chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Red rash, itchy, raised blisters around the injection site. The area turned very dry and itchy, approx. 3 weeks.
This spontaneous case, initially received on 02-Nov-2016, was reported by a health professional and concerns a 44 year old patient. Weight: not provided; Height: not provided. Concomitant medication: Not reported. Administration of company suspect drug(s): On 12-Sep-2016, the patient received AFLURIA. Dose regimen: Not reported, Route of administration: Not reported. Batch number: WT53706. No additional suspect drugs. Adverse event description: On 23-Sep-2016, a nurse reported that a refrigerator went in and out of (temperature) range while there was flu vaccine in it. On 12-Sep-2016, doses were administered (special circumstances: drug administration error without adverse event, incorrect product storage without adverse event). Flu vaccine was first delivered to the vaccination facility on 15-Aug-2016. As the nurse reviewed the refrigerator temperature log, she stated that another excursion occurred on 15-Sep-2016. The doses arrived at 09:00 and were placed in a refrigerator that was at 10 degrees Celsius in the morning. Then the temperature remained at 9 degrees Celsius throughout the 15th and 51 doses were administered on the 16th at a flu clinic. The refrigerator was not back in range until 19-Sep-2016 at a temperature of 8 degrees Celsius. Temperature excursion identified: Log documentation reflected temperature excursions from 31-May-2016 to 23-Sep-2016 which ranged between 8 to 10 degrees Celsius. Vaccines had been given to patients between 31-May-2016 and 23-Sep-2016. The patients will be contacted for revaccination.
pt recv vax &  c/o blisters on rt upper arms following vax & soreness since inj;3 lesion noted on rt upper arm;#1 near inj site, #2 7cm from site clear, watery filled vesicles, #3 clear watery filled vesicles 9cm from inj site;blood blister
Starting on 2/23/21 injection site felt hot, itched and had red painful splotch. On 2/24/21 starting at 11:00 Am my body felt achy , fatigued and I registered a100.2 F temperature.
possible adm . of only vial  1 was given to pt. not discovered until all 5 dose were administration from box. unable to determine which patient  did not get unmixed dose.
brain fog, out of body experience, migraines, neurological issues, neuropathy, tremors, spasms, abdominal and back pain, wrist pain, numbing of arms and legs and tingling of arms and legs, hair loss, heart palpitations, shakes, weight loss, tics, inflammation of body and brain, ear aches and pressure,  burning sensations inside body (all over including chest area)
Suspected KD with cardiac sequelae  Per mom, he began having cold symptoms including runny nose and cough prior to 9/13. Rapid COVID test was negative. He received his second dose of COVID vaccine (Moderna) on 9/13.   On 9/18, mom noticed right cervical lymphadenopathy that was nontender and non-erythematous. On 9/19, began having a fever that persisted until 9/26 (about 1 week). Fevers were as high as 103F around the clock. Rapid COVID tests were negative for first 3 days of fever. Other associated symptoms included conjunctival injection, several episodes of vomiting after meals, low appetite, and increased tiredness/lethargy.    He did not have mucous membrane changes, changes to the lips or tongue, swelling or changes of hands/feet, or rash. He did not have abdominal pain, headaches, mental status changes other than tiredness/lethargy, difficulty breathing, or sore throat/voice changes.    Went to PMD on 9/20 and rapid strep was negative.  Was prescribed Augmentin which he took BID for 8 days.  Right neck lymphadenopathy resolved after 3 days of Augmentin, but he continued to have fevers and conjunctivitis.    He re-presented to PMD on 9/26 and labs were notable for CRP 96.4 (range 0-9mg/L), RVP negative for viral infections, CBC with WBC 14.6, Hgb 11.3, Plt 602, and EBV negative. PMD referred him to cardiology for possible atypical Kawasaki Disease. Echo (9/28) was notable for LAD dilation and possible thrombus. He was referred to LPCH CVICU urgently. Repeat echo (9/28) notable for severe, diffuse dilation of left main coronary artery, left anterior descending, and right coronary arteries. CT angiogram 10/1 with fusiform aneurysmal dilatations of the left main coronary artery extending to the level of the mid left anterior descending artery, as well as the right coronary artery until it gives rise to the PDA. No thrombosis. He has received IVIG , methylprednisolone, aspirin and clopidogrel for treatment of suspected sequelae of KD.     Since 9/26 he has had no fevers, no limitations in activity, no apparent SOB or swelling/edema, no syncope and has overall had improved energy, improved appetite, and normal UOP  Sister with rapid COVID positive on home test 9/19 and fever/URI symptoms. SARS-COV-2 RNA negative on respiratory test on admission 9/28. Due to lower concern but to evaluate for MIS-C, COVID-19 antibody tests sent prior to IVIG and have so far resulted as IgM negative, IgG pending.
