chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Got flu shot Sick as hell; Initial information received  on 20-Jan-2023 regarding an unsolicited valid non-serious case received from a Non-Healthcare Professional.  This case involves an unknown age and unknown gender patient who got flu shot (INFLUENZA VACCINE) and sick as hell.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, formulation, route, dose: unknown) (lot number and expiry date: not reported) in unknown administration site for Prophylactic vaccination.  On an unknown date, the patient developed a non-serious event of got flu shot sick as hell (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It is unknown if the patient experienced any additional symptoms/events. It is unknown if the patient had any medical history, concomitant disease or risk factor. It is unknown if there were lab data/results available.   Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (Got flu shot Sick as hell).  At time of reporting, the outcome was Unknown for the event got flu shot sick as hell.
This case was reported by a healthcare professional and describe the occurrence of "asthma related reaction" in an adult subject of unspecified gender who was vaccinated with influenza virus vaccine (Fluarix) for prophylaxis. The reporter is the co-worker of the subject. On an unspecified date, the subject received a dose of Fluarix (number of previous doses and lot number not provided). On an unspecified date, post vaccination with Fluarix, the subject experienced an "asthma related reaction." The subject was seen at a physician's office. The subject "had to improved "between 14 and 21 days after the (Fluarix) shot." Asthmatic reaction was assessed as medically serious by manufacturer (OMIC).
Case number PHHY2011US44954, is an initial report from a health care professional received on 25 May 2011. This report refers to a female child. The child received vaccination with MENVEO (batch number unknown) on 13 Apr 2011. The patient was administered only MenCYW-135 component (dilutant). No other information was reported.
child was administered expired pentacel in the left thigh with no adverse event reported; Initial information received on 22-May-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 4 months old male patient who was administered expired diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] in the left thigh with no adverse event reported.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine polysacch 23V (Pneumovax) and Rotavirus Vaccine for Prophylactic vaccination (immunization).  On 22-May-2023, the patient received 0.5ml expired dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/ IPV (vero)/HIB (PRP/T) vaccine (batch number: UJ670AAA; expiry date: 13-May-2023) via unknown route in the left thigh for immunization with no adverse event reported (expired product administered) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event child was administered expired pentacel in the left thigh with no adverse event reported.  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.
Previous pneumonia as child x 3 - next day (R) arm very sore - excruciating pain, hives on Friday Oct 8 Tylenol and antihistamines 10/8. Hives for two days.
Blood pooled around the injection site and traveled down his arm and up around his shoulder area. Pt was on COUMADIN and had a similar reaction when he was in a car accident.
Large hiatal hernia - Procedure: Left Posterolateral thoracotomy. Recovery in hospital and discharged to home. Hospital admission within 6 weeks of receiving the COVID vaccine.
Child a a fever two on 10/18/2016. 10/20/2016 am child broke out in terrible rash, starting on face, trunk, and then all over the rest of the body. Resembled measles/German measles/ rubella rashes. Rash was present for 4 days, 2nd day being the worst, 4th day rash is fading.
pt recv vax MAY98 & pt exp impotence, can barely walk, limping, stooping, shoulder problems, popping & snapping in wrist, back & leg problems & overall pain;
pt recvd vax & had a 3 hrs episode of continuous crying & low grade fever; treated w/APAP; pt recovered;
Initial information received on 05-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case was linked with 2018SA279268, 2018SA279274, 2018SA279275 and 2018SA279273 (same reporter). This case involves a 4 years old patient who experienced patient vaccinated with 0.25 ml dose, no adverse event, while he/she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a 0.25ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UT6259KA, Expiry date-30-JUN-2019 via unknown route. It was a case of actual medication error due to Vaccine underdose. No Adverse Events have been noted at time of the call. 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 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. List of documents held by sender: none.
My nose started bleeding this afternoon about an hour ago/start walking it starts bleeding again; This is a spontaneous report from a contactable consumer reported for himself. This male consumer of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 20Jan2021 14:00 at single dose for COVID-19 immunisation. The medical history and concomitant medications were not reported. The consumer reported nose started bleeding in the afternoon about an hour before on 21Jan2021. When the consumer start walking it started bleeding again. The consumer was on clopidogrel bisulfate (PLAVIX). The outcome of the event was unknown. The event was non-serious.  Information on the Lot/Batch number has been requested.
Patient came in reporting pain at the injection site including numbness and tingling moving down her left arm to her fingertips. She reported the pain was so severe it caused her to vomit. She experienced these side effects for 3 days after the vaccination before coming in to report it. She self-treated with OTC Tylenol and ibuprofen which brought her pain down form an 8/10 to a 4-5/10.
