chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Got the shot a year later got shingles / suspected vaccination failure; Got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 year after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 10-NOV-2022 Reporter's comment: This case was reported by the patient via interactive digital media. The patient reported that got the shot a year later got shingles. Additional supportive information: This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
This spontaneous report as received from a nurse, refers to unspecified patients of unknown demography. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, since 02-JUN-2015, unspecified number of patients were vaccinated with improperly stored VAQTA injection (lot # K019560, expiration date: 02-JUN-2017) (strength, dose and route unspecified). No concomitant medications were reported. No adverse effect had been observed or reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Follow up information has been received on 13-JUL-2015, that all telephone attempts to obtain follow-up have been unsuccessful. Follow up information was received on 20-JUN-2015 with additional information on 21-JUN-2015. The patient was approximately 2 years old. The patient demographics were updated. On 06-JUN-2015 the patient was vaccinated with improperly stored VAQTA (lot # K019560, expiration date: 02-JUN-2017) (strength, dose and route unspecified). Additional information has been requested. Patient, suspect therapy and narrative were updated.
Patient contacted pharmacy 24 hours after vaccination reporting itchy feet. When queried about swelling, patient says there is some swelling. Recommended that patient contact PCP & seek medical help immediately if symptoms worsened. Follow up phone call with patient on 11/8 (6 days after vaccination) showed improvement (90% per patient) with daily cold pack & elevation of feet. Patient did not seek help from PCP, just from a friend that worked at a vaccination clinic. Recommended patient notify PCP. Patient also reporting via VSAFE.
2 days following vaccination, red blotchy face for 24 hours; 2 to 5 days following vaccination face intermittently felt numbing sensation; 7 days following vaccination injection site red, swollen, itchy, hives, hard lump to touch growing from 2" to 5" diameter; 7 days following vaccination injection (simultaneous to above) freezing pulses through face that last for 12 hours; Injections site red, swollen, itchiness dissipated over proceeding 5 days; Have pictures of arm reaction
Nausea and light headed that is still happening as of today, on 4/21 around 5:30pm I had pee in my urine which caused sever pain for about 4 hours, I drank plenty of water to flush my system and then I was fine
Evening of 10/3/2009 L arm swollen-went to ER had fluid removed from shoulder.
patient "returning to office today for next dose; no additional adverse events; This spontaneous report was received from a medical assistant and refers to a 16-year-old patient of unknown gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history.  In July 2019, the patient was vaccinated with a dose of with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), lot number R017624, expiration date not reported but upon internal validation estalished as 17-MAR-2021 (dose, route and anatomical location were not reported) for prophylaxis.  It was reported that on 07-JAN-2020 (reported as today), the patient would return to the office for next dose of with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9).  This is one of two reports form the same source.; Sender's Comments:  US-009507513-2001USA002954:
fever; body pain; This is a spontaneous report from a non-contactable consumer (relation with patient was other). A 31-year-old female patient (unknown if pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot/batch number and expiration date unknown), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was unknown if patient had Covid prior vaccination. The patient experienced fever and body pain on unspecified dates. It was unknown if patient had Covid tested post vaccination. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Left arm red, swollen, warm to the touch (area = 9"w x 15"L). Dx: Cellulitis.
Respiratory distress, whole body edema, difficulty swallowing within 4 hrs of vaccines. Seen in ER w/ angioedema & urticaria, given Epi & steroids.
I went to pharmacy to get my shot in. All was well until 3-4 days after when I began having chest pain and weird sensations in my extremeties. I started having tingling in my hands and legs that turned to numbness. I would get shoots of pain throughout my body, legs, hands, arms, feet, head. I also began feeling weak. I ended up going to the hospital to get checked out and the doctor said I was probably having an adverse reaction to the vaccine.
Vaccine was given after expiration time. Vaccine expired at 3:30 pm on 03.08.2022 and was given at 4:30 pm on 03.08.2022
Pt usually stooled about 3-4 x's/day. After Rotateq, Mom noted that pt stool pattern gradually decreased to QD , and as of 8/9/07, had gone 24 hours without a BM. Pt seemed "gassy and in a lot of pain" to Mom. Pt was eval'd on 8/9/07 at our office. Was reassured and later that afternoon, after using a glycerin suppository, noted some blood with next BM. Pt was then seen at hospital 2 hours blood and was allowed to come home. FU on 8/10/07 at our office was satisfactory. Dxs constipation. Pt was treated with lactulose by CMH.
