chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a licensed practical nurse referring to a 30 year old patient of an unknown gender who on 10-APR-2013, was vaccinated with a dose of MMR II (lot# H011889, expiration date, 25-JUN-2014) 0.5 ml, subcutaneous in the right arm, which was improperly stored. MMR II was stored at 48 degrees F for total hours of 25.5. Per National Service Center - potency projection indicated administered doses of MMR II was expected to maintain a potency within label usage. This is one of several reports from the same reporter source. Additional information is not expected.
Information has been received from a physician's assistant concerning a female patient who was vaccinated with a dose of PNEUMOVAX 23 roughly a year ago, in approximately 15-JUL-2009. Approximately one year ago,after vaccination the patient had a lot of swelling and redness in the upper arm around the injection site which developed into cellulitis which lasted for two to three weeks. The patient sought medical attention by going to the doctor's office. Additional information has been requested.
This spontaneous report received from a patient concerned a 79 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included suffers from sciatia nerve pain.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 02-APR-2021 to left arm for prophylactic vaccination. Concomitant medications included cyanocobalamin/pyridoxine hydrochloride/thiamine hydrochloride for pain, and tramadol for sciatic nerve pain.  On 02-APR-2021, the subject experienced vomiting. On 02-APR-2021, the subject experienced achiness. On 02-APR-2021, the subject experienced sore arm. On 02-APR-2021, the subject experienced headache. On 03-APR-2021, the subject experienced chills. On 04-APR-2021, the subject experienced cough. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, and chills on 03-APR-2021, and cough on 05-APR-2021, and was recovering from headache, sore arm, and achiness. This report was non-serious.
The pt received the vaccine and mom called 1 1/2 to 2 hours later reporting the baby was very fussy with a fever, arching back, unable to calm him. The baby slowly improved over the next 48 hours. The baby had mild diarrhea 24 hours later.
After received HPV vaccine, 8 min later - up walking and talking in hallway, then passed out for approx 10-15 sec. Then awake, alert, responsive. No complaints. Vital signs stable.
Initial misuse report received from a healthcare professional on 13 September 2013. This is an invalid case as individual patient identifiers are not reported. The patient had received ACTHIB which was mixed with MMR diluent. No information was provided regarding the patient. No adverse event was reported. List of documents held by sender: none.
Patient noticed a rash on her chest two days after receiving vaccine - she went to a walk in clinic and was told it could be the vaccine, but as she had no other side effects, no treatment was prescribed.
Hallucinations,  headache,  vomiting,  chills,  large heated bump at injection site left arm
Child was noted to have complex partial seizures where she would hum and run fingers through hair 4-6 X day.  After 1st dose of H1N1.  Activity started 2 wk's after 1st dose.  Received second dose of H1N1 and began having convulsive seizures 3 wk's after dose.  (1st seizure 1/24/10).  Mother did not note any unusual behavior on second H1N1 form.  My understanding is that child was not brought into the ER immediately following seizure activity.  Mom waited 1.5 days to have child seen.  No fever was experienced with either dose.  This event was reported to HD on 1/29/10 by mother of child.  She stated she has been the only witness to this activity.
was administrated with Kinrix instead of Pediarix; was administrated with Kinrix instead of Pediarix; This case was reported by a physician via call center representative and described the occurrence of wrong vaccine administered in a 4-month-old patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: No information about patient's identifiers, lot number, expiration date and vaccination date was provided. The patient received Kinrix instead of Pediarix which led to wrong vaccine administered at the age of 4 months which led to inappropriate age at vaccine administration. No adverse event was reported. The reporter consented to follow up.
This spontaneous report as received from a registered nurse refers to multiple unspecified patients who were administered vaccines which were stored improperly. This report refers to the patients who on unknown dates were vaccinated with RECOMBIVAX HB that were stored improperly. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
had an infection; This is a spontaneous report received from a contactable consumer from medical information team.  A 74-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. Relevant medical history included: "heart transplant", start date: 2001 (unspecified if ongoing), notes: 20 years prior; "skin cancer" (unspecified if ongoing), notes: which had an infection. The patient's concomitant medications were not reported. The following information was reported: INFECTION (non-serious), outcome "unknown", described as "had an infection". Therapeutic measures were taken as a result of infection.  Additional information: The reporter mentioned that his husband had a heart transplant 20 years ago, and also developed skin cancer which had an infection. He was prescribed cephalexin 500mg capsule for this infection. The patient was scheduled to get the second dose of the vaccine on 26Mar2021. The reporter was seeking information if the vaccine would have an effect with infection, and vice versa.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
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 09-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 09-Oct-2017, the patient was given vaccine from a vial that leaked. It was reported that, after piercing the vial, when it was turned upside down and upon injection air, vial was dripping from the rubber seal. The nurse could withdraw only 7 doses from the vial. The patient was administered with full dose of vaccine. There were 2 defective units, but the package was not damaged or wet. The nurse used 23 needle gauge of size 3cc. The PTC (product technical complaint) number provided for 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 know 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 on 21-Nov-2017: Added PTC number and the QA (quality assurance) report results. Narrative amended accordingly. Non-significant case correction received 18-Oct-2017: The verbatim of the event 'product leakage' was corrected and the lead sentence in narrative was amended.
