chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Intense skin sensitivity; intense headache; chills; body aches; could not lift left arm; nausea; vomiting; Dizziness; Bit fuzzy; Tired; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the arm left on 29Mar2021 at 10:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history included seasonal allergies, herpes or fever blisters (fever blisters) and anxiety. Concomitant medications included cetirizine hydrochloride (ZYRTEC), triamcinolone acetonide (NASACORT), sertraline hydrochloride (ZOLOFT), aciclovir sodium (ACYCLOVIR), and spironolactone (ALDACTONE) all taken from unspecified dates for unspecified indications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the arm left on 08Mar2021 at 10:30 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 29Mar2021, the patient experienced dizziness immediately after vaccine administration of second dose, fuzzy and tired afterwards. On 29Mar2021 at 15:00, the patient experienced chills, intense headache, body aches, and pain in arm (not able to lift left arm), overnight chills increased, and experienced nausea and vomiting. On 30Mar2021, the patient was too nauseous, and had intense skin sensitivity. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the adverse events. The clinical outcome of the events dizziness, bit fuzzy, tired, chills, intense headache, body aches, could not lift left arm, nausea, vomiting, and intense skin sensitivity were resolved on unspecified dates in Mar2021.  No follow-up attempts are needed. No further information is expected.
sore arms and normal soreness in the muscle; sore arms and normal soreness in the muscle; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (sore arms and normal soreness in the muscle) and MYALGIA (sore arms and normal soreness in the muscle) in an 87-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    No Medical History information was reported.   In 2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form and fifth dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. In 2023, received sixth dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arms and normal soreness in the muscle) and MYALGIA (sore arms and normal soreness in the muscle). At the time of the report, PAIN IN EXTREMITY (sore arms and normal soreness in the muscle) and MYALGIA (sore arms and normal soreness in the muscle) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. She had 2 Moderna COVID-19 shots in 2021 and Moderna COVID-19 booster in 2021. No treatment medication reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-741816 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-741816:same Reporter Booster dose
second on 9Oct2020 / not received the third; This case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a 47-year-old female patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix b (1st dose received on 4th September 2020, batch number BG92Z,expiry date 4th July 2022) and Engerix b (2nd dose received on 9th October 2020, batch number BG92Z,expiry date 4th July 2022).  On an unknown date, the patient received the 3rd dose of Engerix B. On an unknown date, unknown after receiving Engerix B, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: This case was reported by the nurse. The age vaccination was not applicable for this report. The patient missed 3rd dose of Engerix b at the appropriate time an till now, the patient did not receive 3rd dose, which led to incomplete course of vaccination. The reporter consented to followup.
no additional AEs were reported; improperly stored vaccine was administered; This spontaneous report was received from a licensed licensed practical nurse and refers to a patient of unknown age and gender. The patient's medical history, patient's concurrent conditions and concomitant therapies were not reported.  On 17-MAR-2022, the patient was administered an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) lot #U026217, expiration date: 02-NOV-2023 (formulation, strength, dose number, dose and route of administration were not provided) for prophylaxis (product storage error). No additional adverse events (AEs) were reported. Administered dose experienced a temperature excursion of 34.3 degrees Fahrenheit for 55 minutes. There were not previous temperature excursions.  This is one of several reports received from the same reporter.
Father reports-temp started going up at 7pm last Tylenol was given at 5:30pm- Up to 105 at that time-called and MD ordered Ibuprofen q 4h with Tylenol 4 hr alternate so 2 hr between over night-stayed high went to MD at 10:30am 2/19/03 admitted. Decreased to 101-released at 4:30pm going before left hosp-continued went MD's office-given shot-spoke with MD-she does not feel related to vaccine but to otitis media and gastrointeritis dx 2/19/03. By 2/21/03 temp down.
