chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This initial spontaneous report was received from a registered nurse referring to an unspecified number of patients of unknown ages and genders. There were no pertinent medical history or drug allergies/drug reactions reported. The nurse stated that on an unspecified dates, the patients could have received improperly stored GARDASIL injection, Lot# K008931 expiration date 19-FEB-2017 (dose and route not provided). There was no concomitant medication described. No adverse effects were reported. This is one of two reports received form the same reporter. Additional information has been requested.
This is a spontaneous report from a contactable reporter (consumer or other non-HCP). The reporter is the patient.A 12-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07Jan2022 at 15:15 (Lot number: FD7218) at the age of 12 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "None", notes: Other medical history: none; Known allergies: no. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot number: EW0185; Administration time: 16:15; Anatomical site: left arm; Route of administration: unspecified), administration date: 13May2021, when the patient was 12 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot number: EW0191; Administration time: 16:00; Anatomical site: left arm; Route of administration: unspecified), administration date: 03Jun2021, when the patient was 12 years old, for COVID-19 immunisation.The following information was reported: IMMUNISATION (non-serious) with onset 07Jan2022 at 15:15, outcome "unknown", described as "Dose received: 3"; PYREXIA (non-serious) with onset 08Jan2022 at 04:15, outcome "recovered" (09Jan2022 at 04:15), described as "Fever (101.5)"; FATIGUE (non-serious) with onset 08Jan2022 at 04:15, outcome "recovered" (09Jan2022 at 04:15), described as "Fatigue"; VULVAL ULCERATION (non-serious) with onset 09Jan2022 at 20:00, outcome "recovering", described as "48 hours post vaccination, developed painful vulvar ulcer"; BURNING SENSATION (non-serious), PAIN (non-serious) all with onset 09Jan2022 at 20:00, outcome "recovering", and all described as "Burning/stinging sensation". The events "Fever (101.5)", "Fatigue", "48 hours post vaccination, developed painful vulvar ulcer" and "Burning/stinging sensation" were 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 vulval ulceration, burning sensation and pain.Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient was not sexually active. Treatment included topical ointment (Lidocaine and Triamcinolone acet) for vulval ulceration, burning sensation and pain. Since the vaccination, the patient had been tested for COVID-19.
Patient received a high dose flu shot at pharmacy 10/23/18. She had pain in her arm at the injection site that began about 6 hours after the vaccine and has persisted (until present - 11/5/18). She has a feeling of weakness and mild numbness and tingling in the arm, but a normal physical examination.
Right arm Menactra 10x13cm; Left arm TDap x8cm. Fever 104. Very swollen arm.
07/21-Patient presents to the ED with complaints of fever, myalgias, back pain, chills, and cough onset earlier today. Pt reports temp high of 38.5. Denies taking medication for symptom control. Tylenol provided @ ED Intake.
heart racing; tachycardia; random bouts of flushing; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (random bouts of flushing), PALPITATIONS (heart racing) and TACHYCARDIA (tachycardia) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027B21A and 032M20A) for COVID-19 vaccination. Concurrent medical conditions included Chemical sensitivity. On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced FLUSHING (random bouts of flushing). On 23-Apr-2021, the patient experienced PALPITATIONS (heart racing) and TACHYCARDIA (tachycardia). At the time of the report, FLUSHING (random bouts of flushing) had not resolved and PALPITATIONS (heart racing) and TACHYCARDIA (tachycardia) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Apr-2021, Heart rate: irregular (abnormal) irregular and fast heart rate. Patients reports not taking any medication as treatment and not being on any concomitant medications. Patient is experiencing the dehydration but only having to consume twice as much instead of 5 times as much. No treatment details was reported. This case concerns a 52-year-old female patient, with no relevant medical history, who experienced the non-serious unexpected AESI of HEART RATE IRREGULAR. The event occurred one day after receiving the second dose of Spikevax. Rechallenge is not applicable since the event has not resolved. The benefit-risk relation of Spikevax is not affected by this report. This case was linked to MOD-2021-369045 (Patient Link). Sender's Comments: This case concerns a 52-year-old female patient, with no relevant medical history, who experienced the non-serious unexpected AESI of HEART RATE IRREGULAR. The event occurred one day after receiving the second dose of Spikevax. Rechallenge is not applicable since the event has not resolved. The benefit-risk relation of Spikevax is not affected by this report.
Cellulitis at injection site. Treatment: Keflex 500 mg QID x 7 days.  Site measures 13 cm x 9 cm. Warmth and erythema at site. worsening over 24 hours.
