chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Central nervous system lesion, Death, Pulmonary thrombosis
Clinical narrative: DIED; LUNG BLOOD CLOTS; GUILLAIN BARRE SYNDROME; BRAIN LESIONS; This spontaneous report received from a consumer via a company representative via social media concerned a female of unspecified age, race and ethnicity. Initial information was processed along with the additional information received on 22-FEB-2022. The patient's weight, height, and medical history were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced blood clots, guillain barre syndrome, and brain lesions, and was hospitalized for ten months (304 days). The reporter reported that, "My wife died after ten months in the hospital after receiving JNJ vaccine. She fought for 10 months. Doctor telling us never seen this, never treated this. She had Guillain Barre syndrome, Brain lesions and finally lung blood clots. No one wanted to touch that. Yet this is news worthy. Victims, Nope. the average citizen. No help, no regard for human life. News murdered my wife and countless others. Big pharma got protection. Corporate profits over human life. The government ignores whatever they want. They ignore the vaccine victims. Does our government care, A big no. Elected officials work for country, not corporations. News ignored and threatened legal action when I inquired with doctor. He collected my wife's medical records and then turned his back." On an unspecified date, the patient died due to unknown cause of death. It was unspecified whether an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of died on an unspecified date, and the outcome of brain lesions, lung blood clots and guillain barre syndrome was not reported. This report was serious (Death, and Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20220246190-COVID-19 VACCINE AD26.COV2.S- Died, Lung blood clots, Brain lesions. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable  20220246190-COVID-19 VACCINE AD26.COV2.S-Guillain Barre syndrome. This event(s) is labeled per RA and is therefore considered potentially related.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: F
Vaccine: COVID19
Symptoms: Sleep disorder, Tinnitus
Clinical narrative: It made my tinnitus much louder starting the day after the shot, and it intermittently will shoot up very loud; Sometimes even at nite when I am asleep and it wakes me up; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 25Mar2021 13:00 (Lot number: En6206) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Tinnitus" (unspecified if ongoing); "known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: TINNITUS (non-serious) with onset 26Mar2021 08:00, outcome "not recovered", described as "It made my tinnitus much louder starting the day after the shot, and it intermittently will shoot up very loud"; SLEEP DISORDER (non-serious) with onset 26Mar2021 08:00, outcome "not recovered", described as "Sometimes even at nite when I am asleep and it wakes me up". Therapeutic measures were not taken as a result of tinnitus, sleep disorder.  Additional information: It was reported that patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination patient was not tested for COVID-19. Patient did not provide information regarding the reported adverse events with the use of the product.   Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: I got a rash within the 4 hours mark; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 27Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH (non-serious), outcome "unknown", described as "I got a rash within the 4 hours mark".  Additional information: After first vaccine patient got a rash within the 4 hours mark, but it was not a severe rash so patient just can't find that information on what to do, if it wasn't severe but it still was within 4 hours. Patient did not get second shot because patient was advised back at that point, patient think they didn't have as many common adverse reactions and so patient was advised not to get it, but now patient was trying to get the second one, patient just don't know about that whole 4-hour period.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021218401 similar report from same reporter
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus (ear ringing) increased noticeably after first vaccine. Has remained at an increased level. Severity changes from day to day.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Mar2021 16:00 (Lot number: ER8727) at the age of 38 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: DOXYCYCLINE; VITAMIN D3; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. Past drug history included: Amoxicillin, reaction(s): "Allergy:Amoxicillin", notes: Amoxicillin, ceclor; Ceclor, reaction(s): "Allergy:Ceclor". The following information was reported: TINNITUS (non-serious) with onset 26Mar2021 12:00, outcome "recovering", described as "Tinnitus (ear ringing) increased noticeably after first vaccine. Has remained at an increased level. Severity changes from day to day.". The event "tinnitus (ear ringing) increased noticeably after first vaccine. has remained at an increased level. severity changes from day to day." was evaluated at the physician office visit. Therapeutic measures were taken as a result of tinnitus.  Additional information: The patient was treated with over-the-counter supplements: Vitamin C, E, and Co. The reporter classified the event as non-serious. The patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Apr2021 at 11:00 (Lot number: ER8735) at the age of 38 years as dose 2, single for covid-19 immunisation. 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.   No follow-up attempts are possible. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling hot, Feeling of relaxation, Pain, Vaccination site pain
