chrisvoncsefalvay/vaers-outcomes huggingface dataset:
General body pain; Cold symptoms; Pelvic pain; Injection site itching; Injection site hives; COVID-19; This spontaneous case was reported by a non-health professional and describes the occurrence of PAIN (General body pain), NASOPHARYNGITIS (Cold symptoms), COVID-19 (COVID-19), PELVIC PAIN (Pelvic pain) and INJECTION SITE PRURITUS (Injection site itching) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease.    No medical history was reported.  Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. In December 2021, the patient experienced COVID-19 (COVID-19). On an unknown date, the patient experienced PAIN (General body pain), NASOPHARYNGITIS (Cold symptoms), PELVIC PAIN (Pelvic pain), INJECTION SITE PRURITUS (Injection site itching) and INJECTION SITE URTICARIA (Injection site hives). At the time of the report, PAIN (General body pain) and NASOPHARYNGITIS (Cold symptoms) outcome was unknown, COVID-19 (COVID-19) and PELVIC PAIN (Pelvic pain) was resolving and INJECTION SITE PRURITUS (Injection site itching) and INJECTION SITE URTICARIA (Injection site hives) had resolved.            On an unknown date, the patient experienced hives around injection site/ that were itchy, cramps in pelvic pains, moderna vaccine did not agree with body/was sore and achy and cold like symptoms. In December 2021, the patient experienced COVID. On an unknown date, hives around injection site/that were itchy resolved. MODERNA COVID-19 VACCINE (ELASOMERAN) was also considered suspect.   Treatment medication was not reported.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
5-6 days after the injection right upper arm started to itch. Skin had turned bright pink and looked like a rash but was smooth. The pink color extended from my right shoulder halfway down to my elbow and wrapped around the entire upper arm in a band that measured about 6 inches wide. The whole area itched but not constantly or too  intensely. Itching lasted nearly a week. The arm is no longer bright pink, but can tell where the skin  was inflamed. Informed the head pharmisist at location and my family doctor. The pharmist said it was probably an allergic reaction and I should notify my doc, the doc said it was a sign that my body was developing antibodies. It was a little scary and I'm not looking forward to the shot on 3/10/21!!
It was reported that a female pt in her 50's received a Fluzone UNSP '99-'00 vaccination and possibly a PPD test on 10/25/99. Reportedly, on 10/26/99, the pt developed a local reaction of redness, swelling and pain at the injection site. On 10/27/99, the pt experienced chills but no fever was documented.
p/vax pt not walking;crawled a lot to get around;grandma felt shots given incorrectly-below the knee & into the knee itself;knot like area approx 1cm;some redness below the knee;leg tender;
Extreme fatigue--commenced 20 hours after Booster injection.   Fever 102.3  degrees--fever commenced somewhere between 20-22  hours after Booster injection.  Took Tylenol and fever came down.   Sore injection site-achy arm Slept 11am-7:30pm (hour 20-28.5 post injection) and through night (hour 29.5-37.5 post injection).  FELT GREAT when I woke up!
Vaccine on 1/21 and 2/18.  Platelet level 'crashed' to 5 or less within days following vaccination; recovered; crashed again following 2nd vaccination.  More than a dozen data points from early December through present.
Fever, malaise, weakness. Onset approximately 6 hours after the vaccination with  LA soreness and muscle aches. Peak signs/symptoms on 02/15/2020 at 5 am when fever, malaise and muscle pain onset. Worsened throughout 02/15 and was slightly improved with tylenol. Slept throughout the day on 2/15 and throughout the night. Woke up on 02/16 feeling well. Some headaches have persisted, but all original adverse events have been resolved.
Irregular menstruation.  Have been menstruating every 3 weeks with increased bleeding/clots and menstrual pain.
2 locations of skin rash approximately the size of a female palm (excluding fingers) Itchy.
pt recvd vax; pounding ha, SOB, tightness in chest, v 1 1/2 hrs p/ dose;bitten by dog on 20oct93;27jan94 f/u:recvd 2 more doses;Lot j0374 on 5nov93 & lot j0320 on 10nov93;all sxs resolved
Inflammation-severe pain Shortness of Breath Headache Brain Fog-Memory loss, focus Severe Insomnia Lowered oxygen levels Heart arhythmia Lowered body temperature Inability to regulate temperature changes  (Hot/cold) Multiple subsequent infections
Initial information received on 02-Nov-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves patient of unknown demography who received a dose of QUADRACEL for PENTACEL (lot number not reported for both) via unknown route in unknown administration site on an unknown date. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to wrong vaccine administered. It was not reported 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 holders compliance with the requirements set out in Directive and Module VI of the 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.
