chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Paraesthesia, Vaccination site pain
Clinical narrative: Mild tingling at site of previous shingles; Sore arm at site of injection; Fatigue; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 57 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 27Oct2021 07:30 (Lot number: 32030BD) at the age of 57 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Shingles", start date: Apr2021, stop date: May2021; "Dyspepsia" (ongoing). Concomitant medication(s) included: OMEPRAZOLE taken for dyspepsia, start date: Oct2021 (ongoing). Vaccination history included: Bnt162b2 (dose 2 single, Batch/Lot No: ER8732, Location of injection: Arm Right, Vaccine Administration Time: 12:00 PM, Route of Administration: Intramuscular), administration date: 28Mar2021, when the patient was 57 years old, for covid 19 immunization, reaction(s): "Shingles"; Bnt162b2 (dose 1 single, Batch/Lot No: EN6206, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM, Route of Administration: Intramuscular), administration date: 03Mar2021, when the patient was 57 years old, for covid 19 immunization; Flu vaccine (anatomical location: arm left), administration date: 08Oct2021, when the patient was 57 years old. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 27Oct2021 22:00, outcome "recovered" (2021), described as "Sore arm at site of injection"; FATIGUE (non-serious) with onset 27Oct2021 22:00, outcome "recovered" (2021), described as "Fatigue"; PARAESTHESIA (non-serious) with onset 28Oct2021, outcome "recovered" (2021), described as "Mild tingling at site of previous shingles". Therapeutic measures were not taken as a result of vaccination site pain, fatigue, paraesthesia.  Additional information included: On 08Oct2021, the patient received other Flu vaccine with in 4weeks (arm left). The patient was not diagnosed with covid prior vaccination. The patient was not tested for covid-19 post vaccination. Did the patient provide information to you regarding the reported adverse event(s) with the use of the product? Yes. If yes above, do you consider the Pfizer product had a causal effect to the adverse event? Yes. Complete only if a 3rd dose was administered, Check one option: Booster dose due to high risk of frequent institutional or occupational exposure to coronavirus (and at risk of serious COVID-19 complications).  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Pregnancy test
Clinical narrative: I had a positive pregnancy test on 28Sep after my second COVID vaccine. This pregnancy ended in miscarriage on 23Oct2021 at 6w5d pregnant.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 29 year-old female patient (pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Sep2021 (Lot number: 30155BA) as dose 2, single and administered in arm left, administration date 05Sep2021 (Lot number: Fc3183) as dose 1, single for covid-19 immunisation. Relevant medical history included: "known allergies: Penicillin" (unspecified if ongoing); "known allergies: Sulfa" (unspecified if ongoing). The patient was 47 days pregnant at the event onset. Concomitant medication(s) included: FLUOXETINE; VALACYCLOVIR [VALACICLOVIR]; ZYRTEC ALLERGY; PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE]. The following information was reported: EXPOSURE DURING PREGNANCY (non-serious) with onset 23Oct2021, outcome "recovering", described as "I had a positive pregnancy test on 28Sep after my second COVID vaccine. This pregnancy ended in miscarriage on 23Oct2021 at 6w5d pregnant.". The event "i had a positive pregnancy test on 28sep after my second covid vaccine. this pregnancy ended in miscarriage on 23oct2021 at 6w5d pregnant." was 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 exposure during pregnancy.  Additional Information: The patient did not receive other vaccines in four weeks. Patient received other medications in two weeks were Fluoxetine, Valacyclovir, Zyrtec, Prenatal Vitamin. I had a positive pregnancy test on 28Sep after my second COVID vaccine. This pregnancy ended in miscarriage on 23Oct2021 at 6w5d pregnant. The event resulted in Doctor or other healthcare professional office/clinic visit. The outcome of events was recovering. No treatment received for the event. The patient underwent lab tests and procedures which included pregnancy test: positive on 28Sep2021. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101449267 similar report from same reporter
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased
Clinical narrative: she is having a problem with her bloodsugar that went up to 262 today.; This is a spontaneous report from a Pfizer-sponsored program. A 68 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "she had Covid", start date: 2021 (unspecified if ongoing), notes: she had Covid a month ago. The patient's concomitant medications were not reported. The following information was reported: BLOOD GLUCOSE INCREASED (non-serious), outcome "unknown", described as "she is having a problem with her blood sugar that went up to 262 today.". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient had Covid a month ago, and she was thinking about getting the vaccine. But since she had it, she is having a problem with her blood sugar that went up to 262 today. She is wondering if the vaccine is FDA approved because there was information that it is also EUA.   No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Muscle spasms, Tremor
