chrisvoncsefalvay/vaers-outcomes huggingface dataset:
YF-VAX was administered to 5 patients using an expired diluent with no reported adverse event; Initial information was received on 25-Oct-2021 regarding an unsolicited valid non-serious case from a other healthcare professional via Medical Information (under reference:00826473).  This case involves a 46-year-old female patient who was administered YELLOW FEVER VACCINE - US [YF-VAX] using an expired diluent (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a (dose of suspect YELLOW FEVER VACCINE - US (0.5ml, once, total,  lot U6428AA, expiry date: 30-Sep-2021) via intramuscular route in the right deltoid for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used (latency same day)  It was reported "Operations manager is following-up, providing additional information on expired YF-VAX administered to 5 patients."  At time of reporting, the outcome was unknown for the event.  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 guidelines. 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:  00824899: US-SA-2021SA354618: US-SA-2021SA356701: US-SA-2021SA354616:
C/O swelling in area in arm pit that appeared the day after a Tdap injection. Injection site no redness or swelling.
This spontaneous report was received from a physician via company representative, concerning his 23 year old sister-in-law. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unspecified date in 2006 (reported as "many years ago, when patients were first vaccinated"), the patient received three doses of GARDASIL, for prophylaxis (route of administration, anatomical location, lot number and expiration date were not reported). On an unknown date (reported as "shortly after third dose, within 10 months"), the patient started experiencing hair loss. On an unknown date, the patient's symptoms worsened, resulting in alopecia and loss of all body hair, which occurred over the course of four years. It was reported that on an unspecified date, the patient received an unspecified treatment from unspecified specialists, with no return of body hair. By the time of the reporting, the patient was not recovered from alopecia. The reporter did not provide the causal relationship between GARDASIL and the event.
Information has been received from a registered nurse concerning a 31 month old male pt with no past medical history and no known drug allergies who on 09/26/2000 was vaccinated with the first dose of varicella virus vaccine live SC in his leg. On 09/26/2000 the pt was also vaccinated with the second dose of Prevnar IM in his leg and his third dose of IPOL SC in his leg. There were no other concomitant therapies or illnesses at the time of vaccination. On 01/17/2002 after a trip overseas, the pt developed mild varicella with 20 lesions and a slight fever. The child was seen in the physician's office on 01/21/2002 with 6 lesions. No treatment was needed at that time. Additional info has been received from a registered nurse. The nurse reported that the varicella virus vacicne live failed to protect fully as the pt developed 6 vesicles 15 months post vaccination on 01/22/2002 (also reported as 01/17/2002). She reported that the pt was not very ill and that he recovered in January 2002. No further info is available.
Information was received on 13-JUL-2017 from a registered nurse concerning an unspecified number of patients. No medical history or concomitant medications were reported. The nurse reported that on unspecified dates, the unspecified number of patients were inadvertently administered improperly stored reconstituted PROQUAD (lot # N000678, expires 05-JUL-2018) and VARIVAX (lot # N002204, expires 19-JAN-2019)(dose, route and injection sites not reported). No adverse effects reported. The temperature was between 6 degrees F. and 14 degrees F. (13.1 degrees F.) for 40 minutes. There was a previous temperature excursion  between -14 degrees C. to -10 degrees C for 5 hours and 40 minutes. Dilutent was not involved in temperature excursion (lot and expiration were not reported). The was not as a result of data logger. No additional information was reported. Additional information has been requested.
Pt reports that she received a Shingles vaccine on Tues, had some redness and swelling shortly after injection in lt arm. Then last night redness and swelling of lt arm became much worse. Then this am developed red blotches around site and very warm to touch. Pt denies any difficulty breathing at this time. HPI: 61 yo female presents with c/o had a ZOSTAVAX injection medially just above the antecubital LUE. She now has redness, increased heat and swelling that is progressing down the arm. Swelling in hand she had to remove her rings. No ice applied. She spoke with triage and was directed to the UCC. She wants to get back to work. Skin Rash and Purpura. Cephalexin 250mg QID.
Patient reports rash following COVID vaccine, lasting nearly 7 days. She reports no success with Benadryl but is now using hydrocortisone. Symptoms were not so severe to require a doctor or urgent care visit.
Symptoms began appearing on 7/26/21, where the left side of her face wouldn't move.
