chrisvoncsefalvay/vaers-outcomes huggingface dataset:
stayed in bed for three days; chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (stayed in bed for three days), CHILLS (chills) and PYREXIA (Fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MALAISE (stayed in bed for three days), CHILLS (chills) and PYREXIA (Fever). At the time of the report, MALAISE (stayed in bed for three days), CHILLS (chills) and PYREXIA (Fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No medical history or concomitant medications provided. No treatment details were reported.
About 10 days after the vaccine, I had a severe attack of pseudogout in my left hand, the same side as the shot.
approximately 2 weeks post the second shot, I began to have pain in my left arm that radiated to my neck . It started with exertion and then continued with minor activity.   I went to the ER for assessment.
Myalgia, Arthralgia, UrticariaPruritus, shoulder, neck pain 1/22/21 also itching on day 13 Narrative:  used triamcinolone cream
This spontaneous report as received from a nurse refers to a 12 year old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 07-SEP-2017, the patient was vaccinated with improperly stored GARDASIL 9 (dosing details were not reported) (lot # N007931, expiry date: 17-NOV-2019) for prophylaxis. No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as from 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA000054.
Booster dose of 0.25 was given as first dose. Second dose of 0.25ml was administered to complete first dosage of 0.5ml. No adverse events occurred.
I developed an itchy rash on arm below injection site  that I  first noticed  about 24 hours after the injection.  Rash grew in size until it peaked at 8 days after injection.  It is now gone as of today.  Applied Cortaid last 5 days.
6 days after vaccine, Previous site for cellulitis infections reoccurred and needed antibiotic treatment.
Information has been received from a physician concerning a 10 year old male with no medical history and no allergies who on 14-JUL-2009 was vaccinated subcutaneously with the second dose of VARIVAX (Merck) (LOT# 662576/0046Y). There was no concomitant medication. The first dose was received at "about 6 years ago" (in approximately 2003). On 15-JUL-2009, the patient experienced redness and swelling at injection site. On 16-JUL-2009, the patient sought medical attention in the office and was prescribed TYLENOL and BENADRYL; no laboratory or diagnostic tests were performed. The patient was recovering at the time of this report. Additional information has been requested.
About 10 minutes after receiving the dose,  I felt a tingling wave come over me - my head and upper body- and then my left arm and hand started trembling.  It lasted less than a minute.
Prior to the covid vaccine, I didn't have any testicular pain or any lumps. After receiving my first dose I noticed I started to develop pain on my right testicle and a small tender lump. This issue started approximately 13 days after my vaccine and is still present.
Headache, Body ache, chills  middle of the night and whole next day - gone by day 2 post vaccine Sore arm within a couple hours of receiving
The morning after vaccines the Parent noted a large 70mmX70mm area on her Right deltoid that was red, warm and  swollen. Parent denies child had fever, itching, pain or difficulty breathing at any moment. He admits child had wheezing the night of vaccines due to environmental allergens. Child used inhaler. He does not know exact medication in the inhaler.
Information has been received from a certified medical assistant (C.M.A.) concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 25-MAR-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck), lot # K014798 (expiration date 12-MAR-2016, dose and route not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because the physician did not wish to be contacted.
This spontaneous report was received from a licensed vocational nurse of unknown age reporting on herself. No medical history or concurrent conditions were reported. On 28-JUL-2015, the nurse called to report a vial of PNEUMOVAX 23 that was underfilled. During the call, the nurse felt some moisture on her hand when she handled the vial; therefore, she washed her hands during the conversation. No adverse effects were reported. Additional information has been requested.
temp 102-103 x 48 to 72 hr, temperature dropped then measles rash on entire body and limbs
(approximately same for shot 2 and 3...1st vacc produced only a slightly red lump at injection site)  For #2 injection Chills started 9 hours post vaccine. Fever of 103.3 degrees F began shortly thereafter and remained at that temp for 36 hours. Severe "splitting"headache (front to back). Nausea. Vomited once the following morning. Fatigue, stiffness, weakness in legs and arms. Worst adverse events from vax 3. Chills began 8 hrs post vax, fever ran from 101 to 102.5 thought the next54 hours. Severe pain in right shoulder joint to point of immobility for24 hours. Nausea , vomiting twice at 24 hrs post vax and 32 hours post vax. Nausea remains but comes and goes. Too weak to walk down steps until48 hours post vax. Severe pain in hip joints for 48 hours post vax. Severe fatigue for 72 hours post vax.
