chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt put in complaint that she had SIRVA after getting covid shot from the pharmacy way back in 11/01/2021. I called her and followed up with her to get her side of the story on 05/10/2022. Pt says that the Covid vaccine was administered high up in the arm and she had pain from the administration since then. She went to her PCP in March 2022 after the pain became unbearable and then was referred to Orthopedics. When MRI was done on the arm it was found that the pain was due to incorrect administration of the vaccine. She said that there was a small pocket of fluid that built up in the location where the vaccine was administered. Pt said that she is currently scheduled to go thru PT to help her with the pain.
A large ( 2 in x 3 in) red spot with itching and tenderness  on my arm at the site of the injection.  It appeared approximately 4 days ago and is still present.
Arm swollen, red, hot to the touch, sore like I was socked in the arm, itchy.
PVCs; junctional rhythm; irregular heartbeat/ mix of normal rhythm along with PVCs; hypoxia/ pulse ox was 80; blue lips; near syncope; feeling of being unwell; lightheadedness; tingling and numbness from mid-calf down to feet; tingling and numbness from mid-calf down to feet; sudden and intense sensation of GI distress; severe outbreak of intense sweating on forehead and back of neck; bradycardia/ low heart rate/ HR was 49/ HR was 40/ HR was 35; bruising; swelling at injection site; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 18Apr2021 15:00 (Batch/Lot Number: ER8731) at the age of 45 years old as 1st dose, single dose for COVID-19 immunization. Medical history included allergic to scallions. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications (medications the patient received within 2 weeks of vaccination) included possible dose or two of either ibuprofen (ADVIL) and paracetamol (TYLENOL), taken for unspecified indication, start and stop date not reported. COVID-19 vaccine was administered in the hospital. On 18Apr2021 (7-8 minutes after shot), the patient experienced sudden and intense sensation of gastrointestinal (GI) distress, overtaken by severe outbreak of intense sweating on forehead and back of neck. Alerted the staff member who took blood pressure and heart rate. Staff member said blood pressure was perfect, heart rate (HR) was 49. The patient stayed an extra 15 minutes. At the end of that period, blood pressure was 121/81 and HR was 40. On Days 2 to 7 (Apr2021), no symptoms other than bruising and swelling at injection site. On 26Apr2021 (Day 8) around 11:00, the patient was near syncope; there was sudden, intense feeling of being unwell and lightheadedness (was sitting at computer desk). Checked vitals. HR was 35, and pulse ox was 80 on home pulse oximeter device. Also experienced hypoxia, blue lips, tingling and numbness from mid-calf down to feet. On 27Apr2021 (Day 9), the physician confirmed irregular heartbeat, low heart rate and ordered heart monitor and bloodwork. On 03May2021 (Day 15), heart monitor results: mix of normal rhythm along with premature ventricular contractions (PVCs), bradycardia, and junctional rhythm. Since the vaccination, the patient been tested for COVID-19 with polymerase chain reaction (PCR): negative (Nasal Swab) on 01May2021. Adverse events resulted in Doctor or other healthcare professional office/clinic visit. Treatment received included physician and cardiologist visit and echocardiogram. Therapeutic measures were taken as a result of the events. Outcome of the events were recovered with sequelae.  Additional information about batch/lot number has been requested.
The patient now suffer from Guillain barrer syndrome; The patient now suffer from  POTS; The patient now suffer from  brain fog; The patient already had HPV was vaccinated with Gardasil; This spontaneous report was received from a 42-year-old male patient reporting on himself. The patient's  drug reactions or allergies, pertinent medical history and concomitant therapy were not reported.      On unknown date, the patient already had Human papillomavirus infection. On an unknown date, the patient was vaccinated with a dose of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) for prophylaxis (dose, lot #, expiration date and route were not reported) (product use issue).         On an unknown date, the patient experienced guillain-barre syndrome, brain fog (mental disorder), and postural orthostatic tachycardia syndrome (POTS).     At the time of the report, action taken regarding therapy with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL), The outcome of the events and the relationship between the events and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine(GARDASIL) were not reported.  Upon internal review, guillain-barre syndrome was determined to be medically significant.; Sender Comments.
This spontaneous report as received from a pharmacist refers to a 72 years old female patient with no pertinent medical history and no known drug reactions/allergies. The patient was vaccinated subcutaneously with a single dose of ZOSTAVAX, lot # (671901/0421AE), on 20-OCT-2012. No other co-suspects were reported. No concomitant medications were reported. On 21-OCT-2012 the patient developed a reddened area with a central vesicle on the left side of her back. The patient sought medical attention. No laboratory tests were performed. The patient was prescribed valacyclovir as treatment by an unspecified physician. At the time of reporting the patient had not recovered from the events. Relatedness was not provided. Additional information has been requested.
