chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Illness, Loss of personal independence in daily activities, Migraine
Clinical narrative: he can't do anything because of this Vaccine; Had Vaccine about a month ago and since then has severe migraine every day and really sick; Had Vaccine about a month ago and since then has severe migraine every day and really sick; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A male patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 2021, outcome "unknown", described as "he can't do anything because of this Vaccine"; MIGRAINE (non-serious), ILLNESS (non-serious) all with onset 2021, outcome "unknown" and all described as "Had Vaccine about a month ago and since then has severe migraine every day and really sick".  Additional Information: It was reported that the reporters son (consumer) had the Pfizer Vaccine about a month ago and since then he has a very severe migraine every day. What we have to do now (treatment). The reporter stated I am really upset because my son is really sick, he can't do anything because of this Vaccine, do not know what is inside this vaccine, should n0t tell people to take this vaccine because it is not a good vaccine because people (further not clarified. Hence, split not made) are getting sick.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Acne, Fatigue, Pain, Urine odour abnormal, Vaccination site pain
Clinical narrative: After the 1st does I had immediate pain at the injection site that lasted 2 days. Severe acne, some painful, started on day 2 and lasted 15 days. Fatigue for 16 days. Urine had a smell similar to a ca; Severe acne, some painful, started on day 2 and lasted 15 days.; Severe acne, some painful, started on day 2 and lasted 15 days.; Fatigue for 16 days.; Urine had a smell similar to a can of tuna for approximately 14 days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 06Aug2021 12:00 (Lot number: FA6780) at the age of 43 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 07Aug2021 08:00, outcome "recovered" (2021), described as "After the 1st does I had immediate pain at the injection site that lasted 2 days. Severe acne, some painful, started on day 2 and lasted 15 days. Fatigue for 16 days. Urine had a smell similar to a ca"; ACNE (non-serious), PAIN (non-serious) all with onset 07Aug2021 08:00, outcome "recovered" (2021) and all described as "Severe acne, some painful, started on day 2 and lasted 15 days."; FATIGUE (non-serious) with onset 07Aug2021 08:00, outcome "recovered" (2021), described as "Fatigue for 16 days."; URINE ODOUR ABNORMAL (non-serious) with onset 07Aug2021 08:00, outcome "recovered" (2021), described as "Urine had a smell similar to a can of tuna for approximately 14 days". Therapeutic measures were not taken as a result of vaccination site pain, acne, pain, fatigue, urine odour abnormal.  Additional information: No Known allergies was reported. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient has not been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Headache, Nausea, Pain in extremity
Clinical narrative: Headache; severe arm pain; nausea; loss of appetite; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 60 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 04Sep2021 11:30 (Lot number: 3013584) at the age of 60 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "If covid prior vaccination: yes" (unspecified if ongoing). There were no concomitant medications. The following information was reported: HEADACHE (non-serious) with onset 06Sep2021, outcome "not recovered", described as "Headache"; PAIN IN EXTREMITY (non-serious) with onset 06Sep2021, outcome "not recovered", described as "severe arm pain"; NAUSEA (non-serious) with onset 06Sep2021, outcome "not recovered", described as "nausea"; DECREASED APPETITE (non-serious) with onset 06Sep2021, outcome "not recovered", described as "loss of appetite". Therapeutic measures were not taken as a result of headache, pain in extremity, nausea, decreased appetite.  Additional information: COVID prior vaccination was reported as yes. COVID tested post vaccination was reported as no. The patient had no known allergies. Headache every morning when waking up severe arm pain nausea loss of appetite.  Follow-up attempts are completed. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Immunisation, Myalgia, Neck pain