pt recv vax 29SEP97 & the next day pt exp inj site redness (60mm), swelling, warmth & inflammation;
no signs or symptoms reported; temperature excursion on VAQTA/VAQTA was administered to three patients; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 02-MAR-2021, the patient was vaccinated with improperly stored dose of hepatitis a vaccine, inactivated(VAQTA), dose: 0.5 milliliter, lot# T013546, expiry date: 28-OCT-2021 (dose number, route of administration, anatomical location were not provided) for prophylaxis. Administered dose of vaccine experienced the temperature excursion of 47.3 degrees Fahrenheit for 20 minutes. There were no previous excursions related. Data logger was not involved. No adverse events were reported.   This is one of three reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T013546; expirationdate: 28-OCT-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2103USA007895: US-009507513-2103USA007896:
LOST HER GRANDMA TO VACCINE; This spontaneous report received from a consumer via social media concerned a female of unspecified age, race and ethnic origin. The patient's height and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin and batch number: unknown, expiry: unknown) dose and start therapy date were not reported, 1 total administered for prophylactic vaccination (Dose number in series 1). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date it was reported "a customer told me today she lost her grandma to the J&J vaccine on Christmas weekend". It was further reported "we had no idea it would have such an adverse reaction to the medicines she was currently taking". On an unspecified date in DEC-2021 (on Christmas weekend), the patient died from unknown cause of death. It was unknown if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20220100492-COVID-19 VACCINE AD26.COV2.S- lost her grandma to vaccine. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Left sided numbness/paresthesia with difficulty with dexerity on the left side.  Severe pain on entire left side.  Fatigue.
Fifteen minutes after injection of Moderna COVID vaccine, patient came back to pharmacy. She was complaining of severe itching and some throat tightness. Patient was given diphenhydramine 50 mg as one time dose. Patient BP was monitored, and monitored signs for breathing problems. Patient stated "felt better" after 30 minutes of receiving diphenhydramine. Blood pressure returned to normal (130/85 mm/hg). Patient has family member pick her up and went home.
1. CP started Nov 1 2. Admitted Nov 2 with pericarditis and Afib with rapid response. Echo with small pericardial effusion. Normal stress test DC on flecainide eliquis and colchicine 3. Readmitted on Nov 11 with worse CP: Found to have moderate to large pericardial effusion 4. Went for pericardial window on 11/15 5. 11/16: Fall in hospital with left sided weakness, slurred speech and confusion 6. CTA brain on 11/17: 1am with right MCA thrombotic occlusion 7. 11/17 1-3am: Stat neurosurgical consult went for emergent thromectomy
The following day I had uncontrollable muscle spasms on my face. Twitching. Etc
Pt came to clinic after 1 hour of receiving 1st dose of Moderna Vaccine c/o throat swelling and redness around her neck.
Underneath my left armpit, my lymph node swelled and enlarged to the size of a baseball, which has never happened before in my life even after receiving other vaccines such as the flu vaccine. Also, 2 days post-vaccine, I experienced thrombosis of my right leg, specifically the upper thigh area. Now I must get up and walk around often as that area of my leg goes numb and tingles for a while, which if left long enough without walking around turns into sharp pains in that area. I am still experiencing that as well along with the enlarged lymph node under my armpit. I have had neither symptoms before in my life or symptoms similar to that.
Pt c/o dizziness, SOB, feeling of something in her throat. I was not able to visualized the back of her throat very well, due to swelling.  Mild wheezes heard.  BP was 223/119, Pulse 73, RR 24, spo2 95% using 2 liters of oxygen via nasal cannula. Repeated BP confirmed similar results. Gave Benadryl IV, solumedrol, and epi 0.1 mg. After epi was given, pt started to throw up and c/o headache. Gave zofran IV.  BP did come down to 159/100, she says she did not feel the throat swelling any longer, and wheezing disappeared. Left clinic alert, and verbally responsive to Emergency department for further management.
