chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Paraesthesia
Clinical narrative: Dizziness; Palpitation; I had tingling in my face and my legs; Myalgia; Nausea; Headache; Fatigue; This is a spontaneous report from a contactable consumer (emergency department technician like a clinical assistant). A 22-year-old female patient received her first injection of BNT162B2 (Pfizer/ BioNTech Covid-19 vaccine, lot number EK9231) intramuscularly at a single dose on 17Dec2020 for Covid-19 immunization. The patient had a medical history of migraine. Concomitant medications included cyproheptadine for migraine and multivitamins. The patient experienced dizziness and palpitations initially and then little bit later on the day she had tingling in her face and legs and she had myalgia, nausea and headache and fatigue. The symptoms lasted for 2 days. The patient medicated with Benadryl and Famotidine. Outcome of the events was unknown. The patient had her second vaccine injection on 06Jan2021.
Sex: U
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Weird taste in mouth; This is a spontaneous report from a contactable consumer (patient) reported that a patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 04Jan2021 05:00 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was calling because he/she wanted to know as he/she looked up the side effect of the COVID vaccine and he/she got it on the 4th and then he/she noticed this weird taste in his/her mouth and he/she just wanted to know if that is kind of a side effect of the vaccine. The outcome of the event was unknown.   Information on the Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: muscle pain; headache; chills; fever; tiredness; This is a spontaneous report from a Pfizer-sponsored program from a non-contactable healthcare professional who reported for herself. A female patient of an unspecified age received BNT162B2 (Pfizer/ BioNTech Covid-19 vaccine) at a single dose on an unspecified date in Jan2021 (reported as "yesterday") for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was experiencing headache muscle pain, chills fever and tiredness. She was asking even though she was experiencing these side effects it did or did  not mean she was positive for COVID 19. The outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Oxygen saturation, Oxygen saturation decreased, Swelling, Urticaria
Clinical narrative: He can't get his oxygen up above a certain level; It could be some swelling; His back and arms are covered with hives; This is a spontaneous report from a non-contactable consumer (wife). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Jan2021 at single dose for COVID-19 immunization. Medical history included chronic obstructive pulmonary disease (COPD). The patient's concomitant medications were not reported. The patient received yesterday (05Jan2021) and during the night he has developed hives. The concern was if the patient should he get the next shot. The wife doesn't consider what's happened to the husband was a severe reaction although his back and arms are covered with hives. The wife doesn't think that they will go to the hospital or anything. The patient can't get his oxygen up above a certain level and he can't get it to where it normally comes when it does on oxygen. But the wife assumes that's going to improve during the day. It was probably from the hives it could be some swelling and guessed it was going to change. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Rash
Clinical narrative: body rash/back and arms were covered with rash; face flushed; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 06Jan2021 at a single dose for COVID-19 immunization. Medical history was reported as none. There were no concomitant medications. The patient received the vaccine in, health department. On 06Jan2021, patient had a body rash as soon as she got the shot. Her back and arms were covered with rash and her face flushed, it's been six hours. The patient has been taking Benadryl as treatment for the events. 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: U
Vaccine: COVID19
Symptoms: Body temperature, Body temperature decreased, Feeling hot
Clinical narrative: Kind of like a hot feeling; temperature is low like 34.5; temperature is low like 34.5/My temperature dropped; it's very low; This is a spontaneous report from a contactable consumer.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 06Jan2021 at single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient stated, "I had a Covid-19 shot this morning and when I got home, I feel kind of like a hot feeling and I took my temperature and it's low, is that normal? My temperature is low, I think it's my temperature is dropped is this going to be a problem? I want to know if your temperature would drop because my temperature was like 34.5. My temperature should not be that. I took a Covid-19 shot this morning and I took my temperature a while ago and it's very low is this going to be a normal, to be a low "temperature" (not clarified). How do I know what to do? I mean do I need to call the doctor about it or what but there has my "temperature" (not clarified) dropped." The outcome of the events was unknown.   Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Gingival swelling, Lip swelling, Rubber sensitivity
Clinical narrative: She had an allergy from latex and gums are swollen; lips were tiny bit swollen; latex allergy; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were unknown), via an unspecified route of administration on 21Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. A week after patient was vaccinated, she had an allergy from latex and gums were swollen on Dec2020. She said it was mild and her question was if she can still take the second dose of the Covid vaccine this week. She have an allergy to Latex but its a very mild one, her lips were tiny bit swollen and gums were a little swollen on Dec2020. Outcome of the events was unknown.  Information on lot/batch number has been requested.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Body ache; This is a spontaneous report from a contactable nurse (patient) via Pfizer sponsored program. A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) lot number: EJ1686, via an unspecified route of administration on 05Jan2021 at a single dose to prevent getting Covid. The patient's medical history and concomitant medications were not reported. The patient received the covid vaccine about 24 hours ago and was now having a body ache (unknown date in Jan2021) with outcome of unknown. She was wondering if she can take Tylenol or Advil or something to help that. The patient did not receive any treatment for the event.