Clinical narrative: chills; Tremors/Spasms starting 13 hours after vaccination; Tremors/Spasms starting 13 hours after vaccination; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 25Oct2021 11:45 (Lot number: FF2593) at the age of 65 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Chemical Sensitivity" (unspecified if ongoing), notes: other medical history: Chemical Sensitivity. Concomitant medication(s) included: SYNTHROID. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0161, Location of injection: Arm Left), administration date: 20Apr2021, when the patient was 64 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8733, Location of injection: Arm Left), administration date: 28Mar2021, when the patient was 64 years old, for Covid-19 immunization. The following information was reported: CHILLS (non-serious) with onset 26Oct2021 01:15, outcome "not recovered", described as "chills"; TREMOR (non-serious), MUSCLE SPASMS (non-serious) all with onset 26Oct2021 01:15, outcome "not recovered" and all described as "Tremors/Spasms starting 13 hours after vaccination". Therapeutic measures were not taken as a result of chills, tremor, muscle spasms.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient has no covid prior vaccination. Patient was not tested covid post vaccination. No known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Inappropriate schedule of product administration, Pain, SARS-CoV-2 test
Clinical narrative: I'm experiencing numbness in my whole body even my face I don't know what to do; I'm in pain; Inappropriate schedule of vaccine administered; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 24Oct2021 15:00 (Lot number: Fr3592) at the age of 41 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Right), administration date: 22May2021, when the patient was 41 years old, for COVID-19 immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 24Oct2021 15:00, outcome "unknown", described as "Inappropriate schedule of vaccine administered"; HYPOAESTHESIA (non-serious) with onset 26Oct2021 07:00, outcome "not recovered", described as "I'm experiencing numbness in my whole body even my face I don't know what to do"; PAIN (non-serious) with onset 26Oct2021 07:00, outcome "not recovered", described as "I'm in pain". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of hypoaesthesia, pain.  Additional information: 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, the patient was tested for COVID-19. Device date was reported as 26Oct2021.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Energy increased
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient), for a Pfizer sponsored program (005570). A 20-year-old female patient received 1st, 2nd and 3rd (booster) dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown); all single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient experienced increased energy (burst of energy), with outcome of unknown. Additional information included: Reportedly, patient had 3 doses of the Pfizer COVID-19 vaccine. Patient experienced side effects after each dose. One of the side effects, she had after each dose, was a burst of energy. She figured there must be something to this, because she was not the only one who said this. She felt twenty years younger. She cleaned her whole house, all 2800ft². She  never got tired. All three doses gave her this energy. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Depression, Feeling abnormal
Clinical narrative: daughter's ex boyfriend is also having depression; Brain fog; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558).  A male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DEPRESSION (non-serious), outcome "unknown", described as "daughter's ex boyfriend is also having depression"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "Brain fog". Therapeutic measures were taken as a result of depression, feeling abnormal.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: After the COVID vaccine, the mother reports having a sore arm, which she felt was normal.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "After the COVID vaccine, the mother reports having a sore arm, which she felt was normal.". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Parosmia, SARS-CoV-2 test, Taste disorder
Clinical narrative: Certain things smell and taste terrible. Peanut butter is a specific example.; Certain things smell and taste terrible. Peanut butter is a specific example.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 24Oct2021 11:00 (Lot number: Ff5841) at the age of 38 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "covid" (unspecified if ongoing), notes: if covid prior vaccination: Yes. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Fc3121, Location of injection: Left arm), administration date: 02Oct2021, when the patient was 38 years old, for Covid-19 immunization. The following information was reported: TASTE DISORDER (non-serious), PAROSMIA (non-serious) all with onset 25Oct2021, outcome "not recovered" and all described as "Certain things smell and taste terrible. Peanut butter is a specific example.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of taste disorder, parosmia.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination patient was  diagnosed with COVID-19. Since the vaccination patient was  tested for COVID-19. No known allergies. Facility type vaccine was Pharmacy or Drug Store.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased
Clinical narrative: increasing pulse; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEART RATE INCREASED (non-serious), outcome "unknown", described as "increasing pulse". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Had a very sore left arm for about 3 days after dose 1and dose; 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 11Sep2021 13:30 (Lot number: FF2587) at the age of 44 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Fibromyalgia" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing); "Gerd" (unspecified if ongoing); "Depression" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "Painful periods" (unspecified if ongoing); "Penicillin" (unspecified if ongoing). Concomitant medication(s) included: GABAPENTIN; DULOXETINE; AMBIEN; TOPIRAMATE; WELLBUTRIN. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "recovered" (2021), described as "Had a very sore left arm for about 3 days after dose 1and dose". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: the patient later received dose 2 of bnt162b2 on 04Oct2021 15:00, batch/lot number: AA16607 in arm left and about 3 hours after the injection, the site was very red, hot, swollen. It was bigger than the size of a half dollar. It became extremely itchy. She had very sore left arm. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: aching lasted one night; painful swelling under left arm  lasted about 6 days.; Chills; painful swelling under left arm  lasted about 6 days.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 28Sep2021 16:15 (Lot number: 30135BA) at the age of 73 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "penicillin allergy" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Batch/Lot No: EN6198, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 26Feb2021, when the patient was 72 years old, for covid-19 immunization; Bnt162b2 (Dose 2, Batch/Lot No: ER2613, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 18Mar2021, when the patient was 72 years old, for Covid-19 immunization. The following information was reported: PAIN (non-serious) with onset 28Sep2021, outcome "recovered", described as "aching lasted one night"; PERIPHERAL SWELLING (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 28Sep2021, outcome "recovered" and all described as "painful swelling under left arm lasted about 6 days."; CHILLS (non-serious) with onset 28Sep2021, outcome "recovered", described as "Chills". Therapeutic measures were not taken as a result of pain, peripheral swelling, chills, pain in extremity.  Additional information: The patient did not receive other vaccine same date product. The patient did not receive other vaccine in four weeks. The patient received other medications in two weeks. The patient did not have covid prior vaccination. The patient did not get covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Insomnia, Nausea
Clinical narrative: First Dose: couldn''t sleep, nauseous, chills; First Dose: couldn''t sleep, nauseous, chills; First Dose: couldn''t sleep, nauseous, chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71 year-old male patient received bnt162b2 (BNT162B2), administered in arm, administration date 14Jan2021 (Lot number: EL1284) at the age of 71 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "he has a form of cancer" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN CALCIUM; LOSARTAN; HYDROCHLOROTHIAZIDE; ESCITALOPRAM; LEVOTHYROXINE SODIUM; ASPRIN. The following information was reported: INSOMNIA (non-serious), NAUSEA (non-serious), CHILLS (non-serious) all with onset 2021, outcome "recovered" (2021) and all described as "First Dose: couldn''t sleep, nauseous, chills". Additional information: The patient stated that with the first dose he had a little reaction where he could not sleep, was nauseous, and had chills. The patient did not receive any other vaccine within 4 weeks. The patient did not had specific relevant test for thromboembolic events with thrombocytopenia. No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Inappropriate schedule of product administration, Insomnia
Clinical narrative: Second Dose Less than 21 Days After the First Dose; Chills; Couldn''t Sleep; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71 year-old male patient received bnt162b2 (BNT162B2), administered in arm, administration date 01Feb2021 (Lot number: EN5318) at the age of 71 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "he has a form of cancer" (unspecified if ongoing); "CLL" (ongoing), notes: For several years, Pertinent details: None. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (First Dose, Lot number: EL1284, Anatomical site of injection: Arm), administration date: 14Jan2021, when the patient was 71 years old, for COVID-19 immunization, reaction(s): "couldn''t sleep", "nauseous", "chills". The following information was reported: CHILLS (non-serious) with onset 2021, outcome "recovered" (2021), described as "Chills"; INSOMNIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "Couldn''t Sleep"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "Second Dose Less than 21 Days After the First Dose".  