chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Lymphadenopathy
Clinical narrative: swollen axillary lymph nodes; Prolonged trouble breathing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. A 20-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 04Oct2021 14:30 (Lot number: EW0202) at the age of 20 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Chronic Pain" (unspecified if ongoing); "Moderate Asthma" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: Shellfish" (unspecified if ongoing); "Birth control" (unspecified if ongoing). Concomitant medication(s) included: YAZ; WELLBUTRIN. Past drug history included: Amoxicillin, reaction(s): "Reaction: Allergy: Amoxicillin". Vaccination history included: Bnt162b2 (dose number=1, dose product=COVID 19, brand=Pfizer , lot number=EN6202, administration time=03:45 PM, vaccine location=Left arm), administration date: 01Mar2021, when the patient was 20 years old, for Covid-19 immunization, reaction(s): "Prolonged trouble breathing"; Bnt162b2 (dose number=2, product=COVID 19, brand=Pfizer , lot number=EN6206, administration time=02:30 PM, vaccine location=Left arm), administration date: 22Mar2021, when the patient was 20 years old, for Covid-19 immunization, reaction(s): "Prolonged trouble breathing", "Dizziness", "Passed out (fainted)".  The following information was reported: DYSPNOEA (non-serious) with onset Oct2021, outcome "recovering", described as "Prolonged trouble breathing"; LYMPHADENOPATHY (non-serious) with onset 04Oct2021, outcome "recovering", described as "swollen axillary lymph nodes". The events "prolonged trouble breathing" and "swollen axillary lymph nodes" were evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of dyspnoea, lymphadenopathy.  Additional information: The patient was not pregnant at the time of vaccination. Other vaccine same date vaccine date was 04Oct2021. It was unknown that the patient had other vaccine in four weeks. The patient had no covid prior vaccination. The patient had not been tested for COVID-19 post vaccination. The device date was reported as 11Jul2021.  Follow-up attempts are completed. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pain, Pyrexia
Clinical narrative: Fever; Chills; Achiness; Headache; Tenderness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-health care professional and Physician). The reporter is the patient. A 78-year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 05Feb2021 (Lot number: EL9264) at the age of 77 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Glucose intolerance" (ongoing); "Hypolipidemia" (ongoing), "Hypothyroid" (ongoing), "Acid reflux" (ongoing). Concomitant medication(s) included: BIOTIN, CHOLECALCIFEROL; GINGER [ZINGIBER OFFICINALE], LEVOTHYROXINE; METFORMIN, CALCIUM, VITAMIN D [VITAMIN D NOS]. Vaccination history included: Bnt162b2 (Dose: 1, Lot: EL0142, Anatomical site of Location: Left deltoid) administration date: 18Jan2021, when the patient was 77 years old for COVID-19 immunisation, reaction(s): "Tenderness". The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Fever", CHILLS (non-serious), outcome "unknown", described as "Chills", PAIN (non-serious), outcome "unknown", described as "Achiness", HEADACHE (non-serious), outcome "unknown", described as "Headache", TENDERNESS (non-serious), outcome "unknown", described as "Tenderness". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Prior to vaccination, was the patient did not diagnosed with COVID-19.  Follow-up attempts are completed. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Tenderness
Clinical narrative: Fever; Chills; Achiness; Headache; Tenderness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-health care professional and Physician). The reporter is the patient. A 78-year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 05Feb2021 (Lot number: EL9264) at the age of 77 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Glucose intolerance" (ongoing); "Hypolipidemia" (ongoing), "Hypothyroid" (ongoing), "Acid reflux" (ongoing). Concomitant medication(s) included: BIOTIN, CHOLECALCIFEROL; GINGER [ZINGIBER OFFICINALE], LEVOTHYROXINE; METFORMIN, CALCIUM, VITAMIN D [VITAMIN D NOS]. Vaccination history included: Bnt162b2 (Dose: 1, Lot: EL0142, Anatomical site of Location: Left deltoid) administration date: 18Jan2021, when the patient was 77 years old for COVID-19 immunisation, reaction(s): "Tenderness". The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Fever", CHILLS (non-serious), outcome "unknown", described as "Chills", PAIN (non-serious), outcome "unknown", described as "Achiness", HEADACHE (non-serious), outcome "unknown", described as "Headache", TENDERNESS (non-serious), outcome "unknown", described as "Tenderness". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Prior to vaccination, was the patient did not diagnosed with COVID-19.  Follow-up attempts are completed. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Tongue disorder, Tongue exfoliation
