chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Medical assistant calling to report a temperature excursion that occurred 8/14/2020 which involved the following products: GARDASIL9, PEDVAXHIB, RECOMBIVAX, ROTATEQ. Per caller, "it would be possible that at least 100 patients have received vaccines; This spontaneous report was received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies or concomitant medications were not reported.  On 09-SEP-2020, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) as prophylaxis (lot # T011167 with expiration date 27-MAY-2022) (strength, frequency, route of administration and anatomical location were not reported).  The improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) experienced a temperature excursion of 35.4 Fahrenheit degrees (°F) for the time frame of 20 minutes without previous temperature excursions. It was confirmed that a digital data logger was involved.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2009USA006106:
Information has been received from a registered nurse concerning a 24 month old female twin with a history of bronchiolitis and no known drug allergies who on 4/26/04 was vaccinated with a dose of varicella virus vaccine live (lot # 647521/1108N). Secondary suspect vaccinations included HIB conjugate vaccine and MMR. Other concomitant therapy included albuterol sulfate as needed for the treatment of bronchiolitis. On 12/11/04 both twins (associated WAES0412USA02274) experienced breakthrough pustular rashes on their trunks, and became fussy and itchy. Medical attention was sought and Tylenol and Benadryl were given as interventions to help the itching. As of 12/14/04, the patients were recovering. The events were considered other important medical events (OMIC). Additional information has been requested.
Blood Pressure went very high.  192/91 Monday, 189/127 Tuesday.  Back to normal (121/83) by Thursday.
Information has been received from a physician concerning a 79 year old white female patient who on 05-DEC-2007 at 13:45 pm was vaccinated into the right arm with the first dose of ZOSTAVAX. On 07-OCT-2008 the physician noted shingles rash on left buttocks. The patient was treated with VALTREX thrice daily dosage. The patient recovered on 28-OCT-2008. Shingles rash was considered to be other important medical event. Additional information is not expected.
Started to feel burning sensation at previous shingles site which progressed to very painful for 9 hours. Following day less painful.
Several hours after the vaccine I noticed difficulty raising or rotating the arm / pain in the shoulder joint when moving the arm. This remained at the same level for approximately 2 days. After another day, the symptoms have somewhat lessened but it remains difficult to raise or rotate the arm and somewhat painful.
This spontaneous report was received from a licensed nurse practitioner refers to 11 unspecified patients of unknown age. On an unknown date, the patients were vaccinated with an improperly stored dose of RECOMBIVAX HB (lot number, expiry date was unknown). Concomitant medications were not reported. No adverse effects reported. The outcome of the events were unknown. This is one of the several reports received from the same reporter. Additional information has been requested.
t102, chills, tremors, neck & back aches (no local sx noted); tx APAP & Advil, rest, fluids (advised to got to ER but did not);
Case number PHEH2013US026020 is an initial spontaneous report received from a pharmacist on 13 DEC 2013. The report refers to a 48-year old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with 0.5 ml does of FLUVIRIN 2013/2014 (batch number: 13464P) intramuscularly on 13 DEC 2013. This FLUVIRIN prefilled syringe reached 48 F on 03 DEC 2013 at 6 PM; at 8:55 AM on 04-DEC-2013 it was at 46 F. This first excursion duration was 15 hours. Same vaccine then reached 47 F on 04 DEC 2013 at 5 PM. This second excursion duration was 16 hours. Reporter stated that the vaccine has been in range since that excursion. Vaccine was administered to patient after excursions. No adverse reactions were reported. Seriousness, outcome and causality of the event were unknown.
0730 - itchy lips and eyes 0736 - itchy throat  0734 to 0740 - monitored VS  0744 - administered Benadryl IM  0750 - itchy throat resolved  0815 - top lip and eyes still itchy  0835 - recommended follow-up with PCP and to go to urgent care or emergency department for worsening symptoms or any signs of distress
Severe muscle ache, shivering, overwhelming need to ?stretch? muscles to deal with fatigue, nausea, dizziness, inability to sleep
Dizziness, nausea, muscle aches, joint pain, headache, fatigue, tiredness (sleepiness), soreness at injection site, light headed
10-15 minutes after shots were given pt developed nosebleed, skin pruritus & redness. SOLUMEDROL given, pt then reported chest pain dizziness dry mouth SOB pt transport to hospital via ambulance.
