chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case number PHEH2011US01543 is an initial spontaneous report received from a consumer on 11 Aug 2011. This report refers to a patient of unknown age group and gender. This patient was vaccinated with MENVEO (batch number: unknown) intramuscularly on 10 Aug 2011. Subsequently the patient experienced nausea, vomiting and headache. No further details were provided.
Rash all over both legs and stomach denies any itching and temp. Mother very concerned about her child. 12/8/2000 rash no treatment needed. Resolving at this time.
Pt recv vax on 11/12/98; on 11/13/98 pt exp painful Rt Arm w/ red hive-like eruption at vax site; tx=compresses & Benadryl
Approximately 5-6 hours after receiving his 2-month shots, patient began to exhibit severe fussiness, which was followed by myoclonic jerks which continued for 2-3 hours. The seizure-type activity resolved spontaneously.
At 16:07 pt received 3 vaccinations. Pt was cool, pale and clammy after vaccination. Mom states she passed out and with blood draw bt not in trenchlenberg position became conscious right away. V/S (1610) 110/80 60-16 (16:20) 100/700 72 189 (16:40) 110/80 78 16. Given crackers and juice. Voiced no complaints color has returned skin W/D. Left in care of mom. Unable to reach by phone later to check increased on pt.
No adverse event. Vaccine administered to 4 year old in error. Patient returned for 2nd dose today. We denied and said to come back for the second dose when patient turns 5 (in a few days).
Expired vaccine used-17 days after puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used-17 days after puncture) in an 83-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used-17 days after puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used-17 days after puncture) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medicines were reported No treatment medicines were reported Vial was punctured 17 days before administration.  Reporter was looking for a decision as to whether those doses could be counted or if the provider needed to contact the patients for re-administration of the doses.   This case was linked to MOD-2021-333897 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: follow up received contain no significant information
Severe headache, very low blood pressure and blood sugar , dizziness , fatigue that cause fall. Body aches , low grade fever abs coughing and none stop running nose abs very dry throat
Mom noticed decreased activity yesterday 5/26/06 and redness and swelling in left deltoid area at bath time. Pt spontaneously requested to go to bed early after dinner. No fever, but general malaise.
He had very mild muscle soreness; This is a spontaneous report from a contactable consumer (patient). A 92-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown), via an unspecified route of administration on 02Feb2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. It was reported that patient got second shot past tuesday. He asked whether he should be worried that he didn't had any side effects. His son was concerned that the vaccine may not be working. It was stated that he had very mild muscle soreness that did not last very long after receiving the vaccine. He did not specify which dose he was referring to. He has had no side effects whatsoever. He was listening to Dr. associate who said he got the vaccine, and he had a reaction to it. This indicated to him that the vaccine was working. He was just wondering since he didn't had a reaction if he should be worried. He just told his son he guesses he was lucky, but his son told him he should call and ask. He would rather have poured gasoline on it and burned it before he had an email. The outcome of the event was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Moderna was given as first dose, and Pfizer given as second dose in series. Pt had no reportable reaction at time of vaccination.
It was reported that a female pt received a Fluzone SV '00-'01 vaccination in the gluteal area on 11 Oct 2000. Reportedly 12 Oct 2000 the pt developed a local reaction of redness and swelling. Further information requested. Pt received the Flu-vaccine in the hip.
DTAP-IPV-(Sanofi Pasteur) inadvertently mixed with ACTHIB (SP). PC to SP-spoke with medical advisory staff, explained action. She states that it was a "immuniogenic" dose, safe and would not need repeating. Stated to document correct #s
Foster parent reported she observed the baby staring and then had tonic/clonic movements of extremities lasting a few seconds. She is unsure of exact length of time lapse. 911 was called and child was taken to E.R.
This spontaneous report was received from a registered pharmacist concerning an unknown number of patients who on unspecified dates were vaccinated with a dose of VARIVAX (Merck) (dose, route and lot # not provided). The pharmacist reported that an unknown number of doses of VARIVAX (Merck) that were transported between their facilities on dry ice, "possibly" below -58 degrees F (exact temperatures unknown) had been administered to an unknown number of patients. No adverse effect was reported. Additional information has been requested.
None:  Tested positive for Covid 19 on 13Jun2022.  This was approximately 1 week after my wife had tested positive.
Hives like rash on face, chest, w/ in 30 minutes of vaccinations given.
