chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Influenza like illness, Pain, Pyrexia
Clinical narrative: flu-like symptoms; a fever of at least 102.3; dizziness; chills; sweating; full body aches; extreme fatigue; headache; The milk from 3/6 and 3/7, which was when my reaction was strongest, has a green tint to it compared to my milk on  a typical day; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient). A 31-year-old non-pregnant female patient received bnt162b2 (BNT162B2, Batch/Lot Number: EN6205) via an unspecified route of administration on 04Mar2021 at 16:45 as DOSE 2 SINGLE (Age at vaccination: 31-year-old) for covid-19 immunization at Hospital. Medical history included I gave birth to my first child on 12Mar2020. Concomitant medication included ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS) taken for an unspecified indication. The patient had no covid prior vaccination and no covid tested post vaccination. The patient did not take any other vaccines within 4 weeks. The patient had no known allergies. Historical Vaccine received as bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EN6201) via an unspecified route of administration on 12Feb2021 at 06:45 as DOSE 1, SINGLE for covid-19 immunisation at Hospital and experienced flu-like symptoms about 16 hours after her shot. This included a fever (101.5), dizziness, chills with sweating, full body aches, exhaustion and a headache. This lasted approximately 24 hours for the first shot. On 05Mar2021 at 06:00 The patient experienced flu-like symptoms, fever, dizziness, chills, sweating, full body aches, exhaustion, headache, and the milk from 3/6 and 3/7, which was when my reaction was strongest, has a green tint to it compared to my milk on a typical day. It was reported that for second shot, the patient had the same symptoms and experienced extreme fatigue, a fever of at least 102.3, chills with sweating, full body aches, dizziness and a headache. Patient started having symptoms approximately 13 hours after her shot and stayed in bed for approximately 48 hours once my symptoms started. She breastfed before, during and after both reactions. When the patient was unable to breastfeed, the patient pumped and have frozen milk from before, during and after my second dose. The patient did not take any treatment for the events. The patient underwent lab tests and procedures which included body temperature: 102.3 on 05Mar2021. The outcome of the events was recovered on unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, Blood alkaline phosphatase, Blood alkaline phosphatase increased, Blood creatine phosphokinase, Blood creatine phosphokinase increased
Clinical narrative: Ck levels shooting up; cancer antigen doubling; raise in alkaline phosphatase; This is a spontaneous report based on the information received by Pfizer from Genentech (Reference: LRN4245557). A Non-Contactable 77-year-old female consumer (patient) reported that: A 77-years-old female patient received bnt162b2 (PFIZER COVID-19 VACCINE, FORMULATION: Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included Cobimetinib Fumarate (COTELLIC); Vemurafenib (ZELBORAF) and Trastuzumab Emtansine (KADCYLA) taken for an unspecified indication, start and stop date were not reported. The patient experienced CK levels shooting up, Cancer antigen doubling from 62 to 156 and raise in alkaline phosphatase on an unspecified date. The patient underwent lab tests and procedures which included blood alkaline phosphatase: raise on an Unspecified date, blood creatine phosphokinase: from 148 to 605 on an unspecified date. The outcome of event was not recovered.  No follow-up attempts are needed. Information about lot/batch number cannot be requested.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Skin injury
Clinical narrative: skin hurt; had head pain but not a headache; This is a spontaneous report from a contactable other healthcare professional. A contactable other healthcare professional reported for his 50-year-old female patient (sister) that she received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: UNKNOWN) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: UNKNOWN) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. On an unspecified date, the patient experienced skin hurt and had head pain but not a headache. The reporter was just checking in about a reaction to the second vaccine shot. Not too worried. His 50-year-old sister, in good health, received her second shot at noon and at about 6pm all of her skin hurt and she had head pain but not a headache. Checked NCBI, etc, websites and found nothing about generalized skin pain. Curious about thoughts. Not unhappy at all. Hang in there, all of you. He was a former EMT (emergency medical technician). Outcome was unknown for both the events.  Follow-up (01Apr2021): This is a follow-up spontaneous report from a contactable Other HCP. This contactable Other HCP reported for patient.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.  No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Shoulder injury related to vaccine administration