pt w/known heart murmur, confirmed autopsy w/William's synd w/stenosis; mild pulmonary stenosis; died suddenly that noc;
On the morning of the 17th, a week after the immune reaction from the second shot, started off with a painful rash on the right foot and unable to bear weight. Advised Benadryl and Claritin by physician after sending him a photo. Along with that developed a sore throat and painful swelling at the right base of tongue, almost as if it had been bitten, on and off sweats, temperature on and off to 99 degrees, myalgias and arthralgias.  The sore throat got a little better by 2/20, but then started with severe headaches, worse at night, along with intense pain and burning with the neuropathy in my feet flaring up. Dizziness along with the headaches and sharp stabbing pains from the neck on each side up to the back of the years and marked sensitivity of the skull. Almost went to the ER in the middle of the night on 2/21, but increased Tylenol to every 4 hours. the symptoms of the rash and body aches and fever have subsided, but chills come and go. Today, 2/23, the headaches are continuing to get better, but marked sensitivity of skull and head, particularly on the left side, and overall feeling of being tired. I expect over the next few days the headaches will be gone. Didn't expect this delayed reaction after over a week after the second shot, but I guess anything can happen.  Have discussed with other coworkers in the medical field that have heard of similar issues, so we are guessing this is a delayed reaction. At least there was no shortness of breath or difficulty breathing.
Day 10-11 experienced relapse of after testing negative x2 test positive on binax now home test.; Day 10-11 experienced relapse of after testing negative x2 test positive on binax now home test.; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 17Dec2020 at 12:00 as dose 1, single (Lot number: EH9899), in left arm, on 07Jan2021 at 12:00 as dose 2, single (Lot number: EL1284), in left arm and on 09Aug2021 at 12:00 as dose 3 (booster), single (Lot number: EWO173) at the age of 56 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 19Mar2022 at 12:00 as dose 4 (booster), single (Lot number: 026l21b), in left arm for covid-19 immunisation. The patient's relevant medical history included: "None except migraine" (unspecified if ongoing). Concomitant medication(s) included: WELLBUTRIN XL; FIORICET. Past drug history included: Morphine - rash, reaction(s): "Rash", notes: Known allergies: Morphine - rash. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Day 10-11 experienced relapse of after testing negative x2 test positive on binax now home test.". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (20May2022) Positive; (21May2022) Positive; (unspecified date) Positive; (unspecified date) Negative. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical information: Day 10-11 experienced relapse of after testing negative x2 test positive on binax now home test. Recurrence of symptoms -sore throat, severe congestion, low grade temp, severe HA, fatigue prompted retest. The patient received Paxlovid for Covid-19 treatment started on 11May2022 till 15May2022, Lot number= Ga1188. Yes vaccine received.; Sender's Comments: As there is limited information in the case provided, the causal association between the event Drug ineffective and Covid 19 and the suspect drug cannot be ruled out. The case will be reassessed once new information is available.
Developed lg. area of soreness, redness & knotted heat. Also developed mild flu symptoms.
11:12AM Patient was receiving third shot when had a syncopal episode. I asked dad to help me to raise his legs while I held him. When dad got closer to him and was talking to him he was convulsing for less than 30 seconds. He recovered rapidly. Patient did not have anything to eat prior to receiving the vaccine. Provider was made aware of the incident.
Patient wanted Flu Shot and received Pfizer bivalent booster instead. Patient has never received any type of Covid-19 vaccine in the past. Post 24 hours and patient has had no reaction thus far., was advised to fill out form in case
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Dec2020 at 08:00 as dose 1, single (Lot number: Fk9231), in left arm, on 13Jan2021 at 08:00 as dose 2, single (Lot number: FL8982), in right arm and on 04Oct2021 at 10:00 as dose 3 (booster), single (Lot number: FC3184) at the age of 42 years, in left arm for COVID-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, COVID-19. Clinical course: Treatment of COVID-19 was from 21Jul2022 to 25Jul2022. Rebound symptoms started from 30Jul2022 (07:00) and ended on 04Aug2022.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to the lack of efficacy  cannot be ruled out.