Patient complains of major pain after the vaccine and it subsided. The next morning she couldn't get up from sitting down and felt really "sick and fluish." Her friend stayed with her and he reported that her hand clenched up like a claw and she was shaking. She doesn't remember at this time what happened but said she was "spaced out." She couldn't get up from sitting and spent the rest of the day after she recovered laying down. She felt better after a 24 hour period.
60mm x 60 mm erythematous, whealed area to (L) post arm - around injection site.
Headache, nausea, vomiting, severe body aches, gas pains in abdomen, general weakness.
Approximately 3 minutes after vaccine given was standing fell into wall, slump to floor not responsive approximately 15 seconds, responsive when PHN and mom picked up able to walk to chair. FU TC 11/5/15 child fine, normal activity.
About 12  hours after injection I went to bed. No side effects noted during the day. During the night I had insomnia for the entire night. Also noted excessive itching to entire body. No hives or welts. Still itching this morning
fever,chills,bodyache. Fever,chills and bodyache since last night. Wants to get COVID test done. Pt does not want to be seen by ED provide.
rash that started in his forehead then spread to his neck, face, arms, legs, and back; This spontaneous case was reported by an other health care professional and describes the occurrence of RASH (rash that started in his forehead then spread to his neck, face, arms, legs, and back) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced RASH (rash that started in his forehead then spread to his neck, face, arms, legs, and back). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date for Rash all over, at a dose of 1 dosage form. At the time of the report, RASH (rash that started in his forehead then spread to his neck, face, arms, legs, and back) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.
Moderna COVID-19 Vaccine EUA- Seven hours post-vaccine - Chills, Low grade fever (99.0 & 100.0 degrees), Muscle and Body Aches, Ringing in both ears; and sore arm at injection sight. All side-effects subsided approximately 26 hours post-vaccine
period two weeks early; This is Spontaneous report from a contactable Nurse. This Nurse reported similar events for 3 patients. This is a 2nd of 3 reports. A patient of unspecified age and gender started to receive bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  Registered nurse calling regarding the COVID 19 vaccine. She is wondering if people were reporting if they got their periods early? She got her period two weeks early. Mentions she also has two colleagues who had that as well. States she does not have information to provide for her colleagues and declined to report regarding her colleagues. The outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021004161 same reporter/drug/AE, different patient;US-PFIZER INC-2021002844 same reporter/drug/AE, different patient
weird taste in mouth ,breaking out in sweats legs hurt and body stiff ,very tired lasted till around 10am next day.
1st COVID-19 vaccine administered in 3 injections in 10%, 30% and 60% of full dose starting around 11:40 - 12:20 pm. 10% of full dose right arm. Symptoms occurred after a few minutes of mouth, throat and tongue swelling and body/face rash. Waited for symptoms to decrease prior to next injection. No treatment. 30% of full dose right arm. Same symptoms worsened following injection (oral swelling and rash) and mild tiredness also started. Waited again for symptoms to wane prior to final injection. No treatment. 60% of full dose left arm. Oral swelling and rash worsened again immediately following injection. Tiredness increased. Allowed to sleep during 1-hour observation period. Discharged around 2:20 pm and allowed to take Zyrtec. Extreme exhaustion persisted for 3 days. Left arm soreness for 4 days. Left shoulder pain and neck pain started day 1 after vaccine. Mild oral swelling and itchiness lasted for a couple weeks. Day 21 shortness of breath worsened and wheezing. Joint pain in joints I don't normally have pain occurred. Left earache started about a week after vaccine and persisted for over a month.  Similar symptoms oral swelling and rash occurred following second dose of vaccine. Did not experience extreme exhaustion but did continue with left earache and shortness of breath.
Patient felt dizzy , sweaty and was extremely nervous and anxious about feeling dizzy. He was given liquid Benadryl 12.5 mg, however he still felt really dizzy. EMS was called and the patient was taken away to the hospital via ambulance
Moderna vaccine given expired 10/24/2021. Monitoring vitals; stable; no complaints.
Cough with vomiting, fever 101.2 x 2days positive post tussive emesis.
Hours after injection arm very sore. As days progressed these symptoms occurred:  headache, strong sinus pressure( affecting my eyes and teeth), runny, dripping nose. Lower throat...dry...than dry cough started.  Lethargy, aches, feverish on and off, anxiety heightened!  What was happening?  In bed for several days.  No energy, cloudy headed, then....day 6 lost taste and smell.  Why would I get shot 2?    Contacted myDr.  with symptoms.
