chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse concerning a 7 year old female who on 12-JUN-2001 was vaccinated with the first SQ dose of Varivax (Oka/Merck) (Lot #634498/0089L). There was no concomitant medication. On 02-FEB-2007, the patient was seen in the doctor's office. The mother stated the child had a fever 2 weeks ago. On 02-FEB-2007, the patient experienced vesicles on back, trunk, face and thighs. On an unspecified date, the patient recovered from vesicles on back, trunk, face and thighs and fever. No further information is expected.
Extreme severe headaches, backache, neck, shoulder. Could not bend Head at all starting having some sort of episodes which was diagnosed as seizures, weakness in both legs, extreme ringing in ears people talking to me hurt me head, pain in head and neck when I walk, lower back extreme pain,  eyes hurt so much they feel like they?re going to pop out. Some of these symptoms I?ve had but they got severely extreme since the shot and then their are some new ones.
PT STATES RED RAISED, HOT TO TOUCH 3 INCH RING. PT STATES NO BANDAGES WERE APPLIED.
Started with abd pain (generalized), N/V/D in evening after vaccines. Continued the next day with progression to migraine. Seen in office and treated with NUBAIN IM and PHENERGAN IM.
Fever 102, redness and induration at the sight 12 cm x 10 cm.
This case was reported by a other health professional and described the occurrence of drug dose administration interval too short in a 2-year-old female patient who received HAVRIX (batch number C7392, expiry date 14th March 2017). On an unknown date, the patient received the 2nd dose of HAVRIX. On an unknown date, an unknown time after receiving HAVRIX, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown. Additional information: the 2nd dose of HAVRIX was given 7 days too early.
Severe soreness in arm by 9:30 AM, fever, chills, body pain so that I couldn't get up, stabbing pain under arm of injection, lightheaded, dizzy, rapid heart beat, confusion, plugged nose and drainage even after 800 mg Motrin and full dose of Benadryl. Until 02/15/14. Then itchy rash broke out on upper stomach and arms and legs during the night of 02/15/14 I still have the rash.
Pt. got a secondary ZOSTAVAX shot in 2012. Pt. was vaccinated of ZOSTAVAX in 2010. Maybe pt. forgot.
Much milder fever for same number of days (3) as full shot gave me.  Possibly from the pain and fever it exaggerated/worsened/increased the pain and inflammation of the polyps in/on my skull/brain WHICH in past 10 years I had only inflamed that bad 2x, if not counting years 2018-2022. Once the fever and pain went down it wasn't as severe (to the point I had to put a lot of "advil" cream on 1/2 to 3/4 my head to be able to see and even think). My appetite came back, but not as well as year before when I got the full dose covid shot. Like as in migraines, I get an inflamed other times strong dull pain top of stomach (1st thought was my liver or pancreas, still can't say they are fine because not getting any priority care done first that should been done 10 or 15 years ago) sometimes with nausea which I hadn't had those effects since 2017. I know I'm ALSO having nausea And diarrhea because of a main side-effect of the pain cream I have to use or else I get a 12 to 48 hour migraine or experience inflammation light headedness & lights like I'm having one. So the booster might have increased/brought back/worsened the string of effects from the fever/headache/inflammation.
the Imovax  vaccine was injected in the bicep of a patient as opposed to the deltoid; Initial information received on 27-Jun-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 67 years old female patient who received vaccine RABIES (HDC) VACCINE [IMOVAX RABIES] and reported that the Imovax vaccine was injected in the bicep of a patient as opposed to the deltoid.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On 25-Jun-2019, the patient received a 3rd dose of suspect RABIES (HDC) VACCINE 1 ml lot ARBA221A via unknown route in left biceps muscle, possibly the triceps.  It was a case of actual medication error due to vaccine administered at inappropriate site.  It was unknown if the patient had any 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 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.
Moderna COVID-19 Vaccine EUA   - Symptoms the day immediately after the Moderna #2 vaccine: body aches & chills - Symptoms two days and onward after Moderna #2 vaccine: It feels like I pulled both of my calf muscles.  Very painful trying to walk up stairs and bending my ankles.   Maybe I did pull my both my calves - but I wasn't doing anything physical after the vaccine (just laying around watching TV), and I'm not sure how I pulled BOTH at the same time.    It's been 5 days since shot #2 and my calves are still incredibly sore and I'm having trouble walking up stairs.
