chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Culture urine, Pollakiuria, Urine analysis
Clinical narrative: Frequent urination; This is a spontaneous report from a contactable consumer, the patient. A 35-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EP7533) via an unspecified route of administration in the left arm on 13Apr2021 at 13:00 (at the age of 35-years-old) as dose 2, single for COVID-19 immunization. The patient did not have any relevant medical history. The patient had no known allergies. The patient did not receive any other medications within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EN6207) via an unspecified route of administration in the left arm on 23Mar2021 (at the age of 35-years-old) as dose 1, single for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date in Apr2021, the patient experienced frequent urination. On an unknown date in 2021, the patient underwent urine analysis and the result was normal and culture (urine culture) was also negative. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of frequent urination and included unspecified treatment, but that was not helping. The clinical outcome of the event frequent urination was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Concomitant medication information and narrative were amended.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Overdose
Clinical narrative: Administered 0.5 mL of vaccine, not 0.3 mL; This is a spontaneous report from a contactable other healthcare professional. A 39-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the arm right on 08Apr2021 (at the age of 39-years-old) as dose 1, 0.5 mL single for COVID-19 immunization. Medical history and concomitant medications were not reported. On 08Apr2021, the patient was administered with 0.5 mL of vaccine, not 0.3 mL. The patient did not receive any treatment for the event.  No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Products tab, events tab and narrative were amended.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Musculoskeletal stiffness, Neuralgia
Clinical narrative: Muscle cramping, stiffness and sharp/electric pains (assumed nerve pain) in legs, arms, hands, feet, and head.; Muscle cramping, stiffness and sharp/electric pains (assumed nerve pain) in legs, arms, hands, feet, and head.; Muscle cramping, stiffness and sharp/electric pains (assumed nerve pain) in legs, arms, hands, feet, and head.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 06Apr2021 (Lot number: EP7533) at the age of 25 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 (lot_number: EN6199, dose_number: 1, vaccine_location: Left arm), administration date: 09Mar2021, when the patient was 25 years old, for COVID-19 immunization. The following information was reported: MUSCLE SPASMS (non-serious), MUSCULOSKELETAL STIFFNESS (non-serious), NEURALGIA (non-serious) all with onset 12Apr2021, outcome "not recovered" and all described as "Muscle cramping, stiffness and sharp/electric pains (assumed nerve pain) in legs, arms, hands, feet, and head.". The event "muscle cramping, stiffness and sharp/electric pains (assumed nerve pain) in legs, arms, hands, feet, and head.", "muscle cramping, stiffness and sharp/electric pains (assumed nerve pain) in legs, arms, hands, feet, and head." and "muscle cramping, stiffness and sharp/electric pains (assumed nerve pain) in legs, arms, hands, feet, and head." was evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of muscle spasms, musculoskeletal stiffness, neuralgia.  Additional information: No, prolonged hospitalization reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received birth control pills within 2 weeks of vaccination. Muscle cramping, stiffness and sharp/electric pains (assumed nerve pain) in legs, arms, hands, feet, and head. The adverse events were resulted in doctor or other healthcare professional office/clinic visit. The adverse event result in Emergency room/department or urgent care. Gabapentin received for the adverse event. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No known allergies.   No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Exposure during pregnancy
Clinical narrative: Patient last menstrual period date :18May2021; This is a spontaneous report received from contactable reporter (Consumer or other non HCP and Other HCP). The reporter is the patient.  A 37 year-old female patient (pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 27May2021 12:30 (Lot number: EW0172) at the age of 37 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (ongoing); "Anxiety" (unspecified if ongoing); "Depression" (ongoing); "Migrains" (ongoing). Date of last menstrual period: 18May2021. The patient was 1 weeks pregnant at the time of exposure to bnt162b2. The patient was 1 weeks pregnant at the event onset. The patient is expected to deliver a baby(s) on 22Feb2022. Concomitant medication(s) included: ZYRTEC ALLERGY; ESCITALOPRAM taken for depression (ongoing). Past drug history included: Neomycin, reaction(s): "known allergies: Neomycin"; Erythromycin, reaction(s): "known allergies: Erythromycin"; Fluorescein, reaction(s): "known allergies: Fluorescein". The following information was reported: EXPOSURE DURING PREGNANCY (non-serious) with onset 27May2021, outcome "unknown", described as "Patient last menstrual period date :18May2021". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: adverse event: 19Jun2021 miscarriage began. 21Jun2021 called physician and notified, had bloodwork done to confirm no hcg levels remain, 23Jun2021 received rhogam injection on. Also have had long and inconsistent cycles since vaccination. Prior to second dose, have very strong pregnancy symptoms, pointing to healthy and viable pregnancy. the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient provides information to regarding the reported adverse event with the use of product. The Pfizer product had a causal effect to the adverse event. No specific relevant test for thromboembolic events with thrombocytopenia.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101689617 same patient, different dose, different event
