chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lymphadenopathy, Malaise, Pain in extremity
Clinical narrative: Caller states that she was feeling unwell; Discovered swollen lymph nodes; She also states that she had tiredness and a sore arm.; She also states that she had tiredness and a sore arm.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 74 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Mar2021 12:00 (Lot number: EN6199) at the age of 74 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: MALAISE (non-serious) with onset 18Mar2021, outcome "recovered" (21Mar2021), described as "Caller states that she was feeling unwell"; LYMPHADENOPATHY (non-serious) with onset 18Mar2021, outcome "recovering", described as "Discovered swollen lymph nodes"; FATIGUE (non-serious) with onset 15Mar2021, outcome "recovering", PAIN IN EXTREMITY (non-serious) with onset 12Mar2021, outcome "recovered" (15Mar2021) and all described as "She also states that she had tiredness and a sore arm.".  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Musculoskeletal disorder, Pain, Pain in extremity, Tendon pain
Clinical narrative: sore feet; aches and pains; tendon soreness; aches and pains from it in my joints; Problems in my feet; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 63 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 18Mar2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. Relevant medical history included: "tendon soreness" (unspecified if ongoing), notes: after taking some antibiotics. The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "recovering", described as "sore feet"; PAIN (non-serious) with onset Mar2021, outcome "recovering", described as "aches and pains"; TENDON PAIN (non-serious) with onset Mar2021, outcome "recovering", described as "tendon soreness"; ARTHRALGIA (non-serious) with onset Mar2021, outcome "unknown", described as "aches and pains from it in my joints"; MUSCULOSKELETAL DISORDER (non-serious) with onset Mar2021, outcome "recovering", described as "Problems in my feet".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Hot flush, Paraesthesia
Clinical narrative: feeling tingly on her fingers feet, hand.; the always feel cold; hot flashes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 12Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Menopause" (unspecified if ongoing), notes: She's already passed menopause. The patient's concomitant medications were not reported. The following information was reported: PARAESTHESIA (non-serious) with onset Mar2021, outcome "unknown", described as "feeling tingly on her fingers feet, hand."; FEELING COLD (non-serious) with onset Mar2021, outcome "unknown", described as "the always feel cold"; HOT FLUSH (non-serious) with onset Mar2021, outcome "unknown", described as "hot flashes". The event "feeling tingly on her fingers feet, hand." was evaluated at the physician office visit. Therapeutic measures were taken as a result of paraesthesia, feeling cold, hot flush. Additional information: The patient's age was reported as 58 (unit: unknown). Clinical course: 12 hours after the patient's first covid shot, patient started feeling tingly on her fingers, feet, hand. It was intermittent but worse on her feet, and the always feel cold. The patient went to see her health care professional (reported as HCP) who told her she didn't know what to do. The patient was prescribed a steroid pack that she finished but it did not help. She's already passed menopause but has also been experiencing hot flashes like 5 times a day. The patient was querying if she needed to take the second dose because she was concerned about a reaction and querying if the second shot has the same ingredients with the first.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Coagulation test, International normalised ratio increased
Clinical narrative: INR was 5.9 / INR was 4.9, INR goal is 2-3; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 15Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: WARFARIN. Vaccination history included: Bnt162b2 (1st dose), administration date: 22Feb2021, for COVID-19 immunisation, reaction(s): "PT-INR was 2.7, and her INR goal is 2-3". The following information was reported: INTERNATIONAL NORMALISED RATIO INCREASED (non-serious) with onset 24Mar2021, outcome "unknown", described as "INR was 5.9 / INR was 4.9, INR goal is 2-3". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient's age was reported as 66, no unit provided. Warfarin was temporarily discontinued and her INR was reported as 4.9 on 26Mar2021. The patient is going again to get it checked on Monday.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Fatigue, Nasopharyngitis, Odynophagia, Oropharyngeal pain
