chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Limb discomfort, Vaccination site mass, Vaccination site pain
Clinical narrative: Developed a lump a little bit bigger than golf ball size under his left arm in his armpit where he got shot; Uncomfortable and irritable to put his left arm down; Area painful to the touch under his left arm and armpit where he got shot; This is a spontaneous report from a Contactable consumer (reporting himself). This is the second of 2 reports. This 43-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0150), via an unspecified route of administration in left arm on 05Apr2021 as a single dose for COVID-19 immunization. The patients medical history (including any illness at time of vaccination) Provide other relevant medical history including but not limited to these conditions: diagnosed allergies, genetic/ chromosomal abnormalities, endocrine abnormalities (including diabetes) and obesity which included asthma. The patients family medical history was none. The patient had no AEs following prior vaccination. On 05Apr2021, the patient experienced pain at the injection site of left arm and on 06Apr2021, the patient had onset of uncomfortableness under his left arm and armpit, area painful to the touch under his left arm and armpit and it was uncomfortable and irritable to put his left arm down. When the patient woke up on 07Apr2021, that the patient noticed the patient had developed a lump a little bit bigger than golf ball size under his left arm in his armpit which is painful to the touch. The patient thought it may have started to develop that lump on 06Apr2021 but did not notice the lump until morning of 07Apr2021. The patient was wondering what he should do. The patient needs to know if this was serious and the triage nurse couldn't tell him and his doctor hasn't called him back. Event was unusual because the patient has never had a bump like that lump he has at this time-caller stated bump as a descriptor of lump. The agent caller spoke to earlier advised patient that if the patient was uncomfortable or in pain to go to doctors office so patient called primary care provider who said to go in to have it checked. Caller reported the agent tells you about the symptoms and agent said that he had seen swelling of lymph nodes was one of the symptoms in his clinical trials information for the Pfizer-BioNTech COVID-19 Vaccine; and in those reports the swelling of lymph nodes usually goes away in about 10 days. Outcome of that event unable to be clarified as if recovered completely or with lasting effects-when queried caller reported that he did not notice any problems after that, did not have the pain at the injection site of left arm after that day or two.  No Follow-up attempts are needed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoacusis, Pyrexia, Tinnitus
Clinical narrative: Severe tinnitus in both ears for at least a week, maybe more; Some difficulty hearing in normal/quiet circumstances; fever and felt like I could not get out of bed for about 8 hours the day following my vaccine; This is a spontaneous report received from a contactable other healthcare professional. This reporter reported information for both mother and fetus/baby. This is the mother report. A 30-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 22Mar2021 10:00 (Batch/Lot Number: ER8727) as single dose for covid-19 immunisation. Patient received the first dose on 01Mar2021 10:00 with lot number EN6202. Medical history included penicillin allergies. The patient's concomitant medications were not reported. The patient experienced Severe tinnitus in both ears for at least a week, maybe more. Some difficulty hearing in normal/quiet circumstances. Took me a while to identify the pattern and determine/test that it wasn't from listening to headphones or sound issues using my phone or laptop. Patient had a fever and felt like could not get out of bed for about 8 hours the day following vaccine from 26Mar2021 12:00. Outcome of events was not recovered.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) :  same reporter/drug, different patient/event(baby case)
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: was extremely sick; This is a spontaneous report from a Pfizer sponsored program via a contactable consumer (patient).  A male patient of an unspecified age received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Medical history included cancer, congestive heart failure, chemo therapy. The patient's concomitant medications were not reported. The patient previously received the first dose of the same vaccine on an unspecified date for covid-19 immunization. The patient experienced extremely sick on an unspecified date and was unable to function for about a month- only the last few days have been able to function- sickest has ever been worse than chemo therapy-sickness was overwhelming. The outcome of the event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Pruritus, Vomiting
Clinical narrative: throwing up; Itchy; Dizzy; This is the spontaneous report received from a contactable consumer (patient' wife). A male patient of an unspecified age received BNT162B2, dose 1 via an unspecified route of administration on 28Mar2021 11:00 AM (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included cancer. The patient had cancer and his chemo was done three weeks ago, it was his third chemo. The patient's concomitant medications were not reported. The reporter was calling about the covid vaccine. The reporter received the first dose of the vaccine a week ago with her husband, same place and same time. Her husband had been throwing up all day yesterday but then he was feeling good today. The patient had cancer and his chemo was done three weeks ago, it was his third chemo. At first the caller thought the patient was throwing up because of the chemo. The patient had also been itchy and dizzy. The event onset date was not reported. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected. Information about batch number cannot be obtained.
