chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: got ringing in his left ear; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 64 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04Mar2021 (Lot number: EN6203, Expiration Date: Jun2021) at the age of 64 years as dose 1, single and administered in arm left, administration date 25Mar2021 (Lot number: EN6205, Expiration Date: Jun2021) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ROSUVASTATIN. The following information was reported: TINNITUS (non-serious) with onset 2021, outcome "not recovered", described as "got ringing in his left ear".  Additional information: The consumer stated he had the first dose of the vaccine on 04Mar2021 and got ringing in his left ear and wanted to know if he is the only one or if other people have reported this. Consumer stated I had my first Pfizer shot back in 01Mar2021 and I was just curious to see if anybody else complaining about ear ringing, my left ear, right after the shot probably a day or 2 after the shot is been ringing constant for this all time and I just got my second shot on the 25Mar I was wondering if that's the side effect with the shot, anybody else been complaining about. My son was the pharmacist. I actually talked to him about this after I had the shot he looked it up on his phone it did show that people were having some issues with ringing after the Covid shot. So, I want to speak to somebody right from Pfizer to get the accurate report of what is going on. Patient History: No  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: leg pain constantly; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program (159558). The reporter is the patient.  A 54 year-old female patient received bnt162b2 (BNT162B2), administration date 03Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: IBUPROFEN taken for pain in extremity. Vaccination history included: Pfizer-biontech covid-19 vaccine (1st dose -13Mar2021), administration date: 13Mar2021, for covid-19 immunisation. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "leg pain constantly". Therapeutic measures were taken as a result of pain in extremity.  Additional information: The patient has been taking Ibuprofen for leg pain constantly. Did not advise her doctor and vaccination provider about her pain medications and asking if it is ok to take Ibuprofen. she did not remember if it was ok to take Tylenol or Ibuprofen and wanted to know which one, she can take. Said that she normally takes Ibuprofen, and has been prior to taking the vaccine; also, she has already received her second dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Diarrhoea, Off label use, Product use issue, Vomiting
Clinical narrative: She is 10 or 11 years old and had the vomiting and diarrhea.; She is 10 or 11 years old and had the vomiting and diarrhea.; Vomiting; Diarrhea; This is a spontaneous report received from a contactable reporter (Consumer).  A child female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose number unknown, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious), outcome "unknown" and all described as "She is 10 or 11 years old and had the vomiting and diarrhea."; VOMITING (non-serious), outcome "unknown", described as "Vomiting"; DIARRHOEA (non-serious), outcome "unknown", described as "Diarrhea". Relevant laboratory tests and procedures are available in the appropriate section. Additional Information: Patient age was reported as 10 or 11 years old. All of the patient's family has a low temperature of 97.2 and for some reason it hit them. Patient's mother is a doctor and doesn't want to get involved. Patient's mother had taken of everything and doesn't know anything else about this case.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: about an hour after the injection, the allergy symptoms and cough completely disappeared completely; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 30Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "cough variant allergic asthma" (unspecified if ongoing), notes: I have cough variant allergic asthma, take inhalers for it, but cough incessantly. The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "about an hour after the injection, the allergy symptoms and cough completely disappeared completely". Additional information: It was reported that even with the patient's allergy injection where cough was always there disappeared completely. The patient stated that it was a happy side effect.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Diarrhoea, Vomiting
Clinical narrative: Vomiting; Diarrhea; This is a spontaneous report received from a contactable reporter (Consumer).  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose number unknown, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VOMITING (non-serious), outcome "unknown", described as "Vomiting"; DIARRHOEA (non-serious), outcome "unknown", described as "Diarrhea". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Reporter was a consumer reporting on her grand niece who was a doctor and a professor. Reporter stated all of them had a low temperature of 97.2. She explained all of the family were low temperature and for some reason it hit them. She didn't want to get involved regarding this because she was a doctor and she took care of it. She didn't know anything else about it.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: sore arm; Tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; FATIGUE (non-serious), outcome "unknown", described as "Tired".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Pain in extremity