Clinical narrative: throat started to hurt when she swallow; sore throat; ear aches; feeling tired; not sleep well; cold; 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 female patient received bnt162b2 (BNT162B2), administration date 16Mar2021 (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, single), for COVID-19 Immunisation. The following information was reported: EAR PAIN (non-serious) with onset 21Mar2021, outcome "recovering", described as "ear aches"; FATIGUE (non-serious) with onset Mar2021, outcome "unknown", described as "feeling tired"; POOR QUALITY SLEEP (non-serious) with onset Mar2021, outcome "unknown", described as "not sleep well"; NASOPHARYNGITIS (non-serious) with onset Mar2021, outcome "unknown", described as "cold"; ODYNOPHAGIA (non-serious) with onset 26Mar2021, outcome "unknown", described as "throat started to hurt when she swallow"; OROPHARYNGEAL PAIN (non-serious) with onset 26Mar2021, outcome "unknown", described as "sore throat". Therapeutic measures were taken as a result of ear pain.  Additional information: It was reported that 5 days later the patient (age: 71; unit: unknown) experienced ear aches after she washed her hair for removing hair dye. She used some ear drops and it subsided. Patient was asking if this was a side effect or something else. Patient wanted to know information about booster shot after 2 doses of the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Poor quality sleep
Clinical narrative: throat started to hurt when she swallow; sore throat; ear aches; feeling tired; not sleep well; cold; 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 female patient received bnt162b2 (BNT162B2), administration date 16Mar2021 (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, single), for COVID-19 Immunisation. The following information was reported: EAR PAIN (non-serious) with onset 21Mar2021, outcome "recovering", described as "ear aches"; FATIGUE (non-serious) with onset Mar2021, outcome "unknown", described as "feeling tired"; POOR QUALITY SLEEP (non-serious) with onset Mar2021, outcome "unknown", described as "not sleep well"; NASOPHARYNGITIS (non-serious) with onset Mar2021, outcome "unknown", described as "cold"; ODYNOPHAGIA (non-serious) with onset 26Mar2021, outcome "unknown", described as "throat started to hurt when she swallow"; OROPHARYNGEAL PAIN (non-serious) with onset 26Mar2021, outcome "unknown", described as "sore throat". Therapeutic measures were taken as a result of ear pain.  Additional information: It was reported that 5 days later the patient (age: 71; unit: unknown) experienced ear aches after she washed her hair for removing hair dye. She used some ear drops and it subsided. Patient was asking if this was a side effect or something else. Patient wanted to know information about booster shot after 2 doses of the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased, Bone pain, Feeling abnormal, Feeling cold
Clinical narrative: Pt texted me "feels really crummy.; Body aches; Bones hurt; I'm radiating heat but freezing; Got home and temp was 99.8, it is usually around 96.5; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). An adult female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 24Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: IUD NOS; BENADRYL; IBUPROFEN. Vaccination history included: Bnt162b2 (Dose 1, Lot number: Unknown), for COVID-19 immunization.  The following information was reported: FEELING ABNORMAL (non-serious) with onset 25Mar2021 20:00, outcome "recovering", described as "Pt stated "feels really crummy."; PAIN (non-serious) with onset 25Mar2021 20:00, outcome "recovering", described as "Body aches"; BONE PAIN (non-serious) with onset 25Mar2021 20:00, outcome "recovering", described as "Bones hurt"; FEELING COLD (non-serious) with onset 25Mar2021 20:00, outcome "recovering", described as "I'm radiating heat but freezing"; BODY TEMPERATURE INCREASED (non-serious) with onset 25Mar2021 20:00, outcome "recovering", described as "Got home and temp was 99.8, it is usually around 96.5". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of feeling abnormal, pain, bone pain, feeling cold, body temperature increased.  Additional information: It was unknown whether the patient receive any other vaccines within 4 weeks prior to the COVID vaccine or not. List of any other medications the patient received within 2 weeks of vaccination: Pt has an IUD and took OTC Benadryl and Ibuprofen. the patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The events did not result into death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating and Congenital anomaly/birth defect. This report was non-serious.