Age: 0.5
Sex: U
Vaccine: COVID19
Symptoms: Exposure via breast milk, Fever neonatal, Illness, Rash
Clinical narrative: my 6 month old, whom I am breastfeeding, became sick with a moderate fever for 3 days and then a rash about a week about 10 days later; my 6 month old, whom I am breastfeeding, became sick with a moderate fever for 3 days and then a rash about a week about 10 days later; my 6 month old, whom I am breastfeeding, became sick with a moderate fever for 3 days and then a rash about a week about 10 days later; my 6 month old, whom I am breastfeeding, became sick with a moderate fever for 3 days and then a rash about a week about 10 days later; This is a spontaneous report received from a contactable other healthcare professional. This reporter reported information for both mother and fetus/baby. This is the baby report. Only this case is serious. A 6-months-old patient of an unspecified gender received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via other routed of administration on 22Mar2021 10:00 (Batch/Lot Number: ER8727) as single dose for covid-19 immunisation. Patient received the first dose on 01Mar2021 10:00 with lot number EN6202. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient's mother reported that separately, her 6 month old, whom she was breastfeeding, became sick with a moderate fever for 3 days and then a rash about a week about 10 days later. Outcome of events was unknown.   No follow-up attempts are needed. No further information is expected; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-2021387880 same reporter/drug, different patient/event(mother case)
Sex: U
Vaccine: COVID19
Symptoms: Axillary pain, Discomfort, Lymphadenopathy, Pain in extremity
Clinical narrative: Uncomfortable; Pain in my left armpit; Puffy and kind of painful; Pain in my left armpit; Puffy and kind of painful; Sore arm; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 01Apr2021 (2 clock, unknown if AM or PM) (lot number: unknown) at single dose for COVID-19 immunisation. Medical history included Covid diagnosed on 31Dec2020. The patient's concomitant medications were not reported. The patient experienced sore arm on an unspecified date in Apr2021, uncomfortable on 03Apr2021, pain in left armpit / puffy and kind of painful on 03Apr2021. Clinical course as reported: I got my first shot on Thursday at 2 clock and the only reaction that I had up until now is just a sore arm. I was actually diagnosed with Covid on 31Dec2020, so three months ago. I woke up this morning with a pain in my left armpit. I was uncomfortable and then I went to the bathroom and I looked at, it is in the armpit like where the armpit hair is. It is puffy and kind of painful. Any idea what that is? The outcome of the events was unknown. The reporter considered the report was non-serious.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Malaise
Clinical narrative: Felt sick/so sick she had to be assisted; lethargic; This is a spontaneous report from a contactable consumer (Patient) via Medical Information Team. A female patient of an unspecified age (mid 50s-70s) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, patient experienced felt sick/so sick she had to be assisted, lethargic. It was reported that the patient was shopping at the time of event. Patient experienced side effects earlier, but she had a severe episode while she was out. The patient went to her doctor and was advised to wait until 2 weeks for the symptoms to go away. The outcome of the events was unknown.  No Follow-up attempts are needed. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Headache, Hemiparesis, Limb discomfort, Malaise
Clinical narrative: Headache like my head was going to explode/severe headache like migraine/Pain level 10/10; headache like migraine/chronic migraine; symptoms of a stroke; weakness on my right side from tongue to nose; weakness on my right side from tongue to nose; extreme nausea; general malaise; My shot arm feel like felt like I had been hit for several days; This is a spontaneous report from a contactable consumer (the patient). A 74-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN5318) via an unspecified route of administration on 09Feb2021 at age of 74-year-old at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3302) on 19Jan2021 at age of 74-year-old for COVID-19 Immunization, the patient had no soreness or reaction until 10days later on 29Jan2021 when she had a low fever ~0.5-1 degree with chills and aches like a fever for 3 days, the patient experienced aches and pain; hurting all over on 29Jan2021, the patient took no medications, there were no further reaction. The second shot given on 09Feb2021, the patient's shot arm felt like she had been hit for several days beginning 10Feb2021. On 11Feb2021, the patient got a severe headache like migraine. Pain level 10/10. She had chronic migraine with all symptoms of a stroke (extreme nausea and weakness on her right side from tongue to nose, extreme headache about left side of the head). The headache on 11Feb2021 was overlap headache. On both sides of head and nausea. No other migraine symptoms. It lasted for 3 days. The patient was hospitalized due to the event(s) headache like my head was going to explode/severe headache like migraine/ chronic migraine. The patient took only butalbital, caffeine, paracetamol (FIORICET, 50, 325-40) from 11Feb2021 to 12Feb2021 at 40mg caff for several headache like migraine; promethazine (PHENERGAN) from 11Feb2021 to 12Feb2021 at 25mg for several nausea. The patient had several events general malaise where she didnot feel like doing her thing until today 30Mar2021. She had taken no medications or seen a doctor about it. The outcome of "headache like my head was going to explode/severe headache like migraine/pain level 10/10", "headache like migraine/chronic migraine" was recovered in 2021. The outcome of other events was unknown.; Sender's Comments: Linked Report(s) : PFIZER INC-2021145090 same patient, same drug, different event, different dose separated in times