C/O scratchy throat similar to when she eats watermelon.  BP 116/70  HR 74  O2 Sat 98%  No signs of difficulty breathing, speaking, or swelling. Benadryl offered; patient declined.  Patient approximately 40 minutes and stated she felt fine and left facility.  Advised to consult allergist prior to receiving 2nd COVID vaccine.
This spontaneous report as received from a pharmacy technician refers to a 2-year-old patient of unknown gender. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant medications were not reported. On 07-FEB-2018, the patient was vaccinated with improperly stored dose of VARIVAX (lot # N022979, expiry date: 23-AUG-2019) (dose, frequency and route were not reported) for prophylaxis. No adverse effect was reported. The VARIVAX temperature excursion occurred on 14-DEC-2017 and 30-DEC-2017. On 14-DEC-2017, the vaccine was exposed to the temperature of 16.9 degree Fahrenheit (F) for 30 minutes. On 30-DEC-2017, the vaccine was exposed to the temperature of 6 degree Fahrenheit (F) to 14 degree F for 30 minutes. It was reported that the event was because of data logger. No product quality complaint was involved. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1802USA001558.
burning sensation on her arm; redness on her arm / growing larger toward her chest; This case was reported by a consumer and described the occurrence of extremities burning sensation of in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included venetoclax (Venclexta) tablet for chronic lymphocytic leukemia.   Concurrent medical conditions included chronic lymphocytic leukemia and drug allergy (allergic to Lipitor, Oxycodone and Penicillins). Concomitant products included allopurinol, metformin, sitagliptin (Januvia), paracetamol (Tylenol) and obinutuzumab (Gazyva).   On an unknown date, the patient received Shingrix. On 24th September 2020, the patient started Venclexta (oral) 100 mg 3 times daily (400 mg daily). On 13th January 2021, less than 4 months after receiving Shingrix and an unknown time after starting allopurinol, the patient experienced extremities burning sensation of and erythema of extremities. Venclexta was continued with no change. On an unknown date, the outcome of the extremities burning sensation of and erythema of extremities were unknown.   It was unknown if the reporter considered the extremities burning sensation of and erythema of extremities to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, but could be 65 or 66 years. The patient had a response to Shingrix vaccine while being on Venclexta.  The 13th January 2021, 3 months and 20 days after receiving Venclexta and less than 4 months after receiving Shingrix, the patient experienced a redness and a burning sensation on the arm that was growing larger towards the chest. It was unknown if the reporter considered the extremities burning sensation of and erythema of extremities to be related to Venclexta.
11/7/21 presents to EC ED "with fever and myalgias, concern for COVID-19". PMHx "emphysema, mild persistent asthma, HTN, hypothyroidism".
Case fully vaccinated with Pfizer. Last dose on 3/4/21. Tested positive for COVID on 8/11/2021. Admitted to  Community Hospital East on 8/16/2021. Expired on 8/27/2021 while still hospitalized.
Pt presented to the medical department after a single episode of syncope that occurred the day after receiving her vaccine. Upon evaluation, she stated that she had not eaten for an entire day prior to her episode of syncope. She also reported diffuse body aches and a headache. She was given a shot of toradol and 2L of IVF and her symptoms improved.
Patient was given a expired dose (4-6-17) of Rotavirus vaccine. Patient is scheduled to return one month to repeat dose.
8 minutes p/vax pt said didn't feel well; heartbeat became rapid & blood pressure was elevated; pt hyperventilating; heart palpitations until 9PM that noc; had stiff neck & shoulders; had h/a;
4/11/21 Extreme vertigo, nausea, severe vomiting. 4/13/21 Vertigo and nausea persisted, vomiting subsided. 4/15/21 Vertigo, nausea, difficulty swallowing. 4/16/21 Completely unable to swallow. Taken to ER. Upper esophageal sphincter spasm resulting in inability to swallow. 4/27/21 Laryngospasms began intermittently progressing to continuous on 4/28/21 severely compromising ability to breathe. Intubated and placed on ventilator.
General malaise noted 10/02/2003 PM.  Increasing irritability, itchy rash noted right arm 10/03/2003 lunchtime.  Spread "all over". Diagnosis: Varicella.
BUMP ABOUT 2 INCHES BELOW THE INJECTION SITE; LITTLE RASH ON ONE SIDE OF THE BANDAID; SORENESS AT INJECTION SITE AND IT FEELS HOT; This spontaneous report received from a patient concerned a 40 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma allergies, non smoker, and alcohol user, and other pre-existing medical conditions included the patient had no drug or non-drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 09-APR-2021, the subject experienced bump about 2 inches below the injection site. On 09-APR-2021, the subject experienced little rash on one side of the bandaid. On 09-APR-2021, the subject experienced soreness at injection site and it feels hot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from soreness at injection site and it feels hot, bump about 2 inches below the injection site, and little rash on one side of the bandaid. This report was non-serious.