Little fever for about one hour; Sore arm for a couple days; 1st dose was on 04Mar21 and got my second Covid shot (Moderna) on July 5,2021.; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 22-Jul-2021 and was forwarded to Moderna on 22-Jul-2021.    This spontaneous case was reported by a physician and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose was on 04Mar21 and got my second Covid shot (Moderna) on July 5,2021.), PYREXIA (Little fever for about one hour) and MYALGIA (Sore arm for a couple days) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045C21A and 029A21A) for COVID-19 vaccination.     Concurrent medical conditions included Food allergy (Allergic to sorghum), Food allergy (Allergic to sage), Rheumatoid arthritis since 1991 and Blood pressure high since 2004. Concomitant products included RAMIPRIL from 2004 to an unknown date and TAMSULOSIN from 2018 to an unknown date for Blood pressure high, METHOTREXATE from 1991 to an unknown date for Joint swelling, HYDROXYCHLOROQUINE SULFATE from 1991 to an unknown date and FOLIC ACID for Rheumatoid arthritis, METOPROLOL SUCCINATE (METOPROLOL [METOPROLOL SUCCINATE]) from 2004 to an unknown date for Tachycardia.   On 04-Mar-2021 at 4:45 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jul-2021 at 10:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose was on 04Mar21 and got my second Covid shot (Moderna) on July 5,2021.). On an unknown date, the patient experienced PYREXIA (Little fever for about one hour) and MYALGIA (Sore arm for a couple days). On 05-Jul-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose was on 04Mar21 and got my second Covid shot (Moderna) on July 5,2021.) had resolved. At the time of the report, PYREXIA (Little fever for about one hour) and MYALGIA (Sore arm for a couple days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Treatment details were not provided   This case was linked to MOD-2021-222134 (Patient Link).
Child had convulsive shaking episode at home.   Mom says temperature was 103.   Temperature in the Emergency Room 101.2
Resident vaccinated on 01/06/21  she acquired COVID 19 on 01/10/2021. Resident had multiple co morbidities and was declining prior to the vaccine. Resident expired on 01/20/2021
I had a nasty zit on the back of my neck, popped it, and my immune response was extreme. Initial: Itching and burning through my neck and shoulders, and swollen lymph nodes in neck and collarbone. I began sweating at night profusely and losing weight. I have had a lot of trouble sleeping. These symptoms continued in 24-48 hour cycles of flare ups until 04/19/2021 but finally seem to be abating. Progression: secondary symptoms appeared over the course of the month such as full body joint soreness, weakness, stiffness, stabbing pains (in the neck, arms, chest, and abdomen), blood pressure spikes, dry/sore throat, dry eyes, difficulty swallowing. Symptoms are similar to arthritis or other autoimmune diseases. Night sweats continue but are lighter. Weight loss continues but slower. Sleeping remains irregular.
This spontaneous report as received from a Licensed Practical Nurse (LPN) refers to a patient of unknown age. On 29-JUN-2015 the patient was vaccinated with first dose of GARDASIL lot # K016966, expiration 10-MAY-2017). On 01-JUL-2016, the patient was vaccinated with GARDASIL 9 (M004116, expiration 12-OCT-2017 as the second dose of the series. It was reported the patient experienced no adverse event. Additional information has been requested.
Patient was hospitalized due to breakthrough covid-19 infection on 7/23/21 after worsening shortness of breath for the past 5 days. Patient tested positive for covid-19 5 days prior to admission. Patient was pronounced deceased on 8/1/2021 @22:53. Patient completed Pfizer vaccination series in February.  Information below is copied from progress note (8/1/21):   PLAN:  NEURO: h/o peripheral neuropathy, HOH o Lyrica o PRN: Tylenol o PRN: Trazadone Cardio: h/o HTN o Hydralazine prn o Statin daily o  ASA RESP: Acute Hypoxic Respiratory Failure Secondary to Covid - 19 o HFNC, goal O2 sat 88%, wean as able o Bipap QHS o CPT, flutter valve, IS o Solumedrol BID o Guaifenesin prn o Albuterol prn o ABG/CXR PRN RENAL/FEN: h/o CKD 3 o Regular diet o Monitor electrolytes and replete as needed o Monitor renal indices  ENDO:  o Blood glucose checks AC & HS with insulin sliding scale coverage PRN HEME: h/o non hodgkins lymphoma with bone, liver and pulm involvment o Monitor CBC  o Stopped chemo in June- resume when feasible ID: Covid - 19 o  Completed Remdesivir o No ABX at this time o Trend inflammatory markers o Supportive care PPX:  o DVT ppx: SCDs, Lovenox  o GI ppx: Protonix
Treatment of COVID-19; Treatment of COVID-19; Moderna, Dose: 1, 2, 3, 4 / Pfizer, Dose: 5, 6; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose 5 (booster), single (Lot number: GH9702), in left arm and on 07Jun2023 as dose 6 (booster), single (Lot number: Bl2042) at the age of 72 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 09Jan2021 as dose 1, single (Lot number: 029L20A), in left arm, on 16Feb2021 as dose 2, single (Lot number: 029L20A), in left arm, on 28Oct2021 as dose 3 (booster), single (Lot number: r014F21A), in left arm and on 26Apr2022 as dose 4 (booster), single (Lot number: 005M21A), in left arm for covid-19 immunisation. The patient's relevant medical history included: "high blood pressure" (unspecified if ongoing), notes: Other medical history: high blood pressure. The patient's concomitant medications were not reported. Past drug history included: Erythromycin, reaction(s): "Known allergies: Erythromycin", notes: Known allergies: Erythromycin. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 16Sep2022, outcome "unknown", described as "Moderna, Dose: 1, 2, 3, 4 / Pfizer, Dose: 5, 6"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid.; Sender's Comments: Based on the information provided, a causal relationship between BNT162b2, and the events drug ineffective, covid-19, Interchange of vaccine products cannot be excluded.
