chrisvoncsefalvay/vaers-outcomes huggingface dataset:
At 1:00 - 3:00 in morning - 100.3 temperature and chills and headache. Headache became severe - 7:00 in morning. Really severe joint pain and headache - not quite a migraine - no aura but very severe headache. Had to medicate with 1000 mg Tylenol and 600 of Advil. Headache for days. Pain at injection site and that has been with every vaccine I've ever had. Headache went away within three or four days.  Joint pain was there for about two days. Only medicated the headache the first couple of days then it slowly got better. Didn't get vertigo and didn't get flushed after the vaccine. Didn't have the fainting feeling.
Initially, I felt like I had come with down with the flu. Typical lethargy and not feeling well.  I actually went to bed on November 5th, the day of the shot, feeling a little under the weather. The following day, November 6th, I felt like my entire body was on fire !   Inflammation seemed to be in every joint of my body from the base of my skull down to my toes. So I would have to describe my symptoms as inflammation of the nervous system. I told my wife I feel like my entire body is on fire. This is the best way I can describe my reaction to the first shot. The inflammation gradually subsided on November 7th  and by Monday, November 8th, I was able to go to work and function  pretty well.  By the end of the week,  I felt I was back to normal . There are no medical tests or laboratory results that I can provide you with due to this event but I felt this needed to be shared with the world.
the vaccination to be painful going in and coming out compared to other vaccinations; This spontaneous report was received from a pharmacist via a company representative concerning a 31 years old female patient of an unknown race. The patient's pertinent medical history, concurrent conditions, drug allergies or reactions, historical and concomitant drugs were unknown by reporter.  On 14-JUN-2019, the patient was vaccinated with the third dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) intramuscular (frequency, lot number and expiration date were not reported) for human papillomavirus prevention (HPV prevention).  On the same date, the patient stated that the vaccination was painful going in and coming out (vaccination site pain) compared to other vaccinations. Prior doses in series were unknown. No medical attention was sought, and no treatment was given for the adverse event. The outcome of vaccination site pain was reported as recovered.  The relatedness between the event occurrence and HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) administration was not reported.  This is on of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA006827:
Initial misuse report received from a healthcare professional on 21 January 2014. The cases were received at agency on 21 March 2014. It was reported that 17-month-old patient had received 0.5ml dose of FLUZONE vaccine. No adverse event was reported. List of documents held by sender: none.
feeling really bad; cough; allergy symptoms; fever; headache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of   in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Jan-2021, Body temperature: 100.4 f (High) She had  fever that shot up to 100.4 F and after about 20 minutes it went up to 100.7 F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment information provided.   Reporter did not allow further contact
1-2 weeks after receiving vaccine--pt developed significant dyspnea, that persists, and remains unexplained after extensive cardiac & pulmonary testing along with weight loss.
The vial was initially stored in refrigerator on 08-APR-2022/ expired on 16 Apr 2022/ administered on 21-APR-2022; Expired vaccine given to female patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine given to female patient) and PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 08-APR-2022/ expired on 16 Apr 2022/ administered on 21-APR-2022) in a female patient of an unknown age who received mRNA-1273 (Spikevax) (batch no. 007J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 21-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine given to female patient). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 08-APR-2022/ expired on 16 Apr 2022/ administered on 21-APR-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine given to female patient) and PRODUCT STORAGE ERROR (The vial was initially stored in refrigerator on 08-APR-2022/ expired on 16 Apr 2022/ administered on 21-APR-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Vial didnot undergo any temperature excursion. It was reported that no AE reported by patient.   Treatment medications were not reported.
Patient presented with side pain on 5/5/21, found to have multiple subsegemental PE
Shortness of breath, hard to breathe, chocking, inability to swallow, incontinence, blood clot, blood in urine, and death
Patient got Moderna on 4/10/21 at another location, had a seizure that night, reported event to Health Department. Patient's neurologist recommended patient get Pfizer next instead. Pharmacist providing vaccine was not aware of history at the time vaccine was being given on 10/12/21.
