chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Developed bilateral kidney area pain, increased thirst, increased urination approximately 20 hours after Hep B #2 was given.  No problems with vaccines in past, including Hep B #1.  No fever, no diarrhea, no hematuria.  Seen by private provider who referred him to a nephrologist.  As of 03/31/09, GFR (glomerular filtration rate) ordered by nephrologist - results were 44%.  States he had sinus surgery Dec 2008 or Jan 2009, and had a GFR test done in October 2008 as prerequisite for sinus surgery, that result was 72%. Also currently has increased levels of protein in urine. On 03/31/2009, continues to have increased thirst and increased volume of urination.  Diabetes has been ruled out.  Still has kidney pain, less than previously - describes it as "constant dull nag".   Patient is 6'1" tall, weighs 225#. Has been told his condition is an attack on his immune system either from sinus surgery in Dec (or January) or from the Hepatitis B vaccine. Seen by another nephrologist in on 04/01/2009(wasn't happy with the care from the first nephrologist).  Awaiting results from this visit.
Severe headache, followed by severe nausea and vomiting all day.  Unable to eat.
Her arm was sore/arms still hurt; Not able to taste or smell anything/no smell and taste; Not able to taste or smell anything/no smell and taste; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID:. The reporter is the patient.  An 87-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 01), for Covid-19 immunization; Bnt162b2 (Dose: 02), for Covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "not recovered", described as "Her arm was sore/arms still hurt"; AGEUSIA (non-serious), ANOSMIA (non-serious), outcome "unknown" and all described as "Not able to taste or smell anything/no smell and taste".  Additional information: Her 4th dose on 05Apr2022, since then not able to. Her arm was sore and not able to taste or smell anything. Not experienced this with any of the prior 3 shots, just this one. Her Insurance agent heard that the vaccine had caused a lost sense of taste and smell. Thought he had heard it somewhere. Informed caller that a sore arm or injection site pain had been reported as a side effect, however no data available on the loss of taste and smell associated with the vaccine. These may not be all the possible side effects of the vaccine. Serious and unexpected side effects may occur. The possible side effects of the vaccine are still being studied in clinical trials. She got her third vaccine and her arms still hurt from the shot and have no smell and taste. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
SWOLLEN EYES; SLURRED SPEECH; SHAKING; COLD; DECREASED MOTOR ABILITY; EYE PAIN; CHILLS; TIREDNESS; FEVER; MILD HEADACHE; LOWER BACK PAIN; This spontaneous report received from a patient concerned a 35 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unk) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced swollen eyes, slurred speech, shaking, cold, decreased motor ability, eye pain, tiredness, fever, chills, mild headache, and lower back pain. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 100.2 Unit Not Reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from swollen eyes, slurred speech, shaking, cold, decreased motor ability, tiredness, fever, chills, mild headache, and lower back pain, and the outcome of eye pain was not reported. This report was non-serious.
Dizzy, headache, nausea, eyes started swelling under both eyes turned purple and sores with bleeding. Both eyes matted shut in the morning, sore throat, lost voice. Did not see a physician, symptoms lasted 10 days, bleeding under eyes lasted 4 days.
T 104 (R) noted @ 8pm (10 hrs p/ imm) followed by unconsolable crying for 4-5 hrs. Vomited once during noc (approx 16 hrs p/ imm) Pt did not receive acetameophen p/ imm as directed , got 1st dose @ 8pm 28Apr92 which resulted in T dec.
HARD TIME BREATHING,NOT FEELING WELL WAS ADMITTED TO HOSPITAL 2/13/09-records received-for DOS 2/4-2/7/09-DC DX: Influenza A bronchiolitis with hypoxia, now resolved. Pneumonia, resolving. Presented with C/O fever up to 103 the previous night, not sleeping well due to coughing, poor appetite, runny nose for several days with congestion, coughing for 2-3 days. PE: expiratory wheezes.