Terrible backache; hematoma at the injection site after the second vaccine; along with some bleeding at the injection site; ache in neck; swelling under arm; This is a spontaneous report from a contactable consumer (patient) via medical information team received from a Pfizer-sponsored Pro-gram .  A 70-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 12Feb2021 as single dose for covid-19 immunization. Patient previously received her BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on approximately 22Jan2021 as dose 1, single for covid-19 immunization and she experienced chills, fatigue, headache, neckache, pain under her arm which she believes was a swollen lymphnode (swelling went away the following day) on an unknown date in 2021. A week later, she experienced hip bursitis for which she received several weeks of physical therapy after the 1st Pfizer shot, she had difficulty moving in and out of bed, she also stated that she had a reaction to an antibiotic 5 years ago (does not specify which one). Patient was upset that she tested negative for antibodies after the vaccine series. Concomitant medication included mycophenolate mofetil (MYCOPHENOLATE) taken for immunosuppression from an unknown date. She was concerned and upset that the vaccine may not work for her because she was immunosuppressed. On unspecified date in Feb2021 patient stated that she experienced a backache afterwards. She states the hip bursitis went away after the second dose. She also stated that she experienced a hematoma at the injection site after the second vaccine, along with some bleeding at the injection site. Patient queried for if the bursitis was a normal and/or reported side effect of the vaccine. patient also experienced Terrible backache, ache in neck, swelling under arm. Went for antibody test which came back negative. Doctor told her it does not mean the vaccine did not work but that they do not know how effective it may be. Patient was upset that information about immunosuppressed individuals and the Covid vaccine was not more out there for the public to know. She was upset that this population was no included in the clinical trials and was upset that she had been told to proceed with her life as if she wasn't vaccinated. Patient was instructed to wearing a mask and social distancing after receiving the vaccine. outcome of events was unknown.  No follow-up attempts are needed. Information out batch/lot number cannot be obtained.
No adverse event; on unspecified date an unspecified number of patients were administered improperly stored PEDVAXHIB, ROTATEQ, and VAQTA; This spontaneous report was received from a medical assistant referring to a 4-months-old male patient. The patient's medical history, concurrent condition and concomitant medication were unknown.  On 21-OCT-2019, the patient was vaccinated with improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) vial of lot # S004251 with expiration date 22-SEP-2020 (strength, dose, dose number and route of administration were unknown) for prophylaxis (product storage error).   On an unknown date, the vaccine was stored at a temperature above 47 degrees Fahrenheit/9 degrees Celsius (9.3 Celsius (C)) for 23 minutes. Previous temperature excursion was at a temperature above 47 degrees Fahrenheit/9 degrees Celsius (8.7 C) for 36 minutes, 47 degrees Fahrenheit/9 degrees Celsius (8.9 C) for 15 minutes and 47 degrees Fahrenheit/9 degrees Celsius (9 C) for 12 minutes. Digital data logger was involved. No adverse event was reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1910USA012749:
This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with a dose 0.5 ml PNEUMOVAX 23 (lot # 669579/0595AA) that expired on 30-AUG-2012 approximately on 01-OCT-2012 "last week". No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. It was unspecified if the patient had sought medical attention. Additional information is not expected.
Unconsolable crying started at about 13:30, continued until 18:30 on 07/23/2003.  Mom treated patient with Tylenol.  No other treatments prescribed after being seen by doctor.  No other significant findings by doctor.
I was diagnosed with Graves disease on 01Jun2021. Symptoms began after the vaccine, however I do have a family history of thyroid disorder (mother)
Pt began vomiting 12/18/07 PM to ER 12/19/07. Dx with intussuseption. A barium enema was attempted, but did not reduce. Surgical bowel reduction was successful. An appendectomy was also performed.  02/01/2008 MR received for DOS 12/19-21/2007 with DX:  Intussusception. Pt presented with 1 day hx of vomiting (16 episodes).  Had bloody stool in ER. Attempted to reduce with Barium enema but unsuccessful.  Pt had exploratory lap with reduction of ileocolic intussusception, appendectomy, and biopsy of mesenteric lymph nodes.  Mesenteric lymph nodes noted to be enlarged in OR. D/C on POD #2
Patient received ZOSTAVAX vaccine subq on 9/15/15. Twelve hours after receiving the vaccine he developed severe, debilitating lower back pain such that he had to lay on the floor, crawl and then pull himself up on furniture to stand to walk. He made an appointment with his chiropractor but his chiropractor did not find bone misalignment, only severe muscle cramping in the lower back region. This severe back pain did not begin to resolve until about 72 hours later at which time the intense, debilitating pain moved to his right knee and began to swell also causing intense calf pain and ankle swelling. Over the next 3 days, the back pain resolved but the knee pain persisted for 3 more days causing patient to have to use a cane to walk. One month later, the pain in his knee has almost resolved.
