chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient presented to clinic on 24 March 2021 with 4 days of leg pain and swelling. He had no injury or recent travel. An ultrasound was performed that day and patient was placed on a course of Eliquis for three months. Patient then had a second, unprovoked clot while off of Eliquis in August 2021. In April 2021 patient had a normal lab work up for predisposition to clotting.  This has prompted his hematologist to place him on anticoagulation therapy indefinitely moving forward. Patient essentially has developed a predisposition to clotting approximately 10 days after his second dose of the Moderna Vaccine. He will remain under the care of hematology.
Bad pain everywhere, dizziness, blurred vision, ringing in ears, deafness, difficulty breathing, hair/eyelash loss, eye lesions, sleep apnea, difficulty walking.
Patient began feeling hot flash symptoms, breaking into a sweat, queasy in stomach. Patient states he began to feel better after he laid down. 1st innoculation of anthrax.
Patient reported to pharmacy with complaints of prolonged arm soreness and reduced range of motion one month after receiving vaccine.
Patient had a reaction on his left arm that measured 2 in by 3 in. Area is red, warm to touch, hard and painful. Treated with KEFLEX.
Pt recv vax on 12/15/98; 15 min post vax pt exp red, swollen, sore Rt arm; joint aching; itchy upper body; hives; tx=Benadryl PO, Epinephrine SC, SoluMedrol IV, Medrol dose pack
I feel very light-headed, as with fever but no fever. My whole body has kind of a dull ache...aspirin doesn't seem to help. I feel a little nauseous. Nothing debilitating, but all in all an unpleasant morning at work.
This spontaneous report was received from a Registered Nurse and refers to an unspecified number of patients of unknown ages and genders. The patients' pertinent medical history, concurrent conditions drug reactions or allergies were not reported. On an unknown dates in 2016, the patients were vaccinated with improperly stored RECOMBIVAX HB, lot number M001578, expiration date 21-NOV-2018, by intramuscular route, (frequency and anatomical location were not provided). No adverse effects were reported. The temperature and time frames were: on 24-AUG-2016, 34 Fahrenheit degrees for 14 hours, and, on 29-AUG-2016, 30 Fahrenheit degrees for 14 hours; there no were any previous excursion and digital data logger was not involved. Product quality complain was not involved. No other suspect or concomitant therapies were reported. This is one of several reports from the same reporter. Additional information has been requested.
severe headache, body aches (especially on her neck), soreness on the injection site, fever and pain; severe headache, body aches (especially on her neck), soreness on the injection site, fever and pain; severe headache, body aches (especially on her neck), soreness on the injection site, fever and pain; severe headache, body aches (especially on her neck), soreness on the injection site, fever and pain; severe headache, body aches (especially on her neck), soreness on the injection site, fever and pain; A spontaneous report was received from a consumer concerning a 58-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events severe headache, body aches (especially on her neck), soreness on the injection site, fever and.  The patient's medical history was not provided. Concomitant medications reported were Bupropion for drug use for unknown indication.  On 14 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 029l20a) via unknown route in the right arm for prophylaxis of COVID-19 infection.  On 11 Feb 2021, the patient experienced the event(s) severe headache, body aches (especially on her neck), soreness on the injection site, fever and.  Treatment details included Alka-Seltzer.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), severe headache, body aches (especially on her neck), soreness on the injection site, fever and was unknown.
11/23/2011 - Pt presented for flu vaccine. Pt tolerated well. Pt represented to office following week with c/o soreness, stiffness, and swelling. Pt was seen by Dr who referred he to Dr for possible shoulder effusion.