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Nausea, Tongue movement disturbance
Clinical narrative: Headache like my head was going to explode/severe headache like migraine/Pain level 10/10; headache like migraine/chronic migraine; symptoms of a stroke; weakness on my right side from tongue to nose; weakness on my right side from tongue to nose; extreme nausea; general malaise; My shot arm feel like felt like I had been hit for several days; This is a spontaneous report from a contactable consumer (the patient). A 74-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN5318) via an unspecified route of administration on 09Feb2021 at age of 74-year-old at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3302) on 19Jan2021 at age of 74-year-old for COVID-19 Immunization, the patient had no soreness or reaction until 10days later on 29Jan2021 when she had a low fever ~0.5-1 degree with chills and aches like a fever for 3 days, the patient experienced aches and pain; hurting all over on 29Jan2021, the patient took no medications, there were no further reaction. The second shot given on 09Feb2021, the patient's shot arm felt like she had been hit for several days beginning 10Feb2021. On 11Feb2021, the patient got a severe headache like migraine. Pain level 10/10. She had chronic migraine with all symptoms of a stroke (extreme nausea and weakness on her right side from tongue to nose, extreme headache about left side of the head). The headache on 11Feb2021 was overlap headache. On both sides of head and nausea. No other migraine symptoms. It lasted for 3 days. The patient was hospitalized due to the event(s) headache like my head was going to explode/severe headache like migraine/ chronic migraine. The patient took only butalbital, caffeine, paracetamol (FIORICET, 50, 325-40) from 11Feb2021 to 12Feb2021 at 40mg caff for several headache like migraine; promethazine (PHENERGAN) from 11Feb2021 to 12Feb2021 at 25mg for several nausea. The patient had several events general malaise where she didnot feel like doing her thing until today 30Mar2021. She had taken no medications or seen a doctor about it. The outcome of "headache like my head was going to explode/severe headache like migraine/pain level 10/10", "headache like migraine/chronic migraine" was recovered in 2021. The outcome of other events was unknown.; Sender's Comments: Linked Report(s) : PFIZER INC-2021145090 same patient, same drug, different event, different dose separated in times
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Colonoscopy, Large intestine polyp
Clinical narrative: Polyps/COLONOSCOPY: Several Polyps; This is a spontaneous report from a non-contactable consumer (patient), based on information received by Pfizer from Abbvie (manufacturer control number: 21K-163-3835479-00). A 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 intramuscular on 04Mar2021 (Batch/Lot Number: EN6204) as single dose for COVID-19 vaccination; adalimumab (HUMIRA, Solution for injection in pre-filled syringe, strength 40 mg), subcutaneous from 2020 (Batch/Lot number was not reported) and ongoing, at 40 mg (1 in 2 wk) for ulcerative colitis. The patient's medical history included alcohol use from an unknown date and unknown if ongoing (started to drink on her late twenty's; a glass of wine four times a week), former tobacco use from an unknown date to 2014 (started smoking in her early twenty's; a pack of cigarette for two days or more which stopped in 2014), "high blood pressure" from an unknown date and unknown if ongoing, "bipolar" from an unknown date and unknown if ongoing, "Sleeping" from an unknown date and unknown if ongoing, anxiety from an unknown date and unknown if ongoing, and "haemorrhage of colon" from Feb2021 to Feb2021 (The patient stated that she had a colon bleeding for two weeks and stated that she did not take any medications for it and it just so happened that she's already scheduled for Routine Colonoscopy. The patient stated that she did not miss or stop HUMIRA and just took it three days later after the Colonoscopy as per her doctors instruction). No known allergies. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. Concomitant medications included hydrochlorothiazide, valsartan (DIOVAN HCT) taken for "high blood pressure"; lamotrigine (LAMICTAL) taken for "bipolar"; ziprasidone taken for "bipolar"; trazodone taken for "Sleeping"; clonazepam (KLONOPIN) taken for anxiety; vitamins nos (MULTIVITAMIN) taken for supplement; potassium taken for supplement; vitamin e nos (VITAMIN E) taken for an unspecified indication; all start and stop dates were not reported. In Mar2021, the patient experienced "polyps/colonoscopy: several polyps". The patient underwent lab tests and procedures which included colonoscopy on 17Mar2021: several polyps, 6 polyps removed, humira helped her Colon. The action taken in response to the event for suspect drug adalimumab was dose not changed. Therapeutic measures were taken as a result of "polyps/colonoscopy: several polyps". The outcome of the event was recovered in Mar2021. Causality assessment by reporter for bnt162b2 and adalimumab with event "polyps/colonoscopy: several polyps" was "not related". Other company Abbvie assessed this report as other medically important condition.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: The reported event colonic polyp was most likely an concurrent condition and unlikely causally related to the vaccine of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE).
