chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever and chills started at around 7:00pm on April 8th, 2021, the same day as the injection. Fever worsened into the night and then nausea,  vomiting, body aches, and severe headache set in. Headache, fatigue have persisted for several days through April 11th, 2021.
Information has been received from a physician concerning a baby who was vaccinated with a first oral dose of Rotateq. It was reported that the baby had a rash and went "limped" right after administration of Rotateq. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information is not expected.
This is in follow-up to report(s) previously submitted on 5/28/2004. Information has been received from a RN concerning a 14 month old  female child with no illness at the time of vaccination and no allergies and no past medical history who on 10-Feb-2004 was vaccinated subcutaneous in the  right leg with a first dose of MMRII (Lot # 646740/0822N).  The nurse reported that the pt experienced a local site reaction and developed redness at the injection site. The pt was observed and no treatment was needed. Subsequently the patient recovered. The reporter has requested a lot check. The records of testing prior to release of this lot (646740/0822N) have been checked by Quality Assurance and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and Research and was released. No further information is available. The nurse reported another child who experienced a similar reaction after therapy with MMRII (WAES # 0402USA01554).  The nurse also reported that triplets experienced a similar reaction after therapy with varicella virus vaccine live (WAES # 0402USA01433, 0402USA01540, 0402USA04541).  The nurse reported another child who experienced a similar reaction after therapy with varicella virus vaccine live (WAES # 0402USA01546).  It was noted that the triplets had the worst reaction.
This spontaneous case, was initially received from other health professional on 10-Oct-2017, concerning a 32-year-old, adult, patient of an unspecified gender. The patient's medical history and concomitant medications were not reported. On 05-Oct-2017, the patient was administered with FLUCELVAX QUADRIVALENT (dose: 0.5 ml, batch number: 195128, expiry date: 30-Apr-2018, route of administration: intramuscular and anatomical location: deltoid). On the same day, 1 hour after vaccination, the patient experienced redness, itching and swelling at the injection site. It was reported that, the patient had applied ice at the injection site. On 07-Oct-2017, the patient had recovered from the events (reported as after 48 hours). The reporter assessed the events as non-serious. Non-significant case correction received 10-Oct-2017: Batch number (195128) was captured in the case form and narrative was amended accordingly.
PT TOOK A SHORT NAP AFTER VACCINATION AT 9:42AM AND WOKE UP WITH BLURRY VISION THAT HAD NOT RESOLVED WHEN SHE CALLED US (AT APPROXIMATELY 12:30PM). RECOMMENDED DR'S VISIT IF IT DIDN'T RESOLVE SOON, PT SOUNDED LIKE SHE WAS GOING TO GO TO URGENT CARE.
6x6 cm redness on left deltoid, tenderness.  No pus or d/c.  No fevers or other symptoms.
Patient received RECOMBIVAX and FLUVIRIN in right arm and VAQTA 50m/mL and PNEUMOVAX 23 in left arm in deltoid region given IM about 1" or greater apart. He was told to expect injection site soreness post immunization. He complains of pain/inflammation below injection site on left arm near elbow. Pharmacist advised BENADRYL and ibuprofen for symptom relief and notified patient PCP. Also advised patient to seek ER treatment if worsens.
Initial unsolicited report received from a Healthcare on 16 January 2015. A 7-months old female patient, whose medical history and concomitant medications were not reported had received an FLUZONE (batch number U5085AA), (dose, dose number were not reported), via intramuscular route in Left Thigh on 15 January 2015. It was also reported that the patient had previously received a dose of FLUZONE QIV Batch number: U5085AA, (dose, dose number were not reported) via Intramuscular route in Thigh on 1 December 2014. It was reported that 1 to 2 hours post vaccination on 15 January 2015 the child broke out in a rash on both legs and face. Stated the rash is red and blotchy and looks like welts. The patient required emergency room or doctor visit. Rash resolved overnight then reappeared on 16 January 2015. Laboratory investigations and corrective treatments were not reported. At the time of this report, outcome of the event was unknown. Documents held by sender: none. Follow-up report received from a nurse on 30 March 2015. It was reported that the adverse event was resolved on its own and no further treatment was required. Document held by sender: none.
