chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Seizure
Clinical narrative: Seizure; She kept having seizures and progressively got worse; This spontaneous case was reported by a patient family member or friend and describes the occurrence of SEIZURE (Seizure) and CONDITION AGGRAVATED (She kept having seizures and progressively got worse) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SEIZURE (Seizure) (seriousness criterion medically significant) and CONDITION AGGRAVATED (She kept having seizures and progressively got worse) (seriousness criterion medically significant). At the time of the report, SEIZURE (Seizure) outcome was unknown and CONDITION AGGRAVATED (She kept having seizures and progressively got worse) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication provided. No treatment medication reported.  Company Comment: This is a spontaneous case concerning a female patient of unknown age with no relevant medical history, who experienced the unexpected serious events of seizure and condition worsened, seizure progressively got worse. The event seizure occurred the same day after the first dose of mRNA-1273 vaccine administration while the event condition worsened, seizure progressively got worse exact occurrence unknown but stated that the event occurred after the first dose of mRNA-1273 vaccine administration. The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a female patient of unknown age with no relevant medical history, who experienced the unexpected serious events of seizure and condition worsened, seizure progressively got worse. The event seizure occurred the same day after the first dose of mRNA-1273 vaccine administration while the event condition worsened, seizure progressively got worse exact occurrence unknown but stated that the event occurred after the first dose of mRNA-1273 vaccine administration. The rechallenge was not applicable. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Blood urine present, Cough, Drug hypersensitivity, Ear pain
Clinical narrative: Head hurt, after second vaccine; Ears hurt, after second vaccine; Bad cough, after second vaccine; Bad cough, after second vaccine was reported as worsened; Asthma attacks worsened, with wheezing, after second vaccine; Asthma attacks worsened, with wheezing, after second vaccine; Blood in urine, after second vaccine; bad reaction to the second dose of the Covid vaccine/ why do they make vaccines with ingredients that people are allergic to; This is a spontaneous report from Pfizer-sponsored program via contactable consumer or other non hcp. A 66-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8730) via an unspecified route of administration, administered in Arm Right on 16Jul2021 10:00 (Age at vaccination 66-years old) as DOSE 2, SINGLE for COVID-19 immunization. Medical history included ongoing asthma from when she was a little baby, Ongoing chronic obstructive pulmonary disease (COPD), 6 or 7 months ago, Ongoing bad heart, heart surgery about 2 years ago, kidney problems, from when she was born and liver disease about 10 years. There were no concomitant medications. Previously, patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6208) via an unspecified route of administration, administered in Arm Left on 25Jun2021 01:30 PM (Age at vaccination 66-years old) as DOSE 1, SINGLE for COVID-19 immunization. On an unspecified date of Saturday night, the patient experienced head hurt, after second vaccine, ears hurt, after second vaccine, bad cough, after second vaccine; bad cough, after second vaccine was reported as worsened, asthma attacks worsened, with wheezing, after second vaccine, blood in urine, after second vaccine, bad reaction to the second dose of the covid vaccine/ why do they make vaccines with ingredients that people are allergic to. Patient underwent emergency room visit and received treatment, given 20mg of Prednisone, to take one tab by mouth, every 12 hours for 5 days. She was denied for Tylenol as a treatment for pain due to liver issues. Therapeutic measures were taken as a result of head hurt, after second vaccine, ears hurt, after second vaccine, bad cough, after second vaccine; bad cough, after second vaccine was reported as worsened, asthma attacks worsened, with wheezing, after second vaccine, blood in urine, after second vaccine, bad reaction to the second dose of the covid vaccine/ why do they make vaccines with ingredients that people are allergic to. The outcome for the events Asthma attacks worsened, with wheezing, after second vaccine, Blood in urine, after second vaccine, bad reaction to the second dose of the Covid vaccine/ why do they make vaccines with ingredients that people are allergic to was unknown, while other events was not recovered.  Follow-Up (05Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Wheezing
