chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain
Clinical narrative: pain; swelling of left axillary lymph node; This is a spontaneous report from a contactable consumer (patient, self-reported). A 54-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN 5318 and expiration dates were not reported), via an unspecified route of administration in left arm on 12Feb2021 at 12:30 PM, as single dose for COVID-19 immunisation. The medical history included R hip arthritis and allergy codeine causes nausea and vomiting. The concomitant medication included naproxen, ibuprofen, calcium, vit D and glucosamine. The historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL 9261 and expiration dates were not reported), via an unspecified route of administration in right arm on 21Jan2021 at 06:30 PM, at single dose for COVID-19 immunisation. On 13Feb2021 at 12:00 PM, patient experienced pain and swelling of left axillary lymph node. No any other vaccine administered in four weeks. The corrective treatment was not required for the AE. No COVID prior vaccination and no COVID tested post vaccination. The outcome of the patients event was recovering.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: fever; This is Spontaneous report from a contactable consumer. This consumer reported similar events for 2 patients. This is a First of Two reports. This consumer reported for A 83-year-old female patient (mother) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on 13Feb2021 at single dose for COVID-19 immunisation. Historical vaccine included first dose of BNT162B2. Patient medical history included high blood pressure. On 14 Feb 2021 the patient experienced fever, she reached about 100. Treatment: Reporter stated, "I think they just took Tylenol." When probed for any other concern, Reporter stated, "Okay is there anything that help them other than Tylenol. The outcome of the events was unknown.  Information on batch/lot number was requested. ; Sender's Comments: Linked Report(s) : PFIZER INC-2021191131 same drug/reporter/event, different patient
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Eye pain, Eye swelling, Fatigue
Clinical narrative: Lymph Node under left arm starts to itch/hurt/ left arm pit Lymph Node swollen/itchy, achy; Eyes swollen; some wheezing; tired; Lymph Node under left arm starts to itch/hurt/ left arm pit Lymph Node swollen/itchy, achy; Lymph Node under left arm starts to itch/hurt/ left arm pit Lymph Node swollen/itchy, achy; minor tightness in breathing; Sever chills; fever; extreme fatigue; headache; eye ache; This is a spontaneous report from a contactable consumer. A 52-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EN5318), via an unspecified route of administration on arm right on 27Jan2021 at single dose for COVID-19 immunization. The patient medical history included Chronic Kidney Disease Stage III, High Blood Pressure, Asthma from an unspecified date and allergies to Penicillin, Levoquin, Erythromycin, Clindamycin from an unspecified date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19 . The patient Concomitant medications were not reported. Historical vaccines included patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL3249), via an unspecified route of administration on arm right on  06Jan2021 at single dose for COVID-19 immunization. On 28Jan2021, the patient experienced Sever chills, fever, extreme fatigue, headache, eye ache and got cleared on the same day. On 03Feb Lymph Node under left arm starts to itch/hurt. On 07Feb Eyes swollen (right almost swollen shut); left arm pit Lymph Node swollen/itchy, achy; some wheezing; and tired.  Since then: i) swelling in eyes reduces and then swells again, ii) lymph node under left arm still itchy/achy/swollen, iii) at times minor tightness in breathing; and iv) tired.The event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Therapeutic measures were taken, and treatment included prednisone and EpiPen. The outcome of the events was reported as Not recovered.  Follow up (15Feb2021): This follow up report contains no new medically significant safety information.  Follow up (17Feb2021): This follow up report contains no new medically significant safety information.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Lymph node pain, Lymphadenopathy, Pruritus, Pyrexia
Clinical narrative: Lymph Node under left arm starts to itch/hurt/ left arm pit Lymph Node swollen/itchy, achy; Eyes swollen; some wheezing; tired; Lymph Node under left arm starts to itch/hurt/ left arm pit Lymph Node swollen/itchy, achy; Lymph Node under left arm starts to itch/hurt/ left arm pit Lymph Node swollen/itchy, achy; minor tightness in breathing; Sever chills; fever; extreme fatigue; headache; eye ache; This is a spontaneous report from a contactable consumer. A 52-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EN5318), via an unspecified route of administration on arm right on 27Jan2021 at single dose for COVID-19 immunization. The patient medical history included Chronic Kidney Disease Stage III, High Blood Pressure, Asthma from an unspecified date and allergies to Penicillin, Levoquin, Erythromycin, Clindamycin from an unspecified date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19 . The patient Concomitant medications were not reported. Historical vaccines included patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL3249), via an unspecified route of administration on arm right on  06Jan2021 at single dose for COVID-19 immunization. On 28Jan2021, the patient experienced Sever chills, fever, extreme fatigue, headache, eye ache and got cleared on the same day. On 03Feb Lymph Node under left arm starts to itch/hurt. On 07Feb Eyes swollen (right almost swollen shut); left arm pit Lymph Node swollen/itchy, achy; some wheezing; and tired.  Since then: i) swelling in eyes reduces and then swells again, ii) lymph node under left arm still itchy/achy/swollen, iii) at times minor tightness in breathing; and iv) tired.The event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Therapeutic measures were taken, and treatment included prednisone and EpiPen. The outcome of the events was reported as Not recovered.  Follow up (15Feb2021): This follow up report contains no new medically significant safety information.  Follow up (17Feb2021): This follow up report contains no new medically significant safety information.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Wheezing