Sex: M
Vaccine: COVID19
Symptoms: Accidental exposure to product, Exposure via skin contact, Incorrect dose administered, Pain in extremity
Clinical narrative: When Nurse pushed the needle into deltoid muscle after the shot there was some vaccine small amount that dripped out from his arm;; When Nurse pushed the needle into deltoid muscle after the shot there was some vaccine small amount that dripped out from his arm;; When Nurse pushed the needle into deltoid muscle after the shot there was some vaccine small amount that dripped out from his arm;; Feel soreness in arm; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration from an unspecified date to an unspecified date at SINGLE DOSE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient stated that when nurse pushed the needle into deltoid muscle after the shot there was some vaccine small amount that dripped out from his arm. The patient also stated that he feel soreness in arm on an unspecified date. Outcome of the events was unknown.   Information about Lot/Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: she has arm pain after receiving covid vaccine; This is a spontaneous report from a contactable consumer from a Pfizer-sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number and expiry date unknown, via an unspecified route of administration on an unspecified date at a SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient called because she has arm pain after receiving covid vaccine and she wanted to know if she can take tylenol for the pain. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia, Vaccination site pain
Clinical narrative: pain at the injection site; fever; chills last night; This is a spontaneous report from a contactable healthcare professional. A male patient of an unspecified age started to receive bnt162b2 (BNT162B2), via an unspecified route of administration from 06Jan2021 to 06Jan2021 at a single dose for an unspecified indication. The patient's patient medical history and concomitant medications were not reported. It was reported that the patient had reported pain at the injection site, fever and chills last night on 06Jan2021 and feels better today. The outcome of the events was recovering.
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: soreness; This is a spontaneous report from a non-contactable physician via Pfizer sales representative. A patient of unspecified age and gender received bnt162b2 (BNT162B2 also reported as Pfizer COVID-19 vaccine, lot/batch number and expiry date were not reported), via an unspecified route of administration on an unspecified date at single dose for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient reported very mild soreness with first and second dose of Pfizer COVID-19 vaccine. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: injection site pain; This is a spontaneous report from a non-contactable pharmacist (patient). A 27-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EK5730, expiry: unknown), via an unspecified route of administration on 17Dec2020 12:00 at single dose (Left Arm) for COVID-19 immunization. Medical history reported as none. Patient had no known allergies. Patient is not pregnant. The patient's concomitant medications were not reported. Other medications within 2 weeks of vaccination was reported as oral contraceptives. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Only adverse event related to first dose was injection site pain from an unspecified date. The outcome of the event was unknown. The events were reported as non-serious.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: the person who took the 1st dose of the vaccine and still tested positive; the person who took the 1st dose of the vaccine and still tested positive; This is a spontaneous report from a Pfizer sponsored program Pfizer First Connect. A non-contactable consumer reported that a patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route of administration on unspecified date at single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. ~The patient took the 1st dose of the vaccine and still tested positive on unspecified date. They would like to know if the patient still needs to take the 2nd dose of the vaccine or not.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Nasopharyngitis, Pyrexia
Clinical narrative: High fever; Other symptoms of a cold; This is a spontaneous report from a non-contactable consumer. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot/batch number not reported), via an unspecified route of administration on an unspecified date at a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The consumer reported the secondary effects of the Covid-19 Pfizer Vaccine. The consumer reported that a patient was vaccinated with Pfizer's Covid vaccine at a Medical Center on an unspecified date. The patient was having several secondary effects due to the vaccination. He has high fever and other symptoms of a cold on an unspecified date. The outcome of the events was unknown.  No follow-up attempts are possible: information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Pain, Pyrexia
