chrisvoncsefalvay/vaers-outcomes huggingface dataset:
flu like symptoms; fever; chills; This case was reported by a pharmacist via sales rep and described the occurrence of influenza-like symptoms in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, 10 hrs after receiving Shingrix and Shingrix, the patient experienced influenza-like symptoms, fever and chills. On an unknown date, the outcome of the influenza-like symptoms, fever and chills were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, fever and chills to be related to Shingrix and Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient had flu like symptoms that started about 10 to 12 hours after 1st or 2nd dose and lasted for about 10 to 12 hours. The reporter gave consent to follow up via mail. This case has been linked with case US2019AMR209598, reported by same reporter.
I thought was a sinus infection exp wheezing, headache, achiness. By week two went to ER got tested diagnosed with pneumonia was prescribed two inhalers. On week three started running fever even after two antibiotics.Im recovering still exp shortness of breath at times.
PT HAS PERSISTENT ARM PAIN SINCE INJECTION, AND IT HAS BEEN ABOUT 3 MONTHS NOW. HE HAS LIMITED CIRCULAR ARM MOTION.
Received vaccines 11-29-07.  Within 24 hours he developed fever up to 103.6.  Within 48 hours fever was low grade and he developed cough and congestion.  Cough and fever persisted and he developed cyanosis after prolonged cough and was admitted 12-8-07 for acute life threatening event.  Urine culture negative, CSF culture negative, chest x-ray - negative.  Discharge diagnosis - persistent cough.  01/02/2008 MR received for DOS 12/8-9/2007 with dx:  Apparent Life Threatening Event, persistant cough and lymphocytosis with clinical concern for pertussis. Child had a cough x 12 days and during a prolonged coughing episode mom noted perioral paleness/duskiness followed by gasping for air.  Child then returned to normal baseline. PE WNL.  Admitted with Impression: Fever (by hx), Upper Respiratory Infection. Cyanotic episode by hx. .
Extreme metallic taste developed in my mouth, which started right after the injection but got progressively worse to the extent I was extremely nauseated and had difficulty tasting things for 5-6 days (unsure exact time frame).. I forced myself to eat with the family as I?m a very petite person
Received flu vaccine at 3pm. By 6pm had red, swollen area approximately 3x4 inches itchy. No systemic signs/symptoms.
reconstituted with distilled water; reconstituted with distilled water; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 80-year-old patient who received Herpes zoster (Shingrix) (batch number TY2TY, expiry date 09-FEB-2024) for prophylaxis.   On 03-MAY-2023, the patient received the 1st dose of Shingrix. On 03-MAY-2023, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: reconstituted with distilled water) and inappropriate dose of vaccine administered (Verbatim: reconstituted with distilled water). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 04-MAY-2023 The nurse called to inform that a patient received the 1st dose of Shingrix, but such dose was reconstituted using distilled water instead of the approved diluent of Shingrix.  The reporter was consented to follow up. The patient received Shingrix dose which was reconstituted using distilled water instead of the approved diluent of Shingrix, which led to wrong solution used in drug reconstitution and Inappropriate dose of vaccine administered.
The day of the vaccination within 3 hours I had achiness, fever, headache, dull stabbing pain in stomach, sharp pain in upper abdominal pain that wrapped around my back, pain underarm and breast on left side (Developed on right side about a week later) lasting about 6 days. About two weeks after my vaccine I began getting extremely itchy/burning on my stomach and back. It was often unbearable. Shortly after the itching developed began to notice light red irregular rash located from pelvic region and buttocks up to neck. The rash comes and goes without warning or identifiable reason. The portion of my body the rash covers is pretty unchanging but the intensity of the itching has diminished since the original outbreak. The dermatologist thought it could be a delayed sensitivity to the vaccine and advised that I take ZYRTEC 24-48 hours prior to vaccine and continue for at least a month. Has a future appointment with allergist.
Broke out in itching and rash over all body.  Started about three days after shot.
Patient experience redness, swelling, itchiness and soreness in the left arm. This showed up about 3 to 4 days after the injection.  She stated this resolved about 2 weeks later.
5 minutes after the shot a sharp pain to the left side of my neck.  Now my lymph nodes in the neck are swollen.
