chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Inflammation; redness; scabs; Shingles; Developed a rash on left hip into abdomen area about 5 days after vaccine; This is a spontaneous report from a contactable consumer. A 65-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 04Feb2021 09:30 (Batch/Lot Number: EMA10) as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included psoriasis from 2020, Allergies to medications, food, or other products:Latex, Verbatim: She has had spine surgery  before. She has issues with her lower back and inflammation with twitches. The patient's concomitant medications were not reported. She developed a rash 4-5 days after getting the vaccine. She has psoriasis and thought it was that. She used a cream that she has for psoriasis and the rash faded. After the inflammation and redness faded she noticed she had bumps on it like they were scabs. She held off seeing her doctor but did go see him yesterday. She was diagnosed with shingles. Therapeutic measures were taken as a result of the events. The outcome of the event rash, and Inflammation was recovering, while unknown for the other events.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Pt died on 3/3/22 in hospital.  12/17 fever, UTI. PM&R f/u, Cymbalta increased to 60 mg BID, gabapentin increased to 600 mg TID, memantine 10 BID added for neuropathic pain 12/21 bedside sacral wound debridement 12/28 wound clinic, debrided 12/31 feverx1 1/4 ? UTI, abx started, SP cath changed 1/11 recurrent fever 1/13 ID consult, vanc started, ceftriaxone stopped 1/17 1 PRBC 1/19 vanc completed, sacral wound vac placed 1/31 fever 2/1 SP catheter changed 2/3 R shoulder wound debrided, 100 ml pus 2/17 Bilat glenohumeral joint kenalog and ropivacaine injections at interventional pain clinic 2/24 septic shock, Pseudomonas UTI, Bacteroides bacteremia, transitioned to comfort care
pt devel H. Influenza Meningitis 5 days p/2nd immun; hospitalized;
Swelling of upper arm, redness of upper arm, symptoms lasting 2 days presently
Pts were vaccinated with a first and second dose of varicella virus vaccine live.  Subsequently, the pts varicella antibody titers were either negative or equivocal. Additional information has been requested.
This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a elderly male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced injection site pain, injection site erythema, injection site blisters and skin lesion. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site blisters and skin lesion were unknown. It was unknown if the reporter considered the injection site pain, injection site erythema, injection site blisters and skin lesion to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but the patient could be 72 or 73 years old. The clinic did not know lot number of SHINGRIX. The patient came in the clinic complaining of pain and tenderness at injection site. There was a red blister with a lesion at injection site. The reporter did not consent to follow-up.
At night I couldn?t sleep, it felt like my anxiety had anxiety. Just extremely anxious physical feelings and an elevated resting heart rate over night. In the morning that feeling persisted, but I also had nausea and an elevated temperature.
Information has been received from an investigator concerning an 84 year old white female patient with anaemia, coronary artery disease, chronic obstructive pulmonary disease, gastrooesophageal reflux disease, hypertension, hypothyroidism and lipid disorder and a history of polymyalgia rheumatica who entered a study. On 26-JUN-2008 the patient was vaccinated SC with a first dose of ZOSTAVAX. Concomitant therapy included MICARDIS HCT, LEVOXYL, ezetimibe, iron (unspecified), VISION FORMULA tablets, stool softener (unspecified). calcium carbonate, ADVAIR, NEXIUM and SPIRIVA. On 11-JUL-2008 the patient began having facial and eye pain. The patient saw an ophthalmologist on 14-JUL-2008 and was started on TOBRADEX. The facial swelling and eye pain worsened. The patient was admitted to the hospital on 14-JUL-2008. Left facial shingles with corneal involvement was treated with IV acyclovir and hydromorphone in the hospital. The patient's left facial shingles with corneal involvement persisted. The reporting investigator felt that the adverse event was related to the study therapy. The record for this patient was unblinded on 23-JUL-2008. The patient was treated with ZOSTAVAX. Additional information ahs been requested.
Loss of taste Entire body hurt, even my bones felt like they hurt Mind fog/inability to concentrate Lethargy My period had started the day I took my second shot. It completely disappeared that night and hasn't returned as of writing. My flow is incredibly heavy the first two days, so I know I wasn't finished with my cycle.
