chrisvoncsefalvay/vaers-outcomes huggingface dataset:
she had a high fever / low grade fever; arm was swollen after administration; chills; This non-serious case was reported by a consumer via call center representative and described the occurrence of fever in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29-JUN-2023, the patient received the 1st dose of Shingrix (left arm). In JUN-2023, an unknown time after receiving Shingrix, the patient experienced swelling arm (Verbatim: arm was swollen after administration) and chills (Verbatim: chills). On 29-JUN-2023, the patient experienced fever (Verbatim: she had a high fever / low grade fever). The outcome of the fever was resolving and the outcome of the swelling arm and chills were unknown.   It was unknown if the reporter considered the fever, swelling arm and chills to be related to Shingrix.     It was unknown if the company considered the fever, swelling arm and chills to be related to Shingrix.   Additional Information: GSK Receipt Date: 30-JUN-2023 The patient self-reported this case. Less than a day after vaccination, the patient had fever. On the day of reporting, the patient stated her fever had decreased to a low-grade fever. The reporter consented to follow up.
I was fine right after. Then came 4;00 and I was preparing diner and I had cramps in my stomach. I laid down for a while and it got worse and I started throwing up. I was very dehydrated and shacking. I couldn't walk.
At 5:30am on 2/17/00, pt had seizure, for 20 sec. Had 3 more, but not serious. Treated with Phenobarbitol & no further seizures. Developed diarrhea on 2/17/00. Follow-up information received indicating mild flattening of nasolabial fold on left - Todd's paralysis. No further seizures also noted.
On Jan 10 , severe nerve pain left shoulder blade area down left arm and hand. On Jan 12, low grade fever started in conjunction with ongoing nerve pain. On Jan 14 woke up with blister /rash from left armpit down front of arm to wrist. Saw Doctor that morning and began course of Acyclovir 800mg 5 times daily.  On Jan 16 blister/ rash spreading to area near left midline of back and now all over front and back of left arm and on inside of hand. No relief in nerve pain.  On Jan 17 saw doctor again. Started on prednisone therapy starting today with schedule of 30 mg, 25mg, 20mg, 15mg, 10 mg, 5 mg . Listed amounts are day1, day 2, day3, day4, day 5, day 6. Also given Hydrocodone/acetaminophen 5-325 TB every 6 hrs as needed for 5 days.
Systemic: Exhaustion / Lethargy-Medium, Systemic: Joint Pain-Severe
Pfizer vaccine was given, but first dose was Moderna.  Second dose should also have been Moderna.  Therefore, this was a medication error.
Chills, soreness at injection site Rt arm, ill feeling. Took Ibuprofen 60 mg. During day of 2-28-2013 more soreness, chills. that eveing and into 3-1 early am - fever up to 101, increased soreness, swelling around injection site and nodule in right arm pit.
Numbness of left arm and leg; then felt left side radiating from injection site within 12 hours after injection. Numbness subsided except for a 1 inch area around injection site.  10/15/2008 office note received for DOS 9/3/2008. Pt presented with c/o numbness/tingling on L side of body including leg, arm and torso. Innjection site has the worst numness at visit, approx 1 in in diameter. PE (+) for mild induration.  Assessment:  Numbness..
Patient reports 'pain in back' and describes it as 'throbbing' near shoulder blades, pain in both shoulders and occasional L jaw ache. Patient states pain/aching still 'comes and goes'. Denies any redness, swelling or soreness at injection site. Denies any fever, chills, nausea, vomiting, sweating or SOB. I strongly recommend patient notify MD immediately and get medically evaluated.
developed rash over entire body,  saw my local doctor who prescribed Prednisone 20 mg.
syncope momentarily following immun inject-upon picking up-became alert again-no further s/s active, oriented x 3-remain w/RN x 1 hr
Possible Bell's palsy  To whom it may concern: I am an ED physician, I saw this patient for what appears to be Bell's palsy. He had his pfizer covid vaccine 1 week ago, and sx started a few days after that. He does not recall when he had the vaccine exactly and could only give estimate dates. He also did not recall the location he got the vaccine when I saw him in the ED. Further information should be obtained through him as I only know the limited information he had provided me.
Day after patient received all she could smell was "burnt toast" all day, symptom resolved next day
headache; really bad fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) and FATIGUE (really bad fatigue) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     No medical history reported.  Concomitant products included evunatol for anti-inflammatories, LOSARTAN, ACETYLSALICYLIC ACID (BABY ASPIRIN), OMEPRAZOLE and propenarol for an unknown indication.  On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced FATIGUE (really bad fatigue). On an unknown date, the patient experienced HEADACHE (headache). At the time of the report, HEADACHE (headache) and FATIGUE (really bad fatigue) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.
