chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case, initially received on 16-Oct-2017, by other health professional, concerning a 4-year-old, child male patient. The patient's medical history and concomitant medications were not reported. On 16-Oct-2017, the patient (under 4 years of age) received AFLURIA TIV (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: XF32708, expiry date: 30-Jun-2018) (explicitly coded as inappropriate age at vaccination administration). The patient did not experience any adverse events after vaccination (explicitly coded as no adverse event). The outcome of the event was not reported. The reporter considered this case as non-serious. Follow-up report received on 20-Oct-2017: It was reported that, the patient did not experience any adverse events. Amended narrative accordingly. Non-significant case correction received with IRD 16-Oct-2017: Added "special case with No AE" in general tab. Batch number was added in the field. Updated expiry date from Jun-2018 to 30-Jun-2018. The narrative was amended accordingly.
Received on Thursday, injection site red 1.5 inches around site. Redness lasted till Monday, patient felt very tired, site itching.
Left arm was hurting on and off after first vaccine; Nausea; Vomiting; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Left arm was hurting on and off after first vaccine), NAUSEA (Nausea), VOMITING (Vomiting) and FATIGUE (Fatigue) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Surgery. Concurrent medical conditions included Diabetes, Blood pressure and Sleep apnea.    On 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, the patient experienced PAIN IN EXTREMITY (Left arm was hurting on and off after first vaccine), NAUSEA (Nausea), VOMITING (Vomiting) and FATIGUE (Fatigue). On 08-May-2021, NAUSEA (Nausea), VOMITING (Vomiting) and FATIGUE (Fatigue) had resolved. At the time of the report, PAIN IN EXTREMITY (Left arm was hurting on and off after first vaccine) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported  No treatment medication were reported   This case was linked to MOD-2021-286731 (Patient Link).
about 1 1/2hr p/vax pt became listless & started to stare blankly;this cont all day;@ noc pt was moaning 7 SOB & restless w/t100.7;mom gave APAP;pt would not nurse until early evening of 2nd day p/vax;
Healthcare worker reported that second dose of PROQUAD was given to a 7 year old patient.  Some fields were "Refused to Answer" because the healthcare worker did not want to continue with AE reporting and did not want a follow up.  This AE was filed; This spontaneous report was received from Other Health Professional and refers to a 7-year-old patient of unknown gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On an unknown date, the patient started therapy with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, 1 dose, lot #Refused to answer, administered for prophylaxis (strength, expiry date, and route of administration were not provided).  On an unknown date, healthcare worker reported that second dose of PROQUAD was given to a 7 year old patient. Some fields were "Refused to Answer" because the healthcare worker did not want to continue with AE reporting and did not want a follow up. This AE was filed as precaution because the patient received the second dose of PROQUAD older than the recommended age. No further information was available. No pqc.
01/07/2022 Covid symptoms started with itchy throat, stuffy nose, sinus pressure. This lasted until 01/14/2022. Symptoms were very mild and never went into my lungs. The biggest thing I had was a headache that would not go away. I was taking 2000mg Tylenol every 4 hours. The headache was continuous. I don't have headaches anymore but the lingering symptom I have is insomnia and I can't sleep more than 3 hours a night since Covid.
Drug ineffective; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 15Mar2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 54 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 2, single (Batch/Lot number: unknown) and as dose 1, single (Batch/Lot number: unknown) for covid-19 immunization. The patient's relevant medical history included: "Migraines" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "not recovered", described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Result. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: The patient received treatment with paxlovid from 12th Jul to 17th Jul2022. The patient had not received any other medication within 2 weeks. Device timestamp: 21Jul2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Day 4 - rash, redness below vaccine site Day 5 - Continued rash, itchiness Day 6 - Same Day 7 - Same, but now noticeable swelling in the upper part of the arm, and elbow
On March 9th, in evening hours, approx 5pm?.... sudden sense of left side of head with "filling up with air" and within mere seconds , entire loss of hearing in left ear....a harsh piercing ringing sound in my head
Starting 3 days ago (approximately 10 days after vaccine) I started having muscle soreness in the arm the vaccine was given in similar to the soreness right after the vaccine was given.  A few hours after the soreness was noticed I noticed red-raised hives in the injection site. Over all symptoms (soreness to touch same as the soreness right after vaccine was given, itching, redness, raised hives, and warm to touch in the area of redness). The next day the symptoms remained about the same but area of raised-red-hives now seems to be a more defined 4-5 inch long red oval in the area the vaccine was given. 3rd day redness seemed lighter in color but still a pretty defined oval with warmness to touch the soreness was a little better by the 3rd day. I started taking Amoxicillin 500 mg that I had at home on the 3rd day. Today, 4th day, overall seems to be getting better still some soreness, still a red oval but is getting lighter, still soreness but defiantly better than it was. My doctor had me start Keflex 500 mg Q 6 hours for 7 days I started taking that today.
