chrisvoncsefalvay/vaers-outcomes huggingface dataset:
body became very itchy; The arm was real sore; Rash; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (body became very itchy), PAIN IN EXTREMITY (The arm was real sore) and RASH (Rash) 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 12-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (body became very itchy), PAIN IN EXTREMITY (The arm was real sore) and RASH (Rash). At the time of the report, PRURITUS (body became very itchy), PAIN IN EXTREMITY (The arm was real sore) and RASH (Rash) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not Applicable. No concomitant medications reported by investigator  Antibiotics and steroids are the treatment medications provided by the reporter.   Patient went twice to her doctor for these symptoms. Doctor prescribed antibiotics for the first time, because the rash was getting worse patient went back to the doctor and received steroids. Steroids helped with itchiness
Headache, Myalgia, Arthralgia, Fever, NauseaVomiting, similar to covid which she had in june 2020 fever to 103.4 Narrative: used zofran and aleve
Fever of 103 for 2 days  Could not lift left arm - significant pain and swelling Join aches Muscles aches Fatigue  Loss of appetite  Headache
Severe swelling, redness at (R) upper arm. Some moderate urticaria (L) deltoid.
Headache, Fever, Rash, UrticariaPruritus, fatigue,pain,itching, swelling and warm to touch at injection site
This spontaneous report as received from a pharmacist refers to a 60 year old female patient with no pertinent medical history or drug allergies. On 09-SEP-2013 the patient was vaccinated with ZOSTAVAX (lot # J002692, expiry date: 30-APR-2014) 0.65 ml once subcutaneously. There was no concomitant medication. On an unknown date the patient developed a rash after vaccination. Patient called the pharmacy on 12-SEP-2013, and stated there is a rash on her back the size of a "quarter of half dollar". The outcome of the event was reported as not recovered. No treatment was given. No lab test was performed. Additional information has been requested.
Vaccine was expired on 25-Oct-2021 and administered on 24-Oct-2021/administered expired vaccine to patients, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 25-Oct-2021 and administered on 24-Oct-2021/administered expired vaccine to patients, after the manufacture date of expiration) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 25-Oct-2021 and administered on 24-Oct-2021/administered expired vaccine to patients, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was expired on 25-Oct-2021 and administered on 24-Oct-2021/administered expired vaccine to patients, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was reported.  Date the vial was initially stored in the refrigerator reported as unknown. Number of doses/vials was reported as 102 doses.   The vial did not undergo any temperature excursions.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow-up received, additional reporter was added.
Diarrhea two hours after shot explosive GI's occurred for a couple of hours: Black watery stools.
Extremely bad head and neck aches & stiffness, fever. Feeling like I have the flu.
The patient developed esophagitis. He could not tolerate solid food for over a week and lost 15 pounds.
Immediately after injection at 10:20am, I felt hot and light headed. I have passed out from shots and IVs before so I brought my own smelling salts to my appointment, and I used them as soon as I felt faint, which kept me from passing out.  I felt ok after waiting 30 minutes. Later that day around 5pm, I started getting chills and felt a little achy. At 6pm I checked my temperature and it was 99.9, at 7pm it was 101.9, at 7:30pm it was 104 so I took ibuprofen 400 since I had severe chills, headache fatigue and muscle and joint aches. At 8pm it was 102.7 so I took another 400mg of ibuprofen. At  9pm it was 101.7, and at 10pm it was 100.4 and then I went to sleep.  On 4/12: it was 98.7 when I woke up at 9am, then 99 at 10:30 so I took ibuprofen 400, then 100.1 at 11:30 so I took ibuprofen 400 again. Since noon, the fever has subsided and the fatigue and aches and headaches have become mild so that I could work from home.
Arm from shoulder to elbow swelling, tenderness, redness. No fever, no other side effects noted. Lasted for 12-20 hours and resolved without treatment.
Patient was injected with undiluted Pfizer vaccine. No saline diluent was added to the vial of vaccine. the patient received a large dose for the second shot in the two-part series of vaccines. The patient did not speak much English at all. I explained the mistake to the patient's mother, who was present at the time of the vaccination. she did not speak much English either. She did say she understood, but that is still questionable.