Clinical narrative: sore arm; Diarrhea since day got 2nd shot; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 57 year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 31Mar2021 (Lot number: EWOISO) at the age of 57 years as dose 2, single for Covid-19 immunisation. Relevant medical history included: "Type 2 Diabetic" (unspecified if ongoing); "Lactose intolerant" (unspecified if ongoing). Concomitant medication(s) included: OZEMPIC; FARXIGA; SIMVASTATIN; UBRELVY. Vaccination history included: Bnt162b2 (DOSE 1; lot number: ENG207; administration time: 02:30 PM; anatomical location: Arm left), administration date: 09Mar2021, when the patient was 57 years old, for COVID-19 immunization, reaction(s): "sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 31Mar2021 17:00, outcome "unknown", described as "sore arm"; DIARRHOEA (non-serious) with onset 31Mar2021 17:00, outcome "unknown", described as "Diarrhea since day got 2nd shot". Therapeutic measures were not taken as a result of pain in extremity, diarrhoea. Additional Information: There are no other vaccine administered within 4 weeks. Patient has not tested positive for Covid prior/post vaccination. Patient was taking unspecified vitamin.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021361153 same drug/reporter, different dose and events
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Pain; Upon receipt of follow-up information on (16Apr2021), this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (005570). The reporter is the patient.  A 64 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 13Mar2021 11:45 (Lot number: EN6202) at the age of 64 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: PAIN (non-serious), outcome "unknown", described as "Pain". Therapeutic measures were taken as a result of pain.  Additional information: It was reported that she just had a visit with her orthopedic surgeon and was given a corticosteroid shot in her left arm. She didn't even think until today to ask about whether it would effect the vaccine. Now it did not seem like she had an option to hold off the second vaccine, so she would like to know if there would be an issue with efficacy. She should be 80% vaccinated from the first shot. Vaccine was not Administered at Military Facility. No prior vaccinations. The patient was administered with Second dose on 10Apr2021 at 11:15 via intramuscular route of administration in right arm with batch and lot number was EN6200. Corticosteroid injection stated as a treatment for Pain on 01Apr2021. Relevant test reported as none.   No follow-up attempts are possible. No further information is expected.  Follow-up (16Apr2021): New information received from a contactable consumer. A 64-years-old female (patient) reported in response to consumer letter sent via follow-up letter which included that: case considered as valid, updated information: age at vaccination, event added, suspect vaccine information, relevant medical history, treatment.    Follow-up attempts are completed. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: Did not feel well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 63-year-old male patient received BNT162B2 (BNT162B2), administration date 26Mar2021 (Batch/Lot number: unknown) at the age of 63 years as dose 1, single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious) with onset 26Mar2021, outcome "recovered" (29Mar2021), described as "Did not feel well". Additional information: The patient did not feel well for 3 days after getting the 1st dose. He asked if he will be experiencing more side effects on the 2nd dose. He was schedule to get the 2nd dose on 14Apr2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Movement disorder, Pain in extremity, Product administered at inappropriate site
Clinical narrative: Doctor gave shot high up on the shoulder part of her arm, near bone not the muscle of the arm, it hurt and did sting when he gave it; Pain in arm; Can't lift arm/ Cannot write; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 68 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 31Mar2021 10:00 (Lot number: EP6955) at the age of 68 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "allergy: Penicillin Allergy" (unspecified if ongoing), notes: verbatim: Mentions Penicillin Allergy. The patient's concomitant medications were not reported. The following information was reported: PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious) with onset 31Mar2021, outcome "unknown", described as "Doctor gave shot high up on the shoulder part of her arm, near bone not the muscle of the arm, it hurt and did sting when he gave it"; PAIN IN EXTREMITY (non-serious) with onset 31Mar2021, outcome "recovering", described as "Pain in arm"; MOVEMENT DISORDER (non-serious) with onset 31Mar2021, outcome "not recovered", described as "Can't lift arm/ Cannot write".  