chrisvoncsefalvay/vaers-outcomes huggingface dataset:
upset stomach; severe lower left abdominal pain; increase urination; fever; This case was reported by a consumer via call center representative and described the occurrence of upset stomach in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of abdominal discomfort (1st dose received on 4th March 2022, for tolerance refer case US2022AMR105297).   On 10th July 2022, the patient received the 2nd dose of Shingrix (intramuscular). In July 2022, 8 hrs after receiving Shingrix, the patient experienced upset stomach, abdominal pain, increased urinary frequency and fever. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the upset stomach, abdominal pain, increased urinary frequency and fever were recovered/resolved.   It was unknown if the reporter considered the upset stomach, abdominal pain, increased urinary frequency and fever to be related to Shingrix.     Additional Information: GSK Receipt Date: 11th July 2022 Reporter's Comments: This case was reported by the patient. The patient received Shingrix in arm. The patient had exactly the same adverse effect after receiving the both Shingrix vaccine. About 8 hours after receiving the vaccines, the patient had an upset stomach, severe lower left abdominal pain and fever. The symptoms resolved by morning. The patient had increased urination about 10 hours after both doses and that also resolved by morning. The reporter did not consent to follow up. Additional supportive information The time to onset date for event upset stomach, abdominal pain, urine volume increased and fever as per event onset date and product start date was 1 day, however as per case narrative time to onset for upset stomach, abdominal pain, fever was 8 hours and urine volume increased was 10 hours.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR105297:Same case
7 days after receiving the 1st moderna shot I woke up with an itchy upper right arm in the area I received the shot, It felt warm to the touch and was angry red in color. I drew an ink line around the border, and by the end of the day, it was about an inch out of the original border. Started out about 3 0r 4 inches wide and about the same long. I treated it with cortisone cream, baking soda poultice,  calamine lotion. I took ibuprophen and took two Benadryl at night before going to bed. The next morning the redness was less noticeable, still itchy, but by the next day it was about gone. So about 48 hours. A co worker also had this happen to her 7 days later
At 1:30 am I began severe vomiting. This continued every 15 min (I timed it) for 5 hours.  After the first hour it was all severe dry heaves.
The night of my vaccine, I went to sleep feeling fine other than mild tenderness at the injection site. However, I woke up at 2 am with chills and night sweats- before taking any tylenol or ibprofen my temperature was 99.9 degrees. I was awake from 2am-5am unable to find a comfortable body temperature.
On 4/19, I woke up with severe abdominal cramping, vomiting and diarrhea.  The diarrhea turned to bright red blood, so I went to the ER.  I was diagnosed with severe sepsis and colitis.  Although I was diagnosed with sepsis, I never had a fever and all blood cultures came back negative.  Before I was released, I went into uncontrolled atrial fibrillation.  I never had any history of colitis or atrial fibrillation prior to this.  No one can explain why there was no fever or pathogen detected.
This spontaneous report was received from a female patient of approximately 24 year old concerning herself. The patient's medical history included chlamydia. Not drug reactions. The patient was received the correct dosage regimen from January to February 2011 with a first dose of GARDASIL (dose, route and lot number were not reported). In May to June 2011 the patient received the second dose of GARDASIL (dose, route and lot number were not reported). No other co-suspects were reported. Concomitant medications included: AMBIEN. The patient was diagnosed with human papilloma (HPV) after receiving GARDASIL. The following laboratories were performed: Smear cervix (PAP), HPV test which was positive 2 months ago and a colposcopy. At the time of the report, the patient had not recovered from HPC infection. The relatedness for the event was unknown for GARDASIL. The patient sought unspecified medical attention. Additional information is not expected.
got the two series shot. Got shingles again/ suspected vaccination failure; Got shingles again; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On an unknown date, the patient received the 1st dose of Shingles vaccine and the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were reported as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she never had chickenpox, so he/she skipped getting vaccinated and got shingles anyway. The patient received 2 series Shingles vaccine and got shingles again but not as severe. The patient stated vaccine worked. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
post vaccination patient became dizzy and pale vitals 13/66, 96, 22, 98.6, o2 98..911 called to assess patient on arrival patient was stable remained in observation for 30 minutes-mom reported that patients has a history of having extreme anxiety after any injection which causes her to get dizzy, nauseous, sweaty and at times pass out.
