chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Tremor
Clinical narrative: Joint pain; hurting under her arm; swelling in the lymph nodes; top part of the arm was swollen; problems in breathing; problems with breathing; heart was beating very fast; fast heart rate; chest pain; legs were just trembling; legs trembling; Dizzy; chest was a little tight; Arm was really hurting; This is a spontaneous report from a contactable nurse (patient). A 64-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 02Mar2021 (Lot Number: EN6206) (at the age of 64 years old) as dose 1, single for COVID-19 immunisation. The patient's medical history included hysterectomy on an unspecified date and limitations on the left arm (several tests and MRI conducted; patient went to physical therapy). The patient had a test before and everything shows well. The patient did not have diabetes and was not overweight. Concomitant medications included estradiol (0.1 mg patch) for estrogen (as reported). The patient previously received a flu shot and vaccine for hepatitis B for unspecified indications. On unspecified dates in Mar2021, the patient experienced a little bit of joint pain. An hour after the vaccination, she experienced hurting under her arm and also had swelling in the lymph nodes. The top part of the arm was swollen for like two days. Within an hour and a half to get home, the patient started having problems in breathing and claimed that her heart was beating very fast and felt like chest pain. The patient laid on the couch, and when she stood up, her legs were just trembling and even a slight walk to the bathroom was scary for the patient because and claims that her legs almost felt like she did not have control and they were just trembling for no reason. The patient felt dizzy and was afraid to go to sleep. The patient experienced problems with breathing, fast heart rate, and legs trembling for about 3 days. The next morning, her heart was not racing but still had some problem with breathing. She added that her chest was a little tight. She also added that her arm was really hurting when she was working and could not even take her clothes off when she got home. The patient has seen her doctor for a lab test. The patient was upset and was afraid of getting the second dose. The patient recovered from "top part of the arm was swollen", legs trembling, and fast heart rate on unspecified dates in 2021 while the outcome of the other events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site haemorrhage
Clinical narrative: Bleeding through the band aid; Started bleeding in the area where she stuck it in; This is a spontaneous report from a contactable consumer (patient).   A patient of unspecified age and gender received BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 01Apr2021 as dose number unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 01Apr2021, the patient experienced bleeding through the band aid/started bleeding in the area where she stuck it in (as reported). The outcome of the events was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Ocular discomfort, Pulmonary pain, Rhinorrhoea, Wheezing
Clinical narrative: I had really bad allergies in that I had runny eyes, runny nose, wheezing; I had really bad allergies in that I had runny eyes, runny nose, wheezing; I had really bad allergies in that I had runny eyes, runny nose, wheezing; lungs just hurt, I feel a little out of breath; lungs just hurt, I feel a little out of breath; This is a spontaneous report from a contactable consumer or other non hcp the patient reported.  A 23-years-old non pregnant female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 06Apr2021 13:30 as dose 1, single for covid-19 immunisation. The patient medical history included asthma from an unknown date and unknown if ongoing and no known allergies. Concomitant medication(s) included spironolactone (SPIRONOLACTONE) and birth control taken for an unspecified indication, start and stop date were not reported. The patient was not received the treatment. The patient did not have covid prior vaccination and was not tested for covid post vaccination. She reported that on 06Apr2021 at 19:00 she had really bad allergies in that I had runny eyes, runny nose, wheezing but thought it was because of her cats as she did not have a reaction to them before. Her lungs just hurt, she felt a little out of breath and when she laughs or breath out her lungs hurt and feel sore. The outcome for the events was not recovered.  No follow-up attempts are needed. information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Headache, Nausea, Pain
Clinical narrative: Pain at injection site; Headache; Severe nausea; Diarrhea; Fatigue; Body aches; This is a spontaneous report from a non-contactable consumer, the patient. An unknown gender patient of unknown age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the right arm on an unknown date as a single dose for COVID-19 immunisation. Medical history included asthma and celiac disease. The patient had known allergies to latex, gluten (celiac) and sulfas. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included naproxen (MANUFACTURER UNKNOWN), esomeprazole sodium (NEXIUM), cetirizine hydrochloride (ZYRTEC), ondansetron (ZOFRAN), montelukast sodium (SINGULAIR) and formoterol fumarate, mometasone furoate (DULERA); all taken for unknown indications from an unknown date and unknown if ongoing. The patient previously took oseltamivir phosphate (TAMIFLU), pseudoephedrine hydrochloride (SUDAFED) and metoclopramide (REGLAN); all for unknown indications and experienced drug allergy. On an unknown date the patient experienced pain at injection site, headache, severe nausea, diarrhea, fatigue and body aches. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events pain at injection site, headache, severe nausea, diarrhea, fatigue and body aches were resolved on an unknown date.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain at injection site; Headache; Severe nausea; Diarrhea; Fatigue; Body aches; This is a spontaneous report from a non-contactable consumer, the patient. An unknown gender patient of unknown age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the right arm on an unknown date as a single dose for COVID-19 immunisation. Medical history included asthma and celiac disease. The patient had known allergies to latex, gluten (celiac) and sulfas. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included naproxen (MANUFACTURER UNKNOWN), esomeprazole sodium (NEXIUM), cetirizine hydrochloride (ZYRTEC), ondansetron (ZOFRAN), montelukast sodium (SINGULAIR) and formoterol fumarate, mometasone furoate (DULERA); all taken for unknown indications from an unknown date and unknown if ongoing. The patient previously took oseltamivir phosphate (TAMIFLU), pseudoephedrine hydrochloride (SUDAFED) and metoclopramide (REGLAN); all for unknown indications and experienced drug allergy. On an unknown date the patient experienced pain at injection site, headache, severe nausea, diarrhea, fatigue and body aches. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events pain at injection site, headache, severe nausea, diarrhea, fatigue and body aches were resolved on an unknown date.  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Lethargy, Malaise, Pain, Pyrexia
Clinical narrative: Very ill today; she don't feel good; Severe body aches; Lethargic; had a low grade temperature of a 100; This is a spontaneous report from a contactable nurse (parent). A 42-year-old female patient (reporter's daughter) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered on the arm (reported as upper arm) on 31Mar2021 (Batch/Lot number was not reported) (at the age of 42 years old) as dose 1, single for COVID-19 immunisation. The patient's medical history included COVID. The patient was taking an unspecified thyroid medicine. On 01Apr2021, the patient was "very ill today/she don't feel good" and experienced severe body aches, was lethargic, and had a low grade temperature of a 100. The reporter described the symptoms were the same when the patient had COVID. The patient took 2 ibuprofen (ADVIL) as a treatment for the events. The reporter stated that the patient was still experiencing the events and were getting worse. The outcome of the events was not recovered.  The causality assessment for BNT162B2 and the events severe body aches and lethargic was reported as related.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: I got a wide spread rash on my arms and my legs; This is a spontaneous report from a contactable consumer (patient). A 58-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCNE, solution for injection), via an unspecified route of administration on 26Mar2021 (Batch/Lot number was not reported) (at the age of 58 years old) as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced got a wide spread rash on his arms and his legs on 31Mar2021. The outcome of event was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site haemorrhage
Clinical narrative: Bleeding at site when needle was removed; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 45-year-old female patient received bnt162b2 (BNT162B2,Solution for injection,Batch/Lot Number: ER8729,Expiry date was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 08Apr2021 12:15 (Age at vaccination-45 yrs) as DOSE 1, SINGLE for covid-19 immunisation. Patient was not pregnant at the time of vaccination. Patient had no known allergies. Medical history included hypothyroidism, iron deficiency anaemia from an unknown date and unknown if ongoing. Concomitant medication(s) included levothyroxine,ascorbic acid (VIT C),colecalciferol (VIT D [COLECALCIFEROL]),cyanocobalamin (B12 [CYANOCOBALAMIN]), iron, were taken for an unspecified indication, start and stop date were not reported. The patient had not received any other vaccine within 4 weeks. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. On 08Apr2021 12:15 the patient experienced bleeding at site when needle was removed. Therapeutic measures were taken where given Pressure to stop bleeding as a result of bleeding at site when needle was removed was stopped. The clinical outcome of the event was recovered on an unknown date in 2021.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Cough, Headache, Malaise, Musculoskeletal chest pain
Clinical narrative: Headache; Chills; Really bad cough and when I cough my ribs hurt; Really bad cough and when I cough my ribs hurt; Feel lousy; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number: ER8730, Expiration Date: not reported) via an unspecified route of administration on 28Mar2021 as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient woke up with headache and chills. The patient had been having the side effects all week (as reported) and the patient had chills real bad which lasted all night but went away. On an unspecified date, the patient had this really bad cough and his/her ribs hurt when the patient coughs. The patient didn't know if that was from the side effects of the vaccine. On an unspecified date, the patient started feeling a little bit better but the cough was really hurting his/her ribs and the patient was also feel lousy. However, the patient's son that doesn't live with him/her and had his son (patient's grandson) at his/her house on the weekend. But when the patient had tried to drop him off they told the patient that they were exposed to Covid and the patient's son and his wife tested positive (as reported). The patient did not know what to do and was asking if he/she should get the test done. The patient is scheduled for the second shot on 19Apr2021. The patient recovered from chills on an unspecified date, an outcome of unknown for headache and an outcome of not recovered for the rest of the events.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Arthralgia, Chest pain, Headache, Vomiting