Clinical narrative: Muscles around injection site became sore and I was relaxed and tired.; Muscles around injection site became sore and I was relaxed and tired.; Muscles around injection site became sore and I was relaxed and tired.; my whole body ached so badly that just sitting there hurt; Muscles around injection site became sore/ arm muscles hurt around where I got the vaccinate; got really warm/extremely tired; got really warm/extremely tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 23 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 02Apr2021 17:15 (Lot number: EW0150) as dose 1, single and administered in arm left, administration date 23Apr2021 16:45 (Lot number: EW0170) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: LOESTRIN; XYZAL; IRON SUPPLEMENT WITH VIT C & HERBS. Past drug history included: Penicillin for Drug allergy, reaction(s): "Drug allergy", notes: Penicillin/Amoxycillin, apple skin, honey dew melon; Amoxycillin for Drug allergy, reaction(s): "Drug allergy". The following information was reported: VACCINATION SITE PAIN (non-serious), FEELING OF RELAXATION (non-serious), FATIGUE (non-serious) all with onset 23Apr2021 20:00, outcome "recovered" and all described as "Muscles around injection site became sore and I was relaxed and tired."; PAIN (non-serious) with onset 23Apr2021 20:00, outcome "recovered", described as "my whole body ached so badly that just sitting there hurt"; VACCINATION SITE PAIN (non-serious) with onset 03Apr2021 10:30, outcome "recovered", described as "Muscles around injection site became sore/ arm muscles hurt around where I got the vaccinate"; FATIGUE (non-serious), FEELING HOT (non-serious) all with onset 03Apr2021 10:30, outcome "recovered" (03Apr2021 11:30) and all described as "got really warm/extremely tired". Therapeutic measures were not taken as a result of vaccination site pain, feeling of relaxation, fatigue. Therapeutic measures were taken as a result of pain.  Additional information: Around 1030am on 03Apr2021 I got really warm (no fever) and extremely tired. It only lasted about an hour. My arm muscles hurt around where I got the vaccinate from approximately 3 days. Muscles around injection site became sore and I was relaxed and tired. Around 5am 04Apr2021 my muscles in my whole body ached so badly that just sitting there hurt. This continued until Tylenol relieved the pain around 4pm the same day. Arm muscle pain continues for about 2 days. The patient not received any other vaccines within 4 weeks prior to the COVID vaccine, Concomitant medication(s) included, multivitamin. 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: Dizziness, Ear discomfort, Intraocular pressure increased
Clinical narrative: dizziness; My ear had a lot of pressure in there and my eyes has pressure; I was still dizzy; checked for vertigo; My ear had a lot of pressure in there and my eyes has pressure; I was still dizzy; checked for vertigo; 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. The reporter is the patient.  A 51 year-old female patient received bnt162b2 (BNT162B2), administration date 2021 (Lot number: EW0170) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), administration date: 01Apr2021, when the patient was 51 years old, for Covid-19 Immunization.  The following information was reported: DIZZINESS (non-serious) with onset 2021, outcome "unknown", described as "dizziness"; INTRAOCULAR PRESSURE INCREASED (non-serious), EAR DISCOMFORT (non-serious) all with onset 2021, outcome "unknown" and all described as "My ear had a lot of pressure in there and my eyes has pressure; I was still dizzy; checked for vertigo". The event "my ear had a lot of pressure in there and my eyes has pressure; i was still dizzy; checked for vertigo" and "my ear had a lot of pressure in there and my eyes has pressure; i was still dizzy; checked for vertigo" was evaluated at the physician office visit. Therapeutic measures were taken as a result of dizziness.  Additional information: The patient took Meclizine at the dose of 25 mg each, the patient took it as needed, twice a day for the event. Consumer stated when she went to after 2 weeks of the vaccine, she went to urgent care because she drove, drove for the first time and got so dizzy and she was near urgent care and went there, had them check her ear because her ear had a lot of pressure in there too and her eyes had pressure and then went to the ENT, ear, nose and throat doctor because she was still dizzy and they checked ear, they checked for vertigo.  No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness, Vertigo
