chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 02Oct2022 at 14:30 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 46 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and 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. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Dec2022, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
12 hours after receiving the second shot of the vaccine I woke up in pain. My pelvis and legs and ankles ached. As well as my arm at the site of injection. My temp was 99.8. I took  one tylenol around 8:30 am. As the day went on it got worse. I took one tylenol at 10:30 am. I was nauseous, my heart was racing, I felt like I was going to pass out, my arms and legs began to tingle. My temperature peaked at 102.5 around 5pm. All of my joints ached severely. It felt like my pelvis had been crushed. Even laying my knees on top of each other while laying on my side was too much pressure on my knee joints. The only other time I've felt like this is when I had Influenza A. At 8:30 pm I took one tylenol and one benadryl and was finally able to sleep. A few hours after taking the medication the joint pain had greatly decreased.  In the morning I no longer had a fever.
Muscle ache, chills, 102 fever, lethargic-lasted 2-3 days.
After injection in automatic terrible taste in my mouth like I could taste the vaccine. Return  For 20 days experienced severe diarrhea morning noon and night.
Patient stated she had a seizure the day after receiving the vaccine and 4 more the following day. Previously her epilepsy had been under control with no seizure activity during a 6 day observation at the hospital.
Patient presented 2 days post vaccination with a red, raised bump at vaccination site. Told pt to monitor.
Complaints of nausea, chills, abdominal cramps 14 hours after 2nd capsule, increasing in intensity 5 hours after 3rd capsule. No fever, vomiting, rash, diarrhea, respiratory difficulties.
Rash/marks all over body.  Appeared approx. 3 weeks after vaccination.
stroke like symptoms, dizziness, visual disturbance, left side weekness, lethargic
felt flushed, developed hives on forehead and forearm; took 25mg of Benadryl, symptoms went away.
Generalized Urticarial rash 9 days post MMR +facial swelling - generalized arthralgia.
lumps developing in the collarbone or neck area and headaches, got worse in the past 4 days.
Small seizure. He fell to his needs then stiff as a board fell forward onto his face hitting his nose. He seemed like he started to come to and then his eyes went wide and stared off as his body got stiff, his arms went straight to the sides in the air and his body started to bend backward. The doctor and nurses came and monitored him and then it was over. Probably lasted a minute or two maybe. They checked his vitals, waited for him to calm down, as he was in hysterics the moment it ended and had him walk to make sure he was okay. He fell asleep shortly after we got home and slept for a few hours.
Weak / that lasted for 24 hours; Tired / that lasted for 24 hours; Achy that lasted for 24 hours; This case was reported by a consumer via other manufacturer and described the occurrence of weakness in a 53-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced weakness, tiredness and pain. On an unknown date, the outcome of the weakness, tiredness and pain were recovered/resolved.   It was unknown if the reporter considered the weakness, tiredness and pain to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported but could be 52 or 53 years. The patient had no medical history. The patient had no family medical history relevant to adverse events. In 2020, about 6 months ago, the patient received 2nd dose of Shingrix and experienced weak, tired and achy that lasted for 24 hours. No relevant tests were performed. The patient did not have the physician email to provide. The reporter consented to follow-up the primary healthcare professional.
+ Urticaria throughout body and arms and legs, + pruritic, facial swelling, no dyspnea or SOB
Information has been received from a physician concerning a 20 year old female who on 02-APR-2009, was vaccinated intramuscularly with third 0.5 mL dose of GARDASIL (lot number not reported). The physician reported that on 02-APR-2009, the patient "fainted and hit her head" after receiving the third dose of GARDASIL. The physician reported that the patient did not experience adverse events after the first and second doses of GARDASIL. The patient sought unspecified medical attention. Additional information has been requested.
Developed muscle aches, fatigue, cough, congestion, and mild headache on 5/26/2021. Tested positive for COVID on 5/28/2021, with SARS CoV2 RNA NP swab. Advised to go to the ED, with regard to history of Asthma with respiratory manifestation of COVID. Went to the ED, and administered Decadron IV, vitals monitored, EKG and CXR performed, and labs drawn. Labs showed mild anemia, a low WBC, and Lymphcytopenia. Normal EKG and CXR. Given Prednisone orally for 5 days, Zithromax Z-Pack, and Ivermectin 5 day oral course. Returned to the ED on 5/31/2021 for administration of IV monoclonal antibody infusion and repeat Labs/Vital sign evaluation. Remain on 10 quarantine up to today, with ongoing mild SOB and cough unremitting.
