chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Mar2021 at 10:00 as dose 1, single (Batch/Lot number: unknown), in left arm and on 14Apr2021 at 10:00 as dose 2, single (Batch/Lot number: unknown) at the age of 48 years, in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 28Oct2021 at 10:00 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Past drug history included: Keflex, reaction(s): "known allergies: Keflex". Patient did not received other medication in 2 weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 10May2022, outcome "recovered" (17May2022) and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (10May2022) Positive, notes: That test was Tuesday 10May in the evening; (17May2022) Negative, notes: I tested negative Tuesday am 17May. Therapeutic measures were taken as a result of drug ineffective, covid-19. Felt great at end of five days. Symptoms returned on day 8 and 9 head congestion and fatigue. Patient will resolve but I wanted to report for the sake of collecting data about Paxlovid. She began treatment 24 hours after her positive test for covid 19. That test was Tuesday 10May in the evening. She tested negative Tuesday am 17May.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Dec2021 as dose 1, single (Lot number: 4I3197), in Mar2022 as dose 2, single (Lot number: ER8733) and in Apr2022 as dose 3 (booster), single at the age of 62 years for covid-19 immunization. The patient had no relevant medical history and no known allergies. Concomitant medication(s) included: TRAZODONE, start date: Jan2003; METHYLPHENIDATE, start date: Jan2001; FINASTERIDE, start date: Jan2004; DULOXETINE, start date: Jan2001, also reported as other medications in 2 weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: UNKNOWN RESULT, notes: PCR test was worse every day. Therapeutic measures were taken as a result of drug ineffective, suspected covid-19 included Paxlovid (start date 13May2022, stop date 18May2022). Clinical course was reported as, Patient started testing better after day 5 and then each day symptoms and PCR test was worse every day. On 18May2022 the patient was on day 10 and her symptoms were back to day 1. No therapeutic measures were taken as result of symptoms and patient was not recovered from the symptoms.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: I got covid on sat night so i cancelled my last booster; I got covid on sat night so i cancelled my last booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from Regulatory Authority, Program ID:. The reporter is the patient.  A 66-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I got covid on sat night so i cancelled my last booster".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: I got covid on sat night so i cancelled my last booster; I got covid on sat night so i cancelled my last booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from Regulatory Authority, Program ID:. The reporter is the patient.  A 66-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I got covid on sat night so i cancelled my last booster".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: Violent chills (couldn't stop shaking); This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19May2022 as dose 4 (booster), single (Lot number: FP4554) at the age of 77 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Chronic cough" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Codein, reaction(s): "Allergy". Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for Covid-19 Immunization; Covid-19 vaccine (Dose 3 , Unknown Manufacturer), for Covid-19 Immunization. The following information was reported: CHILLS (non-serious) with onset 19May2022, outcome "recovered", described as "Violent chills (couldn't stop shaking)". Therapeutic measures were not taken as a result of chills.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: My wife and I both contracted, we both had all the Pfizer boosters (Unspecified booster), everything else, booster twice, we both ended up with COVID; My wife and I both contracted, we both had all the Pfizer boosters (Unspecified booster), everything else, booster twice, we both ended up with COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "My wife and I both contracted, we both had all the Pfizer boosters (Unspecified booster), everything else, booster twice, we both ended up with COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The reporter stated he and his wife both contracted, they both had all the Pfizer boosters (Unspecified booster) and everything else, booster twice and both ended up with COVID 2 days ago and one of the friend told they should try Paxlovid. But the reporter went to hospital, and they said his vitals were fine just go home and let the go, but they ended up taking one dose, that was the major side effects of diarrhea and loss of appetite. So, reporter think they should stop taking it.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue
Clinical narrative: Caller's wife experienced fatigue 48 hours after the second booster dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Other HCP) from medical information team.  A 62-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete, Single, Unknown Manufacturer), for Covid-19 Immunization; Covid-19 vaccine (1st Booster dose, Single., Unknown Manufacturer), for Covid-19 Immunization. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "Caller's wife experienced fatigue 48 hours after the second booster dose". Additional Information: Caller's wife experienced fatigue 48 hours after the second booster dose. There's no information on the exact correlation between antibody level and reactogenicity/safety profile with additional doses. As far as the PI, it mentions immunogenicity profile of the second booster dose. Immunogenicity of a Second Booster Dose reported as: Among these individuals, approximately 11-fold increases in geometric mean neutralizing antibody titers against wild-type virus and variants, respectively, were reported at two weeks after the second booster as compared to 5 months after the first booster dose. In General, Side effects after the second shot may be more intense than the ones experienced after the first shot. Side effects vary among individual patients. These side effects are normal signs that the body is building protection and should go away within a few days.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: indication=Treatment of COVID-19; indication=Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old male patient received BNT162b2 (BNT162B2), on 30Apr2021 as dose number unknown, single (Lot number: EW0167), in left arm, on 31Jul2021 as dose number unknown, single (Lot number: EW0158), in left arm and on 15Dec2021 as dose number unknown, single (Lot number: FD7218) at the age of 30 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "indication=Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200749574 Same patient and drug, different event separated in time
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Joint noise
Clinical narrative: Popping in both elbows; It has worsened over time; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), on 30Oct2021 as dose 2, single (Lot number: FF2590) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: BNT162b2 (First Dose: , Lot: 301358A), administration date: 09Oct2021, for COVID-19 immunization. The following information was reported: JOINT NOISE (non-serious), outcome "not recovered", described as "Popping in both elbows"; CONDITION AGGRAVATED (non-serious), outcome "not recovered", described as "It has worsened over time". Therapeutic measures were not taken as a result of joint noise, condition aggravated.  Additional information: Caller would not provide any identifiers except phone number. Caller received the first dose of the Pfizer COVID-19 on 09Oct2021 and the second dose on 30Oct2021. He has noticed "popping in both elbows" since he received the vaccine and it has worsened over time. Caller would like to know if this is a side effect of the Pfizer COVID-19 vaccine and how long it may last. Caller clarifies that he does have popping in both elbows. Caller declines to provide any patient identifiers other than his phone number. Caller states it started whenever he got the vaccine shots, well not too long after he got his Pfizer Vaccine Shots. Caller later states he thinks it might have started after his second one and it has gotten worse.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness
Clinical narrative: She is having trouble lifting her right arm high enough to put on a coat and she can not squeeze or hold anything with her right hand; She sits is having trouble lifting her right leg, she needs to use her hands to move it; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 30-year-old female patient received BNT162b2 (BNT162B2), in May2022 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MUSCULAR WEAKNESS (non-serious) with onset May2022, outcome "unknown", described as "She is having trouble lifting her right arm high enough to put on a coat and she can not squeeze or hold anything with her right hand"; MUSCULAR WEAKNESS (non-serious) with onset May2022, outcome "unknown", described as "She sits is having trouble lifting her right leg, she needs to use her hands to move it".  Additional information :Been about a week and a half. Having symptoms and not sure if they are related to the vaccine. Never had this happen before.  Symptoms: It's the right side of her body, right hand and right leg: Cannot use right hand .Cannot lift right leg. Caller states she received the Pfizer COIVD-19 vaccine about a week and a half ago. Caller states this was her first dose and she received it in the left arm but now complaining that she is having trouble lifting her right arm high enough to put on a coat and she can not squeeze or hold anything with her right hand. Also when she sits is having trouble lifting her right leg, she needs to use her hands to move it. Caller is wondering if this is a potential side effect of the vaccine. Made caller aware that after reviewing it does make mention of New or worsened muscle pain, New or worsened joint pain, Pain at the injection site, it did not find information regarding what you are experiencing. As the Prescribing Information does not include all adverse reactions that have been reported or that may occur, please consult with your doctor/healthcare provider about what you have experienced/are experiencing.  Because your doctor/healthcare provider is most familiar with your medical condition, clinical history, how your treatment has been conducted and any relevant information to your specific case, your doctor/healthcare provider is in the best position to advise you about the appropriate action to take.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Gait inability, Loss of personal independence in daily activities, Pain