Additional information: He had chills and could not sleep and was better the next day.   Follow-up attempts completed. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: sore arm; fatigued; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old female patient received bnt162b2 (BNT162B2), administration date 10Mar2021 (Lot number: EN6208) at the age of 67 years as dose 1, single and administration date 31Mar2021 (Lot number: ER8733) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Disability" (unspecified if ongoing); "chronic pain" (unspecified if ongoing); "immunocompromised" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Pneumonia shot (She had annual pneumonia and flu shot day before yesterday and had no reactions.), administration date: 2020; Flu shot (She had annual pneumonia and flu shot day before yesterday and had no reactions.), administration date: 2020. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "recovered" (2021), described as "sore arm"; FATIGUE (non-serious) with onset Mar2021, outcome "recovered" (2021), described as "fatigued".  Additional information: She had annual pneumonia and flu shot day before yesterday and had no reactions. She had very mild reaction with the first two covid-19 doses, the usual sore arm and fatigued and then the next day it was gone, it was a minor reaction with first two doses.   No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): GL-101921-24788 (Agency).  A 48 year-old female patient received bnt162b2 (BNT162B2), administration date 16Oct2021 (Batch/Lot number: unknown) at the age of 48 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Immunocompromised" (unspecified if ongoing); "Myalgic Encephalomyelitis" (unspecified if ongoing); "Chronic fatigue Syndrome" (unspecified if ongoing); "Chronic lyme" (unspecified if ongoing); "Brain injury" (unspecified if ongoing), notes: Brain injury from birth; "Allergy to horse dander" (unspecified if ongoing). Concomitant medication(s) included: NYSTATIN, start date: 11Oct2021; KETOCONAZOLE, start date: 12Oct2021. Past drug history included: Augmentin, reaction(s): "Allergy to augmentin". Vaccination history included: Bnt162b2 (Dose: 1), for COVID-19 Immunization; Bnt162b2 (Dose: 2), for COVID-19 Immunization, reaction(s): "Feel unwell", "Vomit". The following information was reported: HEADACHE (non-serious) with onset 19Oct2021, outcome "not recovered", described as "headache".  Additional information: Patient reported using Cetaphil Gentle Cleansing Bar lot 20014.5 oz size (part of 3 pack) beginning on 17Oct2021 She had ringworm-  it had stopped itching 15Oct2021 and was getting smaller. The rash was getting worse since 18Oct2021 after she had used the product. The rash expanded in size and is more itchy. She had not used the soap directly on the rash. She also noted on 16Oct2021. she had the 3rd Pfizer vaccine. She had a headache today, 19Oct2021 but she believes it is from the vaccine as the second vaccine made her vomit and feel unwell. She discontinued the product for now (last use 18Oct2021) until she speaks to her dermatologist. The events are ongoing. Her medical history was she was immunocompromised-she had Myalgic Encephalomyelitis (chronic fatigue syndrome), chronic Lyme, and a brain injury from birth. She also had an allergy to Augmentin and horse dander. Concomitant products include Nystatin cream since 11Oct2021 Ketoconazole Shampoo since 12Oct2021 and Ketoconazole 2 % cream since 12Oct2021.  No follow up attempts are possible; Information about lot/ batch number cannot be obtained, No further information is expected
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Loss of personal independence in daily activities, Pain
Clinical narrative: Been in pain ever since receiving booster dose vaccine; The patient can hardly use her arm; the booster dose Pfizer Vaccine but the pain has gotten worse.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Oct2021 (Lot number: FH8020) at the age of 48 years as dose 3 (booster), single for covid-19 immunisation; methoxy polyethylene glycol-epoetin beta (MIRCERA), administered in arm right, administration date 18Oct2021 (Lot number: X405R, Expiration Date: Mar2024) as unk unk, single. Relevant medical history included: "Dialysis", start date: 2019 (ongoing), notes: Verbatim: Dialysis (Patient began dialysis two years ago, peridenal). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 2nd, Lot: PF1725, Route of administration: Right arm), administration date: 06Feb2021, when the patient was 48 years old, for Covid-19 immunization; Bnt162b2 (Dose: 1st, Lot: EL1284, Route of administration: Right arm), administration date: 16Jan2021, when the patient was 48 years old, for Covid-19 immunization. The following information was reported: PAIN (non-serious) with onset 18Oct2021, outcome "not recovered", described as "Been in pain ever since receiving booster dose vaccine"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 2021, outcome "unknown", described as "The patient can hardly use her arm"; CONDITION AGGRAVATED (non-serious) with onset 2021, outcome "unknown", described as "the booster dose Pfizer Vaccine but the pain has gotten worse.". Therapeutic measures were taken as a result of pain.  