48 hours after receiving Intradermal FLUZONE pt noted blisters between all fingers on both hands also blisters noted on top of hands. Small in size with a burning feeling when touched. Rx for: Prednisone 50 mg sent 12-20-12.
This spontaneous report was received from a Pharmacist referring to an infant male patient of unspecified age. The patient's concurrent conditions and medical history were not reported. There was no concomitant medication reported. On an unknown date, the patient was vaccinated with a dose of unspecified bcg live (manufacturer unknown) (administered in an unspecified country) (dose, route, anatomical location, lot number and expiration date were not reported) for prophylaxis. Subsequently, on an unknown date, the patient was hospitalized to receive treatment at specific hospital with "disseminated disease". Routine lab work was performed but the results were not provided. At the reporting time, the patient was currently hospitalized. The outcome of the adverse event was reported as not recovered. The causality assessment was not provided.
did flu shot a week ago, it felt like someone punched me in the arm afterward for several days; Initial information received on 18-Oct-2023 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-hcp.  This case involves a patient of an unknown age and gender who received Influenza Vaccine shot a week ago, it felt like someone punched me in the arm afterward for several days.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was unknown if the patient had any concomitant disease or risk factor.   On an unknown date, the patient received a unknown dose of suspect Influenza Vaccine produced by unknown manufacturer (strength, formulation, expiry date and lot number not reported) via unknown route in unknown administration site as Prophylactic vaccination (immunization). Information on the batch number was requested.  On an unknown date the patient did flu shot a week ago, it felt like someone punched me in the arm afterward for several days (vaccination site pain) (unknown latency). It is unknown if the patient experienced any additional symptoms/events.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
This case was reported by a healthcare professional and described the occurrence of arm swelling in a child subject of unspecified gender who was vaccinated with KINRIX (GlaxoSmithKline).  Previous and/or concurrent vaccination included live attenuated measles, mumps (strain not specified), rubella vaccine;  manufacturer unspecified given on the same unspecified date as KINRIX;  measles and varicella virus vaccine;  manufacturer unspecified given on the same unspecified date as KINRIX.  On an unspecified date the subject received 1st dose of KINRIX (unknown).  At an unspecified time after vaccination with KINRIX, the subject experienced arm swelling.  A sales representative reported that a public health nurse stated that she gave ten doses of KINRIX and out of these doses, seven children on their parents reported significant swelling in the arm where they were injected.  All of the children were within the four to six years age range.  She stated that she gave KINRIX on one arm and a MMR vaccine and Varicella vaccine on the other arm.  Please see A0780875A, A0780876A, A0780877A, A0780878A,  A0780879A for the six additional cases reported by the nurse.  At the time of reporting the event was resolved.  The healthcare professional considered the event was probably related to vaccination with KINRIX.
This case was reported by a healthcare professional (nurse) via sales representative and described the occurrence of injection site pain in a 59-year-old female subject who was vaccinated with FLUARIX (GlaxoSmithKline). In October 2013 the subject received a dose of FLUARIX (.5 ml, unknown details, right arm). In October 2013, less then one day after vaccination with FLUARIX, the subject experienced injection site pain. At the time of reporting the event was unresolved. Per the nurse, the subject received "the injection about 4 weeks ago and the pain is still unresolved." Per the nurse, "on a scale of 1 to 10, it [the pain] is about 5." The healthcare professional considered the event was probably related to vaccination with FLUARIX 2013-14.
Trembling/shaking (seizure). Unresponsive. Open/big, wide eyes. Drooling. Pale.
Hospitalization / +SARS on 08/04/2022 No s/s found in notes. SARS ordered for discharge.
I have osteoarthritis, with Heberden's nodes on all of my fingers.   3 days ago the two nodes on the most affected finger (and the first that showed the arthritis) turned bright red.  Now the whole joint is red and a few of the other nodes have turned red.    Except for binding the first finger with the hope it would help (it didn't), I'm not treating them, since of course one can't do anything about osteoarthritis except ease the pain.
patient was due for DTap and HIB vaccines and was inadvertently administered Kinrix; 15 months old received Kinrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 15-month-old female patient who received DTPa-IPV (Kinrix) for prophylaxis.   On 01-MAY-2023, the patient received Kinrix. On 01-MAY-2023, an unknown time after receiving Kinrix, the patient experienced wrong vaccine administered (Verbatim: patient was due for DTap and HIB vaccines and was inadvertently administered Kinrix) and inappropriate age at vaccine administration (Verbatim: 15 months old received Kinrix). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 02-MAY-2023 The vaccine administration facility was the same as primary reporter. The reporter consented to follow up via postal. The reporter did not have the lot or expiry date at time of call.  A 15-month old patient was due for DTap and HIB vaccines and was inadvertently administered Kinrix, which led to wrong vaccine administered and inappropriate age at vaccine administration.
