chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: Cold; This is a spontaneous report received from a contactable reporter (Consumer or other non-healthcare professional). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Lot number: EN6202) 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 Mar2021, outcome "unknown", described as "Cold".  Additional information: NDC number, UPC number and Expiry Date of Covid-19 Vaccine was Unknown. It was reported that the patient was scheduled to have second Pfizer Vaccine (Covid 19 vaccine) today and the patient had turned down with the cold. The patient does not have a fever and haven't been around anybody past 3 weeks since the patient had one. The reporter asked, was it safe for the patient to go and get that? Or should the patient postpone that? In response to further probing, reporter stated, "I do not have a lot of time before my appointment out there." Expiration date of Covid-19 Vaccine: reporter stated, "They did not put that on here."  No follow-up attempts are possible. No further information is expected.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Malaise, Pain
Clinical narrative: Headache; Chills; I did not feel well; Pain; This is a spontaneous report from a contactable consumer. An 72 year-old male patient received bnt162b2 (BNT162B2), administration date 18Mar2021 at 14:00 (Lot number: EN6207) at the age of 72 years as 2nd dose, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First Dose), for Covid-19 immunisation. The following information was reported: HEADACHE (non-serious) with onset 18Mar2021, outcome "recovered" (19Mar2021), described as "Headache"; CHILLS (non-serious) with onset 18Mar2021, outcome "not recovered", described as "Chills"; MALAISE (non-serious) with onset 18Mar2021, outcome "unknown", described as "I did not feel well"; PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "Pain". Therapeutic measures were taken as a result of headache, pain.  Additional information:  "Well, I got the vaccination at hospital yesterday at around 2 O'clock PM. I am calling about the side effects. Last night I had a headache and chills and I didn't feel well. And I took a Motrin (Treatment) for headache for pain and I am laying down and I still have the chills and they told me if I had the side effects just call someone. When asked for the name of the treatment medication; Consumer stated, "It is Ibuprofen, for pain. When probed if the Ibuprofen helped, consumer stated, "No, I do not have the headache because I took it with some water, plenty of water. I set up in my chair. Consumer was informed about the role of Pfizer drug safety. Email address: Consumer stated, "I don't have email address right now. "I don't have primary doctor because Since advisable, everything took down. The only time I can talk to, I want to, I can talk to doctor the doctor calls me."(Further not clarified hence captured as consumer or other non-HCP). Dose: Consumer stated, "I don't know. They did not give me that. "When confirmed the treatment medication as Ibuprofen, consumer stated, "Yes. "When asked for any help, consumer stated, "Well, what do I have to do now for the side effects. What do I have to do?". Consumer was provided with the number of Pfizer Medical Information as # (Option 3, M-S, 8-8 pm as per EST).  No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Chills, Nausea, Vomiting
Clinical narrative: Chills; Nausea; Vomiting; Couldn't get out of bed; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old female patient received bnt162b2 (BNT162B2), administration date 17Mar2021 (Lot number: ER2613) at the age of 69 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Acid reflux" (unspecified if ongoing), notes: Verbatim: Acid reflux; "COVID", start date: Dec2020 (unspecified if ongoing), notes: I had COVID in Dec. Concomitant medication(s) included: LIPITOR [ATORVASTATIN]; DEXILANT taken for gastrooesophageal reflux disease. The following information was reported: CHILLS (non-serious), outcome "unknown", described as "Chills"; NAUSEA (non-serious), outcome "unknown", described as "Nausea"; VOMITING (non-serious), outcome "unknown", described as "Vomiting"; BEDRIDDEN (non-serious), outcome "unknown", described as "Couldn't get out of bed". Therapeutic measures were taken as a result of chills, nausea, vomiting, bedridden.  Additional information: Consumer stated, she received it on 17Mar, her first dose and she got symptoms which she was really surprised because everybody was saying may that happens on the second but she got a reaction to it with the chills, nausea, vomiting, couldn't get out of bed but my question is she had Covid in Dec, she have had bad case of Covid in Dec and then she had the antibody infusion in Dec, she did wait my 90 days could that have played a part in her getting the reaction to the first dose. Consumer stated, "The only thing she took was Tylenol and she took Zofran for nausea. She was probably about a 172 pounds. Patient wanted to ask questions about whether or not my having the Covid previous because nobody else, it was a bunch that had and she was the only one that got a reaction and she was down for like 2 days so."  No follow-up attempts are possible. No further information is expected.