Clinical narrative: chest pain; abdominal pain; joint pain; headache; throwing up; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/lot number and expiration date were not reported), via an unspecified route of administration on 04Mar2021 as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was previously vaccinated with the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on 01Feb2021 for COVID-19 immunisation. The patient experienced chest pain, abdominal pain, joint pain, headache and throwing up on an unspecified date after getting the second dose of the Covid19 vaccine. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Hypersensitivity
Clinical narrative: This is a spontaneous report from a contactable female consumer. A female patient, of unspecified age, received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# and expiry date not reported), via an unspecified route of administration, on Mar 13, 2021, single dose, for COVID-19 immunization. The patient's medical history and concomitant medications not reported. After the vaccination, patient experienced reactions in the neck and face; and difficulty in swallowing on an unspecified date. The 2nd dose scheduled on Apr 2, 2021 (not administered yet). She was wondering if she could proceed in getting the 2nd dose today. The outcome of the events unknown. Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Decreased appetite, Fatigue, Pyrexia
Clinical narrative: No appetite; chills; joint aches; fatigue; possible fever; This is a spontaneous report from a non-contactable consumer. An adult female patient of unknown age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Medical history included COVID-19 on unknown date. Concomitant medications were not reported. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date, the patient experienced no appetite. On an unknown date the patient experienced no appetite, chills, joint aches, fatigue and possible fever. The clinical outcome of the events no appetite, chills, joint aches, fatigue and possible fever was recovered at this time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: added patient country and Vaccination Facility Country.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: No appetite; chills; joint aches; fatigue; possible fever; This is a spontaneous report from a non-contactable consumer. An adult female patient of unknown age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. Medical history included COVID-19 on unknown date. Concomitant medications were not reported. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date, the patient experienced no appetite. On an unknown date the patient experienced no appetite, chills, joint aches, fatigue and possible fever. The clinical outcome of the events no appetite, chills, joint aches, fatigue and possible fever was recovered at this time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported information: added patient country and Vaccination Facility Country.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dry throat, Ear pain, Hypersensitivity, Lymphadenopathy, Productive cough
Clinical narrative: Told had some allergic type reaction; dry voice; productive cough; swollen Lymph nodes; ear pain; This is a spontaneous report from a non-contactable consumer reported for a female patient. A non-pregnant elderly female patient of unspecified age received unknown dose of bnt162b2 (Pfizer covid-19 vaccine, solution for injection, Lot number: not reported), via an unspecified route on an unspecified date as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient allergies were not known. It was unknown if patient received any other vaccines within 4 weeks prior to the COVID vaccine. Patient received unknown medications in two weeks. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, it was unknown if patient has been tested for COVID-19. On an unknown date, patient had some allergic type of reaction within 48hrs of shot. She went to emergency room, given antihistamines. Medical professionals felt related to blood pressure medication. However, now 2 weeks removed she informed my mom, who tells me she still has dry voice, productive cough, swollen Lymph nodes and ear pain. Scheduled to test for an allergen. Adverse event resulted in doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The clinical outcome of the events was patient with lasting effects.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Nausea