Pt had a syncopal event. Vitals: 112/67, 82, O2 100% Pt given crackers and juice.  Pt stable and released from the vaccination site.
Occasional chills; mild chest pain with deep breath; mild chest pain with deep breath; This is a spontaneous report from a contactable consumer (reporting for a patient). A 46-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were not reported), via an unspecified route of administration on the left arm on 08Jan2021 12:00 at a single dose for COVID-19 immunization. There was no other medical history, had no known allergies. Concomitant medications were not reported. The patient did not have COVID and did not receive other vaccine in four weeks prior to vaccination; did not have other medication within two weeks and was not pregnant at the time of vaccination. On 08Jan2021, the patient experienced occasional chills and mild chest pain with deep breath. No treatment was given for the events. The patient has not been tested for COVID post-vaccination. Outcome of the events was recovered on an unspecified date.   Information on the lot/batch number has been requested.
Swollen, red, and itching arm. Blisters present. Patient is using Bendaryl.
Information has been received from a nurse practitioner, via a company representative, concerning a female patient (age not reported), who on an unknown date was vaccinated with the first dose of Gardasil (lot # not reported). The NP stated that "before she could remove the needle from the patient's arm her eyes rolled into the back of her head and she began having seizure-like convulsions." The episode lasted for less than 1 minute, and the patient fully recovered. The patient's mother did not want her daughter to finish the vaccination series. The patient sought unspecified medical attention. Upon internal review, the event was considered to be serious as an other important medical event. Additional information has been requested.
Narrative: The patient received three doses of Pfizer COVID 19 Vaccine in Jan,Feb,Oct 2021. The patient tested positive for COVID 19 on 8 Feb 2022. The patient presented to the ED with shortness of breath and weakness. The patient was admitted on 8 Feb 2022 with covid pneumonia, afib, and anemia. The patient was treated with remdesivir and dexamethasone. The patient's condition did not improve. The patient was referred to hospice care on 4 March 2022. The patient died on 14 March 2022 of respiratory failure and covid pneumonia. Reported per EUA.
Doppler confirmed DVT on same date; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 23Nov2022 at 14:30 as dose 5 (booster), single (Lot number: GH9702) at the age of 73 years, in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: VALSARTAN & HCTZ; LEVOTHYROXINE; LIOTHYRONINE. Vaccination history included: moderna (DOSE 4 (BOOSTER), SINGLE, lot number=005M217), administration date: 14May2022, for COVID-19 immunization; Moderna (DOSE 1, SINGLE,  lot number=037K207), for COVID-19 immunization; Moderna (DOSE 2, SINGLE,  lot number=023m2017), for COVID-19 immunization; Moderna (DOSE 3 (BOOSTER), SINGLE, lot number =026021A), for COVID-19 immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 23Nov2022 at 14:30, outcome "not recovered"; DEEP VEIN THROMBOSIS (medically significant) with onset 15Dec2022, outcome "not recovered", described as "Doppler confirmed DVT on same date". The event "doppler confirmed dvt on same date" required physician office visit. The patient underwent the following laboratory tests and procedures: Ultrasound Doppler: (15Dec2022) DVT, notes: Doppler confirmed DVT on same date. Therapeutic measures were taken as a result of deep vein thrombosis.  Clinical course: It was reported that after receiving vaccine, about a week or so later noticed swelling and tenderness left lower leg. Saw Doctor on 15Dec2022. Doppler confirmed DVT on same date. Eliquis started that day. She was a healthy, active 73 year, Play golf 3-4 times each week. Clean, cook, run errands, etc. She had no reason to have developed DVT. No long car trips, no air flights, no medical issue requiring bedrest. No previous blood clotting disorder. No meds that cause clotting. The patient received unspecified multivitamin medication. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine.
Patient experienced post-vaccination syncope and fell out of chair. Patient denies any pain and/or injuries. EMS was called. BP was within normal limits before EMS arrival. Patient declined juice and crackers and walked to medical tent with EMS. Patient was sent home with spouse.
I expeirienced Body aches and cramoing. It was not sharp pains like cramping but a dull pain and was very stift/sore till next day, approx 18 hours. Mild headache
Left arm pain, chills and shivering, headache noted 30 minutes after vaccine administered, intense headache, developed fever tmax 101.9.
