chrisvoncsefalvay/vaers-outcomes huggingface dataset:
2/27/22: small itchy rash began to develop over right eyebrow 2/28/22: woke up in the morning with itchy red rash with raised bumps covering most of right forehead that moved into the eyebrow and eyelid during the day - was worried about shingles until it popped up in the left hairline. By afternoon my left ear developed red itchy blisters and the cartilage swelled at least twice the size of normal.  Also developed a small cluster of red itchy blisters on the inside of the right upper arm. At this point, I assumed it wasn?t shingles and was more likely related to the vaccine I had the day before.   Either later on 2/28 or 2/29, the same rash developed on the left posterolateral neck at the necklace line, but in a small cluster.  Then multiple blisters formed at the necklace line at the right later neck which started to move up the neck, but not quite to the ear. Began Benadryl at night and doubled my normal valtrex dose to 1000mg/day.   The right arm blisters quickly became tiny itchy scabs. Right forehead rash became less blistery during the week, but all rashes stayed very itchy.   On 3/4/22, same rash developed behind the left medial knee. Had virtual visit with MD who said it was likely an adverse reaction to COVID booster and prescribed: prednisone 20 mg tablet - take 3 tabs daily for three days then 2 tabs daily for three days then 1 tab daily for 7 days triamcinolone acetonide 0.1 % topical ointment - 1 application to (affected) skin topically 2 times per day valacyclovir 1 gram tablet - 1 tab by mouth 3 times per day for 7 days (In case there was also shingles outbreak) MD was very concerned there were still blisters on my eyelid and asked me to f/u with ophthalmologist ASAP. Had a same day appt w/ ophthalmologist who also immediately thought it was shingles until I showed him my other rashes. Eye pressure, cornea, Vision were all normal.
Severe chills, Stiff arm muscles ,Tight Chest, Sweats, Headache, No fever. Any worse would go to E.R. Lasted 48 hours approx.
This spontaneous report was received from a healthcare worker refers to a patient unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapy were not reported. On 27-JUL-2016, the patient was vaccinated with improperly stored M-M-R II (lot number: K014833, expiry date: 14-SEP-2016). No adverse effect was reported. Reporter also mentioned that the patient would be scheduled for revaccination in the future. This is one of the several reports received from the same reporter. Additional information has been requested.
Developed Chickenpox like rash on 08/25/04, which became progressively worse. On 08/30/2004 father brought thte child to Health Department for evaluation. Areas on face and thighs appeared nearly ulcerated. On arms and trunk she had fluid filled vesicles.Referral was made to MD. MD said it was a bacterial infection caused by an abrasion to the face that had occurred when the child fell. He prescribed Augmentin 1 tsp. B.I.D. In a phone call to the mother on 09/02/04 she said that all areas were healing nicely with just a pink tinge to the skin.
fever (subjective) chills, myalgias, malaise, h/a, local redness & swelling;
inadvertently administered a dose of Pentacel that had been exposed to temperatures lower than recommended for 3 hours and 15 minutes, reaching a minimum temperature of 30 degrees F with no reported adverse event; Initial information received on 15-Feb-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 1 years old male patient  who was inadvertently administered with a dose of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [Pentacel (Vero)] that had been exposed to temperatures lower than recommended for 3 hours and 15 minutes, reaching a minimum temperature of 30 degrees f 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 hepatitis A vaccine (Hepatitis A) and pneumococcal vaccine conj 7V (CRM197) (Prevnar) both for Prophylactic vaccination.  On 09-Feb-2023, the patient inadvertently administered  0.5 ml (dose 4) (total) dose of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine  (lot UJ682AAA: strength, formulation and expiry date not reported) via intramuscular route in the left leg (left thigh) for prophylactic vaccination that had been exposed to temperatures lower than recommended for 3 hours and 15 minutes, reaching a minimum temperature of 30 degrees f with no reported adverse event (poor quality product administered) (latency: same day). Vaccines that had undergone temperature excursion down to 30 degrees F for 3 hours and 15 minutes, due to a refrigerator malfunction.  Action taken : not applicable.  Outcome :  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.; Sender's Comments:  US-SA-2023SA057388:01493585 US-SA-2023SA056927:01493871 US-SA-2023SA057103:01493882 US-SA-2023SA055684:01493896 US-SA-2023SA057080:01493906 US-SA-2023SA057083:01495050 US-SA-2023SA057086:1495112 US-SA-2023SA056079:01495161 US-SA-2023SA057474:01495184 US-SA-2023SA057197:01495203 US-SA-2023SA057226:01495215 US-SA-2023SA056292:01495279 US-SA-2023SA056689:01495295
p/vax pt devel an inj site rxn characterized by pain & swelling;tx w/applications of ice, DPH & APAP;
Pt came in for Covid-Bivalent Booster was given regular Covid Vaccine in error
Per telephone conversation with grandmother on 1/6/10. She states her grandson had a nosebleed, runny nose and thick mucus after receiving vaccination. Went to PI. 2 days later  returned 12/31/09. Pt experienced thick mucus and red nose 2 days ago. Pt has not been evaluated by a doctor. Only occurred in left nostril. Advised to seek medical evaluation by Doctor.