I experienced headaches and nausea within first few days. After my 4th shot, I began developing white pigment spots at the corners of my mouth and finger tips. This soon spread to my wrist area and back of my hands. After some time with hopes of these pigments spots to go away, I finally went to sick call when I began to realize this was serious.  The physician on duty diagnosed my condition as vitilligo.  I was sent to the post hospital where the specialist doctor there agreed as well.  UV treatment was mentioned but not tried due to lack of success and overall conditions that would be placed on me not suitable to my MOS and practicality.  I was given a steriod cream followed by cortosone, and now under Pro-topic, all with no success.  I informed both doctors that I did not have these symtoms or conditions prior to my mandatory anthrax vaccinations.  I did recieve all 6 shots before I PCS'ed.  Every doctor and specialist did not want to even consider this possibility and casually dismissed my concerns as coincidence.  My wife also became pregant during this time and experienced a horrible bloody miscarriage at 4 months during the time of my vaccinations.  Currently my conditions have not improved, but only slowly worsen as time passes.  I experience no type of pain or itching on my pigment spots located on my hands and wrist, I feel a slight itch on the spots at the corners of my mouth at times, but they are all visible and imbarassing to deal with.
Macular erythema at the injection site Urticaria began to form on the arms and face Difficulty breathing
Father and mother report that child's arm was sore after vaccine on 15th - remained sore on 4/16/03 to 4/18/03.  On 4/18/03 redness (baseball-sized) and swelling developed.
Shingles appeared across the top of my right foot. About 15 blisters, extremely itchy.
pt recvd vax 3AUG92 & on 8AUG92 pt seen in office w/t101, crying alot, sleeping more than usual, bulging fontanel; head circumference inc 1 cm fom 3AUG92 visit; adm w/inc intracranial pressure probably encephalopathy post DPT vax;
Pt received Pfizer x2.  Pt tested COVID + on 9/17/21 and admitted to hospital for COVID on 9/20/2021. Pt received Regeneron and receiving Remdesivir and Dexamethasone.
Severe body aches, sweating, abdominal pain, headache, dizziness/light-headed. Headache, difficulty breathing, dizziness, and abdominal pain that haven't cleared up.
This case was reported by a pharmacist via call center representative and described the occurrence of headache in a 69-year-old male patient who received SHINGRIX for prophylaxis. On 11th March 2019, the patient received the 1st dose of SHINGRIX. On 11th March 2019, less than a day after receiving SHINGRIX, the patient experienced headache. On an unknown date, the outcome of the headache was not recovered/not resolved. It was unknown if the reporter considered the headache to be related to SHINGRIX. Additional details were provided as follows: The patient experienced headache later on the same day of vaccination. At the time of reporting, the patient was experiencing the headache. No further details were provided.
Mom called on 3/21/ and stated that at the injection site there was a red line with "pus spots". Mom wasn't sure if there was a fever or not. Injection site was the (R) leg.
Starting the day after the the injection til now..and oneward.. injection sight is hard, red, warm, itching and uncomfortable.  There is Increased discomfort and increased itching when touched.  I'd would like to know if I can take the next dose. Please tell me if any action is needed. Thank you.
Swelling in left pectoral (chest area). Became red and squishy. Went to Hospital on 04/19/2021 at 12:30 pm into the Emergency Room. Took 5 hours for a nurse or doctor to look and given an uncertain diagnosis. Was prescribed by the doctor Benadryl and Pepcid AC.
Sore arm; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   On 15-SEP-2023, the patient received the 1st dose of Shingles vaccine. In SEP-2023, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: Sore arm).  In SEP-2023, the outcome of the pain in arm was resolved (duration 1 day).   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 17-Sep-2023 This case was reported via interactive digital media. The patient reported that he/she had shingles 3 times and finally got the vaccine last Friday before reporting. The patient experienced sore arm for a day and reported that 2nd dose will be at the end of October. The follow up could not be possible as no contact details were available.
No adverse events reported at this time.  Reporting because a 1.0ml dose of Moderna COVID19 vaccine was administered.  Patient received a double dose of vaccine.