Patient given vaccines on 10/29/10 and 3 days later he developed swelling and redness at the vaccine site on Rt thigh, and since then symptoms had worsened, with the site red and tender. Started on KEFLEX and BACTRIM. Outlined area - advised mom if symptoms spread to have him be seen. F/u next day on 10/30 - improved nicely. No tenderness, inflammation, was resolving nicely.
Allergic reaction - itchy, swelling all over body, fever, rash lasting longer than 1 week.  Treatment - Benadryl every 6 hours, steroids in ER.
Polio vaccination was given at this date, however it was never added into record. The lot number was L1130-1.
Cried for 3 hours without consoling. Mother went to emergency room. Was given Ibuprofen. Continued to be fussy for the next 4 days.
Subsequent to receiving one dose of varicella virus vaccine live pt experienced a lack of response. Follow up from a physician states no further information is available.
She got the vaccine on Dec 23, and then on Jan 4 she had a mild stroke with left sided arm and face weakness.  She did recover fully.  She already has known CAD and risk factors for CVD.  It is possible, but by no means certain, that the vaccine was an indirect cause of the event.  Since the vaccine provoked an immune response, as it was supposed to, it is possible that this inflammation may have set up a metabolic predisposition that may have contributed to the event, which was 12 days later.
Heart Beat is off, have sharp pain in my heart, Mild cardiomyopathy.  Have been having this issue sense.
Patient was to receive Moderna BIVALENT booster but received Moderna NON-BIVALENT booster.
Chills, fever, swollen, redness and pain with lump 5x8, muscle ache, continued until 11/15/2005. Verbalized she has severe itching, redness but kept under control with Advil and Cortisone cream on arm.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 09Apr2022 at 11:00 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE (other medication in 2 weeks). The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (30Jun2022) Unknown results, notes: Post Paxlovid rebound starting on 30Jun2022; (01Jul2022) Negative, notes: the day after testing negative; (03Jul2022) Positive, notes: 3rd day of rebound and symptoms are beginning to subside. Testing positive gain. Therapeutic measures were taken as a result of drug ineffective, covid-19 (Treated with Paxlovid from 20Jun2022 to 25Jun2022).  Additional information: Post Paxlovid rebound starting on 30Jun2022, the day after testing negative. 3rd day of rebound and symptoms are beginning to subside. Testing positive again.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
This case was reported by a healthcare professional and described the occurrence of thigh erythema in a child subject under the age of 6 years and of unspecified gender who was vaccinated with combined KINRIX, GlaxoSmithKline.  Concurrent vaccination included unspecified vaccines given in an unknown deltoid in December 2008 or January 2009.  Concurrent vaccines were given on the same date as KINRIX.  On an unspecified date (either in December 2008 or January 2009) the subject received unspecified dose of KINRIX in an unknown thigh.  In the evening following KINRIX injection, the subject developed thigh erythema (around the injection site), swelling at the injection site and skin warmth at the injection site.  The events worsened the next day and resolved over the next couple of days.  The healthcare professional considered the events were possibly related to vaccination with KINRIX.  These events occurred in three different subjects under the age of 6 years.  The children's parents called to report the events and were told over the phone to treat the redness and swelling with compresses and Tylenol.  The subjects were not seen in the office.  Linked cases include A0762589A and A0762590A.  Follow-up information received on 27 January 2009 indicated that the subject was a 5 year old female.  Intramuscular KINRIX was administered (0.5 ml) on 05 January 2009.  Concurrent vaccines given on the same date included MMR vaccine, VARIVAX vaccine and flu vaccine (manufacturers unspecified).  Events started one day following administration of KINRIX on 06 January 2009 and resolved three days later on 08 January 2009.  In the reporter's opinion, the events were related to treatment with KINRIX.
tinnitus Narrative: worsening tinnitus after second stot - was seen by audiologist and no hearing loss
injection site pain Narrative: Employee had previously submitted a report for ADR to the first dose of the COVID-19 vaccine, however the injection site pain, swelling, and redness remains over one week afterward. Employee also reports that face is "flushed." No medications have been used for symptom relief.
Petechiae and pruritis below the injection site at the right dorsal upper arm not including the deltoid, pain at the injection site (R deltoid), swelling to the AC space of the arm (below the injection site).