Age: 79.0
Sex: U
Vaccine: COVID19
Symptoms: Gait disturbance, Monocyte count, Myalgia, Pain in extremity, Prostatic specific antigen
Clinical narrative: I am experiencing muscle pain in both of my legs; Having hard time walking/ I can barely walk; Muscle hurt in my legs and felt like hurting; I guess muscle aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79 year-old patient received bnt162b2 (BNT162B2), administered in arm right, administration date 04Mar2021 (Lot number: EN6199) at the age of 79 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "knee replacement", start date: 05Jan2021, stop date: 05Jan2021, notes: Verbatim: Left Knee replacement. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st Dose, Anatomical location: left arm, Lot number: unknown), administration date: 11Feb2021, for Covid-19 immunisation. The following information was reported: MYALGIA (non-serious) with onset 15Mar2021, outcome "not recovered", described as "I am experiencing muscle pain in both of my legs"; GAIT DISTURBANCE (non-serious) with onset 15Mar2021, outcome "not recovered", described as "Having hard time walking/ I can barely walk"; PAIN IN EXTREMITY (non-serious) with onset 15Mar2021, outcome "not recovered", described as "Muscle hurt in my legs and felt like hurting; I guess muscle aches". The events "i am experiencing muscle pain in both of my legs", "having hard time walking/ i can barely walk" and "muscle hurt in my legs and felt like hurting; i guess muscle aches" 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 myalgia, gait disturbance, pain in extremity.  Additional information: Patient had 2nd Pfizer shot, Covid shot about 10 days ago and was experiencing all of the sudden muscle pain in both of legs. Patient wants to know if this was the side effect of the drug or something else. Patient received the second shot on the 4Mar2021 and until 15th March and had hard time getting out of bed, had hard time walking, muscle hurt in legs and felt like hurting, was not sure was that a reaction from the shot or something les. Patient went to doctor on Monday and got blood test. Concomitant medication (knee replacement), patient stated, "No medication, take Motrin once in a while, take Motrin for the pain and "swell" (not clarified). It's 200 mg and it's not all the time, it's a "liquid gel" (not clarified), patient don't take it every day, one "tablet" (not clarified) a day."  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Condition aggravated, Headache, Pain
Clinical narrative: I have got arthritis and I took the shot Friday at 10:00 clock and around Sunday at 03:00 in the morning, it got so bad; Headache; I am in too much pain; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 19Mar2021 10:00 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Arthritis" (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 "Headache"; PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "I am in too much pain"; CONDITION AGGRAVATED (non-serious) with onset 21Mar2021 03:00, outcome "unknown", described as "I have got arthritis and I took the shot Friday at 10:00 clock and around Sunday at 03:00 in the morning, it got so bad".  Additional information: Consumer stated, "I just have one little question. All I want to ask was can I take Aleve for my headache? I have got arthritis and I took the shot Friday at 10:00 clock and around Sunday at 03:00 in the morning, it got so bad. I haven't taken some Aleve in case I am not supposed to." When clarified if consumer got the Pfizer Covid Vaccine, consumer stated, "I already got it like I said. I took the first shot on Friday 10:00 o' clock, I have to go back for the second shot and now I am experiencing pain with it. So, I wanted to take Aleve, if it is okay." Consumer was informed about the role of Pfizer Drug Safety and also informed about Pfizer Medical Information department and provided with the number, Consumer further stated, "Let me call then because I am in too much pain and I have to take it." In response to further probing, consumer stated, "My phone is going to go off, so I will call this number first and find out what is going on."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain
Clinical narrative: chills; headache; body aches; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old female patient received bnt162b2 (BNT162B2), administration date 18Mar2021 14:00 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Von Willebrand's disease" (unspecified if ongoing); "Drug allergies: Penicillin" (unspecified if ongoing); "Drug allergies: Cephalosporins." (unspecified if ongoing); "Oral contraceptive" (unspecified if ongoing); "supplement" (unspecified if ongoing). Concomitant medication(s) included: PROGESTERONE taken for oral contraception; FIBERCON; VITAMIN D [VITAMIN D NOS] taken for supplementation therapy. Past drug history included: Ibuprofen, reaction(s): "Drug allergies: Ibuprofen"; Acetaminophen, reaction(s): "Drug allergies: Acetaminophen"; Moxifloxacin, reaction(s): "Drug allergies: Moxifloxacin"; Ibuprofen, reaction(s): "Erythema multiform", notes: after having take both of them several years ago (so advised to avoid both).; Acetaminophen, reaction(s): "Erythema multiforme", notes: after having take both of them several years ago (so advised to avoid both). Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunisation. The following information was reported: CHILLS (non-serious) with onset Mar2021, outcome "unknown", described as "chills"; HEADACHE (non-serious) with onset Mar2021, outcome "unknown", described as "headache"; PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "body aches".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Hypokalaemic syndrome, Hyponatraemic syndrome