Urticaria on bil arms, legs, assoc with itching to include throat itching. Got worse on 20 Nov, the rash was even worse with some feet swelling and hand swelling, BENADRYL was helping control rash. On 22 Nov finally started to improve and resolved over couple days. No peeling or skin scarring. No clear arthralgia/arthritis. No fevers.
Chest pain, SOB, N/V/D and abd pain. No fever, cough or sore throat. Worsen over the next 2 days prompting ED visit. Dx Pericarditis
PATIENT REPORTS THAT THE DAY FOLLOWING HER INJECTION HER ARM WAS PAINFUL AT THE INJECTION SITE. PT REPORTS THAT SORENESS LINGERING FROM THE INJECTION IS LIMITING MOVEMENT AND CAUSES PAIN WHEN LIFTING HER ARM SEVERAL WEEKS FOLLOWING INJECTION. PATIENT STATES THAT SHE SAW HER DR IN THE DAYS FOLLOWING THE VACCINATION AND WAS TOLD IT APPEARED A CLOT HAD FORMED AT THE INJECTION SITE.
Thick throat, mild itching of throat after vaccine. States allergy to mediations.  Took 50mg diphenhydramine.
2nd dose of Shingrix by only administering the diluent portion / diluent was not mixed with the powder; 2nd dose of Shingrix by only administering the diluent portion / diluent was not mixed with the powder; redness at the site of injection; soreness of the arm; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 78-year-old female patient who received Herpes zoster (Shingrix) (batch number CL2S5, expiry date 5th November 2022) for prophylaxis.   On 10th November 2020, the patient received the 2nd dose of Shingrix. On 10th November 2020, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The reporter stated that the patient received today 2nd dose of Shingrix by only administering the diluent portion of the vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up.   Follow up information received from pharmacist on 25th November 2020: The patient came in for a shingles vaccine. Upon administration, the diluent was not mixed with the powder and was subsequently injected. The patient was notified later that day when the error was found. Upon follow up with the patient experienced some redness at the site of injection and soreness of the arm without any other issues to report. She was otherwise doing well. The reporter considered the injection site erythema and pain in arm to be related to Shingrix.
Pt came to drive through clinic to receive second COVID19 dose. Interview revealed no adverse reaction to first dose on 4-14-21 other than expected sore arm. Pt received 0.5ml dose at approximately 1:15pm while seated in the driver's seat. .  Within a 2-3 minute time frame after his vaccine the wife alerted me that her husband was not doing well. She stated his eyes were rolling back in his head and he was having a seizure.  911 was called. She stated that patient was unconscious for 20-30-seconds but that he revived and was able to resume basic communications. Shortly thereafter the patient began vomiting repeatedly. The patient's seat was leaned forward and to the outside of the vehicle to prevent aspiration. EMT teams arrived quickly to take over patient care. patient was transported to emergency department.
7:00am admin. within 20 minutes itching, swelling, and hot to touch. Then nasal congestion within the hour. Then by 10:30 pm throat felt tight and congested with shortness of breath.