Patient received a 3rd shot of Shingrix.   Patient was feeling pain and fatigue the following day 5/5/23.  Had to stay home from work.
Pt reported feeling numbness on the RIGHT side of her face She had redness by RIGHT ear. About 5 min. later numbness did not subside and pt. reported feeling like her RIGHT nostril was closing. Pt's RIGHT ear and RIGHT side of neck now displayed rash. Pt took EPI pen and had driver take her to ER. She appeared OK able to walk + talk. Spoke to at 3.5 hrs later and she was able to talk
Extreme fatigue, fever, pain in all joints, loss of appetite, headache, vomiting that lasted for 3 days.
This spontaneous report was received from a Nurse refers to a patient of unknown demography. On 14-MAR-2014, the patient was vaccinated with first dose of GARDASIL (0.5 ml) intramuscular that was improperly stored. No adverse effects reported. No further information provided. This case is linked to the case 1403USA008864 (same reporter link). Additional information has been requested.
Extreme exhaustion/fatigue, extreme joint pain,  exhaustion upon rising in the am, constantly resting/napping, brain fog when energy is depleted
Narrative:  Patient is a 59 year old male who was due for both the Prevnar13 and  Shingrix Vaccinations. He received both on 4/14/21, Prevnar13 in the L arm and  Shingrix in the R arm Patient presented to the ED on 4/19/21 with complaints of  burning pain to L elbow since receiving the vaccines. He was given Tordol in the  ED and discharged home on doxycycline, indomethacin, and Vicodin and  recommended to follow up with ortho. Patient never followed up.
Two minutes following vaccination, patient complained of heart palpitations/"strong/heavy" heartbeat. Patient reported pre-existing apical murmur to clinic staff, but noted today's symptoms were different/new. BP=108/68, HR=72, RR=20. Patient received liquid diphenhydramine 30mL/75mg PO 20min post-vaccination. Patient noted several minutes later symptoms improving, "heaviness" decreasing. At discharge 30min post-vaccination, BP=132/82, HR=62, RR=16, Sp02=99% on room air.
ITCHY RASH (RED BUMPS) COVERING FULL BODY WITH EXCEPTION OF THE FACE. RASH STARTED 2 DAYS AFTER VACCINATION AND WAS STILL PRESENT AFTER 2 DAYS OF TREATING WITH CHLORPHENIRAMINE. PATIENT INSTRUCTED TO CONTACT HEALTH CARE PROVIDER, TAKE ZYRTEC, AND APPLY HYDROCORTISONE CREAM TO AFFECTED AREAS.
85 y.o. male history of HFpEF (EF of 50 %), paroxysmal A. fib, T2DM, BPH, hypertension, hyperlipidemia, CAD, SSS, and chronic respiratory failure secondary to ILD on 2 L cannula at home presents to the ED with worsening shortness of breath.  The patient was found to be COVID-positive and was placed on BiPAP.  Patient weaned off BiPAP back to his baseline oxygen 2 L nasal cannula.  Pulmonology was following throughout this hospitalization.  Patient was also treated with steroids due to COVID infection and decline in history of status.  Per pulmonology patient to be tapered from 40 mg daily to 30 mg daily x7 days then continue with home 20 mg prednisone daily.  Patient also completed a course of remdesivir during this hospitalization.  While in the hospital patient endorsed that he needed some help at home.  Social work was consulted and patient was approved to have home health upon discharge.  Patient is stable and states that he is almost back to baseline.  Patient is stable enough to be discharged home this evening.   Acute on chronic respiratory failure-patient back to baseline O2 2 L nasal cannula COVID-19-completed remdesivir, continue steroid taper to home regimen of 20 mg daily Acute exacerbation of HFpEF-resolved Volume overload-patient seems to be back to euvolemic, continue home Lasix 40 mg daily Hypertension-continue home antihypertensive medication Paroxysmal A. Fib-continue home Eliquis Type 2 diabetes-continue Levemir 8 units nightly and metformin 100 mg twice daily BPH-continue home meds
6 hrs post injection, left upper cheek, red rash with slight swelling next day: 3/23/21 -same with slight reduction in swelling, no blister- prescribed valacyclovirhclovir 3/24/21   lab results    varicella zoster  Ab IgM      1.24 index (positive>1.09) varcilla zoster  3/25/21 redness and tearng left eye, MD opthamology  exam = no cornea damage
Pt stated feeling nausea, mother stated pt passed out for 15 seconds then gained consciousness. P:80  BP: 126/79 O2: 99% T: 77.5 F RR:14
