chrisvoncsefalvay/vaers-outcomes huggingface dataset:
TOOK THIRD DOSE OF VIVOTIF WITH SUGAR FREE GATORADE; This spontaneous case report (PVX2019-2685) was received from consumer on 28-Oct-2019. It described a 13-year-old male consumer who "took third dose of Vivotif with sugar free Gatorade" (PT: Product administration error), while being on oral Vivotif for typhoid fever.  Case report: The consumer took the third dose of Vivotif with sugar-free Gatorade on 26-Oct-2019. Then, after taking Vivotif, he ate a handful of chex cereal and potato chips.  Action taken with Vivotif with respect to reported event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "took third dose of Vivotif with sugar free Gatorade" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took third dose of Vivotif with sugar free Gatorade" was considered as not applicable.
Very itchy - different bilateral rashes over areas where I've not experienced before: red itchy blotches in armpits and in groin area, bumpy rashes on back, hips, chest/breasts and shoulders. Topical steroid prescribed. With this and constant moisturizing w thick lotion, the rashes can be knocked back. But they've never ceased for good to date.
4/5/2021; 02:20pm:  Onset of symptoms. Burning, tingling, numbness in injection site left arm, moved to back of shoulder blades, neck, hand/fingers and to right arm and facial and head.  Extreme dizziness. Brain fog,  difficulty swallowing but no swelling, rash or hives.  Evening of 4/5 and all day 4/6 had arm soreness and mild headache that subsided after 2 days. 4/6-4/11: dizziness/lightheaded,  blood pressure fluctuation - systolic and diastolic high, difficulty swallowing on 4/9 and 4/10 - felt like something stuck in middle of throat,  voice hoarseness, slight sore on right side of throat.  4/11: Cold sweat while sleeping 4/12:  Lightheaded (mild), blood pressure fluctuation (not as high as previous readings), voice hoarseness, slightly sore on right side of throat.  Mild/light tingling at right shoulder blade and back of neck.
Rash all over body and then progressed to hives (ears, neck, trunk, arms, legs).
Fever (101.9) and chills Body aches Headache Fatigue (24 hours) Time course: 12 hours
My second shot I had fever for 2 days and swollen lymph node and very hard time swallowing and extremely fatigued
Dose 5: Moderna; Dose 4/dose 3/dose 2/dose 1: Pfizer; COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 64-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), on 07Feb2021 as dose 1, single (Lot number: EL9264), in left arm, on 01Mar2021 as dose 2, single (Batch/Lot number: unknown), in left arm, on 30Sep2021 as dose 3 (booster), single (Lot number: 30155BA), in left arm and on 31May2022 as dose 4 (booster), single (Lot number: CUS9282) at the age of 62 years, in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 24Oct2022 as dose 5 (booster), single (Lot number: 059F2219), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "COVID 19 Treatment"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Dose 5: Moderna; Dose 4/dose 3/dose 2/dose 1: Pfizer". Therapeutic measures were taken as a result of drug ineffective, covid-19 included paxlovid treatment from 23Sep2023 to 27Sep2023.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300316280 same patient, different drug/AE;
complained of lightheadedness and itching followed by diaphoresis and nausea EMS called for evalution
Admitted for COVID-19; family did not want aggressive measures; IP hospice consulted; pt expired
On Tuesday 3/30 I woke up with a rash on my right quad that got more intense as the day went by.  Later that day, I developed a rash around my right elbow, then before bed another rash on my left shoulder.  Throughout the night I developed rashes between and under my breasts, and torso.  Since then, the rash spread throughout my body, including my head, face, hands and genitals.  The rash looks like tiny fluid filled blisters that itch and burn.  I had an E-visit on 3/31 and was diagnosed with dermatitis and was prescribed Citirizine 10 mg and Triamcinolone Acetonide 0.5% ointment.  I had phone visit on 4/2 as the rash spread and did not improve.
Information has been received from a medical assistant concerning a 11 year old female patient with no pertinent medical history and no known drug allergies who on 29-SEP-2009 was vaccinated with a first 0.5 ml IM dose of GARDASIL. There was no concomitant medication. On 30-SEP-2009, the next day after vaccination, the patient developed hives at the injection site of the left arm. The symptoms resolved without treatment. On 11-NOV-2009 the patient received a second 0.5 ml IM dose of GARDASIL. Subsequently on 16-NOV-2009 the patient developed widespread hives. The patient called the physician's office and was recommended to take ZYRTEC or BENADRYL. At the time of this report, the patient was recovering. It was reported that the patient will not be receiving the third dose of GARDASIL. Follow up information was received from the nurse who indicated that the patient on 29-SEP-2009 was vaccinated with a first IM dose of GARDASIL (Lot No. 663453/0249Y) into her left deltoid at 2:45pm, a first IM dose of ADACEL (Lot No. 4F500BA) into her left deltoid at 2:45pm, a first IM dose of MENACTRA (Lot No. U3043AA) into her right deltoid at 2:45pm, a second SQ dose of VARIVAX (Merck) (Lot No. 664903/0864Y) into her left arm at 2:45pm. On approximately 03-OCT-2009 the patient developed blotchy rash and her arm became swollen after her first 'shot' of GARDASIL. On 11-NOV-2009 was vaccinated with a second IM dose of GARDASIL into her left deltoid. The reporter noted there were no other vaccines administered on that day. On 16-NOV-2009 the patient developed hives all over her body. At the time of the report, the patient had recovered (date unspecified). No further information is available.