urticaria @ site of vax lt arm & entire lt arm & face responded to DPh;still w/recurring urticaria;
No adverse effects reported; Multiple patients were vaccinated with improperly stored VAQTA; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's concurrent conditions and medical history, as well as concomitant medications, were not reported.  On 23-MAY-2019, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) 25/0.5 (units not provided), lot # R018935, expiration date 05-SEP-2019, for prophylaxis (dose, route, anatomical site and frequency were not reported). The reporter stated that the vaccine had a temperature excursion of 34.2 F for 4 hours and 54 minutes, which was detected by a data logger. The vaccine had no previous temperature excursion and there were no adverse effects reported.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-1907USA001174: US-009507513-1907USA004852: US-009507513-1907USA004853: US-009507513-1907USA004854: US-009507513-1907USA004855: US-009507513-1907USA004856: US-009507513-1907USA004857: US-009507513-1907USA004858: US-009507513-1907USA004860: US-009507513-1907USA004861: US-009507513-1907USA004862: US-009507513-1907USA004863: US-009507513-1907USA004864: US-009507513-1907USA004865: US-009507513-1907USA004866: US-009507513-1907USA004867: US-009507513-1907USA004868: US-009507513-1907USA004869: US-009507513-1907USA004870: US-009507513-1907USA004871: US-009507513-1907USA004872: US-009507513-1907USA004873: US-009507513-1907USA004874: US-009507513-1907USA004875: US-009507513-1907USA004876: US-009507513-1907USA004877: US-009507513-1907USA004878: US-009507513-1907USA004879: US-009507513-1907USA004880: US-009507513-1907USA004881: US-009507513-1907USA004882: US-009507513-1907USA004883: US-009507513-1907USA004884: US-009507513-1907USA004885: US-009507513-1907USA004886: US-009507513-1907USA004887: US-009507513-1907USA004888: US-009507513-1907USA004889: US-009507513-1907USA004890:
Shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, 6 days after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Shingles). The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 12-JUN-2023 This case was reported by consumer via interactive digital media. The reporter reported that he or she received first dose of Shingle vaccine and 6 days later got shingles. The reporter reported that the physician never told him or her that could happen and the reporter even asked physician if that was a side affect of vaccine  The reporter advised that did not listen to the vaccine pushers.
described by mom as 2 days of inconsolable crying; 19OCT92 checked w/clinic, pulled chart no record of lot#/MFR; no problem w/f/u use of DT vax for doses 3 & 4;
Stools coated with mucus 6/day for about 1 week after last vaccines - mom wondering if possible reaction to ROTARIX? Had been on probiotics at that time for about 3 weeks due to mother having thrush. Says prior to vaccine - was stooling about once every 3 days; and after 1 week, returned to same pattern. Pattern repeated again on 2nd dose - given 9/24/18.
Administration after a below temperature excursion; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Boostrix. On an unknown date, unknown after receiving Boostrix, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 30-Sept-2022 Reporter's comment: The reporter called to report a below temperature excursion where Boostrix and Shingrix were exposed to 27 degree Fahrenheit from the period of 27th July 2022 until 22nd September 2022, due to a malfunction of their fridge.  The reporter reported that during that period a total of 20 patients might had received these vaccines; 15 patients received Boostrix and 5 patients received Shingrix.  No lot number and expiration dates or any patients information was handy at the time was asked.  The vaccine administration facility was the same as primary reporter. Consented to follow up. Additional supportive information: The patient received Boostrix below temperature excursion, which led to incorrect storage of drug. This is  1 of 20 linked cases reported by same reporter for different patients.
marked erythema at injection site the day after vaccination... 2 large clear fluid filled blisters developed on day 2. Complains of itching and some pain. No fever. Ice only provided some relief. Brought to clinic for evaluation.
In July of 2021 I developed a rash on my left leg. I had pain in my left leg that steadily increased over the next 30 days. It was difficult to walk. It then increased to pain in my arms, legs, wrists, hands. The pain moved each day and gradually got worse. At first the pain would just start in the evenings and gradually get worse through the night to where it was difficult to get up and walk in the morning. The pain was subsided with medication and steroid treatment for inflammation but the root cause has not been determined and now the pain is starting to come back even with current medication.
Administration of the Rotarix Diluent Alone; Administration of the Rotarix Diluent Alone; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 8-week-old male patient who received Rota (Rotarix lyophilized formulation) (batch number KB7FJ, expiry date 19-SEP-2024) for prophylaxis.   On 25-OCT-2023, the patient received Rotarix lyophilized formulation. On 25-OCT-2023, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced inappropriate preparation of medication (Verbatim: Administration of the Rotarix Diluent Alone) and inappropriate dose of vaccine administered (Verbatim: Administration of the Rotarix Diluent Alone). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were 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: 02-NOV-2023 Clinic Supervisor reported that 6 kids received Rotarix diluent alone with our mixing it which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up via email. This case is 1 out of 6 cases reported by the same reporter.; Sender's Comments:  US-GSK-US2023152365:Different patient US-GSK-US2023152368:Different patient US-GSK-US2023152370:Different patient US-GSK-US2023152371:Different patient US-GSK-US2023152373:Different patient
Pfizer-BioNTechCOVID-19 Vaccine EUA My fibromyalgia flared up badly, too much pain to move off couch but after 3+ hours it started to settle down
pt recvd vax 25OCT95 & later devel numbness & tingling from mid upper lt arm to finger tips;feels sxs are cont & getting worse more constant & more overpowering; has appt w/neurologist 12JAN96
severe short of breath - cxr with concern for covid change, hospitalized. fully vaccinated pt
Pt. states that after receiving the 3rd Booster of J&J 10/29/2021, started experiencing symptoms that evening of headache, side (left) of the neck soreness, body aches, nerve pain, and left ear ringing (continuing). No noted Primary visit/communication (12/2021 appt. scheduled for Follow-Up).