Mother return 14 year old patient for 2nd Pfizer. Pfizer was given at 14 days instead of 21 days. First dose was given on 05/14/2021. Second dose was given on 05/28/2021. Discussed with mother. 14 year old patient had only a sore arm from the injection only.
Fever; This is a spontaneous report from a contactable consumer reported for his girlfriend (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot Number: EW0176) via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: unknown) via an unspecified route of administration on an unspecified as dose 1, single for covid-19 immunisation. Reporter stated his girlfriend she took second dose of your Pfizer shot (clarified as Covid vaccine) on Friday she was in 103 fever right now and it was 5 days after she took the vaccine shot. Reporter seriousness for fever was unspecified. Outcome of the events was not unknown.  Information on the lot/batch number is available; further information is expected.
Patient was administered a COVID-19 booster approximately 1 month after treatment with monoclonal antibody therapy for COVID-19. Patient received casirivimab-imdevimab on 10/1/21. This was reported by the patient after the vaccine booster was administered (she did state that an infusion had been recently administered but not the type of infusion). No adverse reaction was reported.
decrease in serotypes 1 and 4; patient received 5 doses of PREVNAR 13; This is a spontaneous report from a contactable physician. A 9-year old patient of unspecified gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on Jul2014 (had 5 doses) at a single dose for immunization. The patient's medical history included previous infections. Concomitant medications were not reported. The patient experienced decrease in serotypes 1 and 4 on an unspecified date. He tested 9-year old's antibody response for pneumococcal 13-val conj vac (dipht crm197 protein) at the request of the mother, as child is doing fine now but has had some history of previous infections. Vaccine administered in Jul2014, had 5 doses of pneumococcal 13-val conj vac (dipht crm197 protein). Antibody test in May2020 showed titers: Serotype 1 to be 1.1 and Serotype 4 to be 1.2, lab suggested that antibody should be at least 1.3 to be more effective. Antibody response when previously tested in May2017 titers for Serotype 1 was 1.5 and for Serotype 4 was 1.6. After revaccination in 2014, Serotype 1 went up to 12.6, now back down to 1.1. Serotype 4 went up to 9.2, now down to 1.2. The outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
This case was reported by a physician assistant and described the occurrence of malaise in a 12 year old male subject who was vaccinated with Engerix-B for prophylaxis. The subject's medical history included vomiting with Biaxin, "rash with sulfa" and diarrhea with erythromycin. There were no concurrent medications. On an unspecified date before 08 December 2005, the subject received a dose of Recombivax. The reporter stated that the subject received Recombivax "without any problems." On 08 December 2005 the subject received a dose of Engerix-B in his left arm as the 2nd dose in the hepatitis B vaccination series (lot AHBVB172AA). On 09 December 2005, 1 day after vaccination with Engerix-B, the subject experienced malaise, injection site induration, injection site tenderness and hardening injection site. On 10 December 2005, the subject was seen at a physician's office. The reporter stated that, " the indurated area at the injection site was about 5 inches around." The subject was treated with Keflex. The subject was seen by the reporter again on 12 December 2005. The reporter stated that the subject "is improved." The physician assistant considered the events to probably be related to vaccination with Engerix-B.
Sudden pain and swelling of the throat, fast heart beat, panic, sweat, coughing, trouble breathing
incorrect product storage; This spontaneous report was received from a medical student concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 08-DEC-2021, the patient was vaccinated with an improperly stored of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) for prophylaxis (lot # T034380, has been verified to be a valid lot number measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, expiration date not reported, but upon internal validation establish as 08-JAN-2022) (strength, dose, route of administration and anatomical location were not provided).  The temperature of storage and time frame of the excursion were 66.6° Fahrenheit (F) for 13 hours respectively.  If a digital data logger was involved was not reported.  If the vaccine experienced a previous temperature excursion was reported as multiple.
Patient developed headaches and night sweats the day following the second vaccine administration and symptoms still persisting one month later.
pt recvd vax & 6 days later pt exp a fever & many pox marks which were generally located;No further details were provided
After the vaccine, I developed a terrible headache, which was initially deemed to be a temporary side effect of the vaccination. This headache never subsided and has persisted for 6 months straight, with no alleviation. It is not alleviated by OTC  pain killers or prescriptions from neurologists. This headache can be felt in various places around my head, as well as in my ear canals and often behind the eyes. I have tried countless remedies to no avail.