Felt hard below injection, they had me stay, site turned red, hot, very swollen I returned 4 times for them to check it all said O.K. Went to someone else who said I was allergic to something in it. Took BENADRYL had lots of itching.
I had acute onset of Supraventricular Tachycardia (SVT) with a heart rate in the 180's on 8/31/2021 upon waking up in the morning around 6:30am.  I had symptoms of palpitations, rapid pulse, dizziness, weakness and shortness of breath.  I went to my PCP's office and had an EKG which confirmed that I was in SVT and was sent to the emergency department.  I was seen at Hospital that same morning and they performed vagal maneuvers which successfully converted me back to sinus rhythm.  I then had repeat episodes of SVT on 9/2/2021.  The first episode on this day occurred while working in a medical office, sitting in a patient exam room.  I once again felt palpitations and rapid pulse followed by some dizziness and shortness of breath after my pulse was in the 150-170 range for more than 30 minutes.  I successfully performed vagal maneuvers on myself and was able to convert myself back to sinus rhythm.  On my way home from work on this same day, around 5pm, I had another episode of SVT with my heart rate up into the 160-170's.  I immediately performed vagal maneuvers and converted myself back to sinus rhythm successfully.  I saw a cardiologist on 9/2/2021 and was prescribed metoprolol tartrate 25mg twice daily to help prevent future episodes of SVT.  The cardiologist asked me if there was anything new in my life/medications since I have never had SVT before this.  I couldn't think of anything other than me getting my 3rd booster dose of moderna covid vaccine.
Large unexplained tennis ball size nonpainful bruising on left upper thigh.  Other more common side effects include chills, lethargy, inappetance, sore, neck pain,  difficulty standing , nerve pain
After the patient was administered the vaccine, she walked to the 15 min post-vaccine waiting area and sat down. After ~5-10 minutes her dad told me she  wasn't feeling well. I went straight to the patient who was still sitting, looking pale and being fanned by her mother. I said let's lay her down but she lost conciousness right then so I just caught her in her chair.  A technician  called 911. An associate took over holding the patient in her chair. We raised her feet on to another chair, her mother continued to fan her face. I sent another associate to meet the responders at the front door and bring them to us. Patient was breathing throughout. She started to regain conciousness before the responders arrived. They checked her out and gave her permission to go home with her parents.
Six days post vax the pt broke out with chicken pox. Pt had over 100 lesions on 03/22/2001. As of 03/28/2001 the pt had chicken pox and a fine red raised rash.