Clinical narrative: vertigo; lightheadedness; disequilibrium; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Apr2021 11:45 (Lot number: EW0170) at the age of 63 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE SODIUM; ESCITALOPRAM; BUPROPION; CETIRIZINE. Past drug history included: Penicillin, reaction(s): "known allergies: penicillin", notes: penicillin. Vaccination history included: Bnt162b2 (product: COVID 19, brand: Pfizer,, lot number: ER8733,, lot unknown: False,, administration date: 02Apr2021,, administration time: 01:00 PM,, dose number: 1,, vaccine location: Left arm), administration date: 02Apr2021, when the patient was 63 years old, for COVID-19 immunisation. The following information was reported: VERTIGO (non-serious) with onset 23Apr2021, outcome "not recovered", described as "vertigo"; DIZZINESS (non-serious) with onset 23Apr2021, outcome "not recovered", described as "lightheadedness"; BALANCE DISORDER (non-serious) with onset 23Apr2021, outcome "not recovered", described as "disequilibrium". Therapeutic measures were not taken as a result of vertigo, dizziness, balance disorder.  No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Atopy, Dizziness, Feeling abnormal, Investigation, Magnetic resonance imaging
Clinical narrative: dizziness; benign vertigo; nose is getting very wet; atopic ( Non alergic ) nose; Viral infections; makes the fluid in the ear push the crystals causing them to move out of place; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05May2021 12:30 (Lot number: EW0182) at the age of 41 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hashimoto's thyroiditis" (ongoing). Concomitant medication(s) included: LEVOTHYROXINE taken for autoimmune thyroiditis (ongoing); B12-VITAMIN taken for autoimmune thyroiditis (ongoing). The following information was reported: DIZZINESS (non-serious) with onset 08May2021 08:00, outcome "not recovered", described as "dizziness"; VERTIGO (non-serious) with onset 08May2021 08:00, outcome "not recovered", described as "benign vertigo"; RHINORRHOEA (non-serious) with onset 08May2021 08:00, outcome "not recovered", described as "nose is getting very wet"; ATOPY (non-serious) with onset 08May2021 08:00, outcome "not recovered", described as "atopic ( Non alergic ) nose"; VIRAL INFECTION (non-serious) with onset 08May2021 08:00, outcome "not recovered", described as "Viral infections"; FEELING ABNORMAL (non-serious) with onset 08May2021 08:00, outcome "unknown", described as "makes the fluid in the ear push the crystals causing them to move out of place". The events "dizziness", "benign vertigo", "nose is getting very wet", "atopic ( non alergic ) nose", "viral infections" and "makes the fluid in the ear push the crystals causing them to move out of place" 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 vertigo.  Additional information: The most recent COVID-19 vaccine was administered in pharmacy or drug store. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, the doctor explained that viral infections cause inflammation which makes the fluid in the ear push the crystals causing them to move out of place, It was explained that the vertigo that caused the crystals in his ear to move was caused by a viral infections. The events were reported as non-serious by patient. The patient had epley movement treatment for vertigo.  No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Rhinorrhoea, Vertigo, Viral infection
Clinical narrative: dizziness; benign vertigo; nose is getting very wet; atopic ( Non alergic ) nose; Viral infections; makes the fluid in the ear push the crystals causing them to move out of place; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05May2021 12:30 (Lot number: EW0182) at the age of 41 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hashimoto's thyroiditis" (ongoing). Concomitant medication(s) included: LEVOTHYROXINE taken for autoimmune thyroiditis (ongoing); B12-VITAMIN taken for autoimmune thyroiditis (ongoing). The following information was reported: DIZZINESS (non-serious) with onset 08May2021 08:00, outcome "not recovered", described as "dizziness"; VERTIGO (non-serious) with onset 08May2021 08:00, outcome "not recovered", described as "benign vertigo"; RHINORRHOEA (non-serious) with onset 08May2021 08:00, outcome "not recovered", described as "nose is getting very wet"; ATOPY (non-serious) with onset 08May2021 08:00, outcome "not recovered", described as "atopic ( Non alergic ) nose"; VIRAL INFECTION (non-serious) with onset 08May2021 08:00, outcome "not recovered", described as "Viral infections"; FEELING ABNORMAL (non-serious) with onset 08May2021 08:00, outcome "unknown", described as "makes the fluid in the ear push the crystals causing them to move out of place". The events "dizziness", "benign vertigo", "nose is getting very wet", "atopic ( non alergic ) nose", "viral infections" and "makes the fluid in the ear push the crystals causing them to move out of place" 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 vertigo.  Additional information: The most recent COVID-19 vaccine was administered in pharmacy or drug store. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, the doctor explained that viral infections cause inflammation which makes the fluid in the ear push the crystals causing them to move out of place, It was explained that the vertigo that caused the crystals in his ear to move was caused by a viral infections. The events were reported as non-serious by patient. The patient had epley movement treatment for vertigo.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Pain in extremity, Poor quality product administered