This spontaneous report was received from a healthcare worker regarding unspecified number of patients of unknown age and gender. The patients' pertinent medical history and concurrent conditions were not reported. On an unknown date, the patients may have been vaccinated with doses of improperly stored GARDASIL (lot # K008931, expiry date 04-MAR-2017). Concomitant medications were not reported. No adverse events were reported. Product quality complaint was not filed. Additional information has been requested.
Fever,  chills, nausea, headache,  muscle pain, extreme fatigue
It all started with body aches, tiredness, and headaches and in the morning the next day after the vaccine started this rash on my buttock and then it was spreading all over my private part. I felt very bad and I went to the emergency room in my city on Saturday 5/1/21 at 8:00pm. And then the doctor detected it as Herpes Zoster (Shingles) and she prescribed me Valtrex 1 tablet (1000 mg total) by mouth 3 times a day for 7days. Unfortunately I'm still feeling really bad and this morning I started with back pain and fatigue and I called my primary doctor office to report what had happened and try to get an app.
got very ill; High fever; dizzy; diarrhea; brain fog; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, Lot number: Unknown), for COVID-19 Immunization. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "got very ill"; PYREXIA (non-serious), outcome "unknown", described as "High fever"; DIZZINESS (non-serious), outcome "unknown", described as "dizzy"; DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea"; BRAIN FOG (non-serious), outcome "unknown". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: It was reported that "I got very ill after my second and third shot. High fever, dizzy, diarrhea, brain fog. I have avoided getting a fourth shot. Are the vaccines improved enough that they won't make me sick?"  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300295013 same patient and drug, similar event (separated by time), different dose;
This case was reported by a nurse via sales rep and described the occurrence of headache in a 46-year-old female patient who received FLUARIX QUADRIVALENT (batch number M73CE, expiry date 30th June 2019) for prophylaxis. On 26th September 2018, the patient received FLUARIX QUADRIVALENT. On 27th September 2018, 1 days after receiving FLUARIX QUADRIVALENT, the patient experienced headache and vomiting. On an unknown date, the outcome of the headache was not recovered/not resolved and the outcome of the vomiting was recovering/resolving. It was unknown if the reporter considered the headache and vomiting to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The patient reported that she experienced headache, one day after receiving the injection. The event, at time of report, was unresolved. The patient also experienced vomiting, which had improved.
pt's mom reported that w/in 1 or 2 days p/administration of vax pt spiked a fever of 105 & had sz; no details known;
Pt was admitted for a pelvic abscess and sepsis.  He had 3 days of fevers, chills, abdominal pain, and decreased urine output.  He tested positive for COVID on admission.
Information has been received from a physician concerning a female who on unspecified dates was vaccinated with her first and second doses of GARDASIL (Lot #s not reported).  On an unspecified date, after receiving the third dose of GARDASIL, the patient had "an abnormal PAP".  The patient sought unspecified medical attention.  The patient outcome is unknown.  No further information was provided.
First dose of Rotateq given past recommended age of 14 weeks, 6 days.
Cellulitis at injection site dx by CHOP. Admitted x 48 hours for IV antibiotics, nml, us, neg, cxs. Full recovery of mobility. Had HIB + pneumococcal saccharide immunizations. 9:30 that night decreased activity, would not sit up or roll. Winces with mvmnt to LE.
Under 18 years old received first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Under 18 years old received first dose) in a 16-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Mar-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Under 18 years old received first dose). On 19-Mar-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Under 18 years old received first dose) had resolved.        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.   Concomitant product use was not provided.  Treatment information was not provided.  Upon in internal review on 18 May 2021, the age was corrected to 16 years      This case was linked to US-MODERNATX, INC.-MOD-2021-066855 (E2B Linked Report). This case was linked to MOD-2021-066198, MOD-2021-066206 (Patient Link).; Sender's Comments: This report refers to a case of Product administration error for mRNA-1273, lot# (not reported) with no associated AEs. US-MODERNATX, INC.-MOD-2021-066855:For 17 year old patient
Received KINRIX on 6.22.09. Per mom, noticed swelling, increase - after 24 hours - 6.23.09, went to ER around 11 pm. Thought insect bite caused swelling. ER dx'd her as cellulitis secondary to insect bite. Gave her KEFLEX. 6-24-09 - Saw patient back in our office for increase swelling and redness, with blisters midline on arm. No fever. Had 2 doses KEFLEX.