I developed palpitations Saturday night after receiving my 2nd vaccine dose at 6pm, January 9th.  The palpitations continued through out the day/night on Sunday January 10th.  When I went to work on Monday morning, January 11th, I put myself on an EKG monitor and it showed unifocal PVCs.  (I made a short video recording.)  The PVCs seemed to be gone by Tuesday afternoon.  Also,  on March 17th, I experienced sudden stabbing/sharp pain above/around my left eye which persisted for about 10 minutes.  It was excruciating and I have not had anything like that before in my life.  Although the stabbing feeling has not returned, I have a dull pain above that eye now that persists.
I started itching and found hives on my ankle. It started at my ankle and it moved all the way up to my head and face. My eyes became swollen. I was told to take Benedryl by my doctor. It took three days to clear. It returned a week later. I followed the previous request and took more Benedryl. It cleared and returned again last week. I called the CDC and they informed me that the hives may come and go.
Developed fever and tingling in injected arm and weakness of grip which lasted several days. Now 10 years later fears getting booster. Titer checked and still very high. No shot given.
Fever 100.7, body aches and chills, fatigue  Two doses of  Ibuprofen taken 8 hours apart to help with symptoms. Symptoms lasted approximately 12 hours.
sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 82 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 01Jan2021 12:40 (Lot number: EJ1685, Expiration Date: 31Mar2021) at the age of 82 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Medullary thyroid cancer", start date: 01Sep2004 (ongoing), notes: Sep2004 Thyroid diagnosis monitored twice year with blood work and scans once year; "Breast cancer", start date: Apr2004 (unspecified if ongoing), notes: Mastectomy No treatment; "High blood pressure" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN taken for hypertension, start date: 2005 (ongoing); VITAMIN D 2000, start date: 2005 (ongoing); CRESTOR, start date: 2005 (ongoing); SYNTHROID, start date: 2004 (ongoing).The following information was reported: ARTHRALGIA (non-serious), outcome "unknown", described as "sore arm".  Additional information: Prior vaccine in four weeks: None  No follow-up attempts are possible. No further information is expected.
Pt began complaining of a headache 10 mins after vaccine administration.  Pt denies any other symptoms. Pt does not want to be evaluated by EMS. Pt was monitored for 30 mins with no changes.  Pt left the obs area with same headache.
paralysed for 10 hours, in both arms and legs; This is a spontaneous report from a contactable consumer (patient). A 75-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), on an unspecified date for COVID-19 immunization. The patient took both doses of the Pfizer covid vaccine, but after the second dose he was paralysed for 10 hours, in both arms and legs on an unspecified date. Outcome of the event was recovered on an unspecified date.    Information about lot/batch number has been requested.
Vaccine on Monday 01/11/2021.  Tuesday 01/12/21 morning got up with muscle ache, headache, fever 100.8.
Reporting administration error as per Agency. We contacted Pfizer for expiration dates, Pfizer vaccine specialist advised expiration dates and deemed vaccine viable at the time of vaccine administration. Pfizer vaccine vials only incude manufactuarer dates on the box and vials. Therefore, we contacted Pfizer to attain expiration dates directly from them.   No adverse reaction reported from the patietn at the time of the vaccination and no adverse reaction reported since given vaccine.