Clinical narrative: Vaccine administer beyond the 6 hours limit after reconstitution. Patient reported sore arm.; Vaccine administer beyond the 6 hours limit after reconstitution.; Vaccine administer beyond the 6 hours limit after reconstitution.; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  An adult female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 18May2021 14:30 (Lot number: ew0187) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 18May2021 14:30, outcome "recovered" (May2021), described as "Vaccine administer beyond the 6 hours limit after reconstitution. Patient reported sore arm."; POOR QUALITY PRODUCT ADMINISTERED (non-serious), EXPIRED PRODUCT ADMINISTERED (non-serious) all with onset 18May2021 14:30, outcome "unknown" and all described as "Vaccine administer beyond the 6 hours limit after reconstitution.". Therapeutic measures were not taken as a result of pain in extremity, poor quality product administered, expired product administered.  Additional information: The patient had no known allergy (NKA) to food medication or other product . It was unknown if the patient was diagnosed with COVID-19 prior to vaccination. It was unknown the patient had been tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 18May2021 at 14:30 the patient reported sore arm, vaccine was administer beyond the 6 hours limit after reconstitution. No therapeutic measures were taken as a result of the events. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care.   No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoacusis, Tinnitus
Clinical narrative: On the second day of the dose, 13May, I woke with a headache; On the second day of the dose, 13May, I woke with a headache and increased ringing to my ears. I already have tinnitus but this was way louder than usual; I tried to use a fan to mask the noise that night however, I could barely hear the fan.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11May2021 14:15 (Lot number: EW0169) at the age of 54 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Tinnitus" (unspecified if ongoing), notes: I already have tinnitus but this was way louder than usual. The patient took concomitant medications. The following information was reported: HEADACHE (non-serious) with onset 13May2021 07:30, outcome "unknown", described as "On the second day of the dose, 13May, I woke with a headache"; TINNITUS (non-serious) with onset 13May2021 07:30, outcome "unknown", described as "On the second day of the dose, 13May, I woke with a headache and increased ringing to my ears. I already have tinnitus but this was way louder than usual"; HYPOACUSIS (non-serious) with onset 13May2021 07:30, outcome "unknown", described as "I tried to use a fan to mask the noise that night however, I could barely hear the fan.".  Additional information: This is a spontaneous report received from a contactable consumer. This 54-year-old female consumer (patient) reported for herself that: Facility where the most recent COVID-19 vaccine administered was other. the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Vitamins medications the patient received within 2 weeks of vaccination. On the second day of the dose, 13May, patient woke with a headache and increased ringing to my ears. patient already have tinnitus but this was way louder than usual. Patient tried to use a fan to mask the noise that night however, I could barely hear the fan.    Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Biliary colic, Constipation, Diarrhoea, Gastrointestinal pain
Clinical narrative: My severe upper G I/Gall Bladder pain and diahara/constipation issues continue to get worse; My severe upper G I/Gall Bladder pain and diahara/constipation issues continue to get worse; My severe upper G I/Gall Bladder pain and diahara/constipation issues continue to get worse; My severe upper G I/Gall Bladder pain and diahara/constipation issues continue to get worse; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A 74 year-old patient received bnt162b2 (BNT162B2), administration date 15Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GASTROINTESTINAL PAIN (non-serious), BILIARY COLIC (non-serious), DIARRHOEA (non-serious), CONSTIPATION (non-serious), outcome "unknown" and all described as "My severe upper G I/Gall Bladder pain and diahara/constipation issues continue to get worse".  Additional information:  Patient have had severe physical issues which have continually gotten worse since he/his  2nd injection on 15Mar2021 of your COVID-19 vaccination product. Patient under the treatment of her/his primary care and G I (gastrointestinal) specialist physicians since 01Apr2021. Her/his  severe upper gastrointestinal/Gall Bladder pain and diahara/constipation issues continue to get worse no matter what the doctors do and patient in fear for my live. 74 years old, and wheelchair bound but was in excellent physical condition before the 2nd dose.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Urinary incontinence