Clinical narrative: Lightheaded/dizziness 3 days; Causing nauseous-ness; Headache behind eyes; Very tired; This is a spontaneous report from a non-contactable consumer, the patient. A 65-year-old (estimated age) non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the left arm on 01Apr2021 at 08:30 (at the age of 65-years-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy and sulfa allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 01Apr2021 at 13:30, the patient experienced lightheaded/dizziness for 3 days, nauseousness for 1st day, headache behind eyes and the patient was very tired. These symptoms lasted for more than 3 days and in 3rd day became much less. 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 headache behind eyes, nauseousness for 1st day and the patient was very tired, was recovered on an unknown date in Apr2021 and lightheaded/dizziness for 3 days was recovered on 04Apr2021.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Mild arm pain at injection site; This is a spontaneous report from a non-contactable pharmacist, the patient. An Adult non-pregnant female patient of unknown age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration on 02Apr2021 as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient did not receive any other medications within two weeks of vaccination. On 02Apr2021, the patient experienced mild arm pain at injection site. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19.  The clinical outcome of the event mild arm pain at injection site was resolved in April2021.  No follow-up attempts are possible. No further information is expected.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Presyncope
Clinical narrative: Vasovagal without syncope; This is a spontaneous report from a non-contactable consumer, the patient. A 32-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 07Apr2021 at 10:45 (at the age of 32-year-old) as a single dose for COVID-19 immunisation. Medical history included hypertension. Concomitant medications included lisinopril (MANUFACTURER UNKNOWN) and hydrochlorothiazide (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 07Apr2021 at 10:45, the patient experienced vasovagal without syncope. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events which included treatment with just water and ice packs on an unknown date. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event vasovagal without syncope 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: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain
Clinical narrative: This is a spontaneous report from a noncontactable nurse (patient). A 46-year-old (non-pregnant) female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, batch/lot: unknown), at the age of 46, via an unspecified route of administration, on an unknown date in 2021, single dose, for COVID-19 immunisation. No medical history reported. Prior to the vaccination, patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. The patient received unspecified medication within two weeks of vaccination. The patient previously received Tamiflu (oseltamivir phosphate) for unknown indication on an unknown date and experienced drug allergy. On Apr 7, 2021, patient experienced headache, body ache and extreme tiredness. Since the vaccination, patient has not been tested for COVID-19. Therapeutic measures taken as a result of reported events included treatment with Tylenol (paracetamol). The outcome of headache, body ache and extreme tiredness: not recovered at the time of this report. No follow-up attempts possible. Information about lot/batch number cannot be obtained. No further information expected.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia, Wound complication, Wound haemorrhage
Clinical narrative: my wound was bleeding and was in moderate to severe pain for the first time; Sore arm; tingling in the hand in the same arm after letting go of the steering wheel; I began to have pain in that wound for the first time; This is a spontaneous report from a contactable consumer (patient). A 19-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration, administered in arm left on 07Apr2021 at 15:00 as dose 1, single for COVID-19 immunization (at the age of 19-year-old) at Pharmacy or Drug Store. Medical history included ADHD, bipolar, anxiety disorder and neoplasm removal on foot of the pain (patient had a mole shaved off a one week ago from the vaccination on his foot) all from an unspecified date and unknown if was ongoing. Concomitant medications included lisdexamfetamine mesilate (VYVANSE), bupropion hydrochloride (WELLBUTRIN), isotretinoin (ACCUTANE), propranolol and lamotrigine (LAMICTAL) all from were taken from an unspecified indication from an unknown date and unknown if was ongoing. No other vaccine in four weeks. The patient did not had COVID prior vaccination and not tested for COVID post vaccination. On 07Apr2021 at 15:00, the patient experienced sore arm, tingling in the hand in the same arm after letting go of the steering wheel. He had a mole shaved off a one week ago from the vaccination on his foot. No bleeding or pain at first while applying Aquaphor and band-aid twice a day. The day of the vaccination 7 days after in the morning, he began to have pain in that wound for the first time. After he got the vaccine the pain in the foot was not as bad. When he woke up the next day, his wound was bleeding and was in moderate to severe pain for the first time. The patient did not received any treatment for adverse events. On an unspecified date in Apr2021, the patient recovered from all the events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Aphonia, Chills, Cough, Headache, Oropharyngeal pain
