chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Facial discomfort, Fatigue, Headache
Clinical narrative: Pain in left arm at injection site but pain was up into my neck and down to the elbow.Dizziness 30 mins after and nausea.; Pain in left arm at injection site but pain was up into my neck and down to the elbow.Dizziness 30 mins after and nausea.; Pain in left arm at injection site but pain was up into my neck and down to the elbow.Dizziness 30 mins after and nausea.; Pain in left arm at injection site but pain was up into my neck and down to the elbow.Dizziness 30 mins after and nausea.; Pain in left arm at injection site but pain was up into my neck and down to the elbow.Dizziness 30 mins after and nausea.; very fatigued; Constant headache that only minimizes with ibuprofen; Headache caused sleepless nights; Pressure in my eyes and face; Pressure in my eyes and face; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Nov2021 14:15 (Batch/Lot number: unknown) at the age of 50 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "HTN" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious), NECK PAIN (non-serious), ARTHRALGIA (non-serious), DIZZINESS (non-serious), NAUSEA (non-serious) all with onset 23Nov2021 14:15, outcome "not recovered" and all described as "Pain in left arm at injection site but pain was up into my neck and down to the elbow.Dizziness 30 mins after and nausea."; FATIGUE (non-serious) with onset 23Nov2021 14:15, outcome "not recovered", described as "very fatigued"; HEADACHE (non-serious) with onset 23Nov2021 14:15, outcome "not recovered", described as "Constant headache that only minimizes with ibuprofen"; INSOMNIA (non-serious) with onset 23Nov2021 14:15, outcome "not recovered", described as "Headache caused sleepless nights"; FACIAL DISCOMFORT (non-serious), OCULAR DISCOMFORT (non-serious) all with onset 23Nov2021 14:15, outcome "not recovered" and all described as "Pressure in my eyes and face". Therapeutic measures were not taken as a result of vaccination site pain, neck pain, arthralgia, dizziness, nausea, fatigue, insomnia, facial discomfort, ocular discomfort. Therapeutic measures were taken as a result of headache.  Additional information: No covid prior the vaccination and no covid tested post vaccination. Patient did not have known allergies.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Nausea, Neck pain, Ocular discomfort, Vaccination site pain
Clinical narrative: Pain in left arm at injection site but pain was up into my neck and down to the elbow.Dizziness 30 mins after and nausea.; Pain in left arm at injection site but pain was up into my neck and down to the elbow.Dizziness 30 mins after and nausea.; Pain in left arm at injection site but pain was up into my neck and down to the elbow.Dizziness 30 mins after and nausea.; Pain in left arm at injection site but pain was up into my neck and down to the elbow.Dizziness 30 mins after and nausea.; Pain in left arm at injection site but pain was up into my neck and down to the elbow.Dizziness 30 mins after and nausea.; very fatigued; Constant headache that only minimizes with ibuprofen; Headache caused sleepless nights; Pressure in my eyes and face; Pressure in my eyes and face; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Nov2021 14:15 (Batch/Lot number: unknown) at the age of 50 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "HTN" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious), NECK PAIN (non-serious), ARTHRALGIA (non-serious), DIZZINESS (non-serious), NAUSEA (non-serious) all with onset 23Nov2021 14:15, outcome "not recovered" and all described as "Pain in left arm at injection site but pain was up into my neck and down to the elbow.Dizziness 30 mins after and nausea."; FATIGUE (non-serious) with onset 23Nov2021 14:15, outcome "not recovered", described as "very fatigued"; HEADACHE (non-serious) with onset 23Nov2021 14:15, outcome "not recovered", described as "Constant headache that only minimizes with ibuprofen"; INSOMNIA (non-serious) with onset 23Nov2021 14:15, outcome "not recovered", described as "Headache caused sleepless nights"; FACIAL DISCOMFORT (non-serious), OCULAR DISCOMFORT (non-serious) all with onset 23Nov2021 14:15, outcome "not recovered" and all described as "Pressure in my eyes and face". Therapeutic measures were not taken as a result of vaccination site pain, neck pain, arthralgia, dizziness, nausea, fatigue, insomnia, facial discomfort, ocular discomfort. Therapeutic measures were taken as a result of headache.  Additional information: No covid prior the vaccination and no covid tested post vaccination. Patient did not have known allergies.  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: Blood test, Burning sensation, Pruritus, Rash
