chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Overdose
Clinical narrative: a pediatric dose of the Pfizer-BioNTech COVID-19 Vaccine. a 0.2ml undiluted vaccine was administered to one of their patients; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A child male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, 0.2 ml single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OVERDOSE (non-serious), outcome "unknown", described as "a pediatric dose of the Pfizer-BioNTech COVID-19 Vaccine. a 0.2ml undiluted vaccine was administered to one of their patients".  Additional information: Caller was a pharmacist. She called regarding a paediatric dose of the Pfizer-BioNTech COVID-19 Vaccine. a 0.2ml undiluted vaccine was administered to one of their patients. She asked what she should tell the parents. Caller declined to be transferred to hospital as her colleague will be the one filling the report instead.: e-transmitting AE. Reason for no lot number of Covid-19 Vaccine was reporter stated, "No, I am not at the store, I am left." When probed for the concern, reporter stated, "I am actually off work, but I have a question that I want to call for my Pharmacy colleague that made an error today on dilution of a kid vaccine (administered). I didn't know that there was anything else that we needed to tell the mom other than just give any medication to help with the side effect like how else do we talk to the Mom and tell her. Reporter stated, "Actually his weight is of a smaller dose, but I don't have any specific details of his age. I think he is just a big 10 or 11 year old, but I just didn't know what we needed to tell the Mom other than watching for the side effect and what side effect I should talk her about." Reporter asked, "do you want me to call you back if there's any adverse reaction he had."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Menstrual disorder
Clinical narrative: Missed menustration; Dose Number: 1 (08Apr2021); Dose Number: 2 (22Apr2021); This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administration date 22Apr2021 (Batch/Lot number: unknown) at the age of 44 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 (DOSE 1, SINGLE, route of administration: Intramuscular), administration date: 08Apr2021, when the patient was 44 years old, for COVID-19 immunization. The following information was reported: MENSTRUAL DISORDER (non-serious) with onset 01May2021, outcome "unknown", described as "Missed menustration"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 22Apr2021, outcome "unknown", described as "Dose Number: 1 (08Apr2021); Dose Number: 2 (22Apr2021)". The event "missed menustration" was evaluated at the physician office visit. Additional information: The patient received dose 3 Pfizer COVID-19 vaccine intramuscularly on 05Nov2021. The events were not serious. 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; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up: This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 52.0
Sex: U
Vaccine: COVID19
Symptoms: Chills, Fatigue, Overdose, Pyrexia, Vaccination site pain
Clinical narrative: Received the contents of a full vial instead of just one dose/Patient was inadvertently given 2ml (whole reconstituted vial) of the 0.3 ml recommended dose of this vaccine; sore injection site; Fatigue; Chills; fever less than 5 hours; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team.  A 52 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 03Dec2021 12:55 (Lot number: FJ1620) at the age of 52 years as dose 3 (booster), 2 ml single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Manufacturer unknown, Dose number: Unknown), for COVID-19 immunisation. The following information was reported: OVERDOSE (non-serious) with onset 03Dec2021, outcome "unknown", described as "Received the contents of a full vial instead of just one dose/Patient was inadvertently given 2ml (whole reconstituted vial) of the 0.3 ml recommended dose of this vaccine"; VACCINATION SITE PAIN (non-serious) with onset Dec2021, outcome "unknown", described as "sore injection site"; FATIGUE (non-serious) with onset Dec2021, outcome "unknown", described as "Fatigue"; CHILLS (non-serious) with onset Dec2021, outcome "unknown", described as "Chills"; PYREXIA (non-serious) with onset Dec2021, outcome "recovered" (Dec2021), described as "fever less than 5 hours". Therapeutic measures were not taken as a result of vaccination site pain, fatigue, chills, pyrexia. Additional information: The patient did provide information regarding the reported adverse event (s) with the use of the product. Vaccination facility Type was Health clinic.  Follow-up attempts completed. No further information is expected.  Follow-up (07Jan2022): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.  Follow-up (07Jan2022): This is a spontaneous follow-up report from a contactable Nurse. This Nurse reported in response to HCP letter sent via telephonic follow-up activity that included: No new information was updated.  Follow-up (09Feb2022):  This is a spontaneous follow-up report from a contactable Nurse. This nurse reported in response to HCP letter sent that included: New reporter, Patient information, RMH, Dosing regimen, New event (Vaccination site pain, Fatigue, Chills, Fever) and Treatment received added.  Follow-up attempts are completed. No further information is expected.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Joint stiffness, Musculoskeletal stiffness