Expired ACT-HIB was administered to a patient with no reported adverse event; Initial information received on 13-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 3 months old female patient to whom expired act-hib was administered 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 pneumococcal vaccine CONJ 7V (CRM197) (Prevnar) and hepatitis b vaccine for Prophylactic vaccination.  On 13-Sep-2023, the patient received 0.5 ml (dose 1) of suspect HIB (PRP/T) Vaccine,Powder and solvent for solution for injection (lot UJ798AB, expiry date- 11-Sep-2023) via intramuscular route in the left vastus lateralis for prophylactic vaccination (strength: unknown), expired act-hib was administered to a patient with no reported adverse event (expired product administered) (latency same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event expired product administered  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.
patient presented to pharmacy for dose 2 in Moderna COVID19 vaccine series, dose was drawn up by the pharmacist, syringe appeared perfectly normal during dose draw up and correct dose was drawn up. pt requested to be vaccinated in the left arm, pharmacist went to administer vaccine, stuck needle into patients left deltoid and pushed the syringe plunger, the dose of vaccine ejected out of the syringe at the hub and did not get fully administered to the patient. most of the 0.5ml dose was not administered and instead sprayed onto the patients skin. in accordance with CDC guidelines for incorrect dose less than half dose given, patient was re-dosed in the alternate arm (right deltoid) with 0.5ml with a new syringe and needle
I had a mammogram because I felt like something was going on in my left breast. I could feel a mass in the breast. I had a mammogram on September 8th which confirmed that there was a mass. I had an Ultrasound, Biopsy, MRI, and a biopsy. A Mastectomy was performed on 11-11-2022. I also had routine lab test and genetic testing completed in late September or early October. I was found to be BRCA negative. I am scheduled to have radiation at the first of the year. I may need chemo until I get pending test results back in the next 2 weeks. The biopsy was negative.
p/3rd inject devel large local rxn w/swelling, redness, hard to touch, itchy; area size of 2 silver dollars together; had lesser react of same type w/prev doses 22FEB92 became dizzy & weak, felt unwell; nausea, induration, erythema;
Development of maculopapular rash over R breast in mid 03/2021, was treated with methylprednisolone after biopsy from 04/2021 through 09/2021. No recurrence since then.
Redness, warmth at injection site. *Physician treated with NSAID & antihistamine.
Lungs congested for 5 months. Extremely low BP for a week and a half. Extremely high BP for a week and a half
first Shingrix shot October 2019, second one May 2022. during covid; This case was reported by a consumer via call center representative and described the occurrence of social problem in a 67-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in October 2019).   On 5th May 2022, the patient received the 2nd dose of Shingrix. On 5th May 2022, unknown after receiving Shingrix, the patient experienced social problem. On an unknown date, the outcome of the social problem was unknown.   Additional Information: GSK Receipt Date: 6-May-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient stated that during COVID second shots were being administered over 1 year later per GlaxoSmithKline. The patient asked did he/she need to repeat in 2-6 months. Additional supportive information: The patient received 2nd dose of Shingrix vaccine later than the recommended interval due to Covid. The follow-up would not possible, as no contact, details were available. This case has been linked with case US2022AMR074991 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR074991:same reporter
This case was reported by a consumer via interactive digital media and described the occurrence of headache in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd December 2021, the patient received the 1st dose of Shingrix. On 4th December 2021, 1 days after receiving Shingrix, the patient experienced headache, fever and chills. In December 2021, the patient experienced chest pain, movements reduced, difficulty breathing, pain, painful cough and sneezing. On 5th December 2021, the outcome of the headache, fever and chills were recovered/resolved. On an unknown date, the outcome of the chest pain, pain, painful cough and sneezing were not recovered/not resolved and the outcome of the movements reduced and difficulty breathing were unknown.   It was unknown if the reporter considered the headache, fever, chills, chest pain, movements reduced, difficulty breathing, pain, painful cough and sneezing to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingrix vaccine and experienced numerous common side effects including headache, fever, chills, pain in the right side of his/her chest, near the sternum. The other side effects went away by 5th December 2021 but not the pain in the chest. The pain in his/her chest not only limited his/her movement but also made it hard to breathe and was painful if he/she coughed or sneezed. The pain worsened on 6th December 2021 so his/her doctor advised going to the emergency room, which he/she did. The patient had a work up to rule out a pulmonary embolism but no other cause of the pain was found.  It was now a week after the emergency room visit and he/she was still experiencing pain, although less that a week ago.  The patient asked GlaxoSmithKline had this type of pain been reported as a side effect of Shingrix,  If so, how long should he/she expect the pain to last and what was the recommended treatment. The follow-up would not possible as no contact details were available.