Dose #1 - Injection was on Left Upper Arm - 1 day after injection, a raised red lump at the Injection site was visible, with pain and heat at the site. The following morning, a bruise was visible moving from the injection site toward my left armpit, approximately 1 inch high and 3 inches long, stretching from the injection site. This bruise was visible for over 3 weeks, although the pain from the injection site was significantly reduced within 3 days.   Dose #2 - No bruising was noted, nor was there significant pain at the injection site other than normal intramuscular injection-type soreness.
Soreness at site of injection; redness; raised rash; hot to touch; itching.
Pt presented to our clinic on 10/14/2020 for possible reaction to vaccine/s listed in Item 17 that were administered on 10/08/2020. Pt reports she developed redness and pain in her left upper extremity about 8 hours after receiving these vaccines. Pt reports her pain intensified and spread to her left chest/breast and axilla. She reports she also developed chills and nausea. She reports her pain persists but not as severe. She presently has redness, swelling, and knot over injection site that is warm to the touch. She reports it is also painful to the touch. She has limited mobility in her left arm due to the pain she experiences with movement including lifting her arm. She was diagnosed with cellulitis of left upper limb and was prescribed: Keflex 500 mg TID for 7 days and cetirizine 10 mg once daily. She is to follow up at our clinic in 1 week.
13 year old previously healthy male who presented to ED for 1 day of chest pain. Per chart review patient started having pleuritic chest pain around 1600 today following a Pfizer COVID-19  (LOT Unknown) immunization 2 days ago.  The pain felt like chest heaviness and burning but not sharp and hard to take deep breaths.  ED exam was normal and pain resolved without intervention EKG performed and showed diffused ST elevation in anterior and lateral leads. CXR showed no evidence for acute cardiopulmonary disease. Troponin was elevated to 15.42 at 2200  Presentation is most consistent with myocarditis in association with recent second dose of COVID19 vaccine
10/11 Coughing up blood, ambulance to hospital.  Currently in ICU.  Covid pneumonia in both lungs Antibiotics Antiviral  100%oxygen via bipap machine try nasal when possible during day
PEDIATRIC PFIZER VACCINE 0.2 CC GIVEN IM IN ERROR TO 41 YR OLD ADULT  CLIENT SHOULD HAVE RECIEVED ADULT PFIZER BOOSTER
Chills, myalgias. Followed about 5 hours later by "heavy" sensation in left leg, brief episodes of lightheadedness and bitemporal HA.
Patient admitted on due to Sepsis, UTI, anemia, AKI, and suspected diastolic heart failure. Hospital care and end of life care. Patient passed away on 1/8/22. Visit and hospital admission within 6 weeks of receiving the COVID vaccine.
The vaccine refrigerator went out which  caused a temperature excursion affecting the MMR & IPV vaccines - No adverse effects were reported.
tongue and lips felt funny; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA ORAL (tongue and lips felt funny) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 immunisation.     No medical history was provided by the reporter.  Concomitant products included PANTOPRAZOLE SODIUM SESQUIHYDRATE (PROTONIX [PANTOPRAZOLE SODIUM SESQUIHYDRATE]), BUSPIRONE, METOPROLOL, LOSARTAN, ROSUVASTATIN, ACETYLSALICYLIC ACID (BABY ASPIRIN) and VITAMIN D [VITAMIN D NOS] for an unknown indication.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced PARAESTHESIA ORAL (tongue and lips felt funny). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (oral) at an unspecified dose and frequency. On 25-Jan-2021, PARAESTHESIA ORAL (tongue and lips felt funny) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Severe lower back pain began approximately 12 to 15 hours after injection. Severe pain was spread evenly throughout the lower back muscles, and prevented me from being able to walk for 2 days, and lasted for more than 4 days.