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: My ears started ringing on and off, it'd come and go fast, didn't think much of it, but it started happening more in recent days and now for nearly 48 hours straight they have been ringing, today; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old male patient received second dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8733), via an unspecified route of administration in the left arm on 19April2021 at 10:00 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure and overweight. Concomitant medications included hydrochlorothiazide, Lisinopril 20mg (LISINOPRIL/HCTZ) and Omeprazole Magnesium (PRILOSEC) for an unknown indication and from an unknown date. The patient previously received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727), via an unspecified route of administration in the left arm on 22Mar2021 at 10:00 (at the age of 52-years-old) as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On an unspecified date in April2021, the patient ears started ringing on and off. It would come and go fast, but it started happening more in recent days and then for nearly 48 hours straight they had been ringing. On the day of reporting, it seems it was ringing mostly from the left ear. The patient did not have this issue previously. The clinical outcome of the event ringing in ears was not recovered at the time of this report. No therapeutic measures were taken as a result of the reported event. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient had no allergies to medications, food, or other products.  No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: "Treatment Received? No" was ticked for the event. "No therapeutic measures were taken as a result of the reported event. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient had no allergies to medications, food, or other products." added in narrative.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Pain Started on my forearm day after first COVID 19 shot on May 3; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03May2021 18:30 (Lot number: Ew0173) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Allergies" (unspecified if ongoing); "Hashimotos" (unspecified if ongoing). Concomitant medication(s) included: ARMOUR THYROID. Past drug history included: Codeine, reaction(s): "Known allergies: Codeine". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 04May2021 11:00, outcome "not recovered", described as "Pain Started on my forearm day after first COVID 19 shot on May 3". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: Patient reported no Covid prior and Covid tested post vaccination. Patient reported no other vaccine in four weeks.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Cluster headache, Migraine, SARS-CoV-2 test
Clinical narrative: a cluster migraine headache cycle began; a cluster migraine headache cycle began; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date Apr2021 (Lot number: EW0150) at the age of 60 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "BPH" (unspecified if ongoing), notes: BPH without urinary obstruction; "achillies tendinitis" (unspecified if ongoing); "elevated PSA" (unspecified if ongoing), notes: PSA elevated; "ejaculatory dysfunction" (unspecified if ongoing); "chronic dental health issues", start date: Aug2020, stop date: Feb2021. Concomitant medication(s) included: FINASTERIDE; OMEPRAZOLE; ADVIL [IBUPROFEN]; BUTALBITAL, ASPIRIN AND CAFFEINE. Past drug history included: Amoxicillin, reaction(s): "known_allergies: amoxicillin". The following information was reported: MIGRAINE (non-serious), CLUSTER HEADACHE (non-serious) all with onset 08Apr2021 21:30, outcome "not recovered" and all described as "a cluster migraine headache cycle began". Relevant laboratory tests and procedures are available in the appropriate section.  Addition information: Administration time of first dose was 14:30. 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.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Lichen planus
Clinical narrative: BIOPSY CONFIRMED LICHEN PLANUS which required 8 weeks of treatment
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus in both ears; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 05Jul2021 10:30 (Lot number: FA6780) at the age of 28 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "birth control" (unspecified if ongoing). Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE]; FLONASE [FLUTICASONE PROPIONATE]. The following information was reported: TINNITUS (non-serious) with onset 05Jul2021 12:00, outcome "not recovered", described as "Tinnitus in both ears". The event "tinnitus in both ears" was evaluated at the physician office visit. Therapeutic measures were taken as a result of tinnitus. Additional Information: Adverse event treatment Prednisone received. No covid prior vaccination. No covid tested post vaccination. No known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Oropharyngeal pain, Productive cough, Secretion discharge, Vaccination site pain