Additional Information: Vaccination facility type was Vaccination Center. The Caller, called to advise that she had her first dose of the covid-19 vaccine yesterday, 31Mar2021 and she had been feeling a lot of pain in her arm and cannot lift it without feeling pain. She also said that the Doctor who administered the vaccine has injected the vaccine up high into the shoulder's bone part, not the muscle in the arm. Everyone told her it doesn't hurt, and she doesn't like needles; but it did hurt and did sting when he gave it. States it was high up on the shoulder part of her arm, near bone not down where the muscle of the arm is. There were no unaddressed medical questions referred or forwarded to Medical Information.     No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Speech disorder, Stress
Clinical narrative: lot of anxiety; stress; talking is difficult with the screeching; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ANXIETY (non-serious), described as "lot of anxiety"; STRESS (non-serious), described as "stress"; SPEECH DISORDER (non-serious), described as "talking is difficult with the screeching". It was unknown if therapeutic measures were taken as a result of anxiety, stress, speech disorder.  Additional information: It was reported that, this report was cross referenced to report ID #. The caller stated that, she wanted to find out what could be done to help with a reaction to the Pfizer Covid vaccine. The reporter details stated that, she normally goes by #. The caller stated that, she did not get the second dose and would not let her daughter get it either, because she did not know what else it could do. Stated that, her life was destroyed if this didn't get better. Stated that, it has been causing a lot of anxiety and stress. Stated that, talking was difficult with the screeching. The reason for no lot number of Pfizer Covid 19 vaccine was not probed over call.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Vaccination site pain, Vaccination site swelling
Clinical narrative: The Area outside the 'injection site' 2 or 3 inches away from it is also sore; when I lay on it the first night I could feel the sting, now it's a tiny bit swollen the injection spot, feel the pain or slight swelling; when I lay on it the first night I could feel the sting, now it's a tiny bit swollen the injection spot, feel the pain or slight swelling; when I lay on it the first night I could feel the sting, now it's a tiny bit swollen the injection spot, feel the pain or slight swelling; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 64 year-old female patient received bnt162b2 (BNT162B2), administration date 04Apr2021 (Batch/Lot number: unknown) at the age of 64 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 immunisation. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "The Area outside the 'injection site' 2 or 3 inches away from it is also sore"; PAIN (non-serious), VACCINATION SITE SWELLING (non-serious), VACCINATION SITE PAIN (non-serious), outcome "unknown" and all described as "when I lay on it the first night I could feel the sting, now it's a tiny bit swollen the injection spot, feel the pain or slight swelling".  Additional Context: It was reported that three weeks ago patient  got  her first dose of Pfizer and it was very uneventful and everything was fine. she had a typical you know soreness at the vaccination site just for one night and everything was great. Today she  had her  second dose and as far as I know it went well, I feel okay but it's unusual it is different from the first time, so she  has a  little concern as  have pain in her arm, not only in the vaccination site but two or three inches away from it going towards the inside of my arm." "The pain was different this time. The vaccination site off course it is going to be soreness but the soreness is also in two or three inches away from the vaccination site going towards the inside of my arm.  .   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vertigo
Clinical narrative: dizziness; vertigo; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 62 year-old female patient received bnt162b2 (BNT162B2), administration date 16Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious) with onset Mar2021, outcome "unknown", described as "dizziness"; VERTIGO (non-serious) with onset Mar2021, outcome "recovering", described as "vertigo". Therapeutic measures were taken as a result of vertigo.  Additional information: Seven to 10 days later after first dose, she developed vertigo and they put her on anti-vertigo, it was better but not yet gone. The patient was due for her 2nd injection tomorrow (06Apr2021) and was asking if it was a side effect. Patient asked if we recommend an antidote to take for vertigo if she gets the second dose. Patient also asked how long after the first dose would she have dizziness and what will happen if she only gets one dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, SARS-CoV-2 antibody test