Within 5 minutes of receiving vaccine, developed intense abdominal pain/cramping.  Then developed urticarial rash on face and chest.  All of these resolved within 1 hour and received no medication.  Was evaluated by both EMS and in emergency department.   Had no recurrence after.  Has not had vaccine reactions in past.   Never with breathing problems, facial swelling, vomiting or diarrhea
1 minute post-vaccination the patient experienced syncope and fainted. The patient was transfered to from the chair to the floor and his feet positioned slightly elevated. He regained conciousness while in the laying position. Blood pressure was checked several times. Called 911 and EMS evaluated him on site. He was removed from the premisis via gurney after roughly 20 minutes. He was transported to ER due to inability to maintain BP at sitting and standing positions.
nausea; dizziness; pain; severe headache/splitting headache; throwing up; This is a spontaneous report from a contactable nurse. A 75-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for Covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced nausea, dizziness, pain, severe headache/ splitting headache, throwing up. She was sent to the hospital, for 24 to 48 hours treated with i.v medications. She was scared about getting her next vaccination. The events outcome was unknown.   Information on the Lot number and Batch number has been requested.; Sender's Comments: Assuming a plausible drug-events temporal association, the company cannot completely exclude a causal association between all the reported, serious events and BNT162b2 administration. The impacts of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
It started with a very itchy rash at few spots, kind of like papules and sometimes blisters that were red, they were on my hand, lower arm and my lower leg, and then I had one spot above the left knee and one spot on the right upper tight. The rash was itchy, and I started taking over the counter Zyrtec, using moisturizers, hydrocortisone 1%, I was treating myself. Some days it was mostly mild, other days it was worse. I thought it was something I was allergic to. It kept getting worse and worse. I thought it was poison ivy but then it went for over 2 months and poison ivy does not last that long. In the middle of June the rash started to spread a little bit up my arms and a little bit on my legs, more intense itching. I started to use more over the counter and nothing seemed to work. I went to the doctor and they gave me a steroid injection and some stronger hydrocortisone cream . It got better after that. It seems like it has gone away.
Initial information received on 22-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer/non-HCP. This case involves adult male patient who experienced feeling unwell, infection NOS and a swollen lymph node located around the right axillary, while he received vaccine INFLUENZA VACCINE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 17-Oct-2018, the patient received a dose of suspect INFLUENZA VACCINE not produced by Sanofi Pasteur lot number not reported via unknown route in right arm. On an unknown date, patient developed a non-serious feeling unwell unknown latency following the administration of INFLUENZA VACCINE. On an unknown date, patient developed a non-serious infection NOS unknown latency following the administration of INFLUENZA VACCINE. On an unknown date, patient developed a non-serious a swollen lymph node located around the right axillary unknown latency following the administration of INFLUENZA VACCINE. Both happened in the same arm (right arm). On an unknown date, patient developed a non-serious a little bit of pain where I received the vaccine unknown latency following the administration of INFLUENZA VACCINE. On an unknown date, patient developed a non-serious feeling weak unknown latency following the administration of INFLUENZA VACCINE. On an unknown date, patient developed a non-serious discomfort unknown latency following the administration of INFLUENZA VACCINE. On an unknown date, patient developed a non-serious fever unknown latency following the administration of INFLUENZA VACCINE. On an unknown date, patient developed a non-serious back pain unknown latency following the administration of INFLUENZA VACCINE. On an unknown date, patient developed a non-serious headache unknown latency following the administration of INFLUENZA VACCINE. Final diagnosis was a swollen lymph node located around the right axillary, infection NOS and feeling unwell, little bit of pain where I received the vaccine, feeling weak, discomfort, fever, back pain, headache. Lab data was not reported. The patient was treated with oral antibiotics of CLEOCIN HCL 300 mg. The event were resolving at the time of reporting. List of documents held by sender: none. Follow up information received on 22-Oct-2018. Event was updated. Site and side of administration of vaccine was updated. Event details was updated. Corrective treatment was updated.
Numbness down left arm into left hand then up into left neck and left side of face. One week after vaccine admin progressive generalized weakness and presyncope with tremors and muscle twitching requiring hospitalization.
1 of 2 pt recvd vax & devel inject site reaction-size of a golf ball which consisted of erythema, induration, swelling & site was hot to touch; also had fever to 103;
Patient got swelling on face, the next day, after receiving vaccine, next day - swelling around eyes. Advised to go to see MD right away. Patient got steroid medication from MD for treatment.
Unstable dizziness;  Constant  swishing noise in left ear; Wite blood cell at 10.8 and should be 10.2.; head aches.
The Janssen vaccine was administered about an hour after expiration. A patient was administered with  Janssen vaccine at 1:50pm and when they checked the Vaccine tracking sheet and Janssen vaccine Lot# 1808980 was first puncture on 07/12/2021 at 11:00 am (expiration time 2 hours in room temperature) 01:00 pm. around 2pm then they realized  the vaccine was expired but patent was gone already. I called patient and I have been calling but patient never answer the phone, I leave a voicemail with a phone number  for a call back, patient is not aware that he received an expired vaccine.