SVHC, weak, fatigue, SOB X 6 days, covid pneumonia, congestion, mucous. tx remdesivir, dex. Moderna x 2, oxygen due to COPD. Discharged to home on oxygen.
death ABDOMINAL PAIN JAUNDICE N17.9 - Acute kidney failure, unspecified E87.1 - Hypo-osmolality and hyponatremia
Pt had lump at injection site that evening.  Redness and swelling began on 1/1/2008.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Weakness-Severe, Additional Details: PATIENT FAINTED SEATED DOWN WE NEED TO CALL 911
Complaining of lesions on right wrist, hand, and genital region 8 days after small pox inoculation. Instructions on keeping lesions convered, good hand washing, Atarax for itching. 6/26/09 Per reporter, pt scratched and spread skin lesions, seen at ER and PCP dx: vaccine auto inoculation. 8/28/09 ER report received dated 6/20/09 with dx: Vaccinia-auto-innoculation. Vesicular lesions noted on various ares of the body. Tx: Atarax
This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age. On 16-MAY-2014 the patient was vaccinated with a dose of ZOSTAVAX lot # J001698, exp. 08-MAY-2014, 0.65 ml, subcutaneous. No adverse effects reported. Additional information has been requested.
sore arm/ neck after shot, followed by hives on  the 28th-29th, on May 1st swelling around eyes and lips started,  hives continued and worsened on may 4th , may 6th joints began to stiffen and lock up.
Immunization 2/22/11 DTaP, PREVNAR, Varicella - grand mal seizure 2/25/11. Immunization HIB given 5/12/11 - grand mal seizure 5/14/11.
Premature ventricular contractions; Extreme fatigue (10 days post immunization and counting)
Day after injection pt developed increased redness, swelling. Denies pain. Swelling improved today. Not hard to touch. C/o itching, denies fever. Advised OTC hydrocortisone cream and BENADRYL, ice, f/u if worse.
Baby rec'd 4mo vaccines - PENTACEL given (R) thigh: w/in 5min -> erythema only. By 10 minutes, increased erythema. By 15min erythema & induration of thigh to midcalf. TYLENOL & ice pack given. By 30-40min, erythema to groin and petechiae to lower leg. BENADRYL given. 20min later - erythema gone/petechiae remained at D/C mild induration O2 sat & BP stable throughout. Of note -> 1 petechiae on opposite calf also.
pt recvd vax;arm began to hurt immediately;could not move arm although pain was not so severe;cont to hurt x wks
Persistent headache; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the left arm on 03Mar2021 at 17:00 (at the age of 45-year-old) as a single dose for COVID-19 immunisation. Medical history included penicillin allergy (allergies to medications, food, or other products: Penicillin). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included rosuvastatin calcium (CRESTOR) and escitalopram oxalate (LEXAPRO); both medications from an unknown date and unknown if ongoing for unknown indications. On 07Mar2021, the patient experienced persistent headache. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the event persistent headache was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
back (twisted); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administration date 02Feb2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MUSCLE STRAIN (non-serious), outcome "unknown", described as "back (twisted)". Additional information: The patient pulled her back (twisted). The patient wanted to know if she could take a muscle relaxant (Advil or Naproxen).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a physician concerning a 2 year old pt who, at 12 months of age, was vaccinated with a dose of varicella virus vaccine live. The physician reported that on 01Jun05, the pt developed a case of breakthrough consisting of less than 50 lesions on her thorax and trunk. The pt was noted to be afebrile.  Unspecified medical attention was sought and at the time of this report the pt was recovering from the breakthrough. Follow up information indicated that the child ended up not having breakthrough chickenpox. It was noted that the symptoms persisted for several weeks. Additional follow up information indicated that the dermatologist concluded that the experience was flea bites. No additional information is expected.
Injection site is extremely Itchy with a red lesion about 3 inches across that is firm and painful at
none covid 19 vaccine expired 11/22/2022 given 12-09-2022
It was discovered after vaccine was given that the freezer temperature was out of the correct storage range.  Per manufacturer doses (MMRV) were compromised therefore, this MMRV is invalid.
Information has been received from a licensed practical nurse concerning a 13 year old female who on an unspecified date was vaccinated IM with the first 0.5 ml dose of GARDASIL vaccine (yeast). Concomitant therapy included varicella virus vaccine live (VARIVAX), tetanus toxoid (unspecified, manufacturer unknown) meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA) (Sanofi Pasteur). The patient experienced syncope soon after vaccination. Unspecified medical attention was sought at the office. She recovered on the same day as vaccination at the office and was released. Additional information has been requested. No further information is available.