Clinical narrative: Lymph Node under left arm starts to itch/hurt/ left arm pit Lymph Node swollen/itchy, achy; Eyes swollen; some wheezing; tired; Lymph Node under left arm starts to itch/hurt/ left arm pit Lymph Node swollen/itchy, achy; Lymph Node under left arm starts to itch/hurt/ left arm pit Lymph Node swollen/itchy, achy; minor tightness in breathing; Sever chills; fever; extreme fatigue; headache; eye ache; This is a spontaneous report from a contactable consumer. A 52-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EN5318), via an unspecified route of administration on arm right on 27Jan2021 at single dose for COVID-19 immunization. The patient medical history included Chronic Kidney Disease Stage III, High Blood Pressure, Asthma from an unspecified date and allergies to Penicillin, Levoquin, Erythromycin, Clindamycin from an unspecified date. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19 . The patient Concomitant medications were not reported. Historical vaccines included patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EL3249), via an unspecified route of administration on arm right on  06Jan2021 at single dose for COVID-19 immunization. On 28Jan2021, the patient experienced Sever chills, fever, extreme fatigue, headache, eye ache and got cleared on the same day. On 03Feb Lymph Node under left arm starts to itch/hurt. On 07Feb Eyes swollen (right almost swollen shut); left arm pit Lymph Node swollen/itchy, achy; some wheezing; and tired.  Since then: i) swelling in eyes reduces and then swells again, ii) lymph node under left arm still itchy/achy/swollen, iii) at times minor tightness in breathing; and iv) tired.The event resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Therapeutic measures were taken, and treatment included prednisone and EpiPen. The outcome of the events was reported as Not recovered.  Follow up (15Feb2021): This follow up report contains no new medically significant safety information.  Follow up (17Feb2021): This follow up report contains no new medically significant safety information.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: Started to feel dizzy; nauseous in evening received shot; This is a spontaneous report from a contactable consumer (patient herself). A 76-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot/Batch number: unknown), via an unspecified route of administration on the left arm 13Feb2021 at 2:15pm as a SINGLE DOSE for COVID-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. COVID prior vaccination was none. Since the vaccination, patient had not been tested for COVID-19. COVID tested post vaccination was none. Patient other vaccines within 2 weeks prior to the COVID vaccine included tamsulosin hydrochloride (FLOMAX), ondansetron (ZOFRAN), furosemide, oxycontin and oxycodone. The patient's medical history included bladder issues, celiac disease and allergy (reported as known allergies Yes 17 rxs). On 13Feb2021 at 11pm, the patient started to feel dizzy and nauseous in the evening received shot. The patient reported that the symptoms got progressively more pronounced. It was reported that patient did not receive any treatment for events. The outcome of the events was not resolved.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Joint noise, Joint range of motion decreased, Pain in extremity, Peripheral swelling
Clinical narrative: Hum buzz is now on both sides of body; Pain / continuing down both legs into feet more each day; the upper edge is holding at my hips not moving down; usually has sever arm pain and swelling, but just a tiny bit with this vaccine; usually has sever arm pain and swelling, but just a tiny bit with this vaccine; This is a spontaneous report received from a contactable consumer (reporting on herself). A 67-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot Number: EN6201 and Expiration Date was not reported), via an unspecified route of administration in in Arm Left on Feb2021 10:00 as single dose for COVID-19 immunization. Medical history included high blood pressure, allergies to wheat, rye, oats, avoid milk and eggs by choice, neuralgia, back injury, constant tazer like hum , spinal operation , joint noise, pain, pain in extremity, peripheral swelling all from an unknown date and un-known if ongoing I am one that usually has severe arm pain and swelling. Concomitant medication(s) included lisinopril (LISINOPRIL); venlafaxine (VENLAFAXINE); pantoprazole sodium sesquihydrate (PROTONIX); estradiol (DOTTI); cannabis (CANNABIS) all taken for sleep disorder, start and stop date were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient not tested for COVID-19. It was reported that normal existing nerve pain right side of body from high waist to toes, constant tazer like hum from back injury/surgery. On 11Feb2021, the Hum buzz was now on both sides of body started at 18 hours after vaccine. Started above shoulders slowly poured down my back in 15 band. now mixing with pain I already have. Can't pin point pain to anything else but vaccine, like a cold, fever or activity. It's continuing down both legs into feet more each day. the upper edge was holding at her hips not moving down. She was one that usually has sever arm pain and sewlling, but just a tiny bit with this vaccine. Taking nightime meds during the day (cannibus 1-6.5 mg gummie bear eaten) need 3 for sleeping at night. Patient did not receive any treatment for adverse event. The outcome of the events was not recovered.
