chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Muscle injury, Myalgia, Pain in extremity, Vaccination site pain
Clinical narrative: Yesterday the patient tested positive using a rapid/"instant" test for COVID-19 as well as again today using an "instant" test resulting as positive.; Yesterday the patient tested positive using a rapid/"instant" test for COVID-19 as well as again today using an "instant" test resulting as positive.; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer(patient) reported that a 69-year-old male patient received bnt162b2 (PFIZER-BIONTECH covid-19 vaccine, formulation: solution for injection) via an unspecified route of administration (batch number/lot number: FC3182), in left arm on 30Aug2021 12:00 PM (at the age of 69-years-old) as dose 3, single, via an unspecified route of administration (batch number/lot number: EL9262), in left arm on 02Feb2021 12:00 PM (at the age of 68-years-old) as dose 2, single and via an unspecified route of administration (batch number/lot number: EH9859), in left arm on 12Jan2021 12:00 PM (at the age of 68-years-old) as dose 1, single and all for covid-19 immunization . Medical history included ongoing high cholesterol from ten years. Ongoing concomitant medication included rosuvastatin for high cholesterol from ten years. The patient received his 1st dose of the Pfizer COVID vaccine on 12Jan2021, 2nd dose 02Feb2021, & 3rd dose received on 30Aug2021. On 15Sep2021 the patient tested positive using a rapid/"instant" test for COVID-19 as well as again on 16Sep2021 using an "instant" test resulting as positive. The patient was waiting on the PCR testing results. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 15Sep2021 and sars-cov-2 test: positive on 16Sep2021. The outcome of the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Breakthrough infection with COVID-19; Breakthrough infection with COVID-19; This is a spontaneous report from a non-contactable consumer or other no-health care professional. An adult female (non-pregnant at the time of vaccination) patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection; Batch no: not reported/Lot Number: EP6955) via an unspecified route of administration, administered in Arm Left on 24Mar2021 as dose 1, single and bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection; Batch no: not reported/Lot Number: EP9655) via an unspecified route of administration, administered in Arm Left on 14Apr2021 as dose 2, single for covid-19 immunization at Workplace clinic. The patient had medical history of Rheumatoid arthritis from an un-known date and unknown if ongoing. Concomitant medication included other medications the patient received within 2 weeks of vaccination as adalimumab (HUMIRA) taken for an unspecified indication, start and stop date were not reported. Patient did not receive other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since vaccination patient had been tested for COVID-19. On 08Sep2021, the patient had breakthrough infection with COVID-19 along with vaccination failure. Timeframe between vaccination and starting of symptoms was 5 months 15 days. On 22Dec2020, the patient under-went lab tests and procedures which included Sars-cov-2 test Covid-19 with Nasal swab results negative, on 31Jul2021 patient had Nasal swab with Antigen Covid-19 results negative, on 06Aug2021 patient had Nasal swab with Antigen Covid-19 results negative, on 31Aug2021 patient had Covid-19 with Nasal swab results negative and on 07Sep2021, Covid-19 with Nasal swab results Positive. Patient did not receive any treatment for the event caused. Outcome of the events was recovering.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19 confirmed by positive COVID-19 test; COVID-19 confirmed by positive COVID-19 test/ Severe Coughing/ a little bit of a headache/ also cannot taste well; This is a spontaneous report from a contactable consumer (patient father).   A 19-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER2613, Expiration date was not reported) via an unspecified route of administration on 09Mar2021 (at the age of 19 years) as dose 1, single and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER2613, Expiration date was not reported), via an unspecified route of administration on 20Apr2021 (at the age of 19 years) as dose 2, single, both for covid-19 immunization. Patient had no medical history and family medical history relevant to events. The patient's concomitant medications were not reported. Patient did not take any other vaccinations within four weeks prior to the first administration date of the suspect vaccine and no other vaccines on same date of the vaccination. On an unknown date, patient experienced severe coughing and a little bit of a headache and patient decided to get tested for covid-19. The symptoms were still persisting. Patient also cannot taste well. On 13Sep2021, patient got covid-19 confirmed by positive covid-19 test, after both doses of vaccine. Product complaint was reported as yes. Patient did not visit to emergency room or physician office. The clinical outcome for the events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Breakthrough COVID