Clinical narrative: very stiff in his legs and then it traveled up to hips briefly and then in his shoulders for a longer period of time; very stiff in his legs and then it traveled up to hips briefly and then in his shoulders for a longer period of time; very stiff in his legs and then it traveled up to hips briefly and then in his shoulders for a longer period of time; 1st dose on 16Mar2021 and 2nd dose on 30Mar2021= below 19-day interval; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 30Mar2021 (Batch/Lot number: unknown) at the age of 70 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Time: 15:00, Lot: EN6207), administration date: 16Mar2021, when the patient was 70 years old, for covid-19 immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 30Mar2021, outcome "unknown", described as "1st dose on 16Mar2021 and 2nd dose on 30Mar2021= below 19-day interval"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset Apr2021, outcome "recovering", JOINT STIFFNESS (non-serious), MUSCULOSKELETAL STIFFNESS (non-serious), outcome "recovering" and all described as "very stiff in his legs and then it traveled up to hips briefly and then in his shoulders for a longer period of time". The event "very stiff in his legs and then it traveled up to hips briefly and then in his shoulders for a longer period of time", "very stiff in his legs and then it traveled up to hips briefly and then in his shoulders for a longer period of time" and "very stiff in his legs and then it traveled up to hips briefly and then in his shoulders for a longer period of time" was evaluated at the physician office visit. Therapeutic measures were taken as a result of musculoskeletal stiffness, joint stiffness, musculoskeletal stiffness.  Additional information: Patient has gone to a rheumatologist and has been under her care since April. Patient was on prednisone and then he was on calcium. No additional Vaccines Administered on Same Date of the Pfizer Suspect. Patient Had flu shot after the second dose of the COVID vaccine and had no reaction to it.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness
Clinical narrative: Stiffness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 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, Single.), administration date: 16Mar2021, for Covid-19 Immunization. The following information was reported: MUSCULOSKELETAL STIFFNESS (non-serious) with onset 2021, outcome "unknown", described as "Stiffness".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Additional Information: Two weeks after the second dose, around the 14th or 15th day, he became very stiff in his legs and then it traveled up to hips briefly and then in his shoulders for a longer period of time. He just wanted someone to know about this and he heard of two women that had the same problem.
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: After receiving a 10mcg dose of the Orange Cap formulation on 01Dec, this child experienced tingling in his toes within 15 minutes of administration which resolved a few minutes later; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A 8 year-old male patient received bnt162b2 (BNT162B2), administration date 01Dec2021 (Batch/Lot number: unknown) at the age of 8 years as dose number unknown, 10 ug single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PARAESTHESIA (non-serious) with onset 01Dec2021, outcome "recovered" (01Dec2021), described as "After receiving a 10mcg dose of the Orange Cap formulation on 01Dec, this child experienced tingling in his toes within 15 minutes of administration which resolved a few minutes later".  Additional information: Event took place after use of product.  Follow-up attempts completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Joint stiffness, Musculoskeletal stiffness