pt recv vax 21JAN98 & devel erythema, swelling on 23JAN97 given Keflex;sx resolved almost entirely by 26JAN98;
Shingles; Rashes; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles) and RASH (Rashes) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthma, Allergy to molds, Dust allergy (Dust mites), Allergy to animals (allergy to cats), Allergy to animals (Allergy to dogs), Pollen allergy and Seasonal allergy.   On 26-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced HERPES ZOSTER (Shingles) and RASH (Rashes). At the time of the report, HERPES ZOSTER (Shingles) and RASH (Rashes) had not resolved.            Patient reported to allergy to mildew.  No concomitant medications were reported. no treatment medications were reported.
Information has been received from a nurse concerning a female (age unknown) who, on an unspecified date, was vaccinated with a 0.5mL dose of Gardasil. Subsequently the patient experienced injection site pain that had persisted for over a month after receiving the vaccination. The patient sought unspecified medical attention. At the time of this report, the patient had not recovered. No product quality complaint was involved. Additional information has been requested.
red, hot , itchy rash from site of injection - did not show up until 2 days after injection
PATIENT STARTED TO EXPERIENCE ITCHING THE DAY OF VACCINATION  AND NOTICED RASH ON 3/15/21, IT WAS VERY RED AND WARM TO THE TOUCH AND WENT TO THE URGENT CARE CENTER ON 3/20/21
Nausea, vomiting, headache, fever, chills, severe muscle and joint pain
My first dose of the vaccine was administered on March 11th 2021 at Walgreens Pharmacy, Pfizer Lot number EN6199. The side effects from this dose were mild nausea, shakes, chills, dizzy, somewhat disoriented and "foggy" brain. These disappeared the next day. My second dose was on April 1st. at the same facility. This time I had no reaction. On the morning on April 11th I woke up feeling miserable. The symptoms were identical to the side effects of the first dose, except worse. This time I also had a low grade fever. These symptoms dissipated in 36 hours. On April 13th I woke up to the same symptoms again, though milder, lasting about 8 hours. Today, April 21st,, I woke up with the symptoms one more time, lasting about 5 hours. As I am writing this I feel fine again. As a lay person I have no idea if these are all related. The whole scenario  seems rather odd to me. For your information, I had my yearly physical in late March 2021, all tests were normal.
Day after receiving shot, he complained of itching at site. Left arm very red and swollen from top of shoulder to just below site. Area became very red, extremely swollen. Each day radiated from top of shoulder down to elbow by 3rd day. Area affected increased each day from small area at the top, down to elbow. (Note: There were concomitant vaccines, but the reporter only listed the Infanrix.)
Uterine bleeding after an ablation 15 years ago , subsided after second day, was brownish discharge
This medically confirmed spontaneous report (initial receipt: 22-Oct-2012) concerns a male patient. On 18-Oct-2012 the patient received AFLURIA PFS (batch number: P50708) injection. After receiving AFLURIA, the patient experienced metallic taste. The event outcome was not reported.
Erythema Multiforme Minor, may be from prior URI, vaccinations or possible HSV.
Patient with history of COVID vaccines who admitted to hospital with COVID detected PCR.  Proviced d/c note:  "72 year old female with a history of seizure disorder, schizoaffective disorder, T2DM, hypertension, hyperlipidemia, and hypothyroidism who presented a local HCF on 12/30/22 following seizure-like activity. Upon arrival to the ED, she was noted to be tachycardic with an elevated WBC and lactate. She did test positive for COVID, but had no clinical signs or symptoms of a systemic infection. It was presumed that her presentation was secondary to a breakthrough seizure. She was administered a Keppra loading dose and continued on her home Trileptal. An EEG was order, which failed to demonstrate and evidence of status. Neurology was consulted - recommending patient continue her current anti-epileptic regimen. They suspected that seizure was secondary to acute COVID infection. Patient was discharged in stable condition back to a facility. Seizure precautions were discussed including no driving, stating out of any depth of water/at heights/around heavy machinery or any other situation in which would be dangerous of a seizure what to occur."