Clinical narrative: Awoke with severe neck with all over headache/ felt like head is vice; Awoke with severe neck with all over headache; I had joint and muscle pain for 4 days; I had joint and muscle pain for 4 days; BOOSTER; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 24Sep2021 10:00 (Lot number: 30130BA) at the age of 75 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose:1, Date:27Jan2021, Time: 11 AM, Anatomical site of injection: right arm, Batch/lot number: EL3247), administration date: 27Jan2021, when the patient was 75 years old, for Covid-19 immunization; Bnt162b2 (Dose:2, Date:17Feb2021, Time: 11 AM, Anatomical site of injection: right arm, Batch/lot number: EL9263), administration date: 17Feb2021, when the patient was 75 years old, for Covid-19 immunization, reaction(s): "i had joint and muscle pain", "i had joint and muscle pain". The following information was reported: IMMUNISATION (non-serious) with onset 24Sep2021 10:00, outcome "unknown", described as "BOOSTER"; ARTHRALGIA (non-serious), MYALGIA (non-serious) all with onset 24Sep2021 23:00, outcome "recovered" (2021) and all described as "I had joint and muscle pain for 4 days"; HEADACHE (non-serious) with onset 26Sep2021, outcome "recovered" (2021), described as "Awoke with severe neck with all over headache/ felt like head is vice"; NECK PAIN (non-serious) with onset 26Sep2021, outcome "recovered" (2021), described as "Awoke with severe neck with all over headache". Therapeutic measures were taken as a result of arthralgia, myalgia, headache, neck pain.  Additional information: Booster dose due to high risk of frequent institutional or occupational exposure to coronavirus (and at risk of serious covid -19 complication). Specific relevant test for thromboembolic events with thrombocytopenia: None. Booster: Started with muscle with joint aches about 12 hours after shot. Took Tylenol. On 25Sep- moderate- severe joint with muscle aches all day- took Tylenol. On 26Sep- awoke with severe neck with all over headache felt like head is vice, took Tylenol plus Ikg. On 27Sep- still painful headache, joint pain. Joint pain a little better, took advil. On 28Sep - 30Sep: pain lessened each day ,took Advil until the 29th. Patient didn't receive any other vaccine within 4 weeks prior to COVID vaccine. Patient received any other medication within 2 weeks of vaccination. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination patient was not tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Immunisation
Clinical narrative: Booster; Her arthritis was acting up again; This is a spontaneous report from a contactable consumer or other non hcp (patient's husband) via medical information team. A 74-year-old female patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date was not reported), via an unspecified route of administration on an unspecified date in Sep2021 as dose 3 (BOOSTER), single for COVID-19 immunization. The patient medical history included arthritis. The patient concomitant medications were not reported. The patient historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date was not reported), via an unspecified route of administration on an unspecified date in Mar2021 as dose 1, single for COVID-19 immunization. Also, patient has received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date was not reported), via an unspecified route of administration on an unspecified date in Mar2021 as dose 2, single for COVID-19 immunization. Reporter stated, my wife received the booster dose of the Pfizer covid vaccine yesterday around noon. Reporter wanted to know if she can have ibuprofen. She received her 2 earlier doses in Mar2021. Patient arthritis was acting up again on an unspecified date in 2021. If today is 28 hours later, can she take ibuprofen. On an unspecified date in Sep2021, the patient received booster. The clinical outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.  Follow-up (10Nov2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Feeling hot, Migraine, Musculoskeletal stiffness, Nausea
Clinical narrative: over 1 week of migraine unresponsive to medication; nausea; vomiting; severe stiff neck with pain; severe stiff neck with pain; feels like someone poured acid in my body and set it on fire; feels like someone poured acid in my body and set it on fire; This is a spontaneous report received from a non-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 26Sep2021 11:00 (Batch/Lot number: unknown) at the age of 45 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Fact V Leiden heterogeneous type" (unspecified if ongoing), notes: Fact V Leiden heterogeneous type; "Migraine" (unspecified if ongoing), notes: history of migraine. There were no concomitant medications. Past drug history included: Codeine, reaction(s): "Allergy", notes: Known allergies: Codeine. Vaccination history included: Bnt162b2 (dose administration time= 05:30 PM, dose number= 1,, dose vaccine location= Left arm, Adverse event start date and time: 03Sep2021 18:00 PM), administration date: 03Sep2021, when the patient was 45 years old, for COVID-19 Immunization, reaction(s): "vomiting", "Insomnia", "Nausea", "Headache", "Dizziness". The following information was reported: MIGRAINE (non-serious) with onset 2021, outcome "not recovered", described as "over 1 week of migraine unresponsive to medication"; NAUSEA (non-serious) with onset 2021, outcome "not recovered", described as "nausea"; VOMITING (non-serious) with onset 2021, outcome "not recovered", described as "vomiting"; NECK PAIN (non-serious), MUSCULOSKELETAL STIFFNESS (non-serious) all with onset 2021, outcome "not recovered" and all described as "severe stiff neck with pain"; FEELING ABNORMAL (non-serious), FEELING HOT (non-serious) all with onset 2021, outcome "not recovered" and all described as "feels like someone poured acid in my body and set it on fire". Therapeutic measures were taken as a result of migraine. It was unknown if therapeutic measures were taken as a result of nausea, vomiting, neck pain, musculoskeletal stiffness, feeling abnormal, feeling hot.  