Clinical narrative: A long thing on my shoulder and my neck on the arm where I received the vaccination.; Sore arm; nausea; This is a spontaneous report from a contactable consumer or other non-HCP. A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EP6955), via an unspecified route of administration on 24Mar2021 as DOSE 1, SINGLE (Age of vaccination: Unknown) for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date of 2021, the patient experienced sore arm and nausea. On 28Mar2021 the patient experienced a long thing on my shoulder and my neck on the arm where she received the vaccination. The outcome of all event was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Colonoscopy, Computerised tomogram, Culture stool, Diarrhoea
Clinical narrative: Constant daily diarrhea for over a month - still ongoing.; This is a spontaneous report from a contactable consumer (patient). A 76-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6202), via an unspecified route of administration in left arm on 23Feb2021 at 10:00 (at the age of 76-year-old) as dose 1, single for COVID-19 immunisation at public health clinic/veteran's administration facility. Medical history was none. Concomitant medications included esomeprazole magnesium taken for an unspecified indication, start and stop date were not reported; olmesartan taken for an unspecified indication, start and stop date were not reported; hydrochlorothiazide taken for an unspecified indication, start and stop date were not reported. 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 had no known allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. Reporter (Son) stated, he was called on behalf of his mom who was 77-year-old. She had the Covid vaccine back at early in Mar2021. She had diarrhea on 10Mar2021 at 15:00 for a month, it was still happening. She has had stool test, blood work, everything has been normal. She has had colonoscopy, it was normal. She had got her 'CAT' (Computerised tomogram) scan "today", but the doctors are not been able to find anything wrong, they said her everything was checked normally. The one thing we can think of was that almost 2 weeks prior to her coming down with the diarrhea was the fact that she still has "today". She had taken the first dose of the Pfizer vaccine and I do not know if you heard of diarrhea, the doctors are in little bit 'doubt' also. Doctor prescribed anti-diarrhea and anti-spasm drugs not helping much. The reporter was just called to see if any other 'accounts' of this reported. She was going to the CT scan "tomorrow". She had the colonoscopy last Friday that was normal, but she had diarrhea for 1 month, she still has diarrhea. It was pretty bad, so we just do not know what was going on so. The adverse event was resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient underwent lab tests and procedures which included blood test was normal, colonoscopy result was normal, 'CAT' scan (computerised tomogram): not been able to find anything wrong, stool test result was normal, tested for COVID result was negative (Tested for COVID 2x during the month while sick, was negative). The patient did not receive any treatment for the event. The outcome of the event was reported as not resolved.  No follow-up attempts are possible. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 antibody test
Clinical narrative: Constant daily diarrhea for over a month - still ongoing.; This is a spontaneous report from a contactable consumer (patient). A 76-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6202), via an unspecified route of administration in left arm on 23Feb2021 at 10:00 (at the age of 76-year-old) as dose 1, single for COVID-19 immunisation at public health clinic/veteran's administration facility. Medical history was none. Concomitant medications included esomeprazole magnesium taken for an unspecified indication, start and stop date were not reported; olmesartan taken for an unspecified indication, start and stop date were not reported; hydrochlorothiazide taken for an unspecified indication, start and stop date were not reported. 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 had no known allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. Reporter (Son) stated, he was called on behalf of his mom who was 77-year-old. She had the Covid vaccine back at early in Mar2021. She had diarrhea on 10Mar2021 at 15:00 for a month, it was still happening. She has had stool test, blood work, everything has been normal. She has had colonoscopy, it was normal. She had got her 'CAT' (Computerised tomogram) scan "today", but the doctors are not been able to find anything wrong, they said her everything was checked normally. The one thing we can think of was that almost 2 weeks prior to her coming down with the diarrhea was the fact that she still has "today". She had taken the first dose of the Pfizer vaccine and I do not know if you heard of diarrhea, the doctors are in little bit 'doubt' also. Doctor prescribed anti-diarrhea and anti-spasm