sore arm; can't sleep; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and INSOMNIA (can't sleep) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm) and INSOMNIA (can't sleep). At the time of the report, PAIN IN EXTREMITY (sore arm) and INSOMNIA (can't sleep) had not resolved.            Treatment Information was not provided by the reporter Action taken with the drug in response to the events was not provided by the reporter
Patient reported feeling dizzy after getting out of the vaccination room while consulting Pharmacist with an OTC medication
Patient passed out in the waiting area about 5 minutes after getting vaccinated. She regained consciousness after a minute or two but her skin was pale and gray. EMT was called and she was taken to the ER.
Syncopal episode approximately 5 minutes after administration of vaccine. No injury sustained. No sustained loc. Vital signs stable. Lied down for a bit, drank some juice and regained strength and left office after 20 mins. Did have breakfast this morning. Phone f/u in the evening--child still not feeling completely well--h/a, nausea. No fever. No vomiting. Recommended Tylenol dose.
On 7/20/22 patient stated that she felt tired and week and heavy legs. She stated that she did not experience this from her first vaccine.  She was advised to speak to her doctor about it, but she was worried about catching covid and did not want to risk going to doctor's office. On 8/4 Pharmacist called her back to follow up. At this time, she was clearer about her symptoms. she stated that it is more a numb feeling from her knees down and her ankles hurt. She was strongly advised to see her doctor as soon as possible. Called patient to follow up on 8/14/22 and she reports that she is more used to it, but it is still there. Now she stated that she has more muscle pain from knees to her buttocks.   She reports that she has lost 10 lbs. She still hasn't seen her provider yet for the same reasons mentioned above.
Lymph edema right axilla started 08/27/02 AM. Right upper arm, shoulder, chest swollen and warm. Oral temperature at 99.1 degrees F. Given augmentin by ER and instructed to use ibuprofen or acetaminophen for comfort.
Tingling pain radiating from left shoulder down to fingers. Painful enough for patient cant sleep on it. Started 2 weeks post vaccination
Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 13-Jul-2022; No adverse event; Administered the vaccine to 346 patients after the 30 day by used; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 13-Jul-2022) and NO ADVERSE EVENT (No adverse event) in a 50-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 13-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 13-Jul-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 13-Jul-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator on 04-Jun-2022 and administered vaccine on 13-Jul-2022).    No concomitant medications were reported.   The patient received half dose. The vial did not undergo any temperature excursions.  No treatment details were reported.
Pt received FLUAD while Afluria was indicated. Pt counseled about the error. All questions were answered and pt will report any untoward effects.
Patient is a 15 year old M with hypofibrinogenemia, platelet aggregation disorder and history of COVID admitted to Inpatient Ward from 26 June - 01 July for work-up and management of new onset and severe headache, photophobia, and pain with extraocular movement. Extensive work-up complete but still unclear etiology, though near complete resolution of symptoms with IV steroids.   Neuro: CSF positive for HHV-6, still unclear if this fully explains presentation. CT and brain MRI negative, though limited exam due to braces artifact. Headache complicated by clear post-LP postural headache, though this improved throughout hospitalization, with nausea moderately controlled on Benadryl. Neurology and Ophthalmology consulted, who both thought peri-neuritis was plausible, which is consistent given such rapid improvement with steroids. Pain moderately controlled with Tylenol. Oligoclonal bands and MBP CSF studies pending at time of discharge. Plan for 7-day steroid taper as an outpatient (outlined below in patient instructions), and Neurology follow-up in about 1 month.  ID: Initially empirically covered with Ceftriaxone and Acyclovir, but once negative CSF, both were discontinued. He remained afebrile throughout remainder of hospitalization, so no further antibiotics started. Had remote history of immunodeficiency (confirmed here to be IgA deficiency), underwent more extensive immune work-up with lymphocyte subset 6 pending at time of discharge.   Fen/GI: Nausea and poor PO intake secondary to headache and neurologic symptoms. Unremarkable KUB with no focal findings on exam. Tolerated good liquid PO intake prior to discharge, improving food intake with help of Benadryl and Reglan (Zofran did not help his nausea). Given risk of Reglan side effects, trial of Benadryl alone was given and relieved his nausea.  Will discharge with Benadryl PRN for nausea, though expect this to improve.    Heme: No blood transfusions required, no history of recent bleeding/trauma, no signs of active bleeding. Received TXA for three days following his LP performed on 6/28.  Rheumatology: Patient has preexisting appointment with Rheumatology scheduled on 7/9 due to a history of intermittent joint pain/swelling with skin color changes since April 2020. Ordered requested Rheumatology labs by Doctor while patient is admitted. CRP and ESR resulted normal at 0.31 and 8 (respectively), C3 and C4 within normal limits, dsDNA and ANA negative. Repeat ESR on 6/30 also normal at 10. Pending labs include fecal procalcitonin. Follow up appointment with Rheumatology on 7/9.   CV: Some concern for myocarditis at time of presentation given pleuritic chest pain, history of COVID-19 infection, and recent COVID-19 vaccination. EKG at that time revealed nonspecific T wave changes. However, troponin and BNP resulted negative and patient's chest pain has resolved at this time. Discussed with Cardiology who did not think further work-up was necessary. Chest pain completely resolved at time of discharge.