Patient had her first covid vaccine injection at 0722 this am.   She was escorted to the observation room where she told her nurse that she was experiencing tingling and numbness on the right side of her face from the nose down to the middle of her lip including half her tongue at 0730.  Patient verbalized she had a TIA 10 years ago and this is how she felt when she had that event.  She states she has a history of hypertension and a recently diagnosed aneurysm in her spleen.  vital signs were obtained blood pressure 168/121, Heart rate 68, O2 sat on room air 99 % She denied any pain.  Asked patient to stick her tongue out and it was midline before vitals slightly deviated after vitals were finished.  Patient then states she feels like her face is swelling on the right side.  ER was called.  Patient taken to ER by wheelchair for follow up evaluation.  Event documented on patient consent and event reported.    Patient later admitted to hospital.
Heart palpitations, chest pressure, slightly shortness of breath. Occured after two days after the first dose of Pfizer vaccine - 26.04.2021.  (dd/mm/yyyy) Heart attack like pain during nighttime for the first week. Symptoms gradually disappeared after a month. Got the second dose of the Pfizer vaccine - 04.09.2021. Same symptoms were noticed in the same day, during night time. Pain gets worse while laying down, unable to sleep properly. Slight fever, no fatigue, no swelling, no coughing. This is my fifth day after the vaccine and the heart palpitations along with other symptoms are here, only slightly reduced. Otherwise a healthy 20 year old young male.
Mild soreness started on February 25th, slight rash and slight swelling, itching started on about February 28th.  Still some soreness when touched.  The itchiness has stopped. This seemed to be a pretty mild reaction.
On Wednesday, 10-27-22, one of our new MAs mistakenly vaccinated a patient with Janssen rather than the Pfizer vaccination that he was checked in for. The mistake occurred while MA was training. There was an established process where the PA would draw the vaccines for the patients that had been checked in, while the MAs would collect a syringe and then proceed to administer the vaccination to the patient. In this situation, the patient called MA over asking to be vaccinated quickly (distracting her from the process she was learning from, trainer MA). MA then vaccinated the patient with the janssen vaccine she had on her cart(thinking it was Pfizer), a vaccine that was originally for another patient. Then PA spoke to the patient letting him know of the situation and his options which included talking to his primary care physician and connecting with Dr.
Admit for COVID pna. Fully vaccinated. Treated with steroids, O2, remdesivir, abx, zinc, plasma. Improved and weaned to RA. Discharged home.
Information has been received from an office manager concerning a 26 year old female patient with allergic rhinitis and type 1 diabetes mellitus who on 17-SEP-2009 was vaccinated with a 0.5 ml first dose of GARDASIL (Lot number 0053X). Concomitant therapy included insulin, YAZ and montelukast sodium (MSD). The office manager reported that 3-5 minutes after having received the first dose of GARDASIL the patient fainted. After about 30 minutes the patient was fully recovered. Additional information has been requested.
No adverse event; Patient received expired Bivalent Booster greater than 12 hours post puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired Bivalent Booster >12 hours post puncture) and NO ADVERSE EVENT (No adverse event) in a 68-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 061F22A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2022 at 8:57 AM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 03-Nov-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired Bivalent Booster >12 hours post puncture). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired Bivalent Booster >12 hours post puncture) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient received expired Bivalent Booster >12 hours post puncture).    No concomitant medication was reported.   Date and time vial was first punctured on 02-NOV-2022  at 4:58 PM. The vial did not undergo any temperature excursions. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-668692 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-668692:Patient 1
Had a severe attack of Ulcerative Proctitis within 2 weeks of vaccine.  This was not new, happened for each shot.  Ulcerative proctitis flares continued in subsequent weeks, but each flare was less intense over time.  Flare that started on Jun 26 was worse, and involved low grade fever and fatique/body aches on July 3&4.  I went to urgent care on July 4, who sent me to a local hospital for a CT scan.  Nothing was found and issue cleared up on its own over the next several days.   No additional significant flares have happened since.