Temp over 101; This case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 02-NOV-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The reporter wanted to know could the second shingles shot give a temperature over 101. The follow-up could not be possible as no contact details were available.
When going to inject vaccine, needle was inserted into arm and when the syringe was depressed the needle retracted immediately, sending most of the vaccine down the patients arm and leaving some in the barrel, it is believed to be less than half the dose administered therefore a second full dose of vaccine was administered in the opposite arm.
Local warmth-induration-erythema and swell at injection site suspicious for cellulitis. Tx with antibiotics.
Swelling, redness, warmth and tenderness surrounding vaccine inoculation site, associated with pruritus. Resolved after 3 day without intervention. 0.5 x 0.5cm nodule left in place.
7 days after receiving 2nd dose  of modern a vaccine  Arm swelling. Red , itchy
mom reported tense body, approx 230PM red face, cross-eyed, staring, no jerking of extremities; repeated episode approx 430PM; had BM afterwards; mom brought pt to ER for eval seen by MD; given Phenobarb;
Approx. 3 hrs after vaccine; experienced shortness of breath, swelling at injection site, feeling sick ie....fever, dizziness.
The  wrong vaccine was pulled from inventory. Patient was given hepatitis A vaccine in error. Hepatitis B vaccine was to be administered.
Fever of 101 degrees; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (Fever of 101 degrees) in a 76-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU VACCINE VII) for Flu vaccination.    Patient reported of having no allergies. Patient did not have COVID positive test.    On 02-Nov-2022, the patient received dose of INFLUENZA VACCINE (FLU VACCINE VII) (unknown route) 1 dosage form. On 02-Nov-2022 at 5:30 AM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 03-Nov-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced PYREXIA (Fever of 101 degrees). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever of 101 degrees) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Nov-2022, Body temperature: 101 F.         Patient reported about Concomitant medication, but he did not specify on what medication.  Patient received the flu shot at the same. On 28-JAN-2021, patient received first dose, Lot no. unknown. On 25-FB-2021, patient received second dose, Lot no. unknown. On 25-OCT-2021, patient received third dose, Lot no. unknown.
pt recvd vax; 30oct95 devel a full blown bell's palsy; md felt because pt was  allergic to "so many med", the Bell's palsy was not related to varivax;
Per Database, patient received two doses of Moderna COVID-19 vaccine on 4/28/21 and 5/26/21, respectively. Patient admitted to our hospital on 12/2/2021 and diagnosed with COVID-19 on 12/7/2021
This non-serious spontaneous case, was initially received on 18-Oct-2017 from other health professional (nurse), concerns a patient of an unspecified age and gender. On 06-Oct-2017, the patient was administered with FLUCELVAX QIV (dose: full dose (as reported), batch number: 195128, expiry date: 30-Apr-2018, route of administration, anatomical location: not reported). On 06-Oct-2017, employees were given vaccine from a vial that leaked. It was reported that, after piercing the vial, when it was turned upside down and upon injecting air, vial was dripping from the rubber seal. The nurse could withdraw only 7 doses from the vial. The patient was administered with full doses. There were 2 defective units, but the package was not damaged or wet. The nurse used 23 needle gauge of size 3 cc. The PTC (product technical complaint) number provided was 1025066. Based on the investigation performed, it can be concluded that FLUCELVAX Batch 195128 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No internal root cause was identified in the manufacturing process, or relating to the vial or stopper components, and no trends were identified for the batch. However a known trend was identified for the FLUCELVAX batches from the 2017/2018 FLUCELVAX Commercial Season for vials leaking at the stopper during dosing due to air being added to the vial. The most likely root cause can be attributed to improper handling by the user. Follow-up received and significant case correction received on 21-Nov-2017: Added PTC number and the QA (quality assurance) report results. Narrative amended accordingly. Non-significant case correction received with IRD 18-Oct-2017: The verbatim of the event 'product leakage' was corrected and the lead sentence in narrative was amended.
Redness at injection site. Tenderness / pain at injection site. Mild fever, Mild headache.