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Rash (red bumps); extreme itching on both arms, stomach, and both legs; This is a spontaneous case is received from a contactable consumer. A 77-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number and expiry date was not reported) via an unspecified route of administration in Arm Right on 09Feb2021 15:45 as single dose for covid-19 immunisation. Medical history included covid-19. The patient previously took pfizer biontech covid 19 vaccine, phenolphthalein and experienced drug hypersensitivity. On an unspecifie date, the patient received first dose of BNT162B2. The concomitant medication was not reported. On 10Feb2021 at 12:00 AM, the patient experienced Rash (red bumps) and extreme itching on both arms, stomach, and both legs. The outcome of the event was non recovered.  No follow-up attempts are needed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: headache; Body aches; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration, administered on the left arm on 11Feb2021 15:45 at a single dose for COVID-19 immunisation. Medical history included allergies: sulfa. The patient's concomitant medications were not reported. On Feb2021 the patient experienced headache and body aches. No treatment was received for the events. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The facility where the vaccine was administered was in a hospital. Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. Outcome of the events was recovering.   Information on the lot/batch number has been requested.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: started a very light menstrual period that lasted about 5-6 days; This is a spontaneous report from a contactable consumer (patient herself). A 56-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot Number: EL9261) via an unspecified route of administration, administered in arm left on 22Jan2021 at 07:30 (at the age of 56-year-old) as SINGLE DOSE and dose second via an unspecified route of administration on 11Feb2021 as SINGLE DOSE for covid-19 immunization. Medical history included High risk smoldering multiple myeloma, autoimmune- psoriatic arthritis. The patient had no known allergies. Concomitant medications in two weeks included trazodone (TRAZODONE), sertraline (SERTRALINE) and topiramate (TOPIRAMATE). On 01Feb2021, the patient experienced started a very light menstrual period that lasted about 5-6 days.Patient stated that she started having periods again and her periods stopped around Nov2019, due to menopause. About 2 weeks later, she took first vaccination and a very light menstrual period started that lasted about 5-6 days. The patient not had covid prior vaccination; not tested covid post vaccination. The patient did not receive any treatment for the events. The outcome of the event was unknown.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site swelling
Clinical narrative: Itch on her left wrist; injection site was slightly swollen/elevated about 3inches in diameter and about 1 cc high; This is a spontaneous report from a contactable consumer (patient). A 86-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL9265), via an unspecified route of administration, administered in right arm (right upper arm) on 03Feb2021 08:50 as single dose for COVID-19 immunization. Patient's medical history included aspirin exacerbated upper respiratory disease from an unknown date to ongoing and asthma from an unknown date to ongoing and breast cancer. She had family history included diabetes (Father died of a brain hemorrhage at 86). She had historical vaccine as flu vaccine in Oct2020 or Nov2020. There were no prior vaccinations (within 4 weeks). There were no concomitant medications. There was no history of all previous immunization with the Pfizer vaccine considered as suspect. There was no additional vaccines administered on same date of the Pfizer suspect. On 03Feb2021, patient experienced itch on her left wrist and injection site was slightly swollen/elevated about 3inches in diameter and about 1 cc high. She stated got the shot today (03Feb2021) and the 2 things she experienced after she got the shot. First she felt an itch on her left wrist immediately but it was given in the right arm. She notes she looked at it and it was red but gradually went down over 15 minutes. Also the injection site was slightly swollen. The itching felt like a pimple when she looked at it she described it as redness that followed the vein and muscle. It lasted about 20 minutes and is back to normal now. At the time, maybe it was swollen. She had been told to stay for half an hour and she did that due to having aspirin exacerbated upper respiratory disease and asthma. She has been a patient in the allergy unit and check with them before getting the shot and was told it was ok to get. It was given about 8:50am. When she got home she looked at the place she was given and it was slightly swollen around the injection site. She always gets shots in right arm due to having breast cancer. It was seen about 10 minutes ago for the first time and was not red but elevated about 3 inches in diameter and about 1 cc high. There was no emergency room or physician office visit. She will be getting amoxicillin when she gets a dental appointment but she has not taken or started that at this point. No treatment was received, she just hung around for a little more than a half hour, showed to the nurse who thought she was ok, she has had no fever or other issues. The caller explained she stayed out of work on Monday and Tuesday to insure she wasn't upset or getting any infection. She is prone to get sinus infections that affects her ear canals and that cause dizziness. She has had no dizziness. The outcome of event for vaccination site swelling was not recovered and for localised itching it was recovered.