Clinical narrative: COVID tongue. Reaction is on the tip, left side of the tongue about an inch in length. Seemed to heal, but still had a dent in the side of tongue from the reaction; COVID tongue/ Feels and looks like a bad burn with pealing and bumps; COVID tongue/ Feels and looks like a bad burn with pealing and bumps; Pregnant at the time of vaccination?: Yes/ Gestation period: 35 weeks; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27 year-old female patient (pregnant) received bnt162b2 (BNT162B2), administration date 09Sep2021 (Lot number: FE3592) at the age of 27 years as dose 1, single and administration date 30Sep2021 (Lot number: FF2589) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient was 35 weeks pregnant at the event onset. Concomitant medication(s) included: TDAP taken for immunisation, start date: 09Sep2021, stop date: 09Sep2021. The following information was reported: MATERNAL EXPOSURE DURING PREGNANCY (non-serious) with onset 09Sep2021, outcome "unknown", described as "Pregnant at the time of vaccination?: Yes/ Gestation period: 35 weeks"; TONGUE DISORDER (non-serious) with onset 10Sep2021, outcome "recovering", described as "COVID tongue. Reaction is on the tip, left side of the tongue about an inch in length. Seemed to heal, but still had a dent in the side of tongue from the reaction"; TONGUE EXFOLIATION (non-serious), TONGUE DISORDER (non-serious) all with onset 10Sep2021, outcome "recovering" and all described as "COVID tongue/ Feels and looks like a bad burn with pealing and bumps". Therapeutic measures were not taken as a result of tongue disorder, tongue exfoliation, tongue disorder.  Additional information: The Patient received concomitant medications taken within two weeks of vaccination included shaklee women vitamin supplements for unspecified indication from an unknown date and unknown if ongoing. The reaction occurred 24-48 hours after first shot and lasted a few weeks. reaction was on the tip, left side of the tongue about an inch in length. It seemed to heal, but still had a dent in the side of tongue from the reaction. the same thing had happened with the second dose or shot in the same spot of the tongue, symptoms started 24-48 hours after second shot and had lasted at least a week till the time of report. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for covid-19. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Barium swallow, Body temperature, Computerised tomogram, Endoscopy, Headache
Clinical narrative: a little achy headache; a low grade fever; 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 76 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 09Feb2021 15:00 (Lot number: EM9809) at the age of 76 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "bile/acid reflux", start date: 2009 (ongoing), notes: bile/acid reflux, botox during endoscopy (Jun2021); "achalasia", start date: 2018 (ongoing), notes: botox during endoscopy (Jun2021); "AAA repair", start date: 2004 (ongoing), notes: AAA repair, repair-2006; "current aneurysm", start date: 2011 (ongoing); "fibromyalgia", start date: 1994 (ongoing); "schwannoma", start date: 2018 (ongoing), notes: only nerve root, displacing carotid monitoring for growth; "breast cancer", start date: 2017 (unspecified if ongoing), notes: lumpectomy Anti estrogen drug; "lumpectomy" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1st, Date: 19Jan2021 (3.00 PM), Anatomical site of injection: left arm, Route: Intramuscular, Batch/lot number: EL0142), administration date: 19Jan2021, when the patient was 76 years old, for Covid-19 immunization; Flu (High dose Flu, Anatomical site of location: Left arm), administration date: 23Sep2021, when the patient was 76 years old. The following information was reported: HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "a little achy headache"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "a low grade fever". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported that after her second vaccine dose all she had was a little achy headache and a low grade fever for 24 hours but after the booster she had 5 days with a 102 fever, severe vomiting and stomach pain. She reports that she was going to head to the ER but didn't have to because she had a GI cocktail with lidocaine on hand. Manometry was performed on 23Apr2021.Also reported that her husband got his dose and all he was tired, he took a nap and he was fine.  Follow-up attempts completed. No further information expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Ultrasound scan