Clinical narrative: Pain in lower back; Chills; Aches; too painful to sit upright or walk; too painful to sit upright or walk; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Aug2021 as dose 1, single (Lot number: EW0185), in left arm, on 01Sep2021 as dose 2, single (Lot number: EW0185), in left arm and on 20May2022 as dose 3 (booster), single (Lot number: 4JY989) at the age of 43 years, in left arm for covid-19 immunization. The patient's relevant medical history included: "Endometriosis" (unspecified if ongoing); "Sulfa Based Antibiotics" (unspecified if ongoing), notes: known allergies : Sulfa Based Antibiotics. There were no concomitant medications. The following information was reported: PAIN (non-serious) with onset 21May2022, outcome "recovering", described as "Aches"; CHILLS (non-serious) with onset 21May2022, outcome "recovering"; BACK PAIN (non-serious) with onset 21May2022, outcome "recovering", described as "Pain in lower back"; GAIT INABILITY (non-serious), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) all with onset 21May2022, outcome "recovering" and all described as "too painful to sit upright or walk". Therapeutic measures were not taken as a result of back pain, chills, pain, gait inability, loss of personal independence in daily activities. Clinical course included No other medications in two weeks. No other vaccine in four weeks. No COVID prior vaccination. No COVID tested post vaccination. known allergies included Sulfa Based Antibiotics. Chills, Aches, Pain in lower back  had to spend entire day in bed because it was too painful to sit upright or walk.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 52-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 1, single (Lot number: 330308D), in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), as dose 2, single (Lot number: 048B21A), in left arm and as dose 3 (booster), single (Lot number: 081B21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Just overweight and over 50" (unspecified if ongoing), notes: Just overweight and over 50. Patient had no known allergies. There were no concomitant medications, also reported as no other medication in 2weeks. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 11May2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11May2022) Positive, notes: Took Paxlovid on my first day of COVID test; (20May2022) Negative, notes: Tested negative on day 9; (23May2022) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 Paxlovid (start date: 11May2022, stop date: 15May2022). Clinical course was reported as, patient took Paxlovid on first day of COVID test and symptoms, and tested negative on day 9 and felt fine. On day 11, 21May2022 at 12:00 started feeling like a had a head cold, and tired, today (at the time of report) patient tested and she was positive again. Patient was recovering from symptoms and no treatment received for symptoms.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old male patient received BNT162b2 (BNT162B2), on 06Jan2022 at 12:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 37 years, in left arm for covid-19 immunization. The patient had no relevant medical history and no Known allergies. There were no concomitant medications.The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Rebound of symptoms. Therapeutic measures were taken as a result of drug ineffective, covid-19 included Paxlovid started on 13May2022 and stopped on 18May2022. Clinical course was reported as, Rebound symptoms on 21May2022 at 14:00. No treatment received for symptoms and patient was not recovered from symptoms.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 35-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 34 years, in left arm for covid-19 immunization; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history included: "Obesity" (unspecified if ongoing); "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: ZOLOFT, start date: 23Jan2017; LEVOTHYROXINE, start date: 05Feb2018; also reported as other medication in 2weeks. Past drug history included: Zithromax, reaction(s): "Known allergies: Zithromax". The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19 included Paxlovid from 15May2022 to 19May2022. Clinical course was reported as, patient experienced Return of sore throat, phlegm and coughing 2 days after completing paxlovid regimen on 21May2022. No treatment received for symptoms and patient Not recovered from symptoms.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Nauseous; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed , UNKNOWN MANUFACTURER), for COVID-19 immunization. The following information was reported: NAUSEA (non-serious), outcome "unknown", described as "Nauseous".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes simplex, SARS-CoV-2 test
