chrisvoncsefalvay/vaers-outcomes huggingface dataset:
10 days after receiving the Moderna COVID19 booster I started noticing itching on my neck/scalp. The next morning (Feb 12) I woke up with hives covering most of my torso, back, arms and face. The hives stayed all day, with minimal affect from benadryl or Allegra. The hives would recede and reappear in different spots on my body through Sunday, 13 February. Monday Morning, 14 Feb at 0400 I woke up with a feeling of not being able to breath and the feeling of an object being stuck in my throat. This feeling lasted until 0800 am. I went to the ER at 1100 am 14 February where they prescribed me a 6 day course of prednisone and advised to continue on OTC antihistamines. 15 February at 0830 pm, the hives have mostly receded but red itchy splotches continue to appear randomly across my body. Contact with hot water or heat, such as showering or exercise, causes the hives to reappear.
Ipol reached an unknown temperature for an unknown cumulative time since 06Sep2019, no AE; Initial information received on 06-Sep-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 68 years old male patient who received vaccine IPV (VERO) [IPOL] (batch number and expiry date was not reported) 05-Sep-2019. The patient started a three dose series of Ipol every other month, due to facility regulations, the patient must keep the Ipol vial with him and transport back and forth to the administration facility. The Ipol is transported with ice packs but no specific temperature reading device. No additional information was available at the time of this report. It was also reported that vaccines reached an unknown temperature for an unknown cumulative time since 06-sep-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error due to incorrect product storage.   It was unknown if any adverse event occurred.  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.  Information on the batch number was requested.  List of documents held by sender: none.
20JUL92 pt recvd vax & 2AUG92 devel herpes zoster, was seen by MD & treated w/Zovirax; Herpes Zoster resolved;
03/09/2005 Pt returned to clinic with 2cm x 2cm Erythema edema at PPD site, PPD reading (+) with 12mm x 12mm induration. Tx Benadryl 12.5mg 2 tsp PO BID and Keflex 250mg/5ml. Keflex discontinued on 03/10/2005 due to hives. Returned 03/16/2005 CXR negative. Cellulitis improving. (3 other cases)
Raised red rash approx 2 1/2 in x 1 in at site of injection. According to patient it burns.
Within minutes after flu shots patient reported dizziness, nausea, tingling in legs, loss of sight in one eye. Patient vomited was crying/pale. 911/EMT's were called. Eye sight had returned by time EMT arrived.
Did not use diluent in the box/I am assuming they uses sterile diluent that we keep on the counter; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution. On an unknown date, the outcome of the wrong solution used in drug reconstitution was unknown.   Additional Information: GSK Receipt Date: 27-FEB-2023 Reporter's comment: The reporter reported that someone at their clinic had given a Menveo vaccine without using the diluent in the box. The reporter assuming they used sterile diluent that they kept on the counter. The reporter asked for guidance to know how that affects the individual receiving it. Additional supportive information: The patient had Menveo reconstituted with sterile diluent, instead of the supplied diluents, which led to wrong solution used in drug reconstitution. The follow-up could not be possible as no contact details were available. This is 1 of 4 linked cases reported by same reporter for different patients. Conservatively case was processed with event wrong solution used in drug reconstitution considering the sterile diluent was used in vaccine reconstitution.; Sender's Comments:  US-GSK-US2023AMR032644:Same reporter US-GSK-US2023AMR032666:Same reporter US-GSK-US2023AMR032665:Same reporter
Information has been received from a certified medical assistant (CMA) concerning a 4 year old male who on 20-FEB-2002 was vaccinated SC with a 0.5 mL dose of varicella virus vaccine live. There was no concomitant therapy. The CMA reported that on 08-AUG-2005, the patient presented to the physician's office with 15 - 20 varicella lesions. The patient was noted to be afebrile and was treated with cephalexin (KEFLEX) to prevent infection. AT the time of this report, the patient was recovering from the varicella. Additional information has been requested.
temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; No further AE; This spontaneous report was received from a practice manager and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medication were not reported.  On 26-AUG-2020, the patient was vaccinated with improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 1 injection, lot # R021636 was confirmed to be valid with expiration date 12-MAY-2021 (exact dose, route of administration, anatomical location were not reported) for prophylaxis. The temperature excursion was below 2 Celsius degrees (C) (1.1 C) for 27 hours and 45 minutes and above 9 C for 1 hour and 15 minutes (29 hours cumulative). The digital data logger was involved. No adverse effects were reported.  This is one of two reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R021636; expirationdate: 12-MAY-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other;  followupadditionalinfo :Yes; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:
Information has been received from a physician concerning a female patient "in her early twenties" who was vaccinated with "one dose" of GARDASIL (lot # not reported). Subsequently the patient went to a gynecologist and had an abnormal PAP test. It is unknown if the patient had abnormal PAP tests prior to receiving GARDASIL. This is one of several reports from the same source. No further information is available.
