chrisvoncsefalvay/vaers-outcomes huggingface dataset:
contracted the Covid 19 virus; body aches; chills; sinus pressure; headaches; cough; chest congestion and tightness; chest congestion and tightness; This is a spontaneous report from a contactable consumer (patient) through a Pfizer-sponsored program. This 46-year-old male patient, weight: 90.72 kg & height: 180 cm, received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733), via an unspecified route of administration in the left arm on 02Apr2021 11:30 (at the age of 46-year-old) as single dose for COVID-19 immunization. Medical history included sinus infection with his seasonal allergies. Concomitant medications included cetirizine hydrochloride, pseudoephedrine hydrochloride (ZYRTEC-D) taken to manage his sinus flare ups and drainage during the allergy season. The patient did not receive any other vaccines within four weeks prior to the vaccination. There were no predisposing factors. The patient was not enrolled in the clinical trial. The patient received his first COVID 19 vaccine on 02Apr2021 and subsequently contracted the COVID 19 virus and tested positive for the COVID 19 virus on 12Apr2021 with a rapid test at a physician's office. During the first full week of Apr2021, he started having symptoms: body aches, chills, sinus pressure, headaches, cough, chest congestion and tightness but he did not have a fever. It went on for about 2 weeks, with some varying between his symptoms during that time. He reported that he normally has seasonal allergies and all of his symptoms were coinciding with his typical allergy symptoms. The chills dissipated during the first 3 days following the COVID 19 vaccine and the chills subsided. Then the sinus drainage and all the other symptoms kicked in. He thought maybe his symptoms were from the COVID 19 vaccine but he also thought it could be the sinus symptoms he has in the spring time. Obviously, his symptoms continued, and he knew it was not related to his seasonal allergies. He usually would get a sinus infection with his seasonal allergies, bacteria would jump in his sinus issues, and he didn't have that. His sinus infections can be. That's when he knew what he had was not related to his seasonal allergies. The patient stated that he is due to receive his second COVID 19 Vaccine on 23Apr2021 or if he needs to reschedule the vaccine considering his second vaccine is such close proximity to his COVID 19 diagnosis. The event, chills, was resolved in Apr2021 while the clinical outcome of the events, contracted the COVID 19 virus, body aches, sinus pressure, headaches, cough, chest congestion and tightness were unknown.
DOSE 1: low grade fever x3 days; rash/hives approximately 14 days after in axillary region of arm which shot was received.   DOSE 2: fever (100.8F) x 1.5 days, transitioning to low grade (99.4F) x 2 days. Skin rash/hives on hands, arms, ankles and stomach.
reoccuring ear infections; This is a spontaneous report received from contactable reporter(s) (Physician). Other Case identifier(s): 02350663 (Merck).  A patient (no qualifiers provided) received pneumococcal 13-val conj vac (dipht CRM197 protein) (PREVNAR 13), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: EAR INFECTION (non-serious), outcome "unknown", described as "reoccuring ear infections". Additional information: The physician reports that they have a pediatric patient that has reoccurring ear infections. The pediatric patient has received Prevnar 13. The physician ran titers and the patient was not positive for serotype 3.   The information on the batch/lot number for pneumococcal 13-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (pregnant) in a 33-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (three per week, Prior use) and Ex-smoker (pack a week,Prior use) on 10-Dec-2020. Concurrent medical conditions included Pain. Concomitant products included PARACETAMOL (TYLENOL) for Pain.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 22-Oct-2020 and the estimated date of delivery was 18-Aug-2021. On 17-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-first week of the pregnancy.  On 17-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (pregnant) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Dec-2020, Amniocentesis: normal (normal) normal. On 10-Dec-2020, Pregnancy test: positive (Positive) positive. On 10-Dec-2020, Ultrasound scan: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient previous pregnancy history included live pre-term birth on 30-Jul-2012. On an unspecified date, the patient had ultrasound scan and amniocentesis which were normal. The date of positive pregnancy test was 10-Dec-2020 and estimated date of conception was 18-Aug-2021. The patient has an established prenatal care. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 17-Mar-2021: Internal review on 21-Jul-2021 resulted in updates to the pregnancy details.
