chrisvoncsefalvay/vaers-outcomes huggingface dataset:
packaging confusion between Shingrix and Arexvy; nearly gave Arexvy instead of Shingrix due to package confusion; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of product packaging confusion in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Shingrix and Arexvy. On an unknown date, an unknown time after receiving Shingrix and Arexvy, the patient experienced product packaging confusion (Verbatim: packaging confusion between Shingrix and Arexvy) and intercepted product selection error (Verbatim: nearly gave Arexvy instead of Shingrix due to package confusion). The outcome of the product packaging confusion and intercepted product selection error were unknown.   Additional Information: GSK Receipt Date: 02-NOV-2023 It was reported that the customer did not administered incorrect brand to a patient, but nearly did. The reporter stated that the packaging of Arexvy was so similar to Shingrix which he uses very regularly, that he nearly gave Arexvy to a patient meant to receive Shingrix which led to product packaging confusion and intercepted product selection error. He recognized the error when double checking and did not incorrectly administer but felt that there was a high risk that the two packages could be confused leading to accidental administration of one of the vaccines.
Signs: Fever, chills, lethargy & severe headache. Onset 6-8 hours after shots. Signs lasted 48-72 hours. Pt. self treated with Tylenol & Ibuprofen. All signs resolved completely.
Pt reported she was feeling nauseous,hot and a dry mouth. Nausea proceeded to dry heaves w/o vomiting. Vitals remained stable,airway was not compromised. S/S lasted 45 min, with hydration pt returned to baseline.  Evaluated by PA in house.
See previous page for Shingles outbreaks...several since getting Zoster Vaccine -- AFTER one year post-shot.
I got a node on my arm; Arm is red near the blue mark on my arm; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0186, Expiry date: unknown), via an unspecified route of administration on 02Jul2021 as dose 1, single for covid-19 immunization. The medical history and concomitant medications were not reported. The patient stated, got the shot yesterday (02Jul2021) and now was trying to find out help because of a node on arm, today when woke up the arm was red near the blue mark on arm. The outcome of events was unknown.
8 days after vaccine shot, welt appeared on vaccination arm. 2 X 4 inches. Raised area more than a rash. Itched and stinging sensation.  Lasted 10 days.
Patient received her 2nd COVID-19 Pfizer (Lot#: ER8729) on 7 Apr 2021 in the R arm at the Health Center.  She noted initial soreness in the R arm at the site of the injection without other symptoms. A few days later noted nausea, diarrhea, and headaches that resolved. About a week after the or 2 weeks after her vaccine, she noted recurrence of headache, vomiting with some diarrhea and started to develop joint pain, notable of her R shoulder and later to both arms and wrists. She also noted fatigue and occasional chills but no fevers.  These symptoms persisted and remained for about 4 weeks before improving.  Since that time, she has had persistence of headaches (frontal occipital), intermittent nausea, and persistence of R shoulder pain but also pain of other joints in her upper and lower extremities.  She reports no acute rash or upper/lower respiratory symptoms within the first day of receipt of both 1st and 2nd COVID-19 vaccine.
Red dots on legs and forearms, throat clearing, sniffing, hand splaying bilaterally, emotional, BENADRYL, hydrocortisone cream both topical.
Patient complained of scratchy throat, became pale, confused and weak  then slumped over in chair unresponsive. 911 dispatched EMTs that spent about 30 minutes with him and sent him home with his mom. Her recovered 100% and was okay all night and next day.
My arm is very sore since the injection, can barely life it above my head; Soreness in her arm and it has not gone away it is very painful.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (My arm is very sore since the injection, can barely life it above my head) and PAIN IN EXTREMITY (Soreness in her arm and it has not gone away it is very painful.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (My arm is very sore since the injection, can barely life it above my head) and PAIN IN EXTREMITY (Soreness in her arm and it has not gone away it is very painful.). At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (My arm is very sore since the injection, can barely life it above my head) outcome was unknown and PAIN IN EXTREMITY (Soreness in her arm and it has not gone away it is very painful.) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication  was provided.  Treatment information was not provided.  The patient reported that while receiving the vaccine the health care provider administering it asked if had anything in shoulder like plastic or rubber as it was very difficult for them to inject the vaccine into arm and the patient had had soreness in arm and it has not gone away it was very painful. The patient's arm was still hurting.   Reporter did not allow further contact
Pain Rt upper arm progressing to severe, immobilizing arm by 8/9/10. Treatment: ibuprofen & warm compresses. Improved mobility by 8/16/10.