stroke after taking your two vaccine shots for covid; right side is totally paralyzed; speech is slurred; very hard to even talk; This is a spontaneous report from contactable consumer (patient, self-reporting). A 79-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: Unknown; Expiry Date: Unknown), dose 2 via an unspecified route of administration in 2021 (at the age of 79-years-old) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: Unknown; Expiry Date: Unknown) dose 1 via an unspecified route of administration on 13May2021 as single dose for COVID-19 immunisation. The patient did not know about receive any vaccines within four weeks prior to the vaccination. Consumer sated, first vaccine date was 13May. In 2021, the patient had a stroke after taking two vaccine shots for Covid. Consumer further stated, he wanted to talk about, his right side was totally paralyzed. He had such, speech was slurred and he truly, he was only supported by disability and all his money was gone, he cannot get any bathtub or toilet in the house and his home therapists was running out of insurance and he need help. Consumer stated, he had a stroke, he was not a doctor. This was hard for him; it was very hard to even talk. Consumer stated, he did not remember start date of event, it was just a couple of weeks after he took the shot. He did not like giving his medical history. He was explaining that he got a stroke. Now, he had got all kinds of stroke medicines, he was taking (not clarified further). Consumer stated, He had a lot of lab tests, but he did not know what they were. He had been in a hospital, 8 weeks. He did not need to get on case book, this was ridiculous. He did not question for the stroke. Consumer stated, He did not remember anatomical site of administration, He thought it was in his left but he was not sure. Reporter seriousness for events was unspecified. Outcome of all events was unknown.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
approximately 48 hours - severe headache, joint and muscle aches, temperature of 100.9 took Ibuprofen
Swelling/on the same arm where he got the shot is 'like swollen'; his underarm, underneath, on the same arm where he got the shot is 'like swollen'; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A male patient received bnt162b2 (BNT162B2), administration date 12Nov2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE SWELLING (non-serious) with onset Nov2021, outcome "unknown", described as "Swelling/on the same arm where he got the shot is 'like swollen'"; AXILLARY MASS (non-serious) with onset Nov2021, outcome "unknown", described as "his underarm, underneath, on the same arm where he got the shot is 'like swollen'".  Additional information: Reason for no lot number: of COVID-19 Vaccine: Reporter unwilling to complete the report. Expiry Date of COVID-19 Vaccine: Unknown.   The lot number for bnt162b2 was not provided and will be requested during follow up.
This spontaneous report was received from a medical assistant and refers to a multiple unspecified patients of unknown ages and genders. The patients' pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On an unknown dates, the patients were vaccinated with improperly stored doses of GARDASIL 9, lot number M031557, expiration date 07-APR-2019, (strength, dose, dose number, route and anatomical location were not reported), for prophylaxis. The temperature was between 32 and 36 Fahrenheit degrees during 7 hours, and, below 32 Fahrenheit degrees (the lowest temperature was 29 Fahrenheit degrees), during a time frame of 6 hours. The vaccines did not experience any previous temperature excursions. The digital data logger was involved. No adverse effects were reported. No product quality complain was involved. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA005634: US-009507513-1702USA008037: US-009507513-1702USA008035: US-009507513-1702USA008036:
Extremely sick, fatigued, headache, lethargic, sore throat, and winded.
Loss of consciousness, Twitching arm and legs...After given shot, immediately went to check out of dr office and she lost conciousness and fell against wall.  I was able to keep her from falling to floor.  Dr staff and Dr Checked BP is was extremely low and her arms and legs were shaking like seizure for about a minute.  She regained consciousness within 3-4 minutes and began to feel normal (but embarrassed)...Seems ok this morning, at this point just concerned about continuing with round 2 and 3 of this vaccine?  No previous adverse vaccine reactions.
Petechiae below the right knee. Per the patient, she also experienced this same rash when she had COVID-19 disease back in December 2020.
Pt recvd 1st dose of Hep B vax on 23JUL91 & 1 to 2 days p/vax pt devel a rash & petechiae on lower extremities; Pt had no angioedema, fever, or arthralgias; pt later recovered;
patient experienced COVID-19; patient experienced COVID-19; Lowered antibodies in immune sysytem; FACILITATED COLLECT  This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4252311-00.  A 62 year-old female patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation; adalimumab (HUMIRA), first regimen subcutaneous (Batch/Lot number: unknown) at 40 mg (citrate free (40 mg,1 in 2 wk)) and second regimen subcutaneous (Batch/Lot number: unknown) till Jan2022 at 40 mg (citrate free (40 mg,1 in 2 wk)) for colitis ulcerative, crohn's disease. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", SUSPECTED COVID-19 (medically significant), outcome "not recovered" and all described as "patient experienced COVID-19"; IMMUNOSUPPRESSION (medically significant), outcome "unknown", described as "Lowered antibodies in immune sysytem". The patient underwent the following laboratory tests and procedures: investigation: unknown results. The action taken for adalimumab was unknown.  The reporter's causality for the event(s) of COVID-19 with HUMIRA(ADALIMUMAB) was a reasonable possibility. The reporter's causality for the event(s) of LOWERED ANTIBODIES IN IMMUNE SYSTEM was not provided.  The reporter's causality for the event(s) of COVID-19 with PFIZER BIONTECH COVID-19 VACCINE(TOZINAMERAN) was possible. The reporter's causality for the event(s) of LOWERED ANTIBODIES IN IMMUNE SYSTEM was not provided  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on possible temporal association the causal role of BNT162B2 Vaccine cannot be excluded for reported events .Case will be reviewed further on receipt of FU information  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
Information regarding PREVNAR 13 was received from a healthcare professional regarding a 12-month-old female patient who experienced injection site reaction of swelling. At 12 months of age, the patient received a dose on 20-Jul-2010. The patient experienced injection site reaction of swelling in Jul-2010. Outcome is unknown. No additional information was available at the time of this report.