Sore arm; This is spontaneous report from a contactable consumer, the patient. A 74-years-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6199), via an unspecified route of administration in the right arm on 17Mar2021 (at the age of 74-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6201), via an unspecified route of administration in the right arm on 24Feb2021 at 08:00, (at the age of 74-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced sore arm on 17Mar2021. The patient did not receive treatment for sore arm. The clinical outcome of sore arm was recovering. No follow-up attempts are needed. No further information is expected.
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 30-year-old male patient received BNT162b2 (BNT162B2), on 12Mar2021 at 13:15 as dose number unknown, single (Batch/Lot number: unknown) at the age of 28 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Tinea versicolour" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of Drug ineffective, Covid-19 which includes Paxlovid treatment from 26Apr2023. Clinical course: The patient did not had other medication in 2 weeks. The patient had no known allergies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300173623 Same patient, different drug, different event;
Patient received Janssen Vaccine on 03/06/2021 as per system and Pfizer Dose 1 on 08/07/2021 at facility. Patient reports no adverse reaction.
Constance  ringing in the ears  (Tinnitus) 24/7 and it has persist every since.
Client presented herself on 1/19/2010 to the H1N1 immunization clinic and stated that 15 days after her H1N1 vaccine she visited her private physician due to rash on legs and trunk of body. Client stated that she is on oral cortisone, prescribed by private physician.
Severe flu like symptoms, sweating, freezing and burning up at the same time, extreme body pains, nausea, fever and weakness, intense throbbing headache, disoriented, confusion, increased menthol feeling in lungs, painful swollen lymph node near left collarbone, pain and tingling in right side of face, strange bruise like mark on left inner thigh. The swollen lymph node, burning lungs, thigh mark, and right side of face pain is still here, everything else is gone.
Subsequent to receiving first and second doses of varicella virus vaccine live in 6/97 and in 4/98 the pts laboratory evaluation revealed a lack of response.
Pain immediately felt in (L) arm. Next day it hurt so bad. Tingling in fingers started. Hard time lifting arm, still present. Band aid was far up on arm almost to curve part of shoulder. Has tried pain medication, rest and heat w/no relief. Pt diagnosed with SIRVA.
myalgia; chills; fever; headache; diaphoresis; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 64-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Dec2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 64 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (unspecified if ongoing); "depression" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (Primary immunization completed, Manufacturer Unknown), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE, Manufacturer: Unknown), for COVID-19 Immunization.The Prior to vaccination, the patient was not diagnosed with COVID-19. Since vaccination, patient had not tested for COVID-19. Had no Known allergies.  The following information was reported: CHILLS (non-serious) with onset 11Dec2022 at 12:00, outcome "recovering"; HYPERHIDROSIS (non-serious) with onset 11Dec2022 at 12:00, outcome "recovering", described as "diaphoresis"; PYREXIA (non-serious) with onset 11Dec2022 at 12:00, outcome "recovering", described as "fever"; HEADACHE (non-serious) with onset 11Dec2022 at 12:00, outcome "recovering"; MYALGIA (non-serious) with onset 11Dec2022 at 12:00, outcome "recovering". Therapeutic measures were not taken as a result of myalgia, chills, pyrexia, headache, hyperhidrosis.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Patient develop Acute Disseminated Encephalomyelitis (ADEM) on 8/18/08 approximately three weeks following Tdap and Meningococcal vaccinations.  He developed a neurogenic bladder and aseptic meningitis and was treated with high dose steroids.  MRI was c/w ADEM.  Hospitalized at Hospital. 12/1/08-records received for DOS 8/18/08-presented with urinary retention symptoms following a recent URI. Symptoms started on 8/18/08 with headache, URI, loss of appetite, fatigue and tactile temp. 8/21/08-headache and difficulty urinating. Sense of urgency. 8/22/08-vomited, developed rash after receiving antibiotic. Received IV Benadryl began shaking, convulsions and delusional. Leg weakness.  Final diagnosis: urinary retention. Encephalopathy. 12/11/08-records received for DOS 8/25-/28/08-DX: Presumed aseptic meningitis. Neurogenic bladder. Unspecified encephalomyelitis versus acute disseminated encephalomyelitis verus demyelinating process.  Developed allergic reaction to ceftriaxone and Toradol developed rash. 1/20/09-records received for DOS 8/28-9/2/09-DC DX: Acute disseminated Encephalomyelitis.