Stomach pain after swallowing liquids or solids. This was my second vaccine injection for shingles
This case was retrieved via a search of the scientific literature on 19 December 2009. A 3-year-old male patient had received a dose of HIB vaccine. The date of vaccination, trade name, manufacturer name, lot number, route and site of administration was not reported. The patient, who was fully immunized and otherwise healthy presented to an outside facility with a sore throat and fever. He developed sore throat and temperature of about 103.0 Degrees Fahrenheit abruptly 4 hours prior to arrival. He had mild symptoms of clear rhinorrhea and nasal congestion for two days prior to presentation. The patient had no cough, stridor, trismus, neck stiffness, nausea, vomiting, diarrhea, or rash. Physical examination initially demonstrated mild trismus and pharyngeal erythema. After 2 hours at the outside facility, he developed drooling and a muffled voice. A complete blood count showed a white blood cell count of 12.4 with 74 percent segmented neutrophils, and a blood culture was sent. A nasopharyngeal swab was positive for respiratory syncytial virus (RSV) but negative for influenza A and B. Monospot, rapid strep, and throat culture were all negative. He was initially in no respiratory distress, so a soft tissue neck film and a CT neck without contrast were obtained. The soft tissue neck film showed mild thickening of the epiglottis and aryepiglottic folds, and this was confirmed on CT. During the next three hours, the patient developed worsening odynophagia, inspiratory stridor, and wheezing. He was treated with Solumedrol, nebulized albuterol, racemic epinephrine, and ceftriaxone, with minimal improvement in his stridor and was in a modified sniffing position. He was taken immediately to the operating room. During induction of general anesthesia, he had moderate airway obstruction. Direct laryngoscope revealed a beefy, red epiglottis. He was subsequently intubated without difficult, and a swab culture was obtained from the epiglottis. The patient remained intubated for the next 40 hours, while receiving ampicillin/sulbactam and vancomycin. On hospital day 2, he received intravenous dexamethasone. On hospital day 3, he developed an air leak around his endotracheal tube and was successfully extubated. Blood cultures grew nontypeable H. influenzae biotype I. The culture from the epiglottis grew normal oral flora. Antibiotic coverage was narrowed to only ampicillin/sulbactam. The patient's clinical status rapidly improved, and he was discharged on hospital day 6. Documents held by sender: None.
3 hours after shot arm that shot was given in became unuable due to pain.  9 hours after shot experienced intense body aches, fever of 100.0 and fatigue.  Was unable to sleep.  Had fever for 24 hours.  48 hours after shot side effects have improved but still fatigued and feel out of it. Arm pain has mostly subsided.
8cm x 6.5cm area of pinkness that is patchy and sore to touch. About 1-2cm below injection site and leg achiness.
On 2/27/22 I developed a rash in my V-1 nerve in my face and I visited the ER and they provided the Liothyronine and steroids.  I saw doctor later that week.  The shingles symptoms reappeared in June 2022 and I've been seeing Dr.
Patient reports arm soreness to right arm, redness and swelling located in the area of vaccination.
PT C/O "BEING REALLY HOT WITH MY THROAT FEELING SWOLLEN AND FEELING WEAK ABOUT 4HRS AFTER GETTING THE SHOT."
100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again; 100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again; No Adverse Event; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No Adverse Event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again).    This case contains information for the 84th out of 100 adult male patients described by the reporter. Concomitant Medication use information was not provided by reporter. Nurse reported that an adverse event 100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again. The 100 adult male patients were involved. Moderna COVID19 vaccine bivalent, dosage given in ml unknown to the HCP.  Treatment Medication use information was not provided by reporter.    This case was linked to US-MODERNATX, INC.-MOD-2023-697752 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-697752:Master case
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 18-JUL-2016 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot # L040178, expiration date 18-AUG-2017). This specified lot number vaccine was exposed to temperature excursion one time. The total cumulative excursion time was 48 hours with the lowest recorded temperature of 34 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse event was reported. This is one of several reports received from the same source. Additional information has been requested.
3 minutes into receiving the injection I broke out into a cold sweat.  I became nauseous and almost vomited.  Everything I looked at including the floor, items on the pharmacy self, people walking by me.  Everything was yellow in my sight.  I then had to go to the bathroom because of instant diarrhea.  Within 10 minutes of when it started it was over.  It left me fatigued and exhausted.
Pt recvd vax 20JAN92 & 22JAN92 noticed ulcers in mouth & onset of generalized itching, burning & aching; 24JAN92 eyes became red, itchy & burning; devel h/a, felt weak, exhausted & drained, felt fevered, had chills;
Lymph nodes (right arm pit) swollen. Extreme  fatigue, entire body pain (muscles and joints),  extreme nausea, and headache. Every muscle in my body hurt or throbbed.