Clinical narrative: After vaccination, outbreaks now occur at least every month, sometimes twice a month.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from Regulatory Authority. The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Apr2021 as dose 2, single (Lot number: EP7533) at the age of 40 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Anemia" (unspecified if ongoing); "HSV2", start date: 2005 (unspecified if ongoing), notes: I have had HSV2 since 2005; "Outbreaks" (unspecified if ongoing), notes: have had HSV2 since 2005 with outbreaks occurring every 1-3 years prior to vaccination. There were no concomitant medications. Vaccination history included: BNT162b2 (Prev dose brand: Pfizer,, Prev dose lot number: EP7534,, Prev dose dose number: 1,, Prev dose vaccine location: Left arm), administration date: 18Mar2021, when the patient was 40-year-old, for COVID-19 Immunization. The following information was reported: HERPES SIMPLEX (non-serious) with onset Apr2021, outcome "not recovered", described as "After vaccination, outbreaks now occur at least every month, sometimes twice a month.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of herpes simplex.  Additional information- Facility where the most recent COVID-19 vaccine was administered was Other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There was no list of any other medications the patient received within 2 weeks of vaccination  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Constipation, Diarrhoea, Dizziness, Injection site mass
Clinical narrative: constipation; lightheadedness; dizziness; 2 lumps at Eligard injection site; Diarrhea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): TMR293837 (RA).  A male patient received COVID-19 Vaccine - Manufacturer Unknown, in Feb2022 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; leuprorelin acetate (ELIGARD), since Feb2022 (Batch/Lot number: unknown) at 30 mg. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 01, Unknown Manufacturer), administration date: Oct2021, for COVID-19 Immunization; Covid-19 vaccine (Dose: 02, Unknown Manufacturer), administration date: 2021, for COVID-19 Immunization. The following information was reported: INJECTION SITE MASS (non-serious) with onset Feb2022, outcome "not recovered", described as "2 lumps at Eligard injection site"; DIARRHOEA (non-serious) with onset Feb2022, outcome "recovered" (2022), described as "Diarrhea"; CONSTIPATION (non-serious) with onset Feb2022, outcome "recovered" (2022); DIZZINESS (non-serious) with onset Feb2022, outcome "not recovered"; DIZZINESS (non-serious) with onset Feb2022, outcome "not recovered", described as "lightheadedness". The action taken for leuprorelin acetate was unknown.  Additional information: The patient received the second dose of the COVID-19 vaccine in Nov2021 or Dec2021. All the events started the day after he received his Eligard injection in Feb2022 (exact date unknown).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Dizziness, Feeling abnormal, Headache, Pain
Clinical narrative: Head start hurting; Start getting achy all over; Tried to go to sleep I would take short naps but I felt so achy I would wake up; Start feeling bad; Got really from bad to worse/I am not feeling a 100%; Not have an appetite; Got out of the tub I was so dizzy; Sat on the side of the tub, I do not feel like I could stand without falling; Start throwing up the water; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient received BNT162b2 (BNT162B2), on 28Apr2022 as dose 4 (booster), single (Lot number: FK9894) at the age of 71 years for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing), notes: High blood pressure Consumer stated, "I do have high blood pressure but I went to the doctor and my blood pressure is normal.". Concomitant medication(s) included: HYDROCHLOROTHIAZID taken for hypertension. Vaccination history included: Covid-19 vaccine (Dose:1, Unknown manufacture), for COVID-19 Immunization; Covid-19 vaccine (Dose:2, Unknown manufacture), for COVID-19 Immunization; Covid-19 vaccine (Dose:3, Unknown manufacture, Side effects were worse than the second and the first booster; Side effects lasted longer than before/In the past when I had a side effect, I would be sick for the following day), for COVID-19 Immunization, reaction(s): "Side effects were worse than the second and the first booster; Side effects lasted longer than before/In the past when I had a side effect, I would be sick for the following day". The following information was reported: DIZZINESS (non-serious) with onset 28Apr2022, outcome "unknown", described as "Got out of the tub I was so dizzy; Sat on the side of the tub, I do not feel like I could stand without falling"; HEADACHE (non-serious) with onset 28Apr2022, outcome "unknown", described as "Head start hurting"; DECREASED APPETITE (non-serious) with onset 28Apr2022, outcome "unknown", described as "Not have an appetite"; FEELING ABNORMAL (non-serious) with onset 28Apr2022, outcome "unknown", described as "Start feeling bad; Got really from bad to worse/I am not feeling a 100%"; PAIN (non-serious) with onset 28Apr2022, outcome "unknown", described as "Start getting achy all over; Tried to go to sleep I would take short naps but I felt so achy I would wake up"; VOMITING (non-serious) with onset 28Apr2022, outcome "unknown", described as "Start throwing up the water". Therapeutic measures were taken as a result of headache, pain, feeling abnormal, decreased appetite, dizziness, vomiting.  