chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Ear swelling, Lymphadenopathy, Otitis media, SARS-CoV-1 test
Clinical narrative: Had tenderness under left armpit/neck and right arm (not so much); middle ear infection; left ear swollen shut/pain ear and minor swelling on  neck/face; left ear swollen shut/pain ear and minor swelling on  neck/face; left ear swollen shut/pain ear and minor swelling on  neck/face; left ear swollen shut/pain ear and minor swelling on  neck/face; lymph nodes swelled under left arm and throat/neck; This is a spontaneous report from a contactable consumer. A 55-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL3247), dose 2 via an unspecified route of administration, administered in Arm Left on 11Feb2021 09:30 (age at vaccination 55-years-old) as dose 2, single for covid-19 immunisation. The patient medical history includes included seasonal allergy, lactose intolerance, autoimmune thyroiditis, thyroid cancer, colitis ulcerative, menopause, sinusitis from an unknown date and unknown if ongoing and lymphadenectomy from 2005 to an unknown date and 3 main lymph nodes in neck removed in 2005. Concomitant medication included levothyroxine sodium (TIROSINT), liothyronine sodium (CYTOMEL), mesalamine (MESALAMINE), estradiol (ESTROGEN) taken within two weeks. The patient historical vaccine includes bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL3249) via an unspecified route of administration, administered in Arm Left on 11Feb2021 09:30 (age at vaccination 55-years-old) as dose 1, single for covid-19 immunisation. The patient has not taken any other vaccine in four weeks. The patient stated that 3 days after my 2nd dose my lymph nodes swelled under left arm and throat/neck on 14Feb2021 and Had tenderness under left armpit/neck and right arm (not so much), developed middle ear infection with left ear swollen shut/pain ear and minor swelling on neck/face on 11Mar2021 (02:00). Treatment received with 4 drops 2X day for 7 days of Ciprodex. Ae resulted in Emergency room visit and patient had 3 main lymph nodes in neck removed in 2005 due to thyroid cancer. Patient has stated that she had not been diagnosed with COVID -19 prior to vaccination and has been tested since the vaccination. The patient underwent lab tests and procedures which included sars-cov-1 test and the result was negative on 04Mar2021. Outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Swelling face, Tenderness
Clinical narrative: Had tenderness under left armpit/neck and right arm (not so much); middle ear infection; left ear swollen shut/pain ear and minor swelling on  neck/face; left ear swollen shut/pain ear and minor swelling on  neck/face; left ear swollen shut/pain ear and minor swelling on  neck/face; left ear swollen shut/pain ear and minor swelling on  neck/face; lymph nodes swelled under left arm and throat/neck; This is a spontaneous report from a contactable consumer. A 55-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL3247), dose 2 via an unspecified route of administration, administered in Arm Left on 11Feb2021 09:30 (age at vaccination 55-years-old) as dose 2, single for covid-19 immunisation. The patient medical history includes included seasonal allergy, lactose intolerance, autoimmune thyroiditis, thyroid cancer, colitis ulcerative, menopause, sinusitis from an unknown date and unknown if ongoing and lymphadenectomy from 2005 to an unknown date and 3 main lymph nodes in neck removed in 2005. Concomitant medication included levothyroxine sodium (TIROSINT), liothyronine sodium (CYTOMEL), mesalamine (MESALAMINE), estradiol (ESTROGEN) taken within two weeks. The patient historical vaccine includes bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL3249) via an unspecified route of administration, administered in Arm Left on 11Feb2021 09:30 (age at vaccination 55-years-old) as dose 1, single for covid-19 immunisation. The patient has not taken any other vaccine in four weeks. The patient stated that 3 days after my 2nd dose my lymph nodes swelled under left arm and throat/neck on 14Feb2021 and Had tenderness under left armpit/neck and right arm (not so much), developed middle ear infection with left ear swollen shut/pain ear and minor swelling on neck/face on 11Mar2021 (02:00). Treatment received with 4 drops 2X day for 7 days of Ciprodex. Ae resulted in Emergency room visit and patient had 3 main lymph nodes in neck removed in 2005 due to thyroid cancer. Patient has stated that she had not been diagnosed with COVID -19 prior to vaccination and has been tested since the vaccination. The patient underwent lab tests and procedures which included sars-cov-1 test and the result was negative on 04Mar2021. Outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Itchy full body; rash; This is a spontaneous report from a contactable consumer (patient). This 34-year-old female consumer reported for herself that: A 34-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: EN6199), via an unspecified route of administration, administered in arm left on 12Mar2021 at 14:30 (at the age of 34-years-old) as single dose for covid-19 immunisation at Pharmacy or Drug Store. The patient was not pregnant at the time of vaccination. Medical history included breast feeding. There were no known allergies. Patient not diagnosed with covid-19 prior to vaccination. Concomitant medications included prenatal vitamin, oral birth control and oral antibiotics. Patient was not received any other vaccine four weeks prior vaccination. On 14Mar2021 at 07:00, the patient experienced itchy full body rash. Since vaccination patient not tested for covid-19. The patient did not receive any treatment for the events. The outcome of the events was not recovered.  