Information has been received on 05-MAR-2019 regarding a case in litigation from a lawyer concerning a female patient of unknown age. There was no information provided regarding the patient's concurrent conditions, medical history or concomitant medications. The patient's healthcare provider, recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 23-APR-2012, a pharmacist at a pharmacy administered the ZOSTAVAX (lot number, expiration, dose and route unknown) to the patient. On or about 23-NOV-2013, the patient was treated by a physician at a hospital emergency room for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the Zoster Vaccine Live (ZOSTAVAX), and suffered serious physical, emotional and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events is not recovered. The causality of the events is related. Additional information has been requested.
within hour after getting vaccine: arm hurt; slight headache that evening Day 3&4: chilled Day 5: 7am very dizzy, queasy stomach, severe chills, temp 95.5, extreme fatigue - queasiness & chills over by noon Day 6: fatigued, vertigo; symptoms continued a week more but less every day  2nd dose rec'd 3/8/21 with little reaction except sore arm
Pt developed a varicella like rash consisting of 100 - 200 lesions. Pt also experienced aches but was afebrile. Unspecified medical attention was sought. Subsequently, the pt recovered from the varicella-like rash. Additional information has been requested.
13 year patient had been given the Flublok Quad by mistake,no AE; Initial information regarding an unsolicited valid non-serious case was received from other health professional via Agency (Reference number- 00358544) and transmitted  on 16-Nov-2020.  This case involves a 13 year old patient (gender not specified) had been given the 0.5ml dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] by mistake via unknown route in unknown administration site for prophylactic vaccination on an unknown date (product administered to patient of inappropriate age)  Medical history, medical treatment(s), past vaccination(s) concomitant medication and family history were not provided.  It was a case of an actual medication error due to inappropriate age at vaccine administration (latency same day).  At the time of report, no adverse event was 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 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.  There will be no information available on the batch number for this case.
COVID-19; COVID-19; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 02Mar2021 as dose 1, single (Lot number: EN6203), in left arm, on 24Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 07Oct2021 as dose 3 (booster), single (Lot number: FF8841) at the age of 61 years, in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 10Apr2022 at 13:00 as dose 4 (booster), single (Lot number: 048L21A), in right arm and on 23Sep2022 as dose 5 (booster), single (Lot number: AS7148B), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetic" (unspecified if ongoing); "cholesterol" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing). Concomitant medication(s) included: INSULIN; TRESIBA. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 23Sep2022, outcome "unknown"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: positive, notes: Retesting positive for Covid after 2 days of testing negative; negative, notes: Retesting positive for Covid after 2 days of testing negative. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical course: Known allergies: Yes. Patient received COVID-19 treatment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
red papules; Itchy papules; blister; lesions; This case was reported by a nurse via call center representative and described the occurrence of papular rash in an unspecified number of adult patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced erythropapular rash, itchy skin, blister and skin lesion. On an unknown date, the outcome of the erythropapular rash, itchy skin, blister and skin lesion were unknown.   It was unknown if the reporter considered the erythropapular rash, itchy skin, blister and skin lesion to be related to Shingrix.  Additional details were provided as follows: The age group was not reported but was selected as adult as per vaccine indication. This case has been linked with US2019183533, reported by same reporter.
This is a spontaneous report from a contactable consumer (patient) reported for herself. A 60-years-old European female patient received BNT162B2 (solution for injection, Batch/Lot Number: EP7534), via an unknown route of administration in left arm on 19Mar2021 (at the age of 60-years-old) as dose 1, single and (Batch/Lot Number: ER8731), via an unknown route of administration in left arm on 16Apr2021 as dose 2, single for COVID-19 immunization. Expiry date, UPC and NDC, consumer stated that all it was Pfizer and they have same number that was it, she gave you, she did not see any other number that was all she have. The patient's medical history included blood pressure high and acid reflux; both were from an unknown date and unknown if ongoing. Concomitant medication was not reported. Patient stated, "Yes, I do, well for the hypertension, I take prescription and for acid reflux I take a prescription". On an unknown date, the patient noticed the rash on my breast; but I had it couple of weeks, took the shot on Friday (16Apr2021) the rash got yesterday morning really bad, have like a rectangular shape. Patient stated, "I had my second shot of the Pfizer on the 16 this past Friday (16Apr2021) and my first vaccine was on 19Mar2021 and between I noticed the rash on my breast, I did not think anything of it and do not really know when I got this rash, but I had it couple of weeks then I took the shot on Friday (16Apr2021) the rash got, yesterday morning really bad, I may have like a rectangular shape, so I do not know what is it, anything or if it is nothing but I just wanted to report it." Consumer stated, "I had this (rash) for couple of week, it had to be before few weeks, I am gonna say may be before, 4-5 days after the first shot I am not exactly sure". The outcome of event was unknown. No follow-up attempts are needed. No further information is expected.
