chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a Medical Assistant refers to a 14 year old patient (gender unknown) who on an unknown date was vaccinated with an adult dose of VAQTA (route, dose, lot # and expiration date were not provided) instead of the pediatric dose which was considered as an overdose. No adverse effects reported. Additional information has been requested.
SWELLING BELOW THE INJECTION SITE THAT IS APPROX 120 MM IN CIRCUMFRANCE, HOT TO THE TOUCH AND CAUSES A DULL PAIN EVEN IF NOT COMPRESSED.  SWELLING LIMITS MOVEMENT.  PT STATES HE FEELS TINGLING IN FINGERS ON RIGHT HAND.  PT IS DEPLOYING AND HIS SYMPTOMS HAVE NOT GONE AWAY YET SO I WILL MARK NO FOR THE ANSWER TO PATIENT RECOVERED. BIOPORT CORP WAS THE MANUFACTURER.
Paraoxysmal monomorphic ventricular tachycardia with 16 episode times over a 24-hour period according to AICD interrogation, life-threatening, severe congestive heart failure.
One week after vaccine, pt experiencing swelling, redness, warmth, and itching at injection site. Pt also reports injection site is very painful. Pharmacist recommended diphenhydramine and watchful waiting
This spontaneous report as received from a healthcare worker refers to multiple unspecified patients of unknown age and gender. No concurrent conditions, medical history or allergy/drug reactions were reported. On an unspecified date, the patients were vaccinated with improperly stored VARIVAX (Merck) injection (dose and route not specified) lot # L027287, expiry date: 21-JUL-2017. No adverse effects were reported. There were no product quality complaints (PQC) involved. No further information was provided. Additional information has been requested.
Information has been received from a physician concerning a 76 year old female consumer who on an unspecified date was vaccinated with zoster vaccine live (Oka/Merck). Subsequently, the patient developed shingles within six months after the vaccine was given. Unspecified medical attention was sought and it was unspecified if lab studies were performed. At the time of the report the patient's status was unknown. There was no product quality complaint involved. Additional information has been requested. This is one of several reports from the same source.
Mother states that CDC and Merck wanted VAERS form on Hepatitis B 2Dose Vaccine which was given on 4/4/03.  Since getting the Td vaccination on 7/24/03, this child breaks out every 4-7 days.  Has atopic eczema.  He has had a skin biopsy.  He is also losing his vision.  He moved to on 7/25/03.
Typical soreness after the shot after a few days. Three to four days later I could not lift my arm at all. Excruciating pain with movement along with muscular pain around the shot area.
Information has been received from a physician referring to 14 anonymous patients of unknown age and gender. Patient's concurrent conditions, concomitant medication and medical history were not provided. On unknown dates between 12-APR-2015 and 30-JUN-2015, the 14 patients were vaccinated with expired GARDASIL (lot # H016238, expiry date 11-APR-2015, dose and route were not provided). The physician reported that the GARDASIL had previous temperature excursions on unknown dates and was unable to provide the excursion details at this time. No adverse symptoms were reported. Additional information has been requested.
5 hrs after injection began to feel flushed, achy joints, temperature and general malaise. Next day, symptoms worst, flushed, chills, very sore, no energy, sweat profusely in evening and night. Woke up 4/24/22 feeling more normal, still pain at injection site but felt pretty good.
fever devel 48hr p/vax;T101 increasing to 105 R;ER visit;dx viral illness;blisters  in mouth & rash on rt thigh;
persisting symptoms; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (persisting symptoms) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (persisting symptoms). At the time of the report, VACCINATION COMPLICATION (persisting symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitants were provided. No treatment was provided.   Reporter did not allow further contact
pt recv vax 10JUN96 & pt came back w/redness @ site;large indurated area & very tender;I&D & exploration done;script given for ATB;
Injection site red, swollen, warm to touch. Diagnosed with cellulitis from injection site. Prescribed Augmentin 250-62.5/5ml 3ml BID x 7 days.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age, who was inoculated with ZOSTAVAX (lot number, dosage, and route of administration not provided) on or about 27-JUN-2014 at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 01-NOV-2015, the patient was treated at a medical center for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. 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.