This case was reported by a consumer via call center representative and described the occurrence of ankylosing spondylitis in a male patient who received ENGERIX B for prophylaxis. On an unknown date, the patient received ENGERIX B adult. On an unknown date, unknown after receiving ENGERIX B adult, the patient experienced ankylosing spondylitis (serious criteria GSK medically significant), pernicious anemia, gastritis, vitamin d deficiency and vitamin b12 deficiency. On an unknown date, the outcome of the ankylosing spondylitis, pernicious anemia, gastritis, vitamin d deficiency and vitamin b12 deficiency were unknown. It was unknown if the reporter considered the ankylosing spondylitis, pernicious anemia, gastritis, vitamin d deficiency and vitamin b12 deficiency to be related to ENGERIX B adult. Additional information received as follows: The patient reported that in 2013, after receiving ENGERIX B adult, he experienced pernicious anemia, ankylosing spondylitis, Vitamin B12 deficiency, Vitamin D deficiency and autoimmune gastritis. No any any further information was provided. The patient had denied permission to contact their physician.
Entire left arm has a tingling/ buzzing sensation. It comes and goes about 3 times a day. There is no regular pattern. It lasts a few seconds but strong enough for me to feel it going from top of the arm to the wrist.
Pt received 2nd dose of hepatitis; injection site/shoulder was very sore one day after injection, lasting 2-3 days. Pain progressed to other joints ie, hands, ankles, feet, hips etc., has now been 3+ months. Also muscle aches.
pt had vax 3PM by 4PM high pitched scream for 5 hrs; t102,  lethargic & eyes rolled back; would sleep for hours; took to MD; diaper rash x 6 wks;
Severe Breathing difficulty-at 1st thought was anaphylactic reaction. Less that 10min after shot gave shot EPI PEN (one) got better EMT came stayed 30min got better-seems more like Bronchospastic asthma episode.
Patient had brief syncopal episode about 2 minutes after the vaccine was administered causing her to fall out of the chair on to the floor. Episode only lasted about 10-15 seconds. She was previously asked to wait in our office 15 minutes after administration, therefore, she was waiting in our exam room at the time of incident. Patient rested x 20 minutes and given Powerade after the incident. She returned to baseline and was sent home with mom with recommended observation.
Hands have gone numb quickly over last 2-3 months starting with right hand and up my arm and to my left hand and up. In the last three weeks I have been having numbness growing up my legs rapidly. I am having issues holding things, walking, everyday activities. It does not hurt other than when I walk after sitting. I feel as if this vaccination has triggered something and my doctors are working to find out exactly what it is.
Varicella vaccine breakthrough. Developed rash 5/17/06. No fever. Dx'd by doctor with vaccine modified varicella on 5/18/06. Had over 50 micro-vesicular lesions on trunk, arms and legs.
MOD COVID VACCINE GIVEN AT 1340.  WAS ADVISED TO REMAIN IN LHU X 15 MIN.  PATIENT DECLINED DUE TO DID NOT HAVE A REACTION TO FIRST COVID VACCINE.  PATIENT WENT TO CAR, THEN RETURNED TO BUILDING WITH COMPLAINTS OF SUDDEN LOWER BACK PAIN, FEELING HOT, FLUSHED, ANXIOUS, AND HEART PALPITATIONS.  ASSESSED PATIENT.  PATIENT ANXIOUS, TALKATIVE WITH BP 142/91 PULSE 96 REGULAR AT 1346.  EMS CALLED.  BP 117/76, PULSE 83 REGULAR AT 1353.  EMS ARRIVED 1355.  PATIENT FEELING NORMAL AT THAT TIME AND REFUSED TREATMENT PER EMS.
Information has been received from a physician's office manager concerning a 7 year old male who on 31 July 1999 was vaccinated with a 0.5 ml dose of varicella virus vaccine live (Oka/Merck). The office manager reported that on 14 December 2005, the patient broke out with several vesicular lesions and developed a low grade fever. Unspecified medical attention was sought, but no treatment was given. It was noted that the patient missed one week of school. Subsequently, the patient's vesicular lesions and low grade fever resolved. Additional information has been requested.
Vaccine was painful but then pain partially subsided, then came home and had chills, temp 96F. Went to bed and had muscle aches, pains and headache. Next morning felt flu like symptoms, malaise especially. Tried to work and could only work 3 hours. Arm remained sore.  14 days later still experiencing soreness in injection site (does not appear swollen), tender to the touch. If arm is lifted up then feels like it is "pulling on something."
Patient was administered the monovalent Covid 19 booster instead of the intended Bivalent Pfizer Booster. She was notified by the provider on the same day, and she was counseled about the differences between the boosters, and informed that based on medical history that although dose did not need to be repeated, if an additional dose with the bivalent vaccine for additional protection from the targeted variants was preferred, she could return in 8 weeks to be vaccinated.