Fever and body aches/joint pain began while sleeping, around 12:00am on 1/17/21 and persisted through late morning (around 10:00am) on 1/18/21. Also had chills and extreme fatigue. Slept almost all day on 1/17/21 and went to sleep early. Took 700 mg of Tylenol on 1/17/21 at 7:30am, 2:30pm, 7:30pm, and the morning of the 18th but fever continued to register between 100.2 and 100.8. Was unable to record temperature at highest fever the night of the 17th while sleeping. All symptoms have resolved as of today, 1/19/21.
Had booster Moderna injection on 11/5/21.  Had progressive shortness of breath that worsened in December.  On 12/28/21 went to urgent care due to increased shortness of breath and oximeter 85-88% on room air.  When got into examination room his oximeter was 76% on room air.  Was put on oxygen and sent to ER.  He was admitted to ICU on 12/28/21 with pericardial effusion which needed to be drained.  Also diagnosed with RSV during hospitalization.  Was sent home on 1/1/22 with oxygen.
felt like throat was closing, tightness in chest, wheezing, eyes really dry & puffy; developed flu sx about 7 or 8P; diarrhea & fever, h/a, general malaise;
Fevers, chills, headache, and fatigue occurred 12 hours after receiving first dose. Symptoms lasted for 48 hours and were managed with Nyquil, fluids, and rest.
Pt stated immediately when she got the injection that pain shot down her arm to her elbow.  It has continued to hurt when she wakes up & all day; achy muscle in the upper arm where administered & a little down the arm; feels stiff and achy; she tried an ice pack today and it didn't seem to help.  She can still move her arm.
Arm is still sore 10 days later. Metal plate in left wrist is throbbing. Major rash all over left arm. Headache, fatigue for 10 days
UTI Urinary Track infection; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (UTI Urinary Track infection) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     The patient's past medical history included Low back pain (low back pain from herniated disc). Concurrent medical conditions included Emphysema (lung disease emphysema).    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced URINARY TRACT INFECTION (UTI Urinary Track infection). The patient was treated with HYDROCODONE BITARTRATE, PARACETAMOL (VICODIN) for Low back pain, at an unspecified dose and frequency. At the time of the report, URINARY TRACT INFECTION (UTI Urinary Track infection) 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.  Patients second dose was scheduled on 25-Feb-2021.
right and Left hand swelling in fingers with "hives" rash starting about 5 hours after HPV injection in right deltoid
Pain in left arm, described as throbbing pain that began night of injection and has continued since that day. Patient has been taking TYLENOL for pain and called her physician for an appointment.
pt recvd vax;subsequently devel a 3" by 4"  area of swelling & warmth at inject site;
On Sept 30, 2019, I received the flu injection by a temporary staff person, working at the clinic. Waited to be released for possible reaction.  Went home and within a couple hours upper arm became very painful, never had that much pain from previous flu injections) so placed ice on upper arm and took Tylenol.  By 5 pm I could not lift my arm and had extreme pain running down arm and into the fingers. When I took my shower later that evening I noticed the bandage was placed high up shoulder near joint. I found that very unusual. Took more pain reliever and another ice pack and went to bed. Continued ice and pain reliever throughout Sat, Oct. 1.  At 9:07 pm I contacted Dr., my  primary physician, via the messaging system and relayed what I was experiencing and my fear there was a possible injury to my shoulder.  His response: Having a bad reaction, which is not unusual. Ice and take Tylenol; pain should be gone within 3 days. See immune responses like this quite often.  Rest assure the shoulder joint is fine.  Sunday there was swelling and redness.  On Monday, Oct 5 I called the clinic and appointment was scheduled to see NP, as Dr. was on vacation.  Appointment was scheduled for Oct. 9 @ 2:20 pm.  NP and the staff manager, both examined the arm and stated injection was definitely given in or near the joint.  An ultrasound was scheduled for the next morning at the Medical Center, Results:  ultrasound was normal, no signs of fluid collection, no foreign body. Should resolve in a week.  Pain continued and I decided to get appointment with my Orthopedic Doctor. Appt:  Oct. 28, 2019.  X-ray was taken.  Diagnoses:  Inflammation of shoulder and Frozen Shoulder.  