chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: red rash; very itchy; Nausea; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 74 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid right, administration date 11Apr2021 17:00 (Lot number: EW0153) at the age of 74 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Levothyroxine sodium, notes: Levothyroxine sodium 112 mcg PO (per oral) QD (once a day). The following information was reported: RASH ERYTHEMATOUS (non-serious) with onset 12Apr2021, outcome "recovered", described as "red rash"; RASH PRURITIC (non-serious) with onset 12Apr2021, outcome "recovered", described as "very itchy"; NAUSEA (non-serious) with onset 12Apr2021, outcome "unknown", described as "Nausea". The events "red rash" and "very itchy" 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 rash erythematous, rash pruritic. No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Confusional state, Disorientation, Feeling abnormal, Vaccination site pain
Clinical narrative: he experienced brain fog/mental fog; Confusion; disorientation; anxiety/panic; have a little pain in the shoulder but nothing major, in the right shoulder where he got the shot; 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 61 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 02Aug2021 14:30 (Lot number: FA7484, Expiration Date: 01Sep2021) at the age of 61 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "heart attack" (unspecified if ongoing); "Stenting", start date: 15Jan2019 (unknown if ongoing); "Gallstones", start date: 2016 (unknown if ongoing); "Cholecystectomy" (unspecified if ongoing), notes: Gallstones removal; "Quintuple bypass" (unspecified if ongoing). Family history included: "Coronary artery disease", start date: 27Nov2012 (ongoing). Concomitant medication(s) included: ASPIRIN [ACETYLSALICYLIC ACID] taken for cardiovascular disorder, start date: 2012 (ongoing); METOPROLOL taken for myocardial infarction, cardiovascular disorder, start date: 2012 (ongoing); ISOSORBIDE, start date: 2014 (ongoing). The following information was reported: FEELING ABNORMAL (non-serious) with onset 03Aug2021 16:30, outcome "recovered" (Aug2021), described as "he experienced brain fog/mental fog"; CONFUSIONAL STATE (non-serious) with onset 03Aug2021 16:30, outcome "unknown", described as "Confusion"; DISORIENTATION (non-serious) with onset 03Aug2021 16:30, outcome "unknown", described as "disorientation"; ANXIETY (non-serious) with onset 03Aug2021 16:30, outcome "unknown", described as "anxiety/panic"; VACCINATION SITE PAIN (non-serious) with onset 03Aug2021 16:30, outcome "unknown", described as "have a little pain in the shoulder but nothing major, in the right shoulder where he got the shot". Therapeutic measures were not taken as a result of feeling abnormal.  Additional information: Approximately 26 hours post vaccination patient experienced a severe mental fog lasting several hours resulting in confusion, disorientation and anxiety/panic. patient nearly got lost going home and for a short time patient did not know where he was when patient got home. Patient had not taken any prior vaccination within 4 weeks Covid-19 Vaccine.Family medical history relevant to adverse events was 3 brothers, 1 sister and 1 mother. All bypass surgery or death due to coronary artery disease. Probably not related to adverse vaccination.   No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Pruritus, Rash
Clinical narrative: received first dose of Pfizer covid vaccine in Jan/Caller reports 21Jul2021 he received first (second dose) revaccination dose to restart series; experiencing a rash on his body; itch a lot; 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 49 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21Jul2021 10:00 (Lot number: EY0584) at the age of 49 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "a tooth was extracted." (unspecified if ongoing), notes: a tooth was extracted. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, single), administration date: Jan2021, when the patient was 49 years old, for COVID-19 immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "received first dose of Pfizer covid vaccine in Jan/Caller reports 21Jul2021 he received first (second dose) revaccination dose to restart series"; RASH (non-serious) with onset 23Jul2021, outcome "not recovered", described as "experiencing a rash on his body"; PRURITUS (non-serious) with onset 23Jul2021, outcome "unknown", described as "itch a lot". Therapeutic measures were taken as a result of pruritus with Lanosil cream. Additional Information: Patient did not have any AE(s) require a visit to: Emergency Room/Physician Office. Caller took the first dose through his job. He explains the vaccine facility was supposed to come back to give his second dose, but they didn't show up. He just ignored it. On the 21st of last month, he went to Pharmacy and took the second dose. He clarifies he was re-administered his first dose. 2 days after, he started to develop a few rashes on his body. It's not like he is in great pain, the rashes are just coming out and they itch a lot.   Follow-up attempts are completed. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Erythema, Investigation, Limb discomfort, Magnetic resonance imaging