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Body temperature, Breast swelling, Chest pain, Headache
Clinical narrative: fever 104 Fahrenheit; Severe swelling of right armpit lymph node accompanied by severe pain; Severe swelling of right armpit lymph node accompanied by severe pain; Severe swelling in right breast; Severe headache; Pain in chest when breathing; Pain in chest when breathing; This is a spontaneous report received from a contactable consumer (reported for herself). A 30-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 07Apr2021 12:00 (Lot Number: EW0162) (Age at vaccination: 30 Years) as single dose for covid-19 immunisation. Medical history included Intracranial hypertension, sulfonamide allergy. The patient's concomitant medications were not reported. The patient previous received the first dose of bnt162b2 (lot number: EN6204) in Arm right on 17Mar2021 10:00 (Age at vaccination: 30 Years) for covid-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was Hospital.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No any other medications the patient received within 2 weeks of vaccination. On 08Apr2021 03:00, the patient experienced Severe swelling of right armpit lymph node accompanied by severe pain, Severe swelling in right breast, Severe headache and fever 104 Fahrenheit, Pain in chest when breathing. No treatment received for the adverse events. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The outcome of the events was not recovered.   No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Painful respiration, Pyrexia
Clinical narrative: fever 104 Fahrenheit; Severe swelling of right armpit lymph node accompanied by severe pain; Severe swelling of right armpit lymph node accompanied by severe pain; Severe swelling in right breast; Severe headache; Pain in chest when breathing; Pain in chest when breathing; This is a spontaneous report received from a contactable consumer (reported for herself). A 30-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 07Apr2021 12:00 (Lot Number: EW0162) (Age at vaccination: 30 Years) as single dose for covid-19 immunisation. Medical history included Intracranial hypertension, sulfonamide allergy. The patient's concomitant medications were not reported. The patient previous received the first dose of bnt162b2 (lot number: EN6204) in Arm right on 17Mar2021 10:00 (Age at vaccination: 30 Years) for covid-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was Hospital.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No any other medications the patient received within 2 weeks of vaccination. On 08Apr2021 03:00, the patient experienced Severe swelling of right armpit lymph node accompanied by severe pain, Severe swelling in right breast, Severe headache and fever 104 Fahrenheit, Pain in chest when breathing. No treatment received for the adverse events. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient hadn't been tested for COVID-19. The outcome of the events was not recovered.   No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Deafness unilateral, Sleep disorder, Tinnitus
Clinical narrative: Sound or noise in my right ear. At times can?t hear nor sleep properly.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Pain
Clinical narrative: Extremely severe arm pain at site of injection first and second day after second vaccine. Couldn?t lift arm more than an inch without severe pain. Three weeks later I?m still experiencing muscle soreness at site of injection. It is currently moderate pain
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Rash erythematous
Clinical narrative: Extreme fatigue Red rash on arm on 4/24/21
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Oedema, Pain in extremity, Skin warm
Clinical narrative: Red area on arm about the size of tennis ball, slight edema, and hot to the touch. Increased in area by evening. Applied topical diphenhydramine and hydrocortisone 1% OTC creams and took Tylenol. Persists as of Apr 25. Is painful to the touch.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Moaning, Unresponsive to stimuli
Clinical narrative: Patient woke the morning after vaccine with a headache and then had an episode where she was unresponsive, while her eyes were open she was humming and moaning and husband shaking her no response, episode lasted about 1-1,5 min , patient was tired after episode and went to sleep and did recall what had happened. everything was back to normal at visit 4/6/2021
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Injection site rash
Clinical narrative: Rash at the site of injection  Shingles left chest wall
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, COVID-19, Exposure during pregnancy, Hypoaesthesia, Pain in extremity