Clinical narrative: lots of mucus and phlegm; lots of mucus and phlegm; sick as dog; Sore throat; if she touches in that area it is painful; 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 58 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14Jul2021 16:30 (Lot number: ER8736) at the age of 58 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: SECRETION DISCHARGE (non-serious), PRODUCTIVE COUGH (non-serious) all with onset 15Jul2021 06:30, outcome "not recovered" and all described as "lots of mucus and phlegm"; ILLNESS (non-serious) with onset 15Jul2021 06:30, outcome "not recovered", described as "sick as dog"; OROPHARYNGEAL PAIN (non-serious) with onset 15Jul2021 06:30, outcome "not recovered", described as "Sore throat"; VACCINATION SITE PAIN (non-serious) with onset 15Jul2021 06:30, outcome "not recovered", described as "if she touches in that area it is painful".  Additional information: The patient stated that she was scared to get the shot because it was untested and all that. She went and got it yesterday and was sick as a dog today. She woke up with really bad sore throat and a lot of mucus and phlegm though she was fine yesterday. Her arm was not sore yesterday, but if she touch in that area it was painful that day. Yesterday it was nothing. Some people complaint of sore arm and she was happy yesterday and thought she got away with not getting a sore arm, but that day, it was painful. She also informed that she was a really healthy person and doesn't usually got sick. Her niece who was a nurse told her not to worry about that because the flu shot was egg based and this shot was not egg based. The patient stated that she donated plasma. She donated plasma the week before. She had been donating plasma for the last 2 months. Before she decided to start donating plasma she was donating blood. She also stated that got sick from flu vaccine. She didn't had NDC, lot, and expiry for flu vaccine. It was in the mid 1990's and had never had a flu vaccine since. She was asking if she could take over the counter medication like lozenges for her sore throat as she was doubting that regular throat lozenges or flu medicine could effect the vaccine.  No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Occasional tingling in hands and feet and occasional numbness. Started after the first vaccine and continues to this day.; Occasional tingling in hands and feet and occasional numbness. Started after the first vaccine and continues to this day.; 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 female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 25Jun2021 11:00 (Lot number: ER8735) at the age of 47 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PARAESTHESIA (non-serious), HYPOAESTHESIA (non-serious) all with onset 02Jul2021, outcome "not recovered" and all described as "Occasional tingling in hands and feet and occasional numbness. Started after the first vaccine and continues to this day.". Therapeutic measures were not taken as a result of paraesthesia, hypoaesthesia.  Additional information- It was reported that patient administer vaccine at drug store. Patient did not have known allergies and did not administer any other vaccine in four weeks. The patient did not suffer from covid prior to vaccination and did not covid tested post vaccination.   No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Granuloma annulare
Clinical narrative: I noticed a granuloma annulare on my right breast; 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 17Jul2021 12:30 (Lot number: FA7484) at the age of 36 years as dose 2, single and administered in arm left, administration date 26Jun2021 12:30 (Lot number: EW0177) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Fibroid Adenoma in right breast" (unspecified if ongoing), notes: Fibroid Adenoma in right breast; "ADHD" (unspecified if ongoing), notes: ADHD; "C-Sections", start date: 18Nov2008 (unspecified if ongoing), notes: Surgical History: (3) C-Sections-18Nov2008, 27Aug2016, 23May2018;; "Abdominoplasty", start date: 30Jun2020 (unspecified if ongoing), notes: Surgical History: (1) Abdominoplasty & Breast Augmentation Mastopexy 30Jun2020; "Breast Augmentation Mastopexy", start date: 30Jun2020 (unspecified if ongoing), notes: Surgical History: (1) Abdominoplasty & Breast Augmentation Mastopexy 30Jun2020; "C-Sections", start date: 27Aug2016 (unspecified if ongoing), notes: Surgical History: (3) C-Sections-18Nov2008, 27Aug2016, 23May2018;; "C-Sections", start date: 23May2018 (unspecified if ongoing), notes: Surgical History: (3) C-Sections-18Nov2008, 27Aug2016, 23May2018;. Concomitant medication(s) included: AMFETAMINE;DEXAMFETAMINE. The following information was reported: GRANULOMA ANNULARE (non-serious) with onset 06Aug2021, outcome "recovering", described as "I noticed a granuloma annulare on my right breast". Therapeutic measures were not taken as a result of granuloma annulare.  Additional information: The patient had no symptoms like pain, itching, etc. for granuloma annulare. No other skin irritations or markings were noticed anywhere else on her body. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient also not been tested for COVID-19. She had no known allergies.  