Clinical narrative: I have had test to check my circulation in my leg; Pain; Swelling; Foot swelled up; my toes mainly, red, painful, burning sensation; my toes mainly, red, painful, burning sensation; my toes mainly, red, painful, burning sensation; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 06May2021 (Lot number: EW0170) at the age of 63 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (LOT# for first shot: ER8731, anatomical site: right arm), administration date: 15Apr2021, for Covid-19 immunisation. The following information was reported: LIMB DISCOMFORT (non-serious), outcome "unknown", described as "I have had test to check my circulation in my leg"; PAIN (non-serious), outcome "unknown", described as "Pain"; SWELLING (non-serious), outcome "unknown", described as "Swelling"; PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "Foot swelled up"; BURNING SENSATION (non-serious), ERYTHEMA (non-serious), PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as "my toes mainly, red, painful, burning sensation". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain, swelling.  Additional information: Consumer stated he got his second Pfizer COVID shot on May 6th (not clarified) and his foot swelled up, toes mainly, red, painful, burning sensation. He went to the doctor on May 21st. Consumer reported that he had some lab test. After having the 2nd COVID Vaccine he had X-ray and MRI. He also had test to check circulation in his leg and in his feet different test. He doesn't know the name of them or do not have right off hand. He has a test for gout, a test for infection for diabetes and several others and he would have to go into his health portals to look them. (Further clarification about the laboratory test and the laboratory results were unknown, hence not captured as event). Consumer stated that he was taking treatment in response to adverse event, pain pills and he took Prednisone to bring down the swelling. He had done that 3 times.   No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Peripheral swelling, Swelling, X-ray
Clinical narrative: I have had test to check my circulation in my leg; Pain; Swelling; Foot swelled up; my toes mainly, red, painful, burning sensation; my toes mainly, red, painful, burning sensation; my toes mainly, red, painful, burning sensation; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 06May2021 (Lot number: EW0170) at the age of 63 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (LOT# for first shot: ER8731, anatomical site: right arm), administration date: 15Apr2021, for Covid-19 immunisation. The following information was reported: LIMB DISCOMFORT (non-serious), outcome "unknown", described as "I have had test to check my circulation in my leg"; PAIN (non-serious), outcome "unknown", described as "Pain"; SWELLING (non-serious), outcome "unknown", described as "Swelling"; PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "Foot swelled up"; BURNING SENSATION (non-serious), ERYTHEMA (non-serious), PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as "my toes mainly, red, painful, burning sensation". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain, swelling.  Additional information: Consumer stated he got his second Pfizer COVID shot on May 6th (not clarified) and his foot swelled up, toes mainly, red, painful, burning sensation. He went to the doctor on May 21st. Consumer reported that he had some lab test. After having the 2nd COVID Vaccine he had X-ray and MRI. He also had test to check circulation in his leg and in his feet different test. He doesn't know the name of them or do not have right off hand. He has a test for gout, a test for infection for diabetes and several others and he would have to go into his health portals to look them. (Further clarification about the laboratory test and the laboratory results were unknown, hence not captured as event). Consumer stated that he was taking treatment in response to adverse event, pain pills and he took Prednisone to bring down the swelling. He had done that 3 times.   No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Lymph node pain, Lymphadenopathy, Pharyngeal swelling
Clinical narrative: Painful and swollen glands and lymph nodes; Swollen throat; When she got the shot, she got little bit anxious; Painful and swollen glands and lymph nodes; 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 41-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 03Aug2021 (Lot number: FA7485, Expiration Date: 31Oct2021) at the age of 41 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: LYMPH NODE PAIN (non-serious) with onset Aug2021, outcome "unknown", LYMPHADENOPATHY (non-serious) with onset 05Aug2021, outcome "unknown" and all described as "Painful and swollen glands and lymph nodes"; PHARYNGEAL SWELLING (non-serious) with onset 05Aug2021, outcome "unknown", described as "Swollen throat"; ANXIETY (non-serious) with onset 03Aug2021, outcome "unknown", described as "When she got the shot, she got little bit anxious". Therapeutic measures were taken as a result of lymph node pain, lymphadenopathy.  Additional information: Received call from consumer regarding the Pfizer COVID vaccine. She talked to her pharmacy and had her first dose on 03Aug2021Tuesday. She called pharmacy and they gave her the company number. She has swollen glands and lymph nodes and it is kind of like pain, but she took some Tylenol. She wanted to know if this was normal and if there is anything else to do to treat it or does she let it runs its course.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: PNC13
Symptoms: Injection site pain, Vaccination site pain, Vaccination site swelling
Clinical narrative: swelling and tenderness at the site of the injection; swelling and tenderness at the site of the injection; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  An infant patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) (Batch/Lot number: unknown) as dose 1, single. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE SWELLING (non-serious), VACCINATION SITE PAIN (non-serious), outcome "unknown" and all described as "swelling and tenderness at the site of the injection". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Additional information: Event took place after use of product.