Severe local reaction- erythema, induration 6 X 10 cm left anterior thigh, seen in  ER not recognized as DTaP rxn. Resolved within 12 hours. Seen in ER 22:00
Started with shivers. Then appeared the fever 102F at 7pm. Treated with Tylenol 400mg but then I threw it up. I tried again and tolerated it. At 11pm the fever started to go down. At 00am, I took Tylenol again and at 8am the fever  was 99F. In the course, I had joint pain, tiredness and a little headache.
This young lady just had her immunization shots yesterday and today mother found her with some red substance coming from her nose that she thought was blood and she had "stopped breathing" so she brought her to the ER immediately in her car. When she got to the emergency room the baby was breathing fine no problems with respirations. She was quite asleep and was a hard time getting her awake but when she was awake she was alert and breathing quite well.
Pain arm then spread to (L_ side of body, high fever, body aches, nausea on 8-19-08. 8-21-08 area red, swollen at site radiating to elbow. Rx Tylenol TID x 3 days - Benadryl 50 mg x T dose cold compresses and elevate arm f/u 8-26-08.
Spotting, prolonged bleeding during period, and heavy period. Currently bleeding for 3.5 weeks with cramps
My father received first dose of Pfizer vaccine. Within 30 minutes of receiving injection, he experienced heart palpations, high blood pressure,  and pain in his lower right rib cage area. We stayed at hospital for a couple hours until side effects subsided. My father has a heart condition, a liver condition and high blood pressure.
I woke up in the middle of the night with a 102.9 graver, and heavy shivering.
I've started lactating. It's been over a week and a half and I'm still lactating. In that time I got my period, I'm not pregnant.
p/vax pt devel chills, fever & a few days later nausea;then very ill, turn yellow;seen by MD ATB taken;pt positive for H. Pylori;
This spontaneous report as received from a nurse practitioner concerning a 16 year old female patient. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On an unspecified date, before patient's 15th birthday, she was vaccinated with the first dose of GARDASIL 9 for prophylaxis (dose, route of administration, lot number and expiration date were not reported). On 20-NOV-2017 (reported as today) the patient went to the office to receive GARDASIL 9 second dose for prophylaxis (dose, route of administration, lot number and expiration date were not reported). No adverse effects were reported.
Case number PHEH2014US022016 is an initial spontaneous report received from a health care professional on 31 Oct 2014. This report refers to a 30 years old female patient. Her medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 1412501) at a dose of 0.5 ml intramuscularly in the arm on 10 Oct 2014. It was reported that on an unknown date, she experienced sore and tender arms at the vaccination site. She complained that her arm hurt so much that she could not lift it. The event outcome was unknown. The seriousness and causality were not reported.
First symptom was chills and myalgia about 20 hours after vaccine administration. This was followed by a fever of 100.4 that lasted about 3 hours. Arm soreness was present with these symptoms and is still present 4 days later. Headaches and moderate to severe neck pain started soon after the fever and have persisted through day 4. Increased anxiety and new depression symptoms started on day 3 and are the greatest concern. Fatigue and a general malaise has continued to day 4.
Flu shot on 10/1/18 - nose stopped up for months ended up having sinus surgery Flu shot 10/16/19 - Allergic reaction. Redness around arm where flu shot was given. Pain in arm, itching, cold compress & used benedryl
ARM WARM TO TOUCH,  ARM TURNED RED, SWELLING MOVING DOWN ARM TO BELOW ELBOW. WENT TO DOCTOR SAME DAY. GOT BACTRIM DS 1 TABLET TWICE DAILY FOR 7 DAYS.
Pt recvd measles vax in 1963 & 1976 & @ the time of the report, had no titer of antibodies; also @ the time of report, devel a low but protective antibody level p/receiving rubella vax in MAR90 (WAES 91030340);
This is not an adverse event report. This is a report of administration at an alternative site per the subject's request. Per the subject's request, this vaccine was administered IM to the left gluteus muscle.
My arm swelled up and was black and blue. There was a knot, and I became nauseated with muscle aches and pain for about 7 to 8 days. I did not test for COVID-19, but I do believe that is what this is. The cold went away, and it returned as a head cold and a sore throat. The 2nd time I woke up and could not breath. My throat was closing up. I got up and took TYLENOL and drank hot coffee. I called my doctor once the office opened. I did not go to the doctor. A few days later I had a huge lump in the back throat that had grown. I went to see the doctor. My glands were swollen, and she started me on cetirizine 10mg. She also prescribed omeprazole 20mg. The symptoms improved in about a week. I have completely recovered from the symptoms now.