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: chills about 15-16 hours later, lasted around 4 hours; This is a spontaneous report from a contactable pharmacist. A 57-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: E112B3), second dose intramuscular, administered in left arm on 25Jan2021 09:00 as SINGLE DOSE for covid-19 immunisation. Patient was 57 years old at the time of vaccination. Medical history included diabetes mellitus, hypertension, glaucoma and back pain, all from an unknown date and unknown if ongoing. The patient had no known allergies. On 04Jan2021 at 2pm patient received first dose of Bnt162b2 (lot number=EJ1686, intramuscular in left arm). On 26Jan2021 at 2:00 the patient experienced chills about 15-16 hours late and lasted around 4 hours. Therapeutic measures were taken as a result of the event. Outcome of the event was recovered.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Headache, Pain, Peripheral swelling, Pruritus
Clinical narrative: Hives; I got the itchiness; Headache; Soreness at the spot and achiness; Stomach cramping; Arm was swollen and sore and achy body thing; This is a spontaneous report received from a contactable consumer. A 66-Year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EM9810), via an unspecified route of administration on 04Feb2021 at right arm as a single dose for COVID-19 immunization. Co-suspect medications included paracetamol (TYLENOL) and sulfamethoxazole, trimethoprim (MORTIN). The patient medical history included high blood pressure and allergic to sulfa drugs. Concomitant medications included amlodipine (5mg once daily) (MANUFACTURER UNKNOWN), clonidine (0.1 mg, 2x/day) (MANUFACTURER UNKNOWN) and acetylsalicylic acid (BABY ASPIRIN). The patient had the second Pfizer vaccine on 04Feb2021 and on fifth day 08Feb2021 or beginning of the fifth day experienced hives. The patient had some little headache, soreness, achiness at the spot and reported patient was fine but took some motrin and Tylenol for few days because somebody said after Pfizer vaccine, it works well but then patient got hives on all over my body, so she was suspecting that the allergic reaction was due to the motrin and I want to report it because I got this on fifth day after my second vaccine. The patient got hives on the fifth day after the second vaccine. The patient had itchy, hives all around my body and some stomach cramping. The patient reported arm was swollen and sore and had a headache and achy body thing. Outcome of reported events were unknown.  Follow-up information has been requested and pending to receive.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives; I got the itchiness; Headache; Soreness at the spot and achiness; Stomach cramping; Arm was swollen and sore and achy body thing; This is a spontaneous report received from a contactable consumer. A 66-Year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EM9810), via an unspecified route of administration on 04Feb2021 at right arm as a single dose for COVID-19 immunization. Co-suspect medications included paracetamol (TYLENOL) and sulfamethoxazole, trimethoprim (MORTIN). The patient medical history included high blood pressure and allergic to sulfa drugs. Concomitant medications included amlodipine (5mg once daily) (MANUFACTURER UNKNOWN), clonidine (0.1 mg, 2x/day) (MANUFACTURER UNKNOWN) and acetylsalicylic acid (BABY ASPIRIN). The patient had the second Pfizer vaccine on 04Feb2021 and on fifth day 08Feb2021 or beginning of the fifth day experienced hives. The patient had some little headache, soreness, achiness at the spot and reported patient was fine but took some motrin and Tylenol for few days because somebody said after Pfizer vaccine, it works well but then patient got hives on all over my body, so she was suspecting that the allergic reaction was due to the motrin and I want to report it because I got this on fifth day after my second vaccine. The patient got hives on the fifth day after the second vaccine. The patient had itchy, hives all around my body and some stomach cramping. The patient reported arm was swollen and sore and had a headache and achy body thing. Outcome of reported events were unknown.  Follow-up information has been requested and pending to receive.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Paraesthesia, Pruritus
Clinical narrative: itched; burned; tingled; This is a spontaneous report from a contactable Other HCP. A 42-years-old female patient (non-pregnant) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: El0142, Expiration date:unknown), via an intramuscular in Right arm on 04Jan2021 07:30 as SINGLE DOSE and second dose received of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9261, Expiration date: unknown), via an unspecified route of administration in Right arm on 21Jan2021 at SINGLE DOSE for COVID-19 immunization. Patient medical history included known allergies: Sulfa, penicillin. Concomitant medication included Vitamin C (ascorbic acid), ZINC (zinc), ADVIL (ibuprofen). 10 days after the first dose, patient's toes started itching so bad. On 14Jan2021 07:00,  patient experienced itched, burned, and tingled. For 10 days feet itched, burned, tingled. Patient did not received treatment for the events.  Post to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of event was recovered.