Clinical narrative: Lost his voice completely; he had some chills; He is coughing so bad/ Patient had "dry cough/ coughing has worsened; has a sore throat; headache; This is a spontaneous report from a contactable consumer. This female consumer reported for her husband (patient). A 58-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ET7534, NDC number and expiry date were reported as unknown) via unspecified route of administration on 06Apr2021 at 10:00 (at the age of 58-years-old) in left arm as dose 2, single for covid-19 immunisation in campus. Medical history included diabetes mellitus (diagnosed probably 20 years ago or more). Additional vaccines administered on same date of the Pfizer suspect and prior vaccinations (within 4 weeks) were reported as none. No adverse event following prior vaccinations. The patient's concomitant medications were not reported. The patient's historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EP7534; Expiry date: 31Jul2021) via intramuscular in left arm on 16Mar2021 for covid-19 immunisation. It was reported that the patient received the second dose on 06Apr2021. The first day on 06Apr2021, he was okay, he had some chills, but that was okay. The second day on 07Apr2021, he began to lose his voice, he had lost his voice completely. He was coughing so bad, had sore throat and dry cough. The reporter had been for the past 2 days, and she couldn't find any side effects like that, especially because he lost his voice. Coughing was worsened and sore throat had stayed about the same, he had complained about the coughing more. The adverse events did not require visit to emergency room or physician office. The reporter was planning to take the patient either to the doctor or the ER after she finishes talking to Pfizer. Relevant tests were reported as none. The patient was treated with Tylenol for chills and headache. The reporter wanted to know if the events were possible side effects of the vaccine. The clinical outcome of the events chills and headache was unknown and for all other events was not resolved.  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Headache, Lip blister, Lymphadenopathy, Nausea
Clinical narrative: Lump on my left arm where my shot was given; it is hurting very bad and it got bigger; Lump on my left arm where my shot was given; it is hurting very bad and it got bigger; Nausea; Dizziness; Fever blisters around lips; Fever blisters around lips; Lymph node was inflamed; headaches; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date: Unknown), via an unspecified route of administration, administered in left arm on an unspecified date in 2021 as dose 1, single for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified dates in 2021, within one week of the vaccination, the patient experienced lump on left arm where shot was given; it was hurting very bad and it got bigger, and also experienced nausea, dizziness, fever blisters around lips, lymph node was inflamed and headaches. Patient didn't get any side effects other than nausea, dizziness and headaches for the first two days. But after a week, precise to a week the following Monday (unspecified date in 2021), patient experienced some sort of fever blisters around my lips and then following day, patient noticed, patient don't know when it started, underneath patient armpits where the shot was given. It's been almost two weeks and it has got a larger and larger and it hurts. Patient went through the center care yesterday (unspecified date) and they said there is a lymph node that was inflamed and also they gave some medication (for unspecified reason on unspecified date). That's just not the one, they said that's the largest one. Also, the ones on patients neck from left side, also got inflamed. Patient got the first shot vaccine around almost 3 weeks, tomorrow (at the time of report) would be 3 weeks ago, tomorrow patient was going for second shot. Patient don't know why it was a delayed reaction, patient don't know it has been persisting since the first week. Patient job was asking questions because they can't find a proof of side effects occurring after a week. Is it normal to have side effects after week. Patient believe events are related to the COVID vaccine. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site mass, Vaccination site pain
Clinical narrative: Lump on my left arm where my shot was given; it is hurting very bad and it got bigger; Lump on my left arm where my shot was given; it is hurting very bad and it got bigger; Nausea; Dizziness; Fever blisters around lips; Fever blisters around lips; Lymph node was inflamed; headaches; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date: Unknown), via an unspecified route of administration, administered in left arm on an unspecified date in 2021 as dose 1, single for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified dates in 2021, within one week of the vaccination, the patient experienced lump on left arm where shot was given; it was hurting very bad and it got bigger, and also experienced nausea, dizziness, fever blisters around lips, lymph node was inflamed and headaches. Patient didn't get any side effects other than nausea, dizziness and headaches for the first two days. But after a week, precise to a week the following Monday (unspecified date in 2021), patient experienced some sort of fever blisters around my lips and then following day, patient noticed, patient don't know when it started, underneath patient armpits where the shot was given. It's been almost two weeks and it has got a larger and larger and it hurts. Patient went through the center care yesterday (unspecified date) and they said there is a lymph node that was inflamed and also they gave some medication (for unspecified reason on unspecified date). That's just not the one, they said that's the largest one. Also, the ones on patients neck from left side, also got inflamed. Patient got the first shot vaccine around almost 3 weeks, tomorrow (at the time of report) would be 3 weeks ago, tomorrow patient was going for second shot. Patient don't know why it was a delayed reaction, patient don't know it has been persisting since the first week. Patient job was asking questions because they can't find a proof of side effects occurring after a week. Is it normal to have side effects after week. Patient believe events are related to the COVID vaccine. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Ear pain, Glossodynia, Miliaria, Oropharyngeal pain