Follow-up attempts are completed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Numbness in right thigh; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 12Aug2021 12:00 (Lot number: EW0172) at the age of 45 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Colitis" (unspecified if ongoing); "latex allergy" (unspecified if ongoing). Concomitant medication(s) included: BUDESONIDE; MESALAMINE. The following information was reported: HYPOAESTHESIA (non-serious) with onset 14Aug2021, outcome "not recovered", described as "Numbness in right thigh". Therapeutic measures were not taken as a result of hypoesthesia.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not had any prior to vaccination, diagnosed with COVID-19. Since the vaccination, has the patient has been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: The side effect that he experienced was both of his knees are numb after taking first dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A 32 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 24Jul2021 14:00 (Lot number: EW0196) at the age of 32 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: HYPOAESTHESIA (non-serious) with onset 25Jul2021, outcome "not recovered", described as "The side effect that he experienced was both of his knees are numb after taking first dose".  Additional information: The report related to a study or programme. No other products and investigation assessment. Reporter online was told to call Pfizer by the facility that gave him the vaccine to report side effect and to ask if he can take the second dose. The side effect that he experienced was both of his knees are numb after taking first dose on 24Jul2021. Product is Pfizer BioNTech COVID19 Vaccine. Reporter clarified that the side effect of numbness begins from his ankles and goes up to above his knees. It is the exact same location on both legs. HCP Information currently in between jobs and doesn't have a primary care provider. The numbness started the day after, 25Jul2021. It is ongoing and has stayed exactly the same. Anatomical location of administration of pfizer vaccine considered as suspect was right shoulder. Vaccination facility type was pharmacy inside of target. No vaccine administered at military facility. History of all previous immunization with the Pfizer vaccine considered as suspect reported as not applicable. Additional vaccines administered on same date of the pfizer suspect reported as none. Adverse event time of onset was (24-hour clock) around the afternoon to evening. Adverse event did not result in emergency room and physician office visit. Reporter states he has withheld from going to the ER or physician office and thought he would call Pfizer first. Prior Vaccinations (within 4 weeks) and AE(s) following prior vaccinations reported as none. Family medical history relevant to AE(s) and relevant tests reported as none. Within 24 hours he developed numbness from his ankles up to his knees and inside of his calves on the exact same location in both legs. He is still experiencing it and its stayed exactly the same. It's everywhere between those places. He states its essentially the same but may be a little more, like a tiny bit more, a little more prominent now. Is this a side effect of the vaccine.  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: swelling on or below the right underarm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 14Aug2021 12:00 (Lot number: EW0181) at the age of 42 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "asthma" (unspecified if ongoing); "glaucoma" (unspecified if ongoing). Concomitant medication(s) included: LATANOPROST. The following information was reported: PERIPHERAL SWELLING (non-serious) with onset 16Aug2021 06:30, outcome "unknown", described as "swelling on or below the right underarm". Therapeutic measures were not taken as a result of peripheral swelling.  Additional information: Other vaccine 4weeks details other vaccine 4weeks product: Pfizer-BioNTechCOVID Vaccine. other vaccine 4weeks vaccine date: 24Jul2021. other vaccine 4weeksn lot number: EW0217. other vaccine 4weeks dose number: 1. other vaccine 4weeks vaccine location: Right shoulder. if covid prior vaccination; No. if covid tested post vaccination: No. known allergies; No  No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Metallic/medicinal taste in mouth almost immediately after shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15Aug2021 02:30 (Lot number: FC3182) at the age of 45 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "known_allergies: Latex" (unspecified if ongoing). Concomitant medication(s) included: ALEVE; VITAMIN D3; ZINC. Past drug history included: Aleve; Vitamin d3; Zinc. The following information was reported: DYSGEUSIA (non-serious) with onset 15Aug2021 14:30, outcome "not recovered", described as "Metallic/medicinal taste in mouth almost immediately after shot". Therapeutic measures were not taken as a result of dysgeusia.  Additional Information: Patient did not receive any other vaccine in four weeks. She received Aleve, vitamin D3, Zinc medications in two weeks. She did not have covid prior vaccination and did not test covid post vaccination.   