Woke up with loss of taste and smell today; Woke up with loss of taste and smell today; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (Woke up with loss of taste and smell today) and ANOSMIA (Woke up with loss of taste and smell today) 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 08-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Nov-2021, the patient experienced AGEUSIA (Woke up with loss of taste and smell today) and ANOSMIA (Woke up with loss of taste and smell today). At the time of the report, AGEUSIA (Woke up with loss of taste and smell today) and ANOSMIA (Woke up with loss of taste and smell today) outcome was unknown.            No concomitant medications were provided. No treatment medications were provided.  This case concerns a female patient of unknown age, with no relevant medical history provided, who experienced the non-serious unexpected AESI of ageusia and anosmia. The events occurred the day after receiving the booster dose of the Moderna COVID 19 vaccine. The rechallenge is not applicable as AEs occurred after booster dose. The benefit-risk relationship of the Moderna COVID 19 vaccine is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This case concerns a female patient of unknown age, with no relevant medical history provided, who experienced the non-serious unexpected AESI of ageusia and anosmia. The events occurred the day after receiving the booster dose of the Moderna COVID 19 vaccine. The rechallenge is not applicable as AEs occurred after booster dose. The benefit-risk relationship of the Moderna COVID 19 vaccine is not affected by this report.
Information has been received from a nurse concerning a female who "about 1 year ago", in approximately 2008 was vaccinated with a dose of GARDASIL (dose, route and lot number not reported). The nurse stated that "the patient developed hives after receiving the dose of GARDASIL". The patient sought unspecified medical attention. No further information is available.
Patient had already received both doses of Pfizer COVID vaccine on 1/5/21 and 1/26/21 and therefore, had completed the COVID vaccine series.  He did not need the Moderna vaccine.
Moderate rash for 24 hours, headache for 24 hours and fever for 48 hours along with nausea, additional notes not sure if rash is due to shrimp allergy
Patient did not experience an adverse reaction to Gardasil 9.  3rd dose that was administered on 6/3/22 was not needed. Patient only needed at 2 dose series.  Instructed to report VAERS due to administration error.
Continuous crying for approximately twenty four hours followed by greater than one week of shock like symptoms.  Had to force child to awaken and eat for one week after vaccination.  Smiles, coos, and eye contact ceased for approximately two and one half weeks. Has not met any milestones on time since this vaccination and subsequent adverse reaction.
This case was reported by a pharmacist via other manufacturer and described the occurrence of pain in arm in a adult patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable for this report. The sales representative of other manufacturer called about the new product SHINGRIX and reported that she was just speaking with one of her pharmacists and sharing some data on adverse reactions that could occur post-vaccination. The pharmacist reported that she had been seeing a lot of arm soreness with the SHINGRIX vaccinations. The pharmacist did not name any specific patients and stated that she had been vaccinating quite a few patients and many of them complained about arm soreness. The sales representative did not know the dates of the adverse event. The reported arm soreness she believed occurred recently. The pharmacist stated that she administered 5 of the vaccines specifically and people were complaining about the arm soreness so she felt this occurred relatively recently. She did not have the lot number, NDC, or expiration dates for the vaccines or any product information on hand. She did not know the dose. She believed they would be administered the medication if their doctor recommended it. She did not know the treatment dates. It was verified that she did not know any concomitant medications, other medical conditions, or investigations to report. The sales representative did not have the reporter's email address. The reporter's business details were provided. She did not have any patient identifying data to include initials, date of birth, age, sex, height, weight, or ethnicity. She did not know any of the prescribing physician's information. There was no product complaint to report. There was no medical information request. This case was 1 of the 6 cases reported by the same reporter.
mom reported w/in 24hr of vax pt had a red spot @ vax site;w/in 48hr had swelled to softball size w/redness & warmth;pt had generalized pruritus w/no arms arm remained swollen 1 1/2-2wk;mom called MD who recommended APAP & ice to site;
Patient reports onset of intermittent paresthesia feeling like numbness affecting tips of fingers and toes. She also reports 3/d watery green diarrhea. Otherwise feeling well. Lab evaluation for paresthesia/neuropathy and diarrhea alternative cause ordered but pending at this time.