Clinical narrative: Cold; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 12Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NASOPHARYNGITIS (non-serious) with onset 2021, outcome "unknown", described as "Cold". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient had the first dose of the Pfizer vaccine on 12Mar2021 and she was due for the next on 02Apr2021 (tomorrow). She had a question. She had a cold, not a terrible cold and no fever, just a standard cold. The patient had a Covid test this week and she doesn't have it, just a cold. She asked if she should just take it anyway tomorrow or wait until Monday. She was getting better. It was a standard cold.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigue after vaccination; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "Fatigue after vaccination".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: White blood cell count, White blood cell count increased
Clinical narrative: WBC 19,000; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A 67 year-old female patient received bnt162b2 (BNT162B2), administration date 31Mar2021 (Batch/Lot number: unknown) at the age of 67 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, manufacturer unknown), for Covid-19 immunisation. The following information was reported: WHITE BLOOD CELL COUNT INCREASED (non-serious) with onset 31Mar2021, outcome "unknown", described as "WBC 19,000". The event "wbc 19,000" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The reporter stated his mom was in her early 70s and her and his father got their second dose on Monday. Stated his mom had follow up blood work done yesterday and her white blood cell count was 19,000. Stated he was curious if this was common for someone that got the second dose of the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased
Clinical narrative: Vaccine raises blood sugar; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 21Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetic" (unspecified if ongoing), notes: I'm diabetic, I'm unsure. I watch my sugar really closely.; "keto diet" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: BLOOD GLUCOSE INCREASED (non-serious), outcome "unknown", described as "Vaccine raises blood sugar". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Patient age was reported as 57 (unit: not reported). Clinical course: It was reported that patient was diabetic. He watches sugar really closely. He was on the keto diet. First dose 21Mar2021, 3 days ago. Second dose 12Apr2021. Three days ago. 110, 120, 160. Combining the keto diet with fasting. Patient only eat once per day. He hasn't eating in two days. After 36 hours of fasting. Vaccine raises blood sugar.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 76 year-old male patient received bnt162b2 (BNT162B2), administration date 30Mar2021 14:00 (Lot number: EN6208) at the age of 76 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Type 2 diabetic" (ongoing), notes: Diagnosed 3-4 years ago; states he takes no medication for it. The patient's concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 03Apr2021, outcome "not recovered", described as "fatigue". Therapeutic measures were not taken as a result of fatigue.  Additional Information: Initially told caller that we have no info on the onset and duration. But upon carefully reviewing the documents available, I saw the attached document and immediately called back consumer to correct the information. Also, consumer confirmed that he called in on his HCP/physician clinic and physician confirmed that it was a delayed response for his adverse event. States when he first started experiencing this fatigue, he thought it might be from his diabetes but as it persisted, he doesn't think that is it. States if it is form the diabetes, usually if he eats something it goes away. Any AE(s) require a visit to: Emergency Room: No, Physician Office: No. No prior vaccinations (within 4 weeks). No family medical history relevant to AE(s).  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Headache, SARS-CoV-2 test
Clinical narrative: headaches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 23Mar2021 (Batch/Lot number: unknown) as dose number unknown, single for COVID-19 immunisation. Relevant medical history included: "COVID exposure", start date: Jan2021 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset Mar2021, outcome "unknown", described as "headaches". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site pain