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Neuralgia
Clinical narrative: she mentioned a flame in the nerve; she mentioned a flame in the nerve; This is a spontaneous report from a contactable to a Pfizer-sponsored program . A female patient of an unspecified age received first dose of BNT162B2 (Pfizer Covid-19 Vaccine; solution for injection) via an unspecified route of administration as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced she mentioned a flame in the nerve. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Injection site pain, SARS-CoV-2 test, Somnolence
Clinical narrative: Mild sleepiness; mild dizziness; mild fatigue; mild soreness at injection site; This is a spontaneous report from a contactable consumer (patient). A 56-years-old non-pregnant female patient, received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, in arm Left on 13Feb2021 09:00 (Batch/Lot number: Em 9809 (ks)) as SINGLE DOSE, for covid-19 immunisation. The patient did not have any allergies to medications, food or other products. Patient did not receive other vaccine in four weeks of vaccination. Patient was not diagnosed with COVID-19, prior vaccination. Patient has been tested for COVID-19, post vaccination. Medical history included pcos (polycystic ovarian syndrome) and hbp (hypertension) from an unknown date and unknown if ongoing. Concomitant medications included metformin and atenolol taken for an unspecified indication, start and stop date were not reported. The patient experienced mild sleepiness, mild dizziness, mild fatigue and mild soreness at injection site on 13Feb2021 14:00. The patient underwent lab tests and procedures which included COVID-19 test negative on 23Nov2020. On an unspecified date of Feb2021, the outcome of the events was recovered.   Information about lot/batch number has been requested.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Feeling cold, Pyrexia
Clinical narrative: fever; Feeling cold; This is a follow up spontaneous from a contactable consumer. This 55-year-old male consumer reported that the patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, LOT number: unknown), via an unspecified route of administration on an 10Feb2021 5.00 (Age at vaccination:55-year-old) at single dose for Covid-19 immunization. The patient's medical history and concomitant medications was not reported. The patient did not have anything done on Thursday, but on Friday evening he got a fever and that was right after 2 days of getting the vaccine and he still has a fever. So, Friday night, Saturday night, Sunday night he had fever and on Monday morning he still has it. It goes down when taking Tylenol. Temperature went as high as 100.7.This morning he didn't have any fever, it was 97.9 and now it's at 98.9. He is also feeling cold. The patient wants to know if this is normal or is it because of the vaccine or did he actually get Covid after the shot. Could it be flu or anything, should he get Covid testing. On 10-Feb-2021, the patient was feeling cold and 12-Feb2021 the patient had fever. The patient was taking Tylenol for fever since 12Feb2021, and Tylenol therapy was still ongoing. The outcome of the events was reported as nor recovered.  Information about lot/batch number has been requested.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Fatigue, Headache
Clinical narrative: nauseous; chills; 100 fever; achey all over- neck, shoulders, hips,knees; headache; tired; weakness; fatigue; This is a spontaneous report received from a contactable other HCP(patient). A 21-year-old female patient received second dose of BNT162B2 (BNT162B2, Solution for injection, Lot Number: EN5318) via an Intramuscular route of administration right arm on unspecified date at 09:30 AM (at the age of 21 year old) as single dose for covid-19 immunization.Other medications in two weeks included Birth control medication(contraception). No concomitant medications was reported. Patient received first dose of BNT162B2 (BNT162B2, Solution for injection, Lot Number: EL8982) via an Intramuscular route of administration left arm on 23Jan2021 at 10:30 AM (at the age of 21 year old) as single dose for covid-19 immunization.No other vaccine in four weeks. The patient didn't take any treatment.No covid prior vaccination.No covid tested post vaccination. No Known allergies were reported.On 14Feb2021 at 03:00 AM, the patient experienced nauseous (nausea),chills (chills),100 fever (pyrexia), achey all over- neck, shoulders, hips,knees (pain), headache (headache),tired (fatigue),weakness (asthenia), fatigue (fatigue).The patient underwent lab tests and procedures which included body temperature: 100 on 14FEB2021.all the events were non serious. Outcome of the events was unknown.