chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 02-Oct-2018 regarding an unsolicited valid non-serious case received from other health professional. This case involves a four years old female patient who experienced leg pain, while she received vaccines IPOL and PENTACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included VARICELLA VACCINE for Immunisation; and MMR for Immunisation. On 28-Sep-2018, the patient received a dose of suspect IPV (VERO) lot N1K931M via intramuscular route in the right vastus lateralis and a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number, dose, route and site of administration were not reported. On an unknown date, the patient developed a non-serious leg pain, following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE and IPV (VERO). It was also a case of actual medication error due to extra dose administered. It was reported that patient had received both IPV and then also the Pentacel so had the IPV twice. Relevant tests were not reported. The patient was treated with MOTRIN for Product used for unknown indication. The outcome was not reported for leg pain. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender- none.
patient was sicker than a dog; Initial information received on 09-Oct-2020 regarding an unsolicited valid non-serious social media case received from a consumer.  This case involves patient who experienced was sicker than a dog (illness), while he/she received vaccine INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were unknown.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious patient was sicker than a dog (illness) (Unknown latency) following the administration of INFLUENZA VACCINE.  Relevant laboratory data was not reported.   It was not reported if the patient received a corrective treatment.  The event outcome was reported as Unknown.  There will be no information available on the batch number for this case.
Patient was given the covid 19 vaccine in the deltoid. After shot, patient wanted to leave. I informed her that she needs to be observed for 15 minutes. After a few minutes , she  fell off the chair. She had a pulse and was breathing . She was talking. 911 was called and patient was examined. She went home on her own and was called once she reached home. She was fine.
This study case was received from the investigator in the above mentioned trial on 28 February 2011. A 34-year-old male subject developed acute unspecified pericarditis and unspecified disease of the pericardium 12 days after he received an injection (route and site not reported) of ACAM2000, lot number not reported. The subject's vaccinations on 02 February 2010 included an injection of Anthrax, an injection of Hepatitis B and an injection of  H1N1-09 (lot number, site and route not reported). The subject had no medical history; however, the subject's medical history was not available for eczema. The subject's laboratory testing on 01 March 2010 included abnormal troponin I 00.17 and an abnormal an electrocardiogram (ECG). On 02 March 2010, the subject had an echocardiogram performed with the finding of abnormal. On 02 March 2010, the subject was diagnosed with acute unspecified pericarditis and unspecified disease of the pericardium. The outcome was not reported. Additional information will be requested from the investigator. Documents held by sender: None.
TEMP EXCURSION- ROOM TEMP (68*) FOR >12 HOURS. PT REPORTS NO ADVERSE EFFECTS
Fever 101°F., Muscle aches, joint pain, fatigue (four days in bed), chills, mild loss of taste sensation.  HOWEVER!  NB:  On October 4, 2021 I tested positive for Covid 19.  That test was a routine prep for an unrelated procedure.  I therefore believe I did not have an adverse reaction; rather, I had full-blown Covid.
ON 8-17-06 #4DTAP, #3HIB, #1MMRV, #4PCV. ON 8-19-06 CHILD TAKEN TO E.R. DUE TO 104 FEVER, RASH, & BLISTERS TO MOUTH. DIAGNOSIS OF PNEUMONIA, VIRAL INFECTION, & RASH DUE TO SHOTS. PRESCRIBED ZITHROMAX. 8-29-06 MOTHER REPORTS TODAY RASH ON CHILD FROM HEAD TO TOE AND STILL HAS BLISTERS IN MOUTH. NO FEVER.
Arrived with SOB and cough, positive outside COVID test 2 days PTA (though tested negative in hospital). Admit for COVID pna and bilat PEs. Given O2, steroids, molnupiravir. Improved rapidly and DC home.
Patient experience shivers, chills, fever, fatigue around 6:30PM on 10/11/18 which I informed patient were listed as common side effects per CDC. Patient reported extreme shivering to the point where her teeth chattered uncontrollably by 10PM. Patient stated that her long standing neuropathy was aggravated and was at an all time high. Patient also notified her PCP and is feeling fine today as of 7PM 10/12/18.
