chrisvoncsefalvay/vaers-outcomes huggingface dataset:
He has a spreading, nonitchy blanching urticaria / morbiliform rash on his upper body after receiving a shingles vaccine yesterday morning and amoxicillin for a root canal on Monday. The rash was located on the left arm, right arm flexural surface, neck, left midaxillary area just posterior to the spleen, and anterior bilateral ribcage area. It is tender to palpation on the left upper extremity. He first noticed a 5 x 5 cm expanse of redness on his left arm a few cm below where his shot was administered this morning. This has now expanded to include the rest of his arm above his left neck and then parts of his right arm, chest, as well as back. It is beginning to become itchy on his back. The focus on his left arm is tender at rest and with palpation, 3 to 6 out of 10. His lower extremities or mucosal surfaces do not have the rash. He has received the ZOSTAVAX vaccine before without any issues. He also had taken amoxicillin several times many years back without any issues. He endorses feeling colder since yesterday, but otherwise denies any systemic symptoms including shortness of breath, throat pain, headache, vision changes, muscular pain, joint pain, fever, abdominal pain, hematuria, or bowel changes. He has never had any skin rashes before this.
A physician reported that a 2-month-old male received Prevnar, Tripedia, ActHIB and IPV vaccines on 27-SEP-2001. That same day, the infant had a 4 to 5 hour episode of "non-stop" crying. He also developed fussiness lasting "all night long". The infant was "better" the next day. This is 1 of 4 patients from this facility who had an adverse experience following receipt of Prevnar lot 481-817. Information regarding this event has been forwarded to the manufacturer of the concomitant vaccines.
PATIENT CAME TO THE PHARMACY ON 4/24/22 TO REPORT A WIDE-SPREAD RASH THAT BEGAN 1-2 DAYS AFTER HER 4TH PFIZER COVID VACCINE (2ND BOOSTER).  SHE DID NOT HAVE ANY ISSUES WITH THE PRIOR 3 VACCINES. SHE HAS ALREADY GONE TO THE DR AND RECEIVED 2 KENALOG SHOTS, HYDROXYZINE FOR ITCHING, AND IS ON DAY 4 OF A 12 DAY ORAL PREDNISONE TAPER. SHE HADN'T CONNECTED THE DOTS THAT THE RASH COULD HAVE BEEN FROM HER VACCINE UNTIL TODAY, SO WHEN SHE SAW HER DR, THEY DID NOT KNOW THE CAUSE. SHE WILL BE REACHING OUT TO THEM TO FOLLOW-UP IF THE RASH DOES NOT IMPROVE AND TO LET THEM KNOW THE LINK BETWEEN THE VACCINE TIMING AND THE RASH BEGINING. SHE SAID THE RASH IS ALL OVER HER BODY AND IS EXTREMELY ITCHY. IT ONLY STARTED GETTING BETTER A FEW DAYS AGO, BUT SHE IS STILL SUFFERING. I ADVISED HER TO NOT RECEIVE ANY MORE COVID VACCINES UNTIL SHE GETS CLEARANCE FROM HER PROVIDER
Shingles 2nd shot--Had chills and inflammation and pain in left arm injection site .  On day after immunization.  Chills lasted 1 day and left arm pain and inflammation 6 days
The night of the shots on 10/7/14 (flu and pneumonia shot in same arm)I had minor swelling and pain. I figured it was normal after two injections in the same arm. On 10/8/14 my arm was very red and swollen and sore and hot. The swelling was getting larger on 10/9 & 10/10 and very hot and sore/itchy. I contacted my primary cares office and they told me it was probably normal and to see them over the weekend at urgent care if needed. On the evening of 10/10 my chest felt tight and I was very achy and my arm was very hot and red and swollen. I was brought to the hospital around 10-11 pm for what I thought was a reaction. I was told I had a bacterial infection called cellulitis and was put on Doxycycline. I was released from the hospital around 5:30 am on 10/11 and was told to go back if the infection spread past the line they drew on me. I have not gone back but am watching it carefully, the infection is still there but not getting any larger at this time.