Patient said arm had a rash and was swollen and warm.   It started about six days after the immunization.  Patient went to the doctor & they are watching it to see if it worsens.  The patient said the doctor did not think it was a secondary infection.
Fever 101.1 bad headache body aches sharp pain lower bad sinus pressure rash to throat and chest lymp node around collar bone swollen vomited twice nausea for about 48 hrs.  Got another headache that next evening
Sore arm; Mild fever; Flushing; This is a spontaneous report from a non-contactable Other-HCP via Pfizer sales representative. A patient of unspecified age and gender received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine) via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was unknown whether the patient received any other vaccine within 4 weeks prior to the vaccine. On an unspecified date, the patient experienced sore arm, mild fever and flushing after use of the product. Clinical outcome of the  sore arm, mild fever and flushing was unknown.     No follow-up attempts are possible. Information about batch number cannot be obtained.
This spontaneous report as received from a medical assistant refers to a 17 year old patient of unknown gender. The patient's drug allergies and pertinent medical history was not reported. On 19-JUN-2014 the patient was vaccinated with second dose of VAQTA (dose, frequency and route of administration were not reported) (lot # J011385, expiry date: 10-MAR-2016) which was stored improperly. No adverse effects were noted. No product quality complaint was reported for VAQTA. This case is linked to 1407USA010956, 1407USA012902, 1407USA012903, 1407USA012904, 1407USA012905, 1407USA012906, 1407USA012907, 1407USA012908, 1407USA012909, 1407USA012910, 1407USA012911, 1407USA012912, 1407USA012913, 1407USA012914, 1407USA012915, 1407USA012916, 1407USA012917, 1407USA012918, 1407USA012919, 1407USA012920, 1407USA012921, 1407USA012922, 1407USA012923, 1407USA012924, 1407USA012925, 1407USA012926, 1407USA012927, 1407USA012928, 1407USA012929, 1407USA012930, 1407USA012931, 1407USA012932, 1407USA012933, 1407USA012934, 1407USA012935, 1407USA012936, 1407USA012937, 1407USA012938, 1407USA012939, 1407USA012940, 1407USA012941, 1407USA012942, 1407USA012943, 1407USA012944, 1407USA012945, 1407USA012946, 1407USA012947, 1407USA012948, 1407USA012949, 1407USA012950, 1407USA012951, 1407USA012952, 1407USA012953, 1407USA012954, 1407USA012955, 1407USA012956, 1407USA012957, 1407USA012958, 1407USA012959, 1407USA012960, 1407USA012961, 1407USA012962, 1407USA012963, 1407USA012964, 1407USA012965, 1407USA012966, 1407USA012967, 1407USA012968, 1407USA012969, 1407USA012970, 1407USA012972, 1407USA012973, 1407USA012974, 1407USA012975, 1407USA012976, 1407USA012977, 1407USA012978, 1407USA012979, 1407USA012980, 1407USA012981, 1407USA012982, 1407USA012983, 1407USA012984, 1407USA012985, 1407USA012986, 1407USA012987, 1407USA012988, 1407USA012989, 1407USA012990, 1407USA012991, 1407USA012992, 1407USA012993, 1407USA012994, 1407USA012995, 1407USA012996, 1407USA012997, 1407USA012998, 1407USA012999, 1407USA013000, 1407USA013013 and 1407USA013014 (same reporter link). Additional information has been requested.
Evening of 3/6, there was a little dull ache in my knees. I drove for vaccine and drove back3/7.  Evening of 3/7, I noticed dull ache was more pronounced. After I showered, I noticed back of both knees were swollen. I saw my PCP and she said it was probably a Baker's cyst. After a week or so, I went back to PCP since swelling didn't go down. I had Ultrasound done and no baker's cyst was found and no blood clots. I had a CBC done and it was normal. I also saw an Ortho doc- ruled out Lupus, RA, Osteoarthritis. I didn't do any strenuous activities to pull something. I went through physical therapy, but I was still sore and knees got swollen in front top part of knee. They said I had to build up strength in my quads/hams to support my knee.  PT place I went to overworked me with heavy weights. I then had MRI done and they found some chondromalacia  and patellofemoral syndrome.  I was switched to a different PT and it's working better but still dealing with swollen knees and upper thighs seems swollen too - not sure if that is related to my workouts and building muscles back. I have spend a lot of money and time seeing various doctors/specialists to figure out what is happening. It is very frustrating and a big part of me wished I did not get the vaccine as I was being extremely cautious with going out in public. My family and I didn't interact much with others and always distanced ourselves and wore masks indoors and sometimes outdoors if to close in proximity to people. I am reluctant to give my 13 year old son the vaccine as he has some of my genetics.