Patient's mother called 9/10 to state fever then rash. Fever first night - 101. Rash started 9/6 trunk - face no cough no conjunctivitis. Fever started the night of the vaccination 8/27/18 and rash started 9/6. Seen by a provider on 9/10 and mother reports provider stated it is a reaction to the vaccine, a mild measles case.
found an adenocarcinoma in the gallbladder; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "immunocompromised" (unspecified if ongoing), notes: I am immunocompromised and so I had all 3 rounds of your, vaccine. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose number: 1, Manufacturer: unknown, Lot/ batch number: Unknown), for Covid-19 immunization; Covid-19 vaccine (Dose number: 2, Manufacturer: unknown, Lot/ batch number: Unknown), for Covid-19 immunization. The following information was reported: ADENOCARCINOMA (medically significant), outcome "unknown", described as "found an adenocarcinoma in the gallbladder". Therapeutic measures were taken as a result of adenocarcinoma.  Clinical course: The patient was immunocompromised and so had all 3 rounds of vaccine. Patient had been told, after having to have my gallbladder removed that they have found an adenocarcinoma in the gallbladder and it was a very unusual case and may not be isolated. Patient read online that some people experienced issues with their liver, bile ducts and gallbladder after the vaccine and I want to know from you how many cases of this you have had reported.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
paralyzed; This is a spontaneous report from contactable Other Health Care Professional (HCP). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (unknown age at time of vaccination) at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The HCP mentioned several people she knows that have had serious AE's after receiving the vaccine. She mentioned "2 other girls that are paralyzed". The outcome of event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Based on temporal relationship the possibility of causal association between the event paralysis and the suspect drug BNT162B2 cannot be excluded.   The impact 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.
Chills, headache and vomiting started at 8:00PM and went thru the night.  Since then I have had chill and headache and night sweats twice a day and haven't been able to eat much.  This is the 5th day.
1st dose on 12/8, 2nd on 1/23; This case was reported by a nurse via sales rep and described the occurrence of drug dose administration interval too short in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (SHINGRIX).   On 23rd January 2023, the patient received the 2nd dose of Shingrix. On 23rd January 2023, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 23-Jan-2023 Reporter's Comments: The patient received first dose of Shingrix on 8th December 2022. The second dose was two weeks too early. The reporter agrees to follow up from GlaxoSmithKline. No side effects were noticed. Additional supportive information: The patient received 2nd dose of Shingrix, earlier than the recommended interval, which led to shortening of vaccinations schedule. This case has been linked to the case US2023AMR010993 reported by the same reporter.; Sender's Comments:  US-GSK-US2023AMR010993:Same reporter
Extreme migraine. Nausea. Vomiting. Pain at injection site. Entire left arm is sore and movement is restricted. Muscle pain at injection site and itching as well.
Febrile convulsions NOS on 2013-05-16, clinician comment: Febrile seizures 10 days after MMR and Varicella.
Information has been received from a female consumer (age not reported) with no reported medical history and an allergy to ampicillin who on 21Oct05 was vaccinated with a 0.5mL dose of pneumococcal 23v polysaccharide vaccine (lot 651318/1006P). Concomitant therapy included losartan potassium HCTZ. The pt reported that on 22Oct05 she developed two separate rashes on the arm she received the injection and that same arm was sore. Subsequently, the pt recovered three days after the injection, 24Oct05. There was no product quality complaint involved. Additional information is not expected.
From initial information received on 08/20/03 from a health care professional regarding an adverse event occurring in the USA, it was reported that a 4 year old female pt received a fifth dose of DAPTACEL, Lot # C1387AA, administered in the left upper thigh (route not reported), and a fourth dose of IPOL, Lot # W1233, administered in the left lower thigh (route not reported) on 08/18/03.  Reportedly, the pt's mother called the physician's office on 08/19/03 stating that the pt had developed a mosquito bite sized knot with redness at the injection site. The pt's mother was instructed to apply cool compresses, administer Children's Tylenol and to call the physician if the symptoms worsened.  On 08/20/03 the pt's mother called to inform the physician that the reaction had worsened, increasing in size and redness to 11.5cm in diameter. The pt was seen by a physician and treated with Augmentin for cellulitis. The pt's recovery status was reported as unknown.
was given a dose of IPV and pedirex which contain IPV no adverse reaction noted at this time.