No follow-up attempts were possible, Information about lot/batch number could not be obtained.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Severe joint pain in right hip.; This is a spontaneous report received from a contactable consumer or other non hcp. A 70-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EN6208) via an unspecified route of administration in Arm Right on 07Mar2021 02:30 (age at vaccination 70years old) as single dose for covid-19 immunisation. The patient had known allergies reported as none. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications in two weeks prior to the COVID vaccine. The patient medical history and concomitant medications were not reported. The patient had historical vaccine of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EN9581) via an unspecified route of administration in Arm Right on 4Feb2021 at 02:00PM (age at vaccination 70years old) as single dose for covid-19 immunisation. Since the vaccination, the patient had not been tested positive for COVID-19. On 13Mar2021 12:15 the patient experienced severe joint pain in right hip. The patient received treatment with OTC pain medication, rest for the adverse events. The clinical outcome of the event was not recovered. Therapeutic measures were taken as a result of severe joint pain in right hip.   No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Vaccination site warmth
Clinical narrative: Itching; rash; warmth where injection was adminstered; This is a spontaneous report from a contactable consumer (Patient reported for himself).  A 65-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: Unknown), via an unspecified route of administration, in left arm on 10Mar2021 12:00 (at the age of 65-years-old) as a single dose for COVID-19 immunization. The patient medical history included high blood pressure, high cholesterol and COVID-19. Patient had no known allergies. The concomitant medication of the patient included carvedilol, atorvastatin and telmisartan. The patient did not receive any other vaccines within four weeks prior to the vaccination. Patient had COVID prior the vaccination. Patient was not tested for COVID post vaccination. On 12Mar2021 12:00 the patient experienced itching, rash and warmth where injection was administered. Patient did not receive any treatment for the reported events. Outcome of all the reported events was not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: Itching on my body and red marks on skin; Itching on my body and red marks on skin; This is a spontaneous report from a contactable consumer (patient). A non-pregnant female patient of an unspecified age (elderly 65+ years) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot/batch number was not reported) via an unspecified route of administration, administered in arm left on 06Mar2021 04:45 pm as dose 1, single for covid-19 immunisation. The patient had known allergies of her to mosquito bites. There was no other medical history reported. She had not tested for covid post vaccination. The concomitant medication included pravastatin sodium (PRAVASTIN), Lisinopril, temazepam, gabapentin. The patient experienced itching on her body and red marks on skin on 13Mar2021 12:00 AM. She did not receive treatment for adverse events. The outcome of events was recovered on an unknown date in 2021.  No follow-up attempts were possible. No further information was expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Myalgia, Nasopharyngitis, Pyrexia, Rhinorrhoea
Clinical narrative: Runny nose; fever; cold; chills; muscle aches; This is a spontaneous report from a contactable consumer. This female consumer reported for herself. A 24-years-old non-pregnant female patient (not pregnant at the time of vaccination) 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 Left on 12Mar2021 at 19:45 (24-year-old at the time of vaccination) at a dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient had not received any vaccine within four weeks. The patient had no covid prior to vaccination. The patient was not tested since vaccination. On 13Mar2021, the patient experienced runny nose, fever, cold chills and muscle aches. The outcome of the events were recovering.