Clinical narrative: burning; itching; rash that is primarily to legs and arms; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 66 year-old female patient received bnt162b2 (BNT162B2), administration date Dec2020 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: SINGULAIR. The following information was reported: BURNING SENSATION (non-serious) with onset 2021, outcome "unknown", described as "burning"; PRURITUS (non-serious) with onset 2021, outcome "unknown", described as "itching"; RASH (non-serious) with onset Dec2020, outcome "unknown", described as "rash that is primarily to legs and arms". The events "burning", "itching" and "rash that is primarily to legs and arms" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pruritus, rash.  Additional information: NDC number and Expiry Date of Pfizer COVID-19 vaccine were unknown.The patient had been suffering almost 9 months with a rash that is primarily on her legs and arms. She said she has been to her general practitioner who sent her for bloodwork and then to a dermatologist, and the bloodwork has been extensive but there was nothing wrong with her. She said she was curious if anyone else has reported having this. She said it was an awful burning and itching, constantly. She had been using a cream that was not helping, called Episerum. The patient received second dose on Jan2021, and her booster dose approximately August. she got the booster dose the rash exploded, meaning it got much worse. She said the rash began a couple weeks after her first dose, then it got better, then it would flare, then it would get better, and then it would flare again, she suffered with it for a month then finally went to her doctor who did bloodwork, then to a dermatologist, and now she was there that day. She had also been taking Hydroxyzine HCl 25mg, one every 6-8 hours as needed for itching and an EXP 11Nov2022. She had been taking Cetirizine, which was prescribed for the rash; it was prescription Cetirizine 10mg, once a day by mouth. She had been taking Cetirizine since about a month ago. She said this was also in an orange pharmacy bottle that has expiration 11Nov2022. She said since getting the booster dose she had a steroid shot and was better for a week and a half then boom it was right back. Nothing helped or cures it, nothing helped.  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-202101676872 same patient/different dose/AE
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Pain, Pruritus, SARS-CoV-2 test
Clinical narrative: On my arm is a bruise and itches bruise; On my arm is a bruise and itches bruise; hurts; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 23 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 15May2021 (Batch/Lot number: unknown) at the age of 23 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "if covid_prior vaccination Yes" (unspecified if ongoing), notes: if covid_prior vaccination Yes. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Right), administration date: 17Apr2021, when the patient was 23 years old, for COVID-19 Immunisation. The following information was reported: CONTUSION (non-serious), PRURITUS (non-serious) all with onset 2021, outcome "not recovered" and all described as "On my arm is a bruise and itches bruise"; PAIN (non-serious) with onset 2021, outcome "not recovered", described as "hurts". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of contusion, pruritus, pain.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Heart rate, Heart rate abnormal
Clinical narrative: Head was hurting a lot; Heart rate escalated dramatically/ his heart like while lying down, his rate like increased; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 25 year-old male patient received bnt162b2 (BNT162B2), administration date 26Nov2021 (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: HEART RATE ABNORMAL (non-serious) with onset 26Nov2021, outcome "unknown", described as "Heart rate escalated dramatically/ his heart like while lying down, his rate like increased"; HEADACHE (non-serious) with onset 27Nov2021, outcome "not recovered", described as "Head was hurting a lot". Relevant laboratory tests and procedures are available in the appropriate section.  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: Chills