This spontaneous report as received from a nurse refers to unspecified patients of unknown age and gender. Doses of VARIVAX (Merck) that were exposed to a supported temperature excursion on 05-SEP-2014 have been administered to unspecified patients on unspecified dates since 05-SEP-2014. Concomitant therapy was not reported. No adverse effect has been observed or reported. This is one of several reports from the same source. Additional information has been requested.
adverse reaction or side effects experienced (if any): arm red, warm, then itchy for a couple of days; adverse reaction or side effects experienced (if any): arm red, warm, then itchy for a couple of days; adverse reaction or side effects experienced (if any): arm red, warm, then itchy for a couple of days; This spontaneous report has been received from a lawyer, from a case in litigation for zoster vaccine live (ZOSTAVAX) (regulatory authority # 2108USA004562, in which the reported adverse reactions/side effects for COVID-19 VACCINE MRNA (MRNA 1273) (COVID-19 VACCINE MODERNA) were captured as well), concerning a female patient (pt) who at the time of vaccination with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was 69 years old. The pt's historical conditions included chickenpox and smoking cigarettes. The pt's historical vaccines included zoster vaccine live (ZOSTAVAX), diphtheria vaccine toxoid (+) pertussis vaccine acellular (+) tetanus vaccine toxoid (Tdap), and pneumococcal vaccine conj 13v (CRM197) (PREVNAR 13).  On 25-OCT-2017, the pt was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis (strength, dose, route of administration, anatomical location, lot # and expiration date were not provided).  On unknown dates, the pt experienced arm red, warm, then itchy for a couple of days ("a couple of days" considered to refer to the duration of events only, with onset dates remaining unknown). The outcome of the events was not reported. The reporter considered the events to be related to pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23), as they were provided as adverse reactions to or side effects of the suspect vaccine.; Sender's Comments:  US-009507513-2108USA004562:
In the morning, I had leg cramps. Later in the afternoon, I had abdominal pain. By 8PM, I was in pre-term labor. I had extremely high blood pressure and rapid heart rate upon entrance to the ER. I was in labor for at least 6 hours, giving birth to a stillborn 16-weeks-gestation baby just after 2AM.  Later determined to be chorioamnionitis of the placenta and pneumonia in the baby, resulting in fetal death.  I had an ultrasound and doctor appointment 36 hours prior to the miscarriage and everything appeared healthy with no signs of infection.  The vaccine was administered immediately after the ultrasound on 11/07/2014.
I have my first shot and second shot - minimal symptoms. I had my Booster on 01/24/2022. Within a few hours, I had arm and hand heaviness, and pain under my left arm pit. By night fall, the pain under my arm pit was excruciating. I am thinking it is a swollen gland or lymph node. By night fall that same night, I was not feeling "right", slightly "off", and  just wanted to lie down and be quiet (not like me). Sleeping through the night last night was tough on account of my joints and muscles hurting (especially in my hands and upper back), and the pain underneath my left arm pit. When I got up this morning, my hands still ache, and my arm pit is throbbing. But I am feeling a little better, but bad enough to call my primary.
This spontaneous report was received from a registered nurse reporting to a multiple unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On an unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX lot #M000760 with an expiration date: 06-JAN-2018, lot # L000455 with an expiration date: 06-JAN-2017, lot #M019641 with an expiration date: 20-APR-2018, lot #M010482 with an expiration date: 01-MAR-2018 and lot #M019643 with an expiration date: 20-APR-2018 for prophylaxis (strength, dose, anatomical location and route of administration were not reported). Administered doses of VARIVAX experienced temperature excursion with temperature 21 degrees Fahrenheit for 2760 hours for lot# M00760, 1 640 hours for lot#L000455, 720 hours for lot# M019641, 888 hours for lot#M010482, 576 hours for lot# M019643. There was no previous temperature excursion. Digital data logger was not involved. No adverse effect was reported. Follow up information has been received on 14-NOV-2016. All telephone attempts to obtain follow up information have been unsuccessful. Additional information has been requested. Sender's Comments: MERCK 1609USA001235:Mfr number.
Lymphadenopathy x1 supraclavicular LN Narrative:  Developed enlargement of one supraclavicular LN on the same side of the injection (left side) about 4x days after vaccination, which is still present upon return for 2nd vaccination. No other adverse reactions noted. Evaluated by  PCP with plans for f/u if issues persists.   Other Relevant History:
Immediate paresthesias in L hand (ipsilateral side of vaccine administration), then an hour later paresthesias in both feet.  Hand paresthesias resolved within the next 48 hours, but foot paresthesias remain on day 4, althopugh slightly less.
developed heart problems after and got a heart stent; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 44 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single), for Covid-19 Immunization.  The following information was reported: CARDIAC DISORDER (medically significant), outcome "unknown", described as "developed heart problems after and got a heart stent". Therapeutic measures were taken as a result of cardiac disorder.  Clinical Course: The reporter has a friend who got his second dose of Pfizer covid-19 vaccine and developed heart problems after and got a heart stent. The reporter wanted to ask if there are people reporting side effects of the vaccine. Pfizer Covid 19 vaccine: had heart problems and had to get a stent  Related. The patient's doctors thought this was related to the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  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.