Approximately 20 minutes after receiving the influenza vaccine, patient began feeling swelling in her throat. She received a dose of an EPIPEN and was instructed to go to the ER. She waited and received a 2nd dose of the EPIPEN then went to the ED for further evaluation.
Several hours after vaccine developed a headache which then progressed in to "joint pain all over". "Every joint in my body hurt." Increased fluids and took Ibuprofen. Laid in bed".  Even the sheet touching my body hurt". Could not sleep related to discomfort. Called off work next day. Finally slept about 0700. Slept most of the day. Took more Ibuprofen. Upon awakening around 3 PM, felt better. Joints were stiff but he could move much better. By evening, symptoms resolved. There has been no reoccurrence.
Presented to ED w/gen weakness, diaphoresis and decreased responsiveness; reported recent diagnosis of COVID prior to arrival; pt admitted for COVID0-19 infection; tx w/ abx, Vit C, steroids; did not require O2 therapy; dc'd to home
Case number PHEH2016US023350, is an initial spontaneous report received from a nurse on 13 Sep 2016. This report refers to a 29 years old patient of unknown gender. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1515701) at a dose of 0.5 ml, intramuscularly, in right arm on 01 Dec 2015. On 01 Dec 2015, FLUVIRIN MDV that had been exposed to 8 to 10 temperature excursions was administered to patient. The nurse stated that, no adverse event was reported following this administration error.
Sore, reclarified as left arm after the first and second vaccine; Fell and had knee pain, after first vaccine; Fell and had knee pain, after first vaccine; This is a spontaneous report from a contactable consumer (patient herself). A 60-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: ER8729; Expiration date: unknown) via an unspecified route of administration, administered in Arm Left on 11Apr2021 17:45 (at the age of 60-years-old) as DOSE 1, SINGLE for COVID-19 immunization. Medical history included ongoing glucose tolerance impaired; pre-diabetic, ongoing blood cholesterol increased; high cholesterol caller stated at about the same time as diagnosed with prediabetes. Concomitant medications included naproxen (NAPROXEN) taken for arthralgia from an unspecified start date to 10May2021; valaciclovir hydrochloride (VALACYCLOVIR HCL) taken for herpes zoster from 12May2021 and ongoing. Patient had not family medical history relevant to AE(s). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced fell and had knee pain, after first vaccine on 19Apr2021. Later on patient experienced sore, reclarified as left arm after the first and second vaccine. AEs (fell and had knee pain, after first vaccine) resulted in physician office visit as caller had a video appointment with her doctor. AEs did not require emergency room. Therapeutic measures were taken as a result of fell and had knee pain, after first vaccine. Caller confirmed that the Motrin was effective for the knee pain. Caller stated that the Naproxen helped to lessen the knee pain. Caller stated she went to the Urgent Care, for the knee pain, and they gave her Naproxen. The patient underwent lab tests and procedures which included blood glucose: normal on an unspecified date. The outcome of all events was resolved on an unspecified date in 2021.  Follow-up (28Jun2021): Follow-up attempts completed. No further information expected.
My 15 year old daughter received the first GARDASIL vaccine at about 1:30 pm on 12/9/14. By 5 pm she had a fever over 100 degrees and was dizzy, had trouble seeing and a severe headache. I had her eat some soup, take some MOTRIN and rest. At 5:30 am on 12/10, her fever had returned, and she still had a bad headache and only slight dizziness. I have kept her out of school for the day and am monitoring her symptoms. Upon calling her pediatrician's office, I was informed that they have never seen these side effects and she probably just has a virus that came on at the same time.
Head ache and low grade fever progressed to shaking (not chills) a 102 degree fever with Tylenol extra strength.  Persistent with night sweats  through 2.5 days.