Clinical narrative: throat was kind of sore; little light headedness; feeling pain in arm; tongue was sore; feeling a heat of rash where I had a surgery in the abdominal area; Ear ache; rash on my groin area; This is a spontaneous report from a contactable consumer (patient).  A 62-year-old male patient received BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6208) via an unspecified route of administration, administered in arm right on 29Mar2021 (at the age of 62 years old) as dose 1, single for COVID-19 immunisation. Medical history included hypertension, diabetes mellitus, and surgery in the abdominal area. Concomitant medications included glipizide taken for diabetes mellitus. On an unspecified date, the patient experienced throat was kind of sore, little light headedness, feeling pain in arm, tongue was sore, feeling a heat of rash where patient had a surgery in the abdominal area, earache, and rash on groin area. Treatment (cream) was received for the event rash. The outcome of the events was unknown.  No follow up attempts are possible. No further information is expected.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Rash
Clinical narrative: throat was kind of sore; little light headedness; feeling pain in arm; tongue was sore; feeling a heat of rash where I had a surgery in the abdominal area; Ear ache; rash on my groin area; This is a spontaneous report from a contactable consumer (patient).  A 62-year-old male patient received BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6208) via an unspecified route of administration, administered in arm right on 29Mar2021 (at the age of 62 years old) as dose 1, single for COVID-19 immunisation. Medical history included hypertension, diabetes mellitus, and surgery in the abdominal area. Concomitant medications included glipizide taken for diabetes mellitus. On an unspecified date, the patient experienced throat was kind of sore, little light headedness, feeling pain in arm, tongue was sore, feeling a heat of rash where patient had a surgery in the abdominal area, earache, and rash on groin area. Treatment (cream) was received for the event rash. The outcome of the events was unknown.  No follow up attempts are possible. No further information is expected.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, SARS-CoV-2 test
Clinical narrative: Swollen lymph nodes, severe lymphadenopathy; This is a spontaneous report from a contactable consumer, the patient. A 16-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 05Apr2021 at 10:00 (at the age of 16-year-old) as a single dose for COVID-19 immunisation. Medical history included attention deficit disorder and shellfish allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included amfetamine (AMPHETAMINE) for attention deficit disorder (ADD) from an unknown date and unknown if ongoing. Concomitant medications also included sertraline hydrochloride (ZOLOFT) and lamotrigine (MANUFACTURER UNKNOWN) both for an unknown indication from an unknown date and unknown if ongoing. On 05Apr2021 at 12:00, the patient experienced swollen lymph nodes, severe lymphadenopathy. The event resulted in doctor or other healthcare professional office or clinic visit. Therapeutic measures were taken as a result of the adverse event and included treatment with steroids and MOTRIN started from an unknown date. Since the vaccination, the patient had been tested for COVID-19. On 06Apr2021, the patient underwent nasal swab test for SARS-CoV-2 and the result was negative. The clinical outcome of the event swollen lymph nodes, severe lymphadenopathy was recovering at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain, Somnolence
Clinical narrative: Very tired; Body aches; Cannot stay awake; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 09Apr2021 at 10:00 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. Medical history included slight hypertension. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications included paracetamol (TYLENOL), lisinopril (MANUFACTURER UNKNOWN), gabapentin (MANUFACTURER UNKNOWN), vitamin D NOS (MANUFACTURER UNKNOWN) and lisdexamfetamine mesilate (VYVANSE); all for an unspecified indication from unknown date and unknown if ongoing. The patient previously received morphine (MANUFACTURER UNKNOWN) and azithromycin (ZITHROMAX) and experienced drug allergy. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 19Mar2021 at 17:00 (at the age of 45-years-old) as a single dose for COVID-19 immunisation. On 09Apr2021 at 10:15, the patient experienced very tiredness, body aches and cannot stay awake. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events tiredness, body aches and cannot stay awake were not resolved at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Erythema, Feeling hot, Joint swelling, Pruritus