Patient had an immediate large bump/mound; A spontaneous report was received from a consumer concerning a patient of un unknown age, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced an event of injection site bump.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 26 Jan 2021, prior to the onset of the event the patient received their first of two planned doses of mRNA-1273 (Batch Number: 037K20A) intramuscularly for prophylaxis of COVID-19 infection.  On 26 Jan 2021, the patient experienced the event of an immediate large bump/mound (injection site bump).  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event injection site bump was considered resolved on 28 Jan 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
This spontaneous report was received from a nurse and refers to a 11 years old male patient. The patients' pertinent medical history, concomitant medications and drug reactions or allergies were not reported. On 13-NOV-2018, the patient received improperly stored dose of GARDASIL 9 lot# R002345, expiration date 16-NOV-2020 (exact dose and route of administration were not reported) for prophylaxis. No adverse effects reported. The vaccine was exposed to a temperature of -1.1 degree Celsius (below 0 degree Celsius) for 8 hours 10 minutes. No previous temperature excursion was reported. The call was because of a digital data logger. This is a non-valid report due to lack of patient identifiers. This case was related to MARSS# 1902USA011294 and 1902USA011295 (Same reporter link).
flu like symptoms; Headache; Body aches; Sore arm; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th September 2019, the patient received the 2nd dose of Shingrix. On 12th September 2019, less than a day after receiving Shingrix, the patient experienced influenza-like symptoms, headache, general body pain and pain in arm. On an unknown date, the outcome of the influenza-like symptoms, headache, general body pain and pain in arm were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, headache, general body pain and pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient received the 2nd dose of Shingrix and developed flu like symptoms including headache and body aches. These symptoms were resolved. The patient had sore arms but that resolved. The reporter consented to follow up. This case linked with US2019169078, reported by same reporter.
Itchy skin all over smoke raised/hives over body - appeared 12 hours after receiving 2nd dose. Has gotten more noticeable at 24 hour mark.
Flu like symptoms; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  A 72-year-old male patient received BNT162b2 multivalent nos (BNT162B2 MULTIVALENT NOS), on 14Jul2023 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 72 years intramuscular for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE: 5), for COVID-19 Immunization; Covid-19 vaccine (DOSE: 4), for COVID-19 Immunization; Covid-19 vaccine (DOSE: 3), for COVID-19 Immunization; Covid-19 vaccine (DOSE: 2), for COVID-19 Immunization; Covid-19 vaccine (DOSE: 1), for COVID-19 Immunization. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset 14Jul2023, outcome "recovered", described as "Flu like symptoms". Therapeutic measures were not taken as a result of influenza like illness. Additional information: The adverse event was not resulted in a visit to doctor or other healthcare professional office/clinic or Emergency room/department or urgent care. No other vaccine in four weeks. No COVID prior vaccination; No COVID tested post vaccination.  The information on the batch/lot number for BNT162b2 multivalent nos has been requested and will be submitted if and when received.
EXTREME TIREDNESS; This spontaneous report received from a consumer concerned a 59 year old male. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 28-MAR-2021 12:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 29-MAR-2021, the subject experienced extreme tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from extreme tiredness. This report was non-serious.
PATIENT WAS GIVEN MODERNA FOR HER 2ND SHOT, HOWEVER HER 1ST SHOT WAS PFIZER
Pt presented to clinic 7/9/12 c/o getting a rash to face - head - hands & under bottom of feet - Sore throat and fever of 102 degrees about 48 hours after getting yellow fever & Typhoid vaccine.
SYNCOPE, LEGS ELEVATED ABOVE HEAD AND PATIENT REGAINED CONSCIENCE WITH 1 MINUTE
Received live ?attenuated H1N1 vaccine at age 54. Vaccine licensed for age 2 - 49.
pt recv vax 6OCT97 & on 16FEB98 pt devel approx 15 skin lesions;
Sars-Cov-2 test positive; Fever; Chills; Muscle soreness in his left shoulder; This is a spontaneous report from a contactable consumer (patient) via the Pfizer .   A 66-year-old male patient received the first single dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EL9262), via an unspecified route of administration (only injection reported), left shoulder, on 23Jan2021 (at the age of 66-years-old), for COVID-19 immunization. The patient's medical history included ongoing prostate cancer since 3 years prior to the reporting. The patient stated having fever and chills both on 26Jan2021 and 27Jan2021, at night. The patient also reported muscle soreness in his left shoulder for a couple of days after vaccination (exact onset date not specified). On 28Jan2021, a few days after vaccination, the patient tested for Sars-Cov-2 (swab). Since the results were positive on 29Jan2021, the patient went to ER. He had no respiratory or heart issues. He was treated with a 1 hour infusion of Bamlanivimab 700. The patient recovered from fever, chills and muscle soreness, while the outcome of COVID-19 was unknown.