This case was reported by a nurse and retrospectively described the occurrence of miscarriage in a 24 year old female pt who received hepatitis B vaccine recombinant (Engerix-B). The pt had no known drug allergies. On 05 October 2004, the pt received the first dose of Engerix-B (lot ENG5595B6). On 05 October 2004, the pt also received the second application of tuberculin purified protein derivative (unknown manufacturer). On 05 November 2004, the pt received the second dose of Engerix-B (lot ENG5595B6). Approximately 59 days after the second dose of Engerix-B, on 03 January 2005, the pt experienced "some bleeding" and was seen at a physician's office. The nurse reported that on 03 Januray 2005, "an ultrasound was done and revealed no body parts." The pt was diagnosed with a miscarriage. The nurse stated that, "it was estimated that the pt was 11 weeks [of gestation] on 03 January 2005 and had an estimated conception date between 26 October 2004 and 09 November 2004." The nurse stated that the second dose of Engerix-B was "potentially" administered during the first trimester of pregnancy. Comment: Miscarriage and vaginal bleeding were assessed as medically serious by the manufacturer (OMIC).
Patient received a 3rd dose of Moderna. 1st dose on 2/2/21, 2nd dose on 4/5/21, 3rd dose on 5/5/21.
Minor upper lip swelling  around 30 mins after injection. Could have been from wearing mask 2:41 pm. Migraine level headache, followed by chills and nausea. Went away with advil and an hour nap. Around 6 pm. A hive on collarbone and one on neck. Puffy upper lip. Occasional racing heart feeling. Severely itchy ears, inside of mouth, face, and neck. Took Benadryl and symptoms cleared within 30 mins. Random headache, chills, joint pain, and minor itchy skin throughout the weekend.
Redness, Swelling,tenderness in area of shot, Severe joint pain, headache, body aches for 3 days after injection. No treatment required. Shot administered Thursday September 20th as of today slight itching and some redness, soreness at injection site.
administration of Arexvy to a pregnant woman; 35 years old patient recieved Arexvy; administration of Arexvy to a pregnant woman instead of the RSV vaccine from Pfizer (ABRYSVO); This non-serious prospective pregnancy case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 35-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 09-OCT-2023, the patient received Arexvy. On 09-OCT-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: 35 years old patient recieved Arexvy) and wrong vaccine administered (Verbatim: administration of Arexvy to a pregnant woman instead of the RSV vaccine from Pfizer (ABRYSVO)). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: administration of Arexvy to a pregnant woman).  The outcome of the inappropriate age at vaccine administration, wrong vaccine administered and vaccine exposure during pregnancy were unknown.   Pregnancy exposure: Gestation time at first exposure (Arexvy): 37 Weeks Pregnancy Exposure (Arexvy): To mother in third trimester Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 12-OCT-2023 The nurse reported that the administration of Arexvy to a pregnant woman instead of the RSV vaccine from Pfizer (ABRYSVO). The healthcare professional asked for information regarding this situation. The patient was in her 37th week of pregnancy. The reporter did not provide information about the Arexvy dose given (lot number, expiration date) nor patient initials. The 35 years old patient received Arexvy instead of the RSV vaccine from Pfizer (ABRYSVO), which led to inappropriate age at vaccine administration and wrong vaccine administered. The reporter consented to follow up.
Right deltoid became swollen, red and hot to touch. Treated with Benadryl and improvement already seen.
diluent portion only of Pentacel in the right thigh/no AE; Initial information received on 17-Oct-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves a 2 months old male patient who recieved diluent portion only of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] without HIB in the right thigh, Lot number- UJ104AA, expiration date- 13-Oct-2020 on 01-Oct-2019    The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE) for Immunisation; and PNEUMOCOCCAL VACCINE (PNEUMOCOCCAL VACCINE) for Immunisation.  It was a case of actual medication error due to Active ingredient not added to diluent.  It was unknown if patient had any adverse 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 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.
Suspected vaccination failure/Got shingles from shingles shot; Got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details provided were as follows: The case was reported by patient himself/herself. Age at vaccination was not reported. The patient received Shingles shot and experienced shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up would not be possible as no contact details available.