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: nauseous; chills; 100 fever; achey all over- neck, shoulders, hips,knees; headache; tired; weakness; fatigue; This is a spontaneous report received from a contactable other HCP(patient). A 21-year-old female patient received second dose of BNT162B2 (BNT162B2, Solution for injection, Lot Number: EN5318) via an Intramuscular route of administration right arm on unspecified date at 09:30 AM (at the age of 21 year old) as single dose for covid-19 immunization.Other medications in two weeks included Birth control medication(contraception). No concomitant medications was reported. Patient received first dose of BNT162B2 (BNT162B2, Solution for injection, Lot Number: EL8982) via an Intramuscular route of administration left arm on 23Jan2021 at 10:30 AM (at the age of 21 year old) as single dose for covid-19 immunization.No other vaccine in four weeks. The patient didn't take any treatment.No covid prior vaccination.No covid tested post vaccination. No Known allergies were reported.On 14Feb2021 at 03:00 AM, the patient experienced nauseous (nausea),chills (chills),100 fever (pyrexia), achey all over- neck, shoulders, hips,knees (pain), headache (headache),tired (fatigue),weakness (asthenia), fatigue (fatigue).The patient underwent lab tests and procedures which included body temperature: 100 on 14FEB2021.all the events were non serious. Outcome of the events was unknown.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph node above my clavicle; This is a spontaneous report received from a contactable consumer (patient). A 75-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EN5318), via an unspecified route of administration on 09Feb2021 09:45(at the age of 75-years-old) as a SINGLE DOSE in Left Arm for COVID-19 immunization. The patient medical history was not reported. The patient had no known allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received first dose of bnt162b2 via an unspecified route of administration on 19Jan2021 as SINGLE DOSE in Left Arm for COVID-19 immunization. Concomitant medications included: estrogens conjugated (PREMARIN) vaginal cream and multi vitamin. On 11Feb2021, the patient experienced swollen lymph node above my clavicle two days after vaccine administration. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any treatment for the adverse event. The outcome of event was not recovered.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Pain in extremity, Pain in jaw, Vaccination site pain
Clinical narrative: All of the joints in both arms ached/the joints in my left arm are sore; my left hip aches; As the evening progressed the throbbing pain spread across my pectorals, up to my chin, and all the way to my other arm; As the evening progressed the throbbing pain spread across my pectorals, up to my chin, and all the way to my other arm; As the evening progressed the throbbing pain spread across my pectorals, up to my chin, and all the way to my other arm; vaccine site started being sore; This is a spontaneous report from a contactable consumer/ Non-HCP (patient). This 52-year-old non-pregnant female consumer received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date not reported) via unknown route of administration, in the left arm, on 12Feb2021at 09:30 AM (age at the time of vaccination 52 years), at single dose for COVID-19 immunisation in the hospital. Patient's medical history included hypothyroidism, irritable bowel syndrome, primary hypertension, seasonal affective depression and flu. Patient had no known allergies. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number and expiration date not reported) via unknown route of administration, in left arm on 22Jan2021 at 09:30 AM (age at the time of vaccination 52 years), at single dose for COVID-19 immunisation in the hospital. The patient had no allergies with medications, food or other products. Concomitant medications in two weeks included levothyroxine sodium(thyroxine), sertraline, hyoscyamine and lisinopril. On 12Feb2021, the patient was a little sore that day, but not the next, vaccine site started being sore. On 14Feb2021 patient spent an hour shoveling snow in the morning, but wasn't sore afterwards. On 14Feb2021 (8 plus hours after shoveling snow), the vaccine site started being sore, but the pain was on again/off again. As the evening progressed the