The pt received vaccines on 4/5/01 at approximately 9:00 am. Was presented to ER at 7:30 PM with a seizure. Transferred to the hospital. CT Scan revealed possible hydrocephalus.
no adverse event; Incorrect product or dosage is administered, resulting in a lower than authorized dose; This spontaneous case was reported by a nurse and describes the occurrence of UNDERDOSE (Incorrect product or dosage is administered, resulting in a lower than authorized dose) and NO ADVERSE EVENT (no adverse event) in a 6-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9236B) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Aug-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Aug-2022, the patient experienced UNDERDOSE (Incorrect product or dosage is administered, resulting in a lower than authorized dose). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, UNDERDOSE (Incorrect product or dosage is administered, resulting in a lower than authorized dose) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for UNDERDOSE (Incorrect product or dosage is administered, resulting in a lower than authorized dose).    No concomitant medications were reported.  6 year old patient was administered a first dose of the Moderna COVID19 vaccine for 6 months to 5 years old.  No treatment medications were reported.
11/10/21 Three days after the vaccination I noticed tenderness in back my rt knee. The tenderness increased over the next two days to an ache in my calf and thigh. Saturday Nov 13 I noted a fullness in the back of my rt knee, increased pain with walking and with flexion of my foot I took myself to the ER and testing revealed a  blood clot DVT in rt popliteal vein.  I have never had a blood clot or bleeding problem in my life. I stopped Estradiol immediately.   I am now taking Eliquis blood thinner for 6 months
Patient vaccinated on 11/15/06.  Returned to clinic two days later (11/17/06) with pain, swelling, erythema, and tenderness.  She stated the pain started immediately after receiving the vaccine, and the other symptoms were noticed once she had returned home.  She reported a history of numerous flu shots without problems and denies any allergies including to eggs.  The patient was directed to use ice packs and was given a five day course of dicloxicillin 500mg QID due to the severe tenderness and erythema.  The patient was called the following morning (11/18/06) and reported the erythema, redness, and swelling had all improved.  She was told to complete the course of antibiotic and to follow up in clinic on 11/20/06 (Monday) if she still had problems, which she did not need to do.
Intermittent red and itchy rash on neck, cheek, hands and wrists. Would flare up and subside  irregularly. This has lasted on and off for multiple weeks, from 12/24/21 through 1/12/22. Symptoms subside when taking Zyrtec allergy medication but continue to come back irregularly.
Moderate pain and redness near injection site, chills, fatigue, joint pain, headache, chills
My left arm has limited mobility and pain when limits are reached.  There are certain motions I cannot do including reaching for items.; My left arm has limited mobility and pain when limits are reached.  There are certain motions I cannot do including reaching for items.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12Apr2021 10:00 (Lot number: ER8729) at the age of 53 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "high blood pressure." (unspecified if ongoing); "divriticulitis" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Bnt162b2 (product=COVID 19, brand=Pfizer, lot number=ER2613, administration time=10:00 AM, dose number=1, vaccine location=Left arm), administration date: 19Mar2021, when the patient was 53 years old, for COVID-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), MOBILITY DECREASED (non-serious) all with onset 13Apr2021, outcome "not recovered" and all described as "My left arm has limited mobility and pain when limits are reached. There are certain motions I cannot do including reaching for items.". The event "my left arm has limited mobility and pain when limits are reached. there are certain motions i cannot do including reaching for items." and "my left arm has limited mobility and pain when limits are reached. there are certain motions i cannot do including reaching for items." was evaluated at the physician office visit. Therapeutic measures were not taken as a result of pain in extremity, mobility decreased.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and patient received other medications within 2 weeks of vaccination. Prior to vaccination the patient was not diagnosed with COVID-19 and Since the vaccination the patient has not been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Headache started that evening then felt achy, feverish, and very sick (which was the same as both previous shots) But the headache never went away, it got worse over time until the third day after the shot one pupil was much much larger than the other one and I started seeing flashing shapes in my field of vision for 20 minutes+. The headache eventually subsided but would come back with a vengeance randomly. This lasted for 2 months which resulted in me seeing a neurologist and getting 2 MRIs.