Information has been received from a Licensed Practical Nurse concerning a female with unspecified drug allergies and pertinent medical history who on an unspecified date was vaccinated with a dose of Zostavax (Oka/Merck). Subsequently the patient experienced warmth at the injection site and felt "under the weather". The patient called the physician but it was unspecified if medical attention was sought. At the time of the report the patient was recovering. No product quality complaint was involved. Additional information has been requested.
This spontaneous report as received from a nurse practitioner refers to a 11 years old patient of unknown gender. No information on patient's medical history or concurrent conditions was provided. On 09-JAN-2015, the patient was vaccinated with the dose of GARDASIL lot # K008213 (dose, strength, route of administration and expiration date were not reported) which had temperature excursion (incorrect product storage). No information on patient's concomitant medication was provided. Nurse practitioner confirmed that no adverse events were reported. This is one of several reports from the same reporter. Additional information has been requested.
This spontaneous report as received from a Nurse Practitioner via company representative refers to a female patient of unknown age. On an unknown date, the patient was vaccinated with a dose of GARDASIL (lot #, dose and route: No provided). There was no concomitant medication reported. On unspecified date, the patient developed a blood clot in an unspecified anatomical location after receiving an unspecified number of GARDASIL doses. The patient was unable to complete the GARDASIL series because of the blood clot. The Nurse Practitioner also mentioned this adverse experience may have been previously reported. The outcome of the event was unknown. Additional information has been requested.
Infant given Influenza Vaccine 0.25mL in right thigh.  No distress noted and injection tolerated well.  The Grandmother and infant left the Health Department and the Grandmother returned at 11:15 AM and said the infant vomited. So the infant was brought back in the hospital and the RN did a respiratory, cardiovascular and integumentary assessment.  Respirations 28/minute; Pulse 120/minute and the skin had red patches on the torso.  No rash or Hives.  The Infant appeared to not be in distress and no other occurrence happened.  The infant's pediatrician was contacted, and after hearing of the vomiting and skin redness.  The MD called in Zofran for the infant just in case he continued to vomit.  The MD said that this does sound like a reaction to the influenza vaccine and to not get another influenza injection for a couple of years. The MD instructed the grandmother to take infant to ER if any changes occur, any hives or respiratory distress.  The parent verbalized understanding.  The Grandmother and infant stayed in the clinic 30 minutes longer with no occurrences. At 1:45pm, RN called the Grandmother and asked how the infant was doing.  She said he is doing well, he vomited once more and has had no other occurrences.  She said they are at another MD appointment and he is playing and doing well.  RN instructed the Grandmother to take the infant to ER for any changes or occurrences as MD stated.  The Grandmother verbalized understanding.
fever 100-102.9f, chills, myalgia, malaise, headache persisting several days from Friday evening through Sunday evening.  Severe enough to be unable to continue routine activities, missed work, etc.
Muscle soreness; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Muscle soreness) and FATIGUE (Fatigue) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013m20a) for COVID-19 vaccination.     Concomitant products included BENAZEPRIL, AMLODIPINE and SALBUTAMOL (ALBUTEROL HFA) for an unknown indication.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced MYALGIA (Muscle soreness) and FATIGUE (Fatigue). At the time of the report, MYALGIA (Muscle soreness) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment information provided
This spontaneous report was received from a registered nurse referring to unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical histories and concomitant therapies were not provided. On unknown dates since October 2016, the patients were vaccinated with a dose of PNEUMOVAX23 (dosage, route of administration, lot # and expiry date were not provided) which were improperly-monitored. No adverse experience was reported. The temperatures, when recorded, were always within the recommended storage range. There was a period, when the temperature would not be recorded for 3 or 4 days and there were occasions when the temperature would be recorded only once a day. There was no previous temperature excursion reported. Digital data logger was not involved. No product quality complaint was involved. Follow up information has been received on 11-APR-2017 referring to a patient of unknown age and gender.  Route/ site was reported as 1. The patient declined to be re-vaccinated. There was potential compromise of PNEUMOVAX23 due to multiple in monitoring refrigerator temperature. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA013522:
Inadvertently givenmonovalent IM covid primary instead of bivalent booster.