03/04/2021:  Abdominal pain which required evaluation in the ER ER physician ordered urinalysis (normal), she reported that the ER did an ultra-sound and blood draws.   CBC lymphocytes slightly low 22.5 %all other in normal range Normal Serum glucose, Renal and hepatic function tests. Discharged with tylenol, diagnosis of inflamed GI  system.  04/08,  Pain irradiated to ?right shoulder? just below the clavicle, ?shortness of breath? . ER second visit testing : COVID-19 PCR, Hemogram, arterial gases, Blood chemistry. Results:                        Hemogram WNL                        Glicemia: 96mg/dl                        Kidney function tests WNL                        Arterial gases: pH 7.46,                                                    pCO2: 32.7mmHg                                                   pO273.3mmHg                                                    SO2 95.4%                                                   HCO3 22.50mmol/L                                                   FiO2 0.21                         COVID-19 PCR negative  April 16, 2021: continued pain in right upper chest, radiating to mid-breast. Hurts to breathe deeply. No fever, no other signs/symptoms, referral consultation with Internal Medicine, specialist ordered VES, CRP, COVID-19 PCR, Abdomen and pelvis CT scan, Abdomen ultrasound, chest CT scan, these were performed on 4/20  On 4/24 Pain in chest continues, specialist ordered D-dimer.   On 4/25 Dr. ordered arterial gases a Chest angio CT, abdomen doppler ultrasound and lower limb bilateral doppler ultrasound.  Currently patient hospitalized, receiving treatment with blood thinners.
This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 56-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included lymphoma (completed chemotherapy 4 months before the reporting date and also had radial therapy). On 24th June 2018, the patient received the 1st dose of SHINGRIX. In June 2018, 1 day after receiving SHINGRIX, the patient experienced chills. On 24th June 2018, the patient experienced muscle pain and upset stomach. On an unknown date, the outcome of the muscle pain, chills and upset stomach were not recovered/not resolved. The reporter considered the muscle pain, chills and upset stomach to be related to SHINGRIX. Additional information was received as follows: The patient stated that he experienced upset stomach and muscle aches. At the time of reporting, the patient was experiencing previous symptoms and also experienced chills and shivering.
Patient experienced a blood clot on January 11th. She is unsure if it is related to the vaccine or not.
tinnitus.  started the day after the vaccine in both ears. it is worse on the left. but present in both ears.  it is consistent ringing all day allnight..    I dont notice it if I am busy and active or in a noisy place.
No additional AE information provided.; HCP states that MMR II was accidentally administered to a patient via the intramuscular route instead of subcutaneously into the deltoid area.; This spontaneous report was received from Other Health Professional and refers to a patient of unknown and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 08-NOV-2022, the patient was vaccinated with measles, mumps, and rubella (WISTAR RA 27-3) virus vaccine, live rHA (M-M-R II) 0.5 milliliter, accidentally via the intramuscular route instead of subcutaneously (Incorrect route of product administration) into the deltoid area, valid lot #U013035, expiration date: 23-APR-2023, administered for prophylaxis (strength was not provided). No additional information or adverse event was reported.
the fever at the first vaccine was very livable, was not uncomfortable, and did not last long; This is a spontaneous report from a contactable consumer or other non-hcp (patient herself). A 65-years-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection) via an unspecified route of administration in Arm Left on 09Mar2021 (Lot Number: EN6199, Expiry date: Unknown) as dose 1, single for COVID-19 immunisation. Medical history included drug hypersensitivity from an unknown date and unknown if ongoing, allergic to penicillin, since around 1996, corrected to 1995, she has been diagnosed with this, nodule from 2020 to an unknown date, nodules in throat, diagnosed early last year, diverticulitis from an unknown date and unknown if ongoing caller had three episodes three different times, one way back in May2010 that was the first time, then Apr2016 and the 3rd time was Sep2019, osteoporosis from an unknown date and unknown if ongoing, diagnosed when she was at 35. The patient previously received Flu vaccine and she states in 2012 the flu vaccine really hurt pain in her arm, it had not been like the other times. Concomitant medication included raloxifene hydrochloride (EVISTA) taken for osteoporosis, start and stop date were not reported, has been on for 2 or 3 years or 3.5 or longer maybe and regular vitamins but she did not take yesterday. On an unspecified date in Mar2021, the patient experienced the fever at the first vaccine was very livable, was not uncomfortable, and did not last long. Caller adds fever with first vaccine was very low grade at night in bed, she started perspiring and that woke her up and she knows that mean by then the fever was going down. Caller adds that at the first vaccine, she may have also had this fever a couple of hours. She took notice of it because she thought it was interesting that she was not expecting any reactions. Caller adds that the fever at the first vaccine was very livable, was not uncomfortable, and did not last long. The outcome of the event was recovered on an unspecified date in Mar2021.  No follow-up attempts are needed. No further information is expected.
Joint pain (especially in hips) overnight. Lower back pain and mild nausea the following afternoon. Rash on chest and neck late afternoon. Not painful or itchy.