Started to develop strange noises in left ear the the day after receiving vaccine. After 4 days I lost hearing in left ear. I went to ear doctor who did an exam and a hearing test. There was no congestion or damage in ear. Left ear showed major loss of hearing. Dr. said she thought it was Sudden Hearing Loss, caused by possible swelling of the nerve to the ear. She prescribed Prednisone. I will return in two weeks to see if there is an improvement.
3/14/21 - took a dose of miralax, 30 minutes later became flushed, diaphoretic, developed a red/itchy rash on my head/neck/back/arms, 10 minutes later I had diarrhea, 10 minutes later intractable vomiting, EMS was called, BP 70/30 in ambulance, received 2L NS IVF and 60 mEq potassium (K 2.8 in ED), stayed in ED for 8 hours until BP 110s/70s. 3/19/21 - diagnosed with right occlusive thrombus in superficial cephalic vein large enough it was characterized as a DVT, started on therapeutic Eliquis. 3/22/21 - diagnosed with left occlusive thrombus in main branch of cephalic vein. Had to be out of work for 4 weeks until I was cleared by vascular surgery and hematology to return.
Pt started to experience erythematous papular eruption that is tender to touch around the lips and chin and diffuse papular eruption with surrounding erythema tender rash on the right lower forearm  Treatment: Continue loratidine, pt does not like to take benadry  Prednisone taper prescribed
Itchy red rash on neck approximately 8 days after Vaccination, fatigue, Headache
I had a lot of head congestion and the worse sore throat that I ever had. The first telehealth doctor thought that it was a sinus infection and prescribed a medicine but my symptoms got worse so I called another doctor and they recommended Mucinex sinus, Allegra, and 600 mg of ibuprofen. When I went to see my doctor, they recommended staying on the medication and prescribe azithromycin & benzonatate. My symptoms began on the 27th and I tested positive on the 28th of December. I continued to test positive for 2 weeks. I still had symptoms after 2 weeks despite testing negative. The sore throat was still there. It is still healing currently. I still had a lot of congestions and my allergies were worse than normal. I also got body aches and a aching pain around my kidney area. I had gastrointestinal issues for about a week afterwards. Supplements worked well with alleviating the symptoms. I feel like I have recovered. I am fully functioning.
Olfactory damage; Severe acne(dermatology); Headache; Smell (rancid); Taste; Slight nauseated feeling; Loose bowels; Stomach cramping; Sore arm site inj; Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A female patient in her 10's received bnt162b2 (BNT162B2), administered in arm left, administration date 22Apr2021 (Lot number: EW0169) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (lot number: EW0150, Anatomical location: Left Arm), administration date: 02Apr2021, for Covid-19 Immunization. The following information was reported: OLFACTORY NERVE DISORDER (non-serious) with onset 01May2021, outcome "unknown", described as "Olfactory damage"; ACNE (non-serious) with onset 01May2021, outcome "unknown", described as "Severe acne(dermatology)"; HEADACHE (non-serious) with onset 01May2021, outcome "unknown", described as "Headache"; PAROSMIA (non-serious) with onset 01May2021, outcome "unknown", described as "Smell (rancid)"; TASTE DISORDER (non-serious) with onset 01May2021, outcome "unknown", described as "Taste"; NAUSEA (non-serious) with onset 01May2021, outcome "unknown", described as "Slight nauseated feeling"; DIARRHOEA (non-serious) with onset 01May2021, outcome "unknown", described as "Loose bowels"; ABDOMINAL PAIN UPPER (non-serious) with onset 01May2021, outcome "unknown", described as "Stomach cramping"; VACCINATION SITE PAIN (non-serious) with onset 01May2021, outcome "unknown", described as "Sore arm site inj"; FATIGUE (non-serious) with onset 01May2021, outcome "unknown", described as "Fatigue".  Additional information: 16.5 years of Age- Healthy. No Meds.  No follow-up attempts are possible. No further information was expected.
not feeling well; This spontaneous case from was retrieved on 12-Nov-2021 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 1824719-1), reported by other non-health professional and concerned a patient of unreported age and gender.   The patient's medical history and concomitant medications were not reported.   On unspecified date, the patient was vaccinated with Influenza virus vaccine polyvalent (indication, dose, route of administration, anatomical location: not reported). The batch number was not reported.  On unspecified date, unknown amount of time after receiving Influenza virus vaccine patient was not feeling well (malaise).  The outcome of the event was not reported.  The reporter did not provide a causality assessment.  Company comment: the event malaise was considered unassessable for the suspect product.; Sender's Comments: The event malaise was considered unassessable for the suspect product
her first shot was bad; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (her first shot was bad) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (her first shot was bad). At the time of the report, VACCINATION COMPLICATION (her first shot was bad) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication was reported. No treatment drug details was reported.   This case was linked to MOD-2021-351181, MOD-2021-351210 (Patient Link).   Reporter did not allow further contact
vaso-vagal reaction. Lightheaded and dizzy. Laid down in supine position for 30 minutes and recovered Narrative:
1 day after injection he had severe malaise, headache, nausea and has persisted for 1 week.