Got on an airplane that evening, while on plane, Severe sweating, chills, blood pressure drop and feeling faint. Fever of 101.9 at 10:15pm. Acetaminophen seems to improve symptoms well.
tingling feet and fingers,weakness of arms and legs,difficulty swallowing,back pain, staggering, lumpy feel in throat, no reflexes arms and legs,difficulty walking and maintaining balance,back pain,motor cooridination,difficulty breathing. 2/13/07 Received medical records from hospital which reveal patient experienced progressive weakness & paresthesias of LEs with tingling & numbness for approx 4 days.  Admitted to hospital 12/9-12/14/.  Admit exam revealed areflexia & difficulty standing from squat.  Tx w/IVIG w/some improvement.  D/C to rehab hospital.  FINAL DX: most likely Guillain Barre Syndrome.
This spontaneous report as received from a nurse refers to an unspecified number of patients. On an unknown dates, the patients were vaccinated with an unspecified number of doses of (Merck) VARIVAX (lot#, dose, route and site of administration were not reported) that were reconstituted with sterile diluent (manufacturer unknown). The doses were reconstituted with 0.6 ml of sterile diluent (manufacturer unknown) and were not reconstituted with the entire volume of the supplied sterile diluent (manufacturer unknown) as recommended in the prescribing information. 0.5 ml of vaccine was drawn up for administration after reconstitution. No adverse events were reported. Product quality complaint was involved. This is one of several reports from the same reporter. Additional information has been requested.
The day after receiving the shot, I woke up with body aches, joints hurting, and had to call out of work.  I brushed it off as just the medication.  But for months now, the joint pain has gotten worse, I stay extremely fatigue, my hands go to sleep a lot, I can't take being in the sun, I sweat really bad even if I'm sitting watching TV.
Burning red rash on arm, left side of neck and face. Skin is hot to touch.
On 3/7/01, I began to have all over body itching. There was no extreme rashes. This continued consistently, all hours of the day. On 3/24/01, I went to a doctor who said I probably had "winter itch". He put me on Claritin and gave me some other instructions. I still have the itching. The beginning of April, the muscle in my right arm began to hurt. This is where I had the shot. The pain continued to come and go in my arm. A rash did show up for about 1 week and went away, but itching continues.
Started bleeding later that evening after the shot.; Also started having severe menstual cramps; This is a spontaneous report from a contactable nurse, the patient. A 36-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FE3592) via an unspecified route of administration on 08Sep2021 at 16:30 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as not applicable (N/A). The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE) for birth control from an unknown date and was ongoing. On 08Sep2021 at 22:30, in the evening the patient started bleeding after the shot. The patient was on birth control in a very strict schedule. On the day of the COVID-19 shot, the patient was on day ten of the cycle (taking active pills). The patient also started having severe menstrual cramps. Both the bleeding and the cramping had not subsided even though the patient had continued to taking birth control at the exact same time every day. Prior to getting the COVID shot the patient had a full gynaecological work up and everything was normal, so the only variable was the COVID vaccine. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events started bleeding later that evening after the shot and also started having severe menstrual cramps were not resolved at the time of this report.
9 days after vaccination I am experiencing redness, itching, pain, and swelling at the injection site on my left arm.
This spontaneous report as received from a healthcare worker refers to an unspecified patients of unknown age and gender. The patients pertinent medical history and concurrent conditions were not reported. No previous drug reactions or allergies were reported. On an unknown date unspecified number of patients were vaccinated with improperly stored doses of GARDASIL (strength, dose, frequency and route of administration were not reported) (unspecified lot # and expiration date). No concomitant medications were reported. No adverse effects were reported. There was no product quality complaint. Additional information has been requested.
no adverse event; improperly stored vaccine administered intramuscularly; confirmed route of administartation was intramuscular; This spontaneous report as received from a other health professional refers to a patient of unknown age.    On 10-SEP-2019 the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) lot # S002736 dose 1, .5 milliliter, intramuscular for prophylaxis.    Concomitant therapies included sterile diluent (STERILE DILUENT) (possible lot # S000130, expiry date: 23-AUG-2021).   On 10-SEP-2019, 1 day after onset of therapy the patient experienced product storage error and incorrect route of product administration.  On an unknown date the patient experienced no adverse event.