Clinical narrative: Currently having issues with low potassium and sodium; Currently having issues with low potassium and sodium; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 51 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 17Mar2021 (Lot number: EM9810) at the age of 51 years as dose 2,single for covid-19 immunisation. Relevant medical history included: "High Blood pressure" (unspecified if ongoing); "Shellfish allergies" (unspecified if ongoing), notes: known allergies : Yes, shellfish, codeine, and carmine; "Swelling in my leg" (unspecified if ongoing); "Mild asthma" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Codeine, reaction(s): "Allergy: Codeine", notes: known allergies : Yes, shellfish, codeine, and carmine; Carmine, reaction(s): "Allergy: Carmine", notes: known allergies : Yes, shellfish, codeine, and carmine. Vaccination history included: Bnt162b2 (product=COVID 19, brand=Pfizer, lot number=EL9261, lot unknown=False, administration date=16/02/2021, administration time=09:45 AM, vaccine location=Right arm, dose number=1), administration date: 16Feb2021, when the patient was 51 years old. The following information was reported: HYPOKALAEMIC SYNDROME (non-serious), HYPONATRAEMIC SYNDROME (non-serious), outcome "unknown" and all described as "Currently having issues with low potassium and sodium". Therapeutic measures were taken as a result of hypokalaemic syndrome, hyponatraemic syndrome.  Additional information: Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No. List of any other medications the patient received within 2 weeks of vaccination: Yes. Was treatment received for the adverse event?: Yes: I self administered Benadryl. Prior to vaccination, was the patient diagnosed with COVID-19?:No. Since the vaccination, has the patient been tested for COVID-19?:No. Allergies to medications, food, or other products: Yes, shellfish, codeine, and carmine. Location of injection information is available for all vaccines received on the same date. adverse event: I got hives that lasted for 4 days(evenings and overnights mostly) 1 week and 2 days after the first Covid shot. It was controlled with benedryl and went away on it's own after 4 days/nights. adverse event start date: 25/02/2021 adverse event start time: 3:00 Pm, adverse event country. ae resulted in: ae resulted in if patient recovered: recovered, if treatment ae: Yes, ae treatment: I self administered Benadryl, if covid prior vaccination: No, known allergies : Yes, shellfish, codeine, and carmine, other medical history: High Blood pressure, swelling in my legs, allergies, mild asthma, currently having issues with low potassium and sodium.  No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema
Clinical narrative: mild redness at injection site; Slightly more  soreness in arm after secondshot and still lingers; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17Mar2021 13:30 (Lot number: ER2613) at the age of 67 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "allergies with several antibiotics" (unspecified if ongoing), notes: allergies with several antibiotics; "Latex allergy" (unspecified if ongoing); "Kidney stones" (unspecified if ongoing); "Osteoporosis" (unspecified if ongoing); "Under active thyroid" (unspecified if ongoing), notes: Under active thyroid. Concomitant medication(s) included: BACTRIM. Vaccination history included: Bnt162b2 (Lot number: EN6202, DOSE 1, SINGLE, Anatomical location : Arm Left, at 13:30 (at the age of 67-years-old)), administration date: 24Feb2021, when the patient was 67 years old, for COVID-19 immunisation, reaction(s): "Painful arm". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 17Mar2021 14:00, outcome "recovering", described as "Slightly more soreness in arm after secondshot and still lingers"; VACCINATION SITE ERYTHEMA (non-serious) with onset 19Mar2021, outcome "not recovered", described as "mild redness at injection site". Therapeutic measures were not taken as a result of pain in extremity, vaccination site erythema.  Additional information: The patient was not pregnant at the time of vaccination. The patient received BACTRIM for unknown indication within 2 weeks of vaccination of first shot. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccination. Adverse events didn't result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Any treatment was not taken as a result of these events. The clinical outcome of slightly more soreness was recovering at the time of report. The clinical outcome of mild redness developed at injection site was not recovered at the time of this report.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Inappropriate schedule of product administration