BODY ACHES; COLD CHILLS; LOW FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with covid-19 vaccine ad26. cov2. s (manufacturer not specified, date not specified) (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported (Dose series 1). The patient experienced a few body aches overnight when treated with covid-19 vaccine ad26. cov2. s (unspecified manufacturer) for prophylactic vaccination (dose series 1).  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, administered on an unspecified date in  2021 ("last week") for prophylactic vaccination (dose series 2). The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, following the booster dose, the patient experienced body aches, cold chills, and low fever but only for the night (dose series 2). The patient reported he was fine on the next morning. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, cold chills, and low fever. This report was non-serious.
Initial report was received from a health care professional on 14 November 2011. A 36 year-old male patient had received on 07 November 2011 a first dose subcutaneous left tricep injection of YF VAX, lot number UH101AA; a first dose intramuscular left deltoid injection of TYPHIM Vi, lot number G0481; a first dose intramuscular right deltoid injection of TWINRIX, GSK lot number AHABB223DA and a first dose intramuscular left deltoid injection of AFLURIA, GSK lot number AFLUA609DA. On 10 November 2011, the patient developed cervical, axillary and supraclavicular lymphadenopathy. On 11 and 12 November 2011, the patient developed a fever, chills and sweats. The patient self medicated with ibuprofen 600 mg. He was evaluated by a company physician on 14 November 2011 and was referred to a pvt MD (private MD) and ID (infectious disease) specialist. No further information was available at the time of the report. Outcome was unknown. Follow-up information was received from a health care professional on 25 November 2011. The patient was described to be healthy who was preparing for travel. There were no known contraindications described during the report. According to the reporter, the patient had received all vaccines on 07 November 2011 and approximately four days later on 11 November 2011 (previously reported as 10 November 2011), the patient developed symptoms. The patient was seen by his regular physician who drew blood work that the patient reported to be "all normal". No further information was available at the time of the report. The patient's lymphadenopathy was thought to be resolving. Documents held by sender: none.
Near syncope: Student was vaccinated as part of meningococcal carriage study in high school auditorium.  While standing up from receiving vaccine, student reported feeling dizzy and was assisted to the floor and legs were elevated.  She was not bradycardic, but pulse was thready initially.  BP normal when cuff applied. Recovered after ~15 minutes.
pt received moderna vaccine at 0630am. At ~0850 am, pt experienced muscle twitching in upper and lower limbs. pt given diphenhydramine 50mg IM and pt reported that muscle twitching went away after pt arrived home.
Dull pain and rash on arm in area of injection, starting the night of the injection, continuing through today [36 hours later]. On the day following the injection,  aching muscles, headache, feeling feverish [as if I was coming down with the flu]; these symptoms seem to be easing today.
Information has been received from a health professional concerning a 7 year old male who on 11/14/1995 was vaccinated with one dose of varicella vaccine. On 12/15/2001, the pt was diagnosed with chicken pox. The pt sought unspecified medical attention. Additional info has been requested.
Covid AG + 20Jan2023; Covid AG + 20Jan2023; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A 42-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Nov2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 42 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Seqirus -flucelvax quad flu vaccine.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 20Jan2023, outcome "recovering" and all described as "Covid AG + 20Jan2023". The patient underwent the following laboratory tests and procedures: Nasopharyngeal swab: (20Jan2023) Positive. It was unknown if therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received other vaccine in four weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Based on the available information in the case, an association between the reported events DRUG INEFFECTIVE & COVID-19 and The suspected drug cannot be ruled out.
She began sweating within about 5 minutes, this lasted about 2 hours. She had a minor cough which lasted 3 days. She screamed for 3 days, only wanted to be held while standing up.
Patient's wife states he experienced confusion and paralysis at midnight after receiving his third COVID-19 vaccine. She states he was unable to feed himself or get himself to the bathroom without significant assistance from wife and son. Patient's wife states he has never experienced confusion or paralysis like this before. These symptoms were beginning to improve as of the morning of October 1st when patient's called. The Nurse advised patient's wife to call his primary care provider, then consulted with the Health Office regarding this event, who recommended a report be submitted.
Local swelling, pain lt VE below site of vax 5-6 hrs p/vax; inc creatinine to 3.5 from baseline of 2.3, hematuria, pyuria 120 p/vax;
Benign paroxysmal positional vertigo occurring 7 days after vaccine #2.
Child woke up with raised, blistery patches/rash on buttocks, knees, and wrists.  Rash was red and irritated with white center.