Patient hospitalized with COVID-19; fully vaccinated. HISTORY OF PRESENT ILLNESS: Patient is a 65 y.o. female with a history of oral cancer and type 2 diabetes who presents today with cough.  She has been residing in Home for rehabilitation after hemiglossectomy last month.  Her caregiver expresses concerns about neglect at the facility and does not wish her to go back there.  She was diagnosed with COVID-19 earlier in the day at the facility.  She has been having cough and body aches.  She denies fever.  She is fully vaccinated with the Pfizer vaccine.  On arrival, she is on her baseline supplemental oxygen use of 2 L. She does have leukocytosis.  There is no radiographic evidence of pneumonia.  On exam, she says she is nauseated and hungry.  She otherwise complains of a mild headache.  Plans are discussed for admission and she is agreeable.  She wishes to be listed as full code status. 8/26 DR Chest: No acute cardiopulmonary disease is present. Assessment/Plan; COVID-19 with multiple comorbidities; Fully Vaccinated with Pfizer. CXR negative for any acute findings. Repeat CXR on 8/26 no acute cardiopulmonary disease; Trach in place. Positive date 8/23/21; daily CMP/CRP/D-dimer; Tylenol PRN; Robitussin PRN; Tessalon PRN; PT/OT recommends placement back to skilled nursing facility; Continue Decadron 6 mg Day 7; Remdesivir completed; H/o tongue cancer; S/p hemiglossectomy 7/20/21; Feeds through PEG tube; Trach care per ENT, can do radiation outpatient after placement to SAR; cap trach today, if respiratory status stable for 24 hours, can decannulate per the patient's ENT; Rib pain; Improving. Secondary to cough. Patient unable to take Tylenol and wary of NSAIDs given CKD3. Lidocaine patch without relief. Flexeril does offer some relief added tessalon perles to better control cough no topical NSAID available; Flexeril 5mg TID PRN; if more relief needed, 1x toradol would be appropriate as kidney function stable. Pressure sore; Present under tracheostomy site. No signs of infection on exam. Foam pad, antibiotic ointment may benefit from barrier ointment ie Aquafor or similar if continues to be irritated; GERD; Protonix; Asthma  Albuterol PRN; OAB Oxybutynin; Schizophrenia Prozac; Latuda 40 mg; Hypertension; Currently poorly controlled.  25 mg of Hydralazine daily; Increase lisinopril to 20mg BID; DM2 Poorly controlled and on Dexamethasone Currently on 36 units glargine nightly and high dose corrective q4 hours. On tube feeds 1600-1000. Continue CSI very high dose; increase glargine to 40 units nightly; CKD 3; Baseline around 1.3; CMP daily; Suspected Maltreatment Patient and care give giver report mistreatment from Mission Point; DISPO: COVID treatment with decadron and remdesivir. Placement difficult. Code Status: Full code; Diet: PEG; DVT ppx: Lovenox 40 mg BID.
This spontaneous report was received from a pharmacist regarding a 66 year old female patient. Concomitantly Patient was taking blood pressure and blood glucose medications for blood pressure and blood sugar. On 22-JUN-2017 the patient was vaccinated with PNEUMOVAX 23 once, lot # N010105, expiration date- 15-NOV-2018, dose- 0.65 ml, intramuscular in the left deltoid for prophylaxis. On the beginning of 22-JUN-2017, the patients arm was very swollen and red and warm to the touch, and got worse the morning on 23-JUN-2017 and now the swelling was human head sized and she also had fever. The outcome of swelling, redness and fever was reported as ongoing and was not resolved. Causality between swelling, redness and fever was unknown.       Additional information has been requested.
Sunday December 19 husband and kids started getting sick, kids tested negative Tuesday 12/21 in AM for flu & Covid, husband tested positive for tuesday afternoon - was told to assume everyone in the house is positive.   Thursday 12/23 woke up with a sore throat and coughing, as day progressed got worse, friday 12/24 started having the sweats/chills. Saturday 12/25 - extreme joint & muscle pain - couldn't bend certain fingers due to pain, nausea and exhaustion along with the sore throat & coughing.. Sunday 12/26 - started losing sense of taste and some sense of smell. Monday 12/27 - no improvement.
This spontaneous report as received from a Licensed Vocational Nurse refers to a patient of unknown age. The nurse noted the patient was inadvertently administered a dose of VARIVAX (Merck) (lot # and dose not reported) subcutaneously instead of ZOSTAVAX on 14-JUN-2013. No adverse effect was reported. At the time of reporting, the patient had no known adverse effect. Additional information has been requested.
Patient reported an initial lump at the injection site of Prevnar-13 in her left deltoid, then a spreading red, not raised rash that felt hot and itchy. The rash covered a large area around the injection site.  She did not experience a fever or any other systemic symptoms.  By 10/6/15 the rash had receded and improved but was still visible.  She did not seek any medical attention but took oral acetaminophen for pain.