Clinical narrative: my arm still hurts where they gave me the shot.; muscle is still sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 62 year-old female patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "not recovered", described as "my arm still hurts where they gave me the shot."; MYALGIA (non-serious) with onset 2021, outcome "not recovered", described as "muscle is still sore". Therapeutic measures were taken as a result of vaccination site pain, myalgia.  Additional information: The patient got the second shot over a month ago. And her arm still hurts where they gave her the shot. The muscle is still sore. Sometimes she has to take Advil cause it hurts.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: the first made my arm sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "the first made my arm sore".  Follow Up#1 Information (07pr2021) This is a spontaneous report from a contactable Consumer. This Female consumer reported that: This sounds odd but the second Pfizer shot was totally different from the first. Needle seemed smaller. Sort of like the flu shot you would get at a doctor's office. Bandaid seemed to go on first (which makes no sense) and I didn't see the  needle go in. No reaction while the first made my arm sore. Hours later nothing. Pharmacy said this is normal. Just commenting  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pre-existing condition improved, Therapeutic response unexpected
Clinical narrative: After receiving the Pfizer vaccination all those fore-mentioned things were gone/cloudiness went away in her head after getting vaccine; After receiving the Pfizer vaccination all those fore-mentioned things were gone/cloudiness went away in her head after getting vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP) for a Pfizer sponsored program. The reporter is the patient.  A 54-years-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01Apr2021 16:30 (Lot number: ER8734) at the age of 54 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "head beginning to feel cloudy/cloudiness in her head" (unspecified if ongoing), notes: I was not able to walk in a constant circle without my head beginning to feel cloudy. Neither was I able to squat for any amount of time without feeling light-headed upon standing.; "Surgery" (unspecified if ongoing), notes: I had not felt like this since having an IV in my arm when I had major surgery over 30 years ago. The patient's concomitant medications were not reported. The following information was reported: PRE-EXISTING CONDITION IMPROVED (non-serious), THERAPEUTIC RESPONSE UNEXPECTED (non-serious) all with onset 02Apr2021 07:00, outcome "unknown" and all described as "After receiving the Pfizer vaccination all those fore-mentioned things were gone/cloudiness went away in her head after getting vaccine". Therapeutic measures were not taken as a result of pre-existing condition improved, therapeutic response unexpected.  Additional Information: Before taking the PFIZER Vaccine, the patient was not able to walk in a constant circle without head beginning to feel cloudy. Neither was able to squat for any amount of time without feeling lightheaded upon standing. But the day after receiving the Pfizer vaccination, all those fore-mentioned things were gone. She was doing them without any feelings after. She had not noticed her ability to perform these tasks until a co-worker brought it to her attention. She had nothing but the effects of the PFIZER Vaccine to thank for her increased endurance and energy. She had not felt like this since having an IV in her arm when had major surgery over 30 years ago.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: soreness of the left arm; Tiredness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 56 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "soreness of the left arm"; FATIGUE (non-serious), outcome "unknown", described as "Tiredness".  Additional Information: Reported she had a quick question. She stated she got her first Covid-19 Vaccine (on 12Mar2021), and then was out of state when she was supposed to get her second Covid-19 Vaccine (on 02Apr2021). She said she called today to schedule her second Covid-19 Vaccine dose. She said the earliest she could get her second Covid-19 Vaccine would be either 08Apr2021 or 09Apr2021. Caller asked if it would be a problem for her to get her second Covid-19 Vaccine that long after her first Covid-19 Vaccine dose. Caller was advised she would be transferred to Pfizer Medical Information for further assistance.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Metal taste; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 13Mar2021 13:00 (Lot number: EN6208) at the age of 64 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Penicillin allergy" (unspecified if ongoing); "Asthma" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DYSGEUSIA (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "Metal taste".  Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received unspecified other medications within 2 weeks of vaccination. Patient experienced Metal taste after first vaccine and lasted 4/5 Days. Prior to vaccination, patient was not diagnosed with COVID-19. The patient has been not tested for COVID-19 since the vaccination. Patient also received dose 2 on 04Apr2021.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021374583 same patient, different vaccine dose, partial same event
Sex: F
Vaccine: COVID19
Symptoms: Dizziness postural, Fatigue, Malaise, Restlessness, SARS-CoV-2 test