Information has been received from a health professional concerning a 21 year old white female with a history of acne who on 09-AUG-2007 was vaccinated intramuscularly with the Gardasil. On 10-JAN-2008 the patient was vaccinated intramuscularly with her second dose of Gardasil (lot# 655849/0263U). Concomitant therapy included DENTOMYCIN and topical RETIN-A. The nurse practitioner thinks the patient received a tetanus booster on 10-JAN-2008 at a different anatomic site than Gardasil. On 10-JAN-2008 the patient experienced arm pain after receiving her second dose of Gardasil. The patient experienced pain as she was being injected at the office. The patient continues to have the pain and has difficulty raising her arm. The patient has not recovered. The nurse practitioner expected to examine the patient soon and states the patient was thin with a Body Mass of 19. The patient had no swelling, no bruising and no fever involved. The patient sought medical attention by having her mother call the nurse practitioner. Additional information has been requested.
Pt reported that in 1990 completed series of Hep B vax; 9 months p/completion of the series, pt devel elevated liver enzyme studies w/no other accompanying sx;
Information has been received from a nurse concerning a female with codeine allergy who on 06-AUG-2007 was vaccinated with ZOSTAVAX (Lot # 657764/0584U). Concomitant therapy included insulin, metformin, ZYRTEC, simvastatin (MSD) and aspirin. On approximately 09-AUG-2007 the patient developed shingles lesions on the left side of her back. Subsequently, the patient recovered from the lesions. This is one of several reports from the same source. Additional information has been requested.
I had vaginal itching and discharge that I knew to be like a yeast infection from experience. I had an expired fluconazole tablet from a previous prescription, so I took that and it seemed to go away. Maybe about a month later on March 25, I had green vaginal discharge that also looked like a yeast infection. My sister is a women's health nurse practitioner (NP) and prescribed me fluconazole. I took that and it got better. I went to GYN on March 28 to be tested for yeast, bacterial vaginosis, chlamydia and gonorrhea. NP thought it looked like bacterial vaginosis (BV) as well and prescribed metronidazole gel and more fluconazole to treat yeast infections expected with BV treatment. I used the gel for 1/5 nights before finding out that all tests were negative (I had already treated the yeast infection before testing).  I stopped using the gel. I developed a vaginal odor and discharge congruent with bacterial vaginosis. I didn't have time to go to the GYN, so around mid April, I ended up treating it with the metronidazole gel that I still had. After the first night of using the metro gel, I developed a yeast infection as expected and treated it with the fluconazole. I took one more fluconazole on the fifth/last day of treatment. Everything seemed cured until I developed another yeast infection around mid May. I treated that with one more fluconazole tablet and have been cured since.
Severe muscle soreness spread from left arm injection site throughout the entire body,  Subsided 3 days later and was normal 5 days post injection.
Pt came to clinic for vaccinations. She stated she had rash and itching several hours, post vax, given on 1/11/01. States rash was generalized small bumps and lasted for several hours. Rash and itching gone in several hours.
pt recvd vax; exp 2 welts around the inject site & breathing problems;
The patient was immunized with the Pfizer COVID19 vaccine that had expired (already been in fridge for longer than 6 hours following drawing up).
Diarrhea: 1 day after shot through 3 days after shot High Fever: 1 day after shot to 3 days after shot 102.9F Fatigue: 1 day after shot through 3 days after shot Slight Rash, jaw and chest: 1 day after shot through 3 days after shot
swollen purple right thigh (left) 5 hrs after shots. HIB + Prevnar gave im left leg. Synagis given in same leg 2-3 d before. Was seen at ER 4/407
My right arm has been tingly on and off since about an hour after receiving the vaccine. My head started hurting at the base of my neck approximately 2 hours after the vaccine.