Clinical narrative: bells palsy; Pregnant at the time of vaccination?: Yes; I had a sore arm for about 12 hours but I also got numbness on the left side of my face; I had a sore arm for about 12 hours but I also got numbness on the left side of my face; slight tingling on left ear; This is a spontaneous report from a non-contactable consumer, the patient.  This is a maternal report.  A 33-years-old pregnant female patient received the second dose of  bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE),  via an unspecified route of administration, administered in Arm Left on 05Apr2021 (at the age of 33 years old) (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. The patient medical history and  concomitant medications were not reported. Facility where the most recent COVID-19 vaccine was administered was reported as Other. Historical Vaccine includes  BNT162B2 on 15Mar2021 Dose 1. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19.  On 05Apr2021 The patient experienced bells palsy,  pregnant at the time of vaccination,  had a sore arm for about 12 hours but I also got numbness on the left side of my face, slight tingling on left ear. The patient  reported she became pregnant while taking bnt162b2.  The patient is due to deliver on 14May2021.  The patient underwent lab tests and procedures which included covid-19: negative on an unspecified date. The clinical course was reported as follows got my second shot and honestly have felt great since. Did have one weird symptom. Patient  had a sore arm for about 12 hours but I also got numbness on the left side of my face. All of that disappeared overnight and reported she is doing just fine. Patient is going to talk to her  doctor about it today to make sure it is not  like Bells palsy or something. It  went away overnight. Maybe a slight tingling on left ear still but its same side I got my shot.  No Treatment was given for the events. The clinical outcome of the events Bell's palsy, Pain in arm, Numbness in face, Tingling sensation was recovering while exposure during Exposure during pregnancy was unknown.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: bells palsy; Pregnant at the time of vaccination?: Yes; I had a sore arm for about 12 hours but I also got numbness on the left side of my face; I had a sore arm for about 12 hours but I also got numbness on the left side of my face; slight tingling on left ear; This is a spontaneous report from a non-contactable consumer, the patient.  This is a maternal report.  A 33-years-old pregnant female patient received the second dose of  bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE),  via an unspecified route of administration, administered in Arm Left on 05Apr2021 (at the age of 33 years old) (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunization. The patient medical history and  concomitant medications were not reported. Facility where the most recent COVID-19 vaccine was administered was reported as Other. Historical Vaccine includes  BNT162B2 on 15Mar2021 Dose 1. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19.  On 05Apr2021 The patient experienced bells palsy,  pregnant at the time of vaccination,  had a sore arm for about 12 hours but I also got numbness on the left side of my face, slight tingling on left ear. The patient  reported she became pregnant while taking bnt162b2.  The patient is due to deliver on 14May2021.  The patient underwent lab tests and procedures which included covid-19: negative on an unspecified date. The clinical course was reported as follows got my second shot and honestly have felt great since. Did have one weird symptom. Patient  had a sore arm for about 12 hours but I also got numbness on the left side of my face. All of that disappeared overnight and reported she is doing just fine. Patient is going to talk to her  doctor about it today to make sure it is not  like Bells palsy or something. It  went away overnight. Maybe a slight tingling on left ear still but its same side I got my shot.  No Treatment was given for the events. The clinical outcome of the events Bell's palsy, Pain in arm, Numbness in face, Tingling sensation was recovering while exposure during Exposure during pregnancy was unknown.   No follow-up attempts are needed. No further information is expected.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Nausea, Palpitations
Clinical narrative: first racing heart, chills, aching muscles, headaches, nausea, vomiting, feaver
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: first racing heart, chills, aching muscles, headaches, nausea, vomiting, feaver
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vertigo
Clinical narrative: Extreme dizziness and vertigo 3rd day after vaccine.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Breast tenderness, Dysmenorrhoea, Heavy menstrual bleeding, Menstruation irregular
Clinical narrative: I am post menopausal and my last period before this was February of 2017. Exactly 7 days after the second shot I started experiencing PMS symptoms (breast tenderness), then 7 days after that my period started. This is the first period I've had in four years and it is heavy, with cramps lasting longer than what used to be normal for me.