Follow-up attempts are completed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Injection site became painful to touch; Injection site became red/feverish; Injection site became swollen; Injection site became red/feverish; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 13Aug2021 13:00 (Lot number: EW0176) at the age of 48 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "allergies: Penicillin" (unspecified if ongoing), notes: Known allergies: Penicillin, Codeine, Benadryl; "Covid prior vaccination: Yes" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Codeine for allergy: Codeine, notes: Known allergies: Penicillin, Codeine, Benadryl; Benadryl for allergy: Benadryl, notes: Known allergies: Penicillin, Codeine, Benadryl. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 13Aug2021 14:30, outcome "unknown", described as "Injection site became painful to touch"; VACCINATION SITE WARMTH (non-serious), VACCINATION SITE ERYTHEMA (non-serious) all with onset 13Aug2021 14:30, outcome "unknown" and all described as "Injection site became red/feverish"; VACCINATION SITE SWELLING (non-serious) with onset 13Aug2021 14:30, outcome "unknown", described as "Injection site became swollen". It was unknown if therapeutic measures were taken as a result of vaccination site pain, vaccination site warmth, vaccination site swelling, vaccination site erythema.  Additional information: Injection site became red, swollen, feverish and painful to touch (stingy sensation). An hour after the injection, site became red and swollen and about an inch in diameter. 4 days later, the site is still red, swollen feverish and progressively painful to touch and it is progressively getting larger. Site is 3 inches in diameter or greater. Patient were not administered other vaccine in last four weeks, and any other drugs in last two weeks. Post vaccination, the patient was not diagnosed with COVID-19.  Follow-up attempts are completed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, SARS-CoV-2 test, Vertigo
Clinical narrative: 22 hours after 2nd vaccine sudden onset of body aches; vertigo; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 66 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 26May2021 12:00 (Lot number: EW0150) at the age of 66 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "chronic back pain" (unspecified if ongoing); "depression" (unspecified if ongoing); "occasional anxiety" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN D3; BUPROPION HCL XL; VITAMIN C [ASCORBIC ACID]. Vaccination history included: Bnt162b2 (product=COVID 19, brand=Pfizer, lot number=EWo17, administrator route=Intramuscular, administration time=11:00 AM, dose number=1, vaccine location=Right arm), administration date: 05May2021, when the patient was 66 years old, for Covid-19 immunisation.  The following information was reported: PAIN (non-serious) with onset 27May2021 09:00, outcome "not recovered", described as "22 hours after 2nd vaccine sudden onset of body aches"; VERTIGO (non-serious) with onset 27May2021 09:00, outcome "not recovered", described as "vertigo". The events "22 hours after 2nd vaccine sudden onset of body aches" and "vertigo" 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 pain, vertigo.   Additional information: No known allergies. No covid prior to vaccination. There was no other vaccine in four weeks. Meclizine 12.5 mg PRN, Medrol Dose Pak treatment was given for adverse events.  No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Heart rate, Heart rate increased, Lymphadenopathy
Clinical narrative: Injection site pain; headache; swollen lymph nodes; tiredness; feeling unwell; fast heart beat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 06Aug2021 13:00 (Lot number: EW0171) at the age of 57 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "if covid prior vaccination Yes" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin", notes: Amoxicillin. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 06Aug2021 14:00, outcome "recovering", described as "Injection site pain"; HEADACHE (non-serious) with onset 06Aug2021 14:00, outcome "recovering", described as "headache"; LYMPHADENOPATHY (non-serious) with onset 06Aug2021 14:00, outcome "recovering", described as "swollen lymph nodes"; FATIGUE (non-serious) with onset 06Aug2021 14:00, outcome "recovering", described as "tiredness"; MALAISE (non-serious) with onset 06Aug2021 14:00, outcome "recovering", described as "feeling unwell"; HEART RATE INCREASED (non-serious) with onset 06Aug2021 14:00, outcome "recovering", described as "fast heart beat". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site pain, headache, lymphadenopathy, fatigue, malaise, heart rate increased. Additional information: No covid-19 tested post vaccination. No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Vaccination site pain
Clinical narrative: Injection site pain; headache; swollen lymph nodes; tiredness; feeling unwell; fast heart beat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 06Aug2021 13:00 (Lot number: EW0171) at the age of 57 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "if covid prior vaccination Yes" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Amoxicillin, reaction(s): "Known allergies: Amoxicillin", notes: Amoxicillin. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 06Aug2021 14:00, outcome "recovering", described as "Injection site pain"; HEADACHE (non-serious) with onset 06Aug2021 14:00, outcome "recovering", described as "headache"; LYMPHADENOPATHY (non-serious) with onset 06Aug2021 14:00, outcome "recovering", described as "swollen lymph nodes"; FATIGUE (non-serious) with onset 06Aug2021 14:00, outcome "recovering", described as "tiredness"; MALAISE (non-serious) with onset 06Aug2021 14:00, outcome "recovering", described as "feeling unwell"; HEART RATE INCREASED (non-serious) with onset 06Aug2021 14:00, outcome "recovering", described as "fast heart beat". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site pain, headache, lymphadenopathy, fatigue, malaise, heart rate increased. Additional information: No covid-19 tested post vaccination. No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, SARS-CoV-2 antibody test negative