I tested positive for Covid the day after booster.  I had bad sinusitis symptoms, i.e. congestion, drainage, sore throat, cough,
Pt received PREVNAR vaccine @ thigh on 4/12/09 at 1021 AM.  Awoke from nap approx 3PM & cried as if in pain.  Mom noticed R leg (thigh->toes) very red.  Rx with TYLENOL + cool compress & redness disappeared but pt developed spots on lower leg and fever.  Pt noticed to have petechine on shin at 4:30. CBC done No treatment needed.
Headaches; This is a spontaneous report from a contactable consumer (patient). A 15-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Jun2021 13:00 (Lot number and expiration date was not reported) as dose number unknown, single for COVID-19 immunization at the age of 15-year-old. The patient medical history was not reported. The patient did not receive any concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID prior vaccination. The patient was not tested for COVID post vaccination. The patient experienced headaches on 21Jun2021. The outcome of the event was not recovered. The patient did not receive treatment for the event. The event was reported as non-serious.  Information on lot/batch number has been requested.
Pt recvd 1st dose of Hep B vax on 16SEP91 & 3 hrs p/vax pt exp pain @ inject site; also devel swelling of hand on side of inject; pt went to ER & tx antihistamines; p/1 wk sx subsided; pt recovered;
rapid heartbeat since 2/27 and still on-going, on 2/27 increase blood pressure to 150/100 and is still elevated since then, on 2/27 shortness of breath and still on-going feel winded if talking for long period of time or walking up stairs, on 2/27 feeling of heaviness in chest and still on-going, on 3/1 experienced dull headache on left temple above eye for 6 hours which subsided after taking Tylenol (2 pills/6 hours)
Rash around eyes, nose, and face. 2.5ml of Benadryl given with success. Ordered Benadryl to be given every 6 hours for 24 hours.
Pt recv vax on 3/13/98; on 3/16/98 pt exp fatigue, enlarged lymph nodes on left side of neck, sore neck&shoulder; 3/21/98 pt exp laryngitis, upper respiratory infection, dry cough, flu-like sxs; tx=home remedies
no adverse effect reported; one expired dose of ROTATEQ (N029868 3/12/2019) was inadvertently administered to one patient on 4/26/2019; This spontaneous report was received from a physician regarding a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported.  On 26-APR-2019, the patient inadvertently received an expired dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) administered orally for prophylaxis (dose, dose number and location of administration were not reported) (lot # N029868, expiration date 12-MAR-2019). No adverse events were reported.
Information has been received from a health professional concerning a caucasian female with a history of genital warts who on 01-OCT-2007 was vaccinated with her first dose of Gardasil vaccine, IM (lot# 658563/1063U). On approximately 29-OCT-2007, the patient experienced an outbreak of genital warts. The patient has not had an outbreak of genital warts in about 4 years. The patient's genital warts persisted. On 09-NOV-2007 the patient was seen inthe office for genital warts (first noted 2 weeks prior). Patient asking if new outbreak approximately 3 weeks after GARDISIL was caused by GARDISIL. Additional information has been requested.
fluzone high-dose quadrivalent was administered post excursion with no reported adverse events; Initial information received on 30-Dec-2022 regarding an unsolicited valid  non-serious case received via pharmacist.  This case involves a 65 years old male patient who was diagnosed with fluzone high-dose quadrivalent was administered post excursion with no reported adverse events after receiving vaccine influenza quadrival a-b high dose hv vaccine [Fluzone High-Dose 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 suspect influenza quadrival a-b high dose hv vaccine at a dose of 0.5 ml (strength, frequency, formulation: unknown)(batch number: UJ918AD, Expiry date: 30-Jun-2023) via intramuscular route in unknown administration site for Immunization  On 28-Dec-2022 the patient diagnosed with a non-serious event of fluzone high-dose quadrivalent was administered post excursion with no reported adverse events (poor quality product administered) (unknown latency) following the administration of influenza quadrival a-b high dose hv vaccine.  Action taken was not applicable.  At time of reporting, the outcome was Unknown.    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.