This spontaneous report as received from a pharmacy student refers to a patient of an unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 27-JUL-2016, the patient was inadvertently vaccinated with an expired dose of PNEUMOVAX 23 lot # L001311 with expiration date: 06-JUL-2016 (dose and route of administration were not reported). No adverse effect was reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Narrative: COVID infection following COVID vaccine series 01/15 Pfizer, dose #1 02/05, Pfizer, dose #2 08/21 pt cc: cough, headache, myalgias dyspnea, exposure: unknown 08/24 SARS-COV-2 Variant Sequencing result: pending 08/26 pt admitted to non Facility hospital dx: Covid PNA Los: 15 days Intervention at non Facility hospital: IV Covid therapy, consult: cardiologist for COVID related cardiac condition 08/24 COVID swab, result: detected 09/15 clinically resolved
2 itchy raised welts around the injection site. Patient applied coillodal silver, coconut oil, and CBD oil and they welts have improved within a few hours
Patient received 2nd Moderna vaccine. Patient felt lightheaded and fainted 5 minutes after getting the vaccine. Firefighters and patient's mother brought her outside the observation room for more privacy and sat patient down on a chair with her head tilted down, and patient regained consciousness within 1 to 2 minutes. Patient's blood pressure and pulse were both low and patient stated she couldn't hear out of her left ear. Firefighters decided to call the ambulance and send the patient to the nearest emergency room. I followed up with the patient the next day on 4/10/2021. Patient stated she had a vasovagal response to the injection and received IV fluids at the emergency room. Patient stated it was very unexpected and she had ate before coming to the clinic. She has not felt lightheaded or faint since the incident and is experiencing flu-like symptoms from the vaccine and has been taking Tylenol for it.
Nausea and sweats 10:30 PM. Vomiting and diarrhea 11:30 PM. Fever 11:30 PM - 11/18/2026 10:00 AM. On and off Nausea. Currently still having Nausea and heat flashes. Will be going to the doctors 11/21/16.
105 degree fever for three days, loss of appetite, angry and violent - behavioral change. Sleeping 16 hours per day. Stuttering.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. In OCTOBER of 2014, the patient was inoculated with ZOSTAVAX vaccine (Dose, route of administration, site of administration, Lot number and expiration date were not provided) at a healthcare facility, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On or about 06-JUL-2016, the patient was treated by a physician at the healthcare facility, for a vesicular outbreak, which was diagnosed as herpes zoster.  The patient has been prescribed VALTREX and gabapentin to manage her painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX vaccine, and or despite receiving 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. The reporter considered the events to be related to ZOSTAVAX.  The outcome of the events was unknown. Additional information has been requested.
Information has been received from an 18 year old female for GARDASIL, a Pregnancy Registry product, concerning herself, who on 13-OCT-2010 was vaccinated with the first dose of GARDASIL. The patient had no relevant medical history, concomitant medications, and past drug history. After receiving the GARDASIL vaccine, she developed vaginal bleeding on 20-OCT-2010. On 21-OCT-2010, she found out that she was one month and one week pregnant. The patient's last menstrual period was approximately 14-SEP-2010, estimated delivery date was approximately 21-Jun-2011. There is no relevant laboratory data. The patient did not have a physician. As of 23-OCT-2010, it is unknown if the consumer plans to complete the GARDASIL vaccination series, and she continues to experience vaginal bleeding. No further information is available.
Initial information received on 21-Sep-2018 regarding an unsolicited valid non-serious case received from an other health professional. This case involves Adult patient (age and gender was not reported) and reported that the temperature excursion was to 0.2 degree Celsius but later discovered it was actually negative 0.3 degree Celsius while he/she received vaccine ADACEL. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided. On an unknown date, the patient received a booster dose of 0.5 ml suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number, expiry date and site of administration was not reported) via intramuscular route. It was a case of actual medication error due to product storage error temperature too low. It was unknown if any adverse event was occurred or not following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Administered at least 5ml of Havrix; This case was reported by a consumer via interactive digital media and described the occurrence of accidental overdose in a patient who received HAV (Havrix) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Havrix 5 ml and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced accidental overdose. On an unknown date, the outcome of the accidental overdose was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 20-OCT-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient reported that he/she wants to get a 1ml dose of Hepatitis A vaccine, but by error the doctor's office gave him/her at least 5 ml of the Havrix vaccine. The patient stated that he thought that he was giving him/her the 1 ml dose. Additional supportive information: The patient wanted to receive 1ml dose but by error received at least 5ml of the Havrix vaccine, which led to accidental overdose. Follow-up would not possible as no contact details were available.