THE PATIENT PRESENTED TO A NEARBY ED WITH 3 DAY HISTORY OF DIFFICULTY WALKING, BILATERAL LE PAIN, AND DIFFICULTY VOIDING. HE WAS TRANSFERRED TO OUR FACILITY AND HOSPITALIZED ON 10/25/19 WITH A DIAGNOSIS OF TRANSVERSE MYELITIS BASED ON MRI READING. IT IS OF UNCLEAR ETIOLOGY. HE WAS IN PICU FOR 4 DAYS. HE IS S/P IVIG INFUSION AND IS ON METHYLPREDNISOLONE IV CURRENTLY. HE IS IMPROVING BUT STILL NOT AT BASELINE. HE RECEIVED VACCINATIONS ON 10/16/19. THE ABOVE IS BASED ON VACCINES RECORDS OBTAINED FROM HIS PCP.  ROUTE AND LOT NUMBER IS NOT KNOWN TO ME (THE REPORTER, A HOSPITALIST)
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Similar side effects to those of reporter) and MALAISE (Down on bed for a day) in a 54-year-old male patient 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Similar side effects to those of reporter) and MALAISE (Down on bed for a day). At the time of the report, VACCINATION COMPLICATION (Similar side effects to those of reporter) outcome was unknown and MALAISE (Down on bed for a day) had resolved. Not Provided. Concomitant products were not provided.Treatment medication were not reported.
- Dizziness, hot flash, rigors/chills, fatigue, muscle sorenees in L arm  - most of these symptoms came on suddenly at 12:30pm (I felt like I was about to faint, but I put my head between my knees and breathed deep breaths, and I did not actually faint) - I did not need to seek medical treatment for the symptoms, they resolved on their own with lots of rest, drinking water, and eating food - dizziness and hot flash (the feeling of fainting) resolved within 10 minutes - rigors/chills were intermittent and resolved when waking up on 11/16 (~8am) - fatigue also resolved on 11/16
Information was received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 15-OCT-2011, the patient was vaccinated at a pharmacy with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 15-OCT-2011, the patient was treated by a physician assistant for the onset of a vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster. The patient has been prescribed valacyclovir, prednisone, and gabapentin for management of his painful condition. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
pt recv vax 1996 & pt was pregnant;lab eval revealed a failure to seroconvert;
product storage error; This spontaneous report was received from a licensed practical nurse regarding a 1 year old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On 13-DEC-2019, the patient received improperly stored doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) lot # S037501, expiration date of 12-NOV-2021, subcutaneous in the right thigh , varicella virus vaccine live (oka/merck)(VARIVAX) lot # T017686 with expiration date of 21-MAY-2022, subcutaneous in the left thigh, hepatitis a virus vaccine inactivated(HAVRIX) lot # N592C with expiration date of 12-JUN-2022, intramuscular in the right vastus lateralis and pneumococcal 13v conj vaccine (crm197)(PREVNAR 13) lot # D57723 with expiration date of 30-SEP-2022 intramuscular in the left vastus lateralis, all for prophylaxis The vaccines experienced temperature excursions with a total of 29.5h.   This is one of several reports from the same reporter(US-009507513-2101USA011364).; Sender's Comments:  US-009507513-2101USA011364:
Subject in pneumococcal vaccine trial, with severe COPD was hospitalized for Gastroenteritis, viral. Vaccination took place 1/16/2008. According to the physician the relationship is 'None'. We would be happy to forward the Study's SAE reporting form upon request.  9/22/09 Pneumo Study SAE report hospitalization DOS 8/24/09 to 8/27/09. Assessment: Acute enterocolitis, dehydration. Patient presented with nausea, vomiting, abdominal cramping. Unable to tolerate even liquids. Loose green stools. Harsh breath sounds. Admitted for treatment of dehydration associated with presumed viral gastroenteritis.
Developed Excema on both arms 3 weeks after Moderna booster.   Reoccurred 2 weeks after second Moderna booster in July 2022
Mom called 7/23/08: patient had multiple papules; some with pustules; few vesicles scattered throughout body on extremities; trunk and back (diagnosed today).
5 to 10 minutes after vaccination patient began complaining of throat tightening, very anxious, patient talking with no visible problems breathing or throat swelling or tongue swelling noted, no rash or face swelling noted, pulse elevated, patient request cetirizine 10mg and one cetirizine 10mg given, 911 was called, patient refused epi pen at this time, continued to be alert and breathing but complained of difficulty breathing and throat and swelling, EMS arrived, patient walked to stretcher, continued to be alert, transported to ER.