Patient received PREVNAR vaccine on 12/3/15. Still had localized reaction (warm, red rash approx. 1 inch, lump). No pain. Suggested ice, BENADRYL and give it a little more time.
chronic obstructive pulmonary disease with acute exacerbation; acute on chronic hypoxic respiratory failure; Pneumonia; This spontaneous report has been received from a lawyer regarding a case in litigation, concerning a male patient of unknown age. His concurrent conditions, medical history and concomitant medications were not reported. In or around 22-JAN-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, lot #, expiration date, dosage, injection anatomical location or route of administration were not provided) as routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after vaccination, the patient suffered shortness of breath, cough and fever requiring multiple hospitalizations. He has been diagnosed with chronic obstructive pulmonary disease with acute exacerbation, acute on chronic hypoxic respiratory failure (respiratory failure) and pneumonia. As a direct and proximate result of defective zoster vaccine live (ZOSTAVAX), his symptoms had resulted in physical limitations not present prior to vaccination. He also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of vaccination, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, he 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. As a direct and proximate result, the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.  The chronic obstructive pulmonary disease, respiratory failure and pneumonia were considered disabling events.  Upon internal review, the respiratory failure and pneumonia were medically significant events.
0840- IM injection given - HEPA. HEPB & INFLUENZA given  0845 - Patient feeling weak, dizzy, chest tightness, HR60 blood pressure 60/40  0850 - Patient laid in trendelenbung position  08:53 - Blood pressure 90/70, patient given water, juice  0855 - Blood pressure 100/70
My heart has been hurting since I received the vaccin.  I get a sharp pain, especially at night. The pain goes all the way to my back.
No adverse effects; a MMR II vaccine that expired on 08/24/2019 was administered on 08/26/2019; This spontaneous report has been received from an office manager referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant therapies and drug allergy or reactions were not reported.      On 26-AUG-2019, the patient was vaccinated with expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (rHA) (1 injection, lot # N023146, expiration date: 24-AUG-2019; route was not reported) for prophylaxis (expired product administered). No adverse effects were reported.
VERY SORE MUSCLES, CAN BEND ARM BUT NOT ROTATE IT X 4 WEEKS.  COLD COMPRESSES AND ALEVE HELP SOMEWHAT.
Approximately 2 1/2 weeks after second dose on 04/12, patient states she noticed a rash on her lower legs, inflammation on both shoulder blades, internal discomfort in her sternum area. Rash continues, less inflammation on shoulder blades and less sternum discomfort. Saw PCP on 04/29, ordered steroid cream for legs and lab work.
Injection site pain. No redness or swelling.  Fatigue, dizziness, lightheadedness, night sweats, body aches.
This case was reported by a physician and described the occurrence of fatigue in a 23 year old male pt who received Lyme disease vaccine recombinant OsaA (Lymerix) for prophylaxis.  Concurrent medications included loratadine (Claritin).  On unspecified dates in 1999, the pt received an unspecified number of injections of Lymerix.  Approximately 4 years post-immunization, "several weeks" prior to 08/01/03, the pt presented to the physician with complaints of fatigue and fever.  Total Lyme antibody screen was positive.  The events were unresolved as of 08/01/03.
severe local site reaction; severe local site reaction, itching and swelling; severe local site reaction, itching and swelling; This spontaneous report was received from a 77-year-old female patient referring to herself. The patient's pertinent medical history included severe site reaction that never needed medical attention. The patient's drug reactions and allergies included allergy to bee stings. Concomitant therapies included unspecified asthma inhaler, unspecified sleep aid, unknown antidepressant and vitamin d. On 14-OCT-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) one vaccination in the deltoid in the right arm (exact dose, route of administration, lot # and expiration date were not reported) as pneumonia booster. On the same day, the patient experienced severe local site reaction, itching and swelling. The patient sought medical attention and contacted clinic. She received prednisone as a treatment. The unspecified blood work was done but no results were provided. The outcome of events was reported as not recovered/not resolved. There was no causality assessment provided by the reporter.
Pt states sore arm for first 3 days after injection, then bruising at injection site and couldn't lift arm for days 4-7 after injection. Appoximately after 7 days bruising began down his arm both inside and outside and is currently still present, 1 month after injection. Pt states he believes it's getting better and can now move arm with no issues.
Hot sensation - could feel medication dispersing throughout body thrn heatt begin to flutter and race. EMS was called to pharmacy to monitor and was released after ~1 hour after dose. Heart palpitations continued for months after vaccine was given.