Hives head to toe and measles rash to trunk. Itchy. Fussy. No fevers.
A severe case of  welt-like rash on legs, thigh, torso, scalp, underside of arms. I?m taking Zyrtec, generic Benadryl, cortisone cream.  The rash was a slow build. It started with scattered hives (which I had been getting prior to the shot) day  3-6 is when it worsened and they became giant rashes similar to the photos posted online related to Covid rash. None on my toes or fingers. They are predominately on my thighs, torso, arms, and scalp. Thy are hot, itchy, and stinging.  Day 6 I also had a low grade fever (100.1) and swollen tonsils.
Patient is here for his booster dose of adult-formulation Pfizer, lot number FJ8757 was received at 1316.  At approximately 1325, he c/o to Post-Vaccination Observation RN that he was feeling lightheaded, had tunnel vision, and rushing sounds in his ears. He presented with pallor and diaphoresis. No LOC was noted, he remained sitting in his chair without issues. His BP at 1331 was 99/56 sitting. He reports that he?s had similar incidents in the past. RN alerted this writer to assist at 1333. This writer encouraged him to lay down on cot, and, at 1334, he self-transferred to the cot, rising and moving without difficulty. His color improved once he laid down and he reported improvement to his s/s. BP at 1339 was 110/62 laying, HR was 55, SPO2 was 100% on RA. He reported that the vision changes, rushing noises, and lightheadedness were resolved upon lying down.  At 1344, he tolerated sitting and standing from cot and was able to self-ambulate to chair without difficulty. At 1344, his BP sitting was 122/58, HR 55, and SPO2 was 100% on RA. At 1345, his BP standing was 118/70, his HR was 56. He was provided education on vasovagal reactions, what to expect, and when to seek out medical care. He reports he will have company with him this evening and was advised to be very cautious when driving and pull over if he started to feel any lightheadedness at all. He verbalized understanding.  His BP at 1350 was 120/70 sitting, HR was 50, and SPO2 was 99% on RA. He denied any further symptoms and reported that he was back to baseline. At 1353, he stood and walked without difficulty and his BP was 117/56 standing, HR was 58, SP02 was 99% on RA. He waited a few additional minutes as a precaution before exiting facility at 1400.
Systemic: Confusion-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Severe, Systemic: Nausea-Mild, Systemic: Shakiness-Medium, Additional Details: Patient passed out about 3 minutes after receiving injection. He experienced mild to moderate trembling and became unresponive for about a minute. I contacted 911 and they sent emergency response. Patient came to but was still lethargic and confused. First responders gave patient oxygen for several minutes, took vitals. Patient felt better after oxygen and declined to be taken to hospital. I monitored him for an additional 15 minutes after first responders left. He felt safe to drive home.
Information has been received from a pharmacist concerning an adult male pt, over the age of 65, who was vaccinated with pneumococcal 23v polysaccharide vaccine, "every year for unknown interval of time." The pt sought unspecified medical attention. There was no product complaint involved. Follow up information reported that the pt had injection site soreness. No further information is available.
3-5mins after vaccine (ZOSTAVAX) administered she complained of "funny feeling" to (R) ant neck radiating to (R) of her nose. BENADRYL & EPI administered to some relief. Pt went to ER via EMS walked to stretcher.
Got Covid booster (3/1/2022) - within 2 hours, had hives all over. Took Benadryl 75 mg and passed out. Premedicated with Claritin and Pepcid before her shot as well.  Hives varied for 24 hours and then resolved.
Redness, swelling at injection site. The event was reported by the provider because the MA giving the vaccines mixed the MENACTRA and the DTaP in the same syringe. She was "re-educated". so it will not happen again. The practice has arranged fpr the child to be revaccianted with both vaccines, at no cost to the patient. They advised BENADRYL and ice for the swelling.
Sore arm.  Up to 103.8 fever from midday the day after the vaccine for about 24 hours.  I would take Advil, the fever would break -- I would be soaked, then the fever would come back with a vengeance.  I felt ill -- weak and achy.
This infant's dad walked in to report events of the night before. His daughter received a vaccine about 4:30 PM and at 9:30 PM, she started crying (in a different way)made 8 girggled noises with her back arched, she then turned blue and then became white as paper. Not tonic clonic. The parents called 911 and child appeared ok when they arrived but cried and didn't open her eyes or feed for 3 hours. No treatment or hospital visit.
rash at injection site and burning face ( rash )   treatment - benedryl  and itch cream
The wrong vaccine was given in the series. He was given the Moderna bivalent dose as a primary 1st dose. Per CDC that dose is void and to re-dose with the original Moderna. He has not experienced any side effects.