No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Head start hurting; Start getting achy all over; Tried to go to sleep I would take short naps but I felt so achy I would wake up; Start feeling bad; Got really from bad to worse/I am not feeling a 100%; Not have an appetite; Got out of the tub I was so dizzy; Sat on the side of the tub, I do not feel like I could stand without falling; Start throwing up the water; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient received BNT162b2 (BNT162B2), on 28Apr2022 as dose 4 (booster), single (Lot number: FK9894) at the age of 71 years for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing), notes: High blood pressure Consumer stated, "I do have high blood pressure but I went to the doctor and my blood pressure is normal.". Concomitant medication(s) included: HYDROCHLOROTHIAZID taken for hypertension. Vaccination history included: Covid-19 vaccine (Dose:1, Unknown manufacture), for COVID-19 Immunization; Covid-19 vaccine (Dose:2, Unknown manufacture), for COVID-19 Immunization; Covid-19 vaccine (Dose:3, Unknown manufacture, Side effects were worse than the second and the first booster; Side effects lasted longer than before/In the past when I had a side effect, I would be sick for the following day), for COVID-19 Immunization, reaction(s): "Side effects were worse than the second and the first booster; Side effects lasted longer than before/In the past when I had a side effect, I would be sick for the following day". The following information was reported: DIZZINESS (non-serious) with onset 28Apr2022, outcome "unknown", described as "Got out of the tub I was so dizzy; Sat on the side of the tub, I do not feel like I could stand without falling"; HEADACHE (non-serious) with onset 28Apr2022, outcome "unknown", described as "Head start hurting"; DECREASED APPETITE (non-serious) with onset 28Apr2022, outcome "unknown", described as "Not have an appetite"; FEELING ABNORMAL (non-serious) with onset 28Apr2022, outcome "unknown", described as "Start feeling bad; Got really from bad to worse/I am not feeling a 100%"; PAIN (non-serious) with onset 28Apr2022, outcome "unknown", described as "Start getting achy all over; Tried to go to sleep I would take short naps but I felt so achy I would wake up"; VOMITING (non-serious) with onset 28Apr2022, outcome "unknown", described as "Start throwing up the water". Therapeutic measures were taken as a result of headache, pain, feeling abnormal, decreased appetite, dizziness, vomiting.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Nasopharyngitis, SARS-CoV-2 test
Clinical narrative: just contracted it despite four Pfizer vaccines administered; just contracted it despite four Pfizer vaccines administered; have a small cold; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "just contracted it despite four Pfizer vaccines administered"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "have a small cold". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive.  Addition information: It was reported that: Your Covid vaccine may well have just saved my life. I've been very careful and after two years Covid free, just contracted it despite four Pfizer vaccines administered. I wish it could have prevented me from getting Covid, but I feel like a have a small cold, at best. In fact, I walked 12km (8 miles) today seeking out a PCR test. I could have ended up on a ventilator if not for your vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chest discomfort, Chills, Feeling cold, Gait inability
Clinical narrative: Patient's words: "Fever for 60 hrs beginning 9 hrs after vaccination. Fever ranging from 101.6-102.4.  After 60 hours a series of spikes and breaks in rapid succession causing complete soaking in sweat then freezing cold sensation, shaking and chills.  Horrible head and neck pain beginning about 3 hrs after onset of fever.  Inability to put thoughts together, swelling/numbness in face, nausea, inability to walk and speak due to pain.   Intense back and head pain that felt like I had been beaten with a hammer.   Pressure in front and back of chest."
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Hypoaesthesia, Mental impairment, Nausea
Clinical narrative: Patient's words: "Fever for 60 hrs beginning 9 hrs after vaccination. Fever ranging from 101.6-102.4.  After 60 hours a series of spikes and breaks in rapid succession causing complete soaking in sweat then freezing cold sensation, shaking and chills.  Horrible head and neck pain beginning about 3 hrs after onset of fever.  Inability to put thoughts together, swelling/numbness in face, nausea, inability to walk and speak due to pain.   Intense back and head pain that felt like I had been beaten with a hammer.   Pressure in front and back of chest."
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Pyrexia, Speech disorder, Swelling face, Tremor
Clinical narrative: Patient's words: "Fever for 60 hrs beginning 9 hrs after vaccination. Fever ranging from 101.6-102.4.  After 60 hours a series of spikes and breaks in rapid succession causing complete soaking in sweat then freezing cold sensation, shaking and chills.  Horrible head and neck pain beginning about 3 hrs after onset of fever.  Inability to put thoughts together, swelling/numbness in face, nausea, inability to walk and speak due to pain.   Intense back and head pain that felt like I had been beaten with a hammer.   Pressure in front and back of chest."