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: body ache; joint ache; low grade fever; sore throat; This is a spontaneous report from a contactable consumer. A 41-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiry date was not reported) via an unspecified route of administration, administered in Arm Left on 13Mar2021 16:00 (age at vaccination 41-years-old) as dose number unknown, single for covid-19 immunisation. Medical history included penicillin, cyclosporin and shellfish an unknown date and unknown if ongoing. The patient concomitant medication was not reported. On 14Mar2021 09:00, patient experienced body ache, joint ache, low grade fever, sore throat. Patient has not taken any other vaccine with in four weeks and no other medication in two weeks. No treatment was received for AE. Patient was test for COVID prior vaccination and not been tested since post vaccination. Outcome of the patient was not recovered.  No follow-up attempts are possible, information about lot/batch number cannot been obtained.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Rash
Clinical narrative: red dots on Left hand; Rash on left hand; This is a spontaneous report from a contactable Consumer, patient. A 54-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: EN6207), dose 1 via an unspecified route of administration, administered in Arm Left on 11Mar2021 (at the age of 54-years-old) as a single dose for covid-19 immunization. Medical history included type 2 diabetes mellitus, fatigue, depression, anxiety, tachycardia. Concomitant medication(s) in two weeks included doxepin; famotidine; metformin; oxcarbazepine; venlafaxine. The patient had allergies with compazine, phenergan, morphine, fentanyl. The patient had no other vaccine within four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 14Mar2021 17:00, the patient experienced rash on left hand, red dots. The rash is not raised and there is no pain or sensitivity. The patient did not receive any treatment. Outcome of the event was unknown, at the time of this report. No follow-up attempts are possible. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pain, Pyrexia, Vaccination site pain
Clinical narrative: Temp 101.4  F within 7 hrs lasting 21 hrs.; Body aches; Headache lasting 48 hrs; Soreness at injection site; This is a spontaneous report from a contactable Nurse reported for herself. A 72-year-old female patient (patient was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 11Mar2021 at 12:00 (age at vaccination 72-year-old) as dose 1, single for COVID-19 immunization. The patient's medical history included seasonal environmental allergies and known allergies: walnuts, known allergies: peaches, known allergies: eggplant. Concomitant medication(s) included as other medications in two weeks, fluoxetine (FLUOXETINE) as 30 mg. The facility where the most recent COVID-19 vaccine was administered was Doctor's office/urgent care. 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 previously took azithromycin and experienced known allergies: azithromycin. On 11Mar2021 at 19:00, the patient experienced Temp 101.4 F within 7 hrs lasting 21 hrs., body aches, headache lasting 48 hrs and soreness at injection site. The patient underwent lab tests and procedures which included body temperature which showed 101.4 Fahrenheit (Temp 101.4 F within 7 hrs lasting 21 hrs.) result on 11Mar2021. No treatment was received for the adverse events. The outcome of the events was recovered with Sequel on an unspecified date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Axillary pain, Lymphadenopathy, Mammogram, Pain in extremity
Clinical narrative: arm and entire shoulder area were very sore; arm and entire shoulder area were very sore; I felt a lump in the area of my armpit/I was quite sore in that area; swelling; I felt a lump in the area of my armpit/I was quite sore in that area; This is a spontaneous report from a contactable consumer or other non HCP (Patient). A 73-year-non pregnant old female patient received bnt162b2 (BNT162B2 Formulation: Solution for injection), dose 2 via an unspecified route of administration on 16Feb2021 at 16:15 (Batch/Lot number was not reported) as DOSE 2, SINGLE (at the age of 73-year-old) for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included high blood pressure, Barrett esophagus and Known allergies to Shellfish, Codeine, Adhesive from an unknown date and unknown if ongoing. The patient did not have covid prior to vaccination. Concomitant medications (Other medications in two weeks) included omeprazole, levothyroxine, gabapentin and triamterene taken for an unspecified indication, start and stop date were not reported. Historical vaccine included first dose of bnt162b2 an unknown for covid-19 immunisation. The patient previously took codeine and experienced Known allergies. The patient did not receive any other vaccine in four weeks. On 16Feb2021 at 23.00, the patient experienced arm and entire shoulder area were very sore, felt a lump in the area of my armpit and swelling. It was reported that patient was rubbing it to make it feel better when felt a lump in the area of my armpit. The patient became concerned and since recently had a mammogram and she did not know what should do next. It reported that it was quite sore in that area for a few day. It was reported that after about 3 days it started to feel better, the lump and swelling went away and by one week it was pretty much ok with mild soreness for another week. The patient underwent lab tests and procedures which included mammogram: unknown results on an unknown date and sars-cov-2 test (Nasal Swab) (tested post vaccination): negative on 08Mar2021. No treatment received for events. The outcome of events reported as recovered on an unknown date of 2021.  No follow-up attempts are possible, information about lot/batch number cannot been obtained.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Swelling