Clinical narrative: very stiff in his legs and then it traveled up to hips briefly and then in his shoulders for a longer period of time; very stiff in his legs and then it traveled up to hips briefly and then in his shoulders for a longer period of time; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. This is the report for the male patients he reported with the same problem. This is report 2 of 3.   A 71 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 16Mar2021 15:00 (Lot number: EN6207) as dose 2, single and administered in arm left, administration date 23Feb2021 15:50 (Lot number: EN6202) 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: MUSCULOSKELETAL STIFFNESS (non-serious), JOINT STIFFNESS (non-serious), outcome "unknown" and all described as "very stiff in his legs and then it traveled up to hips briefly and then in his shoulders for a longer period of time".  Additional Information: He was calling about the Pfizer covid vaccine. He was 71 years old and was asking if he should get the booster. 16Mar2021 was when he got the first dose and then 2 weeks later he got second dose. Two weeks after the second dose, around the 14th or 15th day, he became very stiff in his legs and then it traveled up to hips briefly and then in his shoulders for a longer period of time. The prior Vaccinations (with in 4 weeks), concomitant drugs, patient's medical history, relevant tests were reported as none. Specific relevant test for thromboembolic events with thrombocytopenia was none  No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: have leg pain in my calve and thigh; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Nov2021 09:30 (Batch/Lot number: unknown) at the age of 38 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: PROZAC. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 27Nov2021, outcome "not recovered", described as "have leg pain in my calve and thigh". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: No other vaccine in four weeks. No COVID prior vaccination. No COVID tested post vaccination. No known allergies.  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: it did not hurt this bad with the two primary doses; 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 female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (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 "it did not hurt this bad with the two primary doses". Additional information: According to agent, caller received the booster dose of the Pfizer BioNTech Covid-19 vaccine and got struck twice with the needle during vaccination. Caller would like to know if this was okay and if she should receive another shot? Caller states her arm hurts bad, she states it did not hurt this bad with the two primary doses of the Covid-19 vaccine. Caller states when she got home she looked under the band-aid and she could see two pin pricks just above one another. Caller states she got struck with the needle twice and it happened so fast.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Joint range of motion decreased, Pain, Pain in extremity
Clinical narrative: Have not been able to lift my arm up to certain extent; I cannot stand the pain; She said she cannot lift her arm/horrible pain; 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 46 year-old female patient received bnt162b2 (BNT162B2), administration date 08Jul2021 (Batch/Lot number: unknown) at the age of 46 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 (Dose:1), for COVID-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "not recovered", described as "She said she cannot lift her arm/horrible pain"; JOINT RANGE OF MOTION DECREASED (non-serious), outcome "unknown", described as "Have not been able to lift my arm up to certain extent"; PAIN (non-serious), outcome "unknown", described as "I cannot stand the pain". The event "she said she cannot lift her arm/horrible pain" was evaluated at the physician office visit. Therapeutic measures were taken as a result of pain in extremity.  Additional information: Patient described it as horrible pain that keeps on getting worse every time that when she cannot even put on a jacket. She said she's never had this pain before, and that it just happened after her 2nd dose. She said she already consulted her physician and was told that a lot of patients have the same problem as hers. She was told that hers was not normal because the symptoms do not last for more than 4-5 weeks, but hers lasted for months.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue
Clinical narrative: after the first vaccine he had chills and fatigue with the first shot; after the first vaccine he had chills and fatigue with the first shot; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP). The reporter is the patient.  A 40 year-old male patient received bnt162b2 (BNT162B2), administration date 18Mar2021 (Lot number: ER8727) at the age of 39 years 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: CHILLS (non-serious), FATIGUE (non-serious) all with onset 2021, outcome "unknown" and all described as "after the first vaccine he had chills and fatigue with the first shot".  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101761121 same patient, different vaccine dose/AE.