drugs not helping much. The reporter was just called to see if any other 'accounts' of this reported. She was going to the CT scan "tomorrow". She had the colonoscopy last Friday that was normal, but she had diarrhea for 1 month, she still has diarrhea. It was pretty bad, so we just do not know what was going on so. The adverse event was resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient underwent lab tests and procedures which included blood test was normal, colonoscopy result was normal, 'CAT' scan (computerised tomogram): not been able to find anything wrong, stool test result was normal, tested for COVID result was negative (Tested for COVID 2x during the month while sick, was negative). The patient did not receive any treatment for the event. The outcome of the event was reported as not resolved.  No follow-up attempts are possible. No further information is expected.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Haemoglobin, Haemoglobin decreased, Red blood cell count decreased
Clinical narrative: Overall exhaustion; Low hemoglobin; Loss of red blood cells without any bleeding found; Extremely low energy. Being treated with iron sulfate, but not doing more than keep energy levels from dropping lower; Sleep interruptions; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 78-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9265 and expiry date: unknown), dose 2 via an unspecified route of administration, administered in Arm Left on 16Feb2021 at 12:00 as DOSE 2 (Age at vaccination: 78 Years), SINGLE for covid-19 immunisation. Medical history included asthma, hip arthroplasty, arthritis, blood cholesterol increased (High cholesterol). Concomitant medications included ibuprofen (MOTRIN), simvastatin (SIMVASTATIN), vit d [vitamin d nos] (VIT D [VITAMIN D NOS]). The patient previously took clindamycin and experienced drug hypersensitivity, bnt162b2 for covid-19 immunisation and experienced decreased appetite, weight decreased and fatigue. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced overall exhaustion, low hemoglobin, loss of red blood cells without any bleeding found, extremely low energy. being treated with iron sulfate, but not doing more than keep energy levels from dropping lower, sleep interruptions on 2021. The patient underwent lab tests and procedures which included haemoglobin: low hemoglobin on 2021. The event resulted in doctor or other healthcare professional office/clinic visit. The patient was treatment for the events with iron sulfate, but not doing more than keep energy levels from dropping lower. Outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Sleep disorder
Clinical narrative: Overall exhaustion; Low hemoglobin; Loss of red blood cells without any bleeding found; Extremely low energy. Being treated with iron sulfate, but not doing more than keep energy levels from dropping lower; Sleep interruptions; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 78-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9265 and expiry date: unknown), dose 2 via an unspecified route of administration, administered in Arm Left on 16Feb2021 at 12:00 as DOSE 2 (Age at vaccination: 78 Years), SINGLE for covid-19 immunisation. Medical history included asthma, hip arthroplasty, arthritis, blood cholesterol increased (High cholesterol). Concomitant medications included ibuprofen (MOTRIN), simvastatin (SIMVASTATIN), vit d [vitamin d nos] (VIT D [VITAMIN D NOS]). The patient previously took clindamycin and experienced drug hypersensitivity, bnt162b2 for covid-19 immunisation and experienced decreased appetite, weight decreased and fatigue. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced overall exhaustion, low hemoglobin, loss of red blood cells without any bleeding found, extremely low energy. being treated with iron sulfate, but not doing more than keep energy levels from dropping lower, sleep interruptions on 2021. The patient underwent lab tests and procedures which included haemoglobin: low hemoglobin on 2021. The event resulted in doctor or other healthcare professional office/clinic visit. The patient was treatment for the events with iron sulfate, but not doing more than keep energy levels from dropping lower. Outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dizziness, Dry mouth, Headache