Sex: U
Vaccine: PNC13
Symptoms: Peripheral swelling
Clinical narrative: swelling of the upper arm; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative. A patient (no qualifiers provided) received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) (Batch/Lot number: unknown) as dose number unknown, single for immunisation. Relevant medical history included: "hemophilia" (ongoing). The patient's concomitant medications were not reported. The following information was reported: PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "swelling of the upper arm". Additional information reported as after administering Prevnar 13 to a patient with hemophilia, there was a large area of swelling of the upper arm.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Pyrexia
Clinical narrative: Headache; Fever; Soreness of my arm; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 66 year-old male patient received bnt162b2 (BNT162B2), administration date 02Aug2021 (Lot number: EW0202, Expiration Date: 30Sep2021) at the age of 66 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Blood pressure high" (unspecified if ongoing), notes: Verbatim: Blood pressure high; "Prostate cancer" (unspecified if ongoing), notes: Verbatim: Prostate cancer, I had Prostate cancer and treated 3 years back in December.; "Blood thinners" (unspecified if ongoing), notes: I take Eliquis Blood thinner. Concomitant medication(s) included: AMLODIPINE taken for hypertension; LOSARTAN taken for hypertension; ELIQUIS taken for blood disorder. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Aug2021, outcome "unknown", described as "Soreness of my arm"; HEADACHE (non-serious) with onset 03Aug2021, outcome "not recovered", described as "Headache"; PYREXIA (non-serious) with onset 03Aug2021, outcome "not recovered", described as "Fever".  Additional Information: Concomitant Products Losartan: Dose, consumer stated, "It is 125mg, it says "100-25" (not clarified) tab that says on the label.", Eliquis: Consumer stated, "I take Eliquis Blood thinner." Additional Information for Other Conditions: Consumer stated, "I had Prostate cancer and treated 3 years back in December." When probed for the concern, consumer stated, "I got the Pfizer (first dose) shot Monday morning and I did feel side effects and that need to go away soreness of my arm but from last yesterday evening till today night I have a headache and fever." Any Prior vaccination (within 4 weeks): No  Follow-up attempts are completed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Chest discomfort, Headache, Paraesthesia
Clinical narrative: Lower back pain as of yesterday and today; I felt hot weak; Heavy pressure in the center of my chest with a tingling feeling; Heavy pressure in the center of my chest with a tingling feeling; Headache and when I bend down or sleep flat, or after eating a meal; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 31Jul2021 14:00 (Lot number: FA7485) at the age of 44 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hashimotos" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE. The following information was reported: ASTHENIA (non-serious) with onset 31Jul2021, outcome "recovering", described as "I felt hot weak"; CHEST DISCOMFORT (non-serious), PARAESTHESIA (non-serious) all with onset 31Jul2021, outcome "recovering" and all described as "Heavy pressure in the center of my chest with a tingling feeling"; HEADACHE (non-serious) with onset 31Jul2021, outcome "recovering", described as "Headache and when I bend down or sleep flat, or after eating a meal"; BACK PAIN (non-serious) with onset 04Aug2021, outcome "recovering", described as "Lower back pain as of yesterday and today". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of asthenia, chest discomfort, paraesthesia, headache, back pain.  Additional information: Known allergies: None. Facility where the most recent COVID-19 vaccine was administered: facility. Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No. List of any other medications the patient received within 2 weeks of vaccination: Levothyroxine 112 mcg. Reported Event: About 5-7 minutes after receiving the vaccine patient felt hot weak and heavy pressure in the center of her chest with a tingling feeling. As soon as the nurse allowed in the back room where it was very cool from the AC being on then her symptoms went away. It's now been 5 days since she received her vaccine and she had a headache and when she bend down or sleep flat, or after eating a meal, she could feel her headache more. Lower back pain as of yesterday and today. Adverse event start date: 30Jul2021. Adverse event start time: 02:15 PM. AE resulted in: [None of the above]. If treatment AE: No. Prior to vaccination, was the patient diagnosed with COVID-19: No. Since the vaccination, has the patient been tested for COVID-19: Yes, covid test post vaccination covid test type post vaccination=Nasal Swab, covid test date= 30Jul2021, covid test result= negative.  