This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unknown date, the patient was inadvertently vaccinated with an expired dose of RECOMBIVAX HB (strength, dose number, anatomical location and route were not provided) lot # K014697, expired date on 04-FEB-2016. Concomitant therapies were not provided. No adverse event was reports. No product quality complaint was involved. Additional information has been requested.
pt recv vax 24JUN95 & that same day pt exp 1 focal seizure & 1 sz w/o fever;prev hx of febrile sz in past unrelated to vax;pt was reported to have recovered from this exp;
gave a patient the Hib component of PENTACEL that was reconstituted with sterile water with no reported adverse event; Initial information received on 27-Jan-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 1 years old male patient who experienced gave a patient the hib component of pentacel that was reconstituted with sterile water with no reported adverse event while receiving vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE INACT (VAQTA) for Prophylactic vaccination.  On 25-Jan-2022, the patient received a  dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot UJ577AA (Strength and expiry date was unknow) via intramuscular route in unknown administration site for prophylactic vaccination.  On 25-JAN-2022 the patient developed a non-serious gave a patient the hib component of pentacel that was reconstituted with sterile water with no reported adverse event (product preparation error) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL) was not applicable.  It was not reported if the patient received a corrective treatment for the event (gave a patient the Hib component of PENTACEL that was reconstituted with sterile water with no reported adverse event).  At time of reporting, the outcome was Unknown for the event gave a patient the hib component of pentacel that was reconstituted with sterile water with no reported adverse event.     This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Swelling and tenderness of dermal filler (chin) after the 2nd Moderna vaccine
Hives noted around 6pm the evening of dose #1. Small and only a few on wrist. Next day appeared on his neck. 11/8 top lip swelled in center. 11/8 older brother tested positive for COVID. Child began with a cough on 11/9 (child had 7 negative PCRs from 11-8 to 11-28). 11/10 hives on belly button and penis. Penis was swollen, sought medical care at Urgent Care.  Dr. told us to treat with Benadryl and start Claritin in the morning. She did not think this was an allergy to the vaccine and that child could get dose #2 when out of quarantine. Child continued to have hives appear sporadically. We would apply topical Benadryl gel, if the hives continued we would administer Claritin 24 hr. Hives continued. The hives are mild, appearing mainly on the torso and neck. Claritin keeps the hives away for 24-48 hours, occasionally longer. Some days we would give oral Benadryl at night (did not overlap with the Claritin) or apply topical Benadryl Gel.   Spoke with Pediatrician, Dr via telehealth consult on 11-30-21 to review hives since 1st dose. She agreed with urgent care that the reaction was not allergic in nature and that he should get dose #2. He received his #2 dose on 12-1-2021. No increase in hives were noted, they seemed to continue at the same rate and intensity.  Starting 12-13-21 I noticed that the hives were sometimes triggered when the skin was irritated. On 12-13-21 he wore his very heavy backpack from the kitchen to the car and once in the car he had hives from the back pack straps. Hives triggered by roughness to the skin continued, example: he wore a snow suit that was too small and had hives from the straps and on his penis, also hives on his wrist after swinging a bat and the bat rubbed his wrist. He has also had hives on his chest after active play.  Hives remain mild and sporadic.    Just before Christmas I reached out to Dr. as child had more hives on his lip and she is making a referral to a Dermatologist.   Hives continue to date.
Patient stated that she didn't feel good shortly after. Said she was disoriented, chest burned and arms were tingling. Funny sensation in throat
Stomach ache and nausea began within an hour of vaccination.  Child vomited milk on 11/20/2009 at 7:20 AM.
Itchy rash on arm, healthcare provider advised using ointment. Ointment did not work.
Severe throat tightening, itching body, mild hives on hands. I have to take Benadryl every 4 hours to keep these side effects tolerable. I emailed my doctor to see how long this would last or if there is anything I need to be doing. They called me and told me to come in right away. I was unable to see my doctor but was seen by another doctor. She said I was definitely having an allergic reaction after scratching my skin, looking in my nose, ears, and mouth.  She asked if I had changed anything like soaps or laundry detergent recently, which I told her I did not. I said the only thing out of the ordinary that I have done in the past YEAR has been getting the COVID vaccine. She then told me it was probably just seasonal allergies.. which I have never had before. She wrote on my after care summary that I could use OTC eye drops for my eye symptoms (and I don?t have ANY eye symptoms), she also wrote that I could use Flonase for my nose symptoms (which I don?t have any nose symptoms), and to buy Zyrtec for keeping the seasonal allergies at bay. She didn?t even consider the vaccine to be an issue. I also didn?t even know throat tightness could be a vaccine side effect until I looked it up. I don?t know why I was brushed off and told seasonal allergies when my side effects don?t line up with that. I don?t think it was a coincidence I received the vaccine and started to have ?seasonal allergies?. I asked if I should be getting an allergy test to see what ?seasonal? things I?m having this reaction to and she said that doesn?t matter, just to keep treating the symptoms.  So no tests were given.