Shot given about 3:00 pm. Went to ER about 6:00 pm 9-27-12 respiratory, eyes swelling, mouth swelling, dizzy, hard to see, weak, eyes feel like filled with dust.
Information has been received from a physician concerning a male over 65 yrs of age who was vaccinated with pneumococcal 23v polysaccharide vaccine (lot 648139/0009P). Subsequently the pt developed redness and swelling near the injection site that extended to the shoulder to chest and just below the elbow. The physician also reported that the injection site was hot to touch. Unspecified medical attention was sought. No product quality complaint. It was noted that the pt had previously received a vaccination of pneumococcal 23v polysaccharide vaccine. It was also reported that two females had a similar reaction (WAES0409USA00780). Additional information has been requested.
Congestion in chest; Back aches; Describe in one word was like Flu; Chills; Headache; Fatigue; Muscle ache/ all body ache; Hip aches; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (Congestion in chest), BACK PAIN (Back aches), INFLUENZA LIKE ILLNESS (Describe in one word was like Flu), CHILLS (Chills) and HEADACHE (Headache) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Asthma, Hypercholesteremia, Cancer and Hypertension.   On 29-Mar-2021 at 2:30 AM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced CHEST DISCOMFORT (Congestion in chest), BACK PAIN (Back aches), INFLUENZA LIKE ILLNESS (Describe in one word was like Flu), CHILLS (Chills), HEADACHE (Headache), FATIGUE (Fatigue), MYALGIA (Muscle ache/ all body ache) and ARTHRALGIA (Hip aches). At the time of the report, CHEST DISCOMFORT (Congestion in chest), BACK PAIN (Back aches), INFLUENZA LIKE ILLNESS (Describe in one word was like Flu), CHILLS (Chills), HEADACHE (Headache), FATIGUE (Fatigue), MYALGIA (Muscle ache/ all body ache) and ARTHRALGIA (Hip aches) outcome was unknown.            Concomitant medications include cholesterol medication, high blood pressure medication and anticancer medication. treatment medication was not reported.
'Hives on face, legs & chest. Severe itching in stated areas along with the site where the shot was taken was red & the size of a quarter.
No adverse event; Patient received the vaccine from an expired lot; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received the vaccine from an expired lot) and NO ADVERSE EVENT (No adverse event) in a 67-year-old female patient who received mRNA-1273 (Spikevax) (batch no. O70H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 30-Jun-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 30-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received the vaccine from an expired lot). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received the vaccine from an expired lot) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient received the vaccine from an expired lot).    Age of the patient was reported as 67 year 10 months.  Concomitant medication of the patient was not reported.  Reportedly, the patients at the facility received the Moderna vaccine between 08-Apr-2022 and 15-Dec-2022 from the vial with lot number O70H21A. NDC ID was reported as 80777027399.  No treatment information was provided by the reporter.
When the patient stood up after receiving two intra-muscular injections of the seasonal flu vaccine, and the HPV vaccine, he passed out and fell to the floor.
flu; Initial information received on 23-Dec-2022 regarding an unsolicited valid social media serious case received from a consumer/non-HCP.  This case is linked to case 2022SA520918(CLUSTER).  This case involves an unknown age male patient who got flu after receiving influenza vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.   On an unknown date, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer (form, strength, dose, frequency, lot number, expiry date: unknown) via subcutaneous route in unknown administration site for Prophylactic vaccination  On an unknown date the patient developed flu (influenza) (unknown latency) following the administration of influenza vaccine.  It is unknown if there were lab data/results available.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events (flu).  At time of reporting, the outcome was Unknown for the event flu.