On Thursday, April 22, I lost an hour and half of memory.  This was an active hour and did not remember and still do not recall.  I had only that one episode.
Approximately 8 hr after shot began with feeling of something stuck in throat. Proceeded to cough, tightness of chest, belching, diarrhea, chills and an extreme headache that was not relieved by taking my usual treatment of 2 ADVIL. Symptoms persisted til next day.
Paraesthesia of Left arm-no treatment-the condition resolved after 15 minutes without intervention-no further complications reported.
PATIENT GOT VERY SLEEPY, VISION BLURRED, FELT TINGLY, COULDN'T HEAR. 911 WAS CALLED AT THIS TIME.  HE THEN BECOME UNRESPONSIVE . A STERNAL STIMULATION REVIVED HIM. WE KEPT HIM AWAKE, MONITORED HIS PULSE WHILE WE WAITED FOR EMS.  PATIENT BECAME MORE ALERT AND COLOR RETURNED OVER NEXT FEW MINUTES. WHEN EMS ARRIVED HE WAS COHERENT AND TALKING. PARAMEDICS TOOK VITALS AND EXAMINED HIM. HE WAS RELEASED TO GO HOME NO HOSPITAL TRIP WAS NEEDED1
Vomiting; Fever; This case was reported by a other health professional via call center representative and described the occurrence of vomiting in a male patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) (batch number 24PP4, expiry date 30th June 2020) for prophylaxis.   In October 2019, the patient received FluLaval Tetra 2019-2020 season. In October 2019, less than a week after receiving FluLaval Tetra 2019-2020 season, the patient experienced vomiting and fever. On an unknown date, the outcome of the vomiting and fever were unknown.   It was unknown if the reporter considered the vomiting and fever to be related to FluLaval Tetra 2019-2020 season.  Additional details were provided as follows: The age at vaccination was not reported. The medical assistant stated that, the patient received dose of Flulaval quadrivalent season 2019-2020 either on 18th October 2019, or within the week afterwards. The patient experienced events either the day of vaccination, or the day after vaccination. The reporter consented to follow up.
Approximately 7 days following the vaccine, patients breasts became extremely tender. The tenderness lasted for 3 days.  Approximately 9 days following the vaccine, patient's arm from the vaccination site and 6 inches below became bright red, hot, hard and extremely sore. It began itching about a day later.  By 11 days, all the symptoms had resolved.
I feel so tired; a little bit dizzy; Intravenous administration; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program. This female consumer of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) intravenously on 13Feb2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On unspecified dates the patient reported she felt so tired and a little bit dizzy. The clinical outcomes of she felt so tired and a little bit dizzy were unknown. The clinical outcome of intravenous administration was recovered on 13Feb2021.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
I received Shingrix vaccine on the morning of  07/23/2019.  The injection was in the deltoid of my left arm.  Just prior to midnight, I awoke with severe nausea and headache.  I also had significant injection site pain with  slight swelling,  but I expected this to occur.   I took 650 mg. of Tylenol without benefit.  The following day, the nausea and headache persisted and I had an oral temperature of 101.  I also developed a warm, red, macular rash approximately 5 x 7 cm below and medial to the injection site.  On 07/26/2019 I began to feel better.  The nausea and fever have subsided, the headache has improved, and the rash persists.  While I have had multiple vaccines in the past including Zostavax, I have never had such a significant reaction.   I did not seek medical treatment as my husband is a family practice physician.