Diarrhea; This is a spontaneous report from a contactable consumer or other non hcp (patient). An 80-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0151), via an unspecified route of administration, administered in arm on 07Apr2021 (at the age of 80-year-old) at dose 2, single for covid-19 immunisation. Medical history included hysterectomy (Additional Information: Done when the caller was 31 years old). Concomitant medication included omeprazole (OMEPRAZOLE) at 20 mg; lisinopril (LISINOPRIL) at 20 mg once a day taken for blood pressure measurement; acetylsalicylic acid (ASPIRIN 81) at 81 mg once a day; calcium (CALCIUM) at once a day; cyanocobalamin (VITAMIN B12 [CYANOCOBALAMIN]). The reporter was taking 20 mg of the Omeprazole and then her doctor increased it when the diarrhea started. Lot, NDC, and expiration date unknown. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EP7534), via an unspecified route of administration, on 17Mar2021 (at the age of 80-year-old) at dose 1, single for covid-19 immunisation. No reaction on previous exposure to vaccine. On 09Apr2021 the patient experienced diarrhea. Adverse event led to physician office visit. The reporter is calling about the Pfizer covid vaccine. On 17Mar2021 the reporter had her first shot and everything was fine afterwards. On 07Apr2021 the reporter had her second dose, she was in at the time. 2 days after the second shot the reporter got diarrhea when they were leaving to come back and it wasn't very pleasant. The reporter had the diarrhea for 4.5 weeks. The reporter went to her doctor after having the diarrhea for 2 weeks and the doctor started her on rice and all sorts of things, some diet. The reporter was sticking to the diet and it didn't do any good. The reporter doctor referred the reporter to the colonoscopy doctor. The reporter had the colonoscopy last Friday and they found nothing. The reporter felt like the diarrhea came from the shot. The diarrhea left after 4.5 weeks and then 2 weeks after that, the caller had the colonoscopy. Event: The caller clarifies and confirms that before the colonoscopy the diarrhea has stopped probably a week and a half prior. First Dose: Received 17Mar2021, lot EP7534, unknown expiration date and NDC. Second Dose: Received 07Apr2021, lot EW0151, unknown expiration date and NDC. Investigation: The reporter had routine blood work done a couple of days ago and said it was fine. The reporter would not get a booster shot if we offered it because she doesn't want to go through this again. The patient underwent lab tests and procedures which included Blood work: normal on an unspecified date, colonoscopy: normal on 18Jun2021. Description of Product Complaint: The reporter was taking 20 mg of the Omeprazole and then her doctor increased it to 40mg when the diarrhea started. Lot, NDC, and expiration date unknown. Outcome of the event was resolved on an unspecified date in 2021.
Insulin syringes inadvertently delivered and 1 was used to vaccinate a patient. 100 unit syringe,  30 units were administered.  Person vaccinated was unknown  we were unable to identify the patient.  No averse outcome that we were aware of.
6 hours post vaccine: sore arm, chills 24 hours post vaccine: fever (101-102), chills, myalgias, headache, severe soreness at injection site (no other symptoms). All symptoms resolved by 48 hours post vaccine.
Information has been received from a physician concerning a patient who was vaccinated with a dose of Zostavax. It was reported that the patient was healthy and after vaccination, the patient ended in hospital with pneumonia. At the time of report the patient was recovered. Additional information has been requested. This is one of several reports received from the same source.
Information has been received from a physician concerning a female who was vaccinated with 0.5 ml Gardasil (lot and batch number not provided).  Subsequently the patient experienced loss of vision and stomatitis.  The patient was reported to be recovering.  Upon internal review vision loss was considered to be an other important medical event.  No further information is available.
Hives the size of mosquito bites erupted in various places for 3 full days. The hives were itchy, pink in color, and raised above the skin. Locations included ankles, elbows, hand, middle finger, pinky finger opposite hand, thigh, breasts for a total of 15.  Hives became darker red and smaller, but still visible today (11 days later). Day 9 after the vaccine, at the injection site the skin became pink, raised, and itchy in a patch approximately 2" by 3".  The itch and growth of the inflammation subsided the next day but is still visible today (11 days after injection).
Patient was able to ambulate out of clinic on own but while in the parking lot became lightheaded and weak. Patient walked several steps while leaning against her mother and had a controlled fall to the ground where she laid on her back for a moment but was able to sit up until nurse arrived. Patient denies syncope and injury or pain related to fall.
Patient stated arm and shoulder swollen. Unable to sleep or work. He is in a lot of pain. This has not happened with flu shots in the past.
In the evening I had a sore throat.  I tested negative.  The next day, the 25th, I had a large amount of mucous production and a cough.  I started run a fever of 104 degrees that evening.  The morning of the 26, I tested positive and contacted my doctor who prescribed Paxlovid.  I felt much worse of at that point.  Huge amount of mucous production and coughing.  I never lost my sense of taste.