Clinical narrative: chills; body aches; dry mouth; Temp 102 within 24hrs/ Fever; dizzy; headache; This is a spontaneous report from a contactable Nurse reporting on behalf of a physician in response to HCP letter sent in a cross-reference case. A 30-year-old female patient received BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection; Batch/Lot Number: unknown, expiration date: unknown) via intramuscular route of administration on 21Dec2020 13:00 (at the age of 30-years-old) as Dose 1, 0.3 mL, Single for covid-19 immunization at Workplace Clinic. The patient medical history was not reported, and concomitant medications included Ibuprofen and paracetamol (TYLENOL) both were started from 22Dec2021 to unknown stop date taken for unspecified indication. The patient did not take other vaccinations within 4 weeks prior to vaccination. The patient had no history of previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect. On 21Dec2020 at 13:00, the patient experienced Temp 102 within 24hrs, Chills, headache, Dry mouth, dizzy and body aches. Patient was not visit to Emergency Room or Physician Office due to AE reported. The patient was not admitted in hospital. Patient lab test included body temperature with result of Temp 102 within 24hrs on 21Dec2020. NO treatment was given for the adverse events experienced. The outcome of events Temp 102 within 24hrs, Chills, headache and Dry mouth was recovered on an unspecified date in 2021 and outcome of events Dizzy and body aches was unknown. It was reported as Causal Relationship is a reasonable possibility that the event was related to suspect Pfizer product.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: chills; body aches; dry mouth; Temp 102 within 24hrs/ Fever; dizzy; headache; This is a spontaneous report from a contactable Nurse reporting on behalf of a physician in response to HCP letter sent in a cross-reference case. A 30-year-old female patient received BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection; Batch/Lot Number: unknown, expiration date: unknown) via intramuscular route of administration on 21Dec2020 13:00 (at the age of 30-years-old) as Dose 1, 0.3 mL, Single for covid-19 immunization at Workplace Clinic. The patient medical history was not reported, and concomitant medications included Ibuprofen and paracetamol (TYLENOL) both were started from 22Dec2021 to unknown stop date taken for unspecified indication. The patient did not take other vaccinations within 4 weeks prior to vaccination. The patient had no history of previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect. On 21Dec2020 at 13:00, the patient experienced Temp 102 within 24hrs, Chills, headache, Dry mouth, dizzy and body aches. Patient was not visit to Emergency Room or Physician Office due to AE reported. The patient was not admitted in hospital. Patient lab test included body temperature with result of Temp 102 within 24hrs on 21Dec2020. NO treatment was given for the adverse events experienced. The outcome of events Temp 102 within 24hrs, Chills, headache and Dry mouth was recovered on an unspecified date in 2021 and outcome of events Dizzy and body aches was unknown. It was reported as Causal Relationship is a reasonable possibility that the event was related to suspect Pfizer product.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Dry mouth, Eye pain, Headache
Clinical narrative: eye pain; Dizzy; Headache; Fever; Start date (note dates for any subsequent dosing): 21Dec2020 and 07Jan2021; chills; body aches; dry mouth; This is a spontaneous report from a contactable Other HCP (Nurse). This Nurse reported on behalf of a physician for a female patient. A 30-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number was not reported), dose 2 via an intramuscular route of administration on 07Jan2021 at 13:00 (at the age of 30-year-old), as DOSE 2, SINGLE 0.3 ML for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient Medical History (including any illness at the time of vaccination) was none. The patient previously received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number was not reported), via an intramuscular route of administration on 21Dec2020 (at the age of 30-year-old), single 0.3 ML for covid-19 immunisation and experienced Temp 102 within 24hrs, Chills, dizzy, body aches, headache and dry mouth. On 07Jan2021, the patient experienced chills, body aches, dry mouth, eye pain, dizzy, headache and fever. The clinical details of the events as follows: Upon receiving second dose, the patient had same side effects with additional eye pain started following day and lasted from 5am-01:30pm. The patient was not admitted to hospital due to the events. The AEs did not require a visit to Emergency Room and Physician Office. No treatment was required to treat the events. The patient was not patient deceased. Relevant tests were none. The primary infection site was Unknown. No culture was performed. There were no predisposing factors reported. The patient outcome of the events was Resolved on an unspecified date in 2021. Causal Relationship: it was reported that there was a reasonable possibility that the event was related to suspect product/s.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Pain, Pyrexia