Clinical narrative: Left side of face went entirely numb within 30-40 minutes.; This is a spontaneous report received from contactable reporter consumer or other non HCP.The reporter is the patient.  A 42 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07May2021 11:30 (Lot number: ER8735) at the age of 42 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s)included: LISINOPRIL +PHARMA. The following information was reported: HYPOAESTHESIA (non-serious) with onset 07May2021 11:30, outcome "recovered with sequelae" (May2021), described as "Left side of face went entirely numb within 30-40 minutes.". The event "left side of face went entirely numb within 30-40 minutes." 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 hypoaesthesia.  Additional information:-The patient had no known allergies.prior to vaccination patient does not have covid. Covid tested was done after vaccination.Patient had not received any other vaccine in four weeks.The patient underwent covid rapid test(nasal swab) and got SARS-CoV-2 antibody test negative.  No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Depression, Feeling abnormal
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A 61-year-old male patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# FC3180), at the age of 61, on Aug 18, 2021, single dose, for COVID-19 immunisation. No medical history or concomitant medications reported. The patient felt abnormal (fogginess in the brain almost like a blanket and maybe a haziness/brain fog) and depression (making me slightly depressed), onset Aug 2021, with outcome of recovering. No therapeutic measures taken as a result of feeling abnormal and depression. Additional information: Patient stated he received the first dose of the Pfizer-Biontech COVID-19 vaccine Aug 18, 2021. Since the vaccine, he has had brain fog. He felt like it is slight depression. Like he wants to cry but can't. He stated he was doing okay physically, but mentally he did not feel fine. 2 hours after the shot, he sat on his deck and felt like a fogginess came over his brain, like a blanket. It made him feel a little depressed. This was the second day now. He thought he would feel better yesterday after he woke up but he did not. He wanted to know if this is common and if it will lift. The patient stated he was concerned and scared. He doesn't want to lose his mind or get dementia. He stated he talked to a couple people- his wife's boss felt the same thing for a couple days. It lifted. Another person from work said their mom and dad felt haziness in their brain when they got the Pfizer vaccine. Yesterday his wife's friend's daughter got the shot and felt similar, like she was one step behind in her brain or in thinking. The patient stated now he heard from lots of people describing what he is describing. He went online right away and found that Pfizer may cause brain fog. If it was just a headache and nausea, then he wouldn't really bother; but this was concerning his brain. Now he is more concerned and that's why he called. He thought to go to bed and maybe he would wake up feeling better but he didn't. He was still not entirely feeling better. If it is better it is only better very slightly. He confirmed there have been no new events since his report. Follow-up attempts completed. No further information expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Antibody test positive, Dysgeusia, Hypoaesthesia, Hypoaesthesia oral
Clinical narrative: having a metallic taste in my mouth; numbing of the face/numbness in my face/mouth at various places; numbing of the face/numbness in my face/mouth at various places; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Aug2021 08:00 (Batch/Lot number: unknown) at the age of 42 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ATENOLOL; ZYRTEC. The following information was reported: DYSGEUSIA (non-serious) with onset 10Aug2021 08:30, outcome "not recovered", described as "having a metallic taste in my mouth"; HYPOAESTHESIA (non-serious), HYPOAESTHESIA ORAL (non-serious) all with onset 10Aug2021 08:30, outcome "not recovered" and all described as "numbing of the face/numbness in my face/mouth at various places". The events "having a metallic taste in my mouth", "numbing of the face/numbness in my face/mouth at various places" and "numbing of the face/numbness in my face/mouth at various places" 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 dysgeusia, hypoaesthesia, hypoaesthesia oral.  Additional information: The most recent COVID-19 vaccine was administered at hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had immediately started having a metallic taste in mouth. It then followed with numbing of the face. 2 weeks later, still having numbness in face/mouth at various places. The numbness will come and go from day to day and still able to taste and smell. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold
Clinical narrative: cold feelings in her arms and in her neck/felt like she had menthol on the back of her arms and the back of her neck; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old female patient received bnt162b2 (BNT162B2), administration date 21May2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1: she had really bad fatigue for 3 weeks), for COVID-19 immunization, reaction(s): "bad fatigue". The following information was reported: FEELING COLD (non-serious) with onset 2021, outcome "unknown", described as "cold feelings in her arms and in her neck/felt like she had menthol on the back of her arms and the back of her neck".  Additional information: The patient had her last Pfizer COVID vaccine, clarified to 2nd dose, on 21May2021 and she noticed about 5 weeks after she started developing these cold feelings in her arms and in her neck, like she is having nerve issues that she has never had in her life. She is 56 years old and she has never had anything like that happen. How it happened is that she was walking her dog and felt like she had menthol on the back of her arms and the back of her neck. She is wanting to know if Pfizer has heard of anyone having any problems like that and how long it has lasted for others. She says she had called before and completed a safety report with Pfizer after her 1st does because she had really bad fatigue for 3 weeks but she doesn't know if Pfizer still has that information.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Lymphadenopathy
Clinical narrative: 2nd dose 26Mar2021,1st dose 05Jul2021; swollen lymph node under arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 25 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26Mar2021 (Lot number: EP7534) at the age of 25 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (product=COVID 19,, lot_number=EP7534,, administration_date=26/Mar/2021,, dose_number=2,, vaccine_location=Left arm},), administration date: 26Mar2021, when the patient was 25 years old, for COVID-19 immunization, reaction(s): "Swollen lymph nodes on left side of neck and under left arm. Under left arm is still swollen as of 28Jul2021". The following information was reported: LYMPHADENOPATHY (non-serious), outcome "not recovered", described as "swollen lymph node under arm"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "2nd dose 26Mar2021,1st dose 05Jul2021".  Follow-up attempts are completed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: lack of efficacy; contracted covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 23Apr2021 (Lot number: EW0161) at the age of 46 years as dose 2, single and administration date 01Apr2021 (Lot number: EP7533) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ZYRTEC. The following information was reported: VACCINATION FAILURE (medically significant) with onset 21Feb2022, outcome "recovering", described as "lack of efficacy"; COVID-19 (medically significant) with onset 21Feb2022, outcome "recovering", described as "contracted covid". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (21Feb2022) positive, notes: Nasal Swab; (unspecified date) yes, notes: Since the vaccination, the patient has been tested for COVID-19. Therapeutic measures were taken as a result of vaccination failure, covid-19 and treated with Tylenol and delsym.  Clinical Course: Patient did not received any other vaccine within 4 weeks prior to COVID vaccine. Patient received multivitamins within 2 weeks of vaccination. Patient was treated with Tylenol and delsym. Patient was not diagnosed with COVID-19 prior vaccination. Patient had been tested positive for COVID-19 since the vaccination.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Dizziness, Heart rate, Heart rate increased
Clinical narrative: felt dizzy and felt like I wanted to faint; had a strike in blood pressure and was higher than my usual BP; My heart was beating faster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP).  A 28 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 20Aug2021 04:30 (Lot number: FC3181) at the age of 28 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: JUNEL FE 1/20. The following information was reported: DIZZINESS (non-serious) with onset 23Aug2021 10:45, outcome "not recovered", described as "felt dizzy and felt like I wanted to faint"; BLOOD PRESSURE INCREASED (non-serious) with onset 23Aug2021 10:45, outcome "not recovered", described as "had a strike in blood pressure and was higher than my usual BP"; HEART RATE INCREASED (non-serious) with onset 23Aug2021 10:45, outcome "not recovered", described as "My heart was beating faster". The events "felt dizzy and felt like i wanted to faint", "had a strike in blood pressure and was higher than my usual bp" and "my heart was beating faster" 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 dizziness, blood pressure increased, heart rate increased.  Additional information: The patient did not receive other vaccine in four weeks. The patient stated, she received first dose on 20Aug and on the third day (23rd), she felt dizzy and felt like she wanted to faint. She had a strike in blood pressure and was higher than my usual BP. Her heart was beating faster. Today is 29Aug, and she still have the same symptoms of feeling dizzy and faint. The patient was not diagnosed with Covid-19 prior vaccination. The patient was diagnosed with Covid-19 post vaccination.  Follow-up attempts are completed. No further information is expected.