Clinical narrative: Bladder incontinence; 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 24May2021 10:00 (Lot number: EW0172) at the age of 46 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SERTRALINE; VALACYCLOVIR [VALACICLOVIR]; LORAZEPAM; ZALEPLON. Vaccination history included: Bnt162b2 (Dose 1, Single, Lot number: EW0172), administration date: 30Apr2021, when the patient was 46 years old, for Covid-19 immunization, reaction(s): "improper temperature logs, so I got 2 more doses for a total of 3 doses."; Bnt162b2 (Dose 1, Single, Lot number: EW0172), for Covid-19 immunization, reaction(s): "improper temperature logs, so I got 2 more doses for a total of 3 doses". The following information was reported: URINARY INCONTINENCE (non-serious) with onset 27May2021, outcome "not recovered", described as "Bladder incontinence". The event "bladder incontinence" was evaluated at the physician office visit. Therapeutic measures were taken as a result of urinary incontinence.  Additional information: It was reported that, the patient did not received other vaccines within 4 weeks PRIOR to the COVID-19 vaccine. The patient received Oxybutinyn as a treatment for the adverse event. The patient did not have Relevant past drug history and Known allergies. Prior to vaccination the patient was not diagnosed with COVID. Since the vaccination, the patient has not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Migraine, Vertigo
Clinical narrative: feeling dizzy; Vertigo; slight migraine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 30Apr2021 09:30 (Lot number: ER8735) at the age of 32 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Past drug history included: Amoxicilin, reaction(s): "allergies", notes: known allergies: Amoxicilin. Vaccination history included: Bnt162b2 (product= COVID 19, brand= Pfizer,, lot number= ER8733,, lot unknown= False,, administration time= 09:30 AM,, dose number= 1,, vaccine location= Left arm), administration date: 09Apr2021, when the patient was 32 years old, for COVID-19 Immunization. The following information was reported: VERTIGO (non-serious) with onset 19May2021 05:30, outcome "recovering", described as "Vertigo"; MIGRAINE (non-serious) with onset 19May2021 05:30, outcome "recovering", described as "slight migraine"; DIZZINESS (non-serious) with onset 24May2021, outcome "recovering", described as "feeling dizzy". Therapeutic measures were not taken as a result of vertigo, migraine, dizziness.  Additional information: Prior to vaccination, was 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: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Joint range of motion decreased, Lymphadenopathy, Neck pain
Clinical narrative: lymph nodes swollen; her neck was so sore, she could barely move it, it was so swollen; her neck was so sore, she could barely move it, it was so swollen; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old female patient received bnt162b2 (BNT162B2), administered in deltoid left, administration date 21Apr2021 10:30 (Batch/Lot number: unknown) at the age of 61 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "enlarged thyroid" (unspecified if ongoing), notes: Verbatim: enlarged thyroid. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, Batch/lot number: ER6732), administration date: 30Mar2021, when the patient was 60 years old, for COVID-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 23Apr2021, outcome "unknown", described as "lymph nodes swollen"; NECK PAIN (non-serious), JOINT RANGE OF MOTION DECREASED (non-serious) all with onset 23Apr2021, outcome "unknown" and all described as "her neck was so sore, she could barely move it, it was so swollen".  Additional information: Calling with a question, had the Pfizer vaccine, the second one on 21Apr2021, and her lymph nodes are still swollen, how long does it take to do down. She also has an enlarged thyroid. She did not want to go to the ER, she thought by now they would have went down. She has severe narrowing in her neck in 3 areas, and was going to have surgery, but now her lymph nodes are still swollen. Has been trying to get into her primary care doctor, which why she is calling Pfizer. She did not notice the swelling on the first day after getting the second dose, but did notice the second day, her neck was so sore, she could barely move it, it was so swollen, she did not know if it was there on the first day.    Follow-up attempts completed. No further information expected.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: 5 minutes after receiving my vaccination, I vomited.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 19 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22May2021 09:30 (Batch/Lot number: unknown) at the age of 19 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: AMOXICILLIN; IBUPROFEN; TYLENOL; ESTARYLLA. The following information was reported: VOMITING (non-serious) with onset 22May2021 09:35, outcome "recovered" (22May2021), described as "5 minutes after receiving my vaccination, I vomited.". Therapeutic measures were taken as a result of vomiting.  Additional information: The patient had no known allergies to medications, food or other products. Prior to the 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 vaccination. On 22May2021 at 09:35, 5 minutes after vaccination, the patient vomited. The patient was attended by EMTs (Emergency Medical Team) on site, but did not go the hospital because the patient felt fine. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the event and checked out by EMTs on site.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: General physical health deterioration, Muscular weakness, Speech disorder, Walking aid user