Round red rash  with white center. Hard and hot to touch. Has continued to be sore since vaccination  14 days ago.
Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a patient and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 34-year-old female patient (gravida 4, para 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 030M20A) for COVID-19 vaccination.     The patient's past medical history included Alcohol addiction (1-2 glasses of wine per week) on 03-Feb-2021. Concurrent medical conditions included Pregnancy (she received first dose of vaccine prior to aware of pregnancy. she is in the process of prenatal care) on 03-Feb-2021. Concomitant products included PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] for Vitamin supplementation and Pregnancy.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. The patient's last menstrual period was on 01-Jan-2021 and the estimated date of delivery was 08-Oct-2021. On 20-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  second week of the pregnancy. The delivery occurred on an unknown date. For neonate 1, Number of previous pregnancies-4 1st pregnancy end date -27-07-2016 2nd pregnancy undergone  miscarriage in June 2018 and 3rd pregnancy went miscarriage  in mar 2019. 4th pregnancy due date 08-10-2021. At the time of the report, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved.
Pfizer-BioNTech COVID-19 Vaccine EUA: four hours after vaccination patient reported onset of intermittent headache, neck pain/stiffness, muscle twitching, and extremity tingling.  No dyspnea, chest pain, confusion, dizziness, or swelling. Strength and sensation grossly intact with normal gait. Symptoms have gradually improved since vaccination and no new symptoms have developed.
6 days later I noticed a rash around my injection site. The rash started getting much worse and became very red and my arm had hives all around the injection site. It burns and is very swollen. The rash has gotten bigger on my upper left arm.
07/29/2006 pt presented to office c/o bumps on sides of tongue with swelling. C/p a little difficulty swallowing only when she eats. Recommended Benadryl and see PMD pt in no obvious distress at time of examination. No SOB or difficulty breathing.
Swollen Red Large Spot At Injection Site. The red spot was hot and itchy as well as painful. It lasted 3 days. Used ice and ibuprofen
On the above-listed date, a vaccination clinic was held for staff to receive the COVID-19 booster vaccination.  On this day we had Bivalent Moderna Booster dosed vials on hand to be given to those requesting the booster dose.  At the time of the clinic, the vaccinator was operating on incorrect information that the Moderna Booster vaccination for the Bivalent vaccine was 0.25 mgs rather than the new dosage of 0.5mgs.  The error was not noticed until the end of the clinic.  Immediately the error was communicated to those affected.  All patients requesting so were vaccinated with the remaining 0.25 mgs within 24 hours in line with the FDA and CDC recommendations for this specific error.  Two patients were contacted but requested the full dosage of the booster vaccine in the coming weeks.  Three patients were contacted and chose not to be vaccinated further.  There were no reactions noted upon follow-up.  All patients were advised to communicate with their primary care doctors and follow up with them should there be any adverse reactions.  The entire department debriefed and confirmed all new information and rehabilitated the draw-up and delivery of SOPS for all vaccinations in the future. This error was taken very seriously and all means of ensuring this is to not happen in the future were implemented.
pt vaxed 5JUL91; devel local erythema, pain following vax w/edema from shoulder to elbow; elevated temp to 103; office visit required;
At May 7, 2021 / 9:00 am - I woke up with a bright spot in my vision. This spot appeared every time I blinked. It reacted to the light like for example if I went from a darker room to a bright place it appeared/shine.   The same day I went to a optometrist which checked my eyes, but didn?t dilated them only to find that my eyes were healthy. The only issue that encountered was that my eye pressure was a bit high (20) and that my optic discs cups were a bit large.   Through that May 7, the spot began to shrink very slowly. This affected me emotionally because it was the first time I have this kind of issue on my eyes.  I have myopia which I use prescription glasses.  At May 8, The issue continued but not so severe as in May 7. I was very concerned so I went to ER which run me a CT scan without dye of my brain and optic nerves. No issues were discovered.  At May 13 I went to an ophthalmologist, by that that the bright spot disappeared, run me OCT and dilated test and nothing was found. He referred me to a retina specialist which didn?t find any issues  Now a year later from that there?s only a small spot that appear on the site only if I wave my have in from of my left eye only in certain light conditions.
Fever 101-101.5. Headache. Shivering. Cold. Bloodshot eyes.