Initial report was received 27 December 2008 from an investigator as part of a study for which sanofi pasteur is not a sponsor.  A 28-year-old pregnant female with a history of body mass index (BMI) 24, Asthma, Anemia, and Mitral valve prolapse was found to have oligohydramnios 234 days after she had received a first dose of intramuscular left deltoid injection of ADACEL, lot number C455AA on 01 May 2006. She had no history of prior pregnancies, and no history of tobacco, alcohol (ETOH) or drugs. Concomitant medications included Augmentin (indicated for otitis), Albuterol, Flovent and prenatal vitamins. On 21 December 2006, an ultrasound revealed normal growth and a low amniotic fluid index (AFI). Pregnancy, labor and delivery complications occurred and the patient was diagnosed with Oligohydramnios at 40 (3/7) weeks; AFI - 6.6. The patient was induced with misoprostol, augmentation with Pitocin and artificial rupture of membranes (AROM). Fetal heart tones (FHT) decelerations to 100's occurred with return to baseline after one minute throughout the active labor phase. During the second stage of labor, decelerations to 100's occurred with no slow return to baseline, however delivery was imminent, so labor continued. The patient delivered a single live female infant vaginally on 22 December 2006 at 40 (4/7) weeks gestation weighing 3070 grams. A tight nuchal cord was reduced. The infant was handed to nursing, ICN was called due to no respiratory effort. Apgar readings were 2/5 at one and five minutes respectively. The infant was intubated briefly, then extubated. The infant had no congenital anomalies. The patient experienced a second degree laceration and urinary retention post-partum day zero. Her Foley was replaced, and then removed 24 hours later without further problems. The patient's recovery status was not reported. The reporter for this case is the same as cases 2008-04101, 2008-04102, 2008-04103, 2008-04104, 2008-04105, 2008-04107, 2008-04108, 2008-04109, 2008-04110, 2008-04111, 2008-04112, 2008-04113, 2008-04114, 2008-04115 and 2008-04116. Documents held by sender: None.
Narrative: Pt received 2nd dose of COVID-19 vaccine (Moderna) 3/25/21. Reported breast pain on 4/6/21 which she attributed to vaccine. PCP told her to take ibuprofen 800mg BID prn (had previous active order) and order methocarbamol 500mg po qHS prn (did not mention this in their note).
SITE TURNED RED,HOT AND SWOLLEN.DR. EXAMANDEND,TOLD AUNT TO APPLY WARM COMPRESSES,GIVE TYLENOL OR MOTRIN FOR DISCOMFORT.
I traveled out of state, I wore a mask most of the time in both airports. I tested negative when I got there and it came back negative. I tested again a couple of days later after going to a graduation party and that COVID-19 test came back negative. That Sunday my daughter tested positive and that following day and Tuesday I felt tired but I still tested negative. I tested again on Wednesday and that COVID-19 test came back positive. I called my doctor and got a PAXLOVID. I had to stop my other medications to take it. I had a terrible headache and sore throat the day following. On Thursday I woke up and my symptoms were gone. I only tested positive for four days.
Redness, swelling, itch, tenderness of upper arm on side of injection.  Ache from shoulder to elbow, occurring within 24 hours of injection.  No fever.  TX: steroid tapering dose (Medrol dosepak), antihistamine (hydroxyzine 25 mgm q6h).
Patient called pharmacy stating, unlike with the first dose, she now has a swollen, itchy raised bump that is hot to the touch. States previous lifestyle caused several abscesses and this reaction feels similar albeit not as bad. Patient stated she has no symptoms beyond local symptoms. Advised patient that while some injection site reactions are to be expected that there can also be possibility for infections. Advised patient to reach out to primary care provider for observation if symptoms persisted or worsened in next 24-48 hours. Patient stated this is something that she can keep an eye on and will seek treatment if condition worsens.