Additional information: After receiving booster dose patient had localized pain and it got worsen and she was taking Tylenol (lot: SDA002) and that helped her shorter period of time and also put salonpas patch (lot: X5087, expiration: APR-2024) on and a heating pad, patient received micera vaccine on right side as same day of booster dose to do with blood for anemia. The patient doesn't visit emergency room.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: Unknown if consumer experienced any allergic reaction to the COVID-19 Vaccine.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "Unknown if consumer experienced any allergic reaction to the COVID-19 Vaccine.". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Patient reported swelling that lasted approximately 1 week; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): GL-101921-24790 (Agency).  A 55 year-old female patient received bnt162b2 (BNT162B2), administration date Feb2021 (Batch/Lot number: unknown) as dose 1, single and administration date 2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Thyroid Disease" (unspecified if ongoing), notes: Taking levothyroxine for 10 years. Concomitant medication(s) included: RESTYLANE, start date: Jul2021, stop date: Jul2021; LEVOTHYROXINE taken for thyroid disorder. The following information was reported: SWELLING (non-serious) with onset 2021, outcome "recovered" (2021), described as "Patient reported swelling that lasted approximately 1 week". Additional information: Reported Adverse Event Per consumer: Patient was injected in July2021 with approximately 1/2 a syringe of Restylane Kysse (lot and exp. unknown) into the upper and lower lips. Patient reported swelling that lasted approximately 1 week, after swelling went down she noticed she had no results. She contacted the injecting provider who treated her with the other 1/2 syringe of Restylane Kysse and she reported again after 1 week when swelling went down there were no results. She reported that she contacted the injectors office and was told she would have to wait 3 months before trying any more treatments. She reported that she was seen on 08Oct2021 and did not receive another treatment, Injector advised her to call Withheld. Event not resolved. Reported she has had fillers and toxins for 3-4 years. No allergies. Has had the shingles vaccine in May2021. No illnesses in the month prior to treatment. No dental procedures in the last 6-12 months. Follow-up (06Dec2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Colonoscopy, Feeling abnormal, Pain, Vaccination site swelling
Clinical narrative: swelling at injection site; woke up in cold/hot sweat and felt like a hurricane was going in my chest felt Feverish but had no fever felt achy; felt achy; I felt weak and drained the rest of the day; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 11May2021 10:00 (Lot number: EW0141) at the age of 69 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "ulcerative colitis", start date: 2005 (ongoing), notes: Blood infusion 4 pints; "Osteoporosis", start date: 2019 (ongoing); "Colonoscopy" (unspecified if ongoing). Concomitant medication(s) included: MERCAPTOPURINE taken for colitis ulcerative, start date: Nov2005 (ongoing); ALENDRONATE taken for osteoporosis, start date: Dec2009 (ongoing). Vaccination history included: Bnt162b2 (Dose: 1st, Time: 11 AM, Anatomical site of injection: Right arm, Batch/Lot number: ER8732), administration date: 20Apr2021, for Covid-19 Immunization, reaction(s): "vertigo", "ILLNESS", "PAIN IN EXTREMITY", "VACCINATION SITE SWELLING". The following information was reported: VACCINATION SITE SWELLING (non-serious) with onset 2021, outcome "unknown", described as "swelling at injection site"; FEELING ABNORMAL (non-serious) with onset 2021, outcome "recovered", described as "woke up in cold/hot sweat and felt like a hurricane was going in my chest felt Feverish but had no fever felt achy"; PAIN (non-serious) with onset 2021, outcome "recovered", described as "felt achy"; ASTHENIA (non-serious) with onset 2021, outcome "recovered", described as "I felt weak and drained the rest of the day". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site swelling, feeling abnormal, pain, asthenia.  Additional information: Prior vaccinations were reported as none. It was reported that, the patient had no reaction of significance to his first shot. Stated that, he took the second shot around 10 AM on 11May2021. At first, the patient had no reaction other than the slight swelling at injection site and went to bed at 1 AM. Stated that, he woke up in cold/hot sweat and felt like a hurricane was going in his chest felt feverish but had no fever, felt achy H continues for 3 hours then suddenly stopped. Stated that, he felt weak and drained the rest of the day but by the next day, he was fine. The question was will the booster elicit this same reaction or not. The reporter seriousness of the events was reported as non-serious.  Follow-up attempts are completed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity
Clinical narrative: Pain in injection arm; muscle ache in arm; This is a spontaneous report received from a contactable reporter (Other HCP). The reporter is the patient.  A 30 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 25Oct2021 16:45 (Lot number: Fh8920) at the age of 30 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (FLU), administration date 25Oct2021 (Batch/Lot number: unknown) as dose number unknown, single. The patient had no relevant medical history. Concomitant medication(s) included: ORTHO TRI-CYCLEN LO. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Ep6955), administration date: 24Mar2021, when the patient was 30 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: El3247, Location of injection: Arm Left), administration date: 01Mar2021, when the patient was 30 years old, for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 25Oct2021, outcome "recovering", described as "Pain in injection arm"; MYALGIA (non-serious) with onset 25Oct2021, outcome "recovering", described as "muscle ache in arm". The action taken for influenza vaccine was unknown. Therapeutic measures were not taken as a result of pain in extremity, myalgia.  Additional information: No other vaccine in four weeks, other medications in two weeks: Ortho tricyclen lo, no covid prior vaccination, no covid tested post vaccination and no known allergies. Query: Please help to confirm the date that you became aware of the adverse events in this report as this effects regulatory reporting timelines. This awareness date is the date you became aware of the occurrence of the reported events. If you are the patient in the case, your awareness date would be the date that you became aware you were experiencing the reported events. If you are not the patient in the case, your awareness date would be the date you became aware of the occurrence of the reported events. This awareness date represents the Pfizer receipt date of the report and reflects the earliest date that any Pfizer colleague learned of the adverse event. If you learned of these events from another Pfizer colleague, please provide the date that the first Pfizer colleague became aware of the events reported, as regulatory reporting due dates are calculated based on the first day that a Pfizer colleague became aware of the adverse events. Response: Thank you, The first awareness date was onset of the event which was the night of 25Oct2021.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Feeling abnormal, Feeling hot, Malaise, Vomiting
Clinical narrative: mkay; Throwing up everywhere, she can't keep her food down, she can't keep no liquid down; She does not feel good; She's burning up hot; she's burning up hot; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A 25 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 25 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "mkay"; VOMITING (non-serious), outcome "unknown", described as "Throwing up everywhere, she can't keep her food down, she can't keep no liquid down"; MALAISE (non-serious), outcome "unknown", described as "She does not feel good"; BURNING SENSATION (non-serious), outcome "unknown", described as "She's burning up hot"; FEELING HOT (non-serious), outcome "unknown", described as "she's burning up hot".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 47.0
Sex: U
Vaccine: COVID19
Symptoms: Blood cholesterol, Chills, Headache, Hyperhidrosis, Nausea
Clinical narrative: chill; pretty nasty headache; sweating profusely; queasy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid right, administration date 23Oct2021 11:00 (Lot number: FF2590, Expiration Date: 31Dec2021) at the age of 47 years 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, Lot no. EP7534, Expiration date: 31Jul2021), administration date: 16Mar2021, for Covid-19 immunization, reaction(s): "extreme tiredness", "soreness in the injection spot"; Bnt162b2 (Dose 2, single, Lot no. ER8734, Expiration date: 31Jul2021), administration date: 06Apr2021, for Covid-19 immunization, reaction(s): "extreme tiredness", "soreness in the injection spot". The following information was reported: CHILLS (non-serious) with onset 23Oct2021 18:00, outcome "not recovered", described as "chill"; HEADACHE (non-serious) with onset 23Oct2021 18:00, outcome "not recovered", described as "pretty nasty headache"; HYPERHIDROSIS (non-serious) with onset 23Oct2021 18:00, outcome "not recovered", described as "sweating profusely"; NAUSEA (non-serious) with onset 23Oct2021 18:00, outcome "not recovered", described as "queasy". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of chills, headache, hyperhidrosis, nausea.  Additional information: Saturday patient received the booster shot which was the Pfizer vaccine, around like somewhere between 11 am and noon and later on that evening probably around 6 to 7 pm, patient just started experiencing like the those guess chill and got a pretty, pretty nasty headache and then started just sweating profusely and then just started was queasy from Saturday evening until this morning, so patient had never experience that. Treatment: included, "two Tylenol tablets." No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Vaccination site swelling