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Injection site pustule, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: Rash, warm, swollen skin at injection site, oozing pus, painful joints.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Skin weeping
Clinical narrative: Rash, warm, swollen skin at injection site, oozing pus, painful joints.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Lacrimation increased, Migraine
Clinical narrative: Third day after booster  shot was administered had severe migraine headache for 5 consecutive days with last 2 days eyes watering and wearing sock tied across forehead to attempt to reduce pain. Reported earlier to VAERS FND experience after receiving second Moderna dose 749230 Temporary VAERS E-report#.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Medium
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Lymphadenopathy
Clinical narrative: Swollen lymph nodes causing soreness and pain in left armpit. Started morning of this report.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Hyperhidrosis, Hypotension, Nausea
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Medium, Systemic: Nausea-Mild, Systemic: Tinnitus-Mild
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Medium, Systemic: Nausea-Mild, Systemic: Tinnitus-Mild
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pallor, Paraesthesia, Syncope
Clinical narrative: Patient fainted as he was walking out of our counseling room door. I was right behind patient as he was headed out the door. Therefore, I was able to catch him before dropping to the floor as he fainted. He never hit his head. I laid him on the floor and then I called for one of my technicians to come help me. Patient quickly came to after I had laid him down. He asked what happened and I told him he fainted on his way out the door. He said did not realize it happened and said he thought he was in a "dream". My technician then came into the counseling room. She got patient cool rags for on his forehead and the back of his neck. She also got him some of our unused lab coats for his head to rest on along with a bottle of water to drink. Patient was laying on our counseling room floor for about 20min from 5pm to 5:20pm. During the first part of the twenty minutes, patient's coloring was pale, bottom lip was shivering and he said his hands were tingly. RN then suggested that patient elevate his feet up on the chair. During the latter part of the the twenty minutes, he was feeling better (his color came back, no tingling and his bottom lip stopped quivering). Then he sat up leaning against a chair for about 5 minutes while still on the counseling room floor. Then he got up and sat in the chair for another 5-10 minutes. While in the chair, he talked about how he has fainted before while getting blood drawn. I stated that he marked no on our screening question #3. Question #3 reads, Have you ever had a serious reaction or fainted after receiving any vaccination or injectable medication. He stated he marked no that he has not fainted before because it was not after a vaccination or injectable medication like the question had asked, he fainted after having his blood drawn. I told him to make others aware he has fainted due to both factors now. Patient also talked about this being why he only wanted to get the Janssen vaccine because it was the one shot and he didn't want the chance of fainting twice. I then told him that a booster is recommended after getting the J&J and it should be either Pfizer or Moderna. After the 10min of sitting in the chair, he was feeling much better. So I told him that I would like for him to sit out in the waiting area for an additional 15 minutes to make sure he was okay and also so he could finish his bottle of water. He sat there with his friend talking and drinking the water. Then they left. ITEM 22- I HAVE NOT BEEN ABLE TO REACH PATIENT TO VERIFY THAT HIS ANSWER TO THIS QUESTION IS NONE.  BUT HE DID ANSWER NO TO OUR SCREENING QUESTION #7, HAVE YOU RECEIVED ANY VACCINATIONS IN THE PAST 4 WEEKS. ITEM 23- AS STATED ABOVE, HE HAS FAINTED DUE TO BLOOD DRAWN BUT NOT ANY PREVIOUS VACCINES.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: No symptoms in clinic
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Death, Endotracheal intubation
Clinical narrative: DEATH Acute respiratory failure Respiratory failure requiring intubation
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Acute kidney injury, Death, Morganella infection, Proteus infection
Clinical narrative: DEATH N17.9 - Acute kidney failure, unspecified B96.4 - Proteus (mirabilis) (morganii) as the cause of diseases classified elsewhere
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: CLIENT RECEIVED PFIZER COVID VACCINE 2ND DOSE TOO SOON. ONLY 10 DAYS BETWEEN 1ST DOSE AND 2ND DOSE WHEN THE RECOMMENDATION IS TO WAIT 21 DAYS BETWEEN DOSES.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: My lymph nodes under my left arm started causing discomfort on Sunday night following the vaccination to my left arm on Saturday evening. As of this morning (Thurday monring) my lymph nodes are still swollen and the pressure/discomfort has reduced somewhat. Tender when touched or with some movements.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Death, SARS-CoV-2 test positive
Clinical narrative: pt staying in hospital; admitted on 12/17/21; had a positive COVID test on 1/27/22; planned to stay through quarantine period, but pt expired on 2/5/22; DC and med records being sent to info@vaers.org