Clinical narrative: serious dizziness upon standing from lying down; tiredness; turning in bed; both times feeling generally unwell; This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient.  A 72 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 23Mar2021 (Lot number: ER2613) as dose 2, single for COVID-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication included: HUMIRA. Vaccination history included: BNT162B2 (Dose 1, Arm left, 04:15 PM, Lot number: EN6202), administration date: 26Feb2021, for COVID-19 Immunization, reactions: "vertigo", "lethargy", "tiredness". The following information was reported: DIZZINESS POSTURAL (non-serious), outcome "not recovered", described as "serious dizziness upon standing from lying down"; FATIGUE (non-serious), outcome "not recovered", described as "tiredness"; RESTLESSNESS (non-serious), outcome "not recovered", described as "turning in bed"; MALAISE (non-serious), outcome "not recovered", described as "both times feeling generally unwell". The events "serious dizziness upon standing from lying down", "tiredness", "turning in bed" and "both times feeling generally unwell" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dizziness postural, fatigue, restlessness, malaise. Additional information: Patient had not had COVID-19 prior to vaccination. She had no known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Depression, Disturbance in attention, Fatigue, Feeling abnormal
Clinical narrative: Anxiety; Mood swings; Depression; Feeling sick; Panic; Fogginess; Difficulty focusing; Fatigue; Nausea; Feeling hot; Sweating; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 54 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 26Mar2021 07:15 (Lot number: ER8730) at the age of 54 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: FATIGUE (non-serious) with onset 27Mar2021, outcome "unknown", described as "Fatigue"; NAUSEA (non-serious) with onset 27Mar2021, outcome "not recovered", described as "Nausea"; FEELING HOT (non-serious) with onset 27Mar2021, outcome "recovering", described as "Feeling hot"; HYPERHIDROSIS (non-serious) with onset 27Mar2021, outcome "recovering", described as "Sweating"; ANXIETY (non-serious) with onset 31Mar2021, outcome "not recovered", described as "Anxiety "; MOOD SWINGS (non-serious) with onset 31Mar2021, outcome "not recovered", described as "Mood swings"; DEPRESSION (non-serious) with onset 27Mar2021, outcome "not recovered", described as "Depression"; MALAISE (non-serious) with onset 27Mar2021, outcome "unknown", described as "Feeling sick"; PANIC REACTION (non-serious) with onset 27Mar2021, outcome "not recovered", described as "Panic"; FEELING ABNORMAL (non-serious) with onset 27Mar2021, outcome "not recovered", described as "Fogginess"; DISTURBANCE IN ATTENTION (non-serious) with onset 27Mar2021, outcome "not recovered", described as "Difficulty focusing". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information:  The patient was not Vaccine Administered at Facility. The patient did not any Adverse event require a visit to ER or MD office.   No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Hyperhidrosis, Malaise, Mood swings, Nausea
Clinical narrative: Anxiety; Mood swings; Depression; Feeling sick; Panic; Fogginess; Difficulty focusing; Fatigue; Nausea; Feeling hot; Sweating; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 54 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 26Mar2021 07:15 (Lot number: ER8730) at the age of 54 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: FATIGUE (non-serious) with onset 27Mar2021, outcome "unknown", described as "Fatigue"; NAUSEA (non-serious) with onset 27Mar2021, outcome "not recovered", described as "Nausea"; FEELING HOT (non-serious) with onset 27Mar2021, outcome "recovering", described as "Feeling hot"; HYPERHIDROSIS (non-serious) with onset 27Mar2021, outcome "recovering", described as "Sweating"; ANXIETY (non-serious) with onset 31Mar2021, outcome "not recovered", described as "Anxiety "; MOOD SWINGS (non-serious) with onset 31Mar2021, outcome "not recovered", described as "Mood swings"; DEPRESSION (non-serious) with onset 27Mar2021, outcome "not recovered", described as "Depression"; MALAISE (non-serious) with onset 27Mar2021, outcome "unknown", described as "Feeling sick"; PANIC REACTION (non-serious) with onset 27Mar2021, outcome "not recovered", described as "Panic"; FEELING ABNORMAL (non-serious) with onset 27Mar2021, outcome "not recovered", described as "Fogginess"; DISTURBANCE IN ATTENTION (non-serious) with onset 27Mar2021, outcome "not recovered", described as "Difficulty focusing". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information:  The patient was not Vaccine Administered at Facility. The patient did not any Adverse event require a visit to ER or MD office.   No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Panic reaction, SARS-CoV-2 test