Clinical narrative: Severe swelling at injection site; lymph nodes under armpit; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Oct2021 18:00 (Lot number: 3203030) at the age of 39 years 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 Number: 1, Batch/Lot No: EN6210, Location of injection: Arm Left), administration date: 10Feb2021, when the patient was 38 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EN6205, Location of injection: Arm Left), administration date: 03Mar2021, when the patient was 38 years old, for Covid-19 immunization. The following information was reported: VACCINATION SITE SWELLING (non-serious) with onset 22Oct2021, outcome "not recovered", described as "Severe swelling at injection site"; LYMPHADENOPATHY (non-serious) with onset 22Oct2021, outcome "not recovered", described as "lymph nodes under armpit". Therapeutic measures were not taken as a result of vaccination site swelling, lymphadenopathy.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: swelling in my hands and feet; swelling in my hands and feet; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 12Feb2021 (Lot number: EL9261) at the age of 57 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Rheumatoid Arthritis" (unspecified if ongoing); "Hashimotos" (unspecified if ongoing); "Hypothyroid" (unspecified if ongoing). Concomitant medication(s) included: FLU, administration date 21Oct2021; TIROSINT taken for thyroid disorder; TESTOSTERONE/ESTROGEN. Past drug history included: Prednisone, reaction(s): "Known allergies: prednisone". The following information was reported: PERIPHERAL SWELLING (non-serious), PERIPHERAL SWELLING (non-serious) all with onset 2021, outcome "unknown" and all described as "swelling in my hands and feet". Therapeutic measures were not taken as a result of peripheral swelling, peripheral swelling.  Additional information: The patient started having swelling in her hands and feet after the first 2 covid vaccinations. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus
Clinical narrative: itchy arm and soreness; itchy arm and soreness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRURITUS (non-serious), PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as "itchy arm and soreness".   Additional Context:  The report is cross referenced to report ID: (Withheld) Received call from consumer who provided her middle initial as (Withheld). She had her Booster shot of the Pfizer COVID vaccine last Wednesday, 20Oct2021.  She had the two previous ones in Feb and then space and got another one.  She had no effects from the others at all except an itchy arm.  This time it has been worse.  While reporting for herself, she mentioned that she has an itchy arm and soreness and everyone has had that. She did not have anyone specific to report on except two ladies that live in the same senior community.   They had an itchy arm and soreness.  Other than that, they were fine and did not have any lethargy, sore throat, and did not have the feeling that they were not going to be able to make it that she had.  She did not wish to complete a report for them.  This report is to capture information for the second lady.   Follow-up (01Dec2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: she developed a tremor, a violent tremor that is controllable, she could stop it but if she didn't bother it would go on; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 02Oct2021 (Lot number: FF8841) at the age of 76 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (ongoing); "Cancer. Rt breast", start date: 2009 (unspecified if ongoing), notes: Pertinent details: No evidence of recurrence in 11 years; "low Vitamin D" (unspecified if ongoing). Family history included: "High cholesterol" (unspecified if ongoing), notes: Pertinent details: all family runs high. Concomitant medication(s) included: LIOTHYRONINE taken for hypothyroidism, start date: 2019 (ongoing); LEVOTHYROXINE taken for hypothyroidism, start date: 1995; VITAMIN D [VITAMIN D NOS] taken for vitamin d decreased, start date: 2010 (ongoing). Vaccination history included: Bnt162b2 (Dose Number: 1, Lot Number: EN5318, 1st shot she had no symptoms, Anatomical site of Location: Left Arm, Route of administration: Intramuscular), administration date: 27Jan2021, when the patient was 76 years old, for COVID-19 immunization, reaction(s): "1st shot she had no symptoms"; Bnt162b2 (Dose Number: 2, Lot Number: EN6202, her first 2 were fine., Anatomical site of Location: Rt Arm, Lot number: EN6202, Route of administration: Intramuscular), administration date: 03Mar2021, when the patient was 76 years old, for COVID-19 immunization, reaction(s): "her first 2 were fine". The following information was reported: TREMOR (non-serious) with onset 18Oct2021, outcome "unknown", described as "she developed a tremor, a violent tremor that is controllable, she could stop it but if she didn't bother it would go on".  Additional information: Reporter stated that her first 2 were fine. Stated that she got the booster sometime around 02Oct2021 and around 18Oct2021 she developed a tremor, a violent tremor that was controllable, she could stop it but if she didn't bother it would go on. Caller stated it was the arm where she got the shot and she doesn't notice it and if she puts her hand in a certain way it happens. Caller states the interesting thing was she has an identical twin sister and she got the booster and she also now has this tremor. Vaccination Facility Type was Pharmacy or Drug Store. Prior vaccination (within 4 weeks) was none.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101454872 Same reporter/drug/event, different patient.