Clinical narrative: fever; body aches; had 2nd dose of COVID-19 vaccine yesterday at 17 days from 1st dose; This is a spontaneous report from a contactable consumer via a Pfizer Sponsored Program. A female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient has historical COVID-19 vaccine BNT162B2 as first dose on unspecified date. The patient had 2nd dose of COVID vaccine yesterday at 17 days from 1st dose. The patient was experiencing fever and body aches and is wondering if taking the 2nd dose at 17 days was alright. The outcome of the events was unknown.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Pain assessment, Vaccination site pain
Clinical narrative: First dose side effect of moderate 6/10 injection site pain; This is a spontaneous report from a contactable physician. A 35-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in left arm on 17Dec2020 11:00 at single dose for an COVID-19 immunization. The patient medical history included attention deficit hyperactivity disorder (ADHD), allergic rhinitis (no serious/life threatening allergies). Known allergies: isoniazid (rash). The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. First dose side effect of moderate 6/10 injection site pain, responded well to naproxen. Did not seek medical care. Prior to vaccination, the patient was not diagnosed with COVID19. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the event was recovering.  Information on the Lot/Batch Number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Oral herpes
Clinical narrative: Cold sores; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 06Jan2021 at single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient got the COVID Vaccine on 06Jan2021, the first shot and the patient now had broken out with cold sores and the patient has had cold sores before in mouth. Normally, the patient would just take some Acyclovir and Valacyclovir (Intent: Treatment) that had prescribed by doctor but now the patient was concerned about taking it (Acyclovir and Valacyclovir) and it doing something to the vaccine and making it not as efficacious. The patient wondered if that is true. Outcome of the event was unknown.  Information on Lot/Batch has been requested.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Disease recurrence, Laboratory test
Clinical narrative: Feels a little weaker/ a little weak like after the Flu shot; Feels a little weaker/ a little weak like after the Flu shot; This is a spontaneous report from a contactable nurse (patient). A 75-years-old female patient received the second dose of of BNT162B2 (PFIZER-BIONTECH COVID-19, Batch/lot number: EK5730), via an unspecified route of administration on 06Jan2021 at 0.3 mL single (reported as 0.3cc injection) for covid-19 immunization (reported as works with COVID patients on daily basis). Medical history included hypertension, hip replacement from an accident four years before 07Jan2021 in December (Dec2016). The patient was not overweight, exercises, was older, but considered in good health. The had labs in Dec2020 and everything was ok. The patient's concomitant medications were not reported. The past vaccine event included weak after the Flu shot and first dose BNT162B2 on 16Dec2020 (75-years-old) and experienced dental implants and bridge fell out, bones were hurting her, pain in hip. It was reported on 06Jan2021 1PM (06Jan2021 13:00) was kind of weak. And felt a little weaker on 06Jan2021 and 07Jan2021. She did not have a temperature. She wants to know if this only happened to her or if it was a coincidence. She felt ok, but a little weak like after the Flu shot. The event outcome was unknown.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: soreness in the left arm; This is a spontaneous report from a contactable healthcare professional reporting for herself.   A 46-year-old female patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EK5730, expiry date 31Mar2021) via an unspecified route of administration in the left arm on 18Dec2020 right before 9:00 am for COVID-19 immunization. Medical history included migraine (she occasionally had migraines and treated it with ibuprofen). The patient's concomitant medication included ibuprofen for migraine. No other vaccine received within 4 weeks. The patient experienced soreness in the left arm on 18Dec2020. The event lasted for a day and a half and was resolved on 20Dec2020.   The reporter considered the event soreness in the left arm was related to the vaccine.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Paraesthesia