Age: 33.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Vertigo
Clinical narrative: Moderate dizziness/vertigo that comes and goes throughout the day.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Injection site pain, Insomnia, Malaise, Pyrexia
Clinical narrative: Fever 100, injection site moderate pain, chills, moderate malaise, inability to sleep through night
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: sore arm; Had very sore arm at vaccination ate; This is a spontaneous report from a contactable nurse (patient). The 65-years-old female patient received bnt162b2 (BNT162B2), dose 2 intramuscular, administered in Deltoid Left on 03Mar2021 09:30 (Batch/Lot Number: EN6203) as SINGLE DOSE for covid-19 immunisation. Medical history Illness/AE: Covid-19  from 28Nov2020 to 10Jan2021, Patient details: sever headaches for 1 month- post covid fatigue syndrome this Jan. Medical Tx for Hypertension from several years ago and ongoing, control with Benicar 40 mg 1.0 daily it is. Partial retinal detach and tear from 2015. cataract/lens or surg, hysterectomy with BSO from 2013 around age 49. Family medical history relevant to AE included Mother- malignant melanoma-died age 42; Father- Lymphoma/prostate CA/ hypertension-died age 79; Son-asthma; Brother1- tx for hypertension; Brother2-tx for hypertension; Brother 3-skin cancer and melanoma removal of face -resolve. Concomitant medication(s) included ongoing olmesartan (Benicar) for BP control. The patient previously received first dose of bnt162b2 intramuscular in left deltoid on 10Feb2021 09:15 AM (Lot: EN6201) at single dose for Covid-19 immunization and experienced headache (Had Splitting headache a count 10-12 hrs after 1st dose vaccination-gone by next AM). The patient experienced sore arm (sore arm at ate) on 03Mar2021 21:00. Reported as: Had very sore arm at vaccination ate 2nd shot-gone by next AM. The event was assessed as non-serious. The event did not require the initiation of new medication/ other treatment/Procedure. The outcome of the event was recovered. The reporter consider the Pfizer product a causal effect to the adverse event.  No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Have a few rashes on body that are very itchy.  No treatment. Have not gone to doctor.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hyperhidrosis, Myalgia, Pain of skin
Clinical narrative: 8 days of extreme sweating, muscle ache, my skin hurts, extreme tiredness
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Facial pain, Fatigue, Insomnia, Migraine
Clinical narrative: Sore Arm day after getting Vaccinated: Lasted a few days and faded away until there was no pain. Felt very Fatigued the day after getting the Vaccination: Lasted several days. But, got better with time.  Adverse event I wished to report: Seems this Vaccine might have, temporarily, hindered the effectiveness of a medication I take.  I'm on Amytriptyline 25mg, 2 a day at one time, for Postherpetic neuralgia on the right side of my face & right ear. This Amytriptyline medication has helped to cease all pain, including migraines, that I get from the Postherpetic neuralgia, and has also helped with the pain of pinched nerves in my back. Due to that, this medication has really helped improve my quality of life.  After getting the Vaccine, I went home and felt fine the first night. When waking up the next day, I found myself experiencing pain on the right side of my face and in my right ear. Thought this was odd as I took my medication the night before. But, as the day went on, it got a bit worse. That night i had trouble sleeping due to it. Then, the next day, I awoke with not only the pain at a level that it was before having treatment for it, but it also caused light sensitivity, migraines, and I could feel the right upper part of my jaw hurting as if teeth were aching that have been pulled years ago. I was also having vertigo when the ear pain got too bad.  This went on for several days and then faded away around the 20th of April 2021. Although I was confused as to why the Amytriptyline didn't seem to work as well on those days, I figured that it must be something to do with the vaccine effecting my nerves, or interacting with this medication. I did not seek medical advice for this reaction, as it went away. But just wanted to report it using this form. Thankyou.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pain in jaw, Photophobia, Vertigo
Clinical narrative: Sore Arm day after getting Vaccinated: Lasted a few days and faded away until there was no pain. Felt very Fatigued the day after getting the Vaccination: Lasted several days. But, got better with time.  Adverse event I wished to report: Seems this Vaccine might have, temporarily, hindered the effectiveness of a medication I take.  I'm on Amytriptyline 25mg, 2 a day at one time, for Postherpetic neuralgia on the right side of my face & right ear. This Amytriptyline medication has helped to cease all pain, including migraines, that I get from the Postherpetic neuralgia, and has also helped with the pain of pinched nerves in my back. Due to that, this medication has really helped improve my quality of life.  After getting the Vaccine, I went home and felt fine the first night. When waking up the next day, I found myself experiencing pain on the right side of my face and in my right ear. Thought this was odd as I took my medication the night before. But, as the day went on, it got a bit worse. That night i had trouble sleeping due to it. Then, the next day, I awoke with not only the pain at a level that it was before having treatment for it, but it also caused light sensitivity, migraines, and I could feel the right upper part of my jaw hurting as if teeth were aching that have been pulled years ago. I was also having vertigo when the ear pain got too bad.  