chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt received vaccination on 5/14/07.  The next day was brought in by mother due to labored respiration.  Pt was sent to ED, intubated in the ED due to respirtaory failure.  Final diagnosis was congenital diabetes with the presentaiton of DKA.  Pt is currently on daily insulin dose 7/18/07-records received from PCP office. Preliminary DX congenital diabetes.Seen on 5/15/07- with C/O noisy respirations. Labored breathing Eating poorly. PE respiration rhythm and depth abnormal, tachypnea, abdominal breathing. inspiratory retraction and intercostal inspiratory retraction observed, subcostal inspriratory retraction noted. Abnormal breath sounds. No wheezing no rhonchi. Hospitalized for 2 days intubated and placed on insulin drip.  8/22/07-records received for DOS 5/15-5/23/07-DC DX: Diabetic ketoacidosis. Congenital diabetes mellitus. Presenting with hyperglycemia, acidosis and respiratory failure. Bicar<5, glucose 836. Intubated admitted to PICU. Treated with insulin drip. Seen in ED with labored shallow breathing. Decreased eating. Vomited times two in ED. Tachycardic and tachypneic with mottled skin. Had acetone smell. Kussmaul breathing and was not wheezing. Intubated. 2-3 week history of diaper rash.
This spontaneous report as received from a nurse refers to a 14 year old patient of an unknown gender. On 29-JAN-2015, the patient was vaccinated with improperly stored GARDASIL (lot # K007264 and expiry date: 02-MAR-2017). No adverse events were reported. No product quality complaint (PQC) was reported for GARDASIL. This is one of several reports from the same reporter. Additional information has been requested.
Pt's left arm swollen and had a hard knot at site of injection. Pt came in 2 days after receiving shot, his arm is still noticeably swollen, but knot went down.
Rash all over body about 2-3 hours.  Pt tried sleeping it off and woke up to a worse rash.
Patient developed (L) eyelid angioedema less than 20-30 minutes after receiving FLUVIRIN by Novartis. No dyspnea, hoarseness, hypotension. (L) deltoid was warm, not red.
This spontaneous report as received from a medical assistant refers to 4 year old patient of an unknown gender. Information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapy was not reported. On 11-NOV-2016, the patient was vaccinated with improperly stored dose of VARIVAX (lot # M024675 with expiry date on 18-MAY-2018; dose and route of administration were not reported). The administered doses experienced a temperature excursion of 6.3 degrees Fahrenheit for 1 hour and 50 minutes, 6.6 degrees Fahrenheit for 1 hour and 40 minutes, 40.5 degrees Fahrenheit for 2 hours, 5.2 degrees Fahrenheit for 20 minutes and 6.3 degrees Fahrenheit for 1 hour and 50 minutes. Previous temperature excursion included 13.3 degrees Fahrenheit for 80 minutes and 9 degrees Fahrenheit for 420 minutes. Data logger was involved. No symptoms were reported. This is one of several cases received from the same reporter. Additional information is not expected as all relevant information has already been received.; Sender's Comments:  US-009507513-1610USA004609:
Swollen, red from underarm to shoulder. Rash surrounding shot site - left arm was sore for 4-5 days. Trouble lifting arm.
Sore at the injection site; Malaise; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a male patient who received HAB (Twinrix) (batch number H4A37, expiry date 18th October 2021) for prophylaxis.   On 29th October 2019, the patient received the 1st dose of Twinrix. On an unknown date, less than 2 months after receiving Twinrix, the patient experienced injection site pain and malaise. On an unknown date, the outcome of the injection site pain and malaise were unknown.   It was unknown if the reporter considered the injection site pain and malaise to be related to Twinrix.  Additional details were reported as follows: The pharmacist reported that a patient who does not want to receive the third dose of Twinrix at the recommended period because of the Covid-19 situation and because after the two first doses experienced malaise and sore at the injection site The reporter consented to follow up.  For tolerance after 2nd dose refer case US2020075694. Third dose not coded as suspect because of medical reason event occur after two doses.