Information has been received on 07-OCT-2016 from a consumer referring to a 79 year old female patient. The patient's medical history and concomitant therapy are unknown. On 05-OCT-2016 the patient was vaccinated with PNEUMOVAX 23 intramuscular or subcutaneous. The patient states that shortly after receiving the injection, on that same day her arm became very sore and swollen. The patient stated that she has not contacted her physician yet, but will call them today on 07-OCT-2016. The outcome of her arm became very sore and swollen was reported as not recovered/not resolved. No further information was provided. Additional information has been requested.
Noticed 1 inch long "sunburn'-like rash near injection site of ZOSTAVAX 1 day post vaccine. Increased to 3 inches 3 days post and started to itch et rash and all over body. MD recommended BENADRYL and HC cream with limited success then used ATARAX for itch and started MEDROL dose pack 11 days post. Patient is much improved. MD thinks maybe an over-reaction by immune system.
pt remained in store after vaccination as advised, after several minutes reported that she had difficulty speaking, said she did not have difficulty thinking but that could not get the words out easily.  she was speaking very slowly and deliberately.  pt husband was advised to call ED.  paramedics arrived within minutes, examined pt and took her out of building.
The pt complained of "throat feels like it's closing in" and of "tongue thick", skin warm/dry, RR 20, HR 88, BP 137/64. Also, complained of itching/burning at site. It was slightly edematous. Ice applied and Benadryl 25mg po given.
Injection was administered in Left arm.  The injection site is still hot to touch 5 days post injection. Site was more painful for 3 days post injection than I would have anticipated, and I did have swelling of the lymph under the arm on same side as injection site.
Getting a slight cold; A spontaneous report was received from a nurse concerning a 56-year-old, female patient who received Moderna's COVID-19 vaccine and experienced a slight cold.  The patient's medical history, as provided by the reporter, included hypertension. Concomitant medications reported included hydrochlorothiazide.   On 28 Dec 2020, the patient received her first of two planned doses of mRNA-1273 intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On an unreported date in Dec 2020, couple of days after receiving Moderna's COVID-19 vaccine, the patient started to feel like she was "getting a slight cold". Treatment for the event included ibuprofen.   Action taken with mRNA-1273 in response to the event was not reported.   The event, slight cold, was considered resolving.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
HCP stated the system block her from administering a second dose to the patient. HCP stated she was unsure if the system blocked her because of the patient age or insurance.; no adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (HCP stated the system block her from administering a second dose to the patient. HCP stated she was unsure if the system blocked her because of the patient age or insurance.) and NO ADVERSE EVENT (no adverse event) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     HCP did not describe any relevant medical history or conditions.     On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (HCP stated the system block her from administering a second dose to the patient. HCP stated she was unsure if the system blocked her because of the patient age or insurance.) and NO ADVERSE EVENT (no adverse event). At the time of the report, PRODUCT DOSE OMISSION ISSUE (HCP stated the system block her from administering a second dose to the patient. HCP stated she was unsure if the system blocked her because of the patient age or insurance.) 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 PRODUCT DOSE OMISSION ISSUE (HCP stated the system block her from administering a second dose to the patient. HCP stated she was unsure if the system blocked her because of the patient age or insurance.).    Concomitant medication not reported.   It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Treatment medication not reported.   Reporter did not allow further contact
PATIENT WALKED UP TO THE COUNTER AREA AND STATED HE WAS FEELING LIGHTHEADED AND DIZZY. HE SAT DOWN, THEN BEGAN TO SHAKE AND START SWEATING. I STAYED WITH HIM AND MONITORED HIM, PARAMEDICS WERE CALLED. AFTER 3-4 MINUTES, THE PATIENT SAT UP AND BEGAN TO FEEL BETTER.
(L) upper arm where DTaP admin 9/10/08 developed severe swelling, redness, pain starting 9/11/08 - saw doctor 9/12/08. Dx reaction to tetanus - Benadryl given.
Expired dose administered was the Booster dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered was the Booster dose) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012H21B, 009C21A and 048B21A) 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 31-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Mar-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Mar-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered was the Booster dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose administered was the Booster dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medications was reported.  The patients didn´t have any allergies, acute or chronic illnesses at the time of vaccination, and no other vaccines were administered within 1 month prior to Moderna COVID-19 Vaccine. The patients were not experiencing any symptoms after receiving the expired dose.   This case was linked to MOD-2022-521623, MOD-2022-521490 (Patient Link).