Clinical narrative: paresthesia of the left arm and hand; heaviness of the left arm.; This is a spontaneous report from a contactable healthcare professional reporting for herself. A 46-year-old female patient received the second single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EK9231, expiry date 30Apr2021) via an unspecified route of administration in the left arm on 08Jan2021 at 15:30 for COVID-19 immunization. Medical history included migraine (she occasionally had migraines and treated it with ibuprofen). The patient's concomitant medication included ibuprofen for migraine (the last dose of Ibuprofen was two or three days ago before 08Jan2021). The patient had received the first single dose of BNT162B2 on 18Dec2020 for COVID-19 immunization and experienced soreness in the left arm which lasted for a day and a half. No other vaccine received within 4 weeks.   The patient experienced paresthesia of the left arm and hand on 08Jan2021. She received the first dose of the vaccine on 18Dec2020 in her left arm and had some soreness in the left arm at that time, which was resolved on 20Dec2020 (event reported in AER 2021019477). On 08Jan2021, she received the second dose also in her left arm and within five minutes she had this strange paresthesia of the left arm and hand. She also described it as strange heaviness of the left arm. No limited range of motion of the left arm. She didn't know if it was serious. She didn't visit emergency room or physician office. After two hours (the time of reporting) she still had the same sensation. The event was not resolved.   The reporter considered the event paresthesia of the left arm and hand was related to the vaccine.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Blood calcium, Blood glucose, Blood test, Breast pain
Clinical narrative: feeling fatigue; she has swollen lymph nodes in the right axillary area and the right breast; swollen lymph nodes in the right axillary area and the right breast: She noticed at night on 05Jan2021 because it was sore; swollen lymph nodes in the right axillary area and the right breast: She noticed at night on 05Jan2021 because it was sore; had a slightly elevated Hemoglobin; soreness in the left arm where she received injection; This is a spontaneous report from a contactable consumer.  A 33-year-old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EK9231) in the left arm via an unspecified route of administration on 29Dec2020 08:00 at single dose for covid-19 immunisation. Medical history included supraventricular tachycardia  from 2015 (It is under control currently. She was diagnosed in 2015 and she had ablation right away). The patient got the flu vaccine which was required by her workplace was Oct2020. She had flu symptoms, sore throat, and a little headache. Concomitant medication included colecalciferol (VITAMIN D) from 2020 and ongoing. The main side effects was soreness in the left arm where she received injection for one to two days. She couldn't lift her arm. Soreness in the left arm started around 17:00 on 29Dec2020. The patient had a physical on Monday (04Jan2021) and everything was perfectly fine. When she did all the blood work and everything was fine. She had a CBC count on Monday (04Jan2021) and the white blood count was normal. She had a slightly elevated Hemoglobin. All other test like calcium and blood sugar were all normal. Swollen lymph nodes in the right axillary area and the right breast: She noticed at night on 05Jan2021 because it was sore. Then on 06Jan2021 when she looked in the mirror she flexed her arm and saw a line around the breast and it was a little swollen. She got the injection in the left arm. She clarified that she has swollen lymph nodes in the right axillary area and the right breast. There is no swelling on the left. The patient stated today (08Jan2021) the swollen lymph nodes and breast is worse. She is feeling fatigue and can't palpate nodes in breast or axillary area. When she lifts her arm there is a line on the right breast. The outcome of Swollen lymph nodes was not recovered; of other events was unknown.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Full blood count, Haemoglobin, Haemoglobin increased, Lymphadenopathy
Clinical narrative: feeling fatigue; she has swollen lymph nodes in the right axillary area and the right breast; swollen lymph nodes in the right axillary area and the right breast: She noticed at night on 05Jan2021 because it was sore; swollen lymph nodes in the right axillary area and the right breast: She noticed at night on 05Jan2021 because it was sore; had a slightly elevated Hemoglobin; soreness in the left arm where she received injection; This is a spontaneous report from a contactable consumer.  