infection; Breakthrough COVID infection; This is a spontaneous report from a contactable consumer (patient). An adult male patient of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3247) via intramuscular, administered in left arm on 16Feb2021 as DOSE 2, SINGLE, and first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3247) via intramuscular, administered in left arm on 26Jan2021 as DOSE 1, SINGLE for covid-19 immunisation. The medical history included hypertension. The concomitant medication(s) included losartan (LOSARTAN) and modafinil (PROVIGIL [MODAFINIL]) taken for an unspecified indication. The patient had known allergies to amitriptyline and flagyl. On 12Sep2021, the patient experienced breakthrough covid infection. Patient was not tested for covid prior to vaccination. The patient underwent lab tests and procedures which included qRT-PCR COVID-19 test nasal swab on 22Dec2020 with result negative, qRT-PCR COVID-19 test nasal swab on 27Jul2021 with result negative, antigen COVID-19 test nasal swab on 31Jul2021 with result negative, antigen COVID-19 test nasal swab on 06Aug2021 with result negative, qRT-PCR COVID-19 nasal swab on 01Sep2021 with result negative, antigen COVID-19test nasal swab on 11Sep2021 with result negative, and qRT-PCR COVID-19 test nasal swab on 15Sep2021 with result positive. Patient did not receive treatment for the event. The outcome of the events was recovering.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Follow-Up (22Sep2021): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: my husband's ex-wife died; This is a spontaneous report from a contactable consumer. This consumer reported that a female patient of unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date as single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The reporter stated that her husband's ex-wife died. It was unknown if Autopsy Done. The outcome of the event was fatal.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Reported Cause(s) of Death: my husband's ex-wife died
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Menstruation delayed, Pregnancy test
Clinical narrative: Have not started menstruating since receiving the first dose of the vaccine; Severe cramping for 1 day around the time should have been menstruating, but it never came; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0198) via an unspecified route of administration in the left arm on 07Aug2021 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had known allergy to sulfa drugs. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. On 30Aug2021, since receiving the first dose of the vaccine, the patient had not started menstruating. It was supposed to start on 30Aug2021, but the patient was 18 days late so far (at the time of report). On an unknown date in 2021, the patient had taken two pregnancy tests (one 2 weeks ago and another 1 week ago) and the results were unknown. The patient stated that minor fluctuations occurred in her normal cycle and she had never been this late prior to vaccination, without being pregnant. On an unknown date in Aug2021, the patient did experience severe cramping for one day around the time she should have been menstruating, but it never came. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event severe cramping for 1 day around the time should have been menstruating, but it never came was recovered on an unknown date in 2021. The clinical outcome of the event have not started menstruating since receiving the first dose of the vaccine was not recovered at the time of this report. The patient also received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 39308A) via an unspecified route of administration in the left arm on 14Sep2021 (at the age of 40-years-old) as a single dose for COVID-19 immunisation.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Amenorrhoea, Biopsy, Colposcopy, Hot flush, Smear cervix
Clinical narrative: Lost "my" menstrual periods for 5 months.; Severe hot flashes; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the left arm on 25Apr2021 at 13:00 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. The patient's medical history reported as not applicable. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 04Apr2021 at 10:45 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. On an unknown date in Apr2021, the patient reportedly lost her menstrual periods for 5 months. In addition, she experienced severe hot flashes that caused her to believe she was in early menopause. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of loss of menstrual periods for 5 months and severe hot flashes. On an unknown date in 2021, the patient underwent papanicolaou smear test (PAP) and was abnormal with low non-HPV related results; also, it was reported that, the patient had a colposcopy and the biopsy which was done by physician and showed the same results (abnormal). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events lost her menstrual periods for 5 months and severe hot flashes was resolved with sequalae on an unknown date in Sep2021.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dehydration, Dizziness, Gastritis, Headache