Swelling and redness at inject site. 5 x 5 cm Benadryl 12.5 mg after 6 hrs.
itching; big red blotch on the injection site that is little sore; red blotch on the injection site that is little sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itching), VACCINATION SITE ERYTHEMA (big red blotch on the injection site that is little sore) and VACCINATION SITE PAIN (red blotch on the injection site that is little sore) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     The patient's past medical history included Lymphadenectomy (left arm, some lymph nodes removed).    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (itching), VACCINATION SITE ERYTHEMA (big red blotch on the injection site that is little sore) and VACCINATION SITE PAIN (red blotch on the injection site that is little sore). At the time of the report, VACCINATION SITE PRURITUS (itching) and VACCINATION SITE ERYTHEMA (big red blotch on the injection site that is little sore) had not resolved and VACCINATION SITE PAIN (red blotch on the injection site that is little sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were provided No Treatment information provided
PATIENT RECEIVED VACCINE FROM OUTSIDE SOURCE CHRONIC HYPERCAPNIC RESPIRATORY FAILURE HYPERCAPNIC RESPIRATORY FAILURE, UNSPECIFIED ACUITY  4/22/2022,  5/31/2022,  6/21/2022,   7/12/2022 --  RECURRENCE OF SAME SYMPTOMS
Approximately 15 minutes after injection, patient reported nausea/vomiting, difficulty breathing, being clammy and having numbness/tingling in the L side of face and L arm.  Cold packs were applied, BP 165/104 obtained at that time, O2 sats 99% on RA.  O2 via facemask applied.  Sats continued in upper 90's throughout event.  Rapid response called at onset of symptoms.  They connected to monitor upon arrival.  HR maintained 70's-80's throughout event.  At 2304 BP 165/102, HR 85, patient reported feeling better.  At 1108, BP was 159/100.  Patient reported feeling well enough to go home at that time and did so.
This spontaneous report as received from a pharmacist refers to a 66 year old male patient. On 04-APR-2014 the patient was vaccinated with PNEUMOVAX 23 (lot # H012972, expiration date: 09-MAR-2014), 0.5 ml, intramuscular in the right deltoid for an unknown indication. No adverse effects reported. Additional information has been requested.
No true adverse event product was sent short dated from the manufacturer.  Expiration date of the LOT was 09/30/22 but Pfizer determined that the stability data supported immunization with this lot through 10/19/22 and we were instructed that re immunization was not recommended or needed.
22 weeks pregnant (due in May). First side effects I noticed were sore arm, then I had a brief bout of chills. Been very achy today.
extreme muscle fatigue, delirium, fever lasting approx 36hr;MD-self medicated;
EXPIRED VACCINE ADMINISTERED; This spontaneous report received from a consumer concerned a 40 year old of unspecified sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 201A21A expiry: 21-SEP-2021) dose was not reported, administered on 24-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-SEP-2021, the patient experienced expired vaccine administered. The action taken with covid-19 vaccine  was not applicable. The outcome of expired vaccine administered was not reported. This report was non-serious. This case, from the same reporter is linked to 20211132288, 20211132362, 20211132383 and 20211132415.
Information has been received from an LPN concerning a 6 year old pediatric male pt with a history of tonsillectomy, adenoidectomy and no known allergies who in 2001 (initially reported as "6/8/01") was vaccinated with varicella virus vaccine live (dosage and lot number not provided). On 5/10/01, the pt presented to his physician's office with symptoms described as "multiple red, itchy, blisters, some crusted over red base, on face, and one on the trunk". The child had no fever. On follow-up, it was reported by the LPN that on an initial office visit on 5/9/01 as a new pediatric pt, the child's mother had reported that the child had been vaccinated at another unspecified physician's office on 6/8/98 with (1st dose) of varicella virus vaccine live (dosage and lot number not provided). The pt had presented to his current physician's office with symptoms described as "multiple red, itchy, blisters, some crusted over red base, on face and one on the trunk". The child had no fever. Subsequently, the pt was dx'd with varicella. No further information was available.
I have an appointment with an ENT next Monday. The ringing is non-stop. I have to sleep with noise at night so that I can get to sleep.