15 hours after receiving second dose  I experienced severe aches in my body which was in my joints and bones. Hot and cold chills. 101 degree temp  2 days after the second dose I developed a large bullseye rash about 2 inches under the injection site. That same arm feels asleep
She went in to get tested and it came back positive.; She went in to get tested and it came back positive.; This is a spontaneous report from a contactable consumer or other non hcp. An adult nonpregnant female patient received second dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number unspecified, expiration date unspecified), via an unspecified route of administration on Mar2021 as dose 2, single for COVID-19 immunization. Previously the patient received first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number unspecified, expiration date unspecified), via an unspecified route of administration on an unknown date as dose 1, single for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The patient was not diagnosed with COVID-19 prior to the vaccination. The patient's medical history and concomitant medications were not reported. The reporter reported that the patient went out for a small bachelorette party with 4 other friends the first week of August. All wore masks and very healthy. All had been vaccinated and they were mostly outdoors the whole weekend. The patient came home on 09Aug2021. Again, on 10Aug2021, the patient went back and since 12Aug2021, the was feeling sick with covid-Symptoms. The patient then went for SarS-cov-2 infection test and the results came positive. The patient was not treated for the events. The outcome of the events was reported as recovering for covid-19 and unknown for vaccination failure.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Developed a varicella rash at day 10 post vaccination; said rash continued to evolve over a 2 week period developing over 50 lesions.
No additional AE reported; Expired vaccine administered; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender.  The patient's concurrent conditions, medical history and concomitant medications were not reported.  On 03-JAN-2022, the patient was vaccinated with an expired dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB) (expiration date 04-NOV-2021) (dose, route, frequency, anatomical location and lot # were unknown) for prophylaxis (expired product administered). No additional adverse events were reported.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician). The reporter is the patient.  A 69-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 at 11:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 68 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 21Feb2021 at 11:00 as dose 1, single (Batch/Lot number: unknown), in left arm, on 22Mar2021 at 11:00 as dose 2, single (Batch/Lot number: unknown), in left arm and on 05Oct2021 at 11:00 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Sleep apnea" (unspecified if ongoing); "Osteoarthritis" (unspecified if ongoing); "pre- diabetes" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL SUCCINATE, start date: 11Nov2016; TERAZOSIN. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". Therapeutic measures were taken as a result of vaccination failure, covid-19. The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information, a lack of efficacy with the suspect vaccines in this patient cannot be completely excluded.
Zostavax administered 4/8/08. Patient presented with 20 cm diameter erythematous area on 4/11/08. HC 1% cream recommended and used by patient. On 4/23/08 inflamed area has extended from elbow, to shoulder. Began Diprolene cream and oral Zyrtec.
This spontaneous report as received from a medical assistant refers to an unknown number of patients of unknown age and gender. Information about concurrent conditions, concomitant medication and medical history was not provided. The medical assistant reported for temperature excursion and that on unknown dates some improperly stored GARDASIL (lot#, dose, route and frequency were not provided) had been administered to patients. No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
This case was reported by a consumer and described the occurrence of fever in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever, headache, bone pain, tiredness, pain, feeling miserable and influenza-like symptoms. On an unknown date, the outcome of the fever, headache, bone pain, tiredness, pain, feeling miserable and influenza-like symptoms were unknown. It was unknown if the reporter considered the fever, headache, bone pain, tiredness, pain, feeling miserable and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had side effects and questioned that, would she experience them again with the 2nd dose. The patient experienced fever (body temperature: 100 degree F). The patient had achy bones, was tired, sore and felt fly like symptoms. Lab Comments: On an unknown date, the patient's body temperature was found to be 100 degree F.
Pt seen in the ED on 10/24/18 for allergic reaction to flu shot. Was given prescriptions for Epipen (qty 1) and famotidine 20 mg PO BID for 5 days. Symptoms: , 1. RASH; URTICARIA; DYSPNEA Treatment Drugs Used: 1 - EPINEPHRINE Dose: Units: Freq: Route: 2 - FAMOTIDINE Dose: 20 Units: Freq: BID Route:
Super high heart rate night of 11/9 where I felt like I was going to pass out, got to 140 or higher without any physical activity. Heart rate continue to be in the 90s and 80s while resting. 11/12 normal heart rate while resting in the 70s.