Clinical narrative: Got really really dizzy; Severe headache; Whole body was hurting; Severely dehydrated; Some gastro information (gastric inflammation); Severe cold chills and hot flashes when not running a fever; Severe cold chills and hot flashes when not running a fever; Ran a fever; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 10Sep2021 at 10:00 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, it was unknown if the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication included sertraline hydrochloride (ZOLOFT) for an unknown indication from an unknown date and unknown if ongoing. The patient previously received hydrocodone bitartrate/ paracetamol (LORTAB) and experienced drug allergy. On 15Sep2021, the patient got really really dizzy, had severe headache, her whole body was hurting and she was dehydrated, severely dehydrated. The patient also had some gastro information (gastric inflammation). The patient experienced severe cold chills and hot flashes when not running a fever, and then she also ran a fever that she was still fighting. The patient did not have issues with cold chills while running a fever. The events resulted in emergency room/department or urgent care visit. Since the vaccination, the patient had been tested for COVID-19. On 16Sep2021, the patient underwent respiratory panel test via nasal swab and the test result was negative. Therapeutic measures were taken as a result of the events and the patient was prescribed with a muscle relaxer (unspecified). The clinical outcome of the events got really really dizzy, severe headache, whole body was hurting, severely dehydrated, some gastro information (gastric inflammation), severe cold chills and hot flashes when not running a fever and ran a fever was not recovered at the time of the report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush, Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: Got really really dizzy; Severe headache; Whole body was hurting; Severely dehydrated; Some gastro information (gastric inflammation); Severe cold chills and hot flashes when not running a fever; Severe cold chills and hot flashes when not running a fever; Ran a fever; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 10Sep2021 at 10:00 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, it was unknown if the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication included sertraline hydrochloride (ZOLOFT) for an unknown indication from an unknown date and unknown if ongoing. The patient previously received hydrocodone bitartrate/ paracetamol (LORTAB) and experienced drug allergy. On 15Sep2021, the patient got really really dizzy, had severe headache, her whole body was hurting and she was dehydrated, severely dehydrated. The patient also had some gastro information (gastric inflammation). The patient experienced severe cold chills and hot flashes when not running a fever, and then she also ran a fever that she was still fighting. The patient did not have issues with cold chills while running a fever. The events resulted in emergency room/department or urgent care visit. Since the vaccination, the patient had been tested for COVID-19. On 16Sep2021, the patient underwent respiratory panel test via nasal swab and the test result was negative. Therapeutic measures were taken as a result of the events and the patient was prescribed with a muscle relaxer (unspecified). The clinical outcome of the events got really really dizzy, severe headache, whole body was hurting, severely dehydrated, some gastro information (gastric inflammation), severe cold chills and hot flashes when not running a fever and ran a fever was not recovered at the time of the report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Rheumatoid arthritis
Clinical narrative: rheumatoid arthritis (which was going out of control according to caller); This is a spontaneous report from a contactable consumer or other non hcp (patient). A female patient of an unspecified age received BNT162B2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE and second dose of BNT162B2 (Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE both for covid-19 immunisation. Medical history included severe histoplasmosis ongoing from 2015, patient added that severe histoplasmosis was diagnosed in 2015 due to Remicade and she was hospitalized for 21 days. Concomitant medication included posaconazole (NOXAFIL) taken for histoplasmosis, start and stop date were not reported. On an unknown date, patient was inquiring about the booster dose and currently taking Inflectra IV for rheumatoid arthritis (which was going out of control according to caller). The outcome of the event was unknown.  Lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Cold sweat, Fatigue
Clinical narrative: Extreme fatigue; Cold sweats; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 09Aug2021 at 11:00 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure and high cholesterol. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. The patient previously received codeine (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and experienced drug allergy. On 10Aug2021 at 06:00, the patient experienced extreme fatigue and cold sweats. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events extreme fatigue and cold sweats was recovered on unknown date in 2021. The patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 13Sep2021 at 11:00 (at the age of 36-years-old) as a single dose for COVID-19 immunisation.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Pain, Pyrexia