Additional information: 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 has not been tested for COVID-19 since the vaccination. There was no treatment AE. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. Reported Event: First shot--vomiting, nausea, headache, dizziness and insomnia lasted 10 nights.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Vomiting
Clinical narrative: over 1 week of migraine unresponsive to medication; nausea; vomiting; severe stiff neck with pain; severe stiff neck with pain; feels like someone poured acid in my body and set it on fire; feels like someone poured acid in my body and set it on fire; This is a spontaneous report received from a non-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 26Sep2021 11:00 (Batch/Lot number: unknown) at the age of 45 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Fact V Leiden heterogeneous type" (unspecified if ongoing), notes: Fact V Leiden heterogeneous type; "Migraine" (unspecified if ongoing), notes: history of migraine. There were no concomitant medications. Past drug history included: Codeine, reaction(s): "Allergy", notes: Known allergies: Codeine. Vaccination history included: Bnt162b2 (dose administration time= 05:30 PM, dose number= 1,, dose vaccine location= Left arm, Adverse event start date and time: 03Sep2021 18:00 PM), administration date: 03Sep2021, when the patient was 45 years old, for COVID-19 Immunization, reaction(s): "vomiting", "Insomnia", "Nausea", "Headache", "Dizziness". The following information was reported: MIGRAINE (non-serious) with onset 2021, outcome "not recovered", described as "over 1 week of migraine unresponsive to medication"; NAUSEA (non-serious) with onset 2021, outcome "not recovered", described as "nausea"; VOMITING (non-serious) with onset 2021, outcome "not recovered", described as "vomiting"; NECK PAIN (non-serious), MUSCULOSKELETAL STIFFNESS (non-serious) all with onset 2021, outcome "not recovered" and all described as "severe stiff neck with pain"; FEELING ABNORMAL (non-serious), FEELING HOT (non-serious) all with onset 2021, outcome "not recovered" and all described as "feels like someone poured acid in my body and set it on fire". Therapeutic measures were taken as a result of migraine. It was unknown if therapeutic measures were taken as a result of nausea, vomiting, neck pain, musculoskeletal stiffness, feeling abnormal, feeling hot.  Additional information: 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 has not been tested for COVID-19 since the vaccination. There was no treatment AE. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. Reported Event: First shot--vomiting, nausea, headache, dizziness and insomnia lasted 10 nights.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Breast pain, Menstrual disorder, Pain, Polymenorrhoea
Clinical narrative: Since vaccine premenstrual symptoms are more severe; I had never previously experienced sore breasts and now four months in a row I am dealing with pain; I had never previously experienced sore breasts and now four months in a row I am dealing with pain; abdominal crapping; flow and duration have both lessened noticeably; flow and duration have both lessened noticeably; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 30 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Jun2021 (Lot number: ew0202) at the age of 30 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Covid-19" (unspecified if ongoing), notes: If COVID prior vaccination: Yes. Concomitant medication(s) included: ALLEGRA; SINGULAIR; DIVALPROEX SODIUM. Vaccination history included: Bnt162b2 (Prev dose lot number: ew0168, Prev dose dose number: 1, Prev dose vaccine location: Left arm), administration date: 24May2021, when the patient was 30 years old, for Covid-19 immunization. The following information was reported: PREMENSTRUAL SYNDROME (non-serious) with onset 10Jul2021, outcome "unknown", described as "Since vaccine premenstrual symptoms are more severe"; BREAST PAIN (non-serious), PAIN (non-serious) all with onset 10Jul2021, outcome "unknown" and all described as "I had never previously experienced sore breasts and now four months in a row I am dealing with pain"; ABDOMINAL PAIN (non-serious) with onset 10Jul2021, outcome "unknown", described as "abdominal crapping"; MENSTRUAL DISORDER (non-serious), POLYMENORRHOEA (non-serious) all with onset 10Jul2021, outcome "unknown" and all described as "flow and duration have both lessened noticeably". Therapeutic measures were not taken as a result of premenstrual syndrome, breast pain, pain, abdominal pain, menstrual disorder, polymenorrhoea.  