throbbing pain spread across my pectorals, up to my chin, and all the way to my other arm. All of the joints in both arms ached, 600 mg ibuprofen didn't seem to help. On 15Feb2021(Morning), the injection site is a little sore, the joints in her left arm are sore, and, weirdly, her left hip aches. The throbbing pain last night wasn't like any over-used muscle soreness I've ever experienced and the joint aching was also unlike anything I've experienced outside of when I've had the flu. Patient did not receive other vaccines within 4 weeks or prior vaccination. No COVID-19 prior the vaccination and no COVID-19 test was done post vaccination. Patient's treatment medication included ibuprofen. Outcome of the events were recovering.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Fungal infection, Immunodeficiency, Nervousness, SARS-CoV-2 test
Clinical narrative: stated her immune system must be torn down or low; yeast infection after the vaccine; feeling a bit of nervousness and has to move around a lot; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age (reported as 75, units unspecified) received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on 04Feb2021 (at an unspecified age) at single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient's historical vaccine included flu shot for vaccination and stated that she still gets flu. The patient stated that she received the first dose on 04Feb2021, and second dose was scheduled on 25Feb2021. The patient stated that she doesn't know if she does not want to get the second dose but wanted to know what would happen if she doesn't get it. The patient also asked if there is a reverse reaction and why would you need two doses. She stated that she has been feeling a bit of nervousness and has to move around a lot. The patient reported that she has never had a yeast infection in her life, and she contracted a yeast infection after the vaccine. Further clarified that it was not right after, but she happened to get it a few days later. The patient was taking Monistat over the counter. The patient's doctor said that the yeast infection could be from sugar, menopause, or her immune system. The patient got tested for COVID-19 after the vaccine and was tested negative. Her daughter's mother in law tested positive after getting the first dose of the vaccine. One of the sons tested positive, so the daughter's mother in law got tested and was positive. Stated that the daughter's mother in law may have had an infection or her immune system was low. The patient heard that the first vaccine was 60% effective. The patient stated that she still gets flu after getting the flu shot. Also stated that her immune system must be torn down or low, she takes all of her vitamins. Outcome of the events was unknown.  No follow-up attempts are possible, information about batch number cannot be obtained.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Lymphadenopathy
Clinical narrative: Single swollen Lymph node on left armpit (under arm); I discovered a lump in my left armpit on Friday; This is a spontaneous report from a contactable consumer (patient). Follow-up (23Feb2021) was received from same reporter and processed together with initial information.  A 27-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3248 and expiry date was not provided), via an unspecified route of administration, in left arm, on 08Feb2021 at 15:45 PM, as a single dose (at the age of 27-years) for COVID-19 immunization at workplace clinic. Historical vaccine included first dose of BNT162B2 (lot number: EL3248 and expiry date was not provided), via an unspecified route of administration, in left arm, on 19Jan2021 at 15:45 PM, as a single dose (at the age of 27-years) for COVID-19 immunization at workplace clinic. The patient was not pregnant at the time of vaccination. Patient's medical history included known allergies with Benadryl. The patient did not receive any other vaccines within 4 weeks. Concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. It was reported that after four days of vaccination, on 12Feb2021 at night, the patient discovered a lump in her left armpit. On 13Feb2021 at 12:00 AM, the patient had single swollen Lymph node on left armpit (under arm). Patient did not receive any treatment for the events. Since the vaccination the patient had not been tested for COVID-19. On 15Feb2021, the patient submitted her COVID-19 Adverse Report. Outcome of the event single swollen Lymph node on left armpit (under arm) was not recovered and for another event, it was unknown.