Clinical narrative: arm and entire shoulder area were very sore; arm and entire shoulder area were very sore; I felt a lump in the area of my armpit/I was quite sore in that area; swelling; I felt a lump in the area of my armpit/I was quite sore in that area; This is a spontaneous report from a contactable consumer or other non HCP (Patient). A 73-year-non pregnant old female patient received bnt162b2 (BNT162B2 Formulation: Solution for injection), dose 2 via an unspecified route of administration on 16Feb2021 at 16:15 (Batch/Lot number was not reported) as DOSE 2, SINGLE (at the age of 73-year-old) for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included high blood pressure, Barrett esophagus and Known allergies to Shellfish, Codeine, Adhesive from an unknown date and unknown if ongoing. The patient did not have covid prior to vaccination. Concomitant medications (Other medications in two weeks) included omeprazole, levothyroxine, gabapentin and triamterene taken for an unspecified indication, start and stop date were not reported. Historical vaccine included first dose of bnt162b2 an unknown for covid-19 immunisation. The patient previously took codeine and experienced Known allergies. The patient did not receive any other vaccine in four weeks. On 16Feb2021 at 23.00, the patient experienced arm and entire shoulder area were very sore, felt a lump in the area of my armpit and swelling. It was reported that patient was rubbing it to make it feel better when felt a lump in the area of my armpit. The patient became concerned and since recently had a mammogram and she did not know what should do next. It reported that it was quite sore in that area for a few day. It was reported that after about 3 days it started to feel better, the lump and swelling went away and by one week it was pretty much ok with mild soreness for another week. The patient underwent lab tests and procedures which included mammogram: unknown results on an unknown date and sars-cov-2 test (Nasal Swab) (tested post vaccination): negative on 08Mar2021. No treatment received for events. The outcome of events reported as recovered on an unknown date of 2021.  No follow-up attempts are possible, information about lot/batch number cannot been obtained.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Whole body itching; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 09Mar2021 09:00 (Lot Number: EN6198, Expiry date not reported) as DOSE 1, SINGLE for COVID-19 immunization. Medical history included asthma, and contrast media allergy (known allergies: IVP dye). The patient was not pregnant at the time of vaccination. The patient was vaccinated at a public health clinic/veterans administration facility. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications included montelukast sodium (SINGULAIR) taken for an unspecified indication, start and stop date were not reported; budesonide, formoterol fumarate (SYMBICORT) taken for an unspecified indication, start and stop date were not reported; fexofenadine hydrochloride (ALLEGRA) taken for an unspecified indication, start and stop date were not reported; buspirone taken for an unspecified indication, start and stop date were not reported; and zolpidem tartrate (AMBIEN) taken for an unspecified indication, start and stop date were not reported. The patient previously took iodine and experienced drug hypersensitivity. The patient experienced whole body itching on 11Mar2021 17:00 with outcome of not recovered. No therapeutic measures were taken as a result of the event. The event was reported as non-serious.  No follow-up attempts are possible. No further information is expected.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pyrexia
Clinical narrative: Chills; Headache; Nausea; Fever; This is a spontaneous report from a contactable consumer (patient) via Covid-19 Adverse Event Self-Reporting Solution . A 16-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 10Mar2021 13:00 (lot number: EN6205; expiry date: unknown) at the age of 16-years-old, dose 2, single for Covid-19 immunisation. The patient had no relevant medical history and had no known allergies. Concomitant medication included fluoxetine hydrochloride (PROZAC) taken for an unspecified indication, start and stop date were not reported. The patient was not diagnosed with Covid-19 prior vaccination. The patient was not pregnant at the time of vaccination. The vaccine was administered in Public Health Clinic/Veterans Administration facility. The patient did not receive other vaccines in four weeks. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on 19Feb2021 at 14:30 (lot number: EL9266; expiry date: unknown) at the age of 16-years-old in left arm, for Covid-19 immunisation. On 11Mar2021 at 02:15 AM, the patient experienced chills, headache, nausea and fever. The patient did not receive treatment for the events. The patient recovered from the events on unspecified date. The patient has not been tested for Covid-19 post vaccination.   No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chills, Fatigue, SARS-CoV-2 test