COVID; COVID; The initial case was missing the following minimum criteria: valid adverse effect. Upon receipt of follow-up information on 23May2022, this case now contains all required information to be considered valid.  This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). An adult female received COVID-19 immunization at a local pharmacy/drug store with the first dose of intramuscular BNT162B2 (solution for injection; Lot EN5318 and expiry information not provided) as a single dose on 30Mar2021; the second dose of intramuscular BNT162B2 (solution for injection; batch/lot and expiry information not provided) as a single dose on 20Apr2021; and a third (booster) dose of intramuscular BNT162B2 (solution for injection; Lot FA7485 expiry 31Oct2021) as a single dose on 15Aug2021 (at 43-years-old). Relevant medical history included high risk of frequent institutional or occupation exposure to coronavirus. There were no concomitant medications reported. On 22May2022, the patient experienced a breakthrough case of COVID confirmed with positive SARS-CoV-2 test. Treatment details, if any, were not reported. The outcome of the event breakthrough case of COVID was unknown.
got flu shot 9/29/23 in office- leg swelling/redness started after that  never had fevers  +pain to leg with severe itching  R leg swelling progressed with leg being 2-3x L leg with marked erythema/some open lesions from itching  took to urgent care 10/1- given script for possible cellulitis but told to continue benadryl q 6 hours and wait for 24 hours if comfortable before starting abx  Mom waited and yesterday leg started to look much more normal  no motrin/benadryl since last night, taking daily zyrtec  swelling significantly improved, redness improved, itching improved
A 35 year old male pt was vaccinated with 0.1ml rabies vaccine intradermally on 6/18/03. Further suspected vaccinations the same day included Mengivac (A+C) and Engerix B (both IM). On 6/20/03 the pt complained about severe mouth ulceration and difficult swallowing. The symptoms improved. Seriousness criterion: medically significant (OMIC).
Swelling of entire arm and hand of vaccinated (L) arm. Cellulitis and lymphedema ruled out, per MD. Allergic reaction that caused extreme swelling and numbness + tingling in (L) arm. Tingling decreased w/swelling decrease.
Eight days post vax, the pt developed a fever of 102 and a slight rash. The pt sought unspecified medical attention.
had a red mark on her arm the size of a quarter; This is a spontaneous report from a contactable consumer. This female consumer (patient) of an unspecified age reported that she received bnt162b2 (BNT162B2, Solution for injection), dose 1 via an unspecified route of administration on 14Apr2021 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. Medical history included ongoing neoplasm malignant. Concomitant medication included palbociclib (IBRANCE) taken for neoplasm malignant and letrozole (LETROZOLE) taken for neoplasm malignant, start and stop date were not reported. The patient experienced had a red mark on her arm the size of a quarter on an unspecified date. Caller, is a cancer patient is on Ibrance and Letrozole. Received first vaccine and has red mark on arm that is size of a quarter. Wanted to know if she should have second vaccine or not. The action taken in response to the events for bnt162b2 was not applicable. The outcome of the events was reported as unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Vision disturbance; Pain in the shoulder and arm; Weakness in her leg; Red swollen eyes; Red swollen eyes; Pain in the shoulder and arm; Headache; This spontaneous case from was received on 09-Mar-2021 from other non-health professional (consumer) via Communications (reference number: SEQW21-00944) and concerned a 79-year-old, female patient.  The patient's medical history was not reported. It was reported that at that time the patient was in good health. The patient's concomitant medications included unspecified eye drops used for an unreported indication.   On 04-Sep-2014, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine, subunit influenza virus vaccine polyvalent; dose: 0.5 ml, route of administration and anatomical location: not reported) as flu prophylaxis. The batch number was not reported.  On 08-Sep-2014, four days after receiving Flucelvax Quadrivalent, the patient experienced weakness in her leg and pain in the shoulder and arm. The patient was concerned since she additionally developed red, swollen eyes, vision disturbance and headache. It was reported that she did not receive the flu vaccine again. It was unknown if the patient received any corrective treatment.  The outcome of the events was unknown.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: A 79-year-old, female patient was vaccinated with Flucelvax Quadrivalent. Four days after receiving Flucelvax Quadrivalent, the patient experienced weakness in her leg and pain in the shoulder and arm. The patient was concerned since she additionally developed red, swollen eyes, vision disturbance and headache. No alternative aetiology was provided. Causal role of the suspect vaccine is assessed as possibly related for visual impairment, pain in extremity, muscular weakness, ocular hyperaemia, eye swelling, arthralgia and headache.; Sender's Comments: A 79-year-old, female patient was vaccinated with Flucelvax Quadrivalent. Four days after receiving Flucelvax Quadrivalent, the patient experienced weakness in her leg and pain in the shoulder and arm. The patient was concerned since she additionally developed red, swollen eyes, vision disturbance and headache. No alternative aetiology was provided. Causal role of the suspect vaccine is assessed as possibly related for visual impairment, pain in extremity, muscular weakness, ocular hyperaemia, eye swelling, arthralgia and headache.