blurriness of her eyes/ it got worse; blurriness of her eyes/ it got worse; Side effects like breathing things; This is a spontaneous report from a contactable consumer (patient). An 86-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EWO177; Expiration Date: 31Aug2021), intramuscular, administered in left arm on an unspecified date as first dose, single for COVID-19 immunization. Medical history included Blood pressure abnormal (blood pressure), osteoporosis, ongoing blurriness of her eyes, and macular degeneration. Concomitant medication included carvedilol for blood pressure abnormal (blood pressure). The patient has not taken any vaccine 4 weeks prior to the COVID-19 vaccine. The patient stated that 2 weeks ago (unspecified date), she has gotten the first dose of the Pfizer COVID 19 vaccine. She said she did get most of the side effects and until now she is experiencing blurriness of her eyes. She also has a history of Macular Degeneration. She is experiencing blurriness before but after getting the Pfizer COVID 19 vaccine, she said that it seems like it got worse. The patient said that she won't be getting the second COVID 19 vaccine dose. She asked if Pfizer has an antidote and if it will continue to progress. When probed for the concern, she stated that she had the first shot vaccine two weeks before and just had a side effects with this. She stated she has macular degeneration and she sees blurry because of the macular degeneration. She wanted to know its side effect, her vision changed and it got worst. She wanted to know if other people had gone through this blurry vision. She wanted to know the side effects, if it's the side effect or what. When paraphrased the concern, the patient stated, "Yes, I have the other things. I have the side effects like breathing things and such type of things and I want to report it. Hold on I want to get the paper." The patient stated that she had the first shot of the vaccine 2 weeks before and she was afraid on the first day actually that the shot she got had side effects. As she got it, it got more blurry, as her eye, her vision. The vision changed on it on an unspecified date. It wasn't blurry prior to because she has macular degeneration however, ongoing symptoms, her eyes become more blurry and now it seems to be more blurry and she wanted to now if this is gonna last. She asked if this is going to continue and what she can take or do to stop it. The vaccine is in her system now. She said she get 2 treatment for macular degeneration, 3 days later, she got injection in her eye and it's called Eylea. The outcome for the events vision blurred and condition aggravated was not recovered while the outcome of the event respiration abnormal was unknown.
pt recvd vax & devel fever 103-104, nausea, vomiting & diarrhea for 2 days; pt's liver enzymes were found to be elevated; pt recovered;
pt recv vax 28AUG98 & next day woke up w/a blister/redness about an adult closed hand size & weakness to lt leg pt was eval by MD;adm to hosp;
On the 10th day after the booster shot, I started to develop unexplained itching and hives. These hives and rashes come and go all over the body. At one point today my entire body had a burning sensation from the itching.  I had to rush and buy Benadryl for some relief. Relief is temporary and the itching comes and goes at various sites of the body. I did eat poke (raw fish) the evening when the symptoms appeared. But usually If my shellfish allergy is involved, my lips burn almost immediately after the meat makes contact. I wonder if somehow the raw fish caused a response from my immune system in conjunction with  an immune system on high alert from the booster shot.  This is a terrible side effect.
Regular vaccination reaction about the size of a quarter, raised, warm to touch and red. Lasted 1 week. 8 days later the reaction exploded to the size of a lemon, raised, warm to touch and red. Still appears pink, warm to touch and size of lemon. I think it is going away but not totally gone after 3 1/2 weeks.
On March 26th I had acute onset of pain in my left calf.  The pain waxed and wanted but continued to increase in intensity until I had an ultrasound 21 days later.
swelling; join pain; This is a spontaneous report from a contactable consumer (Patient). A 70-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 01Jun2021 as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced swelling and join pain on 04Jun2021. It was reported that patient received first dose of the vaccine on 01Jun2021 and today is the first day she experienced the AE. She also stated that she experienced joint pain. Caller wanted to know if the swelling AE that she experienced would be a contraindication in getting the 2nd dose of the Pfizer BioNTech Covid-19 Vaccine and it was reported that Caller wanted to know if it would be fine for her to take aspirin or aleve after getting the Pfizer BioNTech Covid-19 Vaccine. The outcome of events was unknown.
HEADACHE; NAUSEA; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included suppressed immune system. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, the subject experienced headache, and nausea. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, and nausea. This report was non-serious.
Pt recvd vax 28AUG91 in AM & 7PM inc temp, sz; Pt admitted to hosp 4 days, IV, test-mom states pt was told rxn to DTP; When get 4yr old booster only to het DT; Had EEG-ok;
Underarm lymph swelling and arm pain within 20 minutes of injection. Followed by nausea within 2 hours of injection. Low grade fever of 99.7 within 3 hours of injection, accompanied by minor headache. Fever and headache were treated with Tylenol and subsided within 45 minutes. 5 hours after injection, patient experienced 2 fainting spells 30 minutes apart where consciousness was temporarily lost.  Fatigue and arm pain continue 48 hours after injection. Patient will be speaking on Wednesday June 23 to report any additional side effects and address any concerns.
Swelling of injection site, hot and red. Face red, splotches, itchy. Some mucus in the throat.
Rash and itching that started on fingers of right hand, rash then progressed to chest/back and eventually most of her body. Patient prescribed a steroid cream to relieve itching but rash has never went away.