Clinical narrative: after 12 hours, joint pain and chills began, no fever but lasted about 12 hours; after 12 hours, joint pain and chills began, no fever but lasted about 12 hours; afterwards extreme weakness began and reached a peak within 10 hours making getting out of recliner and standing impossible without assistance; Extreme tiredness set in for next 24 hours; This is a spontaneous report from a contactable consumer.A 74-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: EN6207) via an unspecified route of administration, administered in Arm Left on 11Mar2021 12:30 as DOSE 1, SINGLE dose (at the age of 74-year-old) for covid-19 immunisation. Medical history included atrial fibrillation. The patient's concomitant medications were not reported. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 12Mar2021 00:30, After 12 hours, the patient experienced joint pain and chills began, no fever but lasted about 12 hours, afterwards extreme weakness began and reached a peak within 10 hours making getting out of recliner and standing impossible without assistance. Extreme tiredness set in for next 24 hours. The patient did not received any treatment for the events. The outcome of the events was resolving.   No follow-up attempts are possible; No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Erythema, Fatigue, Nausea
Clinical narrative: Dizziness; redness; large lump at injection site; nausea; chills; fatigue; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 43-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration, administered in right arm on 11Mar2021 at 12:30 (batch/lot number was not reported) as dose 2, single for covid-19 immunization (age at vaccination was 43 years). Medical history included known allergies to Keflex and sulfa meds, autistic, asthmatic, bipolar disorder and endometriosis from an unknown date and unknown if ongoing. The concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in left arm on an unspecified date at 02:00 pm as single dose for COVID-19 immunization. The patient did not have COVID-19 prior to vaccination. Facility type vaccine was reported as hospital. It was reported that after receiving the second dose of vaccine on 12Mar2021 at 14:00 pm the patient experienced dizziness, redness, large lump at injection site, nausea, chills, fatigue. The patient did not test Covid post vaccination. The outcome of all the events was recovering at the time of report.   No follow up attempts are possible. Information about lot/batch number cannot been obtained.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass
Clinical narrative: Dizziness; redness; large lump at injection site; nausea; chills; fatigue; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 43-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration, administered in right arm on 11Mar2021 at 12:30 (batch/lot number was not reported) as dose 2, single for covid-19 immunization (age at vaccination was 43 years). Medical history included known allergies to Keflex and sulfa meds, autistic, asthmatic, bipolar disorder and endometriosis from an unknown date and unknown if ongoing. The concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in left arm on an unspecified date at 02:00 pm as single dose for COVID-19 immunization. The patient did not have COVID-19 prior to vaccination. Facility type vaccine was reported as hospital. It was reported that after receiving the second dose of vaccine on 12Mar2021 at 14:00 pm the patient experienced dizziness, redness, large lump at injection site, nausea, chills, fatigue. The patient did not test Covid post vaccination. The outcome of all the events was recovering at the time of report.   No follow up attempts are possible. Information about lot/batch number cannot been obtained.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Influenza, Pain, Pyrexia
Clinical narrative: Flu symptoms; Fever of 101; Chills; Body aches; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EL9266) via an unspecified route of administration, administered in arm left on 20Feb2021 12:00 AM (age at the time of vaccination was 49 years and she was not pregnant at the time of vaccination) as dose 1, single for covid-19 immunisation. The patient medical history was not reported. No other vaccine administered in four weeks. There were no known allergies. The patient concomitant medications included Vitamin D, Vitamin C (ASCORBIC ACID), cyanocobalamin (VITAMIN B12). The patient experienced flu symptoms, fever of 101, chills, body aches for 12 hours in Feb2021. The patient underwent lab test and procedure included body temperature resulted into 101 on 12Mar2021. She did not receive treatment for adverse events. She had not covid prior vaccination and had not tested for covid post vaccination. The outcome of events was recovered in Feb2021.  No follow-up attempts were possible. No further information was expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Conjunctivitis viral, Pyrexia, SARS-CoV-2 test