Age: 84.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Illness, Vomiting
Clinical narrative: her husband was really sick; he is still weak from it; horrible diarrhea; vomiting; This is a spontaneous report from a contactable Consumer. A 84-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL1283), via an unspecified route of administration in right arm on 03Feb2021 (at 84-years age) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter confirms that her husband received no other vaccines on the same day as the COVID vaccine. On 04Feb2021, the patient received the first dose of the vaccine and experienced diarrhea and vomiting on. The reporter wants to know if the patient could get this after the second dose, too. The reporter also enquired if someone does not have side effects from the first dose, could they get them from the second dose and wants to know what would happen if she delayed her second dose. Two weeks after receiving the first dose patient had a very bad reaction. The reporter wants to know if her husband would experience the same if he received the second dose. The reporter states that her husband no longer has the vomiting and diarrhea, but he was still weak from it. The patient took Imodium AD, because he could not leave the house to see his doctor, because the diarrhea was so severe. The outcome of event diarrhea and vomiting was resolved on 14Feb2021, for weakness was not resolved and for illness was unknown.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Mass, Muscle spasms, Nerve compression, Paraesthesia, Pruritus
Clinical narrative: Muscle spasm; Lump in a small area that she can rub; Tingling in her arm; Itch; Like a tiny pinched nerve; feels like something is biting her in an area that stings; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EJ1686), via an unspecified route of administration, on 21Jan2021, at a single dose, for COVID-19 immunization. The patient's medical history included cataract (pending clarification). The patient's concomitant medications included fluticasone propionate/ salmeterol xinafoate (ADVAIR) and unspecified drops. The patient received the first dose of the COVID-19 vaccine on 21Jan2021 and experienced muscle spasm and a lump in a small area that she can rub out within a couple days on 23Jan2021 (within 2 days of the dose being given); little bit of muscle spasms and a slight lump will come up in that area and she can rub it out. The muscle issue isn't still happening as much. The patient wanted to know if the tingling is a common side effect. In Jan2021, the patient experienced tingling in her arm and asked could that be because the vaccine she received was cold. The patient asked how long the vaccine should sit out at room temperature. In Jan2021, it feels like something is biting her in an area that stings, like a mosquito bite, and nothing is there; like a bite feeling and it will itch in that area and she will think what could have bitten her. The feeling like a bite, it is like a tiny pinched nerve or something like a mosquito bite and she will look but nothing will be there. The feeling will be in like one specific area. It began very close to the muscle thing around 2 to 3 days after the vaccine (Jan2021). It happens about once per day. It might skip a day here or there but pretty much its once per day. It is about every day or every day and a half or so. The patient was in a place that was below zero. It was mostly her legs but last night it was in her arms. The patient was scheduled to have the second dose tomorrow (16Feb2021) and she is concerned. The patient had cataract surgery last week, so she had to get her purse she also has her drops in there. That is why she did not get the second dose exactly 3 weeks because she had surgery. The patient kept thinking what that weird thing was, it is like a no-see-um bite. The patient called her primary care about it and her recommendation was to get the shot anyway and let them know. It was fairly mild, and she was just curious. The outcome of "Lump in a small area that she can rub", "Tingling in her arm", and "Itch" was unknown. The patient was recovering from "Muscle spasm". The patient had not recovered from the remaining event.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Pain in extremity
Clinical narrative: feeling cold throughout the day; sore area on her arm; This is a spontaneous report from a contactable nurse (patient). A 76-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL8982 and expiration date was not reported) intramuscularly on 02Feb2021 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was scheduled to receive the second dose on 23Feb2021. It was stated that she had heard rumors by word of mouth and blogs that the second shot is a real doozer. Some of the things she had heard were really disturbing and was hearing that a lot of elderly people had died from the second shot. On an unspecified date, patient was having a sore area on her arm and feeling cold throughout the day after receiving the first injection, and state that both of those side effects passed throughout the day. Patient asked how many people had died after receiving the second vaccine and probably doesn't have right up to the minute information about how many people were dying from this vaccine. Patient reported that she had friends that took the second dose and they all had chills, body aches, headache and fevers. Patient also asked If she don't take the second shot, or take it months later from now, and a new variant strain comes out, will she more susceptible to the new variant strain by not taking the second shot and being covered totally and stated Dr. (Name)came out and said if she don't take the second dose, she will be more susceptible to the variant strain attacking her and she could die from it. Patient wanted to know instead of taking her second vaccine next week, can she delay it and take it months from now and asked will the vaccine be effective. Patient wondered why there was no expiration date on her vaccine record card. She made the comment might be because it was so new, that's why there wasn't one. The outcome of the events was unknown.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Psoriasis
Clinical narrative: Psoriasis appeared on my scalp in several areas.A dermatologist was consulted and diagnosed this..; This is a spontaneous report from a contactable Consumer. A 78 -year-old non pregnant female consumer received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration administered in Left arm on 13Jan2021 10:00 at single dose for COVID-19 immunisation. Patient medical history and concomitant medications were not reported. No known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive other medications within 2 weeks of vaccination. On 18Jan2021, the patient had experienced Psoriasis appeared on scalp in several areas. A dermatologist was consulted and diagnosed this. Betamethasone dipropionate lotion was received in response to the adverse events. On 04 Feb2021, patient had other vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient was not tested for COVID-19. At the time of reporting, the event was resolving.