PATIENT RECEIVED SHOT ON 8/3/18. ON 8/4/18 PATIENT BEGAN HAVING SYMPTOMS. HER ARM IS RED AND WARM. ON 8/9/18, THE RASH IS LESS RED, BUT HAS EXTENDED TO BELOW THE ELBOW.
(R) arm, red, swelling. Dx: cellulitis: tx: Cefdinir x 10 days.
Patient while in observation during a 30 minute hold due to previous allergy notation. Began to verbalize a complaint of Shortness of breath and a feeling of anxiousness. Patient during observation did not present with any signs of redness, rash or itch but soon developed an indigestion feeling and chest pressure without any signs of anxiety or hyperventilation. Lungs remained clear, grips equal with suggestion of Neuro. No swallowing concerns and speaking full sentences. Vital signs initially 146/82, 96 on cardiac monitor, 14 and 99% room air.  Worked thru additional assessment with pain rated as a pressure at "4" not subsiding with therapeutic conversation, slight anxiousness remains. Patient agreed for EMS transport with a slight pressure on transfer to the ED. 118/84, 93 on cardiac monitor with good pulses.
I received my second dose of the Pfizer vaccine in April 2021 and about 3 weeks later (May 2021)  I start developing hives. Uncontrollable hives all over my body, from head to toe. The hives are completely sporadic and can appear anywhere at any time. The hives are raised bumps, red, and itchy. I have been to a dermatologist, an allergist, and a primary care doctor that cannot give me a clear explanation for my hives. The doctors asked me what has changed in my lifestyle since the hives appeared and the only thing that has changed is getting the second dose of the vaccine.  I am going on 9 months now struggling with these awful hives/itch every day with no hope in sight. The antihistamines (Zyrtec and Allegra) give me temporary relief but the hives always come back. I needed up in urgent care at one point since the hives were so severe that my foot and hands were swollen and the hives were causing me severe joint pain.
5 1/2 cm x 5 1/2 cm erythema left thigh
Pfizer-BioNTech 12 years of age or older formulation (purple cap) administered to a child age 5 through 11 years.
Patient was issued Moderna by mistake. Patient is under the age of 18. No adverse effects due to Moderna dose.  Patient just under age 18.
Moderna COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization/Death. Rec'd Moderna vaccine on 3/18/2021 and 4/19/2021. Presented to ED with acute onset of SOB which started at 1 AM associated with chest tightness, non-productive cough, one episode of n/v. Admitted with acute hypoxic and hypercapnic respiratory failure and elevated lactic acid up to 5. CXR was concerning for PNA with fluid overload. Pt was placed on BiPAP but ABG did not show any improvement. Pt was transitioned to comfort care and pt expired on 10/14/22. Pt treated with cefepime, zosyn, vacomycin, and solumedrol.
onset of rash 3 days p/vax w/inc itchiness & area effected, seen in MD office 10JUL97 as new pt;dx rxn to immun as erythema mult & tx w/DPH;
Severe headache for 18-19 hours. Lower back muscle ache 2 hours. Chills intermittently all day (no fever). Nausea all day.
Information has been received from consumers concerning their "teenager" daughter who started to receive GARDASIL series over a year ago. The patient experienced seizures 3 weeks later after she received the 3rd dose of GARDASIL (date, lot number not reported). At the report time the patient had recovered. Upon internal review, seizures was determined to be another important medical event. Additional information is not expected.
This spontaneous report as received from a healthcare worker refers to a 4 month old male patient. The child was supposed to be vaccinated with PREVNAR, but inadvertently received MMR II 0.5ml (dose, route, frequency, lot# and expire date were unknown). No adverse effects reported. Additional information has been requested.
Following vax pt began to exp h/a; woke am of 27JAN92 w/severe h/a & diplopia; Seen by MD then went to hos for MRI, sp tap & lab work; 28JAN92 sx continued began having weakness; pt adm to hosp & given steroid therapy; cont to have diplopia
Pt vaccinated with Recombivax HB experienced Bell's Palsy w/paresthesia of the lt side of her face, headaches, blurred vision in her lt eye, a low-grade fever, malaise, hypotension, & mild bilateral sensory hearing loss.
Td given 2/20/07-developed fever and arm pain 2/21/07. Mid afternoon-called primary care physician 2/22/07-asked to to come in for evaluation-temp 101.8-inject site 10mm swollen, painful, red and hot. Treated with Keflex 250mg four times a day for 10 days.