Left ankle swelling. Eventually had an ultrasound done and was found to have a DVT blood clot in that leg. Started blood thinner xarelto on 8-17-21. Will be on this for 6 months and retested to see if clot is gone.
Patient had some bleeding and swelling post injection. I gave her an ice pack and suggested to apply pressure to help with the swelling. Patient stayed in waiting area for approximately 10 minutes, after which the swelling had decreased. I tried calling the patient after a couple of hours; I left a message, but have had no callback up to the time of this writing.
(Lt) upper arm with redness and tenderness at site of injection given on 5/20/13 (area app. 7 1/2 cm x 8 cm) s/s began 5/21/13, seen at office 5/22/13 - some (+) warmth at that time. Afebrile; no hives. Tx with PRN BENADRYL and return if s/s increase.
Vasovagal syncope, BP 99/47, HR 50, Assessed by EMS, Refused transport to ER
Headache, grogginess, jittery, shivering, soreness at point of shot, tiredness, feel like a truck ran over me, extremely lethargic. now it's the second day. Feeling cold stopped, a little better.
Rash on full body; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on full body) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     No Medical History information was reported.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, the patient experienced RASH (Rash on full body). At the time of the report, RASH (Rash on full body) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. No treatment information was provided.   Reporter did not allow further contact
This spontaneous report as received from a certified medical assistant (healthcare worker) refers to an unknown number of patients of unknown age and gender. The certified medical assistant reported excursion affecting VARIVAX of -0.4C for a 4 hour period (date unspecified). Excursion was supported. It was reported that on an unknown date the doses of VARIVAX (route, dose and lot# not reported) (also reported as dose and therapy route for VARIVAX products would be as stated in prescribing information as the office had not had any administration errors) had been administered post excursion, however certified medical assistant did not have access to any specific information as their computer systems were not up to date. No adverse effects or concerns noted by any patients. The patients did not seek medical attention. This is one of several reports from the same source. Additional information has been requested.
Inconsolable crying, inflammation right tympanic membrane. Treated with Tylenol and Amoxil.
Information was received on 31-AUG-2017 from a lawyer regarding a case in litigation concerning a male patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. It was reported that the patient was vaccinated with a dose of ZOSTAVAX (lot number, dosage, and route of administration not provided) on or about 20-NOV-2015 at a pharmacy 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. On or about 07-DEC-2015, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. The patient was prescribed valacycloriv, triamcinolone acetonide for management of his painful condition. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result the patient has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. Additional information has been requested.
Narrative: Patient was not previously COVID-19 positive and did not have any predisposing factors(PMH, allergies, etc.) for experiencing an adverse drug event. The ADR did not occur at the time of the administration of the vaccine nor was there an ADR that occurred between the observation period and the date of death. Patient was brought to the ED on 3/15/21 and transferred to another hospital MICU for decompensated heart failure and atrial flutter in the setting of severe mitral stenosis suffering with acute hypoxic respiratory failure. Attending predicted with patient's severe mitral stenosis he did not have but 1-2 months of life left. He was transitioned to palliative care and transferred to inpatient hospice on 3/23/21 where he passed away on 4/5/21.
Severe black and blue at injection site took over 6 wks to go away, red mark at site now pain at injection site and all of left arm, pain in left thumb.
Swelling, throbbing pain, stiffness, jumping muscle sensation, pain ranges from a constant throbbing pain to an severe, severe pain. Doctor has scheduled an ultrasound. Doctor has also prescribed pain medication, topical creams, and heat and ice packs for symptom relief.
Patient presented for second COVID vaccination and had a golf ball sized lump where previous COVID vaccine was administered. Lump was soft and movable.