No additional AE reported.; an expired VAQTA was administered to a patient.; This spontaneous report has been received from a medical assistant referring to a patient of unknown age and gender. Information about medical history, concurrent conditions, concomitant therapies and drug allergies was not provided.   On 12-JAN-2021, the patient was vaccinated with an expired hepatitis a vaccine, inactivated (VAQTA) (0.5 ml, lot # S032359 has been verified to be a valid lot number, expiration date was 11-JAN-2021) via unknown route for prophylaxis (expired product administered). It was confirmed the hepatitis a vaccine, inactivated (VAQTA) had not had any temperature excursions. No additional AE reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S032359; expirationdate: 11-JAN-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
This spontaneous report was received from a registered nurse regarding a patient of unknown demographics. There was no information about concurrent condition and historical condition. On 29-AUG-2016 the patient was vaccinated with expired dose of GARDASIL lot # K008335/ expiration date- 23-JUN-2016. No concomitant medication was reported. No adverse event was reported. The outcome of event was unknown. No PQC(product quality complaint) was involved. Additional information has been requested.
11/24 Pt developed swelling from his wrist to jaw following administration of ZOSTAVAX that was treated w/ZRYTEC & prednisone. 12/16 some swelling still present around elbow very much improved.
BREAKTHROUGH COVID: FULLY VACCINATED 66 YR OLD 1.   Coronavirus disease 2019 - resolved s/p Paxlovid, completed 7 days of ceftriaxone. Initial diagnosis was on 06/29/2022 and repeat test on July 6 is negative.  He does not have any pulmonary symptoms and is not requiring any supplemental oxygen. Gross hematuria, History of deep venous thrombosis, has been on anticoagulation, Leukocytosis, Pulm nodules-s/o metastatic disease,  S/P cystoscopy evacuation of blood clots, transurethral prostate vaporization and fulguration 7/7/2022,  NEW DX OF DVT - Left Lower Extremity, IVC filter placement 7/13. CT urogram suggestive of large left renal mass with renal vein invasion and metastatic nodules to adrenal and lungs.
Cellulitis to Left Arm/ Pain, Redness, Swelling, Fever. Redness radiated down into wrist. Pt was put on antibiotics for the cellulitis.
Pt devel fever of 104, nausea & vomiting, h/a, & progressive weakness over a 2-day period starting 7 days p/immun; pt dx via spinal tap & postive cultures as having Neisseria meningitidis meningitis;
TRANSIENT CEREBRAL ISCHEMIA ACUTE HYPOXEMIC RESPIRATORY FAILURE HYPOXIA 12/19/2022 &  2/10/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Right upper extremity redness and swelling. Treatment: ice, BENADRYL, KEFLEX capsule TID x 7 days.
sore shoulder; chills; fever; passed out; sore; Bruise near the eye; falling down; dehydration; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (passed out) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023C21A and 044B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 27-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LOSS OF CONSCIOUSNESS (passed out) (seriousness criterion medically significant), PAIN (sore), CONTUSION (Bruise near the eye), FALL (falling down), DEHYDRATION (dehydration), ARTHRALGIA (sore shoulder), PYREXIA (fever) and CHILLS (chills). At the time of the report, LOSS OF CONSCIOUSNESS (passed out), PAIN (sore), CONTUSION (Bruise near the eye), FALL (falling down), DEHYDRATION (dehydration), ARTHRALGIA (sore shoulder), PYREXIA (fever) and CHILLS (chills) outcome was unknown.            He was given IV fluids as a treatment . No Concomitant medications were reported by the reporter.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Pt came in to receive booster vaccination. He received the vaccination as it was reported on his consent form and his vaccination card that he had only received 2 doses (04/26/2021 & 05/17/2021). The immunization information system was checked after the vaccination rejected through insurance and it was discovered that he had also received a dose on 10/8/2021 that pt did not account for on his documentation.