A 33-year-old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EK9231) in the left arm via an unspecified route of administration on 29Dec2020 08:00 at single dose for covid-19 immunisation. Medical history included supraventricular tachycardia  from 2015 (It is under control currently. She was diagnosed in 2015 and she had ablation right away). The patient got the flu vaccine which was required by her workplace was Oct2020. She had flu symptoms, sore throat, and a little headache. Concomitant medication included colecalciferol (VITAMIN D) from 2020 and ongoing. The main side effects was soreness in the left arm where she received injection for one to two days. She couldn't lift her arm. Soreness in the left arm started around 17:00 on 29Dec2020. The patient had a physical on Monday (04Jan2021) and everything was perfectly fine. When she did all the blood work and everything was fine. She had a CBC count on Monday (04Jan2021) and the white blood count was normal. She had a slightly elevated Hemoglobin. All other test like calcium and blood sugar were all normal. Swollen lymph nodes in the right axillary area and the right breast: She noticed at night on 05Jan2021 because it was sore. Then on 06Jan2021 when she looked in the mirror she flexed her arm and saw a line around the breast and it was a little swollen. She got the injection in the left arm. She clarified that she has swollen lymph nodes in the right axillary area and the right breast. There is no swelling on the left. The patient stated today (08Jan2021) the swollen lymph nodes and breast is worse. She is feeling fatigue and can't palpate nodes in breast or axillary area. When she lifts her arm there is a line on the right breast. The outcome of Swollen lymph nodes was not recovered; of other events was unknown.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, White blood cell count
Clinical narrative: feeling fatigue; she has swollen lymph nodes in the right axillary area and the right breast; swollen lymph nodes in the right axillary area and the right breast: She noticed at night on 05Jan2021 because it was sore; swollen lymph nodes in the right axillary area and the right breast: She noticed at night on 05Jan2021 because it was sore; had a slightly elevated Hemoglobin; soreness in the left arm where she received injection; This is a spontaneous report from a contactable consumer.  A 33-year-old female patient started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EK9231) in the left arm via an unspecified route of administration on 29Dec2020 08:00 at single dose for covid-19 immunisation. Medical history included supraventricular tachycardia  from 2015 (It is under control currently. She was diagnosed in 2015 and she had ablation right away). The patient got the flu vaccine which was required by her workplace was Oct2020. She had flu symptoms, sore throat, and a little headache. Concomitant medication included colecalciferol (VITAMIN D) from 2020 and ongoing. The main side effects was soreness in the left arm where she received injection for one to two days. She couldn't lift her arm. Soreness in the left arm started around 17:00 on 29Dec2020. The patient had a physical on Monday (04Jan2021) and everything was perfectly fine. When she did all the blood work and everything was fine. She had a CBC count on Monday (04Jan2021) and the white blood count was normal. She had a slightly elevated Hemoglobin. All other test like calcium and blood sugar were all normal. Swollen lymph nodes in the right axillary area and the right breast: She noticed at night on 05Jan2021 because it was sore. Then on 06Jan2021 when she looked in the mirror she flexed her arm and saw a line around the breast and it was a little swollen. She got the injection in the left arm. She clarified that she has swollen lymph nodes in the right axillary area and the right breast. There is no swelling on the left. The patient stated today (08Jan2021) the swollen lymph nodes and breast is worse. She is feeling fatigue and can't palpate nodes in breast or axillary area. When she lifts her arm there is a line on the right breast. The outcome of Swollen lymph nodes was not recovered; of other events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: little sore on the injection spot; This is a spontaneous report from a non-contactable pharmacist. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 06Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced "only felt little sore on the injection spot, no other symptoms and feeling great, so far." The outcome of the event was unknown.   No follow up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: FLUX
Symptoms: Bronchitis, Cough
Clinical narrative: I get bronkidious after the Flu shots; 3 days 24/7 coughing; Initial information received on 11-Dec-2020 regarding an unsolicited valid non-serious case was received from a consumer (patient) via social media.  This case involves an unknown age patient who get bronkidious after the Flu shots (bronchitis) , 3 days 24/7 coughing (cough), while he/she received vaccine Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a dose of suspect Influenza Vaccine produced by unknown manufacturer lot number not reported via unknown route in unknown administration site, for Prophylactic vaccination.  On an unknown date, it was reported that patient get bronkidious after the Flu shots (bronchitis) , 3 days 24/7 coughing (cough) will just take you out (Unknown latency) following the administration of Influenza Vaccine.  Final diagnosis was patient get bronkidious after the Flu shots and 3 days 24/7 coughing.   No laboratory data was reported.  It was not reported if the patient received a corrective treatment.  The event outcome was reported as Unknown for both events.  No further information was reported.