Clinical narrative: eye pain; Dizzy; Headache; Fever; Start date (note dates for any subsequent dosing): 21Dec2020 and 07Jan2021; chills; body aches; dry mouth; This is a spontaneous report from a contactable Other HCP (Nurse). This Nurse reported on behalf of a physician for a female patient. A 30-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number was not reported), dose 2 via an intramuscular route of administration on 07Jan2021 at 13:00 (at the age of 30-year-old), as DOSE 2, SINGLE 0.3 ML for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient Medical History (including any illness at the time of vaccination) was none. The patient previously received her first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number was not reported), via an intramuscular route of administration on 21Dec2020 (at the age of 30-year-old), single 0.3 ML for covid-19 immunisation and experienced Temp 102 within 24hrs, Chills, dizzy, body aches, headache and dry mouth. On 07Jan2021, the patient experienced chills, body aches, dry mouth, eye pain, dizzy, headache and fever. The clinical details of the events as follows: Upon receiving second dose, the patient had same side effects with additional eye pain started following day and lasted from 5am-01:30pm. The patient was not admitted to hospital due to the events. The AEs did not require a visit to Emergency Room and Physician Office. No treatment was required to treat the events. The patient was not patient deceased. Relevant tests were none. The primary infection site was Unknown. No culture was performed. There were no predisposing factors reported. The patient outcome of the events was Resolved on an unspecified date in 2021. Causal Relationship: it was reported that there was a reasonable possibility that the event was related to suspect product/s.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Faeces discoloured, Fatigue, Feeling abnormal, Flatulence, Headache
Clinical narrative: green stools; foggy headed; left arm sore; thick speech; gassy; left arm hurt swollen; shaking; headache; Tiredness in afternoon/ tired; fingers, toes hurt; fingers, toes hurt; itching; This is a spontaneous report from a contactable consumer or other non-HCP. A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8727), via an unspecified route of administration, administered in Left Arm (at the age of: 60-year-old) on 02Apr2021 09:00 as DOSE 1, SINGLE for covid-19 immunization. Medical history included hypertension, intervertebral disc degeneration, drug hypersensitivity, weight fluctuation, arthritis. Concomitant medication(s) included lisinopril (LISINOPRIL); ibuprofen (IBUPROFEN); colecalciferol (VITAMIN D [COLECALCIFEROL]); ascorbic acid, tocopheryl acetate, xantofyl, zeaxanthin, zinc (AREDS). The patient previously took morphine and experienced drug hypersensitivity. The patient did not receive any other vaccine in four weeks. The patient did not have COVID prior vaccination and post vaccination, patient had tested with covid 19. On 02Apr2021 13:00, the patient experienced tiredness in afternoon/ tired, fingers, toes hurt, itching, On 03Apr2021 the patient experienced shaking, headache. On 04Apr2021 the patient experienced gassy, left arm hurt swollen. On 05Apr2021 the patient experienced foggy headed, left arm sore, thick speech, green stools. On 08Apr2021 the patient experienced green stools. Therapeutic measures were taken as a result of itching. The outcome of all events was not recovered.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Limb injury, Pain in extremity, Peripheral swelling, Pruritus, Speech disorder
Clinical narrative: green stools; foggy headed; left arm sore; thick speech; gassy; left arm hurt swollen; shaking; headache; Tiredness in afternoon/ tired; fingers, toes hurt; fingers, toes hurt; itching; This is a spontaneous report from a contactable consumer or other non-HCP. A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8727), via an unspecified route of administration, administered in Left Arm (at the age of: 60-year-old) on 02Apr2021 09:00 as DOSE 1, SINGLE for covid-19 immunization. Medical history included hypertension, intervertebral disc degeneration, drug hypersensitivity, weight fluctuation, arthritis. Concomitant medication(s) included lisinopril (LISINOPRIL); ibuprofen (IBUPROFEN); colecalciferol (VITAMIN D [COLECALCIFEROL]); ascorbic acid, tocopheryl acetate, xantofyl, zeaxanthin, zinc (AREDS). The patient previously took morphine and experienced drug hypersensitivity. The patient did not receive any other vaccine in four weeks. The patient did not have COVID prior vaccination and post vaccination, patient had tested with covid 19. On 02Apr2021 13:00, the patient experienced tiredness in afternoon/ tired, fingers, toes hurt, itching, On 03Apr2021 the patient experienced shaking, headache. On 04Apr2021 the patient experienced gassy, left arm hurt swollen. On 05Apr2021 the patient experienced foggy headed, left arm sore, thick speech, green stools. On 08Apr2021 the patient experienced green stools. Therapeutic measures were taken as a result of itching. The outcome of all events was not recovered.