Upon discharge c/o nausea and headache.  VS 118/76, OxSat 97%, HR 96.  Verbalizes lightheaded dizziness.  Appropriate to questions, sat additional 15 min.  Symptoms relieved, medics monitored and ok to d/c home
1st dose pfizer vaccine was given to patient on 07/03/2021. We found out on 07/09/2021 vaccine was stored outside the recommended 31 day expiration window.
pt recv vax 11JAN95 & became pregnant on 13JAN95;last menstrual period 24DEC94;estimated date of confinement 31OCT95;@ 41 wk gestation pt underwent a C-section d/t fetal distress d/t meconium aspiration;
Administered an expired GARDASIL 9 to a patient; No adverse event; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions, allergies or concomitant medications.   On 11-AUG-2020, the patient was vaccinated with 0.5 ml of an expired dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) for prophylaxis with lot # N021733 and expiration date on 01-FEB-2020 (strength, dose number, anatomical location and route of administration were not reported). No adverse event was reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: N021733; expirationdate: 01-FEB-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Nausea, vomiting, dizziness, severe headache, chills, fever.   Dizziness started a 2-4 hours after injection, with severe dizziness,  headache, and chills approximately 8 hours after.   Fever continued x 3 days.  Several weeks for severe headache to subside, but dizziness with nausea, and frequent headaches continue.
This spontaneous case was reported by a patient family member or friend and describes the occurrence of HEADACHE (Headache), MYALGIA (body ache), CHILLS (chills) and PYREXIA (pyrexia) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024CZ1A) for COVID-19 vaccination.     Concurrent medical conditions included Congenital hypothyroidism (By Birth.). Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) from 20-Dec-2000 to an unknown date for an unknown indication.    On 10-May-2021 at 4:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache), MYALGIA (body ache), CHILLS (chills) and PYREXIA (pyrexia). At the time of the report, HEADACHE (Headache), MYALGIA (body ache), CHILLS (chills) and PYREXIA (pyrexia) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Treatment information was not reported.   This case was linked to MOD-2022-443899, MOD-2022-452235 (Patient Link).
Nurse at facility gave dose to this staff member from a vial that had never been used and only contained 4 doses.
I went to urgent care at 2:30 pm in the afternoon on 4/16 which was a Friday. I got my shot I was fine. Around 5pm - 6pm dinner time on Sat 4/17 I started to feel off. I was feeling weak and tired. I woke up on the morning of the 17th  and I was horribly sick. I had a low grade fever a little over 100 to 101 degrees I had chills and shakes similar to flu symptoms. I had no appetite and did not want to drink anything.  I slept the entire day I had a horrible headache I felt really crappy. I did vomit once but none after that. Monday morning the 19th I started to feel better I was still running a low fever in the 99-100 degree range. At that point I was able to get fluids in and eat and was able to keep everything down. I still had a headache and was feeling run down . Tuesday morning the 20th I was feeling much better I still had a headache but basically all other symptoms had subsided.
Information has been received from a physician concerning a 60 year old female patient with general sensitivity to medications who on 17-MAY-2011 was vaccinated with one dose of ZOSTAVAX (Merck) (Lot # 669865/0362AA, expiration not reported). It was unknown if the patient had concomitant medications. Physician reported that on 17-MAY-2011, immediately after received ZOSTAVAX (Merck) the patient developed swelling, pain, redness, and warmth at the injection site. The patient sought unspecified medical attention. The patient received BENADRYL as treatment for the adverse event. It was reported that the adverse event improved on therapy, but at the time of reporting the patient had not recovered. Additional information has been requested.
PATIENT WAS SEATED FOR FLU SHOT AND STOOD UP WITH NO INDICATION OF FAITNESS OR DIZZINESS, THEN AFTER 4 OR 5 MINUES OF STANDING FELL FORWARD TO HER KNEES.  SHE WAS RE-SEATED AND BLOOD PRESSURE CHECKED AND FOUND TO BE LOW 76/46.  SHE WAS OBSERVED FOR AN ADDITIONAL 30 MINUTES AFTER WHICH TIME SHE STATED THAT SHE FELT FINE AND WAS OKAY TO WALK WITH NO DIZZINESS.   HER PARENTS WERE WITH HER DURING THE VACCINATION AND WERE CALLED THE NEXT DAY AND REPORTED THAT SHE HAD NO ADDITIONAL REACTION.
first dose over 65 days; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose over 65 days) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose over 65 days). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (first dose over 65 days) had resolved.            No treatment related information has been reported.  Patient had no symptoms and patient did not take any medications on daily basis.
Received shot 12-18-13. Next day had massive shaking, body aches, nausea, pain etc.
? Fever 104 8/25/2010, vomiting 8/26/2010 pt - c/o sore throat. Chart to clinic.