This went on for several days and then faded away around the 20th of April 2021. Although I was confused as to why the Amytriptyline didn't seem to work as well on those days, I figured that it must be something to do with the vaccine effecting my nerves, or interacting with this medication. I did not seek medical advice for this reaction, as it went away. But just wanted to report it using this form. Thankyou.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: after one or two days after I received my first dose of vaccine, i start to feel the numbness on my left arm. Even after I tried to move my arm around, the numbness still wouldn't go away. So far, this symptom has lasted about a week or so.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Biliary dilatation, Gamma-glutamyltransferase increased, Hepatic enzyme increased
Clinical narrative: Elevated liver enzymes and dilation of common bile duct found on biopsy to be acute liver rejection in the setting of multiple prior acute liver rejections post transplant
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Liver transplant rejection, Ultrasound Doppler abnormal
Clinical narrative: Elevated liver enzymes and dilation of common bile duct found on biopsy to be acute liver rejection in the setting of multiple prior acute liver rejections post transplant
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle twitching, Muscular weakness, Pain in extremity, Pain of skin, Paraesthesia
Clinical narrative: Within a few hours, "tingling" throughout body and adrenaline rushes. Within 36 hours, tingling feels more like prickling sensations on arms and legs. Day 3, arms and legs felt sunburned and continued feeling tingly and prickly. These sensations continue, and on day 6, legs and arms/hands feel twitchy and tremble. By day 14, tingling in less, but still constant in feet/lower legs when sitting/laying down. Arms and legs randomly feel weak and achey.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram normal, Brain operation, Cerebellar haemorrhage, Cerebrovascular accident, Computerised tomogram
Clinical narrative: Stroke - Cerebellar hemorrhage. Had to have brain surgery to relieve the pressure and a drain placed. She has a history of low blood pressure, never high. They did an angiogram that came back normal and an MRI as well. They have been unable to find a cause of the stroke at this time. She was in ICU for four days then Neuro PCU for about 4 days and now she is in inpatient rehab. She is currently learning to walk and has weakness on her whole left side. Vision issues. And motor control issues of the left arm.   The stroke came on very sudden and she felt fine before her sudden ?worst migraine ever?. Luckily my brother was with her and took her to get help straight away before she became unconscious.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Full blood count, Gait disturbance, Hemiparesis, Intensive care, Laboratory test
Clinical narrative: Stroke - Cerebellar hemorrhage. Had to have brain surgery to relieve the pressure and a drain placed. She has a history of low blood pressure, never high. They did an angiogram that came back normal and an MRI as well. They have been unable to find a cause of the stroke at this time. She was in ICU for four days then Neuro PCU for about 4 days and now she is in inpatient rehab. She is currently learning to walk and has weakness on her whole left side. Vision issues. And motor control issues of the left arm.   The stroke came on very sudden and she felt fine before her sudden ?worst migraine ever?. Luckily my brother was with her and took her to get help straight away before she became unconscious.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Magnetic resonance imaging normal, Migraine, Motor dysfunction, Visual impairment
Clinical narrative: Stroke - Cerebellar hemorrhage. Had to have brain surgery to relieve the pressure and a drain placed. She has a history of low blood pressure, never high. They did an angiogram that came back normal and an MRI as well. They have been unable to find a cause of the stroke at this time. She was in ICU for four days then Neuro PCU for about 4 days and now she is in inpatient rehab. She is currently learning to walk and has weakness on her whole left side. Vision issues. And motor control issues of the left arm.   The stroke came on very sudden and she felt fine before her sudden ?worst migraine ever?. Luckily my brother was with her and took her to get help straight away before she became unconscious.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Felt a lump in left shoulder at injection site exactly 7 days after first injection. Approximately a 2x3 inch c it circular area was red and slightly itchy and mildly sore to the touch.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Headache, Pain, Pyrexia
Clinical narrative: I had a slight head ache after the 30 minute waiting period that I had. Then On Thursday in the middle of the night, I started with the fever. It started with 99.5 and went up to 102.7 and went down to 100; all day. Also, bodyache from Thursday until Friday. By Friday morning, fever went down to normal.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Blood glucose decreased, Blood potassium decreased, Blood test, Chest discomfort