Clinical narrative: fever 101.1; chills; mild viral conjuntivitis; This is a spontaneous report from a contactable consumer (patient). A 71-year-old non-pregnant female patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration, administered in the left arm on 12Mar2021 at 13:45 (Lot Number: EN6202) as dose 2, single for COVID-19 immunization. Medical history included sulphur based allergy on an unknown date. The patient did not have COVID prior to vaccination. Concomitant medications included calcium (manufacturer unknown); fish oil (manufacturer unknown) and latanoprost (manufacturer unknown), all taken for an unspecified indication, start and stop date were not reported. The patient previously received the first dose of BNT162B2 on 19Feb2021 (lot number: EN6201) at 14:45 in the left arm for COVID-19 immunization. On 13Mar2021 at 23:00 the patient experienced fever 101.1, chills and mild viral conjunctivitis. The events resulted in a doctor's clinic visit. The patient nasal swab COVID test on 14Mar2021 with a negative result. The patient received an antibiotic ointment for the eye and acetaminophen as treatment for the events. The events recovered on an unknown date in Mar2021.   No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Pain in extremity, Pruritus
Clinical narrative: fatigue; headache; arm pain; joint pain; rash; welts; itching painful bumps; This is a spontaneous report from a contactable other health care professional reported in response to vaccine HCP letter sent in cross reference case. A 46-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: E23320, expiration date: unknown) via unknown route of administration at left arm on 11Feb2021 (at the age of 46-years) as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had no predisposing factors. The patient had second dose was much worse, experienced extreme fatigue, headache, arm pain, joint pain continued for 2 weeks, rash appeared on back and front mid section, welts and itching painful bumps all over on an unknown date. On 05Mar2021, the patient still had some evidence of mild rash. The patient was self treated with OC medication advil, aloe plus chamomile lotion and had rest. The patient had no chills and nausea. It was reported that the reaction recure on re-administration of product. The patient was not deceased. The patient was not recovered from the event rash while outcome of all other events was reported as unknown.  No follow-up attempts were needed. No further information was expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Urticaria
Clinical narrative: fatigue; headache; arm pain; joint pain; rash; welts; itching painful bumps; This is a spontaneous report from a contactable other health care professional reported in response to vaccine HCP letter sent in cross reference case. A 46-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: E23320, expiration date: unknown) via unknown route of administration at left arm on 11Feb2021 (at the age of 46-years) as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had no predisposing factors. The patient had second dose was much worse, experienced extreme fatigue, headache, arm pain, joint pain continued for 2 weeks, rash appeared on back and front mid section, welts and itching painful bumps all over on an unknown date. On 05Mar2021, the patient still had some evidence of mild rash. The patient was self treated with OC medication advil, aloe plus chamomile lotion and had rest. The patient had no chills and nausea. It was reported that the reaction recure on re-administration of product. The patient was not deceased. The patient was not recovered from the event rash while outcome of all other events was reported as unknown.  No follow-up attempts were needed. No further information was expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Bedridden, Body temperature, Bone pain, Chills, Fatigue
Clinical narrative: bedridden; so sick; I had a crushing headache; starting to feel warm; I got the second vaccine at 10am and started feeling extremely tired about 8 hours; did not sleep due to the pain in her bones and fever with sweats and chills; I started feeling aches.; I woke up a couple hours later with excruciating pain in my bones.; I had a fever of 104; chills; sweats.; This is a spontaneous report from a contactable nurse (patient reported for herself).  A 24-year-old (non-pregnant) female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: not reported) via an unspecified route of administration, administered in arm left on 28Feb2021 at 10.00 (at the age of 24-years) as dose 2, single for covid-19 immunization in hospital. Patient had no known allergies and no relevant medical history. The patient concomitant medications were not reported in two weeks. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE solution for injection, Lot Number: not reported) via an unspecified route of administration, administered in arm left on 06Feb2021 at 10.00 (at the age of 24-years) as dose 1, single for covid-19 immunization. The patient was not pregnant at the tie of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient got the second vaccine at 10.00. On 28Feb2021 at 19.00 the patient started feeling extremely tired about 8 hours after the vaccine. By the time the patient went to bed around 22.00, she had a crushing headache and starting to feel warm. The patient started feeling aches and woke up a couple hours later with excruciating pain in her bones. The patient had a fever of 104 and chills with sweats. The patient did not sleep due to the pain in her bones and fever with sweats and chills. The next day (01Mar2021), the patient was bedridden, so sick and it took a full 48 hours for her to feel back to her normal self. The patient did not receive any treatment for adverse event. The patient did not had vaccination prior to covid. The patient was not tested for covid post vaccination. The patient went lab test: body temperature: 104 (unit not reported) on an unknown date. The outcome of the events bedridden, so sick were recovered with sequel on an unspecified date in Mar2021 and rest of the events was recovered with sequel on an unspecified date in 2021.   No Follow-up attempts are possible. No information is expected further.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Headache, Hyperhidrosis, Illness, Insomnia
Clinical narrative: bedridden; so sick; I had a crushing headache; starting to feel warm; I got the second vaccine at 10am and started feeling extremely tired about 8 hours; did not sleep due to the pain in her bones and fever with sweats and chills; I started feeling aches.; I woke up a couple hours later with excruciating pain in my bones.; I had a fever of 104; chills; sweats.; This is a spontaneous report from a contactable nurse (patient reported for herself).  A 24-year-old (non-pregnant) female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: not reported) via an unspecified route of administration, administered in arm left on 28Feb2021 at 10.00 (at the age of 24-years) as dose 2, single for covid-19 immunization in hospital. Patient had no known allergies and no relevant medical history. The patient concomitant medications were not reported in two weeks. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE solution for injection, Lot Number: not reported) via an unspecified route of administration, administered in arm left on 06Feb2021 at 10.00 (at the age of 24-years) as dose 1, single for covid-19 immunization. The patient was not pregnant at the tie of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient got the second vaccine at 10.00. On 28Feb2021 at 19.00 the patient started feeling extremely tired about 8 hours after the vaccine. By the time the patient went to bed around 22.00, she had a crushing headache and starting to feel warm. The patient started feeling aches and woke up a couple hours later with excruciating pain in her bones. The patient had a fever of 104 and chills with sweats. The patient did not sleep due to the pain in her bones and fever with sweats and chills. The next day (01Mar2021), the patient was bedridden, so sick and it took a full 48 hours for her to feel back to her normal self. The patient did not receive any treatment for adverse event. The patient did not had vaccination prior to covid. The patient was not tested for covid post vaccination. The patient went lab test: body temperature: 104 (unit not reported) on an unknown date. The outcome of the events bedridden, so sick were recovered with sequel on an unspecified date in Mar2021 and rest of the events was recovered with sequel on an unspecified date in 2021.   No Follow-up attempts are possible. No information is expected further.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: bedridden; so sick; I had a crushing headache; starting to feel warm; I got the second vaccine at 10am and started feeling extremely tired about 8 hours; did not sleep due to the pain in her bones and fever with sweats and chills; I started feeling aches.; I woke up a couple hours later with excruciating pain in my bones.; I had a fever of 104; chills; sweats.; This is a spontaneous report from a contactable nurse (patient reported for herself).  A 24-year-old (non-pregnant) female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: not reported) via an unspecified route of administration, administered in arm left on 28Feb2021 at 10.00 (at the age of 24-years) as dose 2, single for covid-19 immunization in hospital. Patient had no known allergies and no relevant medical history. The patient concomitant medications were not reported in two weeks. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE solution for injection, Lot Number: not reported) via an unspecified route of administration, administered in arm left on 06Feb2021 at 10.00 (at the age of 24-years) as dose 1, single for covid-19 immunization. The patient was not pregnant at the tie of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient got the second vaccine at 10.00. On 28Feb2021 at 19.00 the patient started feeling extremely tired about 8 hours after the vaccine. By the time the patient went to bed around 22.00, she had a crushing headache and starting to feel warm. The patient started feeling aches and woke up a couple hours later with excruciating pain in her bones. The patient had a fever of 104 and chills with sweats. The patient did not sleep due to the pain in her bones and fever with sweats and chills. The next day (01Mar2021), the patient was bedridden, so sick and it took a full 48 hours for her to feel back to her normal self. The patient did not receive any treatment for adverse event. The patient did not had vaccination prior to covid. The patient was not tested for covid post vaccination. The patient went lab test: body temperature: 104 (unit not reported) on an unknown date. The outcome of the events bedridden, so sick were recovered with sequel on an unspecified date in Mar2021 and rest of the events was recovered with sequel on an unspecified date in 2021.   No Follow-up attempts are possible. No information is expected further.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Body temperature, Pain, Pyrexia, Urine analysis
Clinical narrative: Fever; very bad pain in his body; This is a spontaneous report from a contactable consumer (patient wife). A 50-years-old male patient (husband) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EN6204), via intramuscular route of administration in the left arm on 11Mar2021 at 15:00 (at the age of 50-years-old) as dose 1, single for COVID-19 immunization. Medical history included covid-19 from 18Jan2021 to an unknown date, her husband was pretty healthy. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Reporter stated that, that day (12Mar2021) her husband woke up at 7 am and was having fever of 99.7 and he took Ibuprofen, 200mg, Lot: OME2332A, Expire date: Jul2021 and was fine. Then, at 10 am, his temperature got to 101.9 and she gave him Acetaminophen, 500mg, Lot: P121876, Expiry date: Sep2023 and he had very bad pain in his body (Mar2021). When reporter checked her husband's temperature during the call and confirmed her husband's current temperature was 100.6 The reporter doesn't know if her husband needs to go to the doctor. They were told the side effects will be for maybe a couple of days, so she doesn't know if her husband needs to go or not. The events did not result in physician and emergency room visit. He had an appointment before the vaccination where the doctor did blood tests and urine test. The patient underwent lab tests and procedures which included blood test: everything is okay on an unspecified date in 2021, body temperature: 99.7, 101.9 and 100.6 on 12Mar2021 and urine analysis: everything was okay on an unspecified date in 2021. Therapeutic measures were taken as a result of events. The clinical outcome for the events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Bone disorder, Chest discomfort, Hot flush, Insomnia, Swelling
Clinical narrative: heaviness in her chest and bones; heaviness in her chest and bones; hot flashes; has not slept in four days; her whole body swelled up; This is a spontaneous report from a non-contactable consumer or other non hcp via medical information team. This consumer reported similar event for 2 patient (Herself and her Brother-in-law). This is second of 2 report (Brother-in-law). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced heaviness in chest and bones, hot flashes, had not slept in four days and whole body swelled up. The outcome of the events were unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021263737 same reporter/drug/AE, different patients
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: In the evenings I get inflamed itchy skin and raised welts on my body.; This is a spontaneous report from a contactable consumer or other non hcp. A 56-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6199, Expiry date: unknown, at the age of 56 years), dose 2 via an unspecified route of administration, administered in Arm Left on 06Mar2021 10:00 as dose 1, single for covid-19 immunisation. The medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: 6200, Expiry date: unknown), dose 1 via an unspecified route of administration, administered in Arm Right on 17Feb2021 17:00 as dose 1, single for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. 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 inflamed itchy skin and raised welts on her body in the evening on 09Mar2021 20:00. Not every single day. And usually in the evenings. It looked terrible and she had photos of that and stated that she never had skin reactions like that. The location changed. After about 30 minutes it calmed down. Hoped it would go away. The patient did not receive any treatment for the event. The outcome of event was not recovered.  No follow-up attempts are possible; No further information is expected.