Flu like symptoms (headache, sore joints, exhaustion) for approximately 24 hours, beginning approximately 12 hours after receiving the shot
Extreme vaginal bleeding; Some difficulty in breathing; Prolonged period; Migraines; Dizziness; Nausea; Lower back pain; Abdominal pain; Weakness; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 21-years-old female patient (patient was not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: ER8735, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 10May2021 (age at vaccination was 21 years) as 2nd dose, single for COVID-19 immunization. Medical history included known allergies to Sulfas. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: ER8735, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 19Apr2021 (age at vaccination was 21 years) as 1st dose, single for COVID-19 immunization. The patient previously took amoxicillin and experienced known allergies. The 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. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient underwent lab tests which included Nasal Swab: negative on 21May2021. On 28May2021, patient experienced extreme vaginal bleeding/ prolonged period/ migraines, dizziness, nausea, lower back pain, abdominal pain, some difficulty in breathing and weakness. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. No treatment was received for the adverse events. The device date was reported as 23Jun2021. The case was reported as non-serious. The outcome of events was not resolved.  Information on lot/batch number was available.
Left arm swollen, red, hard from shoulder to the elbow. Pt also not moving the arm.
Per mom patient developed swelling/puffiness of both legs and feet the evening of vaccine administration, symptoms resolved in a few hours.
This spontaneous report as received from a pharmacist refers to a newborn female patient of unknown age. On 26-OCT-2012 07:55, the patient was vaccinated with RECOMBIVAX HB that had been exposed to temperatures below 32F for 6 hours. During that 6 hour time period, the vaccine was exposed to 28.8F for 1.5 hours. Administration route was not provided. Two lot # were involved and the lot # were reported as: 0294AE, expiry date on 06-SEP-2014; and 0395AE, expiry date on 08-NOV-2014. It was unspecified which lot # the patient was administered. The outcome of event was unknown. It was unspecified if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Vaccine administered after the 31-day refrigerated beyond-use-date but before the 45-day excursion date.
10/31/08 Pt seen in office for vomiting and abd. distention - sent to ER for eval R/O intussusception or bowel obst- transferred to hospital for admit to hosp and BE for tx of intussusception.   10/5/09 Hospital DC summary received DOS 1031/08 to 11/2/09. Assessment: Intussusception. Intussusception resolved with contrast and air enema.
erythema annulare that began a few days p/pt recvd vax occurred on rt thigh predominantly inject site; resolved p/a few days
Patient received paxlovid treatment; Patient received paxlovid treatment; This is a spontaneous report received from a 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 10Dec2021 as dose number unknown, single (Lot number: FH8027), in left arm and on 08Jul2022 as dose number unknown, single (Lot number: FM7553) at the age of 48 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Sulfa" (unspecified if ongoing). Concomitant medication(s) included: HYDROCHLOROTHIAZIDE; LOSARTAN. Past drug history included: Lisinopril, reaction(s): "known allergies". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Patient received paxlovid treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Negative; Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid given on 20Sep2022 to 25Sep2022.
This spontaneous report was received from a physician via a company representative and refers to a 5-year-old male patient. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On 27-FEB-2018, the patient was vaccinated with the second dose of PROQUAD injection via subcutaneous route lot # N025929 with expiration date on 18-MAR-2018 as a five year immunization against measles, mumps, rubella and varicella, reconstituted with sterile diluent (MERCK STERILE DILUENT). On the same day, at the physician's office, the patient experienced an anaphylactic shock further described as coughing, vomiting, and breaking out in a rash and hives. The patient was treated with epinephrine, diphenhydramine hydrochloride (BENADRYL) and unspecified oral steroids. He was observed in the office for two and a half hours, recovered from the event and was able to go home. The relatedness between the event and PROQUAD was not reporter. The event was considered to be life threatening.
Tested positive for COVID-19 after being exposed to others who were positive for COVID-19; Tested positive for COVID-19 after being exposed to others who were positive for COVID-19; She had some sniffles; This is a spontaneous report from a contactable Consumer (Patient). A female patient of unspecified age (reported as 45, Units: Unknown) received the first dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization.  The medical history and concomitant medications were not reported. The patient received first shot of the Pfizer COVID-19 vaccine, but then tested positive for COVID-19 after being exposed to others who were positive for COVID-19. She had some sniffles but experienced no other symptoms. Events took place after use of product. The outcome of the events was unknown.  The information on the batch number has been requested.
Severe spinal pain, mild leg and hip soreness and pain. Spinal pain is mild when I sit in a fixed position. Sharp spinal pain flares up when bending or using lower back to make any movement. I could not stand up or get myself out of my bed without assistance until I received pain medication. Spinal pain persists from 8/23/2021 through 9/7/2021 (ongoing). ER visited on 8/27/2021 for treatment.