Child's parents noticed the child develop sudden tics a couple days after the shot was administered. Started with repeated sniffling then moved to full body convulsions and various other uncontrollable sounds and body movements or convulsions. These symptoms are ongoing and continue to be a challenge on a daily (minute by minute basis. Incredibly shocking and disturbing and worrisome.
This spontaneous report as received from a registered nurse refers to a 13 year and 8 months old male patient. Medical history and drug reactions/allergies were not reported. On approximately 30-JUN-2014 (reported as 4 weeks ago), the patient was vaccinated with PROQUAD (Merck) (lot, dose and route was not reported). Concomitant medication was not reported. No adverse effects reported. The patient did not seek for medical attention. Additional information is not expected as there is no permission for follow up.
RED RAISED RASH AT BOTH SITES OF INJECTION. HOT TO TOUCH AND PNEUMONIA SITE FIRMER THAN OTHER. PATIENT RECIEVED COURSE OF CEPHALEXIN FOR SUSPECTED INFECTION 10/13/2016.
6-8hr p/vax flu like sx began lasting 5 to 6 days;fever 101 on 6th day;9JUL96 swelling & pain lt knee & both ankles;10JUL swelling rt knee joint;12JUL pain in both wrist & neck;arthritic sx lasted 3 to 4 wk p/vax;
Systemic: Fainting / Unresponsive-Medium, Additional Details: patient fainted and fell from the chair he was sitting while being obeserved. after a few minutes, he woke up by him self and got up by himself.when i (rph at the store) got there,he was awake and able to talk to me .i took his blood pressure and it was normal and oxygen sat was also normal.we advised him to contact his pcp asap and fainted again and go to er.
I have a painful almost baseball size know that feels like there is a rash at injection site.  Didn?t really notice it until this morning it is sore to the touch and movement is uncomfortable. Sister in law told me to report it.
No treatment. Both my wife and son were sick and then I got sick. I kinda guessed it was COVID because I got the same strange headache when I got the vaccine. So I decided to get myself tested and I came back positive. Before that my gums left really strange. And I thought I had a sinus infection that went up to my eyes. And that was my initial guess. then I went to the doctor for that and got tested for COVID and got came back positive. My wife also got sick and we took her to the hospital and she was positive. She was given medication Regeneron injection. We thought my son had it too but he didn't get tested. I wasn't as bad as they were. I was down for about 2 or 3 days. I wasn't really bad but I didn't wanna do anything and I got really lethargic and bad headaches mainly.
Information has been received from a 65 year old female patient with allergy to penicillin, sulfa, codeine and possibly thimerosal who on 11-NOV-2010 at 15:00, was vaccinated with a dose of PNEUMOVAX 23 (Lot #, expire date and route not reported), 0.5 ml. Concomitant therapy included LIPITOR, NEXIUM, SYNTHROID, FENHRT and DIOVAN HCT. The patient reported that on 13-NOV-2010 at 04:00, she developed urticaria from receiving a PNEUMOVAX 23 injection. She went to the emergency room and received a cortisone injection which helped relieve her symptoms. No lab diagnostics studies were performed. At the time of the report, the patient was recovering. On follow up information received on 08-DEC-2010, the physician reported that the patient was in his office on 08-DEC-2010 with one hive remaining at the PNEUMOVAX 23 injection site. Additional information has been requested.
BP 140/100 HR 90 RR 18 O2 99 Temp 97.8 Sudden onset of Left arm pain, rash, redness 5 minutes after infection. No respiratory distress or worsening symptoms.  Stayed and observed for 30 minutes and then released
Red rashes on the right leg ( lower extremity), and one red rash on the right forearm have appeared since  8/27/2021 midnight. today 3 spots have added on my right leg. I used hydrocortisone 1% cream on it twice but it wasn't effective. It doesn't have itching but it has a little induration.