Clinical narrative: Had extreme joint pain. Chest heaviness and chest pain. Potassium and sugar bottomed out to critical levels.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: Had extreme joint pain. Chest heaviness and chest pain. Potassium and sugar bottomed out to critical levels.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Chills, Cough, Dehydration
Clinical narrative: I got sick shortly after the shot with on and off fever chills severe pain in legs and arms.. Severe back pain head ache cough soar throat dehydrated weak tired on the sat following the 8th i coughed up blood. My arm that i got the shot in still has pain and so does my back, i also still have a lingering cough every morning
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Haemoptysis, Headache, Oropharyngeal pain, Pain in extremity
Clinical narrative: I got sick shortly after the shot with on and off fever chills severe pain in legs and arms.. Severe back pain head ache cough soar throat dehydrated weak tired on the sat following the 8th i coughed up blood. My arm that i got the shot in still has pain and so does my back, i also still have a lingering cough every morning
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test negative
Clinical narrative: I got sick shortly after the shot with on and off fever chills severe pain in legs and arms.. Severe back pain head ache cough soar throat dehydrated weak tired on the sat following the 8th i coughed up blood. My arm that i got the shot in still has pain and so does my back, i also still have a lingering cough every morning
Age: 59.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Biopsy, Colonoscopy, Intestinal stenosis, Laparoscopy, Myalgia
Clinical narrative: Seven strictures resulting in a loss of 12 to 18 inches of small intestine; Sore leg muscle; This is a non-interventional study report from the marketing program received from a non-contactable 59-year-old female consumer (patient) based on information received by Pfizer that: A 59-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6205 and Expiration date was not reported), via intramuscular on 09Mar2021 as SINGLE DOSE for covid-19 immunization; adalimumab (HUMIRA), subcutaneous from 2019 (Batch/Lot Number: 1136916) to 17Feb2021, at 40 mg, citrate free (40 mg,1 in 1 wk) for moderate to severe adult Crohn's disease. Medical history included depression, hypertension, appendicectomy from 2010 to an unknown date, Nonsmoker and abstains from alcohol. Concomitant medications included celecoxib (CELEXA) taken for depression; pindolol (PINDOLOL) taken for hypertension. In Nov2020, the patient experienced seven strictures resulting in a loss of 12 to 18 inches of small intestine. On 09Mar2021, the patient experienced sore leg muscle. Seriousness of the event seven strictures resulting in a loss of 12 to 18 inches of small intestine was reported as hospitalized and medically significant. The patient underwent lab tests and procedures which included biopsy: no significant findings on 05Feb2021, colonoscopy: stricture on Nov2020, laparoscopy: seven strictures on 05Feb2021. Adalimumab was permanently withdrawn on 17Feb2021.On 05Feb2021, the Seven strictures resulting in a loss of 12 to 18 inches of small intestine resolved. On 10Mar2021, the Sore leg muscle resolved. Causality for HUMIRA 40MG/0.4ML (ADALIMUMAB): The reporter causality for the event(s) of Seven strictures resulting in a loss of 12 to 18 inches of small intestine and Sore leg muscle with HUMIRA 40MG/0.4ML(ADALIMUMAB) was no reasonable possibility. Company opinion is that there is no reasonable possibility that the events of Seven strictures resulting in a loss of 12 to 18 inches of small intestine and Sore leg muscle are related to HUMIRA 40MG/0.4ML(ADALIMUMAB).  No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pruritus, Nasal pruritus, Rhinorrhoea, Sleep disorder, Sneezing
Clinical narrative: I sneezed thousands of times during the day. I have a really itchy and runny nose. I couldn't sleep at night because my nose is super itchy. I might also have itchy eyes. I never had any allergy in my life before having this vaccine.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Abnormal sleep-related event, Injection site pain
Clinical narrative: This is not a harmful AE. However, I wanted to report it for data purposes. I was diagnosed with Non-refreshing, Non-restorative Sleep Disorder about 8 months ago. I typically do not go into deep sleep and rarely ever dream that I am aware of. (I dream approximately 4-6 times a year.) After both doses, I noticed that I went into an incredibly deep, refreshing sleep! After the second dose, that was given on 15Apr2021 at 4pm, I fell  asleep at 7pm for a nap - and dreamed! I dreamed again that night and have dreamed each night since the vaccine for the past 9 days. Again, this is not a harmful AE, but I think there could be correlation between sleep/dreaming and the vaccine that could be further researched. Additionally, I had minor injection-site pain approximately beginning at 6:30am on 16Apr2021 (about 14.5 hours after receiving the shot).
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Burning sensation, Pruritus, Rash
Clinical narrative: Rash on body. Burning and itching. Abdominal pain.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Autoscopy, Hallucinations, mixed
Clinical narrative: One day after receiving my second dose of this vaccine, I began to hear voices.  They were indistinct but persistent and very frightening. This continued until day 3.  On day 3, the voices calmed and I began to have "out-of body" feelings.  I slept as much as possible. On day 4, I woke up without any mental confusion, no voices, no out of body feeling.  Those reactions have completely gone.