Follow-up attempts are completed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Lower back pain as of yesterday and today; I felt hot weak; Heavy pressure in the center of my chest with a tingling feeling; Heavy pressure in the center of my chest with a tingling feeling; Headache and when I bend down or sleep flat, or after eating a meal; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 31Jul2021 14:00 (Lot number: FA7485) at the age of 44 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hashimotos" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE. The following information was reported: ASTHENIA (non-serious) with onset 31Jul2021, outcome "recovering", described as "I felt hot weak"; CHEST DISCOMFORT (non-serious), PARAESTHESIA (non-serious) all with onset 31Jul2021, outcome "recovering" and all described as "Heavy pressure in the center of my chest with a tingling feeling"; HEADACHE (non-serious) with onset 31Jul2021, outcome "recovering", described as "Headache and when I bend down or sleep flat, or after eating a meal"; BACK PAIN (non-serious) with onset 04Aug2021, outcome "recovering", described as "Lower back pain as of yesterday and today". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of asthenia, chest discomfort, paraesthesia, headache, back pain.  Additional information: Known allergies: None. Facility where the most recent COVID-19 vaccine was administered: facility. Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No. List of any other medications the patient received within 2 weeks of vaccination: Levothyroxine 112 mcg. Reported Event: About 5-7 minutes after receiving the vaccine patient felt hot weak and heavy pressure in the center of her chest with a tingling feeling. As soon as the nurse allowed in the back room where it was very cool from the AC being on then her symptoms went away. It's now been 5 days since she received her vaccine and she had a headache and when she bend down or sleep flat, or after eating a meal, she could feel her headache more. Lower back pain as of yesterday and today. Adverse event start date: 30Jul2021. Adverse event start time: 02:15 PM. AE resulted in: [None of the above]. If treatment AE: No. Prior to vaccination, was the patient diagnosed with COVID-19: No. Since the vaccination, has the patient been tested for COVID-19: Yes, covid test post vaccination covid test type post vaccination=Nasal Swab, covid test date= 30Jul2021, covid test result= negative.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash macular, Urticaria
Clinical narrative: hive; rash on her torso area, lower hip area.; red bumps; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 05Aug2021 (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: URTICARIA (non-serious) with onset 2021, outcome "unknown", described as "hive"; RASH (non-serious) with onset 2021, outcome "unknown", described as "rash on her torso area, lower hip area."; RASH MACULAR (non-serious) with onset 2021, outcome "unknown", described as "red bumps".  Additional information: The patient states she got the first Pfizer Covid vaccine on 05Aug2021 and not had really anything, it was pretty uneventful, but she had a slight rash on the torso area, near the lower left hip. After receiving the vaccine patient had noticed a rash on her torso area, lower hip area. A "few red bumps, 2-3 raised like a bite or hive maybe, patient don't know. Then a little around it." The rash starts before her hip starts; she states as per her husband it was the length of her hand. She states she has a small hand and estimates it to be about 5 inches and 2 inches down. The patient would like to know if this was something she was concerned about or if this was normal as well as if this was an urgent matter. She wants to know if there was any issues for concern with that or what. The patient wants to know after a rash after getting the vaccine, would this mean that she cannot get the second shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Blood cholesterol, Blood sodium, Blood test, Fatigue