This spontaneous report as received from a Medical Assistant referring to a patient of unknown age and gender. There was no pertinent medical history, concomitant medication or drug allergies/drug reactions reported. On an unknown date the patient was vaccinated with improperly stored RECOMBIVAX HB intramuscular injection (lot # K018180, expiration date 17-SEP-2017, dose and frequency not provided). The RECOMBIVAX HB was exposed to the following conditions: 34 Fahrenheit (F) for a total time of 65 hours. The previous temperature excursions included 33 F for 13 hours and 47 F for 13 hours. No adverse symptoms reported. This is one of several report received from the same reporter. Additional information has been requested.
pt called in 17NOV92 stated had flu shot 13NOV92 state pneumococcal arm very sore, red, swollen w/swelling moving down to elbow; referred to family MD;
pt had a history of seizures, last seizure about 3.5 months ago. Pt did not have a PCP or neurologist, not taking medications for seizures. Looked it up on lexicomp, hx of seizure was not a contraindication for the pfizer covid vaccine. So administered the vaccine and told her to let me know if she starts feeling anything abnormal. About 5 minutes after the vaccine, she told me she felt like she was going to have a seizure and was having some blurry vision, dizziness, nausea and some chest pain. Immediately called 911 and got pt seated in a chair. A few minutes later she had a seizure for about 10 seconds. a couple minutes after that EMSA showed up and took her to the hospital.
feeling sick; body ache; cold; This is a spontaneous report from a contactable consumer. This female consumer of unknown age reported for herself that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 04Aug2021 as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 04 aug2021, Wednesday the patient was vaccinated, on Thursday and Friday she was fine and there was nothing wrong with her, she had not gone to the doctor for 7 years, however on 08Aug2021 Saturday night she started feeling sick, she has body aches and cold. She went sick from nothing. She felt sick as a dog and has been in bed for 3 days, she can't go to the store and can't do anything. She also said that she was not going to take the second dose if she has to go through this again. She would like to know if the shot gave her Covid, if they gave her a Covid shot. She was supposed to receive the second dose of the vaccine on 28Aug she believed so she would like to know what to do by then because she does not want to feel this way again. Caller was upset. She disconnected the call before transfer to Safety. Information on the lot/batch number has been requested.
Within 5 days of receiving the first vaccination I got a rash under my watch band. A couple of days after that it turned into a blister. I removed the watch and the rash and blister went away. I thought it might have been the manmade material the band was made out of. So, I tried and expensive metal watchband and the same thing happened.  I have tried on several occassions since to wear a watch and each time a rash has started to appear.
Information has been received from a physician concerning a 12 year old male patient who had cellulitis prior vaccination who on 05-AUG-2010 was vaccinated with a dose of VARIVAX (Merck) (Lot # 666367/0248Z and expiration date 04-FEB-2012). Concomitant vaccine given on the same day included a dose of MENACTRA. It was reported that on 07-AUG-2010 the patient called to the office to report the injection site reaction with swelling. No hospitalization and no treatment were added. It was unknown if the patient sought medical attention. At the time of the report the outcome of the patient was not reported. Follow up information has been received via telephone call from a registered nurse concerning a patient who experienced the reaction after the second dose of VARIVAX (Merck). Information on the other vaccinations was not available. This is one of several reports from the same source. The office requested a lot check. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. No further information is available.
Very rapid heartbeat and high blood pressure.  ENT took my vital signs and it was 190/95 HR of 195.  I almost went to ER.
Within 24 hrs. of receiving vaccine pt arm beam sore, swollen & red @ injection site/within 48 hours all symptom intensified with fever 101.1 & swollen axillary lymph nodes RX with ADVIL, given topical cream 4/5/10 all symp. improving by 4/7/10.
2:40 PM Immunizations. Client c/o arm hurting. Parent reports it was erythamatous and edematous from top of shoulder to above elbow, tender and hard to touch. Seen by local physician and Rx for Cephalexin 250mg QID. I saw per Mom, 03/18/2005- no erythema, small area of edema noted and remains tender.
On 6/23 I developed a dry cough overnight.  6/24 Tested with a home test negative.  Dry cough continued through the day.  The next day 6/25 I had upper respiratory symptoms.  Tested positive with at home test on 6/26.  Symptoms decreased by them.  Reached out to physician on 6/27, who prescribed Paxlovid.  Treated symptoms with Dayquil.  Symptoms greatly diminished, but still persist.    Stopped chronic medication to take the Paxlovid.