Clinical narrative: Woke up with chills; Severe body aches; Joint pain; Headache; Fever; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2588) via an unspecified route of administration in the left arm on 13Sep2021 at 13:00 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. Medical history included allergic to sulfa drugs and injection dyes. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication included paracetamol (TYLENOL) for unknown indication from an unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3182) via an unspecified route of administration in the left arm on 22Aug2021 at 17:00 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. The patient previously received codeine (MANUFACTURER UNKNOWN) for unknown indication on an unknown date and experienced drug allergy. On 14Sep2021 at 04:00, the patient woke up with chills, severe body aches, joint pain, headache and fever. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events chills, severe body aches, joint pain, headache and fever was resolved on an unknown date in Sep2021.   No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Fatigue, Lymphadenopathy, Muscle spasms, Palpitations
Clinical narrative: Severe internal /external rash; Blistering at site on chest and face; Swollen lymph node; Heart palpitations; Fatigue; Itchy and blotchy skin; Itchy and blotchy skin; Burning skin; Neck cramp; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FD8448) via an unspecified route of administration in the right arm on 17Aug2021 at 17:00 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergies to penicillin, egg, pork, nickel, pollen, dust, mold, and most alloy metals. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. On 18Aug2021 at 19:45, the patient experienced severe internal/external rash, blistering at site on chest and face, swollen lymph node, heart palpitations, fatigue, itchy and blotchy skin, burning skin, and neck cramp. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events severe internal/external rash, blistering at site on chest and face, itchy and blotchy skin and burning skin and included treatment with unspecified steroid and dermal ointment. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe internal/external rash, blistering at site on chest and face, swollen lymph node, heart palpitations, fatigue, itchy and blotchy skin, burning skin, and neck cramp were resolved with sequelae on an unknown date in 2021.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Rash macular, Skin burning sensation
Clinical narrative: Severe internal /external rash; Blistering at site on chest and face; Swollen lymph node; Heart palpitations; Fatigue; Itchy and blotchy skin; Itchy and blotchy skin; Burning skin; Neck cramp; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FD8448) via an unspecified route of administration in the right arm on 17Aug2021 at 17:00 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergies to penicillin, egg, pork, nickel, pollen, dust, mold, and most alloy metals. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. On 18Aug2021 at 19:45, the patient experienced severe internal/external rash, blistering at site on chest and face, swollen lymph node, heart palpitations, fatigue, itchy and blotchy skin, burning skin, and neck cramp. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events severe internal/external rash, blistering at site on chest and face, itchy and blotchy skin and burning skin and included treatment with unspecified steroid and dermal ointment. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe internal/external rash, blistering at site on chest and face, swollen lymph node, heart palpitations, fatigue, itchy and blotchy skin, burning skin, and neck cramp were resolved with sequelae on an unknown date in 2021.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Dysmenorrhoea, Headache, Pain, Vaginal haemorrhage
Clinical narrative: She started having horrible cramps and bleeding the morning after the 2nd COVID-19 Shot.; She started having horrible cramps and bleeding the morning after the 2nd Covid Shot.; Also had horrible body aches and a headache; Also had horrible body aches and a headache; This is a spontaneous report from a contactable other healthcare professional, the patient. A 28-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2589) via an unspecified route of administration in the right arm on 13Sep2021 at 18:30 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history included idiopathic cranial pressure. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included omeprazole (MANUFACTURER UNKNOWN), cetirizine hydrochloride (ZYRTEC), duloxetine (MANUFACTURER UNKNOWN) 60 mg and etonogestrel (NEXPLANON) for unknown indication from an unknown date and unknown if ongoing. The patient previously received loratadine (CLARITINE) for unknown indication on an unknown date and experienced drug allergy. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0164) via an unspecified route of administration in the left arm on 21Aug2021 at 19:00 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. It was reported that the patient had nexplanon implant and she was not supposed to menstruate with that. On 14Sep2021 at 08:00, patient started having horrible cramps and bleeding, reportedly the morning after the 2nd COVID-19 shot. The patient also had horrible body aches and a headache. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events horrible cramps, bleeding the morning after the 2nd COVID-19 shot, horrible body aches and headache was not recovered at the time of this report.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: 2 and 3 days after second shot having extreme dizziness; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7488) via an unspecified route of administration in the right arm on an unknown date in Sep2021 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medication within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FF2587) via an unspecified route of administration in the right arm on 08Aug2021 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. On 16Sep2021 at 14:00, 2 and 3 days after second shot, the patient experienced extreme dizziness. The event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event 2 and 3 days after second shot having extreme dizziness was unknown at the time of the report.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Tinnitus
Clinical narrative: Started developing tinnitus/ continued to get worse 5 1/2 months out sounds like constant electrical buzz in center of back of the head; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received a second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 26Mar2021 at 14:45 (at the age of 61-years-old) as a single dose for COVID-19 immunization. The patient had no medical history and known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient did not receive any concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the left arm on 05Mar2021 at 14:00 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. On 29Mar2021, the patient started developing tinnitus within few days of the second (2nd) shot. The patient had visited an ENT (Ear nose throat) and the doctor said that structurally everything was fine. The doctor had seen a great uptick in tinnitus for patients after the vaccine. The tinnitus had continued to get worse 5 and a half (1/2) months out and sounds like a constant electrical buzz in the center of the back of the head. It never went away, so loud that the patient heard it over television (TV), fans, etc. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had been tested for COVID-19. The patient underwent a COVID-19 test (reported as blood test) on 17Mar2021, 12May2021, and 07Jul2021 and the result was negative. The patient also underwent a rapid test via nasal swab on 03Sep2021 and the result was negative. The clinical outcome of the event started developing tinnitus/ continued to get worse 5 1/2 months out sounds like constant electrical buzz in center of back of the head was not resolved at the time of the report.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Anti-thyroid antibody, Anti-thyroid antibody positive, Blood thyroid stimulating hormone, Blood thyroid stimulating hormone increased, Inflammation
Clinical narrative: neck inflammation; Thyroid TSH and TPO ab levels increased; TPO ab levels increased; This is a spontaneous report from a contactable consumer (patient himself). A 45-year-old male patient received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, and Lot Number GB8727) via an unspecified route of administration, administered in arm right on 29Mar2021 16:00 (age at vaccination 45 years) as dose 1, single for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included bile salts, collinsonia canadensis root (CHOLACOL), phyllanthus niruri (CHANCA PIEDRA), vitamin d and ImmunoMod-A. The patient previously took oxycodone and lotrimin af. The patient did not received 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 experienced neck inflammation on 30Mar2021, thyroid TSH and TPO ab levels increased on an unspecified date in 2021. It was reported that adverse event resulted in Emergency room/department or urgent care and physician office visit. The reporter assessed the events as non-serious. The patient underwent lab tests and procedures which included TPO ab: increased, Thyroid TSH: increased on unspecified date in 2021 (level increased after each vaccination) and Nasal swab test was negative on Jul2021. Therapeutic measures were taken as a result of the adverse events included vertigo meds, anti-inflammatory, Xanax and Prozac. The outcome of the events was not recovered.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-1 test