Clinical narrative: administration date=19Mar2021/ administration date=05Mar2021; chills; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  An adult male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "COVID" (unspecified if ongoing), notes: if covid prior vaccination: Yes. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, product=COVID 19 , brand: Pfizer , lot unknown: False, vaccine location: Left arm), administration date: 05Mar2021, for COVID-19 immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "administration date=19Mar2021/ administration date=05Mar2021"; CHILLS (non-serious) with onset 19Mar2021, outcome "recovering", described as "chills". Therapeutic measures were not taken as a result of chills.  Additional Information: The patient had not received any other vaccine within 4 weeks. Patient received other medications in 2 weeks. Prior to vaccination patient was diagnosed with COVID-19.  Since the vaccination the patient had not tested for COVID-19. Query reported as the Pfizer US Drug safety unit recently received the attached report submitted by you via (webmail withheld). Please help to confirm the date that you became aware of the adverse events in this report as this effects regulatory reporting timelines. This awareness date is the date you became aware of the occurrence of the reported events. If you are the patient in the case, your awareness date would be the date that you became aware you were experiencing the reported events. If you are not the patient in the case, your awareness date would be the date you became aware of the occurrence of the reported events. This awareness date represents the Pfizer receipt date of the report and reflects the earliest date that any Pfizer colleague learned of the adverse event. If you learned of these events from another Pfizer colleague, please provide the date that the first Pfizer colleague became aware of the events reported, as regulatory reporting due dates are calculated based on the first day that a Pfizer colleague became aware of the adverse events. And please also provide the primary reporter information (the person who reported this adverse event info to you). Response reported as I learned of the event on 19Mar2021 from the sister of the person vaccinated.  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: Pain in extremity
Clinical narrative: Mild sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 67 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 24Feb2021 01:30 (Lot number: EN6202) at the age of 67 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Under active thyroid" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing); "kidney stones" (unspecified if ongoing); "Allerigies: Latex" (unspecified if ongoing); "several antibiotics" (unspecified if ongoing). Concomitant medication(s) included: BACTRIM. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "Mild sore arm". Therapeutic measures were not taken as a result of pain in extremity.  Additional Information: The patient was not Pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received Bactrim during the time of the first shot within 2 weeks of vaccination. Prior to vaccination the patient was did not diagnosed with COVID-19. Since the vaccination, the patient did not been tested for COVID-19. Allergies to medications, food, or other products: Latex and several antibiotics. The patient reported Event was Mild sore arm day if and after 1st shot.  Slightly more soreness after second shot and still lingers.  Also developed mild redness at injection site after second shot.  Appeared two days after shot and still present.  The patient did not received treatment for the adverse event.  No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Somnolence, Vaccination site pain
Clinical narrative: 1st Dose very painful going into arm; Stabbing pain at injection site; sleepy; nauseous; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 26Feb2021 15:15 (Lot number: EN6200) at the age of 61 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "I think I have a Latex sensitivity (use latex free)" (unspecified if ongoing), notes: Known Allergies: I think I have a Latex, sensitivity; "AVN" (unspecified if ongoing), notes: Other medical history: AVN. Concomitant medication(s) included: PHENOBARB [PHENOBARBITAL]; SIMVASTATIN; ASPRIN; PLAVIX; TOPAMAX.  The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered" (2021), described as "1st Dose very painful going into arm"; VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "recovered" (2021), described as "Stabbing pain at injection site"; SOMNOLENCE (non-serious) with onset 2021, outcome "recovered" (2021), described as "sleepy"; NAUSEA (non-serious) with onset 2021, outcome "recovered" (2021), described as "nauseous".  Additional Information: Other medications in two weeks: Phenobarb, simvastatin, aspirin, Plavix, Topamax and 6 more. Adverse event: 1st dose very painful going into arm. Stabbing pain at injection site, sleepy and nauseous (All) for 2 days. Patient had no COVID prior vaccination and not tested for COVID post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Swelling