Face got shingles on its left side by my mouth but it's not a cold sore; red, hurt, little blisters and itching on left side of my face; it's gotten bitter; side of my face by my mouth is red, it hurt, little blisters; side of my face by my mouth is red, it hurt, little blisters; they are itching this is on the left side of my face; side of my face by my mouth is red, it hurt, little blisters; Feels like my face is swelling; Left eye is itchy; This is a spontaneous report from a contactable consumer. A 53-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 22Apr2021 (Batch/Lot Number: ER8732) as 1ST DOSE, SINGLE for covid-19 immunisation.  Medical history included: Allergy, double amputee. Concomitant medications included lamotrigine (LAMOTRIGINE); alprazolam (XANAX); venlafaxine (VENLAFAXINE); aripiprazole (ABILIFY); diclofenac diethylamine (DIFENAC [DICLOFENAC DIETHYLAMINE]); diphenhydramine hydrochloride (BENADRYL); ibuprofen (IBUPROFEN); eszopiclone (LUNESTA); budesonide, formoterol fumarate (SYMBICORT);  (ALBUTEROL); all taken for unspecified indications, start and stop dates were not reported. The patient had her (first) Covid shot yesterday and her face got shingles on it now and it's on the left side by her mouth but it's not a cold sore. Reported as "shingles, on the side of my face by my mouth is red, it hurt, little blisters and they are itching this is on the left side of my face/ Face got shingles on its left side by my mouth but it's not a cold sore; red, hurt, little blisters and itching on left side of my face; it's gotten bitter. My left eye is itchy and it feels like my face is swelling." The outcome of the events was unknown.   No follow-up attempts are needed. No further information is expected.
slight discomfort at the site of injection; occasional soreness at the site of injection; This is a spontaneous report from a contactable physician reporting for herself. A 76-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685), intramuscular in left arm on 22Dec2020 12:00 at single dose for COVID-19 immunization. Medical history included high cholesterol from an unknown date and unknown if ongoing. Concomitant medication included atorvastatin, calcium, ibuprofen, estrogens conjugated (PREMARIN), ergocalciferol (VIT D) and multivit (as reported). The patient was not pregnant. For vaccine dose 1, it was reported that the patient experienced slight discomfort at the site of injection and occasional soreness at the site of injection over on 22Dec2020. No treatment was given to the patient for the events. The outcome of the events was recovered on unspecified date. The facility where the most recent COVID-19 vaccine was administered was in the Health Clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.
This was my second breakthrough case. I had more chest congestion than usual and I had an usual persistent sore throat. I had a fever but never checked my temperature. I had muscle aches. I took Aspirin. I had a headache as well, which was a dull ache. I was prescribed Paxlovid. I had an awful taste in my mouth that lasted the whole time due to the medication.
No adverse symptoms reported; the patient received an improperly stored dose of VARIVAX on 5/4/2020; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history or concomitant medications was provided.  On 04-MAY-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (exact dose, frequency and route of administration were not reported) lot # S022755 has been verified to be a valid lot number for varicella virus vaccine live (oka/merck), expiration date reported as 22-JUL-2022, but upon internal validation established as 22-JUL-2021. The vaccine was reconstituted with sterile diluent, it was not reported if sterile diluent was stored with the vaccine. No adverse symptoms were reported.  The vaccine was stored in -14 degrees Celsius (C) -10 C (-12.9 C) for 1 hour and 8 minutes. There was no previous temperature excursion. The storage was recorded by Digital Data Logger.
This spontaneous report as received from a registered nurse reported that different facilities might have administered vaccines after vaccines were exposed to temperatures outside of recommended storage range. She stated that she does not have any patient specific information. At the first facility they might have administered VAQTA, RECOMBIVAX HB, and GARDASIL which had been exposed to 33F for 129 hours. No adverse effects reported. The nurse reported that at a second facility they have two sets of vaccines which have both been exposed to temperatures outside of range, and may have been administered to patients. The first set of vaccines were RECOMBIVAX HB, COMVAX, GARDASIL, ROTATEQ which were exposed to 30F for 466 hours, and 47F for 39 hours and may have been administered to an unspecified number of patients. No adverse effects reported. The second set of vaccines for this facility were COMVAX and GARDASIL which were exposed to 30F for 221 hours and 47F for 15 hours and may have been administered to an unspecified number of patients. No adverse effects reported. This is one of the several reports received from the same source (same reporter link: 1406USA000768, 1406USA007003, 1406USA007004, 1406USA007005). Additional information has been requested.
Patient complained of soreness in arm. She says she can't move her arm or lift her head.