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Pt texted me "feels really crummy.; Body aches; Bones hurt; I'm radiating heat but freezing; Got home and temp was 99.8, it is usually around 96.5; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). An adult female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 24Mar2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: IUD NOS; BENADRYL; IBUPROFEN. Vaccination history included: Bnt162b2 (Dose 1, Lot number: Unknown), for COVID-19 immunization.  The following information was reported: FEELING ABNORMAL (non-serious) with onset 25Mar2021 20:00, outcome "recovering", described as "Pt stated "feels really crummy."; PAIN (non-serious) with onset 25Mar2021 20:00, outcome "recovering", described as "Body aches"; BONE PAIN (non-serious) with onset 25Mar2021 20:00, outcome "recovering", described as "Bones hurt"; FEELING COLD (non-serious) with onset 25Mar2021 20:00, outcome "recovering", described as "I'm radiating heat but freezing"; BODY TEMPERATURE INCREASED (non-serious) with onset 25Mar2021 20:00, outcome "recovering", described as "Got home and temp was 99.8, it is usually around 96.5". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of feeling abnormal, pain, bone pain, feeling cold, body temperature increased.  Additional information: It was unknown whether the patient receive any other vaccines within 4 weeks prior to the COVID vaccine or not. List of any other medications the patient received within 2 weeks of vaccination: Pt has an IUD and took OTC Benadryl and Ibuprofen. the patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The events did not result into death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating and Congenital anomaly/birth defect. This report was non-serious.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Feeling abnormal, Headache, Lethargy
Clinical narrative: extreme vertigo; nausea; diarrhea; lethargy; Headache; she described as brain fog; fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15Mar2021 (Lot number: EN6207) at the age of 73 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Diabetes mellitus" (ongoing), notes: 12years ago; "Multiple Sclerosis" (ongoing). Concomitant medication(s) included: ACETAMINOPHEN taken for headache (ongoing); ASPIRIN (E.C.) taken for headache (ongoing); CAFFEINE taken for headache (ongoing). Past drug history included: Penicillin for known allergy. Vaccination history included: Bnt162b2 (product=COVID 19, brand=pfizerbioNTech covid19,, lot number=EN6200,, administration date=17Feb2021,, administration time=02:00 PM,, vaccine location=Left arm,, dose number=1), administration date: 17Feb2021, when the patient was 73 years old, for Covid-19 Immunization, reaction(s): "Fatigue". The following information was reported: VERTIGO (non-serious) with onset 18Mar2021, outcome "recovering", described as "extreme vertigo"; NAUSEA (non-serious) with onset 18Mar2021, outcome "recovered" (19Mar2021), described as "nausea"; DIARRHOEA (non-serious) with onset 18Mar2021, outcome "recovering", described as "diarrhea"; LETHARGY (non-serious) with onset 18Mar2021, outcome "recovering", described as "lethargy"; HEADACHE (non-serious) with onset Mar2021, outcome "unknown", described as "Headache"; FEELING ABNORMAL (non-serious) with onset Mar2021, outcome "unknown", described as "she described as brain fog"; FATIGUE (non-serious) with onset 17Feb2021, outcome "unknown", described as "fatigue". Therapeutic measures were not taken as a result of vertigo, nausea, diarrhoea, lethargy.  Additional information: The most recent COVID-19 vaccine was administered at Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient has not been tested for COVID-19. Prior Vaccinations (within 4 weeks) include Pfizer Covid-19 vaccine, first dose. Adverse events did not require a visit to Emergency Room/Physician Office.AE(s) following prior vaccinations, Relevant Tests were reported as None.  No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vertigo
Clinical narrative: extreme vertigo; nausea; diarrhea; lethargy; Headache; she described as brain fog; fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15Mar2021 (Lot number: EN6207) at the age of 73 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Diabetes mellitus" (ongoing), notes: 12years ago; "Multiple Sclerosis" (ongoing). Concomitant medication(s) included: ACETAMINOPHEN taken for headache (ongoing); ASPIRIN (E.C.) taken for headache (ongoing); CAFFEINE taken for headache (ongoing). Past drug history included: Penicillin for known allergy. Vaccination history included: Bnt162b2 (product=COVID 19, brand=pfizerbioNTech covid19,, lot number=EN6200,, administration date=17Feb2021,, administration time=02:00 PM,, vaccine location=Left arm,, dose number=1), administration date: 17Feb2021, when the patient was 73 years old, for Covid-19 Immunization, reaction(s): "Fatigue". The