Severe Arm Pain; Severe Itching; Severe Body Aches; 101.9F fever; Severe Headache; Nausea; Vomiting; Redness at injection site 6 cm in diameter; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Severe Arm Pain), VACCINATION SITE PRURITUS (Severe Itching), MYALGIA (Severe Body Aches), PYREXIA (101.9F fever) and HEADACHE (Severe Headache) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced PAIN IN EXTREMITY (Severe Arm Pain), VACCINATION SITE PRURITUS (Severe Itching), MYALGIA (Severe Body Aches), PYREXIA (101.9F fever), HEADACHE (Severe Headache), NAUSEA (Nausea), VOMITING (Vomiting) and VACCINATION SITE ERYTHEMA (Redness at injection site 6 cm in diameter). The patient was treated with HYDROCODONE at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Severe Arm Pain), VACCINATION SITE PRURITUS (Severe Itching), MYALGIA (Severe Body Aches), PYREXIA (101.9F fever), HEADACHE (Severe Headache), NAUSEA (Nausea), VOMITING (Vomiting) and VACCINATION SITE ERYTHEMA (Redness at injection site 6 cm in diameter) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment also includes a Antibiotic   Reporter did not allow further contact
injection site sore; This case was reported by a consumer and described the occurrence of injection site pain in a 57-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th March 2022, the patient received the 1st dose of Shingrix. In March 2022, less than a week after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The case was self-reported by the patient. The age at vaccination was unknown. The patient received first dose of Shingrix vaccine on 14th March 2022 which was administered by the physician. After 2 days, the patient contacted doctor and asked how long the injection site would be sore. The patient's physician told there might be pain for 1-2 weeks. This case was linked with US2022AMR048529, reported by same reporter for different patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR048529:Same reporter. Hearsay case
w/in 24hr arm felt like boil entire upper arm red swollen et edema for 4 days w/gradual subsiding w/no tx;
Mom stated child broke out with hives all over body the night after #1 hepatitis A. Mom couldn't remember time interval. Was seen by PA at clinic. Treatment for 3 days (doesn't remember name of medicine).
No other AE; temperature excursion on VARIVAX; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.   On 12-AUG-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) for prophylaxis (dose, vaccination scheme frequency, route of administration and anatomical site of vaccination were not reported).  The following lot numbers were involved in the temperature excursion: U002398 (expiration date 22-JAN-2023), T041687 (expiration date 10-DEC-2022), T035399 (expiration date 16-OCT-2022), T028304 (expiration date 20-AUG-2022) and S036637 (expiration date 14-NOV-2021).  The vaccine was stored in a temperature of 7.3 degree Fahrenheit (°F) for 20 minutes. There was a previous temperature excursion reported (details not provided).  This is one of several reports received from the same reporter.
On 10/26/2018, I awoke with severe lower back pain. Over the next days I lost left patellar reflex, and then weakening of left quadriceps and left adductor muscles; MRI negative and Nerve conduction and EMG shoed Lumbosacral plexopathy. Over next 5 weeks continued pain although less severe but progressed to pain in left thigh. Weakness worsened and placed on decahedron one week with less pain and more strength. Tapered off decahedron and pain and weakness reoccurred with pain less but weakness same. Now at the lebel with loss of 3 cm circumference left thigh. Had multiple tests various autoimmune, HIV, RPR hepatitis and HIGV all negative. I believe DR may also have filed a report to this VAERS. I have kept a daily chart of symptoms, too lengthy of this report but available. I am also a physician.
temp to 106-sz (eyes deviated to left) unresponsive 2 episodes-ER visit x 2-finally stayed overnoc;blood UA done-no source identified;
10 to 12 days after vaccination, I started to break out with Hives. This is ongoing and has become chronic. I have never had any allergic reactions to any vaccinations. No allergies. I was also administered the Flu shot the same day in the opposite arm. I had informed the nurse that I had an infection of Covid that tested positive for 10 days on June 3 2022. The hives would break out after the consumption of food within 45mins. There is no breakout after consuming black coffee. I have been on 2 medications x 2 a day, cetrizine, famotidine, since the breakout occurred to prevent reoccurence of hives on a daily basis.