Additional Information: Facility type vaccine: Pharmacy or Drug Store. It was reported that patient abdominal crapping has become only manageable with medication. Prior to vaccination, patient was diagnosed with Covid-19. Since the vaccination, patient has not been tested for Covid-19. No known allergies. Patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine.  No Follow-up attempts are possible. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Premenstrual syndrome
Clinical narrative: Since vaccine premenstrual symptoms are more severe; I had never previously experienced sore breasts and now four months in a row I am dealing with pain; I had never previously experienced sore breasts and now four months in a row I am dealing with pain; abdominal crapping; flow and duration have both lessened noticeably; flow and duration have both lessened noticeably; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 30 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Jun2021 (Lot number: ew0202) at the age of 30 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Covid-19" (unspecified if ongoing), notes: If COVID prior vaccination: Yes. Concomitant medication(s) included: ALLEGRA; SINGULAIR; DIVALPROEX SODIUM. Vaccination history included: Bnt162b2 (Prev dose lot number: ew0168, Prev dose dose number: 1, Prev dose vaccine location: Left arm), administration date: 24May2021, when the patient was 30 years old, for Covid-19 immunization. The following information was reported: PREMENSTRUAL SYNDROME (non-serious) with onset 10Jul2021, outcome "unknown", described as "Since vaccine premenstrual symptoms are more severe"; BREAST PAIN (non-serious), PAIN (non-serious) all with onset 10Jul2021, outcome "unknown" and all described as "I had never previously experienced sore breasts and now four months in a row I am dealing with pain"; ABDOMINAL PAIN (non-serious) with onset 10Jul2021, outcome "unknown", described as "abdominal crapping"; MENSTRUAL DISORDER (non-serious), POLYMENORRHOEA (non-serious) all with onset 10Jul2021, outcome "unknown" and all described as "flow and duration have both lessened noticeably". Therapeutic measures were not taken as a result of premenstrual syndrome, breast pain, pain, abdominal pain, menstrual disorder, polymenorrhoea.  Additional Information: Facility type vaccine: Pharmacy or Drug Store. It was reported that patient abdominal crapping has become only manageable with medication. Prior to vaccination, patient was diagnosed with Covid-19. Since the vaccination, patient has not been tested for Covid-19. No known allergies. Patient did not receive any other vaccines within 4 weeks prior to the Covid vaccine.  No Follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hilar lymphadenopathy, Lymphadenopathy, Lymphadenopathy mediastinal
Clinical narrative: mediastinal, bilateral hilar, axillary lymphadenopathy; mediastinal, bilateral hilar, axillary lymphadenopathy; mediastinal, bilateral hilar, axillary lymphadenopathy; This is a spontaneous report received from a contactable reporter(s) (Consumer-patient's husband) from legal division.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LYMPHADENOPATHY MEDIASTINAL (medically significant), HILAR LYMPHADENOPATHY (medically significant), LYMPHADENOPATHY (medically significant), outcome "recovered" and all described as "mediastinal, bilateral hilar, axillary lymphadenopathy". The event "mediastinal, bilateral hilar, axillary lymphadenopathy", "mediastinal, bilateral hilar, axillary lymphadenopathy" and "mediastinal, bilateral hilar, axillary lymphadenopathy" was evaluated at the physician office visit. Therapeutic measures were taken as a result of lymphadenopathy mediastinal, hilar lymphadenopathy, lymphadenopathy. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Blister, Immunisation, Pruritus, Rash macular, Varicella