Pain and inflammation at injection site beginning at night on the day following the injection.  Inflammation involved swelling approximately 6 inches in diameter and raised off the skin approximately 1 to 2 inches.  Inflammation was painful.  Symptoms resolved by 5-22-23.
Low grade fever, chills, severe headache, nausea, body aches, increase in blood pressure 140/90
I started to feel nauseous on the day I received the vaccine (March 23) around 2:00. As the day went on, I got a fever (temperature was 100.3) that day and I was getting chills, headaches, body aches and was very drowsy. These symptoms continued until Thursday, March 24. On Wednesday, March 23, I was in a car for 15 minutes and nausea was worst and felt dizzy. Fever dropped to 99.3 on Thursday but was still having headaches, chills and was physically drained. I spent most of the day sleeping from Thursday to Sunday. On Monday, fever was completely got but still feeling drained. On Thursday, I noticed that my breathing was labored with movement and had to use my inhaler more frequently throughout the day. I met with my dr today (March 30) because I was concerned about the length of the symptoms so she ordered a COVID test for me, which I will get done tomorrow.
12 hours after vaccination: temp of 102-103 for ~24 hours, followed by severe fatigue for another ~24 hours
Initial misuse case was received from a healthcare professional on 29 OCT 2013. Cases were received on 21 March 2014. A child patient whose demographic details, medical history and concomitant medication were not reported received a 0.5 ml dose of FLUZONE on unspecified date (route, site, dose and batch number not reported). It was reported that on an unspecified date patient received incorrect dose 0.5 ml instead of 0.25 ml. Laboratory investigation were not reported. No adverse event was reported. List of documents held by sender: None.
severe pain in shoulder and arm where shot was administered. Up all night with major nausea. Next day so far mild nausea still present, weakness and extreme fatigue.
Light headed; nauseous; Diarrhea; This is a spontaneous report from a non-contactable consumer, the patient. A 38-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via the unspecified route of administration in the left arm on 17Mar2021 as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no allergies to medications, food, or other products. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within 2 weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. It was unknown if the patient was pregnant at the time of vaccination. The events did not result in doctor or other healthcare professional office or clinic visits, emergency room or department, or urgent care. On 19Mar2021, the patient experienced lightheaded, nauseous and diarrhoea for 5 days after vaccination. Since the vaccination, the patient had been tested for COVID-19. On 20Mar2021, the patient underwent a nasal swab test and the result was negative. The patient did not receive treatment for the events. The clinical outcome for the event diarrhoea was recovered on 24Mar2021; while the events of lightheaded and nauseous were not recovered at the time of this report.   Information about lot/batch number cannot be obtained. No further information is expected.
pt experienced pain in the whole arm as well as a bruise on a location other than the injection site lower on the bicep towards the inner elbow a few days after receiving  the COMNARTY shot on 10/16/23 . pt experienced the same a few days after given flu and RSV vaccinations in her left arm on 08/29/23 (pain in the whole arm which still exists preventing her from moving her arm and a bruise close to her inner elbow). pt saw the physician about the pain in the arm and was prescribed prednisone for it.
Patient states that from her ears to her throat feels tight, she is hot and ear ache as well, feels yucky all of sudden. My tongue and throat feel fat and weird. Exactly like when she eats shrimp
ACUTE RESPIRATORY FAILURE 11/25/2022 CARDIAC ARREST DUE TO UNDERLYING NONCARDIAC CONDITION
Chills severe, tiredness ~ I had 2 throw blankets, 1 thermal blanket doubled, long sleeve blouse, long pants, slippers, a space heater directed at me, the temp in the house was 72 and I was still freezing. Finally, I put my head under the covers and slept for hours. I woke up around 10:00PM and went to bed. I wasn't freezing, at that time, but I wasn't hot either and slept with 2 blankets (1 was a weighted blanket) all night. I woke with a headache, but took 2 Tylenols and felt better after 30 minutes. I'm feeling well now, but I don't think I will get the 2nd vaccine.
(Per patient) the evening after getting vaccine, she noticed area was sore & had a knot (which she says she knew to expect). Next morning, area was warm to touch, knot was bigger & had turned red. Keeps getting bigger, is hard, & sore to touch. Also itching now, but just discolored (not so much red anymore). She had Dr. appt. today & let him look at it, but he said he didn't know of anything he could do about it, I recommended pt. seek emergency medical attention if swelling spread to throat & she agreed.