Information has been received on 20-MAR-2017 from an attorney in the form of an initial legal complaint regarding a female consumer (age not reported) who received  ZOSTAVAX vaccine for the prevention of shingles as part of a routine adult medical examination (date not reported). Prior to receiving ZOSTAVAX, the patient had never suffered from or been diagnosed with herpes zoster, or any other ailment collectively referred to as "shingles." On or about 20-JUN-2016, the patient went to her primary care physician, where she was treated for complaints of painful bumps, which were diagnosed as shingles. The patient was prescribed valacyclovir and was referred to an ophthalmologist. On or about 21-JUN-2016 the patient was treated by the ophthalmologist for swollen eyelids and painful blisters. The physician identified shingled on the right side of the face and a vesicle on the right upper lid and periorbital skin. The physician reaffirmed the prior diagnosis of herpes zoster keratoconjunctivitis. The patient was prescribed valacyclovir (VALTREX) and "viroptix" 1% to prevent the spread of the blisters deeper into her right eye. As a direct result of the vaccine, the patient suffered, is suffering and/or will continue to suffer from mental and emotional distress due to resulting physical limitations and seriousness of her condition. The patient sustained severe and permanent personal injuries. Furthermore the patient suffered serious, progressive, permanent and incurable injuries as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. Additional information has been requested.
Confirmed breakthrough case  COVID-19 (Moderna) 1 09/01/2021 Pharmacy Moderna 939893   COVID-19 (Moderna) 2 04/07/2022 Pharmacy Moderna 002M21A
Low grade fever, chills & sweats night after vaccine administered (11:00 p.m - 2:30 a.m. chills, following by 1 hour of sweats). Low grade fever <100 persisted intermittently info afternoon of 10/7.
Patient keeps breaking out in Hives on and off. Allergy Meds were given and didn't treat condition. so Doctor appt. was made.
no adverse effect; patient received unspecified dose of PEDVAXHIB that was improperly stored/experienced excursion; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 14-MAY-2018, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) (exact dose and route of administration were not reported, lot # N003536, expiration date 02-NOV-2019) for prophylaxis. On 10-MAY-2018, the administered dose of vaccine experienced the temperature excursion of 8.72 degrees Celsius for 1 hour and 35 minutes. Data logger was involved. There was more than 1 previous excursion reported. There was no adverse effects reported.
About 2 weeks after my second vaccine, i got very ill; abdominal issues, sever fatigue followed by severe sinus congestion which lasted for about 10 days. This has been followed by ongoing severe fatigue, inflammation of my joins, painful movement and walking, brain fog and inability to concentrate. i am still dealing with the debilitating effects 7 weeks out.
Information has been received from a physician assistant concerning an 18 year old female who on unspecified dates was vaccinated with a first, second and third dose of GARDASIL, lot # unknown. It was reported that the patient had been short of breath since receiving her third dose of GARDASIL. At the time of reporting, the outcome of the event was unknown.  2/3/09 MR received from Pulmonary Med consults dated 9/9/08, 10/27/08 and 1212/10/08 with DX: Shortness of breath/chest tightness.  Allergic rhinitis improved.  Referred by PCP for eval of increasing SOB and chronic cough. Sleeping more lately and waking at night and unable to catch breath. PE WNL. O2 sat 96-98%.  Referred for heart cath later in the yr to r/o pulmonary HTN.
Chills and extreme fatigue 6 hrs after shot; extreme myalgias and headache and subjective fever 11 hrs after shot;  abd cramps and nausea vomiting diarrhea 24 hrs after shot;   symptoms resolving in 3 days with only fatigue lingering until 1 week
following immun pt had episode of unusual high-pitch cry for 2 1/2 hrs; pt was listless for 2-3 days;
This case was reported by a healthcare professional and described the occurrence of swelling injection site in a 38-year-old female subject who was vaccinated with BOOSTRIX, (GlaxoSmithKline). There were no concurrent medications. On 13 April 2009 at 10:41 the subject received unspecified dose of BOOSTRIX (.5 ml, unknown, right arm). On 13 April 2009, 1 hour after vaccination with BOOSTRIX, the subject experienced swelling at the injection site and discomfort. On an unspecified date between 13 April 2009 and 15 April 2009, within several days after vaccination with BOOSTIRX, the subject experienced 11 x 12 centimeter induration with no redness. Medical attention was required at the clinic where the vaccine was administered. The subject was treated with ibuprofen. At the time of reporting, the outcome of the injection site swelling and discomfort was improved. The outcome of the induration was unspecified. Follow-up received 06 May 2009 from the reporter: The events resolved on 24  April 2009. The reported considered the events could have been associated with " last tetanus diphtheria vaccine was 2005". The reported considered the events were related to vaccination with BOOSTRIX.