Clinical narrative: pain and swelling of arm pit, hurts when she lifts her arm; pain and swelling of arm pit; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 56 year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm right, administration date 16Mar2021 15:30 (Lot number: EN6206) at the age of 56 years 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: AXILLARY PAIN (non-serious) with onset 19Mar2021, outcome "not recovered", described as "pain and swelling of arm pit, hurts when she lifts her arm"; SWELLING (non-serious) with onset 19Mar2021, outcome "not recovered", described as "pain and swelling of arm pit". Therapeutic measures were not taken as a result of axillary pain, swelling. Additional information: Patient did not receive any other vaccines within 4 weeks or any other medications within 2 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Patient has not been tested for COVID-19 since the vaccination. Patient has no known allergies. Reporter was made aware of the side effects on 20Mar2021 10:11.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: I didn't even feel like I got a shot; Maybe something was wrong with it; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) 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. Vaccination history included: Flu shot (verbatim: I get a flu shot (Unspecified medication) I always have arm or muscle pain for a couple of days.), reaction(s): "arm or muscle pain". The following information was reported: MALAISE (non-serious), outcome "unknown", described as "I didn't even feel like I got a shot; Maybe something was wrong with it".  Additional information: Consumer stated, "Patient had a concern that patient received the Pfizer vaccine and not had any side effect or even any arm pain at all, patient didn't even feel like got a shot whenever patient get a flu shot (Unspecified medication) patient always have arm or muscle pain for a couple of days. Patient just didn't had anything at all. Patient just wondering if patient should be concerned that maybe something was wrong with it (COVID 19 vaccine)."  No follow-up attempts are possible; information about lot/batch number cannot be obtained
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Vomiting
Clinical narrative: Chills; Vomiting; Diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old female patient received bnt162b2 (BNT162B2), administration date 19Mar2021 (Lot number: ER2613) at the age of 66 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 (First Dose, single), for COVID-19 IMMUNIZATION. The following information was reported: CHILLS (non-serious) with onset 19Mar2021, outcome "recovered" (2021), described as "Chills"; VOMITING (non-serious) with onset 19Mar2021, outcome "recovered" (2021), described as "Vomiting"; DIARRHOEA (non-serious) with onset 19Mar2021, outcome "recovered" (2021), described as "Diarrhea". Therapeutic measures were not taken as a result of chills, vomiting, diarrhoea.  Additional Information: Patient calling because patient got the second vaccination and this is from Pfizer and last night patient experienced some symptoms, chills, vomiting and diarrhea so is everything okay.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Bone density abnormal, Investigation, SARS-CoV-2 test, Ultrasound scan, Vaccination site pain
Clinical narrative: some sore at the site of the injection; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 66 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 27Feb2021 08:10 (Lot number: EN6201) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Osteoporosis", start date: 05Oct2015 (ongoing), notes: Pertinent Details: (Protia surgical med. Q (every) 6 month SQ (subcutaneous inj).; "Procedure colon", start date: 26Jan2021 (unspecified if ongoing), notes: Removal potyps. The patient's concomitant medications were not reported. Vaccination history included: Shingrix (Manufacturer:, Batch/Lot#: NDC58160-0823-11, Route: Intramuscular,Anatomical site: R arm, No. of previous Doses: 1), administration date: 04Feb2021, for immunization; Bnt162b2 (Dose-1, Batch/Lot number: EM9800, Anatomical site- Right Arm, Route: Intramuscular, Time (24hr): 12 NOON), administration date: 07Feb2021, when the patient was 66 years old, for COVID-19 Immunization, reaction(s): "Sore at injection site", "A little sore, but more in her arms than anything else", "She had some general achiness a couple of days after receiving the Covid vaccine". The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "some sore at the site of the injection". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient had no Prior vaccinations (within 4 weeks). Family medical history relevant to AE(s): Breast CA, ABD CA, Pancreas CA, Lung CA, Skin CA, Dementia. The patient reported that she did not have any negative reaction only mildly sore at the injection site. During her first vaccine it was snowing and raining and she was not having or wore the proper weather protection. She was three and half hours waiting to get in the center. During this time she was moving constantly, small runs and exercises to avoid to get to frozen. She believed her generalize achiness was because the situation with the weather and exercises but not due to the vaccine. Her side effect during both vaccines was some sore at the site of the injection.  No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: funny taste in mouth; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 04Mar2021 10:30 (Batch/Lot number: unknown) at the age of 48 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Sensitive to medicine" (unspecified if ongoing); "MS" (unspecified if ongoing); "allergic to unspecified medicines" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DYSGEUSIA (non-serious) with onset 04Mar2021 11:00, outcome "recovered" (04Mar2021), described as "funny taste in mouth". Therapeutic measures were not taken as a result of dysgeusia. Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included vitamins for an unknown indication. Since the vaccination, the patient had not been tested positive for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. On 04Mar2021 at 11:00, the patient experienced funny taste in mouth for about 15-30 minutes.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021322781 same product/event, different patient;US-PFIZER INC-2021322782 same product/event, different patient