PCR 03Jan2022; Result: Positive; PCR 03Jan2022; Result: Positive; booster; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  An adult female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administration date 14Dec2021 (Lot number: FF2589) as dose 3 (booster), single, administration date 15Mar2021 (Lot number: EL3247) as dose 2, single and administration date 22Feb2021 (Lot number: EL3247) 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: IMMUNISATION (medically significant) with onset 14Dec2021, outcome "unknown", described as "booster"; VACCINATION FAILURE (medically significant) with onset 29Dec2021, outcome "unknown", COVID-19 (medically significant) with onset 29Dec2021, outcome "recovered" and all described as "PCR 03Jan2022; Result: Positive". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (03Jan2022) positive, notes: PCR. It was unknown if therapeutic measures were taken as a result of covid-19. Additional information:  It is unknown if the patient receive any other vaccines within 4 weeks prior to the COVID vaccine.  The patient experienced slight cough and congestion 29Dec2021 after exposure to infected cousin. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19. No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events Booster, Vaccination failure, and COVID-19 cannot be totally excluded.  The case will be reassessed if additional information becomes available.
I received my flu shot in my upper left arm on Oct 19th. Approximately 2 weeks later, I experienced tremendous soreness and lack of mobility in that arm. Almost impossible to take a shirt on or off.
I passed out, fell to floor and was unresponsive for multiple minutes; fell to floor; Momentary feeling of nausea and lightheadedness before passing out; Momentary feeling of nausea and lightheadedness before passing out; mild sore arm; This is a spontaneous report from a contactable consumer reporting for himself. A 52-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EN6198/expiration date: not provided), via an unspecified route of administration, on 10Mar2021 at 14:00 (as a single dose in the right arm for COVID-19 IMMUNIZATION. The patient had known allergies to statins and aspirin. The patient had no other medical history. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication (other medications taken in two weeks) were none.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 10Mar2021, the patient experienced a mild sore arm. On 13Mar2021 at 17:30, the patient experienced nausea and lightheadedness before passing out. The clinical course was as follows: On 10Mar2021 afternoon, the patient received the first dose of COVID-19 vaccine. No overt signs of illness or other symptoms beyond mild sore arm. On 13Mar2021, in the afternoon, the patient passed out, fell to floor and was unresponsive for multiple minutes. Momentary feeling of nausea and lightheadedness before passing out. No other signs of illness at time. Paramedics and subsequence ER visit did not find any signs of physical symptoms that would have attributed to syncope. Lightheadedness lasted for awhile and was still occurring on and off during ER visit. The adverse events resulted in a doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. The patient did not receive any treatment for these events. The outcome of the events mild sore arm, passed out, nausea and lightheadedness was recovered on an unspecified date in Mar2021. Since the vaccination, the patient had not been tested for COVID-19.
pt recv vax & devel vesicular lesions on hands (same side as inj site);following morning devel lesions on the other hand as well;lesions appeared w/in 24hr p/vax;
Initial and follow up information have been received from a doctor of osteopathic and a medical assistant concerning a 24 year old female with no pertinent medical history and no drug reactions or allergies who on 05-MAY-2011 was vaccinated IM into right arm with the first dose of 0.5 ml GARDASIL (lot # 668554/0306AA, expiration date 10-MAY-2013). There was no concomitant vaccinations. On 05-MAY-2011 the patient developed muscle pain in both legs which became "tingling and numb" which progressed to both arms. The patient became flushed and dizzy and the physician laid the patient down. The patient was monitored for 40 minutes and stated she felt "like she was floating in air". The physician called for an ambulance and had her transported to the emergency room of a hospital. The hospital did blood work (result unknown), administered IV fluids and the patient recovered within 4 to 5 hours afterwards on the same day. The physician reported that the patient had not eaten and had drunk coffee with 4 espresso shots. The patient was referred to a neurologist for follow-up. Additional information has been requested.