Presents for SOB & generalized weakness x3 days. O2 90% on RA. Admit for COVID & dialysis (unable to go in to dialysis center due to feeling poorly). Tx: abx, O2, dialysis, steroids; remdesivir deferred due to ESRD. DC home.
Patient had swelling in the back of the left upper arm and left deltoid.  The back of the left upper arm appeared red and raised (approximately the size of a 50 cent coin).  Both areas were firm to touch.
LIGHTHEADEDNESS/DIZZINESS; MUSCLE CRAMPS/CRAMPING IN ARMS AND LEGS; ABDOMINAL PAIN (DESCRIBED AS LABOUR PAIN)/ STOMACH MUSCLES SORENESS; FELT WARM WITH NO FEVER; BURPING; DIFFICULTY IN SLEEPING; CHILLS; SORE ARM PAIN; BACK PAIN; This spontaneous report received from a patient concerned a 60 year old female. The patient's height, and weight were not reported. The patient's past medical history included bronchitis, and concurrent conditions included diabetes, and bipolar disorder. The patient experienced drug allergy-rash when treated with sulfamethoxazole/trimethoprim.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: FC 202A21A expiry: 07-AUG-2021) dose was not reported, administered on 07-JUN-2021 for prophylactic vaccination. No concomitant medications were reported.  On 07-JUN-2021, the subject experienced back pain. On 07-JUN-2021, the subject experienced sore arm pain. On 16-JUN-2021, the subject experienced muscle cramps/cramping in arms and legs. On 16-JUN-2021, the subject experienced abdominal pain (described as labour pain) / stomach muscles soreness. On 16-JUN-2021, the subject experienced felt warm with no fever. On 16-JUN-2021, the subject experienced burping. On 16-JUN-2021, the subject experienced difficulty in sleeping. On 16-JUN-2021, the subject experienced chills. On 17-JUN-2021, the subject experienced lightheadedness/dizziness. Treatment medications (dates unspecified) included: acetylsalicylic acid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from muscle cramps/cramping in arms and legs, abdominal pain (described as labour pain)/ stomach muscles soreness, and difficulty in sleeping on 16-JUN-2021, and back pain, burping, chills, and sore arm pain on 17-JUN-2021, and had not recovered from lightheadedness/dizziness, and felt warm with no fever. This report was non-serious.
Information has been received from a registered nurse concerning a 10 week old male with no pertinent medical history or drug allergies who on 17-FEB-2009 was vaccinated with the second dose of RECOMBIVAX HB (lot #: 662421/1040X) and the first dose of ROTATEQ (lot #: 661358/1522X). On 18-FEB-2009 the patient developed rash at injection site. It was reported that some lesions were papular and others resembled hives. The patient was seen in the office on 24-FEB-2009, the rash was not recovered at that time. It was reported that the patient received his first dose of RECOMBIVAX HB in the hospital after birth. Follow up information was received from a registered nurse (R.N.) and medical records reported that the patient was a 10 weeks old male with no pre-existing allergies, birth defects, medical conditions who on 10-DEC-2008 and 17-FEB-2009 was vaccinated intramuscularly in his right upper thigh with a first and second dose of RECOMBIVAX HB (lot# 662421/1040X). Secondary suspect vaccination included a first dose of ROTATEQ (lot# 661358/1522X) given orally on 17-FEB-2009. Concomitant therapy included a first dose of PREVNAR (lot# D07543) vaccinated intramuscularly in his left lower thigh and a first dose of PENTACEL (lot# C3186AA) vaccinated intramuscularly in his left upper thigh on 17-FEB-2009. There was no illness at the time of vaccination. On 18-FEB-2009 the patient developed whole body rash which was possibly erythema multiforme. On 04-MAR-2009 the patient went to ER accompanied by his parents, with a chief complaint of fever. The patient was in H until that day at noon, when FOC felt he was warmer than normal. His temperature was 100.4. The patient was more fussy at that day than before, only additional associated symptom was rash which was discrete, erythematous lesions, initially on face and all four extremities, it was only found on extremities at that day. No central clearing, almost urticarial in appearance. No evidence of super infection. The patient appeared alert and interactive, grossly nonfocal. Urine analysis and urine culture were performed but the results were pending. The diagnosis was fever. The patient's parents insisted on leaving despite discussion of risk of possible underlying urine infection. At the time of reporting, the events persisted. Additional information has been requested.