DROOPING ON RIGHT SIDE OF FACE, EYE LID, RIGHT CHECK, RIGHT SIDE OF MOUTH, HEADACHE N SOME RIGHT EAR DISCOMFORT, EYE IRRITATION. CAT SCAN DONE AND ALL SHOWED OK AND THE FINAL OUTCOME ITS BELLS PALSY
Information has been received from a medical assistant concerning a 48 year old female housewife with no known drug allergies, and a viral infection at time of vaccination who on 10/15/02 at 10am was vaccinated SC in the right deltoid with a first dose of pneumococcal vaccine 23 polyvalent (643782/0675M). On 10/15/02 at 10:05am the pt was concomitantly vaccinated with a SC dose of influenza virus vaccine (Fluvirin) (E30132FA) and at 10:15am an IM dose of diphtheria toxoid/pertussis vaccine/teta (Acelluvax DTP) (U0521AA). Subsequently the pt developed a metallic taste in her mouth, which progressed to no taste and then became a sweet taste. The physician reported that the pt developed a virus of her trigeminal nerve which caused her metallic taste that was discussed with "ENT" physicians and was not associated with her vaccine. However, the pt stated that this metallic taste did occur after she received her influenza and pneumococcal shots. It was noted that the pt recovered. No further info is requested.
my tongue feels weird/tingling above my lip; bumps all over the back of my tongue; throat swell a bit; hard to swallow; tremendous pain in my gums, like I was biting down on nails; This is a spontaneous report from a contactable consumer. A 41-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number er8735 & Expiry date not reported)  via an unspecified route of administration, administered in  Left arm  on 19Apr2021 at 12:45 (at age of 41-years-old) as dose 2,single for COVID-19 immunisation .Patient medical history include allergic to all nuts except peanuts, seasonal allergy, allergic to bees, Oral allergy to many fruits and vegetable.  Concomitant medication(s) includes epinephrine (EPIPEN) taken for an unspecified indication, start and stop date were not reported; levocetirizine dihydrochloride (XYZAL) taken for an allergy nose spray, start and stop date were not reported. Patient previously took sulfites and experienced allergic to sulfites (lip swell).Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number er8733, & Expiry date not reported)  via an unspecified route of administration in left arm on Mar2021 at 12:45 as 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 has not been tested for COVID-19. On 19Apr2021 at 13:00 (15 mins after vaccination) Patient experienced events. It was reported that at the 15-minute mark my husband and I left the clinic.  As we left, I remarked to him, my tongue feels weird. When I got in the car, I removed my mask and saw bumps all over the back of my tongue. A few minutes after that I felt my throat swell a bit.I am allergic to all nuts (except peanuts) and have felt my throat swell before.If I had not had this allergic reaction in the past, I would have been very scared. But I carry an EpiPen and felt that if things got worse, I'd use the EpiPen. Since this was not as severe so we did not return to the clinic.Shortly after that it was hard to swallow. I drank about 12 oz of water to help my system process everything.Within an hour these symptoms subsided.About an hour after that I felt tingling above my lip.Shortly after that I felt tremendous pain in my gums, like I was biting down on nails.(I am also allergic to sulfites and have oral food allergic reactions to most raw fruits and some vegetables.) Patient did not receive any treatment for the events. The Outcome of the events was recovered on unspecified day in Apr2021.   No follow-up attempts are needed. No further information is expected.
Guillain-Barre syndrome. Hospitalized in PICU. Discharge summary states nausea, vomiting, ataxia, respiratory distress syndrome,weakness. msv
PATIENT CALLED ON 8/16/2015 AND TALKED TO PHARMACIST ON DUTY. SHE SAID SHE HAS A HEADACHE AND JOINT PAIN. PATIENT SAID SHE WILL CALL HER DR.
Lightheaded 18hrs of the second vaccine, developed over the next 4 hours into a bad headache, minor nausea, light sensitivity. I think it may have been a fever but I couldn?t find a thermometer. I just remember feeling really hot.
Developed pain around midsection left side 2/05/09 broke-out with shingles rash 2/9/09. As of 11/4/10 still have postherpetic neuralgia. Should I get shingles vac. or would I risk getting shingles again?
I did not have an adverse reaction to the vaccine. In 12/2021, I developed a loud noise in my right ear.  It sounds like an electronic chirpy noise. When the noise is loud, I get very dizzy, and I feel like I would fall to the left. The doctors and specialists I have seen have not been able to determine what is going on. I have an appointment on 06/09/2023 with an ENT specialist.