Clinical narrative: Anxiety; Mood swings; Depression; Feeling sick; Panic; Fogginess; Difficulty focusing; Fatigue; Nausea; Feeling hot; Sweating; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An 54 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 26Mar2021 07:15 (Lot number: ER8730) at the age of 54 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: FATIGUE (non-serious) with onset 27Mar2021, outcome "unknown", described as "Fatigue"; NAUSEA (non-serious) with onset 27Mar2021, outcome "not recovered", described as "Nausea"; FEELING HOT (non-serious) with onset 27Mar2021, outcome "recovering", described as "Feeling hot"; HYPERHIDROSIS (non-serious) with onset 27Mar2021, outcome "recovering", described as "Sweating"; ANXIETY (non-serious) with onset 31Mar2021, outcome "not recovered", described as "Anxiety "; MOOD SWINGS (non-serious) with onset 31Mar2021, outcome "not recovered", described as "Mood swings"; DEPRESSION (non-serious) with onset 27Mar2021, outcome "not recovered", described as "Depression"; MALAISE (non-serious) with onset 27Mar2021, outcome "unknown", described as "Feeling sick"; PANIC REACTION (non-serious) with onset 27Mar2021, outcome "not recovered", described as "Panic"; FEELING ABNORMAL (non-serious) with onset 27Mar2021, outcome "not recovered", described as "Fogginess"; DISTURBANCE IN ATTENTION (non-serious) with onset 27Mar2021, outcome "not recovered", described as "Difficulty focusing". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information:  The patient was not Vaccine Administered at Facility. The patient did not any Adverse event require a visit to ER or MD office.   No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Joint swelling, Neck pain
Clinical narrative: Joint swelling; increase in neck pain.; Also had fatigue; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 04Mar2021 14:30 (Lot number: EN6206) at the age of 50 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Enteropathic Arthritis" (unspecified if ongoing), notes: Enteropathic Arthritis/Arthritis Associated With Inflammatory Bowel Disease; "Bowel disease" (unspecified if ongoing), notes: Enteropathic Arthritis/Arthritis Associated With Inflammatory Bowel Disease; "Small fiber peripheral neuropathy" (unspecified if ongoing); "vulvodynia" (unspecified if ongoing); "frequent PVCs" (unspecified if ongoing); "Allergies to pollen" (unspecified if ongoing); "allergies to mold" (unspecified if ongoing); "allergies to fungi" (unspecified if ongoing), notes: allergies to fungi; "Allergies to dander" (unspecified if ongoing); "allergies to dust" (unspecified if ongoing); "known allergies: food sensitivities, but not true allergic reactions" (unspecified if ongoing), notes: known allergies: food sensitivities, but not true, allergic reactions. The patient took concomitant medications. The following information was reported: JOINT SWELLING (non-serious) with onset 05Mar2021 08:00, outcome "not recovered", described as "Joint swelling"; FATIGUE (non-serious) with onset 05Mar2021, outcome "recovered" (07Mar2021), described as "Also had fatigue"; NECK PAIN (non-serious) with onset 05Mar2021 08:00, outcome "not recovered", described as "increase in neck pain.". Therapeutic measures were not taken as a result of joint swelling, fatigue, neck pain.  Additional information: The patient experienced joint swelling in right thumb PIP joint that was not previously swollen and in joints with some existing swelling became more swollen right ankle, left hip, right shoulder, right wrist and increase in neck pain. Joint swelling went down slightly then back up again after second dose. The patient did not receive any other vaccine in four weeks. The patient was not diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination. The AE did not result in emergency room or physician office visit.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Mouth ulceration, Stomatitis
Clinical narrative: Irritation noted to both sides of mouth with several read ulcers noted; Irritation noted to both sides of mouth; administration date of dose 1 was 01Feb2021/administration date of dose 2 was 05Apr2021; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 58 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 05Apr2021 11:45 (Lot number: EP7533) at the age of 58 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Fruit allergy" (unspecified if ongoing), notes: Known allergies: Pan Strawberries.; "Sulfonamide allergy" (unspecified if ongoing), notes: Known allergies: Sulfa. Concomitant medication(s) included: VITAMIN D NOS. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot Number: EL3247; Administration time: 12:00; Anatomical Location: Right arm, First dose 3 red ulcers noted inside mouth next day), administration date: 01Feb2021, when the patient was 58 years old, for COVID-19 immunisation, reaction(s): "red ulcers". The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 05Apr2021 11:45, outcome "unknown", described as "administration date of dose 1 was 01Feb2021/administration date of dose 2 was 05Apr2021"; MOUTH ULCERATION (non-serious) with onset 05Apr2021 17:00, outcome "not recovered", described as "Irritation noted to both sides of mouth with several read ulcers noted"; STOMATITIS (non-serious) with onset 05Apr2021 17:00, outcome "not recovered", described as "Irritation noted to both sides of mouth". Therapeutic measures were not taken as a result of mouth ulceration, stomatitis.  Additional information: Prior to the vaccination, it was unknown if the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination.  No follow-up attempts are possible. No further information is expected.