19MAR97 mom reported to clinic that approx 5PM on 18MAR97 that pt temp was 104.8 ax;states gave Ibuprofen as instructed by MD approx 830PM t104 ax;
I woke up at 9am on 04/08/2021 and I was nit feeling well, as the day progress I noticed a rash on the back of my upper left arm and shoulder blade. Around 1 or 2 in the afternoon I notice my lymph nodes were swollen on the back of my head. I had a headache for a week after the vaccine. I had a telehealth visit with the doctor a week after and was told to take Tylenol and if symptom worsen to contact the doctor.
Telephone report for clients mother indicates child experienced seizure like activity that lasted approximately the morning after vaccination.  Some fever also noted by mother at the time.  Acetaminophen 2.5 ml given.  No fever at the time of the call at approximately 2pm on 5/2/2023.
Patient came in for Janseen covid vaccine, was inadvertently given 0.5ml undiluted Pfizer pediatric vaccine in stead
Initial report received from a consumer's parent on 25 August 2011. A healthy 15 month-old male patient who was in for a well child visit on 23 August 2011 received a 4th left thigh dose of DTAP vaccine and a dose of HIB vaccine. The manufacturer names and lot numbers were unknown for both vaccines. The following day after vaccination, the patient was found to have redness, swelling, and hardness at the injection site; and she felt warm, her temperature at the time was unknown. The patient did not require medical evaluation, and the parent administered the patient TRIAMINIC and Ibuprofen. Recovery status was not reported. Follow-up information was received from a health care professional on 24 February 2012. The reporter clarified that the patient received a dose 4 injection in the left thigh of PENTACEL, sanofi pasteur Ltd. lot number C3912AA. The patient's outcome was unknown. Documents held by sender: None. Follow up information received on 03 May 2012: The patient received PENTAXIM vaccine via intramuscular route.
splotchy arm rash two days after the first shot; painful leg pain; joint stiffness; muscle ache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (painful leg pain), JOINT STIFFNESS (joint stiffness), MYALGIA (muscle ache) and VACCINATION SITE RASH (splotchy arm rash two days after the first shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 01-Mar-2021, the patient experienced VACCINATION SITE RASH (splotchy arm rash two days after the first shot).   In March 2021, the patient experienced PAIN IN EXTREMITY (painful leg pain), JOINT STIFFNESS (joint stiffness) and MYALGIA (muscle ache).   At the time of the report, PAIN IN EXTREMITY (painful leg pain), JOINT STIFFNESS (joint stiffness), MYALGIA (muscle ache) and VACCINATION SITE RASH (splotchy arm rash two days after the first shot) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.
This spontaneous report as received from a physician refers to a male patient of unknown age. In 2012 ("about one year ago"), the patient was vaccinated with ROTATEQ, orally, lot #, dose and frequency unspecified. The patient experienced projectile vomiting in the office immediately after administration of ROTATEQ. No treatment or medical attention was provided. The outcome of the patient was unknown. This one of several reports received from the same reporter. Additional information is not expected.
; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (Patient received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (Patient received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (Patient received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (Patient received 0.25mL of Moderna Covid-19 Vaccine, Bivalent.).    No concomitant medications were reported. It was unknown that the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Live Non-Significant follow up- Patient initial and Date of birth added.
DIZZY LIGHTHEADED , FEELING LIKE PASSING OUT, HEART RACING.
Fainted and feel out of chair in recovery,  arose when touched and spoken to, no C/O of any pain, brought to cot, monitored VS, all stable, stayed for an additional 25 minutes, he stated he felt well and would drive self home
#1 - given shingrix 9/4/19, 11/14/19 and 3/3/22; This case was reported by a other health professional and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 4th September 2019) and Shingrix (2nd dose received on 14th November 2019).   On 3rd March 2022, the patient received the 3rd dose of Shingrix. On 3rd March 2022, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 7-APR-2022 Reporter's Comment: The patient received three doses of Shingrix vaccine. The reporter asked could GlaxoSmithKline tell him/her if there were any ramification of three doses of Shingrix was given to a patient. The reporter consented to follow-up Additional supportive information: The patient received 3rd dose of Shingrix, which led to Extra dose administered. This is one of 2 cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR062300:same reporter
Patient reports left sided chest pain and pressure with heart racing shortly after the vaccine.  Reports also feeling fatigue.  Symptoms lasted 3-4 days.  Pain reported as a 5 out of 10.  Left side of chest.  Did not seek medical attention at the time and symptoms have completely resolved