On 4-9, noticed a rash on chest, some skin tenderness.  The rash spread under my arm and around to my back in the next 2 days.  I contacted my doctor on Monday 4-12 and started an anti viral and prednisone dose pack.  On Tuesday 4-13, I had an appointment with Dr and he diagnosed me with shingles.  I have nerve pain and tenderness, and the rash has grown larger but basically in the same areas.
FEVER S/P VACCINE ADMIN OF PEDIARIX,PREVNAR,HIB AND ROTATEQ.
pt recv vax 5SEP96 & 7SEP96 pt devel urticaria;rx pred & DPH;
Corona Virus Concern      SPO2 89% with ambultaion. -sent by PCP     HPI 58-year-old male with history of hypertension presenting to the ER with chief complaint of COVID concern. Patient notes he tested positive on January 7. He notes increased shortness of breath and fatigue since then. He has been having cough. Denies any fevers or chills. Received 2 vaccines most recently in April. Denies any underlying asthma COPD or heart history. Denies any lower extremity edema. Denies any tobacco use or alcohol use. Has been unable to work due to the COVID symptoms. Review of Systems  Constitutional: Positive for fatigue. Negative for chills and fever.  HENT: Negative for ear pain, rhinorrhea and sore throat.   Eyes: Negative for visual disturbance.  Respiratory: Positive for cough and shortness of breath. Negative for wheezing.   Cardiovascular: Negative for chest pain, palpitations and leg swelling.  Gastrointestinal: Negative for abdominal pain, diarrhea, nausea and vomiting.  Genitourinary: Negative for dysuria, hematuria and urgency.  Musculoskeletal: Negative for arthralgias, neck pain and neck stiffness.  Skin: Negative for rash.  Neurological: Negative for dizziness, weakness and headaches.       NO LOC
Information has been received from a nurse referring to a patient of unknown age and gender. On 07-JUN-2016 the patient was vaccinated with an improperly stored dose of GARDASIL 9 (lot # L040164 with expiration date of 20-FEB-2018; strength, dosage, frequency and route unspecified) (incorrect product storage). The patient did not experience any adverse effects. This is one of the three reports received from the same reporter. Additional information has been requested.
A report was received from a health care professional on 12/2/03 concerning an unspecified number (approximately 5 to 6) vaccinees under 4 years of age who inadvertently received Fluvirin on unspecified dates. On unspecified dates, the vaccinees inadvertently received Fluvirin 0.5ml IM. The vaccinees did not experience any adverse symptoms at the time of reporting. There was insufficient information to determine the reporter's causality assessment. Update 1/20/04: A follow up report was received from a health care professional concerning an 8 month old male vaccinee who inadvertently received Fluvirin on 11/20/03. On 11/20/03 the vaccinee inadvertently received Fluvirin. No adverse effects were reported at the time of reporting. No follow up pending. All information received.
Pain in injection site, lasted several days. Tiredness lasted about 24 hours Headache lasted about 30 hours, treated with ibuprofen Shivering lasted about 9 hours, getting progressively worse over that time
Started 3 days after injection.  Arm is red, hard and warm at injection site.  About the size of a baseball.
nurse mistakenly gave him Flublok, when he intended to have Fluzone High-Dose Quadrivalent, no AE; Initial information received on 09-Sep-2020 regarding an unsolicited valid non-serious case received from other healthcare professional.  This case involves a 73-year-old male patient who was administered INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot QFAA2003, Expiry date 19-May-2021) via an unknown route in an unknown administration site for prophylactic vaccination on 03-Aug-2020, instead of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (wrong product administered).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  It was an actual medication error case due to wrong vaccine administered (latency same day).   Reporter asked if it is possible for him to take the Fluzone vaccine maybe in October 2020  At the time of reporting, 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 holders 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.
INCREASED BACK TO BACK HEAVY NOSE BLEEDS FROM BOTH NOSTRILS; ARM SORENESS; HEAVINESS IN ARM; This spontaneous report received from a consumer concerned a 19 year old male. The patient's height, and weight were not reported. The patient's past medical history included nose bleed and concurrent conditions included seasonal allergy to pollen. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, the subject experienced heaviness in arm. On 12-APR-2021, the subject experienced arm soreness. On 16-APR-2021, the subject experienced increased back to back heavy nose bleeds from both nostrils. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm soreness on 14-APR-2021, had not recovered from increased back to back heavy nose bleeds from both nostrils, and the outcome of heaviness in arm was not reported. This report was non-serious.