I received the vaccination at the clinic.  About 24 hours after receiving the vaccination, my urine became very dark (amber) and stayed this way for 9 days.  I was not dehydrated.  Five days after the vaccination, my stool became very pale (clay color) and stayed this way  for 6 days.  Both conditions resolved on their own.  I was very tired for a couple of days after the vaccination,  had some soreness in the vaccination site and my appetite was off a little for a few days. These were the only other symptoms.
Within 24 hours of vaccination, patient developed vomiting and fever. Hospitalized for dehydration, fever, and right otitis media.  Nurse follow up on 11/01/04 states: "gastroenteritis
rash appeared 1 day p/vax;pt recv tx by MD who advised warm compress-massage,motrin&DPH
This spontaneous report was received from a registered nurse and refers to a 4 year old male patient. The patient's concurrent conditions, medical history and concomitant therapies were not reported. The stock of vaccine was received on 11-OCT-2016. On 28-DEC-2016, the patient was vaccinated with an improperly stored dose of PROQUAD, lot # M023931 with expiration date of 09-NOV-2017 (dose, route and frequency were not reported) for prophylaxis. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 48 days. It was reported that there was no need to repeat vaccine. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1705USA013888.
Following a typhoid injection, child developed a rash around both eyes, within about 2 minutes. No other rashes were found on body. Child remained happy and cooperative during 30 minutes wait following vaccine administration and had no other symptoms.
States became short of breath pretty soon after last Covid Bivalent vaccine 3/7/2023. Diagnosed with Bilateral Pulmonary Embolus on 3/21/2023 at Hospital at follow up visit for post partial pancreatomy and splenectomy surgery about one and half a year ago. Also reports after first Covid vaccine 2/11/2021 she soon afterwards was diagnosed with bilateral lower extremity deep vein thrombus and was on blood thinner for about a year and then was discontinued.
Information has been received from a case in litigation from a lawyer concerning a patient who on 19-SEP-2003 was vaccinated with a dose of Hep B (manufacturer unknown) (dose, route and lot number not reported). Concomitant therapy included DTaP (manufacturer unknown). It was reported that the patient sustained the first "symptom of manifestation" of an encephalopathy within the time frame set forth. It was reported that the petitioners also alleged that the patient suffered a chronic encephalopathy with injuries "including, but not limited to, global developmental delays, behavioral disorders, social anxiety disorder, selective mutism and motor delay". Upon internal review encephalopathy was determined to be an other important medical event. No further information is available.
nausea; Sick; This case was reported by a consumer and described the occurrence of nausea in a 63-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced nausea and sickness. On an unknown date, the outcome of the nausea and sickness were not recovered/not resolved.   It was unknown if the reporter considered the nausea and sickness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not provided. The patient received Shingrix vaccine 2 months before the reporting date and experienced nauseous every day. The patient was sick ever since the vaccination.
Erythematous papules on neck. Began 3-4 hours after vaccination. Denied change of skin products, laundry det. etc. Triamcinolone acetonide 0.1% cream. Hydroxyzine hydrochloride 25 mg p.o. Q 4-6 hr. ordered.
Starting April 4th, I started getting a sore throat and swollen tonsils. I had fever and chills and extreme fatigue. I went to the doctor on 04/07/2022 and they prescribed me antibiotics for tonsillitis. By Saturday, I felt better. However, on 04/12/2022 I developed a sore throat. Then the following day it got worse and then I started the antibiotics. I got tested for COVID on 04/13/2022 which was negative and so I continued the antibiotics and had a stuffy nose and sore throat. By 04/15/20022, the sore throat was gone but I developed a cough. Today, my sore throat and cough are gone but I have a mild stuffy nose.