Information has been received on 09-JUL-2018 regarding a case in litigation from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 11-OCT-2012, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 04-OCT-2013, the patient was treated at a physician's office for a blistering vesicular outbreak, which was diagnosed as herpes zoster. The patient has been prescribed VALTREX for management of his painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, 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.
patient was given expired menactra this morning with no reported adverse event; Initial information received on 13-Feb-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 12 years old male patient who was given expired meningococcal A-C-Y-W135 (D CONJ) vaccine [Menactra] this morning with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HPV vaccine, influenza vaccine (flu [influenza vaccine]) and diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP) all for Prophylactic vaccination.  On 13-Feb-2023 at around 10.30, the patient received expired dose of 0.5 ml suspect meningococcal A-C-Y-W135 (D CONJ) vaccine solution for injection (lot: U7208AA, expiry date: 10-Feb-2023) via unknown route in unknown administration site for immunization with no reported adverse event (expired product administered).  Action taken: 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.
Extreme fatigue, chills, sever headache, body aches, low fever, and hot flashes.
On 5/21/21, patient and his mom wanted to get Moderna 2nd dose before he headed back to school up north.  They were adamant that the vaccine is due.  Both technician and I did not see the date on vaccine card when patient was previously received at .  I administered second dose for him after asking him about the first dose, and counseled him on adverse effects.  When we processed the prescription later in the afternoon, insurance rejected prescription and stated earlier than 24 days.  I found patient had received the dose on 5/4/21.  Patient and did not answer the phone, and patient called back confirming the date of first dose given on 5/4/21.  Patient did not feel anything except a sore arm, and did not have PCP.
HEARING IMPAIRMENT IN BOTH EARS FOR 5 DAYS WENT TO URGENT CARE WAS TOLD I HAD EXTREME FLUID IN MY EARS CAUSING MY IMPAIRMENT AND I HAVE NEVER HAD EAR ISSUE EVER! DR. GAVE ME EAR DROPS WHICH SEEM TO BE HELPING SOMEWHAT
Per vaccine clinic recovery RN notes: "Patient was sent to ER (in front of vaccine clinic) for evaluation with c/o  numbness of the right side of the face. States sudden onset and increasingly numb, and worse than after the first covid vaccination. States last time, numbness subsided within 1 hour and no further symptoms.  Patient tolerated walking across parking lot to the ED, registration without problems."
Received Dose 1 of Pfizer COVID vaccine.  Per  vaccine administrator: Patient stated she felt lightheaded  She did not appear pale or diaphoretic  I continued to engage her I conversation and she was conversing normally  No intervention.  I observed her for 10  minutes while seated with me at vaccination station.  She stood up without assistance and I observed her walk and she appeared steady and stated she felt normal.
No history of migraine headaches.  The day following the shot he started with headache that sounds very muscle contraction-like but by 3 days later had a severe migraine headache that resulted in treatment at a walk-in clinic and then emergency room the following day.  Now headache free 1 week later
Redness; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy and Thyroid disorder. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), AMLODIPINE, METOPROLOL and PRAVASTATIN for an unknown indication.    On 21-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) Unknown. On an unknown date, the patient experienced ERYTHEMA (Redness). At the time of the report, ERYTHEMA (Redness) had resolved.            Patient also taking centrum silver for her eyes. No treatment details were provided.   This case was linked to MOD-2021-037805 (Patient Link).
Patient noticed redness around the injection site on 8/2/2020.  No other symptoms aside from that.
vaccine recipient less than 18 yr old, first dose; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine recipient less than 18 yr old, first dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LISDEXAMFETAMINE MESILATE (VYVANSE) for an unknown indication.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine recipient less than 18 yr old, first dose). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine recipient less than 18 yr old, first dose) had resolved. Not Provided      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 medications were reported
day p/vax pt exp generalized seizure w/lip smacking, lips turning blue.
Hives (redness, itchy) that come with any contact. They come and go.
This spontaneous report as received from a certified medical assistant refers to unspecified number of patients of unknown age and gender. It was reported that since 24-JUL-2014 the patients were vaccinated with the doses of improperly stored VAQTA (dose, route and lot number were not reported). No adverse effects were noted. No additional information was reported. No product quality complaint (PQC) was involved. This is one of several reports from the same reporter. Additional information has been requested.
Low grade fever- slept it off, drank fluids Skin slightly red(arms, legs & cheeks) & slightly warm - no treatments, put on lotion to slightly cool
Patient presented with 5 cm erythema to the left thigh. Area is site of KINRIX injection given 1/28/10. Patient went to ER 1/30/2010 given Benadryl and told to follow up with Dr. today 2/1/10 at which time he ordered Allegra q day.
Injection 03/31/2006.  Erythema, warmth began 04/03/2006.  General pruritus.  No skin peeling.  No significant swelling.