Screaming. a mother reported her child received injection of Prevnar on 3/9/01. That evening the child was screaming, crying and unable to sleep through the night. She also developed a little knot at the injection site. The mother reported that the child had received a dose of Prevnar on 2/20/01.
Slight fever, nausea, achiness, pain at each injection site with subsequent injections.  Vomiting, malaise, inability to concentrate.  Symptoms worsened over the course of treatment.
pt recvd vax & 36 hrs later the pt devel rt inguinal lymphadenopathy; pt was treated w/ATB & the problem is resolving;
For First Dose: arm was sore; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received first dose (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 07Jan2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced arm was sore after first dose on an unspecified date in Jan2021. When she went on 28Jan2021 for her second dose, her husband had a sore arm but she had no symptoms. She doubt the person gave her the vaccine because she didn't feel anything and had zero symptoms. Se feel frightened, scared, worried and regret going there. They need to train these people. The person that vaccinated her did put the needle but didn't push the plunger. The outcome of the event was unknown.  Follow-up attempts have been completed and no further information is expected. lot/batch number is not available despite the follow-up attempts made.
Mother reports, sob, light headedness, Dizziness, Numbness and tingling of upper extremities, Nausea.
Pain at injection site, rash on chest and face, severe body aches and pains, nausea, dry heaves, diarrhea.
COVID PNEUMONIA ACUTE HYPOXEMIC RESPIRATORY FAILUTRE TACHYCARDIA ELECROLYTE ABNORMALITIES HYPOKLEMIA HYPOMAGNESEMIA ELEVATED AST ELEVATED LIPASE
Pt had only orange for breakfast ,no PMH of seizure, had Flu vaccine in previous years.  had Flu vaccine around noon on 1/29/21, then went to lab draw. During lab draw pt had shaking episode lasted about 30 sec and unresponsive for about 12 min. Sent to ER via 911 EMS. In ER pt had another episode with fist clenching, fall forward, no post ictal phase. Pt had workup in ER , neg. ER dx with vasovagal syncope.
very red swollen lesion inside her mouth; a rash which turned out to be shingles; red swollen eyes; red swollen eyesred swollen eyes; swelling of the right side of her face; This spontaneous case was reported by a consumer and describes the occurrence of ORAL DISORDER (very red swollen lesion inside her mouth), HERPES ZOSTER (a rash which turned out to be shingles), EYE SWELLING (red swollen eyes), OCULAR HYPERAEMIA (red swollen eyesred swollen eyes) and SWELLING FACE (swelling of the right side of her face) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020f21a and 047c21a) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included APIXABAN (ELIQUIS), DILTIAZEM (CARDIZEM [DILTIAZEM]) and SOTALOL for an unknown indication.   On 26-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced ORAL DISORDER (very red swollen lesion inside her mouth), HERPES ZOSTER (a rash which turned out to be shingles), EYE SWELLING (red swollen eyes), OCULAR HYPERAEMIA (red swollen eyesred swollen eyes) and SWELLING FACE (swelling of the right side of her face). The patient was treated with ACYCLOVIR [ACICLOVIR] for Shingles, at an unspecified dose and frequency. At the time of the report, ORAL DISORDER (very red swollen lesion inside her mouth), HERPES ZOSTER (a rash which turned out to be shingles), EYE SWELLING (red swollen eyes), OCULAR HYPERAEMIA (red swollen eyesred swollen eyes) and SWELLING FACE (swelling of the right side of her face) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.
Clients wife came in to center to receive vaccine and stated that he has started to see blackspots, has body aches, soreness after receiving vaccine. He has also started a new diet where he is cutting out sugar and does not know if they are related.
Initial dizziness subsided after several minutes. Later in the evening hives appeared over head, neck, and upper torso.
Within 1 hour of the vaccination, patient developed headache (lasted 2-3 days), and 1 week of nausea, intermittent vomiting, extreme fatigue, generalized weakness.  He had decreased oral intake for solids and liquids, up to 5-6 total episodes of emesis over the last week.  He was seen in urgent care 5/5 and treated with Zofran.  He had decreased urine output the next two days (~15 hours without voiding). And was seen in ED 5/7 and transferred to ICU for management of severe hyponatremia, though never developed seizures or neurologic abnormalities.
This patient has had 3 doses (7/10, 7/13, 7/17/12) of rabies post exposure vaccine. Within a few hours of receiving each vaccination this patient complained of "severe neck pain with stiffness". She takes her migraine medicine to relieve it with good results.