Clinical narrative: a little achy headache; a low grade fever; 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 76 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 09Feb2021 15:00 (Lot number: EM9809) at the age of 76 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "bile/acid reflux", start date: 2009 (ongoing), notes: bile/acid reflux, botox during endoscopy (Jun2021); "achalasia", start date: 2018 (ongoing), notes: botox during endoscopy (Jun2021); "AAA repair", start date: 2004 (ongoing), notes: AAA repair, repair-2006; "current aneurysm", start date: 2011 (ongoing); "fibromyalgia", start date: 1994 (ongoing); "schwannoma", start date: 2018 (ongoing), notes: only nerve root, displacing carotid monitoring for growth; "breast cancer", start date: 2017 (unspecified if ongoing), notes: lumpectomy Anti estrogen drug; "lumpectomy" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1st, Date: 19Jan2021 (3.00 PM), Anatomical site of injection: left arm, Route: Intramuscular, Batch/lot number: EL0142), administration date: 19Jan2021, when the patient was 76 years old, for Covid-19 immunization; Flu (High dose Flu, Anatomical site of location: Left arm), administration date: 23Sep2021, when the patient was 76 years old. The following information was reported: HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "a little achy headache"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "a low grade fever". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported that after her second vaccine dose all she had was a little achy headache and a low grade fever for 24 hours but after the booster she had 5 days with a 102 fever, severe vomiting and stomach pain. She reports that she was going to head to the ER but didn't have to because she had a GI cocktail with lidocaine on hand. Manometry was performed on 23Apr2021.Also reported that her husband got his dose and all he was tired, he took a nap and he was fine.  Follow-up attempts completed. No further information expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pyrexia, Tremor
Clinical narrative: really shaky; fever/Pretty wicked fever/low grade fever; wicked chills/Rigors; Headache; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 51 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 06Aug2021 13:00 (Lot number: EW0217) at the age of 51 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "I suspect I was infected seriously in Mar2020", start date: Mar2020 (unspecified if ongoing), notes: I suspect I was infected seriously in Mar2020; "Hypercholesterolemia", start date: 2001 (unspecified if ongoing), notes: stable. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1st, Time: 13:00, Anatomical site of Injection: L Deltoid, Route of administration: Intramuscular, Batch/Lot number: ER8732), administration date: 16Jul2021, when the patient was 50 years old, for Covid-19 immunization, reaction(s): "Achy", "Chills", "Fever 101.5", "Headache", "Rigors". The following information was reported: TREMOR (non-serious) with onset 06Aug2021 22:00, outcome "recovered" (2021), described as "really shaky"; PYREXIA (non-serious) with onset 06Aug2021 22:00, outcome "recovered" (2021), described as "fever/Pretty wicked fever/low grade fever"; CHILLS (non-serious) with onset 06Aug2021 22:00, outcome "recovered" (2021), described as "wicked chills/Rigors"; HEADACHE (non-serious) with onset 06Aug2021 22:00, outcome "recovered" (2021), described as "Headache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of tremor, pyrexia, chills, headache.  Additional information: There are no relevant test. Patient received treatment for event with Tylenol and Ibuprofen. It was reported that the Wicked chills (really shaky) plus fever for about 24 hours. Then I was fine. I suspect I was infected seriously in Mar2020 but there was no test to confirm (I work at a hospital) and had a low grade fever for 10 days (37-39 degree).The Concomitant Drugs was none.Specific Relevant Test for Thromboembolic events with thromboembolic was none.Pretty wicked fever, chills, headache for about 24 hours. Recovered fully.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Low fever; chills; arm pain; nausea; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right (Lot number: ff5841) as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Ff5841), for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown), for Covid-19 immunization.  The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "Low fever"; CHILLS (non-serious), outcome "unknown", described as "chills"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm pain"; NAUSEA (non-serious), outcome "unknown", described as "nausea". Therapeutic measures were not taken as a result of pyrexia, chills, pain in extremity, nausea.  Additional information: Patient's age was unknown. The patient was not pregnant at the time of vaccination. Facility type Vaccine was Pharmacy or Drug Store. No known allergies. No other medical history. No other vaccine in four weeks. No other medications in two weeks. No covid prior vaccination. Not tested for covid post vaccination.    No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Nausea, Pyrexia, SARS-CoV-2 test