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: green stools; foggy headed; left arm sore; thick speech; gassy; left arm hurt swollen; shaking; headache; Tiredness in afternoon/ tired; fingers, toes hurt; fingers, toes hurt; itching; This is a spontaneous report from a contactable consumer or other non-HCP. A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: ER8727), via an unspecified route of administration, administered in Left Arm (at the age of: 60-year-old) on 02Apr2021 09:00 as DOSE 1, SINGLE for covid-19 immunization. Medical history included hypertension, intervertebral disc degeneration, drug hypersensitivity, weight fluctuation, arthritis. Concomitant medication(s) included lisinopril (LISINOPRIL); ibuprofen (IBUPROFEN); colecalciferol (VITAMIN D [COLECALCIFEROL]); ascorbic acid, tocopheryl acetate, xantofyl, zeaxanthin, zinc (AREDS). The patient previously took morphine and experienced drug hypersensitivity. The patient did not receive any other vaccine in four weeks. The patient did not have COVID prior vaccination and post vaccination, patient had tested with covid 19. On 02Apr2021 13:00, the patient experienced tiredness in afternoon/ tired, fingers, toes hurt, itching, On 03Apr2021 the patient experienced shaking, headache. On 04Apr2021 the patient experienced gassy, left arm hurt swollen. On 05Apr2021 the patient experienced foggy headed, left arm sore, thick speech, green stools. On 08Apr2021 the patient experienced green stools. Therapeutic measures were taken as a result of itching. The outcome of all events was not recovered.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood alkaline phosphatase increased, Blood test, Body temperature
Clinical narrative: elevated ALk Phos; elevated ALT; elevated AST; feel bad; feverish/ 102+ degree fever; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient). A 21-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration date was not reported), via an unspecified route of administration on 30Mar2021 17:00 (at the age of 21 years) as dose number unknown, single for covid-19 immunization. Medical history included known allergies from Tree Pollen from an unknown date and unknown if ongoing (known allergies: Tree Pollen). Concomitant medication(s) included ibuprofen and vitamin d nos taken for an unspecified indication, start and stop date were not reported taken within 2 weeks of vaccination.  The patient previously took trumenba and experienced adverse event. Prior to vaccination, was the patient was not diagnosed with COVID-19 and Since the vaccination, has the patient been tested for COVID-19. On 03Apr2021 the patient experienced feel bad, feverish after 4 days after the vaccination then 2 days after that he had a 102+ degree fever continued for at least 10 days and Blood test 13 days after vaccination patient had elevated ALK PHOS, ALT, AST on an unspecified date of 2021. Adverse Events were considered as nonserious. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. No treatment received for the adverse event. On unspecified date the patient underwent lab tests and procedures which included blood test included elevated alk phos, alt and ast, body temperature found to be 102+ degree, tested for flu found to be negative, tested for mono and tested for strep found to be negative. On 05Apr2021 patient was tested for PCR Test and Rapid Test found to be negative. The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza virus test, Malaise, Mononucleosis heterophile test, Pyrexia, SARS-CoV-2 test
Clinical narrative: elevated ALk Phos; elevated ALT; elevated AST; feel bad; feverish/ 102+ degree fever; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient). A 21-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration date was not reported), via an unspecified route of administration on 30Mar2021 17:00 (at the age of 21 years) as dose number unknown, single for covid-19 immunization. Medical history included known allergies from Tree Pollen from an unknown date and unknown if ongoing (known allergies: Tree Pollen). Concomitant medication(s) included ibuprofen and vitamin d nos taken for an unspecified indication, start and stop date were not reported taken within 2 weeks of vaccination.  The patient previously took trumenba and experienced adverse event. Prior to vaccination, was the patient was not diagnosed with COVID-19 and Since the vaccination, has the patient been tested for COVID-19. On 03Apr2021 the patient experienced feel bad, feverish after 4 days after the vaccination then 2 days after that he had a 102+ degree fever continued for at least 10 days and Blood test 13 days after vaccination patient had elevated ALK PHOS, ALT, AST on an unspecified date of 2021. Adverse Events were considered as nonserious. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. No treatment received for the adverse event. On unspecified date the patient underwent lab tests and procedures which included blood test included elevated alk phos, alt and ast, body temperature found to be 102+ degree, tested for flu found to be negative, tested for mono and tested for strep found to be negative. On 05Apr2021 patient was tested for PCR Test and Rapid Test found to be negative. The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Streptococcus test