PNEUMOVAX caused anemia; inflammation of his arm; fever that was "a bit high; This spontaneous report as received from a consumer refers to a 68-year-old male patient with adverse reaction and prophylaxis. The patient did not have any known allergies or reactions. The patient did not have any medical history. Concomitant mediation was reported as none. Historical vaccines include: covid-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE) administered on 25-FEB-2021. The same day, on 25-FEB-2021 the patient experienced a "bad reaction" (adverse reaction) for a week (stop date : 04-MAR-2021).   On 11-APR-2021, the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis (dose, route of administration, lot number and expiration date were not reported which resulted in inflammation of his arm (inflammation), approximately on the same date (conflicting information also reported as 25-FEB-2021).   He mentioned the "bad reaction"(adverse reaction), he received from the covid-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE) may have gotten worse after receiving the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) vaccine.   The patient reported that the inflammation from the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) vaccine caused anemia, on an an unknown date in 2021 and sometimes he would have a fever that was "a bit high"(pyrexia). He stated that he would feel "achy and sick" if he did not take any ibuprofen. He reported that he is still having these problems even though it had been months now and he was wondering if this is a common side effect from the pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) vaccine.No laboratory/diagnostic tests were reported.Treatment included : ibuprofen and  prednisone (manufacturer unspecified).  The outcome of inflammation, pyrexia, and anaemia was reported as not recovered.   The reporter considered anaemia to be related to Pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23).  The causality of the remaining events was unspecified for Pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23).
A few days after the second shot lymph nodes under arm very very swollen under left arm as large as an apple now several months later lymph nodes are still swollen and resting heart rate is quite high and wife has cystic acne also months after and NEVER had acne previously.
beginning 2 days after vaccination - experienced sore throat, hoarseness, labored breathing. The follow up received on 4/21/03 states condition eventually diagnosed as bronchitis with sinusitis.
Patient complained feeling dizzy 5 minutes following vaccination. Immediately after he had a syncopal episode and was unresponsive for about 30 seconds. We lowered him to the floor in a supine position and elevated his legs and called 911 . We immediately cancelled 911 after he was responsive and alert. He remained in a supine position for about 5 minutes then sat back in a chair. We gave him a bottle of water and he remained in the store for about 30 minutes out of an abundance of caution. He felt better and remained in his car outside for some time then left.
Information has been received from a consumer concerning an 83 year old female with hypertension and no allergies who on 04-APR-2007 was vaccinated with a single dose of Zostavax (Oka/Merck). Concomitant therapy included DIOVAN, "CLONODINE", LASIX and VERAPAMIL ER. On 01-MAY-2007 the patient developed rash on back side of left knee. The rash continued to spread and the patient was treated with prednisone. Within 7 days the rash completely cleared up. After stopping the prednisone treatment the rash appeared on the back of patient's right shoulder and it continued to spread. The patient again was treated with prednisone and the rash cleared in the same time frame. After stopping prednisone the rash appeared on the back of patient's right leg and it was spreading. Diagnostic laboratory test of "culture tests" was undertaken. At the time of report the patient was not recovered. A product quality complaint was not involved. Additional information has been requested.
This spontaneous report was received from a registered nurse concerning a patient who was vaccinated with an expired dose of MMR II (Lot # not reported expiration date 06-APR-2012) on 26-JUN-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse effect was reported. Additional information has been requested.
I've never had problems with tinnitus in my life.  The same night I got my shot, when I went to bed my ears were ringing and they haven't stopped since i got this shot.
5 minutes after administration, she started having a headache and then nausea.  Afterwards she felt hot and was shaking.  She reported chest pain. Vitals were stable.  EMS transported her due to inability to reach parents and inability to drive herself home.
About 24 hours after vaccine Mom noted swelling, more sore vax day, no fever. Pt reacts femoral hot, induration area lat. No streak.
fever to 103.6 R hrs p/immun lasting 4 days; shots given 2JUL93 rechecked in office 6JUL93 ? immun reaction;