Clinical narrative: itching; just legs from the top of leg down to feet; knee has started puffing; knees started hurting and very red; knee has started puffing; knees started hurting and very red; it got really hot and then both of legs got very hot; knee got very big and puffed out; This is a spontaneous report from a contactable consumer (patient). An 84-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number:EP6955, Expiration Date was not reported), via an unspecified route of administration on 01Apr2021 10:00 (at the age of 84-year-old), as dose 2, single for COVID-19 immunisation. Medical history included knee that has got replaced 12-14 years ago. The patient's concomitant medications were not reported. Patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number, Expiration Date was not reported), via an unspecified route of administration on an unspecified date, as dose 1, single for COVID-19 immunization and experienced no adverse events (reported as everything was perfect). After the second dose, the patient experienced knee got very big and puffed out on 01Apr2021, itching; just legs from the top of my leg down to feet, knee has started puffing; knees started hurting and very red, it got really hot and then both of legs got very hot on an unspecified date. It was reported that patient have a knee that got replaced 12-14 years ago. So, she never had a problem with it. She had noticed that it got very big and puffed out and was also worried about the size of them . Within half hour, both of knees started itching, just the legs from the top of leg down to feet and it was so severe that at that time, patient just did not know what to do with herself. She then tried and put some stuff on it and rubbed on her legs. She did not know what to do. It was so severe. It finally calmed down after about half an hour and She went to bed. She woke up this morning and was fine and thought no more about it. She had never ever had anything like that, there were no itches on her hands, arms, face, body itself, just on her legs. So, she thought that maybe she just should report this as anybody else may have it. Now, her knee has started puffing up again right now. Patient also reported that after getting the shot yesterday, 01Apr2021, when the evening came, about in the 7 Hours and knees started hurting and very rare because it has been really build a long time ago and then all of a sudden it got really hot and then both of legs got very hot. Patient treated events with unspecified ointment on it thinking that it would help it. But patient said that she did not think that it did. She thought of washing it all off again and then washed the stuff off because it was all burning. The outcome of pruritus, knee pain was recovered on an unspecified date, knee swelling was not recovered, and the rest of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Neck pain, Pain in extremity, Swollen tongue
Clinical narrative: Tongue swelling; Arm and shoulder hurt up to the neck; Arm and shoulder hurt up to the neck; Arm and shoulder hurt up to the neck; This is a spontaneous report from a contactable consumer or other non hcp (patient). An 80-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, solution for injection, Batch/Lot Number: EN6204), dose 1 via an unspecified route of administration, administered in Arm Left on 24Mar2021 (at the age of 80-year old) as DOSE 1, SINGLE for covid-19 immunization. Medical history included allergy to Bactrim from an unknown date and unknown if ongoing (found this allergy 20-30 years ago), breast cancer from an unknown date and unknown if ongoing and glaucoma from an unknown date and unknown if ongoing. Concomitant medications included brimonidine tartrate, timolol maleate (COMBIGAN) taken for glaucoma from an unspecified start date and ongoing (taken at least for 5 years), exemestane (EXEMESTANE) taken for breast cancer from an unspecified start date and ongoing. On 24Mar2021 the patient experienced tongue swelling, arm and shoulder hurt up to the neck on an unspecified date with outcome of unknown. She mentioned how she was upset but not sure if that was related or not but she experienced tongue swelling on 24Mar2021 in the evening after her first dose of the Pfizer vaccine. She stated it went away the next day. She stated, "It wasn't bad enough that she couldn't swallow but it was swollen; Not so bad that I couldn't eat, but it felt bigger. Outcome of the event swollen tongue was recovered on 25Mar2021. Outcome of other events was recovered on 28Mar2021.  No follow-up attempts are needed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Fatigue, Headache, Pain
Clinical narrative: Severe bodyaches; Especially back & front thigh to below knee; Especially back & front thigh to below knee; Especially back & front thigh to below knee; Fatigue; Headache; This is a spontaneous report from a contactable consumer, the patient. A 58-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UUNKOWN) via an unspecified route of administration in the right arm on 07Apr2021 at 15:00 (at the age of 58-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure, high cholesterol, diabetes 2 and COVID-19. The patient had no known allergies. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included multiple plus insulin (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and unknown if ongoing. On 07Apr2021 at 16:30, the patient experienced severe body aches especially back & front thigh to below knee, fatigue and headache. 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 severe body aches especially back & front thigh to below knee, fatigue and headache were not resolved at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.