Clinical narrative: elevated ALk Phos; elevated ALT; elevated AST; feel bad; feverish/ 102+ degree fever; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient). A 21-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number and expiration date was not reported), via an unspecified route of administration on 30Mar2021 17:00 (at the age of 21 years) as dose number unknown, single for covid-19 immunization. Medical history included known allergies from Tree Pollen from an unknown date and unknown if ongoing (known allergies: Tree Pollen). Concomitant medication(s) included ibuprofen and vitamin d nos taken for an unspecified indication, start and stop date were not reported taken within 2 weeks of vaccination.  The patient previously took trumenba and experienced adverse event. Prior to vaccination, was the patient was not diagnosed with COVID-19 and Since the vaccination, has the patient been tested for COVID-19. On 03Apr2021 the patient experienced feel bad, feverish after 4 days after the vaccination then 2 days after that he had a 102+ degree fever continued for at least 10 days and Blood test 13 days after vaccination patient had elevated ALK PHOS, ALT, AST on an unspecified date of 2021. Adverse Events were considered as nonserious. The adverse event resulted in Doctor or other healthcare professional office/clinic visit. No treatment received for the adverse event. On unspecified date the patient underwent lab tests and procedures which included blood test included elevated alk phos, alt and ast, body temperature found to be 102+ degree, tested for flu found to be negative, tested for mono and tested for strep found to be negative. On 05Apr2021 patient was tested for PCR Test and Rapid Test found to be negative. The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphoedema
Clinical narrative: Lymphedema in left arm pit lymph node started after 1st vaccine dose.; This is a spontaneous report from a contactable consumer. A 40-years-old female patient received bnt162b2 (Formulation: Solution for injection; Batch/Lot Number: ER2613), dose 1 via an unspecified route of administration, administered in Arm Left on 17Mar2021 as DOSE 1, SINGLE for covid-19 immunisation. Medical history included asthma, mitral valve prolapse and high blood pressure and pulses. Concomitant medications included cetirizine hydrochloride (ZYRTEC), flecainide (MANUFACTURER UNKNOWN) and valaciclovir hydrochloride (VALACYCLOVIR) and hydrochlorothiazide (MANUFACTURER UNKNOWN); all started on unknown dates and for unspecified indications. The patient was allergic to mild eggs, dairy, peanuts and severely to mushroom. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On an unknown date in Apr2021, the patient experienced lymphedema in left arm pit lymph node which started after 1st vaccine dose. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event lymphedema in left arm pit lymph node was recovering, at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dizziness, Hypoaesthesia, Limb injury, Pain
Clinical narrative: blurred vision; dizziness; extreme pressure/pain to ears; numbness in hands/feet; tingling; Chest pain; bruised arm; This is a spontaneous report from a contactable other hcp (patient). A 35-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration in left arm on 28Jan2021 at 11:30 (at the age of 34-years-old) (Batch/Lot Number: EL9263) as dose 1, single for COVID-19 immunization. Concomitant medication(s) included spironolactone (SPIRONOLACTONE); sambucus nigra (ELDERBERRY EXTRACT) and daily vitamin. It was unknown if the patient had known allergies. On Jan2021, the patient experienced blurred vision, dizziness, extreme pressure/pain to ears, numbness in hands/feet, tingling, chest pain, bruised arm. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Vision blurred
Clinical narrative: blurred vision; dizziness; extreme pressure/pain to ears; numbness in hands/feet; tingling; Chest pain; bruised arm; This is a spontaneous report from a contactable other hcp (patient). A 35-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration in left arm on 28Jan2021 at 11:30 (at the age of 34-years-old) (Batch/Lot Number: EL9263) as dose 1, single for COVID-19 immunization. Concomitant medication(s) included spironolactone (SPIRONOLACTONE); sambucus nigra (ELDERBERRY EXTRACT) and daily vitamin. It was unknown if the patient had known allergies. On Jan2021, the patient experienced blurred vision, dizziness, extreme pressure/pain to ears, numbness in hands/feet, tingling, chest pain, bruised arm. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash, Throat tightness, Urticaria
Clinical narrative: Itching; redness; rash; hives; tightness in throat, felt like there was something in my throat; This is a spontaneous report from a contactable consumer (patient). A 38-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: Er8729), via an unspecified route of administration, administered in Arm Left on 11Apr2021 07:30 (age at the time of vaccination 38-years-old), as a single dose for COVID-19 immunization. The patient's medical history included asthma. The patient's concomitant medications included Ibuprofen, and inhaler. Patient had no Known allergies. On 11Apr2021 08:30, the patient Itching, redness, rash, hives, and tightness in throat, felt like there was something in my throat. Adverse events result in Emergency room/department or urgent care. Treatment received for the adverse event which included prescribe prednisone, cetirizine, and Benadryl. No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination. The outcome for all the events was recovering.  No follow-up attempts are Possible. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Headache, Nausea, Pain in extremity