Clinical narrative: Right arm has chicken pox type blotches sprinkled over arm area.  Left arm has some.  Are below belly also has a few; Right arm has chicken pox type blotches sprinkled over arm area.  Left arm has some.  Are below belly also has a few; A bit itchy; Watery bumps noticed; Booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 76 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 08Oct2021 (Lot number: EW0179) at the age of 76 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Parkinson's" (ongoing), notes: Verbatim: Parkinson's; "Sleep disorder" (ongoing). Concomitant medication(s) included: AMLODIPINE (ongoing); ATORVASTATIN (ongoing); CARBIDOPA LEVODOPA taken for parkinson's disease (ongoing); CLONAZEPAM taken for sleep disorder (ongoing); LOSARTAN (ongoing). Vaccination history included: Bnt162b2 (Lot/Batch number: EL3248, Route of administration: Intramuscular, Anatomical location: Right arm, Dose no: 1), administration date: 22Jan2021, when the patient was 75 years old, for Covid-19 immunization; Bnt162b2 (Lot/Batch number: EM9810, Route of administration: Intramuscular, Anatomical location: Right arm, Dose no: 2), administration date: 12Feb2021, when the patient was 75 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 08Oct2021, outcome "unknown", described as "Booster"; VARICELLA (non-serious), RASH MACULAR (non-serious) all with onset 12Oct2021, outcome "not recovered" and all described as "Right arm has chicken pox type blotches sprinkled over arm area. Left arm has some. Are below belly also has a few"; PRURITUS (non-serious) with onset 12Oct2021, outcome "not recovered", described as "A bit itchy"; BLISTER (non-serious) with onset 11Oct2021, outcome "recovered" (2021), described as "Watery bumps noticed". Therapeutic measures were not taken as a result of varicella, rash macular, pruritus, blister. Additional information: Specific relevant test for thromboembolic events with thrombocytopenia was not done. Patient did not have covid prior vaccination and patient was not tested positive for covid after vaccination. Patient was not received any other vaccine in four weeks. They appeared late as one day before report (reported as yesterday) with more appearing on the day of the report (reported as today). shot on Friday, 08Oct202, breakout today, the 13Oct2021.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Immunisation, Pain in extremity
Clinical narrative: dose number 3; sore arm; light headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  An elderly female patient (not pregnant) received bnt162b2 (COMIRNATY), administration date 12Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 immunization; Bnt162b2 (Dose 2), administration date: Feb2021, for Covid-19 immunization, reaction(s): "Headache", "Sore arm". The following information was reported: IMMUNISATION (non-serious) with onset 12Oct2021, outcome "unknown", described as "dose number 3"; PAIN IN EXTREMITY (non-serious) with onset 12Oct2021, outcome "unknown", described as "sore arm"; HEADACHE (non-serious) with onset 12Oct2021, outcome "unknown", described as "light headache". It was unknown if therapeutic measures were taken as a result of pain in extremity, headache.  Additional information: The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up. It was unknown, if patient receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if patient diagnosed with COVID-19, prior to vaccination. It was unknown if patient been tested for COVID-19, Since the vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Axillary pain, Body temperature, Headache, Myalgia
Clinical narrative: severe armpit pain; Headache; Fever; joint pain; muscle pain; This is a spontaneous report received from a non-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 13Oct2021 13:00 (Lot number: 30145BA) at the age of 45 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "known allergies: gantricine" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FC3184, Location of injection: Arm Left, Vaccine Administration Time: 13.00), administration date: 20Sep2021, when the patient was 45 years old, for Covid-19 immunization. The following information was reported: AXILLARY PAIN (non-serious) with onset 14Oct2021 02:00, outcome "recovered with sequelae", described as "severe armpit pain"; HEADACHE (non-serious) with onset 14Oct2021 02:00, outcome "recovered with sequelae", described as "Headache"; PYREXIA (non-serious) with onset 14Oct2021 02:00, outcome "recovered with sequelae", described as "Fever"; ARTHRALGIA (non-serious) with onset 14Oct2021 02:00, outcome "recovered with sequelae", described as "joint pain"; MYALGIA (non-serious) with onset 14Oct2021 02:00, outcome "recovered with sequelae", described as "muscle pain". The events "severe armpit pain", "headache", "fever" and "muscle pain" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: body temperature: unknown result, notes: fever. Therapeutic measures were not taken as a result of axillary pain, headache, pyrexia, arthralgia, myalgia.  