Clinical narrative: Head hurt, after second vaccine; Ears hurt, after second vaccine; Bad cough, after second vaccine; Bad cough, after second vaccine was reported as worsened; Asthma attacks worsened, with wheezing, after second vaccine; Asthma attacks worsened, with wheezing, after second vaccine; Blood in urine, after second vaccine; bad reaction to the second dose of the Covid vaccine/ why do they make vaccines with ingredients that people are allergic to; This is a spontaneous report from Pfizer-sponsored program via contactable consumer or other non hcp. A 66-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8730) via an unspecified route of administration, administered in Arm Right on 16Jul2021 10:00 (Age at vaccination 66-years old) as DOSE 2, SINGLE for COVID-19 immunization. Medical history included ongoing asthma from when she was a little baby, Ongoing chronic obstructive pulmonary disease (COPD), 6 or 7 months ago, Ongoing bad heart, heart surgery about 2 years ago, kidney problems, from when she was born and liver disease about 10 years. There were no concomitant medications. Previously, patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6208) via an unspecified route of administration, administered in Arm Left on 25Jun2021 01:30 PM (Age at vaccination 66-years old) as DOSE 1, SINGLE for COVID-19 immunization. On an unspecified date of Saturday night, the patient experienced head hurt, after second vaccine, ears hurt, after second vaccine, bad cough, after second vaccine; bad cough, after second vaccine was reported as worsened, asthma attacks worsened, with wheezing, after second vaccine, blood in urine, after second vaccine, bad reaction to the second dose of the covid vaccine/ why do they make vaccines with ingredients that people are allergic to. Patient underwent emergency room visit and received treatment, given 20mg of Prednisone, to take one tab by mouth, every 12 hours for 5 days. She was denied for Tylenol as a treatment for pain due to liver issues. Therapeutic measures were taken as a result of head hurt, after second vaccine, ears hurt, after second vaccine, bad cough, after second vaccine; bad cough, after second vaccine was reported as worsened, asthma attacks worsened, with wheezing, after second vaccine, blood in urine, after second vaccine, bad reaction to the second dose of the covid vaccine/ why do they make vaccines with ingredients that people are allergic to. The outcome for the events Asthma attacks worsened, with wheezing, after second vaccine, Blood in urine, after second vaccine, bad reaction to the second dose of the Covid vaccine/ why do they make vaccines with ingredients that people are allergic to was unknown, while other events was not recovered.  Follow-Up (05Aug2021): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2, Lip swelling
Clinical narrative: she noticed swelling in her upper lip; exposed to Covid; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). This report was received via Pfizer sales representative. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. After her second vaccine she noticed swelling in her upper lip. Symptoms lasted 24-36 hours. She states now she was having the same symptoms, duration was about the same on an unspecified date. She wonders if she was exposed to Covid and was having an immune response that was causing the same swelling in her upper lip on an unspecified date. She received cosmetic filler for swelling in her upper lip as treatment. The outcome of event she noticed swelling in her upper lip was not recovered while other event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Pain in extremity
Clinical narrative: right arm pain from her shoulder to where you arm bends in the elbow/ her other arm is killing her; She could not move her arm; This is a spontaneous report from a contactable consumer (patient). A 51-years-old female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration, administered in arm left on 19Sep2021 (at the age of 51 years old) as dose 1, single for COVID-19 immunization. Medical history included diabetes mellitus and thrombosis from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. On 20Sep2021, the patient experienced right arm pain from her shoulder to where you arm bends in the elbow/ her other arm is killing her, she could not move her arm. Patient reported that she once broke her left arm and went through physical therapy. She is using the physical therapy exercises she learned on her right arm, it continues to feel heavy and it hurts. Other clinical information includes Diagnosed before the Pfizer Covid19 vaccine; states she takes medication for this and takes Eliquis twice per day by mouth and does not have the dosage with her and started taking it for quite a while but can't remember; states she wants to say she has taken Eliquis for 6-8 months but was first on a medication that was stopped and she caught more blood clots and the first clot was in her leg, had one in her chest and the last one was in her groin 6 months ago and that is when she started Eliquis. The outcome of the event pain in arm was not recovered and rest event was unknown.   Follow-up attempts completed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Vaccination site mass, Vaccination site pain, Weight