Clinical narrative: moraines/migraine; nausea; Experienced a low grade temp; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 20Aug2021 (Batch/Lot number: unknown) at the age of 48 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Migraines" (unspecified if ongoing), notes: Other medical history: Migraines. The patient's concomitant medications were not reported. Past drug history included: Kna, reaction(s): "Known allergies: KNA", notes: Known allergies: KNA. Vaccination history included: Bnt162b2 (prev_dose administration_date=20Aug2021 , prev_dose_dose_number=1, prev_dose_vaccine_location=Left arm), for Covid-19 Immunization.  The following information was reported: PYREXIA (non-serious) with onset 21Aug2021, outcome "recovered" (2021), described as "Experienced a low grade temp"; MIGRAINE (non-serious) with onset 23Aug2021, outcome "recovered" (27Aug2021), described as "moraines/migraine"; NAUSEA (non-serious) with onset 23Aug2021, outcome "recovered" (27Aug2021), described as "nausea". The events "experienced a low grade temp", "moraines/migraine" and "nausea" 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 pyrexia, migraine, nausea (Axert 12.5 mg, ondansetron 1 tablet)  Additional information: Patient took more than 2 axert doses within a 24-hour period. Patient also took anti-nausea medication. Patient had not taken any other vaccine in four weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2
Clinical narrative: She was actually had this exposure to someone who is positive; Found out that my granddaughter was tested for COVID and I was with her last night; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 07Oct2021 14:00 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Family history included: "COVID-19" (unspecified if ongoing), notes: granddaughter tested positive. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunisation; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 Immunisation. The following information was reported: EXPOSURE TO SARS-COV-2 (non-serious) with onset 07Oct2021, outcome "unknown", described as "She was actually had this exposure to someone who is positive; Found out that my granddaughter was tested for COVID and I was with her last night".  Additional information: Transferring agent stated, "The patient got her caller on the other line and unfortunately she didn't provide her phone number. So, now her concern was that she already had the booster shot actually today 2 PM and unfortunately her granddaughter tested positive. Yeah, she was actually had this exposure to someone who is positive. She is asking if that's okay since she already got the booster shot?". Consumer stated, "Today, I received my booster shot, okay and at noon at 2 o'clock I got a call from my granddaughter who tested positive for COVID, was there a concern?" Consumer stated, "And she found out that her granddaughter was tested for COVID and she was with her last night (further clarification unknown if granddaughter got the COVID 19 Vaccine and got positive for COVID, hence split case not made), was there a concern?". Reporter seriousness for She was actually had this exposure to someone who is positive; Found out that my granddaughter was tested for COVID and she was with her last night: Unspecified.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Laboratory test, Lichen planus, Onychomadesis, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from contactable consumer or other non-HCP (patient). A 52-year-old male patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# EI1283), at the age of 52, in left arm, on Jan 20, 2021, single dose, for COVID-19 immunisation. Medical history included high blood pressure (unspecified if ongoing). The patient takes concomitant medications. The patient experienced lichen planus (patient is not sure but all tests were negative triggering lichen planus), and onychomadesis (loss of all finger and toenails), onset Mar 1, 2021, with outcome of not recovered. Relevant laboratory tests and procedures available in the appropriate section. Therapeutic measures were taken as a result of lichen planus and onychomadesis: steroid shots. Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has tested for COVID-19. On Sep 28, 2021, nasal swab (PCR) test positive; May 11, 2021 negative. No follow-up attempts possible. No further information expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: I have swollen lymph nodes at back of my neck (left side); left arm has been hurting like some joint pain feeling; I noted my shoulder (Left) being painful; Xray showed degenerative changes; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 36 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 14Jun2021 12:30 (Lot number: EW0179) at the age of 36 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Latex" (unspecified if ongoing); "COVID-19" (not ongoing), notes: if covid prior vaccination: Yes. Concomitant medication(s) included: BIOTIN taken for supplementation therapy (ongoing); VIT C taken for supplementation therapy (ongoing); PROBIOTICS taken for supplementation therapy (ongoing). Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0161, Location of injection: Arm Left, Vaccine Administration Time: 12:30 PM), administration date: 24May2021, when the patient was 36 years old, for COVID-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 20Sep2021 12:00, outcome "not recovered", described as "I have swollen lymph nodes at back of my neck (left side)"; VACCINATION SITE JOINT PAIN (non-serious) with onset 20Sep2021 12:00, outcome "not recovered", described as "left arm has been hurting like some joint pain feeling"; VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "not recovered", described as "I noted my shoulder (Left) being painful"; DEGENERATIVE BONE DISEASE (non-serious) with onset 2021, outcome "not recovered", described as "Xray showed degenerative changes". The events "i have swollen lymph nodes at back of my neck (left side)" and "left arm has been hurting like some joint pain feeling" 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 lymphadenopathy, vaccination site joint pain, vaccination site pain, degenerative bone disease.  Additional Information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Treatment received for the adverse event was Steroid injection, Tizanidine pills for 7 days. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Patient provided information that Pfizer product had a casual effect to the adverse event. Vaccine was not Administered at a Facility. No Prior Vaccinations. No Patient Medical History. Family Medical History Relevant To AE(s) Father: Hypertension, DM2, Liver Disease; Mother: Hypertension. Stroke. Patient received new medication/other treatment/procedure which included Tizanidine 4mg CHS X7 days, Dexamethasone inj. given IM once. Patient reported it only gives me a little ease. I noticed my lymph nodes at the back of my neck (Left side) to be swollen as well.  Follow-up attempts are completed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Platelet count, Pyrexia
Clinical narrative: Chills; temperature up to 100.8 degrees; This is a spontaneous report received from a contactable reporter(s) (Other HCP) received via COVID-19 Adverse Event Self-Reporting Solution. The reporter is the patient. A 66 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Oct2021 07:15 (Lot number: EW0151) at the age of 66 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "ITP" (ongoing), notes: about 10 yrs ago, Pertinent details : Platelets less than 150,000 but greater than 100,000; "hypothyroidism" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "Seasonal allergies" (ongoing); "Partial thyroidectomy" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE taken for thyroidectomy (ongoing); ROSUVASTATIN taken for hypercholesterolaemia (ongoing); ZYRTEC [CETIRIZINE HYDROCHLORIDE]; CLARITIN [CLARITHROMYCIN]; CETIRIZINE taken for seasonal allergy (ongoing); LORATADINE taken for seasonal allergy (ongoing). Vaccination history included: Bnt162b2 (Dose Number: 1, lot number: EK9231, administration time: 16:00 PM, vaccine location: Left arm), administration date: 30Dec2020, when the patient was 66 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 2, lot number: EL8982, administration time: 14:00PM, vaccine location: Left arm), administration date: 22Jan2021, when the patient was 66 years old, for Covid-19 immunization. The following information was reported: CHILLS (non-serious) with onset 08Oct2021 19:00, outcome "recovered" (Oct2021), described as "Chills"; PYREXIA (non-serious) with onset 08Oct2021 19:00, outcome "recovered" (Oct2021), described as "temperature up to 100.8 degrees". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of chills, pyrexia.  Additional information: Vaccine facility type was reported as Hospital. Patient did not receive other vaccine in four weeks. Events started 12 hours after injection. Patient was not tested COVID post vaccination. Patient had no known allergies. The product had a causal effect to the adverse event. Prior vaccinations was reported as none.  No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Muscle spasms, SARS-CoV-2 test
Clinical narrative: Extreme Muscular cramps across neck and spine and rotating parts of body for over 8 days; tightness around heart; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Sep2021 11:00 (Lot number: ff8841) at the age of 66 years as dose 1, single for covid-19 immunization. Relevant medical history included: "allergies: iodine" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTIN.  The following information was reported: MUSCLE SPASMS (non-serious) with onset 30Sep2021 12:00, outcome "not recovered", described as "Extreme Muscular cramps across neck and spine and rotating parts of body for over 8 days"; CHEST DISCOMFORT (non-serious) with onset 30Sep2021 12:00, outcome "not recovered", described as "tightness around heart". The events "extreme muscular cramps across neck and spine and rotating parts of body for over 8 days" and "tightness around heart" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of muscle spasms, chest discomfort.  