Clinical narrative: some reactions to it and had chills; This is a spontaneous report received from a contactable reporter (Other HCP) from medical information team. The reporter is the patient.  A 90 year-old male 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: CHILLS (non-serious), outcome "unknown", described as "some reactions to it and had chills".  Additional information: It was reported that the patient was a retired Dentist in a good health. He was reporting that after receiving the first and second dose of Pfizer BioNtech Covid vaccine, after 24hours he had some reactions to it and had chills. He understood that this reactions were not that common but they did happen. He was told that he shouldn't get the booster because of this reaction but he wanted to know what were the risks of getting chills after booster shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Lymphadenopathy, Neck pain, SARS-CoV-2 test
Clinical narrative: swollen lymph node under my left arm pit; very sore neck and shoulders; a very sore neck and shoulders; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date May2021 (Batch/Lot number: unknown) at the age of 42 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Known allergies: Broccoli, chocolate, plumbs, wheat,bakers yeast etc." (unspecified if ongoing). Concomitant medication(s) included: ADVIL [IBUPROFEN]; TYLENOL.  The following information was reported: LYMPHADENOPATHY (non-serious) with onset May2021, outcome "not recovered", described as "swollen lymph node under my left arm pit"; NECK PAIN (non-serious) with onset May2021, outcome "not recovered", described as "very sore neck and shoulders"; ARTHRALGIA (non-serious) with onset May2021, outcome "not recovered", described as "a very sore neck and shoulders". The events "swollen lymph node under my left arm pit", "very sore neck and shoulders" and "a very sore neck and shoulders" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (Jun2021) negative; (Jul2021) negative; (Aug2021) negative. Therapeutic measures were taken as a result of lymphadenopathy, neck pain, arthralgia.  Additional information:  Patient reported that since vaccine, the patient was also apparently allergic to foods and environmental things that she had never been allergic to in her whole life.   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: U
Vaccine: COVID19
Symptoms: Abdominal discomfort, Headache, Illness, Pyrexia, Vomiting
Clinical narrative: headaches; fever; stomach issues; throwing up; sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 2021 (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: HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "headaches"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "fever"; ABDOMINAL DISCOMFORT (non-serious) with onset 2021, outcome "unknown", described as "stomach issues"; VOMITING (non-serious) with onset 2021, outcome "unknown", described as "throwing up"; ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "sick".  Follow-up attempts completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: feels like she has a cold coming on; 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) (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: NASOPHARYNGITIS (non-serious), outcome "not recovered", described as "feels like she has a cold coming on".  Additional information: Reporter (patient) clarified she did not have a high fever, she felt like she had a cold coming on, she had been skiing. This was why she needs to reschedule her booster dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia
Clinical narrative: loss of taste; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 69 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date Mar2021 (Batch/Lot number: unknown) at the age of 69 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypertension" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. , Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: Feb2021, when the patient was 69 years old, for COVID-19 immunization. The following information was reported: AGEUSIA (non-serious) with onset Mar2021, outcome "not recovered", described as "loss of taste". Therapeutic measures were not taken as a result of ageusia.  Additional Information: The patient has no other vaccine within 4 weeks. the patient has not had prior covid. The patient has not been tested for covid after vaccination. There were no known allergies. She had never had symptoms of Covid infection.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arthralgia, Back pain, Headache, Neck pain