Clinical narrative: then the second shot I got the chills; it's still sore on top; I had a bump there; This is a spontaneous report from a contactable consumer (patient, self-reported).  A 63-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EN6208 and expiry date: Jun2021), via an unspecified route of administration, in Arm Left, on 16Mar2021, as DOSE 2, SINGLE for COVID-19 immunization (Age at vaccination: 63 years). The patient medical history included asthma. Concomitant medication included metoprolol (METOPROLOL), lorazepam (LORAZEPAM), tiotropium bromide monohydrate (SPIRIVA) for asthma, dextromethorphan, guaifenesin, paracetamol, pseudoephedrine (BENYLIN 1), ibuprofen (IBUPROFEN) and salbutamol sulfate (VENTOLIN HFA) for asthma. Patient previously received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EN6203 and expiry date: Jun2021), via an unspecified route of administration, on 23Feb2021, as DOSE 1, SINGLE for COVID-19 immunization. On an unspecified date, the patient got the chills, very bad chills for one day, for 5 hours actually, just for 5 hours. The patient further stated, Now, first two shots that she got, the first one was simple, the second one, the lady seemed like she took the needle and grounded it in my arm. This lady put it in the left arm up a little higher and she have still like it's still sore on top, she had a bump there, yeah, the bump is gone away. On an unspecified date, the patient underwent lab tests and procedures which included weight: Weigh about 141(pounds) lbs on, around 140 (pounds), 141 (pounds) seems like. Outcome of the events were recovered on an unspecified date.  Follow-Up (12Oct2021): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Purulent discharge, Scar, Skin reaction, Skin warm
Clinical narrative: awful looking bumps that swelled up and have a black indent in the middle and sometimes stuff comes out- green "crud" comes out of the top inner crust that stays open; awful looking bumps that swelled up and have a black indent in the middle and sometimes stuff comes out- green "crud" comes out of the top inner crust that stays open; scarring; painful; warm to the touch; This is a spontaneous report from a Pfizer sponsored program from a contactable consumer (patient herself). A 52-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 20Sep2021 as dose 2, single for COVID-19 immunization. Medical history included, autoimmune deficiency/tolerance and Covid from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 on 26Aug2021 as dose 1, single for COVID-19 immunisation and after the first dose she developed little tiny red bumps like little fire ant bites and they kind a went away. Within 2 days after the second dose on an unspecified date in Sep2021, she developed awful looking bumps that swelled up and have a black indent in the middle and sometimes stuff comes out- green "crud" comes out of the top inner crust that stays open. These had developed all over her face, neck, arms and chest and are causing scarring. They were very painful and warm to the touch. They did not look like a blister they look like big bumps. She had been using Neosporin and surgical soap on it, but nothing was "touching" it. She was very worried about it. She had an autoimmune deficiency/tolerance but did not had AIDS. She stated her immune system was not good. She had already had COVID-19 and it almost took her life from her. Her doctor urged her to get the vaccine so she would not get it again. She had been to her doctor and dermatologist, and they did not know anything. The pharmacist told her it was a rare side effect of the vaccine that it was destroying her immune system. Patient received Neosporin and surgical soap as treatment for events. The outcome of all events was not recovered.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made.   Follow-up attempts completed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Sinusitis
Clinical narrative: My sinus infection has come back; This is a spontaneous report from a Pfizer-sponsored program, from a contactable Other Health Professional (nurse reporting for herself). A 53-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 01Oct2021 as dose 3 (booster), single for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included levothyroxine (LEVOTHYROXINE) 125 micrograms, everyday; gabapentin (GABAPENTIN) 1000 milligrams, twice a day; sertraline hydrochloride (ZOLOFT); buspirone (BUSPIRONE) 15 milligrams twice a day; cranberry (CRANBERRY); calcium (CALCIUM); colecalciferol (VITAMINE D); mometasone furoate (MOMETASONE [MOMETASONE FUROATE])- all taken for unspecified indication, start and stop date were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: ER2613), via an unspecified route of administration as dose1, single and dose2, single for COVID-19 immunisation. The patient reported that 'my sinus infection has come back' on an unspecified date. No Investigation assessment reported. Nurse stated that she had a sinus infection. So, she was on