Clinical narrative: neck inflammation; Thyroid TSH and TPO ab levels increased; TPO ab levels increased; This is a spontaneous report from a contactable consumer (patient himself). A 45-year-old male patient received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 VACCINE, Solution for injection, and Lot Number GB8727) via an unspecified route of administration, administered in arm right on 29Mar2021 16:00 (age at vaccination 45 years) as dose 1, single for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included bile salts, collinsonia canadensis root (CHOLACOL), phyllanthus niruri (CHANCA PIEDRA), vitamin d and ImmunoMod-A. The patient previously took oxycodone and lotrimin af. The patient did not received 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 experienced neck inflammation on 30Mar2021, thyroid TSH and TPO ab levels increased on an unspecified date in 2021. It was reported that adverse event resulted in Emergency room/department or urgent care and physician office visit. The reporter assessed the events as non-serious. The patient underwent lab tests and procedures which included TPO ab: increased, Thyroid TSH: increased on unspecified date in 2021 (level increased after each vaccination) and Nasal swab test was negative on Jul2021. Therapeutic measures were taken as a result of the adverse events included vertigo meds, anti-inflammatory, Xanax and Prozac. The outcome of the events was not recovered.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity, Polymerase chain reaction, Pruritus, Rash
Clinical narrative: Allergic reaction.; Rash; Itching all over body; This is a spontaneous report from a contactable consumer, the patient. A 42-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0196) via an unspecified route of administration in the arm left on 19Aug2021 at 09:00 (at the age of 42-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive concomitant medication. On 26Aug2021 at 18:00, the patient experienced an allergic reaction, rash and itching all over his body. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures taken as a result of events included treatment with cortisone cream (MANUFACTURER UNKNOWN) from an unknown date. Since the vaccination, the patient had been tested for COVID-19. On 14Sep2021, the patient underwent polymerase chain reaction (PCR) test (nasal swab) and the result was negative. The clinical outcome of the events allergic reaction, rash and itching all over body was not resolved at the time of this report. The patient also received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FD8448) via an unspecified route of administration in the arm left on an unspecified date in 2021 (at the age of 42-year-old) as a single dose for COVID-19 immunisation.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Rash papular, Rash pruritic, SARS-CoV-2 test
Clinical narrative: Red, horribly itchy bumps all over body; Red, horribly itchy bumps all over body; Red, horribly itchy bumps all over body; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 27Aug2021 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history included few unspecified histories and known allergies to penicillin, shellfish and hares. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received unspecified concomitant medications (reported as the patient had received same medications for over a year). On 30Aug2021, the patient experienced red, horribly itchy bumps all over the body which was not really like hives, but more like chickenpox or shingles. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events which included treatment with steroids, creams and lotions. Since the vaccination, the patient had been tested for COVID-19. On 01Sep2021, the patient underwent Nasal Swab CoV-2 test and the result was negative. The clinical outcome of the events red, horribly itchy bumps all over body was not resolved at the time of this report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Erythema, Flushing, Headache, Lymphadenopathy
Clinical narrative: Headache; Flush red face; Flush red face; Low fever; Swollen lymph nodes under arm on right and left side; Low energy; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3184) via an unspecified route of administration in the right arm on 10Sep2021 at 16:00 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and known allergies to sulfa drugs. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient received unspecified concomitant medications. On 10Sep2021 at 21:00, the patient experienced headache, flush red face, low fever, swollen lymph nodes under arm on right and left side and low energy. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, flush red face, low fever, swollen lymph nodes under arm on right and left side and low energy was not resolved at the time of this report.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Headache; Flush red face; Flush red face; Low fever; Swollen lymph nodes under arm on right and left side; Low energy; This is a spontaneous report from a contactable consumer, the patient. A 64-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3184) via an unspecified route of administration in the right arm on 10Sep2021 at 16:00 (at the age of 64-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and known allergies to sulfa drugs. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient received unspecified concomitant medications. On 10Sep2021 at 21:00, the patient experienced headache, flush red face, low fever, swollen lymph nodes under arm on right and left side and low energy. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events headache, flush red face, low fever, swollen lymph nodes under arm on right and left side and low energy was not resolved at the time of this report.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Extra dose administered, Hyperacusis, Off label use, Tinnitus
