sweats; This is a spontaneous report received from contactable consumer (patient).  A 47-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EK5730), via an unspecified route of administration, administered in Arm Left on 23Mar2021 at 03:45 PM (at the age of 47-year-old) as single dose for covid-19 immunisation at clinic. Medical history included allergy to sulfa drug from an unknown date and unknown if ongoing and other medical history reported as none. The patient's concomitant medications were not reported. Patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EJ1685), via an unspecified route of administration, administered in Arm Left on 04Mar2021 at 01:15PM as single dose for covid-19 immunisation at clinic. Prior to vaccination, patient was not diagnosed with covid-19. Since the vaccination, patient was not tested for covid-19. Patient did not receive any other vaccine four weeks prior of vaccination and any other medication two weeks of vaccination. On 23Mar2021 at 09:00 PM, the patient experienced fever 104 solid with constant intense ringing in the head, chills/sweats, extreme exhaustion/body fatigue, point of injection is sore with some bruising and armpit muscle extremely sore. Patient visited to healthcare professional office/clinic for the events. No therapeutic measures were taken because of the events. The outcome of the events was reported as recovering.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Contusion, Fatigue, Headache
Clinical narrative: felt very tired with first dose; headache with first dose; bruised sore in the musculature; bruised sore in the musculature; musculature from the shoulder to almost elbow was very sore; nausea/a little bit of nausea with the first dose; low level fever up to 100/low grade fever after first dose; sore/achy; arm extremely sore after first dose; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 69-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6198), via an unspecified route of administration, administered in Arm Left on 24Feb2021 around 3-4 PM (at the time of vaccination 69-years-old), as a DOSE 1, SINGLE for COVID-19 immunization. The patient's medical history included Allergies, and physical injury that happened 3 years ago. The patient's concomitant medications were not reported. Historical vaccine included Flu Shot on an unspecified date in Oct 2020 and patient previously took tetracycline and she experienced allergy to tetracyclin (hasn't taken in 25 years). On 24Feb2021, the patient experienced sore/achy and arm extremely sore after first dose, on 25Feb2021 low level fever up to 100/low grade fever after first dose, on 26Feb2021 nausea/a little bit of nausea with the first dose, on an unspecified date felt very tired with first dose, headache with first dose, bruised sore in the musculature, and musculature from the shoulder to almost elbow was very sore. Patient states she took Tylenol and aspirin for low level fever up to 100/low grade fever after first dose. The seriousness of the events was reported as non serious. The outcome of an events sore/achy, arm extremely sore after first dose resolved on 10Mar2021, low level fever up to 100/low grade fever after first dose resolved on 04Mar2021, nausea/a little bit of nausea with the first dose resolved on 01Mar2021 and other events was reported as unknown.   No follow-up attempts are needed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pain, Pain in extremity, Pyrexia
Clinical narrative: felt very tired with first dose; headache with first dose; bruised sore in the musculature; bruised sore in the musculature; musculature from the shoulder to almost elbow was very sore; nausea/a little bit of nausea with the first dose; low level fever up to 100/low grade fever after first dose; sore/achy; arm extremely sore after first dose; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 69-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6198), via an unspecified route of administration, administered in Arm Left on 24Feb2021 around 3-4 PM (at the time of vaccination 69-years-old), as a DOSE 1, SINGLE for COVID-19 immunization. The patient's medical history included Allergies, and physical injury that happened 3 years ago. The patient's concomitant medications were not reported. Historical vaccine included Flu Shot on an unspecified date in Oct 2020 and patient previously took tetracycline and she experienced allergy to tetracyclin (hasn't taken in 25 years). On 24Feb2021, the patient experienced sore/achy and arm extremely sore after first dose, on 25Feb2021 low level fever up to 100/low grade fever after first dose, on 26Feb2021 nausea/a little bit of nausea with the first dose, on an unspecified date felt very tired with first dose, headache with first dose, bruised sore in the musculature, and musculature from the shoulder to almost elbow was very sore. Patient states she took Tylenol and aspirin for low level fever up to 100/low grade fever after first dose. The seriousness of the events was reported as non serious. The outcome of an events sore/achy, arm extremely sore after first dose resolved on 10Mar2021, low level fever up to 100/low grade fever after first dose resolved on 04Mar2021, nausea/a little bit of nausea with the first dose resolved on 01Mar2021 and other events was reported as unknown.   No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling
Clinical narrative: Lower lip swelling; This is spontaneous report received from a contactable consumer (patient). A 53-year-old female patient received BNT126B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown), administered in right arm on 19Mar2021 01:15 PM as dose 1, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Age at vaccination was 53-year-old (reported as 53).The patient's medical history was not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient's concomitant medications received within two weeks of vaccination included gabapentin, sertraline and levothyroxine, all from unspecified date. The patient previously took sulfamethoxazole/trimethoprim (BACTRIM), from unspecified date and it was reported as known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 25Mar2021 the patient experienced lower lip swelling. No treatment was received for the event. The patient has not been tested for COVID-19 since the vaccination. The outcome of the event was not resolved.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Hyperhidrosis, Insomnia, Lethargy
Clinical narrative: Fever; Chills; Body Aches; Sweating; Fatigue; Insomnia; Sensation of pounding heart (could feel heart beat); Lethargy; This is a spontaneous report from a contactable consumer (patient). A 34-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection Lot Number: ER8727) via an unspecified route, administered in Left Arm on 23Mar2021 at 10:15 AM (34-year-old at vaccination) as single dose for covid-19 immunization. The patient's medical history included heart murmur and occasional anemia. Allergies to medications, food, or other products was reported as none. The patient's concomitant medications were reported as none within 2 weeks of vaccination. Prior to vaccination, the patient was diagnosed with COVID-19. Facility where the most recent COVID-19 vaccine was administered was reported as Pharmacy or Drug Store. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. On 23Mar2021 at 22:30, the patient experienced fever, chills, body aches, sweating, fatigue, insomnia, sensation of pounding heart (could feel heartbeat), lethargy. The events began 12hrs after 1st dose, and latest for 3 days, but still battling fatigue even after mild activity. Since the vaccination, has the patient was not been tested for COVID-19. No treatment received for resulted adverse events. The outcome of the event fatigue was not recovered, and the outcome of other events was resolving.  Follow-up activities closed. No Further information is expected.