Extreme arm pain; bad headache; general malaise weak feeling similar to how feel early stage flu.
This spontaneous report was received from a registered nurse and refers to multiple unspecified patients of unknown age and gender. Patient's pertinent medical history and drug reactions or allergies were not reported. On unknown dates, patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot # J013394 and expiration date 25-AUG-2016, dose and route of administration were not reported). Concomitant therapy was not reported. No adverse effects were reported. No product quality complaint (PQC) was involved. The temperature of the first excursion was 59F and the time frame was 16 hours. The temperature of the second excursion was 32F and the time frame was 120 hours. This is one of several reports received from the same reporter. Additional information has been requested.
Excrutiating pain in right arm (where I received the shot) about 2 hours after shot. Over the next hour or two a gradually increasing weakness in that arm. Within a few hours I lost complete use of my right arm. I could only move it by lifting it with my left arm. The weakness went on for several days. Eventually I could use my right arm again. But I don't know that it's the same as it was before. It feels weaker two months later.
I developed a lump approximately the size of an orange in my lymph node/ armpit area on my left side. (same side as my shot). I also developed excessive swelling in the neck, shoulder, and collar bone area of the left side. I had experienced muscle pain throughout my body and more pain in my lymph node area of my right groin. I have experienced "brain fog" or forgetfulness/difficulty remembering how to spell or find the words to simple word such as soup or triangle.
Began with left side low back pain which increased over several days to a week and spread toward left hip, mild raised rash evident on lower back moving toward left hip (a few lesions appearing blister like), visual light sensivity also. Pain (neuralgia) in lower back & left hip increased significantly throughout Dec, at some points becoming excrutiating, especially upon sitting.  Dr diagnosed case of Shingles at patient visit on 11Dec2019. Prescribed Lyrica, hydrocodone with acetaminophen and Voltarin for neuralgia, pain.  End of Jan 2020 patient's pain has improved, but not completely resolved.  Pain levels vary from day to day. Pt. has begun physical therapy to increase strength and endurance.
Patient received the Pfizer bivalent vaccine on Monday 1/30/2023 and had no reactions that day or the next day (01/31/2023). On Wednesday (02/01/2023), she started experiencing arrhythmias, which still are occurring. She contacted her doctor, who advised her to contact us to report it.
Swollen arm, redness at site, body aches, limited use of right limb.
migraine; first dose of Moderna COVID-19 vaccine around FEB2021 & Never got the Second shot; Swollen (Right Lip); This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (Swollen (Right Lip)), MIGRAINE (migraine) and PRODUCT DOSE OMISSION ISSUE (first dose of Moderna COVID-19 vaccine around FEB2021 & Never got the Second shot) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced LIP SWELLING (Swollen (Right Lip)). On 04-Aug-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (first dose of Moderna COVID-19 vaccine around FEB2021 & Never got the Second shot). On an unknown date, the patient experienced MIGRAINE (migraine). At the time of the report, LIP SWELLING (Swollen (Right Lip)) had not resolved, MIGRAINE (migraine) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (first dose of Moderna COVID-19 vaccine around FEB2021 & Never got the Second shot) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication provided. No treatment medication provided. patients  reaction on the side of her lip is still going on. She has been to doctors and MRI/CT-Scan shows everything is normal.  She states that she would like to receive the second dose of the COVID-19 vaccine but nobody is willing to give it to her because of her reaction.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Follow up received on 21-JUL-2021 contained: Updated contact details- Email ID; On 04-Aug-2021: Follow-up received: Event added
Within a week or so started with tingling in feet, legs getting weak, back hurting bad, hands going numb. By 11-10-16 admitted into hospital unable to move, couldn't breathe correctly.
Nausea, she concerned due to her history of hypotension, bradycardia. Upon observation and she drank her Gatorade, she become  normal and discharged to home. Pulse 83 Respiration 16 SPO2 96% BP 110/70
Dose given past the 12 hour post puncture time; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose given past the 12 hour post puncture time) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose given past the 12 hour post puncture time). On 03-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Dose given past the 12 hour post puncture time) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided. Treatment information was not provided.   This case was linked to MOD-2021-328946, MOD-2021-328010 (Patient Link).