following information was reported: VERTIGO (non-serious) with onset 18Mar2021, outcome "recovering", described as "extreme vertigo"; NAUSEA (non-serious) with onset 18Mar2021, outcome "recovered" (19Mar2021), described as "nausea"; DIARRHOEA (non-serious) with onset 18Mar2021, outcome "recovering", described as "diarrhea"; LETHARGY (non-serious) with onset 18Mar2021, outcome "recovering", described as "lethargy"; HEADACHE (non-serious) with onset Mar2021, outcome "unknown", described as "Headache"; FEELING ABNORMAL (non-serious) with onset Mar2021, outcome "unknown", described as "she described as brain fog"; FATIGUE (non-serious) with onset 17Feb2021, outcome "unknown", described as "fatigue". Therapeutic measures were not taken as a result of vertigo, nausea, diarrhoea, lethargy.  Additional information: The most recent COVID-19 vaccine was administered at Hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient has not been tested for COVID-19. Prior Vaccinations (within 4 weeks) include Pfizer Covid-19 vaccine, first dose. Adverse events did not require a visit to Emergency Room/Physician Office.AE(s) following prior vaccinations, Relevant Tests were reported as None.  No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Palpitations
Clinical narrative: lightheadedness; racing heart beat; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 64 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 24Mar2021 10:30 (Lot number: ER8732) at the age of 64 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Prediabetes" (ongoing); "Thyroid problem" (ongoing); "High blood pressure" (ongoing). Concomitant medication(s) included: METFORMIN taken for glucose tolerance impaired (ongoing); LEVOTHYROXINE SODIUM taken for thyroid disorder, start date: 2015 (ongoing); LOSARTAN taken for hypertension, start date: 2015 (ongoing); LOTENSIN [TIMOLOL MALEATE] taken for hypertension (ongoing). Vaccination history included: Bnt162b2 (dose 1, single, administered in arm right, Lot number: EN6199), administration date: 03Mar2021, when the patient was 64 years old, for COVID-19 IMMUNISATION, reaction(s): "Fatigue", "Arm sore where she got her first dose"; Flu vaccine (she had mild flu like symptoms but they went away the next day and she felt good), administration date: 2020, for immunisation, reaction(s): "mild flu like symptoms". The following information was reported: DIZZINESS (non-serious) with onset 25Mar2021, outcome "not recovered", described as "lightheadedness"; PALPITATIONS (non-serious) with onset 25Mar2021, outcome "not recovered", described as "racing heart beat". Therapeutic measures were taken as a result of dizziness, palpitations.  Additional Information: The patient reported that she has been taking metformin for over 10 years and has been taking levothyroxine and losartan since probably 6 years ago. The patient mentioned that he didn't take her medications the day of the vaccine and didn't eat anything either for both doses. She hydrated very much before. Because of the events, the patient tried to relax and was laying down and it just comes on. It was not constant but it just comes on. It had worsened, that's why she made an appointment with her doctor. The patient took paracetamol (TYLENOL) the night of the vaccine and her daughter told her it made the vaccine less effective. The reporter was asking if it was true.  No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: This is a spontaneous report received from contactable consumer (patient). A 73-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# EN6202), at the age of 73, in right arm, on Feb 26, 2021, at 10:45, single dose, for COVID-19 immunisation. No medical history or concomitant medications reported. The patient had pain in extremity (her arm was sore), onset Feb 26, 2021, with outcome of recovered (Feb 28, 2021). No follow-up attempts possible. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Malaise
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP. An 81-year-old male patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. Vaccination history included the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), for COVID-19 immunisation. The patient experienced  fatigue (feeling tired, and woke up still tired today), onset Mar 25, 2021, with outcome of not recovered; and malaise (feeling unwell), onset Mar 25, 2021, with outcome of unknown. Additional information: Patient cancelled a dental appointment because he felt unwell. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP. A 76-year-old male patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# EN6200, expiration date: Feb 2022), at the age of 76, in left arm, on Feb 17, 2021, at 14:00, single dose, for COVID-19 immunisation. No medical history or concomitant medications reported. The patient had a headache, onset Feb 2021, with outcome of unknown; and fatigue, with outcome of recovered. Therapeutic measures were taken as a result of headache. Treatment with Excedrin (two tablets once or twice per day as needed) taken Feb 18, 2021 for the headache. No therapeutic measures taken for the fatigue. Additional information: The patient was fatigued after the first dose of the COVID-19 vaccine. Fatigue resolved after a couple of days. Patient also experienced headache. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. Patient had no related tests. No follow-up attempts possible. No further information expected. Sender's comments: Linked report(s): US-PFIZER INC-2021335698 same reporter and drug; similar events; different patient.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Euphoric mood
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A 29-year-old female patient (not pregnant) received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# EN6204), at the age of 29, in left arm, on Mar 5, 2021, at 15:30, single dose, for COVID-19 immunisation. Medical history included chocolate and Kiwi allergy (unspecified if ongoing). The patient's concomitant medications not reported. The patient experienced euphoric mood/slight euphoric feeling, onset Mar 5, 2021, at 16:10, with outcome of recovered (Mar 5, 2021, at 18:10). Therapeutic measures were not taken as a result of euphoric mood. Additional information: The patient was not diagnosed with COVID-19 prior to vaccination, and has not tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. No follow-up attempts needed. No further information expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hypersomnia, Pain, Tremor
Clinical narrative: slept a lot; real bad chills; shakes; aches, soreness in the area; 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), administration date 24Mar2021 (Lot number: ER8732, Expiration Date: 31Jul2021) at the age of 61 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: IBUPROFEN AND PHENYLEPHRINE. Vaccination history included: Bnt162b2 (First dose; lot# EN6199; Expiration date: 30Jun2021. , ), administration date: 03Mar2021, when the patient was 61 years old, for COVID-19 immunisation. The following information was reported: CHILLS (non-serious) with onset 24Mar2021, outcome "not recovered", described as "real bad chills"; TREMOR (non-serious) with onset 24Mar2021, outcome "recovering", described as "shakes"; PAIN (non-serious) with onset 24Mar2021, outcome "unknown", described as "aches, soreness in the area"; HYPERSOMNIA (non-serious) with onset 25Mar2021, outcome "unknown", described as "slept a lot". Therapeutic measures were taken as a result of chills, tremor, pain. Additional information:  The patient got her second dose on Wednesday, 24Mar2021, and experienced real bad chills, aches, soreness in the area and stated that she has taken ibuprofen (ADVIL) and ALEVE as treatment for the events, but the chills was not going away. It was also reported that the patient slept a lot yesterday, 25Mar2021 and all she could eat was cereal. Patient stated that she wanted to make sure there was something she can take to relieve the symptoms. Patient would like to know how long the symptoms will last. 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 and since the vaccination, the patient has not been tested for COVID-19. The patient had no allergies to medications, food, or other products.  No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Fatigue, Feeling abnormal, Insomnia, Pain in extremity
Clinical narrative: fatigue; extreme insomnia / Unable to sleep more than 30-45 minutes at a time; brain was on overdrive (anxiety thoughts that were somewhat irrational); brain was on overdrive (anxiety thoughts that were somewhat irrational); Sore arm; brain fog; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 25Mar2021 12:45 (Lot number: EP6955) at the age of 45 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "known allergies like  Peanuts, tree nuts, soy" (unspecified if ongoing). Concomitant medication(s) included: OMEPRAZOL; HYDROCHLOROTHIAZIDE. Vaccination history included: Bnt162b2 (lot number: EN6203, time: 02:00 PM, Location: Left arm, Dose 1), administration date: 04Mar2021, when the patient was 45 years old, for COVID-19 immunisation. The following information was reported: INSOMNIA (non-serious) with onset 26Mar2021 01:00, outcome "recovering", described as "extreme insomnia / Unable to sleep more than 30-45 minutes at a time"; ANXIETY (non-serious), THINKING ABNORMAL (non-serious) all with onset 26Mar2021 01:00, outcome "recovering" and all described as "brain was on overdrive (anxiety thoughts that were somewhat irrational)"; PAIN IN EXTREMITY (non-serious) with onset 26Mar2021 01:00, outcome "recovering", described as "Sore arm"; FEELING ABNORMAL (non-serious) with onset 26Mar2021 01:00, outcome "recovering", described as "brain fog"; FATIGUE (non-serious) with onset 27Mar2021, outcome "recovering", described as "fatigue". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of insomnia, anxiety, thinking abnormal, pain in extremity, feeling abnormal, fatigue.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient reported taking an unspecified multivitamin as concomitant medication. Events did not result to emergency room visit and physician office visit.  No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Thinking abnormal