Additional information: The patient did not receive other vaccine in four weeks. The patient did visit doctor or other healthcare professional office/clinic visit as resulted adverse event. The patient was Recovered with lasting effects. The patient did not receive adverse event for treatment. The patient had not Covid prior vaccination. The patient was not Covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: severe armpit pain; Headache; Fever; joint pain; muscle pain; This is a spontaneous report received from a non-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 13Oct2021 13:00 (Lot number: 30145BA) at the age of 45 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "known allergies: gantricine" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FC3184, Location of injection: Arm Left, Vaccine Administration Time: 13.00), administration date: 20Sep2021, when the patient was 45 years old, for Covid-19 immunization. The following information was reported: AXILLARY PAIN (non-serious) with onset 14Oct2021 02:00, outcome "recovered with sequelae", described as "severe armpit pain"; HEADACHE (non-serious) with onset 14Oct2021 02:00, outcome "recovered with sequelae", described as "Headache"; PYREXIA (non-serious) with onset 14Oct2021 02:00, outcome "recovered with sequelae", described as "Fever"; ARTHRALGIA (non-serious) with onset 14Oct2021 02:00, outcome "recovered with sequelae", described as "joint pain"; MYALGIA (non-serious) with onset 14Oct2021 02:00, outcome "recovered with sequelae", described as "muscle pain". The events "severe armpit pain", "headache", "fever" and "muscle pain" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: body temperature: unknown result, notes: fever. Therapeutic measures were not taken as a result of axillary pain, headache, pyrexia, arthralgia, myalgia.  Additional information: The patient did not receive other vaccine in four weeks. The patient did visit doctor or other healthcare professional office/clinic visit as resulted adverse event. The patient was Recovered with lasting effects. The patient did not receive adverse event for treatment. The patient had not Covid prior vaccination. The patient was not Covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Immunisation, Insomnia, Pain in extremity
Clinical narrative: booster shot; my left arm aint never stopped hurting since I took the booster shot; I haven''t been sleeping since I received the Pfizer shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 04Oct2021 10:00 (Lot number: FF2588) at the age of 47 years as dose 3 (booster) , single for covid-19 immunisation. Relevant medical history included: "Vitamin deficiency" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing); "weakened immune system" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN D3 taken for hypovitaminosis, start date: 22Jul2021 (ongoing); LISINOPRIL HCTZ taken for hypertension, start date: 28Oct2019 (ongoing); ATORVASTATIN taken for blood cholesterol increased, start date: 04May2020 (ongoing). Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EN6205, Location of injection: Arm Left, Vaccine Administration Time: 02:45 PM), administration date: 01Apr2021, when the patient was 47 years old, for COVID-19 Immunization, reaction(s): "I haven''t been sleeping since I received the Pfizer shot"; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6198, Location of injection: Arm Left, Vaccine Administration Time: 11:30 AM), administration date: 11Mar2021, when the patient was 46 years old, for COVID-19 Immunization, reaction(s): "I haven''t been sleeping since I received the Pfizer shot". The following information was reported: IMMUNISATION (non-serious) with onset 04Oct2021, outcome "unknown", described as "booster shot"; INSOMNIA (non-serious) with onset 01Apr2021 22:00, outcome "not recovered", described as "I haven''t been sleeping since I received the Pfizer shot"; PAIN IN EXTREMITY (non-serious) with onset Oct2021, outcome "not recovered", described as "my left arm aint never stopped hurting since I took the booster shot". The event "i haven''t been sleeping since i received the pfizer shot" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of insomnia, pain in extremity.  Additional information: The patient had no other vaccine within four weeks and no other medications received within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not have any allergies.   Follow-up attempts are completed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Immunisation, Insomnia, Lethargy
Clinical narrative: The next day, I flet lethargic all day; I got severe chills; headache; Dose received: 3; I couldn't sleep that night at all; This is a spontaneous report received from 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 left, administration date 20Oct2021 09:30 (Lot number: FE3590) at the age of 66 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "allergies: Penicillin" (unspecified if ongoing); "low tolerance to Narcotics or pain meds" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EL9264, Location of injection: Arm Left, Vaccine Administration Time: 03:30 PM), administration date: 13Feb2021, when the patient was 65 years old, for covid-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EN6204, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 06Mar2021, when the patient was 65 years old, for