Clinical narrative: Sore injection site; sore right arm; sore right arm/joint/neck/jaw/back; sore right arm/joint/neck/jaw/back; sore right arm/joint/neck/jaw/back; sore right arm/joint/neck/jaw/back; headache; upset stomach; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 30Nov2021 14:30 (Batch/Lot number: unknown) at the age of 40 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "owrens" (unspecified if ongoing); "Anemia" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing); "IBS" (unspecified if ongoing), notes: Irritable bowel syndrome; "Hypoglycemia" (unspecified if ongoing); "migraines" (unspecified if ongoing); "known allergies: Yes" (unspecified if ongoing), notes: known allergies: Yes. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Right), administration date: 22Apr2021, when the patient was 40 years old, for Covid-19 Immunisation; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), administration date: 30Mar2021, when the patient was 40 years old, for Covid-19 Immunisation. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 01Dec2021 06:00, outcome "not recovered", described as "Sore injection site"; PAIN IN EXTREMITY (non-serious) with onset 01Dec2021 06:00, outcome "not recovered", described as "sore right arm"; ARTHRALGIA (non-serious), NECK PAIN (non-serious), PAIN IN JAW (non-serious), BACK PAIN (non-serious) all with onset 01Dec2021 06:00, outcome "not recovered" and all described as "sore right arm/joint/neck/jaw/back"; HEADACHE (non-serious) with onset 01Dec2021 06:00, outcome "not recovered", described as "headache"; ABDOMINAL DISCOMFORT (non-serious) with onset 01Dec2021 06:00, outcome "not recovered", described as "upset stomach". Therapeutic measures were not taken as a result of vaccination site pain, pain in extremity, arthralgia, neck pain, pain in jaw, back pain, headache, abdominal discomfort.  Additional information: The patient not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. The patient received several other medications within 2 weeks of vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pain in jaw, Vaccination site pain
Clinical narrative: Sore injection site; sore right arm; sore right arm/joint/neck/jaw/back; sore right arm/joint/neck/jaw/back; sore right arm/joint/neck/jaw/back; sore right arm/joint/neck/jaw/back; headache; upset stomach; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 30Nov2021 14:30 (Batch/Lot number: unknown) at the age of 40 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "owrens" (unspecified if ongoing); "Anemia" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing); "IBS" (unspecified if ongoing), notes: Irritable bowel syndrome; "Hypoglycemia" (unspecified if ongoing); "migraines" (unspecified if ongoing); "known allergies: Yes" (unspecified if ongoing), notes: known allergies: Yes. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Location of injection: Arm Right), administration date: 22Apr2021, when the patient was 40 years old, for Covid-19 Immunisation; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), administration date: 30Mar2021, when the patient was 40 years old, for Covid-19 Immunisation. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 01Dec2021 06:00, outcome "not recovered", described as "Sore injection site"; PAIN IN EXTREMITY (non-serious) with onset 01Dec2021 06:00, outcome "not recovered", described as "sore right arm"; ARTHRALGIA (non-serious), NECK PAIN (non-serious), PAIN IN JAW (non-serious), BACK PAIN (non-serious) all with onset 01Dec2021 06:00, outcome "not recovered" and all described as "sore right arm/joint/neck/jaw/back"; HEADACHE (non-serious) with onset 01Dec2021 06:00, outcome "not recovered", described as "headache"; ABDOMINAL DISCOMFORT (non-serious) with onset 01Dec2021 06:00, outcome "not recovered", described as "upset stomach". Therapeutic measures were not taken as a result of vaccination site pain, pain in extremity, arthralgia, neck pain, pain in jaw, back pain, headache, abdominal discomfort.  Additional information: The patient not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. The patient received several other medications within 2 weeks of vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 38.0
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Bladder cancer, Inappropriate schedule of product administration, Investigation, Lipids
Clinical narrative: Dose 1- 23Jun2021, Dose 2- 24Aug2021; After the second shot like body ache, elbows both sides, shoulders and in knees like cup of the knee.; After the second shot like body ache, elbows both sides, shoulders and in knees like cup of the knee.; started having horrible side-errors in my muscles; developed very bad pain in my knees that then went to my thighs.; 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), intramuscular, administration date 24Aug2021 (Lot number: FC3182) at the age of 38 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Acid reflux" (unspecified if ongoing). Concomitant medication(s) included: NEXUM taken for gastrooesophageal reflux disease (ongoing); PEPCID AC taken for gastrooesophageal reflux disease (ongoing). Vaccination history included: Bnt162b2 (Dose 1, Patient Route