Clinical narrative: ON A WALKER; LOSS OF MUSCLE STRENGTH IN UPPER AND LOWER BODY; SPEECH AFFECTED; DOWNWARD SPIRAL IN HEALTH / GOING DOWN HILL; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the patient experienced speech affected, downward spiral in health / going down hill, and loss of muscle strength in upper and lower body. On an unspecified date, the patient experienced on a walker. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from speech affected, downward spiral in health / going down hill, loss of muscle strength in upper and lower body, and on a walker. This report was non-serious.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose increased, Joint swelling, Peripheral swelling
Clinical narrative: hands and ankles were swollen; hands and ankles were swollen; This spontaneous case was reported by an other health care professional and describes the occurrence of PERIPHERAL SWELLING (hands and ankles were swollen) and JOINT SWELLING (hands and ankles were swollen) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024C21A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Glipizide), Sulfonamide allergy and Diabetes mellitus.   On 04-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jun-2021, the patient experienced PERIPHERAL SWELLING (hands and ankles were swollen) and JOINT SWELLING (hands and ankles were swollen). At the time of the report, PERIPHERAL SWELLING (hands and ankles were swollen) and JOINT SWELLING (hands and ankles were swollen) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Jun-2021, Blood glucose increased: 210 (High) High.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was provided by the reporter.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: they both felt tired and after a day or two that went away; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75 year-old female patient received bnt162b2 (BNT162B2), administration date 25Feb2021 (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), for Covid-19 immunisation. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "they both felt tired and after a day or two that went away". Additional Information: Wife joined the call and stated she received her second dose 25Feb2021 and reported they both felt tired and after a day or two that went away. She stated they knew there were side effects but heard they usually went away within a few days.   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: Tinnitus
Clinical narrative: Constant tinnitus since the second dose /Seems to be worsening. Symptoms are worse in right ear vs left ear /Rining in ears is not stop throughout the day; 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 29Apr2021 10:45 (Lot number: ER8735) at the age of 38 years as dose 2, single for covid-19 immunisation. Family history included: "DM" (unspecified if ongoing); "HTN" (unspecified if ongoing); "HLD" (unspecified if ongoing). Concomitant medication(s) included: MIRENA taken for contraception (ongoing). Vaccination history included: Bnt162b2 (Product: Covid 19, brand: Pfizer, lot Number:  ER8729, Administration Time : 16:30 , vaccination Location: Left arm, Dose: 01, Route of administration: Intramuscular), administration date: 08Apr2021, when the patient was 38 years old, for COVID-19 Immunization. The following information was reported: TINNITUS (non-serious) with onset 29Apr2021 13:00, outcome "not recovered", described as "Constant tinnitus since the second dose /Seems to be worsening. Symptoms are worse in right ear vs left ear /Rining in ears is not stop throughout the day". Therapeutic measures were not taken as a result of tinnitus.  Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination was Multivitamin. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination the patient had not tested for COVID-19. The patient had no known allergies. Other medical History was reported as none. Patient had Mirena for Birth control via IUD (Intra-uterine). Adverse events: Constant tinnitus since the second dose. It started a couple hours after and gas not gone away. Predominantly in the right ear. The left ear does not seem as "loud." No treatment was received. Patient have not made PCP or ENT appointment Yet. Comments/Narrative: Constant tinnitus in ears. Started about 1 hr after second dose of Pfizer COVID-19 vaccine. Ongoing for the past 2 months. Seems to be worsening. Symptoms are worse in right ear vs left ear. Rining in ears is not stop through-out the day.  Follow-up attempts are completed. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Eyelid function disorder, Tinnitus