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: reporter had a funny taste in her mouth and her 2 daughters just got their first Pfizer vaccine and said the same thing; 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: DYSGEUSIA (non-serious), outcome "unknown", described as "reporter had a funny taste in her mouth and her 2 daughters just got their first Pfizer vaccine and said the same thing".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021322709 same reporter, vaccine and event different patient;US-PFIZER INC-2021322782 same reporter, vaccine and event different patient
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: reporter had a funny taste in her mouth and her 2 daughters just got their first Pfizer vaccine and said the same thing; 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), administered in arm right (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: DYSGEUSIA (non-serious), outcome "unknown", described as "reporter had a funny taste in her mouth and her 2 daughters just got their first Pfizer vaccine and said the same thing".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021322781 same product/event, different patient;US-PFIZER INC-2021322709 same product/event, different patient
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Condition aggravated, Feeling abnormal
Clinical narrative: it doesn't feel right, it feels weird/weird symptoms in his back; Throbbing is consistent and is becoming more and more and more; Throbbing in lower back/throbbing was on his left side; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Mar2021 (Lot number: EN6208) at the age of 44 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma", start date: 2002 (ongoing), notes: asthma was diagnosed years ago. He thinks it was in 2002, maybe longer. There were no concomitant medications. The following information was reported: BACK PAIN (non-serious) with onset 17Mar2021, outcome "not recovered", described as "Throbbing in lower back/throbbing was on his left side"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "it doesn't feel right, it feels weird/weird symptoms in his back"; CONDITION AGGRAVATED (non-serious) with onset 19Mar2021, outcome "unknown", described as "Throbbing is consistent and is becoming more and more and more".  Additional Information: Caller reported the throbbing was by his kidney. He later clarified that the throbbing was on his left side, that it could be his kidney, liver, or lung, he didn't know. He reported that it doesn't feel right, it feels weird. At first after receiving the Covid-19 vaccine it was ok, the second day the throbbing in his lower back was off and on, and that today, 19Mar2021, the throbbing is consistent and is becoming more and more and more. Caller reported that he felt the throbbing in his lower back when he went to bed the night of 17Mar2021.  No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus in Left Ear mainly; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 03Mar2021 04:45 (Lot number: EN6203) at the age of 45 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: NORTRIPTYLINE; NORVASC. The following information was reported: TINNITUS (non-serious) with onset 20Mar2021 21:45, outcome "not recovered", described as "Tinnitus in Left Ear mainly". The event "tinnitus in left ear mainly" was evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of tinnitus. Additional information: the most recent COVID-19 vaccine was administered at the Workplace clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Gait disturbance, Vertigo
Clinical narrative: Vertigo and dizziness this friday; Vertigo and dizziness this friday; slight unsteady on feet; 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 female patient received bnt162b2 (BNT162B2), administration date 13Mar2021 (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: Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN, Batch/lot number: Unknown), for COVID-19 Immunisation. The following information was reported: GAIT DISTURBANCE (non-serious) with onset 18Mar2021, outcome "unknown", described as "slight unsteady on feet"; VERTIGO (non-serious), DIZZINESS (non-serious) all with onset 19Mar2021, outcome "unknown" and all described as "Vertigo and dizziness this friday".  Additional information: Verbatim and event description: Patient stated she got her 2nd dose last week Saturday (13Mar2021) and this Thursday (18Mar2021) she experienced slight unsteady on feet, vertigo and dizziness this Friday (19Mar2021). Asked if she can take medication and asking how long will the vaccine will cause these side effects such as dizziness (as reported).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Confusional state
Clinical narrative: asked for clarification and the patient became confused; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. 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. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CONFUSIONAL STATE (non-serious), outcome "unknown", described as "asked for clarification and the patient became confused". Additional information: the patient received his first covid vaccine on 21Mar2021. When asked for clarification the patient became confused. The patient was told that the 21st was two days from now and that he may have received his first covid vaccine on the 21Feb instead which he would be two weeks over his 21 days.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Joint dislocation, Muscular weakness