Pt called the following day with c/o fever >102, body aches, chilling and cough, encouraged Tylenol around the clock for the next 24 hours and push fluid intake, return call if no improvement. Thursday, August 13, pt was seen by PCP as no change in s/s other than temperature remained elevated over 103. Pt called this office and reported multiple lab tests done, including H1N1 and started oral atb. Pt's PCP notified this office 8/17/09 after business hours that H1N1 testing was negative as were other labs and he'd spoken to Matt who was feeling "fine" now. PCP reports "no doubt in my mind this was a vaccine reaction"
This spontaneous report was received from a pharmacist refers to unspecified number of patients of unknown age and gender. On unknown date the patients were vaccinated with PNEUMOVAX23 (dose, route and lot # were not reported). It was reported that on unspecified date the patients may have received more than one dose of PNEUMOVAX23. This is one of several reports received from the same reporter. Additional information has been requested.
I got my Covid Booster on Jan 3rd and started to notice smell and taste symptoms on the following Sunday.  Coffee smells and tastes like chemicals along with peanut butter and certain nuts, raw seasoning and popcorn. it's lasted two weeks. today Jan 20th I have a metalic taste in my mouth and awful smells have continued. My PCR was negetive.   I was covid positive in November  ( 5th-10th) and lost all taste and smell for two weeks. Other than that no major issues with covid or prior Vaccinations. I had Moderna for my first and second April 2021/ May 2021
This case was reported by a other health professional via call center representative and described the occurrence of hives in a female patient who received FLULAVAL QUADRIVALENT for prophylaxis. Co-suspect products included FLULAVAL QUADRIVALENT for prophylaxis. Concurrent medical conditions included allergy to chemicals. On an unknown date, the patient received FluLaval Quadrivalent at an unknown dose and FLULAVAL QUADRIVALENT .25 ml. On an unknown date, less than a year after receiving FLULAVAL QUADRIVALENT and not applicable after receiving FLULAVAL QUADRIVALENT, the patient experienced hives, pruritus, allergic reaction to excipient and underdose. On an unknown date, the outcome of the hives and pruritus were recovered/resolved and the outcome of the allergic reaction to excipient and underdose were unknown. It was unknown if the reporter considered the hives, pruritus and allergic reaction to excipient to be related to FLULAVAL QUADRIVALENT. It was unknown if the reporter considered the allergic reaction to excipient to be related to FLULAVAL QUADRIVALENT. Additional details were provided as follows: Age at vaccination was not reported. The patient was employee at the health care professional office. The patient was allergic to the formaldehyde. The patient gets the Flu vaccine yearly. When the patient received the full dose of FLULAVAL QUADRIVALENT, she breaks out in hives which were itchy. From the current season, the patient gets the vaccine (FLULAVAL QUADRIVALENT) administered as half a dose at a time, which led to underdose. The reporter was not aware of the patient's having any reaction with the current administration.
Child has small flat prickly rash all over body. Has had rash approx 4 days. Has also had fever ranging from 101-102 (axillary)
Inflamed, itchy, painful, 3x3 inch round swelling at the injection site.
pt recvd vax on 10FEB92 & 13FEB92 exp vomiting & diarrhea & the next day devel angioedema w/swelling of face, which was most pronounced around eyes & eyelids; also had swollen hands; No further details were provided;
Right shoulder soreness, redness, 24 hours after DTaP given; slightly indurated ~ 4 x 3 area.
My wife had tested positive COVID-19 in January 2023. We had been quarantining away from each other as I had some meetings to attend to and I did not want expose anyone. Out of caution I did test myself on February 4, 2023, with a home COVID-19 test, it came back positive; I called and spoke a physician's assistant at the doctor's office. We discussed my positive COVID-19 test and my symptoms, we decided against the antiviral in part because of my blood pressure medications and in part that I was mainly asymptomatic.
Patient presented to ED with complaint of URI signs and symptoms including increased productive cough with purulent sputum production and shortness of breath and congestion. Patient?s family reported patient his pulse ox was 86% and seemed more out of breath than usual. Patient used Albuterol and Atrovent nebulizers at home, but he does not use them very much. Pfizer vaccine 2nd booster received 5/17/22. Chest X-ray-Positive for atelectasis and/or scarring present in the right lung base increased. Patient was placed on 2 L of oxygen via nasal cannula, continue oxygen, continue breathing treatment, RT protocol, steroid management for COPD exacerbation and COVID-19 virus infection -Continue isolation per protocol -Consult infectious disease.  No further information in known about this patient?s outcome. Please contact patient?s provider for any additional information.
Td vaccine given to the patient that was expired for 3 days. Mother reports that child had low grade subjective fever last night, mother gave him tylenol and he felt better, he woke up well next morning, with mild soreness at injection site, and was able to go to school. Mother advised to monitor child's symptoms. Follow up appointment schedule. All questions and concerns were discussed at length with mother.