Additional Information: There was no other vaccine in four weeks. Other medications in two weeks: included atorvastin. It was reported that patient had extreme Muscular cramps across neck and spine and rotating parts of body for over 8 days tightness around heart. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient did not had covid prior vaccination. The patient had tested for covid post vaccination included test name: abbott test type: Nasal Swab (test date 01Oct2021) with Negative result.  Follow-up attempts are completed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative, Urticaria
Clinical narrative: Random Hives. Have had hives every day after 40 hours of receiving the shot.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17Sep2021 13:15 (Lot number: FF2588) at the age of 36 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Pulmonary embolism", start date: 2015 (unspecified if ongoing), notes: Pulmonary embolism in 2015; "IBS" (unspecified if ongoing). Concomitant medication(s) included: MIRENA. The following information was reported: URTICARIA (non-serious) with onset 19Sep2021 09:30, outcome "not recovered", described as "Random Hives. Have had hives every day after 40 hours of receiving the shot.". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Other vaccine in four weeks was reported as no. Other medications in two weeks were reported as daily multi-vitamin and Omega 3. Patient only had hives two other times in life. It was reported that patient had No known food or drug allergies, no soap or detergent or cleaning changes and no changes in food groups. Patient tried elimination process for foods and nothing showed and only change was the vaccine. It was unknown if patient had covid prior vaccination and no covid tested post vaccination. Patient did possibly have COVID on 21Mar but had negative results when her husband was positive even though patient was symptomatic.  Follow-up attempts are completed. No further information is expected
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Chills, Insomnia, Pain in extremity, Pyrexia
Clinical narrative: I have pain at injection site; I have pain at injection site but there is pain under my armpit; my arms started hurting bad and under my arms; Pain at the injection site not that bad but it's under my armpit; Fever; At night I had chills; My arms started hurting bad and under my arms; It did in night in my sleep last night yes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08Oct2021 (Lot number: EW0180, Expiration Date: Nov2021) at the age of 67 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Blood triglycerides" (ongoing); "Thyroid" (unspecified if ongoing). Concomitant medication(s) included: INFLUENZA VACCINE, administration date 30Sep2021; EUTHYROX taken for thyroid disorder; TRIGLYCERIDES. Vaccination history included: Bnt162b2 (Dose 1), administration date: 2021, for COVID-19 Immunization; Bnt162b2 (Dose 2), administration date: 2021, for COVID-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "unknown", described as "I have pain at injection site"; AXILLARY PAIN (non-serious) with onset 2021, outcome "unknown", described as "I have pain at injection site but there is pain under my armpit; my arms started hurting bad and under my arms; Pain at the injection site not that bad but it's under my armpit"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "Fever"; CHILLS (non-serious) with onset 2021, outcome "unknown", described as "At night I had chills"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "My arms started hurting bad and under my arms"; INSOMNIA (non-serious) with onset 2021, outcome "unknown", described as "It did in night in my sleep last night yes". Therapeutic measures were taken as a result of vaccination site pain, axillary pain, pyrexia, chills, pain in extremity, insomnia.  Additional information: Any prior vaccination within 4 weeks included flu shot. Concomitant Products Euthyrox: Consumer stated, "0.75, Once in a morning, Tablet for Thyroid. Patient have pain at injection site but there is pain under armpit. Patient have a fever and at night had chills. When paraphrased the above concern, patient stated, "It did in night in my sleep last night yes, I got the chills and my arms started hurting bad and under my arms. Treatment: Consumer stated, "Ibuprofen, just 2 tablets of 500 mg, I just took the first one this morning so, next day patient woke up with they didn't bother me at night I didn't get up to take anything last night."  