Clinical narrative: Leg is weak; Knee goes out and she tips over; 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) (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: MUSCULAR WEAKNESS (non-serious), outcome "unknown", described as "Leg is weak"; JOINT DISLOCATION (non-serious), outcome "unknown", described as "Knee goes out and she tips over".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Tooth extraction
Clinical narrative: he had to get couple teeth removed; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date Feb2021 (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: TOOTH EXTRACTION (non-serious), outcome "unknown", described as "he had to get couple teeth removed". Therapeutic measures were taken as a result of tooth extraction. Clinical course: Verbatim and event description included that he was scheduled 1st dose of vaccine for Feb. Found out he had to get couple teeth removed and would be getting Novocain. Spoke to someone and said it would be ok to have Novocain. No unaddressed medical questions were referred or forwarded to Medical Information.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Pain, Vomiting
Clinical narrative: Today which is March 20, she became nauseous and feel achy; Today which is March 20, she became nauseous and feel achy; She also had chills and has been throwing up.; She also had chills and has been throwing up.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). This is a spontaneous report received from Pfizer sponsor program Support.  A female patient received bnt162b2 (BNT162B2), administration date 19Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Migraines" (unspecified if ongoing); "Crohn's disease" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: NAUSEA (non-serious), PAIN (non-serious) all with onset 20Mar2021, outcome "unknown" and all described as "Today which is March 20, she became nauseous and feel achy"; CHILLS (non-serious), VOMITING (non-serious) all with onset 20Mar2021, outcome "unknown" and all described as "She also had chills and has been throwing up.". Therapeutic measures were taken as a result of nausea, pain, chills, vomiting.  Additional Information: A contactable consumer for her friends mom. The patient has Crohn's disease and gets migraines often. The patient had her first shot yesterday the 19March. Today which is Mar20, she became nauseous and feel achy. She also had chills and has been throwing up. She has already taken Tylenol and Dramamine. The caller wants to know what other medication to take to subside the side effects. Cold transferred and created Manual AE Form. Were any unaddressed medical questions referred or forwarded to Medical Information? No  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: felt like little bit sick; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 17Mar2021 (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: MALAISE (non-serious) with onset 18Mar2021, outcome "recovered" (Mar2021), described as "felt like little bit sick".  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: pain on the right arm; 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), administered in arm left, administration date 18Mar2021 (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) with onset 19Mar2021, outcome "unknown", described as "pain on the right arm".  Additional information: Caller had taken her first vaccine shot 18Mar2021 on left arm and when she woke up the next day, she was experiencing pain on the right arm and wanted to know if that was normal. Medical Information. Were any unaddressed medical questions referred or forwarded to Medical Information.  No follow-up attempts are possible; information about lot/batch cannot be obtained.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Faeces discoloured
Clinical narrative: Started seeing red color in stool from day 3 after taking vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Mar2021 10:30 (Lot number: EN6208) at the age of 31 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN; GLIMEPIRIDE.  The following information was reported: FAECES DISCOLOURED (non-serious) with onset 19Mar2021 08:00, outcome "not recovered", described as "Started seeing red color in stool from day 3 after taking vaccine". Therapeutic measures were not taken as a result of feces discolored.  Additional information: Allergies to medications, food, or other products: No. known allergies: No. List of any other medications the patient received within 2 weeks of vaccination: Metformin 1000 mg and Glimepiride 4 mg. Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No. Prior to vaccination, was the patient diagnosed with COVID-19?: No. Since the vaccination, has the patient been tested for COVID-19?: No. Serious: No, Seriousness criteria-Results in death: No, Seriousness criteria-Life threatening: No, Seriousness criteria-Caused/prolonged hospitalization: No, Seriousness criteria-Disabling/Incapacitating: No, Seriousness criteria-Congenital anomaly/birth defect: No.  No follow up attempts are needed. No further information is expected.