prednisone from 08Sep2021 to 15Sep2021 and she had her last dose on 15Sep2021 and then she got her Pfizer third booster shot early on 01Oct2021 because she was a healthcare professional. So, her sinus infection has come back and her ear, nose and throat doctor put me on a product Augmentin and she wanted to know if she want to take the prednisone. She stated, LOT 301558A (further not clarified). Prior vaccinations (within 4 weeks): Nurse stated, "I think I had an allergy shot (further not clarified hence, captured as Unspecified Shot), last Wednesday" (further clarifications unknown). Therapeutic measures were taken as a result of sinus infection. Treatment: Nurse stated she took a Augmentin from 08Sep2021 to 15Sep2021. She took 875 milligrams of Augmentin for a week, twice a day with the prednisone 40 milligrams (voice not clear). The end is on15Sep2021 and then they just gave her a prescription to start Augmentin again 875 milligrams to start tonight 875 milligrams, twice a day for 10 days. Outcome of event was unknown.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Immunisation, Mass
Clinical narrative: booster; The redness has grown in the course of the last five days; When I received the vaccination I had a modest lump and little bit of redness; This is a spontaneous report from a contactable consumer. A 73-year-old female patient received third dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 04Oct2021 (Batch/Lot Number: 30145BA) (at the age of 73-year-old) as dose 3 (booster), single for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included hydrochlorothiazide, potassium, acetylsalicylic acid (BABY ASPIRIN), vitamin D3 and Gummy vitamins. The patient received first and second dose of BNT162B2 on unknown date for covid-19 immunization. On 04Oct2021 the patient experienced booster. On an unknown date in Oct2021 the patient experienced The redness has grown in the course of the last five days and When I received the vaccination I had a modest lump and little bit of redness. Therapeutic measures were taken as a result of The redness has grown in the course of the last five days and When I received the vaccination I had a modest lump and little bit of redness. The patient reported that she received two Pfizer vaccinations (Covid-19 Vaccine) and this week on Monday got the booster and had a question regarding the side effects. When she received the vaccination she had a modest lump and little bit of redness but this is Friday , she got the vaccination on Monday, today is Friday and the red area has grown considerably. It was modest, the average size. The redness has grown in the course of the last five days. She asked if that was okay and was it supposed to grow in size or supposed to get smaller. She took one Tylenol. She stated that she should be concerned about her arm getting red. She was advised to consult with her healthcare provider. The outcome of the event The redness has grown in the course of the last five days was not resolved, for the event When I received the vaccination I had a modest lump and little bit of redness the outcome was unknown. Follow-up attempts completed. No further information expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Gastroenteritis, Lactose tolerance test
Clinical narrative: Gastroenteritis; This is a spontaneous report from a contactable Physician.  A 41-years-old male received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number was not reported) via an unspecified route of administration, on 01Jul2021 (age at the time of vaccination was 40-years-old) as a DOSE 1, SINGLE for COVID-19 immunization. Medical history and concomitant medications were not reported. On 20Jul2021, the patient experienced Gastroenteritis. The patient received BENTYL PPN as a treatment medication for adverse event. The patient underwent lab tests and medical procedures on 17Sep2021 which included Lactose tolerance which showed result as Negative. The clinical outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Hordeolum
Clinical narrative: This adult male patient (Pt) had 2 styes after receiving Pfizer vaccine (in each eye with most recent eye affected in Oct2021 right eye which swelled so much his eye was shut).; This is a spontaneous report from a contactable hcp(nurse). This nurse reported similar events for 4 patients. This is first of 4 reports.   An adult male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The family history includes patient's mom had history of styes. The historical vaccine includes first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient did not had COVID prior vaccination. The patient had 2 styes after receiving Pfizer vaccine (in each eye with most recent eye affected in Oct2021 right eye which swelled so much his eye was shut). Therapeutic measures include antibiotics oral and eye cream unspecified. The patient and his wife reported to the physician that the patient's sister, and her son (sister and sister's son styes as bad as patient's eyes or worse) and patient's daughter (stye not as bad), all had styes after Pfizer vaccine. all had styes after Pfizer vaccine, the doctor reportedly, was respectful but poo-pooed the idea of patient's mention that the styes correlated to Pfizer vaccine. The physician stated that he saw zero occurrences. The patient did not pursue reporting, and did not give permission to be contacted at this time. The event outcome was reported as not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101375859 same reporter, drug and event, different patient;US-PFIZER INC-202101375851 same reporter, drug and event, different patient;US-PFIZER INC-202101375858 same reporter, drug and event, different patient