it is hot, like a fever; can't move it/she could not move it until this morning; arm is red; arm is swollen/it is big and round as the palm of her hand; This spontaneous case was reported by a consumer and describes the occurrence of SKIN WARM (it is hot, like a fever), HYPOKINESIA (can't move it/she could not move it until this morning), ERYTHEMA (arm is red) and PERIPHERAL SWELLING (arm is swollen/it is big and round as the palm of her hand) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014F21A, 026A21A and 032B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SKIN WARM (it is hot, like a fever), HYPOKINESIA (can't move it/she could not move it until this morning), ERYTHEMA (arm is red) and PERIPHERAL SWELLING (arm is swollen/it is big and round as the palm of her hand). At the time of the report, SKIN WARM (it is hot, like a fever), HYPOKINESIA (can't move it/she could not move it until this morning), ERYTHEMA (arm is red) and PERIPHERAL SWELLING (arm is swollen/it is big and round as the palm of her hand) outcome was unknown.            No Concomitant medications were provided by the reporter. Treatment: Put ice on it.   Reporter did not allow further contact
pt recvd vax & devel urticaria 30 days following vax w/Hep B vax;
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2010, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster, also known as shingles and other complications. In 2012, the patient was treated at a medical center for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. 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.
felt very tired /run down; more than 35 days between Moderna Covid-19 vaccines.; sore injection site left arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (sore injection site left arm), FATIGUE (felt very tired /run down) and PRODUCT DOSE OMISSION ISSUE (more than 35 days between Moderna Covid-19 vaccines.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Skin infection.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INJECTION SITE PAIN (sore injection site left arm). On an unknown date, the patient experienced FATIGUE (felt very tired /run down) and PRODUCT DOSE OMISSION ISSUE (more than 35 days between Moderna Covid-19 vaccines.). At the time of the report, INJECTION SITE PAIN (sore injection site left arm) and FATIGUE (felt very tired /run down) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (more than 35 days between Moderna Covid-19 vaccines.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant medications were reported.  No Treatment information was reported.
Information has been received from a physician, author of the article, regarding a healthy 2-month-old boy (patient 4) who presented with 3 days of nonbloody diarrhea and 2 days of fever and irritability (also reported as diarrhea none and 4 days of vomiting with a maximum of 3 episodes in 24 hours). On physical exam, he was fussy but consolable with a slightly distended abdomen and hyperactive bowels sounds. Negative laboratory examinations included complete blood count with differential, urinalysis, and urine culture (catheterized). The patient was orally rehydrated and discharged. He received his first dose of Live, Oral, ROTATEQ 2 days before illness onset (also reported as 1 day). Four distinct VP7 genotypes were detected in a specimen obtained 3 days after illness onset: the G1 gene of Live, Oral, ROTATEQ component strain W179-9 (G1P[5]) (100% identity in 116 bases); the G2 gene of strain SC2-9 (G2P[5]) (100% identity in 202 bases); the G4 gene of strain BrB-9 (G4P[5]) (100% identity in 363 bases); and the G6 gene of strain W179-4 (G6P[8]) (99.8% identity in 421 bases). The VP4 P[8] gene (99.9% identity in 835 bases) and VP6 12 (100% identity in 342 bases) genes from Live, Oral ROTATEQ strain W179-4 (G6P[8]) were detected. The VP3 M2 gene matched the sequence of strains W179-4 (G6P [8]), W178-8 (G3P{5]), and BrB-9 (G4P[5]) (100% identity in 500 bases). This specimen appears to contain 4 strains, the W179-4 (G6P[8]) component strain itself and 3 potential reassortant strains each composed of strain W179-4 (G6P[8]) but expressing G1, G2, and G4 individually. Rotaviruses were observed by EM, and real-time Rt-PCR was positive for norovirus genogroup II. All other tests were negative. This patient illustrate a spectrum of potential clinical and virologic outcomes associated with routine use of live, attenuated rotavirus vaccines. The diversity of these occurrences include detection of an Live, Oral, ROTATEQ in a recently vaccinated child (patient 4). Patient 4 had diarrhea without respiratory symptoms, the presence of norovirus genogroup II in his fecal specimen along with the potential vaccine-reassortant strains makes it impossible to discern the cause of his illness. The presence of multiple reassortant Live, Oral ROTATEQ strains in patient 4 stool is very unusual, and these findings will be confirmed using an advanced genetic characterization method such as microarray analysis and/or deep sequencing. This is one of the several reports of the same source. Additional information has been requested.