Sex: F
Vaccine: FLU4
Symptoms: Hypokinesia, Tremor, Vomiting, Weight decreased
Clinical narrative: shakes; She could not move her hands and toes, the back of her legs and arms; She has  lost 13 pounds/She reports she felt like she had no skin on her bones; She was vomiting.; Initial information received on 06-Jan-2021 regarding an unsolicited valid non-serious case received from a consumer.  This case involves Elderly female patient who experienced shakes (tremor), she could not move her hands and toes, the back of her legs and arms (hypokinesia), she was vomiting. (vomiting), she has  lost 13 pounds/she reports she felt like she had no skin on her bones (weight decreased), while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QIV].  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications were unknown.  On 03-Nov-2020, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot J536AA via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious shakes (tremor), she could not move her hands and toes, the back of her legs and arms (hypokinesia), she was vomiting. (vomiting), she has  lost 13 pounds/she reports she felt like she had no skin on her bones (weight decreased) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Relevant laboratory data was not reported.  It was not reported if the patient received a corrective treatment.  The outcome was reported as Resolving for all events.
Age: 0.92
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: expired dose of DAPTACEL was given to a patient an 11 month old patient/no AE; Initial information regarding an unsolicited valid non-serious case via Agency (Reference number- 00420720) was received from a nurse and transmitted to Sanofi on 07-Jan-2021.  This case involved an 11 month old male patient who received an expired dose of 0.5 ml of DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot number: C5367AA and Expiry date: 30-Jan-2021) on 07-Jan-2021 via unknown route at an unknown administration site for prophylactic vaccination (expired product administered).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HIB VACCINE CONJ (TET TOX) (ACT-HIB) for prophylactic vaccination.  It was an actual medication error case due to expired vaccine used (latency same day).   At the time of reporting, no adverse event was reported.  Nurse stated another staff member couldn't put the product lot into the computer after she gave the dose. Also stated the employee was new and fortunately this was the first dose out of this box but didn't know how it slipped by and stayed in the refrigerator so long.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 42.0
Sex: F
Vaccine: HPV9, UNK
Symptoms: Product storage error
Clinical narrative: no additional AE; temperature excursion; This spontaneous report was received from medical assistant and refers to a 42-year-old female patient. Her pertinent medical history, concomitant medications and drug reactions or allergies were unknown.  On 28-DEC-2020, the patient was vaccinated with improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (exact dose and route of administration were not reported) lot # S022598, expiration date 25-FEB-2022, 1 dose for prophylaxis. The medical assistant reported that the temperature excursion occurred on 24-DEC-2020, recorded temperature was 47.77 degrees Fahrenheit (F) for 31 minutes and there was no previous excursion. A digital data logger was used to capture the excursion. No additional adverse event was reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S022598; expirationdate: 25-FEB-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: F
Vaccine: VARZOS
Symptoms: Blood immunoglobulin G increased, Dyskinesia, Facial paralysis
Clinical narrative: Alterations in her mouth that seemed Bell´s Palsy; Not sure whether patient has Bell´s Palsy or shingles; This case was reported by a physician via call center representative and described the occurrence of bell's palsy in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th November 2020, the patient received the 1st dose of Shingrix. On 4th December 2020, 9 days after receiving Shingrix, the patient experienced bell's palsy (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the bell's palsy and shingles were unknown.   It was unknown if the reporter considered the bell's palsy and shingles to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported, however it could be 75 or 76 years old. On 4th December 2020, the patient experienced little alterations in her mouth that seemed Bell´s Palsy. Her VZV (Varicella zoster virus) IgM antibodies levels were measured 4 weeks after vaccination and they had increased.  The reporter was not sure whether patient had Bell´s palsy or shingles. The reporter was reticent to provide details but agreed to follow-up.