This spontaneous report was received from a pharmacy intern regarding a female patient of unknown age. Patient's concurrent conditions were unspecified. Patient was allergic to Penicillin. She underwent a periodontal procedure on an unspecified date. On 28-JUL-2015 the patient was vaccinated with 19400 plaque-forming united (PFA) ZOSTAVAX (lot # L007222, expiry date: 03-JUN-2016) subcutaneously in the right arm (reported as right posterior triceps area). Concomitant therapies included PERCOCET, hydrochlorothiazide (manufacturer unknown), prednisone (manufacturer unknown), VICODIN, atorvastatin, meloxicam (manufacturer unknown) and Z-PAK. Reporting pharmacy intern stated that the patient experienced redness at her injection site (injection site erythema) since an unspecified date in 2015. The injection site redness was 1 by 2 inches in size. Reporting pharmacy intern stated that the patient did not experienced a rash. Pharmacy intern also stated that the patient did not consulted her healthcare provider, who was unaware about this redness at  her injection site. Till 11-AUG-2015, the patient still experienced redness in her injection site. No treatment was provided for the adverse event. Reporting pharmacy intern stated that the patient started to take azithromycin (Z-PAK) on 25-JUL-2015 (reported as three days before she received ZOSTAVAX for a periodontal procedure which was performed on an unspecified date. Outcome of the event, injection site erythema was reported as not recovered. Pharmacy intern did not assessed the causality of the event with respect to vaccination with ZOSTAVAX. Additional information is not expected as the reporter did not wish further contact.
A report has been received from a physician concerning a 8 year old, female subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT (intranasal) started on 02-Sep-2014. The patient experienced fever of 101, headache, stuffy nose and not feeling well which started on 05-Sep-2014. The outcome of the event of fever of 101, headache, stuffy nose and not feeling well is unknown. The report was considered to be non-serious.
Employee received Influenza vaccine at 11:00 am 10/25/2006 at 13:05 reported to occupational health services with hives face, mouth, neck, trunk and arms, hands tingling, by mouth Diphenhydramine 50 mg given 1310.  Employee stated chest tightness, asthma like signs and symptoms. Three 1:1000 Epi given SQ taken to emergency room.
Information has been received from a registered nurse concerning a currently 30 year old female who on 27-JUN-2012 was vaccinated in the left arm with the third dose of of hepatitis B virus vaccine rHBsAg (lot number AHBV803AB expiration date April 2012, dose and route not reported). The registered nurse stated that the patient was having a titer drawn to see if she seroconverted. No adverse effects reported. Lot number AHBVB803AB is an invalid lot number for Hepatitis B Vaccine (Recombinant). No further information is available.
Left clavicle, close to end shoulder gland is swollen. When moving arm too much and laying flat up,  it gets more swollen[gland pops out]  and feels heavy, aching and uncomfortable. Swollen is there But it doesn?t bother you nor pain, when you  don?t use left arm.
Dose1: pain on site -manageable   Coughing after4 days-occassional Dose 2: fever and chills the night after injection 103F lasted 1 1/2 days, coughing continues with postnasal drip? been taking loratidine eversince the onset but no changes and even with cough meds
My partner and I both received the Pfizer booster shot on the same day, along with the flu shot. With in few days of receiving the vaccine we both experienced severe tinnitus. As of this date, 11/1112021 the tinnitus has not gone away or lessened
The patient developed an itchy rash to the face approximately 10-15 minutes after the immunizations were administered. The patient was treated with Benadryl.
Got both shots/ Still had a very mild case / suspected vaccination failure; very mild case; 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.   On an unknown date, the patient received Shingles vaccine and 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 provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient stated he/she had both shots of Shingles vaccine and still had a very mild shingle. The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure, since the details regarding the laboratory confirmation were not provided.
Muscle pain in left arm from shoulder up to neck to head, left side of scalp was tender to the touch. Worse in the mornings when first waking up and improved as day went on, but repeated with severe pain in the morning.
He is allergic to eggs so he was admistered only 10% of the vaccine as per recommendation in the allergist office.  Immediately after getting the shot, he broke out in a rash (tiny dots scattered across body).  The nurse indicated she had never seen this type of reaction before so the remaining dose was not given.
15 minutes after administration of vaccines patient was noted to have a pink localized macular rash on both legs with patchy blotches on abdomen & face, child was in no apparent distress breathing normally & smiling; doctor was present & consulted, he suggested Children's Benadryl be administered one time today as rash was fading within 15 minutes of its appearance.  Doctor also suggested pre-administering Benadryl prior to next administration of vaccines as rash looked to be a localized histamine reaction; child had twice previously had same series of vaccines without problems.
Developed headache, chills, stomach pain and nausea Tuesday afternoon.  Symptoms increased and then major fatigue Wednesday . Lack of appetite . Feeling better Wednesday night.