Clinical narrative: fatigue; extreme insomnia / Unable to sleep more than 30-45 minutes at a time; brain was on overdrive (anxiety thoughts that were somewhat irrational); brain was on overdrive (anxiety thoughts that were somewhat irrational); Sore arm; brain fog; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 25Mar2021 12:45 (Lot number: EP6955) at the age of 45 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "known allergies like  Peanuts, tree nuts, soy" (unspecified if ongoing). Concomitant medication(s) included: OMEPRAZOL; HYDROCHLOROTHIAZIDE. Vaccination history included: Bnt162b2 (lot number: EN6203, time: 02:00 PM, Location: Left arm, Dose 1), administration date: 04Mar2021, when the patient was 45 years old, for COVID-19 immunisation. The following information was reported: INSOMNIA (non-serious) with onset 26Mar2021 01:00, outcome "recovering", described as "extreme insomnia / Unable to sleep more than 30-45 minutes at a time"; ANXIETY (non-serious), THINKING ABNORMAL (non-serious) all with onset 26Mar2021 01:00, outcome "recovering" and all described as "brain was on overdrive (anxiety thoughts that were somewhat irrational)"; PAIN IN EXTREMITY (non-serious) with onset 26Mar2021 01:00, outcome "recovering", described as "Sore arm"; FEELING ABNORMAL (non-serious) with onset 26Mar2021 01:00, outcome "recovering", described as "brain fog"; FATIGUE (non-serious) with onset 27Mar2021, outcome "recovering", described as "fatigue". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of insomnia, anxiety, thinking abnormal, pain in extremity, feeling abnormal, fatigue.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient reported taking an unspecified multivitamin as concomitant medication. Events did not result to emergency room visit and physician office visit.  No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Diarrhoea, Illness, Malaise
Clinical narrative: chills; diarrhea; nausea; she was so sick and this caused her stomach to start acting; she was so sick and this caused her stomach to start acting; deathly ill; pain at the shot site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administered in arm right, administration date 24Mar2021 10:00 (Lot number: ER2613) at the age of 63 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Diabetic" (unspecified if ongoing), notes: Diabetic, from one year; "Gastroparesis" (unspecified if ongoing), notes: Gastroparesis, from 5 years; "Thyroid" (unspecified if ongoing). Concomitant medication(s) included: FARXIGA taken for diabetes mellitus (ongoing); LEVOTHYROXINE taken for thyroid disorder (ongoing); LISINOPRIL taken for blood pressure measurement (ongoing); FAMOTIDINE taken for gastrooesophageal reflux disease (ongoing); REGLAN [METOCLOPRAMIDE HYDROCHLORIDE] (ongoing); NEXIUM 1-2-3 (ongoing).  The following information was reported: MALAISE (non-serious) with onset 24Mar2021, outcome "unknown", described as "deathly ill"; VACCINATION SITE PAIN (non-serious) with onset 24Mar2021, outcome "recovered" (26Mar2021), described as "pain at the shot site"; CHILLS (non-serious) with onset 25Mar2021, outcome "recovered" (25Mar2021), described as "chills"; DIARRHOEA (non-serious) with onset 25Mar2021, outcome "recovered" (26Mar2021), described as "diarrhea"; NAUSEA (non-serious) with onset 25Mar2021, outcome "recovering", described as "nausea"; ILLNESS (non-serious), ABDOMINAL DISCOMFORT (non-serious) all with onset 24Mar2021, outcome "unknown" and all described as "she was so sick and this caused her stomach to start acting".  Additional information: The events did not require a visit to emergency room and physician office. There were no prior vaccinations within 4 weeks.  No follow-up attempts are possible. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vaccination site pain