Sex: M
Vaccine: COVID19
Symptoms: Hordeolum
Clinical narrative: all had styes after Pfizer vaccine; This is a spontaneous report from contactable nurse. This nurse reported similar events for 4 patients. This is one of the 4 reports (for reporter's sister son). A adult male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, solution for injection) (Lot number was not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient medical history and patient's concomitant medications were not reported. Patient did not receive any COVID prior vaccination. On Oct2021, patient experienced all had styes after Pfizer vaccine. Therapeutic measures were taken as a result of all had styes after pfizer vaccine. The outcome was not recovered.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101375744 same reporter, drug and event, different patient;US-PFIZER INC-202101375858 same reporter, drug and event, different patient
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Cough, Dysphonia, Inflammation, Nasal congestion
Clinical narrative: Neutropenia; sounds like a cold; Voice change; Throat issues; gotten worse; Sinusitis; cough; Nasal issues; burning sensation in throat; Severely congested and inflamed; Swollen cheeks; Severely congested and inflamed; This is a spontaneous report from a contactable consumer (patient).  A 54-year-old female patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization.  Medical history and concomitant medications were not reported.  Previously patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date (at the age of 54 years), as dose 1, single for COVID-19 immunization. On 14Oct2021 the patient experienced sounds like a cold, voice change, throat issues. on 2021 gotten worse, sinusitis, cough, nasal issues, burning sensation in throat, severely congested and inflamed, swollen cheeks, severely congested and inflamed, Neutropenia. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 16Oct2021. The patient was diagnosed with Sinusitis. The outcome of the events was sounds like a cold, Voice change, Throat issues, gotten worse was not recovered. All the other events was unknown.  Lot/batch number is not available despite the follow up attempts made. Follow-up attempts are completed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal disorder, Nasopharyngitis, Neutropenia, Oropharyngeal discomfort, SARS-CoV-2 test
Clinical narrative: Neutropenia; sounds like a cold; Voice change; Throat issues; gotten worse; Sinusitis; cough; Nasal issues; burning sensation in throat; Severely congested and inflamed; Swollen cheeks; Severely congested and inflamed; This is a spontaneous report from a contactable consumer (patient).  A 54-year-old female patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization.  Medical history and concomitant medications were not reported.  Previously patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date (at the age of 54 years), as dose 1, single for COVID-19 immunization. On 14Oct2021 the patient experienced sounds like a cold, voice change, throat issues. on 2021 gotten worse, sinusitis, cough, nasal issues, burning sensation in throat, severely congested and inflamed, swollen cheeks, severely congested and inflamed, Neutropenia. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 16Oct2021. The patient was diagnosed with Sinusitis. The outcome of the events was sounds like a cold, Voice change, Throat issues, gotten worse was not recovered. All the other events was unknown.  Lot/batch number is not available despite the follow up attempts made. Follow-up attempts are completed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Sinusitis, Swelling face, Throat irritation
Clinical narrative: Neutropenia; sounds like a cold; Voice change; Throat issues; gotten worse; Sinusitis; cough; Nasal issues; burning sensation in throat; Severely congested and inflamed; Swollen cheeks; Severely congested and inflamed; This is a spontaneous report from a contactable consumer (patient).  A 54-year-old female patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization.  Medical history and concomitant medications were not reported.  Previously patient received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date (at the age of 54 years), as dose 1, single for COVID-19 immunization. On 14Oct2021 the patient experienced sounds like a cold, voice change, throat issues. on 2021 gotten worse, sinusitis, cough, nasal issues, burning sensation in throat, severely congested and inflamed, swollen cheeks, severely congested and inflamed, Neutropenia. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 16Oct2021. The patient was diagnosed with Sinusitis. The outcome of the events was sounds like a cold, Voice change, Throat issues, gotten worse was not recovered. All the other events was unknown.  Lot/batch number is not available despite the follow up attempts made. Follow-up attempts are completed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Immunisation, Vaccination site pain