Patient received Moderna COVID vaccine 1/27/21 and 2/24/21. There was a COVID infection outbreak in the ALF and patient tested positive for COVID on 2/22/22 in the facility. On 2/25/22, patient admitted to our inpatient facility with COVID-19 infection, vomiting, diarrhea, malaise, generalized weakness, and leukopenia and thrombocytopenia secondary to COVID infection. Patient was discharged back to the ALF on 3/1/22.
She reports her daughter's itching started about 1.5 to 2 hours after receiving the first Covid 19 vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 47 year-old female patient received bnt162b2 (BNT162B2), administration date 18Feb2021 17:15 (Batch/Lot number: unknown) at the age of 46 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: JUNEL FE taken for oral contraception. The following information was reported: PRURITUS (non-serious) with onset 18Feb2021, outcome "recovered" (2021), described as "She reports her daughter's itching started about 1.5 to 2 hours after receiving the first Covid 19 vaccine". The event "she reports her daughter's itching started about 1.5 to 2 hours after receiving the first covid 19 vaccine" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pruritus.  Additional information: Reporter daughter takes birth control pills, Junel FE, but there was no interaction. Therapeutic measures were taken as a result of pruritus included Benadryl. Reporter thinks vaccine administered on the right arm because that was the arm that her daughter moves the most. Additional Vaccines administered on Same Date of the Pfizer Suspect was none. Prior Vaccinations (within 4 weeks) and list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine was none. AE(s) following prior vaccinations was none. Reporter seriousness for the event itching was Unspecified. Patient received the second Covid 19 vaccine on 11Mar2021.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101317746 similar report from same reporter
9 days after receiving my booster shot I began getting a rash with hives that began at night starting with my head and then would go away and reappear in other spots.  When scratching the hives it would get worse and spread even more and leave red marks for about 30 minutes after scratching and then go away. I took Claritin and Benadryl with no ease of symptoms.  It was pretty severe for weeks, when I finally saw my doctor and she prescribed Prednisone Steroid. This helped some while I was on it but came back soon after doses were done.  I started taking Zyrtec and a lot of Zinc, vitamin C and D, and that would help to ease the hives as long as I was on it, so I kept taking that for about a week but cut back the Zyrtec to only once a week because I don't like staying on medication like that. I'm on week 11 now, still trying to take a lot of Zinc, C, and D, and I do not take the Zyrtec anymore.  I still get small, less intense hives everyday usually in the evenings and at night. I recently (12 days ago) have been infected with the Covid virus, and hives have stayed about the same while sick.
TWENTY MINUTES AFTER THE VACCINE WAS ADMINISTERED I BECAME JITTERY, MY ADRENALINE INCREASED, SAME REACTION I HAD AFTER TAKING HIGH DOSES OF STEROIDS (IN THE PAST FOR PREVIOUS SURGERY).  MY HEART RATE INCREASED, SHORTNESS OF BREATH, PAIN IN MY CHEST, ETC?. I DRANK AT LEAST 3 LITERS OF WATER AFTER THE EVENT, TOOK HIGH DOSES OF RESVERATROL, COQ10, MY HEART RATE STARTED TO COME DOWN.  STILL JITTERY .
onset of hives & inc t102.3 in evening p/receiving vax; mom adivsed to give DPH & APAP; hives became generalized w/red rashy across; hives also noted @ rt inject site on the following day; MD dx adverse react & ordered cont of DPH;
HEADACHE, EXCESSIVE CHILLS, EXCESSIVE SWEATING, FEVER, BODYACHES, STOMACHACHE
Patient Received the COVID Janssen vaccine on 3/9/2021.  On 4/11/2021, the patient developed symptoms described as right lower leg weakness (leg "bowed" out, felt, like a "lead" foot).  She also complained of right upper arm weakness.  She was admitted on 4/12 and determined to have an acute CVA.  Her symptoms quickly resolved.  She was started on enoxaparin, ASA, and rosuvastatin and discharged on 4/13.
Fever; Flu-like Symptoms; Aching; Chills; Insect Bites; Redness; Itchiness; This case was reported by a consumer via call center representative and described the occurrence of fever in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In May 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced fever, influenza-like symptoms, pain, chills, insect bite nos, erythema and pruritus. On an unknown date, the outcome of the fever, influenza-like symptoms, pain, chills and erythema were recovered/resolved and the outcome of the insect bite nos and pruritus were not recovered/not resolved.   It was unknown if the reporter considered the fever, influenza-like symptoms, pain, chills, insect bite nos, erythema and pruritus to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After receiving Shingrix, the patient experienced fever, flu-like symptoms, aching, chills, insect bites, redness, and itchiness. The reporter was consented to follow up.
Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Joint pain) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ESTRADIOL, PROGESTERONE, ACETYLSALICYLIC ACID (BABY ASPIRIN), ESCITALOPRAM, ROSUVASTATIN CALCIUM (CRESTOR), LORATADINE (CLARITIN [LORATADINE]), FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]), MAGNESIUM and ASCORBIC ACID (VITAMIN C ACID) for an unknown indication.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Joint pain). At the time of the report, ARTHRALGIA (Joint pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided
Pain in left calf Had ultrasound on left leg 3-16-2021 DX: hematoma left leg Told to apply hotpack q20 min off & on
This spontaneous report was received from a medical assistant referring to unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date the patient was vaccinated with improperly stored GARDASIL 9 (dose and route were not reported) lot # M03478 and expiry date: 15-APR-2019 for prophylaxis. The vaccine was exposed to a temperature frame of 47 Fahrenheit to 77 Fahrenheit for 2 hours. There was a previous temperature excursion of 47 Fahrenheit to 77 Fahrenheit for 3 hours and 10 minutes. The call was because of data logger. No adverse effects were reported. No further information provided. This is one of the several cases from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1707USA009637: US-009507513-1707USA009636:
Pt recv vax on 4/27/99; on 4/28/99 pt exp hemorrhagic rash on upper chest &around neck&chin
Client reported dizziness. The client ambulated and sat down in the anti-gravity chair. Vitals obtained at 1:25 PM were as follows: BP 128/83, HR 93, O2 98%. The client reported a history of anxiety, which he stopped taking his medications for. Repeat vitals obtained at 1:30 PM were as follows: O2 95%, HR 91, BP 139/79. The client stated the dizziness was getting better and was sitting upright in the anti-gravity chair. Repeat vitals obtained at 1:37PM were as follows: O2 97%, HR 94, BP 140/88. The client denied any persistent dizziness and stated he was calm. The client asked to leave at 1:44 PM. At that time the client stated he was feeling better and stated his anxiety was under control.
Rash below site of injection, size of a silver dollar; Rash at injection site was pinkish in color; Small rash on middle of stomach; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Small rash on middle of stomach), INJECTION SITE RASH (Rash below site of injection, size of a silver dollar) and INJECTION SITE ERYTHEMA (Rash at injection site was pinkish in color) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, the patient experienced RASH (Small rash on middle of stomach). On 29-Apr-2021, the patient experienced INJECTION SITE RASH (Rash below site of injection, size of a silver dollar) and INJECTION SITE ERYTHEMA (Rash at injection site was pinkish in color). On 24-Apr-2021, RASH (Small rash on middle of stomach) had resolved. On 30-Apr-2021, INJECTION SITE RASH (Rash below site of injection, size of a silver dollar) and INJECTION SITE ERYTHEMA (Rash at injection site was pinkish in color) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
bloating discomfort that comes and goes in her stomach and even in her back; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISTENSION (bloating discomfort that comes and goes in her stomach and even in her back) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No relevant concomitant medications reported. No relevant medical history was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Feb-2021, the patient experienced ABDOMINAL DISTENSION (bloating discomfort that comes and goes in her stomach and even in her back). At the time of the report, ABDOMINAL DISTENSION (bloating discomfort that comes and goes in her stomach and even in her back) outcome was unknown.            Treatment medicine include antacid.
Fever 102 degrees F 10 days after vaccine lasing 2 days then appearance of rash on face, torso, arms and legs.
Patient reported getting booster on 10 June. Developed fever on 15 June, tested (+) for Covid-19. On/around 17 June developed muscle twitches in left arm and right leg, followed by right leg weakness. Symptoms have persisted and worsened to include abnormal speech. Sought care with PC November who referred to Neurology while on travel.
Cellulitis appeared within 24 hours over about a 25cm square area of upper arm. Patient went to Hospital for examination and received Doxycyline Rx which was picked up 10-14-22 at 11am, at which time patient displayed reaction to pharmacist on duty
7MAY, mom noticed that pt not moving legs & had fever (never higher than 101); Both sx lasted about 1 wk; Fever stopped & resumed about 10% of leg function which previously had only been combat crawl movement; Referred to neurologist;
sore injection site. no treatment. fever of 100.0 lasting approximately 8 hours. no treatment.