of administration: Intramuscular, Anatomical site of injection: left, Lot No: EW0198), administration date: 23Jun2021, when the patient was 38 years old, for Covid-19 immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "Dose 1- 23Jun2021, Dose 2- 24Aug2021"; PAIN (non-serious), ARTHRALGIA (non-serious), outcome "unknown" and all described as "After the second shot like body ache, elbows both sides, shoulders and in knees like cup of the knee."; MUSCLE DISORDER (non-serious), outcome "unknown", described as "started having horrible side-errors in my muscles"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "developed very bad pain in my knees that then went to my thighs.". The events "after the second shot like body ache, elbows both sides, shoulders and in knees like cup of the knee.", "after the second shot like body ache, elbows both sides, shoulders and in knees like cup of the knee.", "started having horrible side-errors in my muscles" and "developed very bad pain in my knees that then went to my thighs." were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Prior vaccinations within 4 weeks was reported as none. The patient reported that after receiving the second dose of the Pfizer Vaccine I started having horrible side-errors in my muscles. I developed very bad pain in my knees that then went to my thighs. The pain also extended to my elbows, shoulders and forearms and underarms. I have been to the ER because the pain is too much to handle. Unfortunately, the doctor's haven't found the cause for my pain and medication doesn't seem to work. No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: U
Vaccine: COVID19
Symptoms: Metabolic function test, Muscle disorder, Pain, Pain in extremity, Rheumatoid factor
Clinical narrative: Dose 1- 23Jun2021, Dose 2- 24Aug2021; After the second shot like body ache, elbows both sides, shoulders and in knees like cup of the knee.; After the second shot like body ache, elbows both sides, shoulders and in knees like cup of the knee.; started having horrible side-errors in my muscles; developed very bad pain in my knees that then went to my thighs.; 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), intramuscular, administration date 24Aug2021 (Lot number: FC3182) at the age of 38 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Acid reflux" (unspecified if ongoing). Concomitant medication(s) included: NEXUM taken for gastrooesophageal reflux disease (ongoing); PEPCID AC taken for gastrooesophageal reflux disease (ongoing). Vaccination history included: Bnt162b2 (Dose 1, Patient Route of administration: Intramuscular, Anatomical site of injection: left, Lot No: EW0198), administration date: 23Jun2021, when the patient was 38 years old, for Covid-19 immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "Dose 1- 23Jun2021, Dose 2- 24Aug2021"; PAIN (non-serious), ARTHRALGIA (non-serious), outcome "unknown" and all described as "After the second shot like body ache, elbows both sides, shoulders and in knees like cup of the knee."; MUSCLE DISORDER (non-serious), outcome "unknown", described as "started having horrible side-errors in my muscles"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "developed very bad pain in my knees that then went to my thighs.". The events "after the second shot like body ache, elbows both sides, shoulders and in knees like cup of the knee.", "after the second shot like body ache, elbows both sides, shoulders and in knees like cup of the knee.", "started having horrible side-errors in my muscles" and "developed very bad pain in my knees that then went to my thighs." were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Prior vaccinations within 4 weeks was reported as none. The patient reported that after receiving the second dose of the Pfizer Vaccine I started having horrible side-errors in my muscles. I developed very bad pain in my knees that then went to my thighs. The pain also extended to my elbows, shoulders and forearms and underarms. I have been to the ER because the pain is too much to handle. Unfortunately, the doctor's haven't found the cause for my pain and medication doesn't seem to work. No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: U
Vaccine: COVID19
Symptoms: Ultrasound scan, Urine analysis, X-ray