No additional AE reported; a female patient informed her she has been receiving "yearly flu and PNEUMOVAX 23 vaccines at Walgreen's pharmacy for the last 3 years"; This spontaneous report was received from a nurse practitioner via a company representative, concerning a female patient of unknown age. The patient's pertinent medical history, concurrent conditions, concomitant medications, and drug allergies were not reported.   On approximately an unknown date in 2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, at the dose of 0.5 milliliter for prophylaxis (strength, route of administration, anatomical location, lot number, and expiration date were not reported).   It was stated that the patient informed that she was receiving yearly flu and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) for the last 3 years (onset date: approximately 2020) (inappropriate schedule of product administration). No additional adverse event reported, nor product quality complain involved.    The outcome of the event was unknown.
Pt received shot 4/11 came in 4/17. Reports of severe itching and redness at site and at spot on L. lower back, had received a dose of  REMICADE on 4/12, went to MD and to urgent care to see if was shingles, they thought just a delayed response due to REMICADE, checked for cellulitis and told pt just to watch area.
This case was reported by a nurse via sales rep and described the occurrence of influenza-like symptoms in unspecified number of patients who received FLULAVAL QUADRIVALENT (batch number 7754S, expiry date 30th June 2016). On an unknown date, the patients received FLULAVAL QUADRIVALENT. On an unknown date, several days after receiving FLULAVAL QUADRIVALENT, the patients experienced influenza-like symptoms and injection site pain. On an unknown date, the outcome of the influenza-like symptoms and injection site pain were unknown. It was unknown if the reporter considered the influenza-like symptoms and injection site pain to be related to FLULAVAL QUADRIVALENT. Additional details were provided as follows: The nurse reported to internal GlaxoSmithKline employee that her office had several patients who experienced flu like symptoms a couple days after vaccination with FLULAVAL QUADRIVALENT. The patients also experienced pain in the arm at the injection site. The nurse did not provide any additional details or how many patients were affected. The nurse might follow up with GlaxoSmithKline with additional details after she speaks with her supervisor.
T.C. received from employee health.  She reported the patient who is an employee, had a varicella vaccine on 06/11/2015 @ County Health Clinic.  On 06/15/2015, patient experienced fever, sore throat and rash to legs, torso and upper arms, a lacy rash in appearence.  Patient went to an ED on 06/16/2015 amd was given prednisone. Per health department, patient's symptoms have since subsided. Also, per health department, ED doctor told patient that she most likely had an adverse reaction to the varicella vaccine and she should not receive another vaccine.  06/23/2015-T.C. to Pt to follow up.  Patient stated that her rash is gone-states she has some nasal congestion and sore throat in am- no fever.
loose bowels; Diarrhea; excess gas/getting a lot of gas. Sounds like a war going on in the stomach; sore arm/Ver, very little pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 69 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 16Mar2021 (Lot number: EN6208, Expiration Date: 30Jun2021) at the age of 69 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Gall bladder out" (unspecified if ongoing), notes: gall bladder out 3 or 4 years ago; "depression" (unspecified if ongoing); "blood cholesterol " (unspecified if ongoing). Concomitant medication(s) included: BUPROPION taken for depression; SERTRALINE HCL taken for depression; SIMVASTATIN taken for blood cholesterol abnormal. The following information was reported: DIARRHOEA (non-serious), outcome "not recovered", described as "loose bowels"; DIARRHOEA (non-serious), outcome "unknown", described as "Diarrhea"; FLATULENCE (non-serious), outcome "unknown", described as "excess gas/getting a lot of gas. Sounds like a war going on in the stomach"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm/Ver, very little pain". Therapeutic measures were taken as a result of diarrhoea, diarrhoea.  No follow-up attempts are possible. No further information is expected.
Child died suddenly at day care on or about 6/5/03. No other specifics known. Autopsy report report received on 12/16/2003 states COD was bacterial pneumonia, bronchitis, and cerebral edema.
It was reported that a 37 year old female patient was vaccinated 11/05/01 with Fluzone SV'01 -'02 , lot number UO681AA. On 11/08/01, the patient called health care facility to report that she had body aches, headaches and a temperature of 99.5 F-100 F. Patient was not evaluated by a physician.
patient awakened 12 hours after vaccine given with svt- seen at er with hypotension and svt. adenosine given and arrhythmia terminated. labs normal
Had the hives on my shoulders and used triamcinolone cream and it helped.  Called my Dr. and she said it was alright.  Had hives all week of shot.  Very red around shot area.