Age: 4.0
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: FLUBLOK was administered to 4 year old female patient with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from a nurse via Medical Information (Reference number- 00414233) and transmitted to Sanofi on 04-Jan-2021.  This case was linked with 2021SA002156, 2021SA002607, 2021SA002631, 2021SA002726, 2021SA002799, 2021SA002850, 2021SA002575, 2021SA003127, 2021SA003182, 2021SA002085 (same reporter)  This case involved a 4 year old female patient who was administered with a standard 0.5ml dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (prefilled syringe, lot UJ509AA, expiration date 10 May 2021) once via intramuscular route at the left deltoid for prophylactic vaccination on 22-Dec-2021 (Product administered to patient of inappropriate age).  Medical history, past medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MEASLES VACCINE LIVE (ENDERS-EDMONSTON), MUMPS VACCINE LIVE (JERYL LYNN), RUBELLA VACCINE LIVE (WISTAR RA 27/3) (MMRVAXPRO) and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (KINRIX) both for prophylactic vaccination.   It was a case of actual medication error due to inappropriate age at vaccine administration (latency-same day).   Reporter stated that FLUBLOK had been administered to 11 pediatric patients and would like to know if patients were covered for influenza vaccination for the season  At the time of reporting, no adverse event reported (reported as none).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLU4
Symptoms: Unevaluable event
Clinical narrative: The patient had an adverse event reaction at some point; Initial information received on 08-Jan-2021 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a patient who experienced the patient had an adverse event reaction at some point (adverse event), while he/she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.   Concomitant medications were unknown.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious the patient had an adverse event reaction at some point (adverse event) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Relevant laboratory data was not reported.  It was not reported if the patient received a corrective treatment.  The patient outcome is reported as Unknown for the patient had an adverse event reaction at some point.  There will be no information available on the batch number for this case.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthropathy, Chest X-ray normal, Cold sweat, Computerised tomogram head normal, Computerised tomogram neck
Clinical narrative: Generalized myalagias, weakness, vertigo, nausea with emesis, one episode of urinary incontinence. Admitted for observation. Patient improved without intervention with some residual dizziness on day two of symptoms.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Echocardiogram normal, Hyperhidrosis, Magnetic resonance imaging brain normal, Magnetic resonance imaging neck, Motion sickness
Clinical narrative: Generalized myalagias, weakness, vertigo, nausea with emesis, one episode of urinary incontinence. Admitted for observation. Patient improved without intervention with some residual dizziness on day two of symptoms.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Muscle disorder, Troponin I increased, Urinary incontinence, Vertigo, Vision blurred
Clinical narrative: Generalized myalagias, weakness, vertigo, nausea with emesis, one episode of urinary incontinence. Admitted for observation. Patient improved without intervention with some residual dizziness on day two of symptoms.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: Generalized myalagias, weakness, vertigo, nausea with emesis, one episode of urinary incontinence. Admitted for observation. Patient improved without intervention with some residual dizziness on day two of symptoms.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, Chest X-ray normal, Computerised tomogram head normal, Dizziness, Electrocardiogram normal
Clinical narrative: Generalized myalagias, weakness, vertigo, nausea with emesis, one episode of urinary incontinence. Admitted for observation. Patient improved without intervention with some residual dizziness on day two of symptoms.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Magnetic resonance imaging brain normal, Myalgia, Nausea, Troponin increased, Urinary incontinence
Clinical narrative: Generalized myalagias, weakness, vertigo, nausea with emesis, one episode of urinary incontinence. Admitted for observation. Patient improved without intervention with some residual dizziness on day two of symptoms.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Vertigo, Vomiting
Clinical narrative: Generalized myalagias, weakness, vertigo, nausea with emesis, one episode of urinary incontinence. Admitted for observation. Patient improved without intervention with some residual dizziness on day two of symptoms.