While patient was receiving her second dose of the Pfizer brand Covid-19 vaccination (at 14:50), she mentioned to me that she had a sustained local reaction to her first dose.  Her arm had a hard, red, hot spot for approximately a week.  At this time I told her we would like her to stay under observation for 30  Min instead of the normal 15 min. At approximately 25 min post vaccination, the pt reported the following: "arm felt heavy, both arms did, but more so the affected arm, instant headache, sore neck, vision went fuzzy, breathing wasn't difficult but felt labored, throat felt like it was closing/congested, rash on the inside of the affected arm".    Pt stated that her heart felt like it was "pounding".    VS:  162/96, 99% RA, HR in the 70's.    Patient was administered 50ml IM diphenhydramine and monitored for 90 minutes in the clinic area.  Dr. was consulted and also spoke with the pt, advising her to continue with OTC diphenhydramine once at home.     The symptoms resolved after approximately 40 minutes.  By 17:00 the patient was deemed stable to go home with the instructions to go immediately to ED should any further Sx present.  It was verified that she did not live alone and would have someone with her that could assist.    Pt was subsequently followed up with a phone call on the next day by RN who relayed that she was very tired, but no other complications.
patient states that they have a discolored bicep and arm pain as eel as light headedness for the following day. followed up with patient several times patient now is feeling fine and the reddish yellow coloration that he states as on his arm is now gone. patient states that is was painful and alarming.
Information has been received from a registered nurse concerning an approximately 2 months old male patient who on 14-AUG-2009 and on 22-OCT-2009 was vaccinated by mouth with a 2mL first and second dose ROTATEQ (first dose lot # 664400/0616Y) respectively. On 22-DEC-2009 at the age of 6 months, the patient was accidentally administered with the third dose of ROTATEQ into one of his nostrils instead of his mouth. On 22-DEC-2009, the patient concomitantly received a dose of PEDIARIX. On an unknown date in 2009 the patient had blood in his stools. It was unknown if the patient had blood in his stools before or after receiving ROTATEQ. It was unknown if laboratory or diagnostic tests were performed. On 22-DEC-2009, the patient was doing fine while at a clinic at the time of vaccination. The blood in his stool resolved on an unknown date. As of 22-DEC-2009 it was unknown if the patient continued on ROTATEQ. Upon internal review "blood in stools" was considered to be an other important medical event. This is one of two reports concerning the same patient (WAES # 0912USA03642). Additional information has been requested.
Patient presented to pharmacy with red area approximately 4 inches in circumference. Area was hot to touch and patient complained of soreness in the area.
RN gave covid vaccination to staff member, at approximately 1015am and went and sat in the vaccination waiting area. At approximately 1025 patient reported to RN that she was feeling like her heart rate was racing and she felt dizzy. RN and NP started to monitor patient in the waiting area. On the monitor, patients HR was 144 while sitting.Patient admitted to feeling nervous/ anxious prior to getting vaccine and stated she also had a allergy to Contrast.  NP continued to monitor vitals every 5-10 min. Patient symptoms started to improve. Pharmacist identified a possible correlation with an ingredient in contrast and the vaccine and a rapid response was called. Rapid team gave patient Benadryl and patient was monitored in the clinic for approximately 1 hour with continued improving symptoms. Husband was called to give her a ride home.
Pt. with vaccines 9/13/18. (R) thigh with large mass at upper area with fine pink, papular rash at same site. Pt with maculopap rash the body, esp at hands/palms and feet. Canker sores t/o mouth. (Coxsackie-like reaction).
the pharmacist, purposely jabbed my left arm in the top upper section of muscle which induced such incredible pain I had to cry out quite loudly. Have never been vaxed in such a harmful manner in my life until now. (This pain has lingered, extremely sore at site and most movement is inhibited).   this man has been a pharmacist for years and should know better. this was done either with malice aforethought, or his ability to perform his duties has diminished and he needs to be removed from injuring anyone else.
Like tiredness and he can't get over that/ real real tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Like tiredness and he can't get over that/ real real tired) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Like tiredness and he can't get over that/ real real tired). At the time of the report, FATIGUE (Like tiredness and he can't get over that/ real real tired) had not resolved.            No concomitant medication was reported. No treatment medication was reported.