Clinical narrative: Dose 1- 23Jun2021, Dose 2- 24Aug2021; After the second shot like body ache, elbows both sides, shoulders and in knees like cup of the knee.; After the second shot like body ache, elbows both sides, shoulders and in knees like cup of the knee.; started having horrible side-errors in my muscles; developed very bad pain in my knees that then went to my thighs.; 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), intramuscular, administration date 24Aug2021 (Lot number: FC3182) at the age of 38 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Acid reflux" (unspecified if ongoing). Concomitant medication(s) included: NEXUM taken for gastrooesophageal reflux disease (ongoing); PEPCID AC taken for gastrooesophageal reflux disease (ongoing). Vaccination history included: Bnt162b2 (Dose 1, Patient Route of administration: Intramuscular, Anatomical site of injection: left, Lot No: EW0198), administration date: 23Jun2021, when the patient was 38 years old, for Covid-19 immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "Dose 1- 23Jun2021, Dose 2- 24Aug2021"; PAIN (non-serious), ARTHRALGIA (non-serious), outcome "unknown" and all described as "After the second shot like body ache, elbows both sides, shoulders and in knees like cup of the knee."; MUSCLE DISORDER (non-serious), outcome "unknown", described as "started having horrible side-errors in my muscles"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "developed very bad pain in my knees that then went to my thighs.". The events "after the second shot like body ache, elbows both sides, shoulders and in knees like cup of the knee.", "after the second shot like body ache, elbows both sides, shoulders and in knees like cup of the knee.", "started having horrible side-errors in my muscles" and "developed very bad pain in my knees that then went to my thighs." were evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Prior vaccinations within 4 weeks was reported as none. The patient reported that after receiving the second dose of the Pfizer Vaccine I started having horrible side-errors in my muscles. I developed very bad pain in my knees that then went to my thighs. The pain also extended to my elbows, shoulders and forearms and underarms. I have been to the ER because the pain is too much to handle. Unfortunately, the doctor's haven't found the cause for my pain and medication doesn't seem to work. No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperaesthesia, Muscular weakness, Pain, Pain in extremity, Paraesthesia
Clinical narrative: pain continued to elbow; arm of injection continued to feel sore and weak; Injection site was sore to the touch; injection site was sore to the touch; arm of injection continued to feel sore and weak; arm is weak and sometimes tingly; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17Nov2021 (Lot number: FD0809) at the age of 56 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU VACCINE VII taken for immunisation, start date: 2021, stop date: 2021. Vaccination history included: Bnt162b2 (Prev dose product: COVID-19, Prev dose brand: Pfizer, Prev dose Lot number: ER8730,, Prev dose dose number: 2, Prev dose vaccine location: Left arm), administration date: 21Mar2021, when the patient was 55 years old, for COVID-19 immunization; Bnt162b2 (Prev dose product: COVID-19, Prev dose brand: Pfizer, Prev dose Lot number: EM9809,, Prev dose dose number: 1, Prev dose vaccine location: Left arm), administration date: 28Feb2021, when the patient was 55 years old, for COVID-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 17Nov2021, outcome "not recovered", described as "Injection site was sore to the touch"; HYPERAESTHESIA (non-serious) with onset 17Nov2021, outcome "not recovered", described as "injection site was sore to the touch"; PAIN (non-serious) with onset 20Nov2021, outcome "not recovered", described as "pain continued to elbow"; PAIN IN EXTREMITY (non-serious) with onset 17Nov2021, outcome "not recovered", MUSCULAR WEAKNESS (non-serious) with onset 2021, outcome "not recovered" and all described as "arm of injection continued to feel sore and weak"; PARAESTHESIA (non-serious) with onset 2021, outcome "not recovered", described as "arm is weak and sometimes tingly". Therapeutic measures were not taken as a result of vaccination site pain, hyperaesthesia, pain, pain in extremity, muscular weakness, paraesthesia.  Additional information: Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, has the patient was not been tested for COVID-19.  Follow-Up (07Dec2021): Follow-up attempts are completed. No further information is expected.