This case was reported by a consumer via call center representative and described the occurrence of fever in a 72-year-old female patient who received SHINGRIX for prophylaxis. In August 2018, the patient received the 1st dose of SHINGRIX. In August 2018, 1 day after receiving SHINGRIX, the patient experienced fever, injection site pain, injection site swelling, erythema, feeling unwell, injection site warmth and injected limb mobility decreased. On an unknown date, the outcome of the fever, injection site pain, injection site swelling, erythema, feeling unwell, injection site warmth and injected limb mobility decreased were recovered/resolved. It was unknown if the reporter considered the fever, injection site pain, injection site swelling, erythema, feeling unwell, injection site warmth and injected limb mobility decreased to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX vaccine on left arm. The vaccine was administered at the end of August at 11:00 or 1:00 in the afternoon. That same day the injection site was hot to the touch and swollen and painful. The less than a week after receiving SHINGRIX, the patient could not move her arm due to the pain. The patient said less than a week after receiving SHINGRIX, she felt sick but couldn't remember details regarding feeling sick. The next morning 1 day after receiving SHINGRIX, she woke with a fever of 102 or 103. The fever reduced the following day to 99.3 or 4.
Pt called on-call doctor, complaining of tingling in her fingers, pressure in her throat, pale and jittery. He instructed her to go to Emergency room. Pt did not go. When we reached her she said she felt fine by the next morning.
This reaction is from a Recombinant Zoster Vaccine (Wasn't a choice for the above on the vaccines!)  I got a bright red spot on my arm about the size of a medium sand dollar and it was warm to the touch.  It itched too.
Patient developed symptoms of MISC on 2/19/22; fevers also began on 2/19/22 with a Tmax of 39.5 degrees Celsius.  Over the course of illness, symptoms and complications included fevers, abdominal pain, vomiting, diarrhea, rash, mucocutaneous lesions/conjunctivitis, and headache. Abnormal labs included elevated NT-ProBNP, elevated CRP, and elevated ferritin. ECHO studies showed left ventricular dysfunction, mild tricuspid regurgitation, and trivial mitral regurgitation. Patient was admitted to the hospital on 2/22/22 and treated with IVIG, infliximab, and aspirin. He was discharged on 2/27/22.
No additional AE'S; Temperature excursion involving administered PROQUAD vaccine; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical and drug history, current conditions, and concomitant medications were not provided.     On an unknown date, the patient was vaccinated with measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) as prophylaxis (lot number reported as U022726 expiration date 16-JAN-2023 ; dose, vaccination scheme, route of administration,and anatomical site of vaccination were not reported).     The medical assistance reported that on 13-DEC-2021 temperature excursion involving administered measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (PROQUAD) vaccines (product storage error).  No product quality complaint (PQC) and no additional adverse event (AEs) (no adverse event) were reported.
Pt's arm was swollen from shoulder to elbow, red, hot, generalized swelling. Pt felt feverish. Pt iced area and swelling went down & didn't spread. The next day pt said it was better.
1/23/12 2:11pm client called to report redness & swelling on back of (L) arm from injection site down to 2" above elbow. Area also hot & itchy. Onset date 1/20/12. Has used natural creams with improvement. Rec cont with cream & apply heat. 1/25/12 called client arm better - no redness/itching.
MOTHER STATES LEG BECAME RED THAT NIGHT. SWELLING STARTED AND BY TODAY( MONDAY) THE THIGH IS SWOLLEN AND RED FROM THE KNEE TO THE HIP.  TOOK TO DR. FOR HIM TO EVAULUATE.  STATES NOT INFECTED JUST A REACTION TO THE PREVNAR IMMUNIZATION.  ADVISED TO GIVE BENADRYL AND IBUPROFEN BY MD.
Within 1min after administration: Tachycardia, mental fog, dizziness Within 5min after administration: Tachycardia resolved, mental fog worsening, dizziness, muscle weakness Within 15min after administration: Nausea, dizziness, mental fog (feeling like an out of body experience), muscle weakness (feeling like my legs wouldn't support me). Two hours post- administration: Severe nausea and mental fog Six hours post-administration: Muscle aches and joint pain. Nausea and dizziness resolved. Soreness and muscle ache in arm with injection site. 12 hours post-administration: Diarrhea, increase in nausea, and vomiting. Dull headache. Tylenol taken. 22 hours: Fever (99.1F), chills, sweating 32 hours: Fever (99.9F), chills, sweating, muscle weakness, body aches, headache. Tylenol taken. 43 hours: Tested for COVID by nasal swab d/t recent exposure at place of employment and presence of S&S. Test pending. Fever 99.0F. Tylenol taken. Dull headache.