Pt is a 20 yo Female who presented to clinic for lightheaded/dizziness that started 15 minutes after receiving her JEV-1 (R deltoid IM) and Anthrax (L deltoid IM) vaccines. She also developed R forearm pain/swelling around the same time. Medic came to pt's shop to administer vaccines and pt was brought to clinic when she started experiencing symptoms. Pt had golf ball sized swelling at R forearm, just inferior to antecubital space, with extreme tenderness to palpation and pain with any movement distal to swelling. Injection site had drop of dried blood with mild erythema where bandage adhesive was attached. No evidence of streaking, broken skin any where in right upper extremity. Pt also reported mild numbness/tingling at palmar aspect of R hand. Pt had mild decreased range of motion and weakness due to pain. Pt was observe in office from 1100 to 1500 with no evidence of shortness of breath, chest pain, dyspnea, swelling elsewhere. Pt was given Benadryl 50 mg and Naproxen 500 mg.  With no improvement. Heat was applied to area 20 minutes on/20 minutes off for an hour and then ice was applied for the same time frame with no improvement. Pt was advised on return precautions for anaphylaxis, compartment syndrome, cellulitis. Pt advised to have buddy at all times for next 12-24 hours. Pt advised to follow up in clinic on Monday, 11JUN18, but did not.
Pharmacy intern grabbed the infant vial (maroon top) instead of the pediatric vial (orange top) and diluted the maroon vial with 1.3 ml of sodium chloride instead of 2.2 ml.  A dose of 0.2 ml was given resulting in a dose of about 1/3 the amount of what they should have received.  No adverse event by the patient or parents was reported.
11/18/99:Pt recv'd 1st dose of Pneumovax. Pt dvlped swelling, redness, & warmth at inject site;it progressed to her elbow on 11/20 sending her to ER.Tx for cellulitis w/Levaquin.
Swelling, redness to site. Approx. 50 mm by 55 mm.
Patient received first dose of covid-19 Janssen vaccine after online consent. Counseled patient after vaccine to remain seated in store for 15 mins of observation. Patient questioned if and why it was necessary for her to stay in which I responded that she has not received this vaccine before and if a reaction were to happen we would be here to help. After a few minutes, I responded to patient as she was asking for help. When I reached the patient she was extremely sweaty. She felt she had passed out, light headed, shaky and felt as if her blood sugar dropped. As I was helping the patient she became more alert and responsive after providing her with water and kleenex. We called 911 and the paramedics assessed the patient. They offered to take her to the hospital to which she declined. They said to observe the patient for another 10 mins in which I did. I asked the patient if she could have someone come get her so she did not drive herself home and stay with her throughout the rest of the day which she declined but did say her boyfriend may be able to come over later. I requested the patient call when she reached her location, but she also did not provide any other further updates.
Patient came to the pharmacy on 1/4/14 and the vaccine was administered, she said that the area started to itch and bodered. Came to the pharmacy on 01/06/14 and reported that the area was hot, red and swelled. Patient called the doctor.
fainted in May and again in July.  none of the tests that have been taken have found anything wrong that would cause me to faint. that is why i am reporting this to see if anyone else has experienced an issue like this.
I had a vasovagal response- vasodilation. I felt hot, flushed, nauseous, then it developed into feeling dizzy and feeling like I might be sick. I was brought outside and asked to lay flat on the ground and I felt much better. The doctor came out to check on me and said that I looked pale, and that my blood pressure had dropped and asked if this has happened before and if I exercise regularly. After laying down for a little bit, I was guided to sit up slowly as I felt ready. Later that evening within 3 hours or so from the injection, I felt joint pain, and nerve "pinches" throughout my body. This continued through the night and into the next day 2/3/2021. These nerve pinches were mostly on my hands, left wrist, feet, legs, and jumped around a bit throughout my body-shoulder, back etc. I've experiences sciatica and other nerve pain before so know what nerve pain "pinches" feel like,
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Physician). The reporter is the patient.  A 41-year-old male patient received bnt162b2 (BNT162B2), on 24Sep2021 as dose 3 (booster), single (Lot number: 3013458A) at the age of 39 years for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures (Paxlovid treatment start date: 01Oct2023, end date: 06Oct2023) were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: The vaccine efficacy varies from one patient to another and can be affected by different factors; however, a contributory role of the suspect vaccine BNT162B2 to drug ineffectiveness and COVID-19 cannot be ruled out. Events are considered related conservatively. Case will be reassessed upon receipt of additional information.,Linked Report(s) : US-PFIZER INC-202300323668 same patient/reporter, different drug/event;