Body aches, joint aches, severe chills, fever with temperature up to 104.8, headache, nausea, vomiting, loss of appetite, fatigue, brain fog
My husband was having shortness of breath and we thought he was having heart problems. He was put on a blood thinner right away because they discovered blood clots in his lungs it in ER, for a week I gave him shots in his stomach, and he has been on Pradaxa 150 mg twice daily.
Excruciating headache, nausea and body aches onset at noon. Worsened throughout day. Developed fever, fatigue, tachycardia and vomiting that night. Nausea/vomiting uncontrolled with ZOFRAN. Headache and body aches uncontrolled with ibuprofen and TYLENOL. Symptoms lasted until 8pm on 10/13/16, then slowly improved. 10/14/16- nausea and headache remained, though mild.
Patient became pale, light headed and diaphoretic after vaccine. Stable in less than 20 min.
At the end of August, I broke out in welts. It started on my legs. Then it moved to the left side of my torso and some in my arms and elbows. I went to the doctor and she thought it was a skin infection. We started to treat that with an antibiotic ointment. It would just stay the same. About 4 or 5 days she prescribed an oral antibiotic. She thinks I had an allergic reaction to the antibiotic, so she prescribed an oral steroid and it was an immediate relief. Everything started to clear out.
muscle weakness; This case was reported by a consumer via interactive digital media and described the occurrence of muscle weakness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. In July 2022, unknown after receiving Shingles vaccine, the patient experienced muscle weakness. On an unknown date, the outcome of the muscle weakness was unknown.   It was unknown if the reporter considered the muscle weakness to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 27-July-2022 Reporter's Comments: The patient self-reported this case via interactive digital media. The follow-up would not possible, as no contact, details were available.
Headache; Chills; Fatigue; Malaise; This is a spontaneous report from a contactable nurse. A 25-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 10May2021 at 18:00 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. The patient's medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 11May2021, the patient experienced headache, chills, fatigue and malaise. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the reported adverse events and included treatment with ibuprofen. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event headache, chills, fatigue and malaise was unknown at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Upper back pain extending to the breast area. Diagnosed as Chest Wall Strain.  Minor pain leading up to March 8, 2021 becoming unbearable around March 11, 2021. Visited Hospital Emergency Room on the 12th of March, chest Wall pain identified as the problem. Visited primary doctor, after examination and was prescribed, cyclobenzaprine 10mg, gabapentin 100mg, ibuprofen 800mg, and tramadol 50mg. Did not have any pain while sleeping. Pain would return after waking up. The pain has persisted up to this day, April 13, 2021.  Acupuncture has been recommended and is scheduled for April 14, 2021. The prescriptions prescribed up to this point has not help.
First day fatigue. 2nd day more fatigue. Wake up to pain of injection site. 3rd Day Injection site hard, red,  swollen and feels like slight burning sensation. Hot to touch. Area about the size of the palm of my hand. Neck on side of injection is getting stiff an discomfort in upper back on side of injection. Getting worse not better.
arm was sore on Sunday; swollen lymph nodes on the left arm; This is a spontaneous report from a contactable consumer and from a sponsored program Support. This 45-year-old female Consumer reported for herself that she received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 08Aug2021 as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient had previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 18Jul2021 (at the age of 45-years-old) as DOSE 1, SINGLE for COVID-19 immunization. On 09Aug2021 after the second dose of vaccination, the patient experienced swollen lymph nodes on the left arm and on an unspecified date arm was sore on Sunday. It was reported that after got second dose of vaccine, patient was experienced swollen lymph nodes on the left arm (side of injection) that began yesterday and became worse last night. Patient also reported that her arm was sore on Sunday.  Her question was, was that normal because she needs to know if she needs to go to urgent care.  After information provided, patient stated that she will watch and if it did get better, she will reach out to her Healthcare Professional. Patient asked if she can took Tylenol for her symptoms. Patient provided PMI number and HOO. While talking to the agent and providing the caller's demographics, the call got disconnected. Created AE form. The outcome of events were unknown.  Unknown if reporter was a Healthcare Professional (HCP). Unknown if reporter's contact information available to you or a sub-contracted party. The reporter was not the prescribing Healthcare professional Medical Information: Yes, Customer and/or medical inquiry forwarded or referred to   Information on the lot/batch number has been requested.