Clinical narrative: Aching; Headache; Weak; Feel sick; I have fibromyalgia and chronic fatigue and it's like it made it 10 times worse; "I have fibromyalgia and chronic fatigue and it's like it made it 10 times worse; Aching muscle; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78 year-old female patient received bnt162b2 (BNT162B2), administration date 30Jul2021 (Lot number: FA7484) at the age of 78 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Fibromyalgia" (unspecified if ongoing); "Chronic fatigue" (unspecified if ongoing). Concomitant medication(s) included: CALCIUM. Vaccination history included: Bnt162b2 (First Shot: LOT#: FA6780.), administration date: 08Jul2021, when the patient was 77 years old, for COVID-19 immunization, reaction(s): "I suffered for months, when I got first shot and I didn't feel well for three week", "My sodium chloride was little on the low side"; Bnt162b2 (First Shot: LOT#: FA6780.), administration date: 08Jul2021, when the patient was 77 years old, for Covid-19 Immunization, reaction(s): "high cholesterol". The following information was reported: PAIN (non-serious) with onset 2021, outcome "unknown", described as "Aching"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "Headache"; ASTHENIA (non-serious) with onset 2021, outcome "unknown", described as "Weak"; ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "Feel sick"; FIBROMYALGIA (non-serious) with onset 2021, outcome "unknown", described as "I have fibromyalgia and chronic fatigue and it's like it made it 10 times worse"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as ""I have fibromyalgia and chronic fatigue and it's like it made it 10 times worse"; MYALGIA (non-serious) with onset 2021, outcome "unknown", described as "Aching muscle". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain, headache, myalgia. Therapeutic measures were not taken as a result of asthenia, illness, fibromyalgia, fatigue.  Additional information: Consumer stated, She had fibromyalgia and chronic fatigue and it is like it made it 10 times worse, the fatigue its just its dragging and aching the aching muscle. Patient did not have heart issues, she is not diabetic. Consumer stated that she took Ibuprofen for her pain and aspirin for headache. Concomitants medication also included multivitamins. Family History: Consumer stated, No my family, my sister and they have no problems at all. Some of them has Pfizer some have Moderna.The day that felt a little tired but nothing like what I am having.  No follow-up attempts are possible. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fibromyalgia, Headache, Illness, Myalgia, Pain
Clinical narrative: Aching; Headache; Weak; Feel sick; I have fibromyalgia and chronic fatigue and it's like it made it 10 times worse; "I have fibromyalgia and chronic fatigue and it's like it made it 10 times worse; Aching muscle; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78 year-old female patient received bnt162b2 (BNT162B2), administration date 30Jul2021 (Lot number: FA7484) at the age of 78 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Fibromyalgia" (unspecified if ongoing); "Chronic fatigue" (unspecified if ongoing). Concomitant medication(s) included: CALCIUM. Vaccination history included: Bnt162b2 (First Shot: LOT#: FA6780.), administration date: 08Jul2021, when the patient was 77 years old, for COVID-19 immunization, reaction(s): "I suffered for months, when I got first shot and I didn't feel well for three week", "My sodium chloride was little on the low side"; Bnt162b2 (First Shot: LOT#: FA6780.), administration date: 08Jul2021, when the patient was 77 years old, for Covid-19 Immunization, reaction(s): "high cholesterol". The following information was reported: PAIN (non-serious) with onset 2021, outcome "unknown", described as "Aching"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "Headache"; ASTHENIA (non-serious) with onset 2021, outcome "unknown", described as "Weak"; ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "Feel sick"; FIBROMYALGIA (non-serious) with onset 2021, outcome "unknown", described as "I have fibromyalgia and chronic fatigue and it's like it made it 10 times worse"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as ""I have fibromyalgia and chronic fatigue and it's like it made it 10 times worse"; MYALGIA (non-serious) with onset 2021, outcome "unknown", described as "Aching muscle". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain, headache, myalgia. Therapeutic measures were not taken as a result of asthenia, illness, fibromyalgia, fatigue.  Additional information: Consumer stated, She had fibromyalgia and chronic fatigue and it is like it made it 10 times worse, the fatigue its just its dragging and aching the aching muscle. Patient did not have heart issues, she is not diabetic. Consumer stated that she took Ibuprofen for her pain and aspirin for headache. Concomitants medication also included multivitamins. Family History: Consumer stated, No my family, my sister and they have no problems at all. Some of them has Pfizer some have Moderna.The day that felt a little tired but nothing like what I am having.  No follow-up attempts are possible. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood cholesterol, Diarrhoea, Fatigue, Full blood count, Illness