Clinical narrative: chills; diarrhea; nausea; she was so sick and this caused her stomach to start acting; she was so sick and this caused her stomach to start acting; deathly ill; pain at the shot site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administered in arm right, administration date 24Mar2021 10:00 (Lot number: ER2613) at the age of 63 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Diabetic" (unspecified if ongoing), notes: Diabetic, from one year; "Gastroparesis" (unspecified if ongoing), notes: Gastroparesis, from 5 years; "Thyroid" (unspecified if ongoing). Concomitant medication(s) included: FARXIGA taken for diabetes mellitus (ongoing); LEVOTHYROXINE taken for thyroid disorder (ongoing); LISINOPRIL taken for blood pressure measurement (ongoing); FAMOTIDINE taken for gastrooesophageal reflux disease (ongoing); REGLAN [METOCLOPRAMIDE HYDROCHLORIDE] (ongoing); NEXIUM 1-2-3 (ongoing).  The following information was reported: MALAISE (non-serious) with onset 24Mar2021, outcome "unknown", described as "deathly ill"; VACCINATION SITE PAIN (non-serious) with onset 24Mar2021, outcome "recovered" (26Mar2021), described as "pain at the shot site"; CHILLS (non-serious) with onset 25Mar2021, outcome "recovered" (25Mar2021), described as "chills"; DIARRHOEA (non-serious) with onset 25Mar2021, outcome "recovered" (26Mar2021), described as "diarrhea"; NAUSEA (non-serious) with onset 25Mar2021, outcome "recovering", described as "nausea"; ILLNESS (non-serious), ABDOMINAL DISCOMFORT (non-serious) all with onset 24Mar2021, outcome "unknown" and all described as "she was so sick and this caused her stomach to start acting".  Additional information: The events did not require a visit to emergency room and physician office. There were no prior vaccinations within 4 weeks.  No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash, Vaccination site warmth
Clinical narrative: 72 hours after the injection I have a dinner-plate sized red rash around the injection site; It is hot to the touch; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 23Mar2021 13:00 (Lot number: EN6202) at the age of 66 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "HBP" (unspecified if ongoing); "Obesity" (unspecified if ongoing). Concomitant medication(s) included: FLUOXETINE; HYDROCHLORIC ACID; AMLODIPINE. Vaccination history included: Bnt162b2 (Lot number : ER2613, Dose number :1, Vaccine location : Upper Right Arm), administration date: 02Mar2021, when the patient was 66 years old, for Covid-19 immunization. The following information was reported: VACCINATION SITE RASH (non-serious) with onset 26Mar2021 06:15, outcome "unknown", described as "72 hours after the injection I have a dinner-plate sized red rash around the injection site"; VACCINATION SITE WARMTH (non-serious) with onset 26Mar2021 06:15, outcome "unknown", described as "It is hot to the touch". Therapeutic measures were not taken as a result of vaccination site rash, vaccination site warmth.  Additional information: Patient has no allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. Patient reported that red rash was not painful.  No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache, Pain of skin, SARS-CoV-2 test
Clinical narrative: Light-headed; Slight headache; Soreness in scalp on his head / When he presses on the surface of his head it is sore in a couple of spots; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 66 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 28Feb2021 (Lot number: EN6203) at the age of 66 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "retreatment of root canal", start date: Feb2021 (unspecified if ongoing), notes: performed a couple of days before first dose of Pfizer COVID-19 Vaccine administered.; "infection in mouth due to root canal", start date: Feb2021 (unspecified if ongoing); "aches and pains" (unspecified if ongoing); "shingles" (unspecified if ongoing), notes: had it 20 years ago; "sharp pain in the back, which was isolated pain" (unspecified if ongoing); "wasn't able to sleep" (unspecified if ongoing). Concomitant medication(s) included: AMOXICILLIN taken for oral infection, start date: 28Feb2021, stop date: 07Mar2021. Vaccination history included: Shingles vaccine, for immunisation, reaction(s): "felt pretty crummy". The following information was reported: DIZZINESS (non-serious), outcome "recovered", described as "Light-headed"; HEADACHE (non-serious), outcome "recovered", described as "Slight headache"; PAIN OF SKIN (non-serious), outcome "not recovered", described as "Soreness in scalp on his head / When he presses on the surface of his head it is sore in a couple of spots". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Muscular weakness, Nausea