Sex: M
Vaccine: COVID19
Symptoms: Muscle twitching, Myalgia
Clinical narrative: muscle ache; muscle just jumps, like a twitch; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 72 year-old male patient received bnt162b2 (BNT162B2), administration date Mar2021 (Batch/Lot number: unknown) as dose 2, single and administration date Mar2021 (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: MYALGIA (non-serious), outcome "unknown", described as "muscle ache"; MUSCLE TWITCHING (non-serious), outcome "unknown", described as "muscle just jumps, like a twitch".  Additional information: It was reported that "the patient's 1st shot in Mar 2021. Months later, he notice that he get a slight muscle ache, it jumps, it was not that severe, but in the last 1 week or 2, he noticed that the muscle just jumps, like a twitch, but it does not hurt, he was not in pain. He had second dose in March. The person at the clinic told him that this may not be related to the vaccine, asking was that true.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Hypoacusis, Tinnitus
Clinical narrative: tinnitus/he's suffering like me; he's stop to hearing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received bnt162b2 (COMIRNATY) (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: TINNITUS (non-serious), outcome "unknown", described as "tinnitus/he's suffering like me"; HYPOACUSIS (non-serious), outcome "unknown", described as "he's stop to hearing".  Additional information: Caller said that "Today after 2 hours I'm gonna take MRI." and added, "I read yesterday about the statement, I'm not alone in my school also this guy get the vaccine, he's suffering like me but he's one year he's stop to hearing and also he has noise ha start to do this all and little be better, and his doctor told him don't take a lot of medication your body will cause a lot of different problem. Any medication is bad. So he has some problem like me, he tried to workout." No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Fatigue, Flatulence, Headache, Malaise
Clinical narrative: Bone pain; Muscle pain; Not feeling good since she had the shot; Headache; Gas; Feeling tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 91 year-old female patient received bnt162b2 (COMIRNATY), administration date Dec2021 (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), administration date: Oct2021, when the patient was 91 years old, for Covid-19 Immunization, reaction(s): "She had a lot of sickness, so she couldn't do it". The following information was reported: BONE PAIN (non-serious) with onset 2021, outcome "unknown", described as "Bone pain"; MYALGIA (non-serious) with onset 2021, outcome "unknown", described as "Muscle pain"; MALAISE (non-serious) with onset 2021, outcome "unknown", described as "Not feeling good since she had the shot"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "Headache"; FLATULENCE (non-serious) with onset 2021, outcome "unknown", described as "Gas"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "Feeling tired".  Additional information: Reporter stated, "The concern is that my mother, she had her second shot of COVID up there like a month 'after' she had the first one. She is not feeling good since she had the shot. She has like muscle pain, bones pain, gas, headache. I want to know if this is a normal thing that happens to elderly people after the second shot?"Name of the vaccine: Pfizer COVID-19 Vaccine .On confirming the name of the vaccine, Reporter stated, "Yes, she took the first dose in October. Then she was taking (Voice not clear) because she had a lot of sickness, so she couldn't do it. She did the second shot 2 days ago, 2 or 3 days ago and since then she is not feeling good. She has a headache, muscle pain, bones pain, gas, feeling tired.  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-202101775885 Same patient and drug, different dose
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Bone pain; Muscle pain; Not feeling good since she had the shot; Headache; Gas; Feeling tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 91 year-old female patient received bnt162b2 (COMIRNATY), administration date Dec2021 (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), administration date: Oct2021, when the patient was 91 years old, for Covid-19 Immunization, reaction(s): "She had a lot of sickness, so she couldn't do it". The following information was reported: BONE PAIN (non-serious) with onset 2021, outcome "unknown", described as "Bone pain"; MYALGIA (non-serious) with onset 2021, outcome "unknown", described as "Muscle pain"; MALAISE (non-serious) with onset 2021, outcome "unknown", described as "Not feeling good since she had the shot"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "Headache"; FLATULENCE (non-serious) with onset 2021, outcome "unknown", described as "Gas"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "Feeling tired".  Additional information: Reporter stated, "The concern is that my mother, she had her second shot of COVID up there like a month 'after' she had the first one. She is not feeling good since she had the shot. She has like muscle pain, bones pain, gas, headache. I want to know if this is a normal thing that happens to elderly people after the second shot?"Name of the vaccine: Pfizer COVID-19 Vaccine .On confirming the name of the vaccine, Reporter stated, "Yes, she took the first dose in October. Then she was taking (Voice not clear) because she had a lot of sickness, so she couldn't do it. She did the second shot 2 days ago, 2 or 3 days ago and since then she is not feeling good. She has a headache, muscle pain, bones pain, gas, feeling tired.  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-202101775885 Same patient and drug, different dose