Clinical narrative: Aching; Headache; Weak; Feel sick; I have fibromyalgia and chronic fatigue and it's like it made it 10 times worse; "I have fibromyalgia and chronic fatigue and it's like it made it 10 times worse; Aching muscle; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78 year-old female patient received bnt162b2 (BNT162B2), administration date 30Jul2021 (Lot number: FA7484) at the age of 78 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Fibromyalgia" (unspecified if ongoing); "Chronic fatigue" (unspecified if ongoing). Concomitant medication(s) included: CALCIUM. Vaccination history included: Bnt162b2 (First Shot: LOT#: FA6780.), administration date: 08Jul2021, when the patient was 77 years old, for COVID-19 immunization, reaction(s): "I suffered for months, when I got first shot and I didn't feel well for three week", "My sodium chloride was little on the low side"; Bnt162b2 (First Shot: LOT#: FA6780.), administration date: 08Jul2021, when the patient was 77 years old, for Covid-19 Immunization, reaction(s): "high cholesterol". The following information was reported: PAIN (non-serious) with onset 2021, outcome "unknown", described as "Aching"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "Headache"; ASTHENIA (non-serious) with onset 2021, outcome "unknown", described as "Weak"; ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "Feel sick"; FIBROMYALGIA (non-serious) with onset 2021, outcome "unknown", described as "I have fibromyalgia and chronic fatigue and it's like it made it 10 times worse"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as ""I have fibromyalgia and chronic fatigue and it's like it made it 10 times worse"; MYALGIA (non-serious) with onset 2021, outcome "unknown", described as "Aching muscle". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain, headache, myalgia. Therapeutic measures were not taken as a result of asthenia, illness, fibromyalgia, fatigue.  Additional information: Consumer stated, She had fibromyalgia and chronic fatigue and it is like it made it 10 times worse, the fatigue its just its dragging and aching the aching muscle. Patient did not have heart issues, she is not diabetic. Consumer stated that she took Ibuprofen for her pain and aspirin for headache. Concomitants medication also included multivitamins. Family History: Consumer stated, No my family, my sister and they have no problems at all. Some of them has Pfizer some have Moderna.The day that felt a little tired but nothing like what I am having.  No follow-up attempts are possible. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Influenza, Laboratory test, Nausea, Pain
Clinical narrative: Aching; Headache; Weak; Feel sick; I have fibromyalgia and chronic fatigue and it's like it made it 10 times worse; "I have fibromyalgia and chronic fatigue and it's like it made it 10 times worse; Aching muscle; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78 year-old female patient received bnt162b2 (BNT162B2), administration date 30Jul2021 (Lot number: FA7484) at the age of 78 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Fibromyalgia" (unspecified if ongoing); "Chronic fatigue" (unspecified if ongoing). Concomitant medication(s) included: CALCIUM. Vaccination history included: Bnt162b2 (First Shot: LOT#: FA6780.), administration date: 08Jul2021, when the patient was 77 years old, for COVID-19 immunization, reaction(s): "I suffered for months, when I got first shot and I didn't feel well for three week", "My sodium chloride was little on the low side"; Bnt162b2 (First Shot: LOT#: FA6780.), administration date: 08Jul2021, when the patient was 77 years old, for Covid-19 Immunization, reaction(s): "high cholesterol". The following information was reported: PAIN (non-serious) with onset 2021, outcome "unknown", described as "Aching"; HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "Headache"; ASTHENIA (non-serious) with onset 2021, outcome "unknown", described as "Weak"; ILLNESS (non-serious) with onset 2021, outcome "unknown", described as "Feel sick"; FIBROMYALGIA (non-serious) with onset 2021, outcome "unknown", described as "I have fibromyalgia and chronic fatigue and it's like it made it 10 times worse"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as ""I have fibromyalgia and chronic fatigue and it's like it made it 10 times worse"; MYALGIA (non-serious) with onset 2021, outcome "unknown", described as "Aching muscle". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain, headache, myalgia. Therapeutic measures were not taken as a result of asthenia, illness, fibromyalgia, fatigue.  Additional information: Consumer stated, She had fibromyalgia and chronic fatigue and it is like it made it 10 times worse, the fatigue its just its dragging and aching the aching muscle. Patient did not have heart issues, she is not diabetic. Consumer stated that she took Ibuprofen for her pain and aspirin for headache. Concomitants medication also included multivitamins. Family History: Consumer stated, No my family, my sister and they have no problems at all. Some of them has Pfizer some have Moderna.The day that felt a little tired but nothing like what I am having.  No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity, Pain in extremity, Peripheral swelling, Rash, Skin disorder