Clinical narrative: I have a swollen red spot on the injection site which also has a knot in it; I have a swollen red spot on the injection site which also has a knot in it; I have a swollen red spot on the injection site which also has a knot in it; My arm is very sore; I have had a severe headache; nausea; chills; diarrhea; This is a spontaneous report from a contactable consumer (patient). A 34-years-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EW0162), via an unspecified route of administration, administered in Arm Left on 14Apr2021 14:30 (age at the time of vaccination 34-years-old), as a single dose for COVID-19 immunization. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EN6208), via an unspecified route of administration, administered in Arm Left on 17Mar2021 14:30 (age at the time of vaccination 34-years-old), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient had known allergies to Sulfa related meds. On 14Apr2021 20:00, the patient experienced I have a swollen red spot on the injection site which also has a knot in it, My arm is very sore, I have had a severe headache, nausea, chills, and diarrhea. No treatment received for adverse event. No covid prior vaccination. No covid tested post vaccination. No other vaccine in four weeks. The outcome for all the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site mass, Vaccination site swelling
Clinical narrative: I have a swollen red spot on the injection site which also has a knot in it; I have a swollen red spot on the injection site which also has a knot in it; I have a swollen red spot on the injection site which also has a knot in it; My arm is very sore; I have had a severe headache; nausea; chills; diarrhea; This is a spontaneous report from a contactable consumer (patient). A 34-years-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EW0162), via an unspecified route of administration, administered in Arm Left on 14Apr2021 14:30 (age at the time of vaccination 34-years-old), as a single dose for COVID-19 immunization. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EN6208), via an unspecified route of administration, administered in Arm Left on 17Mar2021 14:30 (age at the time of vaccination 34-years-old), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient had known allergies to Sulfa related meds. On 14Apr2021 20:00, the patient experienced I have a swollen red spot on the injection site which also has a knot in it, My arm is very sore, I have had a severe headache, nausea, chills, and diarrhea. No treatment received for adverse event. No covid prior vaccination. No covid tested post vaccination. No other vaccine in four weeks. The outcome for all the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Feeling abnormal, Hypotension, Myalgia
Clinical narrative: Extreme exhaustion and muscle aches for about a week after second shot; Extreme exhaustion and muscle aches for about a week after second shot; foggy; soreness with small rash around injection site; soreness with small rash around injection site; very low blood pressure; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 68-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Right on 02Apr2021 14:00 (at the age of 68-year-old) as dose 2, single for covid-19 immunisation. Medical history included hypertension from an unknown date and unknown if ongoing, urticaria from an unknown date and unknown if ongoing, blood cholesterol increased from an unknown date and unknown if ongoing. Concomitant medications included atorvastatin taken for an unspecified indication, start and stop date were not reported; losartan taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient had no known allergies. Patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Right on 12Mar2021 14:30 (at the age of 68-year-old) as dose 1, single for covid-19 immunisation and experienced uncontrollable shivering, 101.1 fever, severe headaches, could not stand, weak, dizzy, nausea, vomited once in bed fir 3 days. On 02Apr2021, the patient experienced extreme exhaustion and muscle aches for about a week after second shot, foggy, soreness with small rash around injection site, very low blood pressure. Felt nearly back to normal 8 days later. The patient underwent lab tests and procedures which included body temperature: 101.1 on 02Apr2021. Therapeutic measures were taken as a result of extreme exhaustion and muscle aches for about a week after second shot, foggy, soreness with small rash around injection site included Tylenol. The outcome of the events were recovered on an unspecified date in Apr2021.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.