Sex: U
Vaccine: COVID19
Symptoms: Blood test, Discomfort
Clinical narrative: I don't feel comfortable; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 61 year-old patient received bnt162b2 (BNT162B2), administration date Apr2021 (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), administration date: Mar2021, for COVID-19 Immunization. The following information was reported: DISCOMFORT (non-serious) with onset 2021, outcome "unknown", described as "I don't feel comfortable". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient asked the rheumatologist should the patient get the booster and he checked the antibodies, and he does the blood work, the patient don't know it was a PCR test (consumer was unsure) It was not sure what the physician did but when it came the range was 1 (Clarification unknown) The patient's dates for the blood work came out, when it came the range was 1 and the patient came out at 250 and the physician said that the patient is perfectly protected, cancel the booster vaccine. The patient was not comfortable with that. Then the patient went online and did another research as the patient was Registered nurse. The physician was telling the patient two hundred and fifty times (250 times) the antibodies that's very-very good let's wait and see but then the patient read online that you can have up to thousands so 250 is not that great. Limited information was available over the call.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: she had some little pain in the arm where she got it; 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 (BNT162B2), administration date Mar2021 (Batch/Lot number: unknown) as dose 2, single and administration date Mar2021 (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 2021, outcome "unknown", described as "she had some little pain in the arm where she got 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: Pain in extremity
Clinical narrative: whole arm was hurting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "whole arm was hurting".  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: the common warts on my hands disappeared; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "warts on my hands" (unspecified if ongoing), notes: disappeared, after 25 years and many different , attempts to get rid of them. The patient's concomitant medications were not reported. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "the common warts on my hands disappeared".  Additional information: Clinical course: It was reported that two weeks after patient first covid vaccine, the common warts on patient hands disappeared, after 25 years and many different attempts to get rid of them.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood test, Ear discomfort, Fatigue, Feeling abnormal
Clinical narrative: First Dose: 28Nov2021; Second Dose: 12Dec2021; Her ear is blocked; Constantly tired; Has no energy what so ever; Has been feeling lousy and feels like everything is being drained out of her; 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 52 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 12Dec2021 10:00 (Batch/Lot number: unknown) at the age of 52 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hyperthyroidism" (unspecified if ongoing). Concomitant medication(s) included: ARMOUR THYROID taken for hyperthyroidism (ongoing). Vaccination history included: Bnt162b2 (Dose: 1, Dosage text: First Dose; right arm, Time the Vaccination Was Given: 10:00am, both doses), administration date: 28Nov2021, when the patient was 52 years old, for COVID-19 Immunization, reaction(s): "Ear has been blocked and cannot hear anything", "Constantly tired", "Having no energy what so ever". The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 12Dec2021 10:00, outcome "unknown", described as "First Dose: 28Nov2021; Second Dose: 12Dec2021"; EAR DISCOMFORT (non-serious) with onset 2021, outcome "not recovered", described as "Her ear is blocked"; FATIGUE (non-serious) with onset 2021, outcome "not recovered", described as "Constantly tired"; ASTHENIA (non-serious) with onset 2021, outcome "unknown", described as "Has no energy what so ever"; FEELING ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "Has been feeling lousy and feels like everything is being drained out of her". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of ear discomfort, fatigue, asthenia, feeling abnormal.  Additional information: Patient received Vitamins and Armour Thyroid as concomitant product.Caller states Armour is a form of Synthroid that she takes, over the counter. She has never had issues with this and has been on it for years. Patient was using Advil as treatment.Patient did not received any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Thyroid function test