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: pain continued to elbow; arm of injection continued to feel sore and weak; Injection site was sore to the touch; injection site was sore to the touch; arm of injection continued to feel sore and weak; arm is weak and sometimes tingly; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17Nov2021 (Lot number: FD0809) at the age of 56 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU VACCINE VII taken for immunisation, start date: 2021, stop date: 2021. Vaccination history included: Bnt162b2 (Prev dose product: COVID-19, Prev dose brand: Pfizer, Prev dose Lot number: ER8730,, Prev dose dose number: 2, Prev dose vaccine location: Left arm), administration date: 21Mar2021, when the patient was 55 years old, for COVID-19 immunization; Bnt162b2 (Prev dose product: COVID-19, Prev dose brand: Pfizer, Prev dose Lot number: EM9809,, Prev dose dose number: 1, Prev dose vaccine location: Left arm), administration date: 28Feb2021, when the patient was 55 years old, for COVID-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 17Nov2021, outcome "not recovered", described as "Injection site was sore to the touch"; HYPERAESTHESIA (non-serious) with onset 17Nov2021, outcome "not recovered", described as "injection site was sore to the touch"; PAIN (non-serious) with onset 20Nov2021, outcome "not recovered", described as "pain continued to elbow"; PAIN IN EXTREMITY (non-serious) with onset 17Nov2021, outcome "not recovered", MUSCULAR WEAKNESS (non-serious) with onset 2021, outcome "not recovered" and all described as "arm of injection continued to feel sore and weak"; PARAESTHESIA (non-serious) with onset 2021, outcome "not recovered", described as "arm is weak and sometimes tingly". Therapeutic measures were not taken as a result of vaccination site pain, hyperaesthesia, pain, pain in extremity, muscular weakness, paraesthesia.  Additional information: Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, has the patient was not been tested for COVID-19.  Follow-Up (07Dec2021): Follow-up attempts are completed. No further information is expected.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Nasopharyngitis, Pyrexia
Clinical narrative: I was ''chilling'' like my body.; I was having fever; feeling like cold; Headache; 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), administration date 01Dec2021 (Batch/Lot number: unknown) as dose 3 (booster) , 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; Bnt162b2 (DOSE:2), for COVID-19 Immunization. The following information was reported: CHILLS (non-serious), outcome "unknown", described as "I was ''chilling'' like my body."; PYREXIA (non-serious), outcome "unknown", described as "I was having fever"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "feeling like cold"; HEADACHE (non-serious), outcome "unknown", described as "Headache".  Additional information: It was reported that the patient enquired about administering Tylenol for headache after receiving booster dose. Have headache so, taking Tylenol but some people say, cannot take Tylenol.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Asthenia, Fatigue
Clinical narrative: she is tired with no energy; feeling so exhausted/feeling tired all the time; 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 (159558). The reporter is the patient.  A 83 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 1, single and administration date 26Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE) (Batch/Lot number: unknown) as dose number unknown, single for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ASTHENIA (non-serious), outcome "unknown", described as "she is tired with no energy"; FATIGUE (non-serious), outcome "unknown", described as "feeling so exhausted/feeling tired all the time".  Additional information: It was reported that Caller has received both doses of Comirnaty and wanted to know if it is necessary to receive the booster dose. Caller stated lately she has been feeling so exhausted, feeling tired all the time. She mentioned she took the flu shot and repeated she is tired with no energy. Caller asked if this is a bad sign or is this a norm. 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.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal distension, Abdominal pain upper, Blood test, Endoscopy, Gastrooesophageal reflux disease
Clinical narrative: Acid reflux; Has been experiencing on going bloating sensation; Achy feeling in the stomach/stomach pain; Nausea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 74 year-old male patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 19Apr2021 (Lot number: EW0161) as dose 2, single and administered in arm left, administration date 22Mar2021 10:00 (Lot number: ER8730) as dose 1, single for covid-19 immunisation. Relevant medical history included: "breaking out in hives", start date: Aug2019 (unspecified if ongoing), notes: Started breaking out in hives; "immune system concentration" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE taken for hypertension; VALSARTAN taken for hypertension; ROSUVASTATIN taken for blood cholesterol increased. The following information was reported: ABDOMINAL DISTENSION (non-serious) with onset 22Mar2021, outcome "not recovered", described as "Has been experiencing on going bloating sensation"; ABDOMINAL PAIN UPPER (non-serious) with onset 22Mar2021, outcome "recovering", described as "Achy feeling in the stomach/stomach pain"; NAUSEA (non-serious) with onset 22Mar2021, outcome "recovering", described as "Nausea"; GASTROOESOPHAGEAL REFLUX DISEASE (non-serious), outcome "unknown", described as "Acid reflux". The event "acid reflux" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of gastrooesophageal reflux disease.  