Clinical narrative: rash or bumps on arm; rash or bumps on arm; my inners legs swells like little bumps; other arm which feels like a shot; I had an allergic reaction, symptoms occurred the following day they progressively grown and it's behind my arm on the arm that I got the shot; 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. Other Case identifier(s): US-PFIZER INC-202101021874.  A 31 year-old male patient received bnt162b2 (BNT162B2), administration date 29Jul2021 (Lot number: EW0179) at the age of 31 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: PERIPHERAL SWELLING (non-serious) with onset 30Jul2021, outcome "unknown", described as "my inners legs swells like little bumps"; PAIN IN EXTREMITY (non-serious) with onset 30Jul2021, outcome "unknown", described as "other arm which feels like a shot"; HYPERSENSITIVITY (non-serious) with onset 30Jul2021, outcome "unknown", described as "I had an allergic reaction, symptoms occurred the following day they progressively grown and it's behind my arm on the arm that I got the shot"; SKIN DISORDER (non-serious), RASH (non-serious), outcome "unknown" and all described as "rash or bumps on arm".  Additional information: There nothing is changing and it's been 9 days afterwards. I took Claritin put like lotion on and I don't know what to do." It all came at once, the only thing I've taken is Claritin twice, but it brings it down to smaller bumps, but the bigger ones won't be as itchy.   Follow-up attempts are completed. No further information is expected
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Oropharyngeal pain, Poor quality product administered, Product temperature excursion issue, Pyrexia
Clinical narrative: second dose is consider invalid because it was stored in the freezer for longer than the recommended time frame; second dose is consider invalid because it was stored in the freezer for longer than the recommended time frame; uncomfortable feeling; fever; sore throat; 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 parent.  A 12 year-old male patient received bnt162b2 (BNT162B2), administration date 06Jun2021 (Lot number: EW0186, Expiration Date: 31Aug2021) at the age of 12 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose No: 1, Batch/lot number: EW0186 Lot# EW0186, Expiry 31Aug2021, Why was the patient taking Covid 19 vaccine (Verbatim): to prevent the covid 19 virus), administration date: 15May2021, when the patient was 12 years old, for COVID-19 Immunization. The following information was reported: PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious), POOR QUALITY PRODUCT ADMINISTERED (non-serious) all with onset 06Jun2021, outcome "unknown" and all described as "second dose is consider invalid because it was stored in the freezer for longer than the recommended time frame"; MALAISE (non-serious) with onset 2021, outcome "unknown", described as "uncomfortable feeling"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "fever"; OROPHARYNGEAL PAIN (non-serious) with onset 2021, outcome "unknown", described as "sore throat".  Additional information: Reporter reported that her son thinks he received both injections in his left arm but he is not 100 percent sure. The vaccine was not administered at facility. AE(s) did not require a visit to emergency room and physician office. There were no other vaccinations within four weeks prior to the first administration date of the suspect. There were no AE(s) following prior vaccinations.   No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Telangiectasia, Urticaria
Clinical narrative: the blood vessels are breaking; developed a rash; hives; 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 71 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 21Jul2021 08:30 (Lot number: EWA70, Expiration Date: Aug2021) at the age of 71 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "mastectomy" (unspecified if ongoing), notes: She had a mastectomy with her lymph nodes removed about a year ago; "lymph nodes removed" (unspecified if ongoing), notes: She had a mastectomy with her lymph nodes removed about a year ago. The patient's concomitant medications were not reported. The following information was reported: TELANGIECTASIA (non-serious) with onset 24Jul2021, outcome "not recovered", described as "the blood vessels are breaking"; RASH (non-serious) with onset 24Jul2021, outcome "not recovered", described as "developed a rash"; URTICARIA (non-serious) with onset 24Jul2021, outcome "not recovered", described as "hives". The events "the blood vessels are breaking", "developed a rash" and "hives" were evaluated at the emergency room visit.  Additional information: There was no additional vaccines administered on Same Date of the Pfizer vaccine. The patient did not receive any vaccine within four weeks prior to the first administration date of the suspect vaccine. There was no AE(s) following prior vaccinations. The patient medical history (including any illness at time of vaccination) was reported as none.  No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia
Clinical narrative: Severe elbow pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21Jul2021 09:30 (Lot number: EW0177) at the age of 44 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Autism" (unspecified if ongoing); "Back pain" (unspecified if ongoing); "Knee arthritis" (unspecified if ongoing); "Gastro" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Penicillin, reaction(s): "Penicillin allergy"; Ceclor, reaction(s): "drug allergy"; Benadryl, reaction(s): "drug allergy"; Lexapro, reaction(s): "drug allergy". The following information was reported: ARTHRALGIA (non-serious) with onset 2021, outcome "not recovered", described as "Severe elbow pain". The event "severe elbow pain" was evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of arthralgia.  Additional information: Facility where the most recent COVID-19 vaccine was administered was public health clinic/veterans administration facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Cognitive disorder, Condition aggravated, Pyrexia
Clinical narrative: Severe elbow pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21Jul2021 09:30 (Lot number: EW0177) at the age of 44 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Autism" (unspecified if ongoing); "Back pain" (unspecified if ongoing); "Knee arthritis" (unspecified if ongoing); "Gastro" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Penicillin, reaction(s): "Penicillin allergy"; Ceclor, reaction(s): "drug allergy"; Benadryl, reaction(s): "drug allergy"; Lexapro, reaction(s): "drug allergy". The following information was reported: ARTHRALGIA (non-serious) with onset 2021, outcome "not recovered", described as "Severe elbow pain". The event "severe elbow pain" was evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of arthralgia.  Additional information: Facility where the most recent COVID-19 vaccine was administered was public health clinic/veterans administration facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Age: 44.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia
Clinical narrative: Severe elbow pain. Started with dose 1, got much worse with dose 2; Severe elbow pain. Started with dose 1, got much worse with dose 2; Fevers; loss of cognitive functions; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44 year-old male patient received bnt162b2 (BNT162B2, Solution for injection), administered in arm left, administration date 21Jul2021 09:30 (Lot number: EW0177) at the age of 44 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Autism" (unspecified if ongoing); "Back pain" (unspecified if ongoing); "Knee arthritis" (unspecified if ongoing); "Gastro" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Sleep" (unspecified if ongoing); "Pain" (unspecified if ongoing); "Known Allergies: Penicillin" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Ceclor, reaction(s): "Known allergies: Ceclor"; Benadryl, reaction(s): "Known allergies: Benadryl"; Lexapro, reaction(s): "Known allergies: Lexapro". Vaccination history included: Bnt162b2 (Dose 1, product=COVID 19 , Brand: Pfizer Biotech COVID-19 vaccine EUA, Lot number: Ew0177, Administration time: 10:45 AM, Anatomical location: Left arm), administration date: 30Jun2021, when the patient was 44 years old, for COVID-19 Immunization, reaction(s): "Severe elbow pain". The following information was reported: ARTHRALGIA (non-serious), CONDITION AGGRAVATED (non-serious) all with onset Jul2021, outcome "not recovered" and all described as "Severe elbow pain. Started with dose 1, got much worse with dose 2"; PYREXIA (non-serious) with onset Jul2021, outcome "not recovered", described as "Fevers"; COGNITIVE DISORDER (non-serious) with onset Jul2021, outcome "not recovered", described as "loss of cognitive functions". The events "severe elbow pain. started with dose 1, got much worse with dose 2", "severe elbow pain. started with dose 1, got much worse with dose 2", "fevers" and "loss of cognitive functions" were evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of arthralgia, condition aggravated, pyrexia, cognitive disorder. Additional information: Patient was administered most recent covid-19 vaccine in Public Health Clinic/Veterans Administration facility. patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with covid-19 prior to vaccination nor after vaccination.  Follow-up attempts completed. No further information expected.