Itchy, red,  warm to touch, slightly raise at the injection sight. ?COVID Arm? according to some source. Otherwise normal. Just reporting symptoms to give data.
Patient came in for catch up vaccine series and received ActHib. After administration it was noted that the vaccine had expired 10 days prior on 08/13/2021. This was not caught prior to administration. Family was informed of error and patient informed of s/s to watch for.  Mother stated patient was doing fine and no adverse reactions noted on day of administration. Patient scheduled for repeat dose in near future.
ON 9/1/21 AT 5:50PM, I ADMINISTERED THE PFIZER VACCINE INTO PATIENT'S ARM. SHE WAS A BIT NERVOUS TO RECEIVE THE VACCINE. AT 5:52PM, PATIENT'S BOYFRIEND TOLD ME SHE WAS HAVING AN ADVERSE REACTION. PATIENT SLUMPED IN THE CHAIR IN THE WAITING ROOM, HER BOYFRIEND CAUGHT HER WHEN SHE BECAME UNCONSCIOUS, AND PLACED HER ON THE FLOOR WHEN SHE WAS HAVING SEIZURE LIKE JERKING OF HER ARMS AND LEGS. 911 WAS CALLED. PATIENT QUICKLY REGAINED CONSCIOUSNESS AND SAID SHE FELT LIKE SHE WAS DREAMING FOR A FEW MOMENTS. THE JERKING LASTED FOR 15 SECONDS WITH HER LOST OF CONSCIOUSNESS TO A TIME OF ABOUT 20 SECONDS. WE REMOVED HER FACIAL MASK AND PLACED AN INSTANT ICE PACK ON HER FOREHEAD WITH HER PERMISSION. SHE DID NOT FALL AND SHE DID NOT HIT HER HEAD BECAUSE HER BOYFRIEND CAUGHT HER. THE FIRE DEPARTMENT'S PARAMEDICS QUICKLY ARRIVED AND EVALUATED HER. PATIENT'S VITAL SIGNS WERE NORMAL, SHE WAS FULLY COHERENT, REFUSED FURTHER TREATMENT, AND SAID THAT SHE WOULD FOLLOW UP WITH HER DOCTOR. I CALLED AND SPOKE TO PATIENT AT 9:09PM ON 9/1/21 AND SHE SAID THAT SHE WAS FEELING OK. I CALLED AND REPORTED THIS INCIDENT TO HER PCP'S NURSE AT 10:45AM ON 9/2/21 AT WHICH TIME PATIENT WAS AT THE OFFICE FOR AN APPOINTMENT.
The client requested the Moderna Vaccine. DOCSII was checked and determined the client had not received any Covid vaccines.  The syringe had .5ml Moderna vaccine. however .25 ml was wasted and witnessed by my colleague. Client received .25 ml of Moderna in his right  Deltoid. It was his first dose of Moderna vaccine and he should have been given .5ml of the the Moderna vaccine. I did not discover the error until I had left the clinic.  There were no noted symptoms after administering the .25ml of Moderna. The client was contacted on 10/25/2021 and notified that he received .25ml of Moderna instead of .5ml of Moderna. He was informed that he should contact his health provider to determine the course of action.
No adverse effects were reported in the patient; patient received a vaccine following a temperature excursion; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant therapies, as well as drug reactions or allergies were not reported.    On an unknown date, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA), one dose for prophylaxis (strength, frequency, route of administration, anatomical location, lot number and expiration date were not reported).        On 29-OCT-2019, it was detected the temperature excursion was lowest below 36 degrees Fahrenheit (F)/ 2 degrees Celsius (35 F) for a time frame of 430 minutes, and no had the previous temperature excursion (product storage error). It was reported that not call was due to data logger.  No adverse effect were reported in the patient.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1911USA000822: US-009507513-1911USA000833:
Posterior of arm was erythematous all along the triceps with an area of redness that looked like it pooled at the elbow. I had a mild ulnar neuropathy for 2 days that resolved. Suspect injection hit nerve sheath.
Woke up to baby face up, she looked fine, when I went to pick her up she was stiff still warm, but stiff, and not breathing, called 911 paramedics arrived and tried to resuscitate, she had been dead approx 12 mins. Med ex. said it was SIDS. Autopsy report cause of death "undetermined" manner of death: "undetermined, prematurity by history"
Approx 12 hours after injection, pt began having chills, shakes, headache, and nausea, followed by chest pain, increased heart rate and blood pressure. Advice nurse told pt at 9am on 12/11/8 to proceed to ER, which pt did and spent 7-8 hrs there. Nothing obviously wrong was diagnosed there (pt states bloodwork and EKGs were normal). Pt has follow-up appointment with her regular doctor regarding this ER visit upcoming on 12/17/18.