Age: 53.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: Generalized myalagias, weakness, vertigo, nausea with emesis, one episode of urinary incontinence. Admitted for observation. Patient improved without intervention with some residual dizziness on day two of symptoms.
Age: 59.0
Sex: F
Vaccine: FLUC4, VARZOS
Symptoms: Abdominal distension, Chills, Fatigue, Muscular weakness, Pain
Clinical narrative: Significant shivering, especially from hips down through legs and feet and heat in kidneys area, headache, muscle weakness in both legs, energetic fatique, painful digestive bloat with pain wrapping around front and back of left-bottom of rib cage and radiating up left side of spine into back of left shoulder--this pain was so significant that it was difficult to take full breaths. Taking an NSAID helped to reduce this pain. Digestive distress continued daily for approximately 12 days, not as painful as the first attack.  Bottom of left side of ribcage remains slightly tender to date.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Dry mouth, Enlarged uvula, Flushing, Swollen tongue, Tachycardia
Clinical narrative: Flushing sensation, tachycardia, tongue swelling, dry mouth - occurred within 3 minutes of receiving vaccine.  Benadryl 25 mg PO was immediately administered.  I was observed for approximately 75 minutes.  Dry mouth, flushing, and tachycardia resolved.  I was able to eat and drink and drove home.  My uvula appeared swollen until approximately 5 hours after the injection.
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Mobility decreased, Muscular weakness, Vaccination site movement impairment
Clinical narrative: Patient states that the vaccine administered to his left arm worsened his left arm weakness. He had surgery as listed earlier on 12/2/2020, he then mentioned to multiple healthcare providers on 12/21/2020 that he could not lift his left arm past his nipple line. He was then started on dexamethasone for three days. The vaccine was then given on 12/24/2020 to the left deltoid. Of note, PPSV23 was given to his right arm that day as well. The patient then states that a few days later and according to our documentation (1/2/21) he could no longer lift his left arm past his navel. He has been getting occupational/physical therapy with minimal to no improvement.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Eye pain, Eye pruritus, Eye swelling, Ocular hyperaemia
Clinical narrative: Itchy eyes. Skin around both eyes turned red and puffy.  Lasted about 24 hours.  Stinging sensation in both eyes.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Bundle branch block right, Chest pain, Electrocardiogram abnormal, Eructation, Gastrointestinal disorder
Clinical narrative: History of Present Illness:   Patient is a 80 y.o. male who presents with chest pain.  Patient reported that he 1st had the chest pain approximately 2 weeks ago when he woke from sleep.  At that time patient pain lasted about 5 minutes or so and resolved when he got out of bed.  He did well for the rest of the day up until yesterday.  Patient reported that yesterday morning he woke up with the pain at the lasted about 30 minutes or so.  Patient also had associated burping felt that it is likely GI in nature.  The pain was located mainly in the left side of the chest without any radiation.  No diaphoresis.  No shortness of breath or palpitation.  No radiation for the pain.  Since yesterday morning he had another 3 episodes of pain the last after dinner tonight.  Patient reported that this pain was located more on the left side of the chest, likely lasted about 10 minutes or so.  There was no exertional component to the pain.  No known history of heart disease.  Due to rather recurrent nature of the pain patient was brought to the hospital by his son who is a cardiologist to be evaluated.  No fever or chills.  No cough . Patient reported that he got vaccination for COVID 2 days ago-of a concern that this may be a side effect of the vaccine.  No dizziness lightheadedness. Patient with history of GI bleed in the past at that time patient was on NSAIDs.  Patient with burping associated with the pain