Patient reported prior to getting vaccinated that the last time she had these vaccines (10AUG2017) she had an anaphylactic reaction 24 hours after. Pt states that she saw an allergist and was tested for food allergies. Pt states all allergy tests came back negative, but the doctor was doubtful that the reaction was caused by the MMR and Varicella vaccinations that she received because the reaction was so delayed. Upon hearing this from the patient I told her that she needed to sit in the lobby for 30 minutes after vaccine was administered. The vaccine was given at 0928. At 1000, she reported feeling itchiness in her throat. Patient was coughing mildly. Patient's voice was getting hoarse. Patient was brought to the acute care area. Patient started to cough more, and was complaining of more itchiness and feeling more constricted. Patient's voice was very hoarse at this point. Duty RN approved the administration of auto-inject epinephrine. The EPIPEN was administered by myself at 1010. Emergency services were called so that she could be transported via ambulance to the emergency room. Paramedics arrived and approved administration of 1ML of 50 MG BENADRYL, which was administered by myself at 1020 in the left arm IM deltoid. Patient was then turned over to the paramedics for transport.
This is in follow-up to report(s) previously submitted on 7/16/2007. Initial and follow-up information has been received from a medical assistant concerning a 25 year old female with drug hypersensitivity to KETEK and latex allergy and a history of hypoglycaemia, anxiety, panic attacks and a syncopal attack who on 21-MAY-2007 at 9:00 am, was vaccinated IM in the left upper quadrant of the buttocks with her first dose of 0.5 ml of GARDASIL (Lot # 655617/1447F). Illness at the time of vaccine was stress. Concomitant therapy included LEXAPRO, hormonal contraceptives (unspecified) and NASACORT AQ. On 21-MAY-2007 at 09:00 am, the patient complained of burning at injection site for a couple of minutes. Subsequently, the burning resolved on its own. No laboratory or diagnostic tests were performed. Additional information is not expected.
The lymphnodes in my left armpit are swollen and tender; The lymphnodes in my left armpit are swollen and tender; This is a spontaneous report from a contactable consumer (patient).  This 36-year-old female patient (not pregnant) received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL3302), via an unknown route, on 21Jan2021 (at 07:30 AM) at single dose on the left arm, for COVID-19 immunisation. No relevant medical history and concomitant medications were provided. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EL1284) administered on 31Dec2020 (at 06:45 AM) on the left arm. The patient was vaccinated at hospital, age at vaccination was 36-year-old. No other vaccine was received in four weeks. Pre-vaccination and post-vaccination COVID tests were not performed. No known allergies. On 22Jan2021 (at 06:00 AM), the patient stated 'the lymphnodes in my left armpit are swollen and tender'. The events were assessed as non-serious. No treatments were given for the events. The patient had not recovered from the events.
Information has been received from a healthcare professional referring to a 49 year old male patient. The patients' pertinent medical history and drug allergies were not reported. On 26-JUN-2015 the patient was vaccinated with the first dose of RECOMBIVAX HB 10/1.0 mcg/ml (lot#, dose, strength and route unknown). On 09-DEC-2015 the patient was vaccinated with the second dose of RECOMBIVAX HB 10/1.0 mcg/ml (lot # L026598 with expiration date of 26-JUN-2017, 1.0 ml, intramuscular). No adverse events were reported. Additional information has been requested.
I noticed my facial nerves are sensitive when eating/ chewing or lick lips, I can feel my facial nerves as though something is rubbing up along my jaw up to eyes and temple area, or if I scratch my nose depending which side I feel as though something is rubbing just under my bottoms eye lid.  I never felt this prior to the vaccine. Please help and direct me in the right direction in getting this reaction cleared up. Thank you