Rash on inner aspect bilateral upper extremities and across the Chest C/o SOA  , Hyperactivity
Bruising; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CONTUSION (non-serious), outcome "unknown", described as "Bruising".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Soreness at shot site for 3 days. Soreness progressed further down upper arm into muscle pain that has been persistent for two weeks. Not getting better. Affecting ability to carry things and keeping me up at night w the pain. Center of  upper arm.
High temp 102/with uncontrollable shaking/aches in all muscles & joints. I had no reaction to the 1st shot in the series other than soreness and redness at the vaccine injection point.
Patient stated she felt light headed @1:35pm. 1st set of vitals BP102/64, pulse 78, Oxygen sta. 98% on room air and RR 25. Pt offered water and was able to keep water down. After 0 min. pt began to feel better and her normal self. Pt states she received influenza vaccine 10/20/22, one day prior to COVID-19 Bivalent booster vaccine. Post status vitals at 1:55pm BP 11070, Pulse 55, RR 18, oxygen saturation 98% on Room Air.
I have a severe welt 3' by 3' below the injection site and a rash also on the injection site arm. I have  pain and tingling throughout the entire arm and fever, chills and flu like symptoms. The fever lasted 36 hours. The injection site giving off heat and is extremely warm to the touch. I have pain in back shoulder on the left side and stiffness in neck and even my teeth hurt. Its been 48 hours and sign of relief.
This case was reported by a consumer via call center representative and described the occurrence of pain in a 61-year-old male patient who received SHINGRIX. On 2nd may 2018 08:30, the patient received the 1st dose of SHINGRIX (subcutaneous). In May 2018, 1 day after receiving SHINGRIX, the patient experienced pain, swelling and erythema. On an unknown date, the patient experienced intramuscular formulation administered by other route. On an unknown date the outcome of the pain, swelling and erythema were recovering/resolved and the outcome of the intramuscular formulation administered by other route was unknown. The reporter considered the pain, swelling and erythema to be related to SHINGRIX. Additional information was reported as follows: The patient was vaccinated with SHINGRIX via subcutaneously route, in the skin beneath his left tricep instead of intramuscular route, which led to intramuscular formulation administered by other route.
Experienced very rapid heartbeat, shortness of breath/rapid shallow breathing and lightheadedness approximately 4 minutes after receiving shot. Staff assisted me and provided water and suggestions to alleviate symptoms, I walked around a bit and also put head between knees and this helped.    Symptoms subsided after about 2 minutes.  No problems experienced so far in the 24 hours after that event.   I have never experienced these symptoms with any other vaccination including the two previous Pfizer COVID vaccinations I received in April and May 2021.
This is a spontaneous report from a contactable nurse. A 11-years-old male patient received on 31Aug2017 TRUMENBA (lot number: R94916, Exp date Jan2018), intramuscular in left deltoid at 0.5 ml, single for immunisation. Medical history was none. Concomitant medication included the first dose of diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP IMMUN, Lot number: GS22H, Expiration date: 21Mar2018, Manufacturer: GlaxoSmithKline) on 31Aug2017 at 0.5ml single intramuscular injection into the left deltoid for immunisation. The patient was supposed to receive MENACTRA for prevention of meningitis ACY and W but was given TRUMENBA instead which was for prevention of meningitis B. The patient was diagnosed with Lyme disease on 03Oct2017. The reporter mentioned that the patient had some current issues going on that she did not know if they were as a result of receiving the meningococcal group b rlp2086 vaccine or another issue. She later explained that the patient was diagnosed with Lyme disease on 03Oct2017. The reporter did not share when the patient started to experience the concurrent issues that let up to his diagnosis of Lyme disease. The reporter finally considered Lyme disease medically significant and to be unrelated to meningococcal group b rlp2086 vaccine. The patient was seen at physician office due to the events. On 29Sep2017 lab test were performed, results were as follows. Lyme total antibody test: Positive for Lyme disease. Lyme antibody IGG: Positive for Lyme 18, 30, 39, 41, 66, bands. Lyme antibody IGM: Positive for Lyme disease 41, 23 bands.; Sender's Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, as appropriate. The case will be reassessed if additional information becomes available.