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Inappropriate schedule of product administration, SARS-CoV-2 test positive
Clinical narrative: Pfizer 3/23/21, 4/20/21. Positive on 5/26/22
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Cough, Dyspnoea, SARS-CoV-2 test positive
Clinical narrative: Vaccinated pt admitted to inpatient facility and tested positive for covid infection.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: On 05/20/22 I had diarrhea. I am prone to it because I have no gallbladder and certain foods I eat. At first I didn't think anything about it but then thought why was it happening. Nothing I had eaten should have given me problems. It was severe diarrhea. I almost didn't make it to the restroom. The next day I was fine until after dinner. I took Imodium and it helped. It was one episode of diarrhea every day after the afternoon time for about 3 days. I did eat desert on the days I had a diarrhea and stopped because I thought it was the pie crust in the the desert. I have not had diarrhea since Sunday 05/22/2022.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Erythema, Injection site pain, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: The second dose caused headache, low grade fever, chills began 8 hours after vaccination and lasted 12 hours; took Tylenol and side effect dissipated  The fourth dose 5/23/22 caused soreness and minor swelling at injection site began 8 hours later; swelling continued to enlarge over the course of the next day (5/24/22); swelling on 5/25/22 became the size of a large egg, became itchy, red and sore and rash appeared (flat, red dots) at injection site confined in a circular pattern the size of a small round teacup; 5/26/22 the site is warm to the touch, decreased in swelling slightly, reddened and rash remains. Cortisone cream applied to the injection site once with no relief
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Pruritus, Rash erythematous, Vaccination site reaction
Clinical narrative: The second dose caused headache, low grade fever, chills began 8 hours after vaccination and lasted 12 hours; took Tylenol and side effect dissipated  The fourth dose 5/23/22 caused soreness and minor swelling at injection site began 8 hours later; swelling continued to enlarge over the course of the next day (5/24/22); swelling on 5/25/22 became the size of a large egg, became itchy, red and sore and rash appeared (flat, red dots) at injection site confined in a circular pattern the size of a small round teacup; 5/26/22 the site is warm to the touch, decreased in swelling slightly, reddened and rash remains. Cortisone cream applied to the injection site once with no relief
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Brain oedema, COVID-19, Cerebrovascular accident, Encephalopathy, Pulse absent
Clinical narrative: pt admitted to hospital on 12/3/21 for acute encephalopathy, acute right MCA stroke, cerebral edema; pt had a positive COVID test on 1/17/22; found without breath and pulseless on 2/5/22.  DC and med records sent to info@vaers.org
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory arrest, SARS-CoV-2 test positive
Clinical narrative: pt admitted to hospital on 12/3/21 for acute encephalopathy, acute right MCA stroke, cerebral edema; pt had a positive COVID test on 1/17/22; found without breath and pulseless on 2/5/22.  DC and med records sent to info@vaers.org
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Atelectasis, COVID-19, Chest X-ray abnormal, Cough, Dyspnoea
Clinical narrative: Patient hospitalized on 5/25/2022 with a 2 day history of cough and dyspnea. Upon admission, he required supplemental oxygen.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Pleural effusion, SARS-CoV-2 test positive
Clinical narrative: Patient hospitalized on 5/25/2022 with a 2 day history of cough and dyspnea. Upon admission, he required supplemental oxygen.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Exposure to SARS-CoV-2
Clinical narrative: Contracted Covid sometime after the vaccine, about a month after. I believe that I got it from my daughter in law who did test positive about a day after. I am reporting this just to have it documented that I do not believe the vaccine was the cause of it and I do believe that it made my symptoms milder, however I was still able to contract the virus quite easily.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Blood test abnormal, Chills, Culture wound positive, Flank pain
Clinical narrative: - April 4, 2022 patient got 3rd COVID vaccine - Vaccine in left arm and left side hurt right away - Within 3-4 hours patient got 103F fever, body aches, chills, puss from eyes, lesions of unknown type on bottom that were painful. - Took "a whole bunch of fever reducers" to go to work - Next day went to ER, wounds swabbed, and was told she was positive and was negative for herpes. Labs unremarkable. - Went to OB/GYN, who stated that she was the 3rd or 4th person that have shown symptoms like this after COVID booster. Blood work WNL except some thyroid dysfunction- retest last week all WNL. - Continues to have fevers and cannot eliminate fever for more than a few hours daily that is 101-102F. Rarely goes below 99.5F. - Started Augmentin sometime last week when she went to another urgent care for continued symptoms. Fever went down for a couple days, but has returned. - Lots of pain on left side and abdomen, at times all over. Visited GYN earlier this week without symptoms other than pain. - Moderna has not been notified to the patients knowledge. Patient has gotten all COVID vaccines at pharmacy.