COVID-19 Immunization. The following information was reported: CHILLS (non-serious) with onset 20Oct2021 23:30, outcome "recovered" (2021), described as "I got severe chills"; HEADACHE (non-serious) with onset 20Oct2021 23:30, outcome "recovered" (2021), described as "headache"; INSOMNIA (non-serious) with onset 20Oct2021, outcome "recovered" (2021), described as "I couldn't sleep that night at all"; LETHARGY (non-serious) with onset 21Oct2021, outcome "recovered" (2021), described as "The next day, I felt lethargic all day"; IMMUNISATION (non-serious) with onset 20Oct2021 09:30, outcome "unknown", described as "Dose received: 3". Therapeutic measures were not taken as a result of chills, headache, insomnia, lethargy, immunisation.  Additional Information : No other vaccine in four weeks. No Other medications in two weeks. No covid prior vaccination. Patient was not tested post vaccination for covid. Facility type Vaccine was Pharmacy or Drug Store. After vaccination next day felt lethargic all day. Patient did not have the side effects on the last 2 doses. Follow-up attempts are completed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Condition aggravated, Pain in extremity, SARS-CoV-2 test
Clinical narrative: weakness; arm pain; knee pain; which increased daily for over 6 weeks; This is a spontaneous report received from contactable Consumer or other non-HCP. The reporter is the patient.  A 54 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07Apr2021 10:15 (Batch/Lot number: unknown) at the age of 54 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "known allergies: Latex" (unspecified if ongoing); "known allergies: Eye drops" (unspecified if ongoing), notes: known allergies: Eye drops. Concomitant medication(s) included: VIT D [COLECALCIFEROL]. Vaccination history included: Bnt162b2 (Dose Number: 1, Location of injection: Arm Right), administration date: 12Mar2021, when the patient was 54 years old, for COVID-19 Immunization, reaction(s): "First dose felt like waking from anesthesia". The following information was reported: ASTHENIA (non-serious) with onset 07Apr2021, outcome "recovered with sequelae", described as "weakness"; PAIN IN EXTREMITY (non-serious) with onset 07Apr2021, outcome "recovered with sequelae", described as "arm pain "; ARTHRALGIA (non-serious) with onset 07Apr2021, outcome "recovered with sequelae", described as "knee pain"; CONDITION AGGRAVATED (non-serious) with onset 07Apr2021, outcome "recovered with sequelae", described as "which increased daily for over 6 weeks". The events "weakness", "arm pain ", "knee pain" and "which increased daily for over 6 weeks" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of asthenia, pain in extremity, arthralgia, condition aggravated.  Additional information: The patient did not receive no other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination as Vitamin d multivitamin. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. Device Date mentioned as 30Oct2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Feeding disorder, Immunisation, Malaise
Clinical narrative: nauseated on and off/ was a little nauseated; chills; not feeling any better; a little dizzy; she was not eating much today because she was nauseated; Booster; did not sleep well for the rest of the night; This is a spontaneous report from a contactable consumer (patient herself). A 83 year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via unspecified route of administration on 31Oct2021 16:00 (Lot number: 32030BD) at the age of 83 years as dose 3 (booster), single for COVID-19 immunization. Relevant medical history included: "Afib" (ongoing) (diagnosed 6 years ago. Medication is working); "CKD" (ongoing); "Osteoporosis" (ongoing); "Hypertension" (ongoing) and "Increase Cholesterol". Concomitant medications included: LOVASTATIN, XARELTO, DILTIAZEM, FLECAINIDE and TIMOLOL. Vaccination history included: Bnt162b2 (Dose: 1, Lot/Batch number: EL9263), administration date: 23Jan2021, when the patient was 83 years old, for COVID-19 immunization; Bnt162b2 (Dose: 2, Lot/Batch number: EN6201), administration date: 15Feb2021, when the patient was 83 years old, for COVID-19 immunization, reaction(s): "headache". On 31Oct2021 16:00, the patient had booster and on the same day, did not sleep well for the rest of the night. On 01Nov2021 11:30, the patient experienced nauseated on and off/ was a little nauseated, chills, not feeling any better, a little dizzy and she was not eating much today because she was nauseated. The clinical outcome of the events nauseated on and off/ was a little nauseated, chills, not feeling any better, a little dizzy and she was not eating much today because she was nauseated was recovering and for remaining was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Poor quality sleep