Additional information: The patient reported that This week the cardiologist also put him on Ezetimibe 10mg. They wanted to give him more cholesterol medication, but he did not want to because of the cramps. He would get leg cramps on 20mg of the Rosuvastatin occasionally. He just assumed it would be worse if they doubled it. It made him feel uncomfortable, so they prescribed the Ezetimibe to take along with the 20mg Rosuvastatin.The manufacturer of the Rosuvastatin is Aurobindo, Lot OF2021022-A, Expiration Jun2023. They said the Ezetimibe would also help lower bad cholesterol. They put him on 20mg Prilosec, which has done nothing and then they doubled the dose. He then stated it is not Prilosec, but a form of Prilosec, which he named as Omeprazole, and that is the only thing they gave him. They are 20mg capsules. The manufacturer is Xiromed, LLC, Lot and expiration are unknown as it is in a pharmacy vial. The count size is, this is his 2nd fill, of 90. The doctor said to double his dose this week and he did two days ago, and it was not doing anything.  No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Positron emission tomogram, Scan bone marrow, Ultrasound scan
Clinical narrative: Acid reflux; Has been experiencing on going bloating sensation; Achy feeling in the stomach/stomach pain; Nausea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 74 year-old male patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 19Apr2021 (Lot number: EW0161) as dose 2, single and administered in arm left, administration date 22Mar2021 10:00 (Lot number: ER8730) as dose 1, single for covid-19 immunisation. Relevant medical history included: "breaking out in hives", start date: Aug2019 (unspecified if ongoing), notes: Started breaking out in hives; "immune system concentration" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE taken for hypertension; VALSARTAN taken for hypertension; ROSUVASTATIN taken for blood cholesterol increased. The following information was reported: ABDOMINAL DISTENSION (non-serious) with onset 22Mar2021, outcome "not recovered", described as "Has been experiencing on going bloating sensation"; ABDOMINAL PAIN UPPER (non-serious) with onset 22Mar2021, outcome "recovering", described as "Achy feeling in the stomach/stomach pain"; NAUSEA (non-serious) with onset 22Mar2021, outcome "recovering", described as "Nausea"; GASTROOESOPHAGEAL REFLUX DISEASE (non-serious), outcome "unknown", described as "Acid reflux". The event "acid reflux" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of gastrooesophageal reflux disease.  Additional information: The patient reported that This week the cardiologist also put him on Ezetimibe 10mg. They wanted to give him more cholesterol medication, but he did not want to because of the cramps. He would get leg cramps on 20mg of the Rosuvastatin occasionally. He just assumed it would be worse if they doubled it. It made him feel uncomfortable, so they prescribed the Ezetimibe to take along with the 20mg Rosuvastatin.The manufacturer of the Rosuvastatin is Aurobindo, Lot OF2021022-A, Expiration Jun2023. They said the Ezetimibe would also help lower bad cholesterol. They put him on 20mg Prilosec, which has done nothing and then they doubled the dose. He then stated it is not Prilosec, but a form of Prilosec, which he named as Omeprazole, and that is the only thing they gave him. They are 20mg capsules. The manufacturer is Xiromed, LLC, Lot and expiration are unknown as it is in a pharmacy vial. The count size is, this is his 2nd fill, of 90. The doctor said to double his dose this week and he did two days ago, and it was not doing anything.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia
Clinical narrative: feeling feverish; having chills; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunization. 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: PYREXIA (non-serious), outcome "unknown", described as "feeling feverish"; CHILLS (non-serious), outcome "unknown", described as "having chills". Relevant laboratory tests and procedures are available in the appropriate section.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.