Clinical narrative: 3rd dose of the vaccine; 3rd dose of the vaccine; Ringing and hypersensitivity of left ear; Ringing and hypersensitivity of left ear; This is a spontaneous report from a contactable nurse, the patient. A 30-year-old non-pregnant female patient received third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0198) via an unspecified route of administration in the left arm on 24Aug2021 at 11:00 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included Crohn's disease and chronic immunosupressive therapy. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included azathioprine (MANUFACTURER UNKNOWN) and cyanocobalamin (Vitamin b-12), and unspecified prenatal medication; all for unknown indication from unknown date and unknown if ongoing. The patient previously received first dose of COVID-19 VACCINE (MANUFACTURER UNKNOWN; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date and also second dose of COVID-19 VACCINE (MANUFACTURER UNKNOWN; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 26Aug2021, the patient had ringing and hypersensitivity of her left ear which was began in the same week of her injection. It occurred frequently and had faded. The patient had not noticed the problem at the time of report. It was reported that, this was her third dose of the vaccine about 7 months after her second dose series. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events ringing and hypersensitivity of left ear was resolved on an unknown date in 2021.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypersensitivity, Sensory disturbance, Tinnitus
Clinical narrative: 3rd dose of the vaccine; 3rd dose of the vaccine; Ringing and hypersensitivity of left ear; Ringing and hypersensitivity of left ear; This is a spontaneous report from a contactable nurse, the patient. A 30-year-old non-pregnant female patient received third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0198) via an unspecified route of administration in the left arm on 24Aug2021 at 11:00 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included Crohn's disease and chronic immunosupressive therapy. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included azathioprine (MANUFACTURER UNKNOWN) and cyanocobalamin (Vitamin b-12), and unspecified prenatal medication; all for unknown indication from unknown date and unknown if ongoing. The patient previously received first dose of COVID-19 VACCINE (MANUFACTURER UNKNOWN; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date and also second dose of COVID-19 VACCINE (MANUFACTURER UNKNOWN; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunisation. On 26Aug2021, the patient had ringing and hypersensitivity of her left ear which was began in the same week of her injection. It occurred frequently and had faded. The patient had not noticed the problem at the time of report. It was reported that, this was her third dose of the vaccine about 7 months after her second dose series. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events ringing and hypersensitivity of left ear was resolved on an unknown date in 2021.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic, Swelling, Vaccination site pruritus, Vaccination site rash
Clinical narrative: Severe rash that also itches at injection site, on arm and face and right side swelling; Severe rash that also itches at injection site, on arm and face and right side swelling; Severe rash that also itches at injection site, on arm and face and right side swelling; Right side swelling; This is a spontaneous report from a contactable consumer, the patient. A 23-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EE3592) via an unspecified route of administration in the right arm on 14Sep2021 at 17:15 (at the age of 23-years-old) as a single dose for COVID-19 immunisation. Medical history included Charcot-Marie-Tooth disease (CMT), Sjogren's, Multiple Sclerosis (MS), irritable bowel syndrome (IBS), allergy to latex and allergy to adhesive (Contact dermatitis). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks of vaccination. The patient did not receive any concomitant medications. The patient previously took atomoxetine hydrochloride (STRATTERA), paracetamol (TYLENOL), lamotrigine (LAMICTAL), risperidone (RISPERDAL); all for an unknown indication on an unknown date and experienced drug allergy. On 14Sep2021 at 18:00, the patient experienced severe rash that also itched at injection site, on arm and face and right-side swelling. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe rash that also itched at injection site, on arm and face and right-side swelling were not resolved at the time of this report.