Slight fever, overall body ache, tired and some nausea 'without' actually vomiting.
Pityriasis rosea,  triamcinolone acetonide, ongoing  mucopurulent conjunctivitis, right eye, polymyxin B-trimethoprim ophthalmic 10000 units-1 mg/mL ophthalmic solution, 10 days
Information has been received from a nurse concerning a female who was vaccinated with Gardasil concomitantly with hepatitis A virus vaccine (manufacturer unspecified). Subsequently the patient experienced a seizure. Upon internal review, seizure was determined to be an Other Important Medical Event. Additional information has been requested.
Was notified by observer that patient was non-responsive and that it appeared that patient may fall. Approached patient, she was indeed not verbally responsive or able to follow verbal commands. Patient repeatedly opening and closing eyes and appearing diaphoretic, unable to hold self up in chair. Transferred patient to wheelchair and moved to triage area, patient remains unable to follow commands or hold self up in wheelchair. Called emergency line and notified them of incident and also let on call doctor know who agreed to calling 911. Patient transferred to other facility.
A nurse reported that a 49 year old male received FluMist vaccine at an inappropriate site. At approximately 3:45pm on Oct 15 05, a nurse administered FluMist vaccine to the patient via intramuscular injection. The nurse reported that he was unfamiliar with FluMist and was unaware that it is approved for intra nasal use only. Not noticing the label that said for intra nasal use only, he broke off the tip of the FluMist syringe and aspirated the 0.5ml content using a different syringe with needle and injected it to the patient. As of Oct 24 2005, the patient did not report any adverse events but was advised to inform the nurse or call for emergency help if there need be. The reporter causality is not provided. Information received 06/23/2006. Lot # not available. Lost during act of nature.
On approximately 09/28/2000, the patient developed a varicella like rash and a low grade fever. It was reported by the patient's father that she had more than 100 lesions. The patient sought unspecified medical attention. Follow up information received from the physician's office indicated that this is not one of their patients. No further information is available.
9/19/18 8:00 pm Left deltoid began throbbing in evening day of injection. 9/20/18, next day, Began with radiation of pain to left anterior chest & back shoulder; swelling, redness & warmth to injection site. No fever reported. On 9/21/18 took BENADRYL 50 mg and subsequently swelling and redness decreased. Pain to anterior chest & back shoulder also resolved.
Patient got a shingles vaccine at a different pharmacy but reported to us here at other pharmacy. Patient complains of headache, neck pain, neck stiffness, arm pain, and has a red discoloration on the upper arm. Advised patient to go to ER.
Pain from the injection; This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The pharmacy student stated that her mom experienced pain from the injection when she received Shingrix.  The reporter consented to follow up. Additional details not provided at the time of this call, but pharmacy student granted permission to follow up.
Woke up Sunday with a fever, chills and sore throat, but figured allergies. Sunday night I noticed my lips and around my mouth was getting itchy. I took some Benadryl and when I woke up this morning, my bottom lip is swollen and my whole lower face is itchy.
Given ADACEL instead of DTaP; Initial information regarding an unsolicited valid non-serious case was received from a other health professional via Medical Information (Reference number-00381714) and transmitted to Sanofi on 04-Dec -2020 via call-center.  This case involves a 4-years-old male patient who received a vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot number: U6737AA and expiry date: 07-Sep -2022) on 09-Sep-2020 via an unknown route in Left Deltoid instead of DTaP (Wrong product administered) for prophylactic vaccination.  The patient's medical history, past medical treatment, vaccination and family history were not provided. The patient's concomitant medication included POLIO VACCINE INACT 3V (VERO) (IPOL [POLIO VACCINE INACT 3V (VERO)]); MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE).   It was an actual medication error case due to wrong vaccine administered (latency: unknown).  At the time of report no adverse event was reported.  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.