No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: I have pain at injection site; I have pain at injection site but there is pain under my armpit; my arms started hurting bad and under my arms; Pain at the injection site not that bad but it's under my armpit; Fever; At night I had chills; My arms started hurting bad and under my arms; It did in night in my sleep last night yes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08Oct2021 (Lot number: EW0180, Expiration Date: Nov2021) at the age of 67 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Blood triglycerides" (ongoing); "Thyroid" (unspecified if ongoing). Concomitant medication(s) included: INFLUENZA VACCINE, administration date 30Sep2021; EUTHYROX taken for thyroid disorder; TRIGLYCERIDES. Vaccination history included: Bnt162b2 (Dose 1), administration date: 2021, for COVID-19 Immunization; Bnt162b2 (Dose 2), administration date: 2021, for COVID-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "unknown", described as "I have pain at injection site"; AXILLARY PAIN (non-serious) with onset 2021, outcome "unknown", described as "I have pain at injection site but there is pain under my armpit; my arms started hurting bad and under my arms; Pain at the injection site not that bad but it's under my armpit"; PYREXIA (non-serious) with onset 2021, outcome "unknown", described as "Fever"; CHILLS (non-serious) with onset 2021, outcome "unknown", described as "At night I had chills"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "My arms started hurting bad and under my arms"; INSOMNIA (non-serious) with onset 2021, outcome "unknown", described as "It did in night in my sleep last night yes". Therapeutic measures were taken as a result of vaccination site pain, axillary pain, pyrexia, chills, pain in extremity, insomnia.  Additional information: Any prior vaccination within 4 weeks included flu shot. Concomitant Products Euthyrox: Consumer stated, "0.75, Once in a morning, Tablet for Thyroid. Patient have pain at injection site but there is pain under armpit. Patient have a fever and at night had chills. When paraphrased the above concern, patient stated, "It did in night in my sleep last night yes, I got the chills and my arms started hurting bad and under my arms. Treatment: Consumer stated, "Ibuprofen, just 2 tablets of 500 mg, I just took the first one this morning so, next day patient woke up with they didn't bother me at night I didn't get up to take anything last night."  No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Swelling, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: This is a spontaneous report received from a noncontactable consumer or other non-HCP (patient). A 70-year-old female patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), at the age of 70, on Oct 7, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. Vaccination history included the 1st dose of the COVID-19 vaccine (manufacturer unknown), for immunization. The patient developed pruritus/swelling/swollen/itchy, onset Oct 7, 2021, with outcome of unknown; vaccination site pruritus and vaccination site swelling (injection site is slightly swollen and itchy), with outcome of unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pyrexia
Clinical narrative: Fever; little bit of sore throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 07Oct2021 (Lot number: FE3590) 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, SINGLE), for COVID-19 immunisation; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunisation. The following information was reported: PYREXIA (non-serious) with onset 08Oct2021, outcome "unknown", described as "Fever"; OROPHARYNGEAL PAIN (non-serious) with onset 08Oct2021, outcome "unknown", described as "little bit of sore throat".  Additional information: The dates, seriousness for fever and little bit of sore throat was unspecified. RA number and expiry date of Booster Vaccine was Unknown. Concern stated she got the booster yesterday and unfortunately she is having fever right now and she is asking if she is allowed to be with other people as she is having this fever and a little bit of sore throat too not really bad. It was stated that talking about the Pfizer booster vaccine. She was informed that Pfizer Medical Information is the concerned department to answer the question and offered the number. Consumer was again informed about the role of Pfizer and informed about filling of safety report, She don't see an expiration date. She already had 2 shots, the booster shot and she stated that she have to hear everything about the first shot.   No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Ephelides, Headache, Muscle spasms