Referred to Physical Therapist for the Frozen shoulder.  Physical therapy began Oct. 29 with PT  (seven days).  Returned for follow-up visit with Dr. (Nov 11)  with continued pain.  Ordered MRI . MRI was done on Nov 21 and follow up visit on Nov 25 with Dr., diagnoses Torn Rotator Cuff.  Referred to Dr. specialist in shoulder problems at same clinic with appointment on Dec. 3, 2019.  Was given a cortisone injection, which helped some.  Pain continued to get worse again and Mar 3, 2020 another injection was given and surgery was recommended.  Then COVID 19 stopped all elective surgeries.  Another injection given on May 26 to help with pain until surgery could be done.  Finally, elective surgeries could be done and on July 2 saw Dr. again for pre-surgery visit and scheduled surgery for July 22, 2020.  July 14, 2020, Pre-Op Clearance Exam completed.  July 22, 2020 surgery was performed.  July 28 visit with PA for suture removal and PT instructions to be performed at home.  Aug 18 first post-op exam and continued At-home PT with additional instructions.  Next appointment set for Oct. 19, 2020 for evaluation of shoulder.
Patient developed severe case of ocular shingles several weeks after receiving the shingles vaccine (ZOSTAVAX). Patient then referred to ophthalmologist who treated patient with oral antiviral therapy which is still ongoing (2/2010).
Symptoms began 12/23 in the AM. I was sick as a dog, my fever was so high it caused me to hallucinate. Cough, congestion, and fever of 104.1. Telehealth visit with urgent clinic on 12/24 and was prescribed PAXLOVID, didn't lose sense of smell but taste was off. Symptoms began to resolve on 12/27. It took and additional 2.5 weeks for symptoms to completely resolve.
Shakiness; Nausea; Headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shakiness), NAUSEA (Nausea), HEADACHE (Headache) and FATIGUE (Fatigue) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced TREMOR (Shakiness), NAUSEA (Nausea), HEADACHE (Headache) and FATIGUE (Fatigue). At the time of the report, TREMOR (Shakiness), NAUSEA (Nausea), HEADACHE (Headache) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.
slight SOB, cough later the same day of vaccine, then high fever, body aches for 1 day and injection site red, hot, and swollen which improved over 4 days.
I got COVID-19 after my vaccine; I got COVID-19 after my vaccine; This is a spontaneous report from a Pfizer sponsored program. A non-contactable consumer (patient) reported that:  A patient of an unspecified age and gender received unspecified dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot number and Expiry date was not reported) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient medical history was not reported. The patient concomitant medications were not reported. On an unspecified date patient experienced COVID-19 after vaccination (drug ineffective). The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
lightheaded, dizzy, sweaty laid in stretcher with feet elevated for about 10 min felt better left asymptomatic
Received Varicella 01/06/04-appointment 01/22/04, 16 days after Varicella. Area quarter to half dollar sized indurated, red, with dot like lacey red-pinch eruptions-not well defined.  Recheck 01/21/04.  Redness gone 1/2-1cm area of induration remains.
On Wednesday, started rash, left abdomen. Has "shooting pains" occasionally, "starts and stops". Will se Dr tomorrow.
Incorrect information was documented on the VAR record by the staff. During patient assessment, verified with nurse and patient and was confirmed that patient received Moderna first dose. Pharmacist verbally confirmed with the patient that she was indeed received Moderna as first dose before giving the second dose. After vaccine was given, patient pulled out the vaccination record card and it was stated that she got Pfizer first dose. Patient was observed for 30 minutes and no adverse reactions.   Outcome: Nursing home was notified of incorrect documentation. Different manufacturer of Covid vaccine was given. Notified appropriate department per protocol.
I got a severe headache that lasts about 2 days after I got vaccinated. I also have on and off fever (about 100.1 Fahrenheit) for 2 days.
This spontaneous report was received from a registered nurse regarding a 19 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not provided. On an unspecified date, the patient was inadvertently vaccinated with a pediatric dose of VAQTA 25/0.5 injection, intramuscularly lot # N019924 with expiration date 02-SEP-2018 for prophylaxis (accidental underdose). No adverse effect reported.