Clinical narrative: nauseated on and off/ was a little nauseated; chills; not feeling any better; a little dizzy; she was not eating much today because she was nauseated; Booster; did not sleep well for the rest of the night; This is a spontaneous report from a contactable consumer (patient herself). A 83 year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via unspecified route of administration on 31Oct2021 16:00 (Lot number: 32030BD) at the age of 83 years as dose 3 (booster), single for COVID-19 immunization. Relevant medical history included: "Afib" (ongoing) (diagnosed 6 years ago. Medication is working); "CKD" (ongoing); "Osteoporosis" (ongoing); "Hypertension" (ongoing) and "Increase Cholesterol". Concomitant medications included: LOVASTATIN, XARELTO, DILTIAZEM, FLECAINIDE and TIMOLOL. Vaccination history included: Bnt162b2 (Dose: 1, Lot/Batch number: EL9263), administration date: 23Jan2021, when the patient was 83 years old, for COVID-19 immunization; Bnt162b2 (Dose: 2, Lot/Batch number: EN6201), administration date: 15Feb2021, when the patient was 83 years old, for COVID-19 immunization, reaction(s): "headache". On 31Oct2021 16:00, the patient had booster and on the same day, did not sleep well for the rest of the night. On 01Nov2021 11:30, the patient experienced nauseated on and off/ was a little nauseated, chills, not feeling any better, a little dizzy and she was not eating much today because she was nauseated. The clinical outcome of the events nauseated on and off/ was a little nauseated, chills, not feeling any better, a little dizzy and she was not eating much today because she was nauseated was recovering and for remaining was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 85.0
Sex: U
Vaccine: COVID19
Symptoms: Blood test, Immunisation, Rash
Clinical narrative: Booster; slight rash on my left shoulder; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 85 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 17Oct2021 14:00 (Lot number: FE3590) at the age of 85 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (1st dose:, Time(24hrs): 14:00, Anatomical site of injection: Left shoulder, Route of Administration: Intramuscular, Batch/Lot number: EL1283), administration date: 27Jan2021, for Covid-19 Immunization, reaction(s): "rash on my left shoulder at injection site"; Bnt162b2 (2nd dose:, Time(24hrs): 13:00, Anatomical site of injection: Left shoulder, Route of Administration: Intramuscular, Batch/Lot number: EL9262), administration date: 17Mar2021, for Covid-19 Immunization, reaction(s): "rash reappeared on my left shoulder". The following information was reported: IMMUNISATION (non-serious) with onset 17Oct2021 14:00, outcome "unknown", described as "Booster"; RASH (non-serious) with onset 2021, outcome "unknown", described as "A Slight rash on my left shoulder". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Prior Vaccination (within 4 weeks): None.   Follow-up attempts completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Immunisation, Vaccination site discolouration, Vaccination site pain, Vaccination site swelling
Clinical narrative: Little blue where the shot was given; Little blue where the shot was given, so it feels like a mosquito bite, it's a little swollen and it hurts; Little blue where the shot was given, so it feels like a mosquito bite, it's a little swollen and it hurts; I had Pfizer Booster shot; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot number: unknown), as dose 3 (booster), single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose and Bnt162b2 Second dose), for COVID-19 immunization. The following information was reported: On an unspecified date, the patient had Pfizer Booster shot (unspecified shot) yesterday and had a side effect, it's little blue where the shot was given, so it feels like a mosquito bite and it's a little swollen (and it hurts). The clinical outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Vertigo
Clinical narrative: Severe vertigo approximately 5 days after; On 2nd shot: Migraine headaches on day 2; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Apr2021 (Lot number: E0102) at the age of 47 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number: 1, Lot number: ER2613, Vaccine location: Left arm), administration date: 21Mar2021, when the patient was 47 years old, for COVID-19 Immunization. The following information was reported: MIGRAINE (non-serious) with onset 12Apr2021, outcome "unknown", described as "On 2nd shot: Migraine headaches on day 2"; VERTIGO (non-serious) with onset 15Apr2021, outcome "unknown", described as "Severe vertigo approximately 5 days after". The events "on 2nd shot: migraine headaches on day 2" and "severe vertigo approximately 5 days after" were evaluated at the physician office visit.  Additional Information: On 3rd shot: Tinnitus in the right ear, still ongoing after 1 week  No follow-up attempts are possible. No further information is expected.