Clinical narrative: First Dose: 28Nov2021; Second Dose: 12Dec2021; Her ear is blocked; Constantly tired; Has no energy what so ever; Has been feeling lousy and feels like everything is being drained out of her; 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 52 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 12Dec2021 10:00 (Batch/Lot number: unknown) at the age of 52 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hyperthyroidism" (unspecified if ongoing). Concomitant medication(s) included: ARMOUR THYROID taken for hyperthyroidism (ongoing). Vaccination history included: Bnt162b2 (Dose: 1, Dosage text: First Dose; right arm, Time the Vaccination Was Given: 10:00am, both doses), administration date: 28Nov2021, when the patient was 52 years old, for COVID-19 Immunization, reaction(s): "Ear has been blocked and cannot hear anything", "Constantly tired", "Having no energy what so ever". The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 12Dec2021 10:00, outcome "unknown", described as "First Dose: 28Nov2021; Second Dose: 12Dec2021"; EAR DISCOMFORT (non-serious) with onset 2021, outcome "not recovered", described as "Her ear is blocked"; FATIGUE (non-serious) with onset 2021, outcome "not recovered", described as "Constantly tired"; ASTHENIA (non-serious) with onset 2021, outcome "unknown", described as "Has no energy what so ever"; FEELING ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "Has been feeling lousy and feels like everything is being drained out of her". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of ear discomfort, fatigue, asthenia, feeling abnormal.  Additional information: Patient received Vitamins and Armour Thyroid as concomitant product.Caller states Armour is a form of Synthroid that she takes, over the counter. She has never had issues with this and has been on it for years. Patient was using Advil as treatment.Patient did not received any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Heart rate, Heart rate increased, Insomnia, Tremor
Clinical narrative: Body is shaking; heart was jumping out of her chest; she was very uncomfortable for 8 to 10 hours; not able to get back to sleep at all, she was up the entire night; 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 68-year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 2, single and (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: TREMOR (non-serious) with onset Mar2021, outcome "unknown", described as "body is shaking"; HEART RATE INCREASED (non-serious) with onset Mar2021, outcome "unknown", described as "heart was jumping out of her chest"; FEELING ABNORMAL (non-serious) with onset Mar2021, outcome "recovered", described as "she was very uncomfortable for 8 to 10 hours"; INSOMNIA (non-serious) with onset Mar2021, outcome "recovered", described as "not able to get back to sleep at all, she was up the entire night". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reporter stated she was interested in getting the Pfizer-BioNTech Covid19 Vaccine booster dose, but she had a very bad reaction from the 1st and 2nd dose that she had back in March. Reporter stated, 12-hrs after her 1st dose, she woke up out of a sound sleep with her whole body is shaking, her heart was jumping out of her chest, she was very uncomfortable for 8 to 10 hours and was not able to get back to sleep at all, she was up the entire night, and it was worse on the 2nd dose. Reporter stated wants to know if this has been reported before.  Follow-up attempts completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Soreness and tenderness in his arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, 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 and tenderness in his arm".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: My tinnitus has gotten much louder since receiving the first two doses.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04Mar2021 10:30 (Batch/Lot number: unknown) at the age of 34 years as dose 2, single and administered in arm left, administration date 13Apr2021 10:30 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunization. Relevant medical history included: "Psoriasis" (unspecified if ongoing), notes: Verbatim: Psoriasis.; "very high pitched ring/hiss in my ears" (unspecified if ongoing), notes: I previously (for at least five years) had a very high pitched ring/hiss in my ears but it wasn't noticeable unless in a quiet setting. The patient's concomitant medications were not reported. The following information was reported: TINNITUS (non-serious) with onset 2021, outcome "not recovered", described as "My tinnitus has gotten much louder since receiving the first two doses. I previously (for at least five years) had a very high pitched ring/hiss in my ears but it wasn''t noticeable unless in a quiet s".  Additional information: My tinnitus has gotten much louder since receiving the first two doses. I previously (for at least five years) had a very high pitched ring/hiss in my ears but it wasn't noticeable unless in a quiet setting. Now I can hear it constantly, and it's very loud. Additionally, 36 hours after the booster shot, I experienced a new tone, much lower than the usual one and only in my left ear. This has an incredibly negative impact on my ability to function at work, and my mental health.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-up (20Jan2022): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain
Clinical narrative: Have some really sharp abdominal pain;; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 23 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, 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: ABDOMINAL PAIN (non-serious), outcome "unknown", described as "Have some really sharp abdominal pain;".  Additional information: Patient had some really sharp abdominal pain; That is like a little more serious than just feeling crummy; Really sharp pain in her stomach. She had no health issues at all, she was not allergic to anything.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives/Hives was reported as worsened.; Hives itched; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team.  A 27 year-old male patient received bnt162b2 (BNT162B2), administration date 20Nov2021 (Batch/Lot number: unknown) at the age of 27 years as dose 2, 0.3 ml single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 01, Lot/NDC/Expiry: Unknown), for COVID-19 immunization. The following information was reported: URTICARIA (non-serious) with onset Nov2021, outcome "not recovered", described as "Hives/Hives was reported as worsened."; PRURITUS (non-serious) with onset Nov2021, outcome "not recovered", described as "Hives itched". The event "hives/hives was reported as worsened." was evaluated at the physician office visit. Therapeutic measures were taken as a result of urticaria, pruritus.  Additional information:This Nurse reported that they had a patient come in 20Dec2021 who had gotten the second dose of Pfizer Covid-19 Vaccine on 20Nov2021 and 1 week later developed hives which have continued through today. Date of onset of hives: Onset date approximately 1 week after 20Nov2021; he reported hives for 3 weeks as of today and that prior to the last week the hives were intermittent; but event got worse over the last 1 week. The hives were heavy and still present. The onset of the symptoms may vary. Caller indicated hives itched. Caller reported it sounded like the patient had seen his doctor back in withheld a couple of times for this event as well. Second dose completed his prescribe therapy. Caller had no known allergies per his record. Caller reported that the only information she was aware of regarding and treatment or medical interventions performed relative to this event were that he had been given some steroids; hydroxyzine, probably for the itch; and over the counter standard treatment of oatmeal baths and aloe. The patient did not visit the Emergency Room. It was unknown that any prior vaccinations (within 4 weeks) of the suspect vaccine. Patient was not hospitalized for events.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Cardiomegaly
Clinical narrative: Enlarged heart; 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 68 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: LISINOPRIL. Vaccination history included: Bnt162b2 (Dose: 1), administration date: 13Mar2021, for COVID-19 Immunization. The following information was reported: CARDIOMEGALY (non-serious) with onset 2021, outcome "unknown", described as "Enlarged heart".  Additional Information: The patient received booster shot on 17Dec2021.   Follow-up attempts completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Penis disorder
Clinical narrative: after a while his penis shrunk; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 2, single and (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: PENIS DISORDER (non-serious), outcome "unknown", described as "after a while his penis shrunk".  Additional information: reporter stated that he is calling for someone else that is really upset and bashful, stating that it seems his penis has shrunk. Consumer stated that he did not want to share any information or and do not contact again.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Bedridden, Body temperature, Headache, Pyrexia, SARS-CoV-2 test
Clinical narrative: he had high fever of 104; vomiting; headache; He was in bed; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558).  A 60 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10May2021 (Batch/Lot number: unknown) at the age of 60 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Sjogren's disease" (unspecified if ongoing); "Neck Fusion" (unspecified if ongoing), notes: it has been 3-4 years since he had the Neck fusion.; "had covid virus", start date: 18Nov2020 (unspecified if ongoing); "Allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: ZOLOFT taken for sjogren's syndrome; PREDNISONE taken for sjogren's syndrome. The following information was reported: PYREXIA (non-serious) with onset May2021, outcome "unknown", described as "he had high fever of 104"; VOMITING (non-serious) with onset May2021, outcome "unknown", described as "vomiting"; HEADACHE (non-serious) with onset May2021, outcome "unknown", described as "headache"; BEDRIDDEN (non-serious) with onset May2021, outcome "recovered" (May2021), described as "He was in bed". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: On an unspecified date in may2021, the patient underwent lab test for Body temperature and result was 104 degrees. On 03Aug2021, the patient underwent SARS-CoV-2 test and result was negative.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.