Behavioral health admit. Over the course of the hospital stay, patient stabilized quickly and maintained behavioral control and clarity of thought. Hospital admission within 6 weeks of receiving the COVID vaccine.
Pt devel rash, swollen lips, treated in ER w/DPH follow up w/pvt MD;
8/15/11 Here for 6mo PE. Mom reported episodes of intense crying after receiving vaccines at both 2mo & 4mo visits - crying lasting hours. Child well at this visit. Given only PREVNAR & ROTATEQ at visit with no problems after. Returned on 8/25/11 for HIB & IPV - again after 24 hours no reaction noted.
Pt has a cough, congestion, and other cold symptoms. Pt requiring oxygen. Pt admitted for NSTEMI, flash pulmonary edema, acute hypoxemic respiratory failure, and COVID.
Approximately 30 minutes after vaccine injection I was driving home and noticed a sensation (itch) on  my left shoulder (back).  I felt the area and detected a lump, about twice the size as a mosquito bite.  A few minutes later, I felt again and noticed a second and then third bump.  An hour later I noted a fourth lump at the top of my left shoulder, this time on the front side of my body.  I took a 25 mg Benadryl liqui-gel tablet.  I then spent several hours in a recliner, as I believe the Benadryl made me sleepy.  It is now 8:04 PM, 5 1/2 after hours after the shot.  I have noticed no other side effects from the shot, but three "nodules" still remain.  They appear to be hives.  They are not hot to the touch.  The swelling itself (left front) is slightly red and "itches" if I touch it.  The two bumps on the back, taken together, feel about the size of a quarter.
pt w/ ongoing diarrhea recv vax 27OCT98 & 3NOV98 diarrhea worsened;the diarrhea cont on 8NOV98 & pt was seen by provider;CBC performed 8NOV98 revealed an absolute neutrophil count of 462;9NOV98 pt devel runny nose & congestion;pt hosp;
12 cm X 8 cm erythema, no fever, warm to touch, slight pain when this area is bumped. Instructed pt. to take BENADRYL 25 mg and CLARITIN 10 mg for next 3-7, apply ice to area BID.
On 8-8-2022 I began having a scratchy throat and I tested using a home COVID-19 test with negative results. On 8-9-2022, I felt fatigued. I again tested negative with home COVID-19 test. On 8-10, I was having a hard time functioning due to weakness so I retested with a home COVID-19 test and this time it was positive. I called my doctor and I spoke with the on call doctor who sent in a prescription of Paxlovid. I started taking it on 8-11 after speaking with my cardiologist. During the night of 8-11, I woke up sweating and it is questionable if I had a fever due to it not being over 99.0. I started feeling better on 8-14 or 8-15. I am reporting a breakthrough case of COVID-19.
On 3/15/00, client returned to clinic complaining of redness at injection site, states is having some itching and is warm to touch. Site appears red and approximately 3 vesicles noted. Swelling and redness noted at injection site. Informed client to apply warm compress to site 3 or 4 times daily. Informed client that series would not be completed until she had 2nd doses. Instructed her to return in 8 weeks for 2nd dose. If any questions, she should contact PMD. On 3/29/00, pt into clinic complaining of a fine red rash all over her body and states it is itching. She is taking Benadryl and states she has been to her PMD and he gave her steroid dose pak. On 4/5/00, pt returned call and states she is better, rash is gone, but states she does not want 2nd varicella vaccine. Advised pt to discuss with her PMD, regarding antibody screening and 2nd varicella.
Initial information received on 06-Aug-2018 regarding an unsolicited valid non-serious case received from other non-health care professional. This case involves a 7 months old female patient who was administered 0.5 ml dose of expired vaccine PENTACEL lot C5386AB, expiry date 17 Jul 2018 via intramuscular route in the right thigh on 06 Aug 2018. The patients past medical history and family history were not provided. Concomitant medications included ROTAVIRUS, HEPATITIS B and PREVNAR vaccine (Lot number, expiry date, dose, route and site of administration not reported) on an unknown date. It was an actual medication error due to expired vaccine used. It was reported that patient received Pentacel vaccine on 06 Aug 2018 that was expired on 17 July 2018. The patient did not experience any side effects. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.
Arthralgia, swelling of several fingers, joints, ankle. Painful to walk. Symptoms x 5D Tx with Ibuprofen and Benadryl Q6 hrs.