Clinical narrative: Generalized site tenderness with swelling; headache frontal; posterior eyes; 101.2 temp; joint pain; tendons cramping/Achilles/carpal tendons cramping; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 57 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 06Oct2021 09:30 (Lot number: EW0158) at the age of 57 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Lot Number: EL3248, prev dose vaccine location: Arm Right, prev dose administration time: 02:00 PM), administration date: 27Jan2021, when the patient was 57 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Lot Number: EL0142, prev dose vaccine location: Arm Left, prev dose administration time: 02:00 PM), administration date: 06Jan2021, when the patient was 57 years old, for Covid-19 immunization.  The following information was reported: VACCINATION SITE SWELLING (non-serious) with onset 07Oct2021 16:30, outcome "not recovered", described as "Generalized site tenderness with swelling"; ARTHRALGIA (non-serious) with onset 06Oct2021 15:30, outcome "not recovered", described as "joint pain"; MUSCLE SPASMS (non-serious) with onset 06Oct2021 15:30, outcome "not recovered", described as "tendons cramping/Achilles/carpal tendons cramping"; HEADACHE (non-serious) with onset 07Oct2021 08:30, outcome "not recovered", described as "headache frontal"; EPHELIDES (non-serious) with onset 07Oct2021 08:30, outcome "not recovered", described as "posterior eyes"; PYREXIA (non-serious) with onset 07Oct2021 08:30, outcome "not recovered", described as "101.2 temp". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site swelling, arthralgia, muscle spasms, headache, ephelides, pyrexia.  Additional information: It was reported that 6 hours post 3rd dose started feeling joint pain and Achilles/carpal tendons cramping; 23 hours post started headache frontal/posterior eyes with101.2 temp. Generalized site tenderness with swelling for first 24 plus hours. No issues with dose 1&2.  No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site swelling
Clinical narrative: Generalized site tenderness with swelling; headache frontal; posterior eyes; 101.2 temp; joint pain; tendons cramping/Achilles/carpal tendons cramping; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 57 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 06Oct2021 09:30 (Lot number: EW0158) at the age of 57 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Lot Number: EL3248, prev dose vaccine location: Arm Right, prev dose administration time: 02:00 PM), administration date: 27Jan2021, when the patient was 57 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Lot Number: EL0142, prev dose vaccine location: Arm Left, prev dose administration time: 02:00 PM), administration date: 06Jan2021, when the patient was 57 years old, for Covid-19 immunization.  The following information was reported: VACCINATION SITE SWELLING (non-serious) with onset 07Oct2021 16:30, outcome "not recovered", described as "Generalized site tenderness with swelling"; ARTHRALGIA (non-serious) with onset 06Oct2021 15:30, outcome "not recovered", described as "joint pain"; MUSCLE SPASMS (non-serious) with onset 06Oct2021 15:30, outcome "not recovered", described as "tendons cramping/Achilles/carpal tendons cramping"; HEADACHE (non-serious) with onset 07Oct2021 08:30, outcome "not recovered", described as "headache frontal"; EPHELIDES (non-serious) with onset 07Oct2021 08:30, outcome "not recovered", described as "posterior eyes"; PYREXIA (non-serious) with onset 07Oct2021 08:30, outcome "not recovered", described as "101.2 temp". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site swelling, arthralgia, muscle spasms, headache, ephelides, pyrexia.  Additional information: It was reported that 6 hours post 3rd dose started feeling joint pain and Achilles/carpal tendons cramping; 23 hours post started headache frontal/posterior eyes with101.2 temp. Generalized site tenderness with swelling for first 24 plus hours. No issues with dose 1&2.  No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Myalgia, Pyrexia
Clinical narrative: joint pain; fatigue; low grade fever; myalgia; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 06Oct2021 12:00 (Lot number: EW0217) at the age of 37 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL3247, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM, Route of Administration: Intramuscular), administration date: 10Feb2021, when the patient was 37 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM, Route of Administration: Intramuscular), administration date: 20Jan2021, when the patient was 37 years old, for Covid-19 immunization. The following information was reported: ARTHRALGIA (non-serious) with onset 07Oct2021 08:00, outcome "recovering", described as "joint pain"; FATIGUE (non-serious) with onset 07Oct2021 08:00, outcome "recovering", described as "fatigue"; PYREXIA (non-serious) with onset 07Oct2021 08:00, outcome "recovering", described as "low grade fever"; MYALGIA (non-serious) with onset 07Oct2021 08:00, outcome "recovering", described as "myalgia". Therapeutic measures were taken as a result of arthralgia, fatigue, pyrexia, myalgia.  Additional information: Treatment received for adverse event was Ibuprofen. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. There was no known allergies. Other medical history was none.   No follow-up attempts are possible. No further information is expected.