Clinical narrative: Received dose 3 on 22Oct2021; Soreness at the injection site; This is a spontaneous report from a contactable consumer (Patient) via COVID-19 Adverse Event Self-Reporting sysytem. A 42-year-old female patient(not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EW0188), via an unspecified route of administration, administered in left arm on 22Oct2021 15:45 (at age of 42-year-old)as dose 3 (BOOSTER), single for covid-19 immunization in hospital. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine and she was not diagnosed with COVID-19 prior to vaccination. On 12Mar2021(at age of 41-year-old), the patient received bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number: EN6206), via an unspecified route of administration, administered in left arm  as dose 2, single for Covid-19 immunization and experienced sore arm and Low-grade fever (100.2). On 22Feb2021(at age of 41-year-old), the patient received bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number: EL9266), via an unspecified route of administration, administered in left arm as dose 1, single for Covid-19 immunization and experienced soreness at injection site. Medical history included asthma and overweight and the known allergies were Penicillin, possibly aspartame. Concomitant medications in 2 weeks included ibuprofen (ADVIL), probiotics and tocopherol (VITAMIN E). The patient experienced soreness at the injection site on 22Oct2021. The patient underwent lab tests and procedures which included body temperature: 100.2 fahrenheit on 13Mar2021. The outcome of soreness at the injection site was recovering with treatment including paracetamol(Tylenol). Since the vaccination, the patient has not been tested for COVID-19.  No Follow-up attempts are needed. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site mass
Clinical narrative: felt a little knot where they injected the needle/had a little mark or bump where he had the injection/Bump on my arm; I can feel it on my arm; This is a spontaneous report from a contactable consumer (patient) or other non hcp.   A 65-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) (Batch/Lot Number: EW6602) dose 2 via an unspecified route of administration, administered in Arm Left on 24Feb2021 as dose 2, single, dose 1 (Batch/Lot Number: EM9810) via an unspecified route of administration, administered in Arm Left on 04Feb2021 is dose 1, single (age at vaccination: 65-yesr-old) for COVID-19 immunization. Medical history included blood pressure high, cholesterol. Concomitant medication(s) included amlodipine (AMLODIPINE); rosuvastatin (ROSUVASTATIN) taken for hypertension, blood cholesterol increased, start and stop date were not reported; aspirin [acetylsalicylic acid] (ASPIRIN [ACETYLSALICYLIC ACID]) (1x/day (Low dose Aspirin)) taken for an unspecified indication, start and stop date were not reported. Patient reported Weight (kg) as 104.33 and Height (cm) as 182. On unspecified date patient previously took Flu shots. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. On Jul2021, patient experienced felt a little knot where they injected the needle/had a little mark or bump where he had the injection/bump on my arm; i can feel it on my arm, it's a bump on my arm, it doesn't hurt or anything. it is a bump on my arm that doesn't hurt but i can feel it on my arm. there was no treatment reported. The outcome of event was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Eye haemorrhage, Rash pruritic, SARS-CoV-2 test, Urticaria
Clinical narrative: red, itchy rash/on her chest and spread to her head, neck, ears and back. It also spread in a smaller amount to her arm, wrists, legs and ankles; Welts/Hives; burst blood vessel in her eye; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular, administered in arm left on 07Oct2021 at 15:00 (Lot Number: 301568A) as dose 2, single (at the age of 52 years old) for COVID-19 immunization. Medical history included celiac, hypothyroid from 08Jan2017 and ongoing, "adrenal insuff" from 01Aug2020 and ongoing, menopause from 01Nov2018 to an unknown date, seasonal affective disorder (SAD)/anxiety from 01Nov2018 and ongoing. Concomitant medications included levothyroxine sodium (SYNTHROID) taken for thyroid from 08Jan2017 and ongoing; liothyronine sodium (CYTOMEL) taken for thyroid from 08Jan2017 and ongoing; bupropion hydrochloride (WELLBUTRIN) taken for SAD/Anxiety from 01Nov2018 and ongoing; hydrocortisone taken for adrenal insuff from 01Aug2020 and ongoing; progesterone taken for menopause from 01Nov2018 and ongoing. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via intramuscular administered in left arm on 16Sep2021 at 11:00 AM (however also reported as 2100) as dose 1 (at the age of 52 years old) for COVID-19 immunization; gluten and experienced allergy. No other vaccine in four weeks/ No Prior vaccinations (within 4 weeks). No COVID prior vaccination. On 18Oct2021 at 12:00 AM, about 10 days after second dose, the patient developed a red, itchy rash. It started on her chest and spread to her head, neck, ears and back. It also spread in a smaller amount to her arm, wrists, legs and ankles. The patient's 2nd vaccine was taken (as recommended) 3 week after her 1st-on 07Oct2021. On 09Oct2021, she woke up with a burst blood vessel in her eye, she had never had one before. It looked awful, but it didn't hurt. Around 16Oct2021, she developed a red itchy rash on her neck plus chest. It spread to her head, face, ears and back. There were welts, hives, red bumps, etc. Her wrists and ankles got small red, itchy dots on them, her ears and chest were hot, itchy and sore. After a few days, it got a little better with ibuprofen and cold compresses. Then it flared up again. She went to a quick care facility and was given a steroid shot, pills and creme to treat a severe allergic reaction. After 10 days, she got a refill because it was still red plus itchy, but not as bad as before she went to the Doctor. The patient underwent lab tests and procedures which included Covid-19: negative on 17Oct2021 and on 29Oct2021, Nasal Swab: negative on 16Oct2021. Therapeutic measures were taken as a result of the events. The outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Erythema, Eye haemorrhage, Pruritus, Rash, Rash erythematous
Clinical narrative: red, itchy rash/on her chest and spread to her head, neck, ears and back. It also spread in a smaller amount to her arm, wrists, legs and ankles; Welts/Hives; burst blood vessel in her eye; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular, administered in arm left on 07Oct2021 at 15:00 (Lot Number: 301568A) as dose 2, single (at the age of 52 years old) for COVID-19 immunization. Medical history included celiac, hypothyroid from 08Jan2017 and ongoing, "adrenal insuff" from 01Aug2020 and ongoing, menopause from 01Nov2018 to an unknown date, seasonal affective disorder (SAD)/anxiety from 01Nov2018 and ongoing. Concomitant medications included levothyroxine sodium (SYNTHROID) taken for thyroid from 08Jan2017 and ongoing; liothyronine sodium (CYTOMEL) taken for thyroid from 08Jan2017 and ongoing; bupropion hydrochloride (WELLBUTRIN) taken for SAD/Anxiety from 01Nov2018 and ongoing; hydrocortisone taken for adrenal insuff from 01Aug2020 and ongoing; progesterone taken for menopause from 01Nov2018 and ongoing. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via intramuscular administered in left arm on 16Sep2021 at 11:00 AM (however also reported as 2100) as dose 1 (at the age of 52 years old) for COVID-19 immunization; gluten and experienced allergy. No other vaccine in four weeks/ No Prior vaccinations (within 4 weeks). No COVID prior vaccination. On 18Oct2021 at 12:00 AM, about 10 days after second dose, the patient developed a red, itchy rash. It started on her chest and spread to her head, neck, ears and back. It also spread in a smaller amount to her arm, wrists, legs and ankles. The patient's 2nd vaccine was taken (as recommended) 3 week after her 1st-on 07Oct2021. On 09Oct2021, she woke up with a burst blood vessel in her eye, she had never had one before. It looked awful, but it didn't hurt. Around 16Oct2021, she developed a red itchy rash on her neck plus chest. It spread to her head, face, ears and back. There were welts, hives, red bumps, etc. Her wrists and ankles got small red, itchy dots on them, her ears and chest were hot, itchy and sore. After a few days, it got a little better with ibuprofen and cold compresses. Then it flared up again. She went to a quick care facility and was given a steroid shot, pills and creme to treat a severe allergic reaction. After 10 days, she got a refill because it was still red plus itchy, but not as bad as before she went to the Doctor. The patient underwent lab tests and procedures which included Covid-19: negative on 17Oct2021 and on 29Oct2021, Nasal Swab: negative on 16Oct2021. Therapeutic measures were taken as a result of the events. The outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Rash papular, Rash pruritic, Swelling, Swelling of eyelid