Clinical narrative: Dizziness / dizzy; Muscle weakness / weak in his muscle; Felt nauseated / stomach is nauseous; Tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 59 year-old male patient received bnt162b2 (BNT162B2), administration date 23Mar2021 (Lot number: EP6955) 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: DIZZINESS (non-serious) with onset 24Mar2021, outcome "recovered" (24Mar2021), described as "Dizziness / dizzy"; MUSCULAR WEAKNESS (non-serious) with onset 24Mar2021, outcome "recovered" (24Mar2021), described as "Muscle weakness / weak in his muscle"; NAUSEA (non-serious) with onset 24Mar2021, outcome "unknown", described as "Felt nauseated / stomach is nauseous"; FATIGUE (non-serious) with onset 24Mar2021, outcome "unknown", described as "Tired".  Additional information: The events dizziness / dizzy and muscle weakness / weak in his muscle lasted for 3 hours, as reported.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Skin disorder
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient), for a Pfizer sponsored program (159558). A 55-year-old female patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), on Mar 7, 2021, single dose, for COVID-19 immunisation. Medical history included lupus (unspecified if ongoing); thyroid disorder (unspecified if ongoing); fibromyalgia (unspecified if ongoing) and back pain (unspecified if ongoing). Concomitant medication included: Hydroxychloroquine for systemic lupus erythematosus; Tylenol for fibromyalgia and back pain. The patient developed a skin disorder (some small dots on her cheek which lasted a week), onset Mar 7, 2021, with outcome of recovered (Mar 14, 2021). No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Feeling drunk, Pain, Vertigo, Visual impairment
Clinical narrative: really dizzy off and on; The room was spinning pretty good and I felt like I was drunk; The room was spinning pretty good and I felt like I was drunk; My vision sort of moves and I don't get a stable view of what I'm looking at; after the shot I felt okay just sore; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 20Mar2021 (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: DIZZINESS (non-serious) with onset 23Mar2021, outcome "unknown", described as "really dizzy off and on"; VERTIGO (non-serious), FEELING DRUNK (non-serious) all with onset 23Mar2021, outcome "unknown" and all described as "The room was spinning pretty good and I felt like I was drunk"; VISUAL IMPAIRMENT (non-serious) with onset 23Mar2021, outcome "unknown", described as "My vision sort of moves and I don't get a stable view of what I'm looking at"; PAIN (non-serious) with onset 21Mar2021, outcome "unknown", described as "after the shot I felt okay just sore".  Additional information: The patient received his first dose first dose of the Pfizer COVID-19 vaccine on Saturday, 20Mar2021, and for the past 2 days he had been really dizzy off and on. He stated he was not sure if this was a side effect of the vaccine. The room was spinning pretty good and he felt like he was drunk. When he moved fast or got up, he can tell. His vision sort of moved and he did not get a stable view of what he was looking at. The first day after the shot, he felt okay just sore, the second day, he felt great and the third day, he got out of bed and the whole room was spinning. It seemed to get worse when he moved suddenly.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness postural
Clinical narrative: really dizzy off and on; The room was spinning pretty good and I felt like I was drunk; The room was spinning pretty good and I felt like I was drunk; My vision sort of moves and I don't get a stable view of what I'm looking at; after the shot I felt okay just sore; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 20Mar2021 (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: DIZZINESS (non-serious) with onset 23Mar2021, outcome "unknown", described as "really dizzy off and on"; VERTIGO (non-serious), FEELING DRUNK (non-serious) all with onset 23Mar2021, outcome "unknown" and all described as "The room was spinning pretty good and I felt like I was drunk"; VISUAL IMPAIRMENT (non-serious) with onset 23Mar2021, outcome "unknown", described as "My vision sort of moves and I don't get a stable view of what I'm looking at"; PAIN (non-serious) with onset 21Mar2021, outcome "unknown", described as "after the shot I felt okay just sore".  Additional information: The patient received his first dose first dose of the Pfizer COVID-19 vaccine on Saturday, 20Mar2021, and for the past 2 days he had been really dizzy off and on. He stated he was not sure if this was a side effect of the vaccine. The room was spinning pretty good and he felt like he was drunk. When he moved fast or got up, he can tell. His vision sort of moved and he did not get a stable view of what he was looking at. The first day after the shot, he felt okay just sore, the second day, he felt great and the third day, he got out of bed and the whole room was spinning. It seemed to get worse when he moved suddenly.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.