Clinical narrative: After second dose, worsening pulsatile tinnitus/constant ringing in both ears (like crickets); After second dose, worsening pulsatile tinnitus; left eyelid drooping; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28 year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Lot number: ER8736) at the age of 28 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LEVOTHYROXINE [LEVOTHYROXINE SODIUM]. Vaccination history included: Bnt162b2 (Dose: 1, pulsatile tinnitus in left ear after first dose, lot number:ER8733.), for COVID-19 Immunization, reaction(s): "pulsatile tinnitus in left ear". The following information was reported: TINNITUS (non-serious), outcome "not recovered", described as "After second dose, worsening pulsatile tinnitus/constant ringing in both ears (like crickets)"; TINNITUS (non-serious), outcome "not recovered", described as "After second dose, worsening pulsatile tinnitus"; EYELID FUNCTION DISORDER (non-serious), outcome "not recovered", described as "left eyelid drooping". The events "after second dose, worsening pulsatile tinnitus/constant ringing in both ears (like crickets)", "after second dose, worsening pulsatile tinnitus" and "left eyelid drooping" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of tinnitus, tinnitus, eyelid function disorder.  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 was not tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus (persistent ringing in both ears); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 23 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Jun2021 16:00 (Lot number: EWO191) at the age of 23 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Covid" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (product= COVID 19, brand= Pfizer, lot number= EWO183, lot unknown= False, administration date= 09May2021, administration time= 02:00 pm, dose number= 1, vaccine location= Left arm), administration date: 09May2021, when the patient was 23 years old, for COVID-19 Immunization. The following information was reported: TINNITUS (non-serious) with onset 02Jun2021 08:00, outcome "not recovered", described as "Tinnitus (persistent ringing in both ears)". Therapeutic measures were not taken as a result of tinnitus.  Additional information: There was no Covid prior vaccination and patient was not tested for Covid .  Follow-Up (14Jul2021): Follow-up attempts are completed. No further information is expected.  Follow-Up (28Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: tinnitus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 09May2021 (Batch/Lot number: unknown) at the age of 33 years as dose number unknown, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: TINNITUS (non-serious) with onset 14May2021, outcome "not recovered", described as "tinnitus". Therapeutic measures were not taken as a result of tinnitus.  Additional Information: The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  Follow-up attempts have been completed and no further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymphadenopathy, Nausea, Vaccination site pain
Clinical narrative: Nausea began around 2 pm (about 5 hours after the vaccine) and lasted for several hours (I did not take any medicine to help).; Headache; My left arm started to ache (at the site of the vaccine) in the early evening and was very painful by 10PM (it impacted my sleep), and the discomfort was totally gone in about two days; On Thursday after the vaccine (10Jun, two days later) my lymph nodes under both arms were swollen and very uncomfortable; 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 female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Jun2021 09:00 (Lot number: EW0171) at the age of 25 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NAUSEA (non-serious) with onset 08Jun2021 14:00, outcome "recovered" (2021), described as "Nausea began around 2 pm (about 5 hours after the vaccine) and lasted for several hours (I did not take any medicine to help)."; HEADACHE (non-serious) with onset 08Jun2021 14:00, outcome "recovered" (09Jun2021), described as "Headache"; VACCINATION SITE PAIN (non-serious) with onset 08Jun2021 14:00, outcome "recovered" (10Jun2021), described as "My left arm started to ache (at the site of the vaccine) in the early evening and was very painful by 10PM (it impacted my sleep), and the discomfort was totally gone in about two days"; LYMPHADENOPATHY (non-serious) with onset 08Jun2021 14:00, outcome "recovered" (13Jun2021), described as "On Thursday after the vaccine (10Jun, two days later) my lymph nodes under both arms were swollen and very uncomfortable". Therapeutic measures were not taken as a result of nausea, vaccination site pain, lymphadenopathy. Therapeutic measures were taken as a result of headache. No follow-up attempts are possible. No further information is expected.  Additional information: Headache began a little sooner and lasted about 24 hours (she took Advil OTC, two tablets and it helped a little). Patient did not receive other vaccine in four weeks and other medications in two weeks. No covid prior vaccination, not covid tested post vaccination and no known allergies. She did not call a doctor for this because her friend sent her an article about this being associated with the vaccine, so she did not worry about it. The discomfort was gone by the evening on 13Jun. She did not have any other symptoms.   No follow-up attempts are possible. No further information is expected.  Follow-Up (14Jul2021): Follow-up attempts are completed. No further information is expected.  Follow-Up (28Jul2021): Follow-up attempts are completed. No further information is expected.