Clinical narrative: red, itchy rash/on her chest and spread to her head, neck, ears and back. It also spread in a smaller amount to her arm, wrists, legs and ankles; Welts/Hives; burst blood vessel in her eye; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular, administered in arm left on 07Oct2021 at 15:00 (Lot Number: 301568A) as dose 2, single (at the age of 52 years old) for COVID-19 immunization. Medical history included celiac, hypothyroid from 08Jan2017 and ongoing, "adrenal insuff" from 01Aug2020 and ongoing, menopause from 01Nov2018 to an unknown date, seasonal affective disorder (SAD)/anxiety from 01Nov2018 and ongoing. Concomitant medications included levothyroxine sodium (SYNTHROID) taken for thyroid from 08Jan2017 and ongoing; liothyronine sodium (CYTOMEL) taken for thyroid from 08Jan2017 and ongoing; bupropion hydrochloride (WELLBUTRIN) taken for SAD/Anxiety from 01Nov2018 and ongoing; hydrocortisone taken for adrenal insuff from 01Aug2020 and ongoing; progesterone taken for menopause from 01Nov2018 and ongoing. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via intramuscular administered in left arm on 16Sep2021 at 11:00 AM (however also reported as 2100) as dose 1 (at the age of 52 years old) for COVID-19 immunization; gluten and experienced allergy. No other vaccine in four weeks/ No Prior vaccinations (within 4 weeks). No COVID prior vaccination. On 18Oct2021 at 12:00 AM, about 10 days after second dose, the patient developed a red, itchy rash. It started on her chest and spread to her head, neck, ears and back. It also spread in a smaller amount to her arm, wrists, legs and ankles. The patient's 2nd vaccine was taken (as recommended) 3 week after her 1st-on 07Oct2021. On 09Oct2021, she woke up with a burst blood vessel in her eye, she had never had one before. It looked awful, but it didn't hurt. Around 16Oct2021, she developed a red itchy rash on her neck plus chest. It spread to her head, face, ears and back. There were welts, hives, red bumps, etc. Her wrists and ankles got small red, itchy dots on them, her ears and chest were hot, itchy and sore. After a few days, it got a little better with ibuprofen and cold compresses. Then it flared up again. She went to a quick care facility and was given a steroid shot, pills and creme to treat a severe allergic reaction. After 10 days, she got a refill because it was still red plus itchy, but not as bad as before she went to the Doctor. The patient underwent lab tests and procedures which included Covid-19: negative on 17Oct2021 and on 29Oct2021, Nasal Swab: negative on 16Oct2021. Therapeutic measures were taken as a result of the events. The outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Alopecia, Ear swelling, Eye haemorrhage, Otorrhoea, Rash
Clinical narrative: red, itchy rash/on her chest and spread to her head, neck, ears and back. It also spread in a smaller amount to her arm, wrists, legs and ankles; Welts/Hives; burst blood vessel in her eye; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular, administered in arm left on 07Oct2021 at 15:00 (Lot Number: 301568A) as dose 2, single (at the age of 52 years old) for COVID-19 immunization. Medical history included celiac, hypothyroid from 08Jan2017 and ongoing, "adrenal insuff" from 01Aug2020 and ongoing, menopause from 01Nov2018 to an unknown date, seasonal affective disorder (SAD)/anxiety from 01Nov2018 and ongoing. Concomitant medications included levothyroxine sodium (SYNTHROID) taken for thyroid from 08Jan2017 and ongoing; liothyronine sodium (CYTOMEL) taken for thyroid from 08Jan2017 and ongoing; bupropion hydrochloride (WELLBUTRIN) taken for SAD/Anxiety from 01Nov2018 and ongoing; hydrocortisone taken for adrenal insuff from 01Aug2020 and ongoing; progesterone taken for menopause from 01Nov2018 and ongoing. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via intramuscular administered in left arm on 16Sep2021 at 11:00 AM (however also reported as 2100) as dose 1 (at the age of 52 years old) for COVID-19 immunization; gluten and experienced allergy. No other vaccine in four weeks/ No Prior vaccinations (within 4 weeks). No COVID prior vaccination. On 18Oct2021 at 12:00 AM, about 10 days after second dose, the patient developed a red, itchy rash. It started on her chest and spread to her head, neck, ears and back. It also spread in a smaller amount to her arm, wrists, legs and ankles. The patient's 2nd vaccine was taken (as recommended) 3 week after her 1st-on 07Oct2021. On 09Oct2021, she woke up with a burst blood vessel in her eye, she had never had one before. It looked awful, but it didn't hurt. Around 16Oct2021, she developed a red itchy rash on her neck plus chest. It spread to her head, face, ears and back. There were welts, hives, red bumps, etc. Her wrists and ankles got small red, itchy dots on them, her ears and chest were hot, itchy and sore. After a few days, it got a little better with ibuprofen and cold compresses. Then it flared up again. She went to a quick care facility and was given a steroid shot, pills and creme to treat a severe allergic reaction. After 10 days, she got a refill because it was still red plus itchy, but not as bad as before she went to the Doctor. The patient underwent lab tests and procedures which included Covid-19: negative on 17Oct2021 and on 29Oct2021, Nasal Swab: negative on 16Oct2021. Therapeutic measures were taken as a result of the events. The outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.