I had some slight arm pain the day of the shot, but the morning after my arm that received the injection was in so much pain that I could barely even move it. Very little mobility, slight bruising and a red circle around the injection site about 1.5 inches. However, I felt fine most of the entire day besides that. Around hour 28 of getting vaccinated I started to get very bad chills that lasted for about 3 hours. Took my temperature, which stayed around 100 degrees the entire night, 100.5 at its highest point that I checked. The next day it was standing in around 99.9. Felt slight muscle soreness the last couple days, but no fever since then. My arm gained a little mobility on Sunday, 2 days since vaccination so I thought it was getting better. but Monday and today (Tuesday) my knot/lump in my arm at the vaccination site is back to hurting extremely bad and the swelling and size of the lump and red circle is actually growing and pain is starting to increase again.  The red circle is around 4.5 inches now and the pain is sharper where the injection happened.  I am starting to get worried something is wrong, but will give it another day or so before checking in with a doctor.
Flu-like symptoms the morning after injection. Around 9pm the day after injection, began shaking uncontrollably and was unable move or speak, fever rose to 104.8. Shaking subsided about one hour and fever persisted into the next day around 101-103.
muscle tenderness; This case was reported by a consumer via interactive digital media and described the occurrence of tenderness muscle in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE CONJ 20V (CRM197) (PREVNAR 20) for prophylaxis.   On an unknown date, the patient received Shingrix and PREVNAR 20. On an unknown date, unknown after receiving Shingrix, the patient experienced tenderness muscle. On an unknown date, the outcome of the tenderness muscle was unknown.   It was unknown if the reporter considered the tenderness muscle to be related to Shingrix.     Additional Information: GSK Receipt Date: 08-DEC-2022 Reporter's comment: This case was reported by the patient via interactive digital media. The reporter had asked that was it ok to take Aleve for muscle tenderness after the Shingrix and Prevnar 20 vaccines. It was unknown if the reporter had considered the tenderness muscle to be related to Prevnar 20. Follow-up would not possible as no contact details were available.
left deltoid hurt a lot for a while; got left actual swelling like in his armpit; This is a spontaneous report from a contactable consumer (patient). This 49-year-old male patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration at left deltoid on 18Dec2020 at single dose for COVID-19 immunization. Medical history and concomitant medications were unknown. The patient received the COVID vaccine Friday morning as part of work. The patient had a lot of, kind of significant actual swelling in the (incomplete sentence). The patient was too much concerned about this, but it was out of the ordinary enough that the patient felt it was worth reporting. So the patient got the vaccine in his left deltoid and the left deltoid hurt a lot for a while but currently the patient got left actual swelling like in his armpit it's, where the lymph nodes were, the patient got a very significant swelling. The patient stated he was experiencing it on 20Dec2020. So his age was 49 years. The patient was assuming it was a normal immune response, but he never had it with the flu vaccine or anything, so the patient wanted to report it. It's a COVID-19 Vaccine. No treatment was received for events. Outcome of the events was unknown.   Information about lot/batch number has been requested.
Within 24 hours?fever, chills, headache, nauseous Within 48 hours?sever nauseousness, severe vomiting, headache, diarrhea Within 72 hours?headache, nauseous, diarrhea
no additional AE's; temperature excursion / temperature 34.1 F; This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. There was no information regarding their medical history, current conditions nor concomitant therapies provided.  On 02-APR-2021, the patient was vaccinated with an improperly stored dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9), dose/frequency reported as 1 (unit not provided), lot # 1687292, expiration date 25-AUG-2022 (exact dose, route of administration and anatomical location were not provided) for prophylaxis. The administered dose was stored in temperature of 34.1 degrees Fahrenheit (F) for 4 hours and 15 minutes. Previous temperature excursions were reported as follows: 34.8 F for 45 minutes and 34.7 F for 2 hours and 45 minutes (dates not provided). Digital data logger was involved. The patient was reported to be asymptomatic, no adverse events (AE's) were reported.  This is one of several reports 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: 1687292; expirationdate: 25-AUG-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA007278: US-009507513-2104USA007277: US-009507513-2104USA007276: US-009507513-2104USA007270:
Left arm sore and stiff, temperature 101 degrees.  Seen by Private Physician. Treated with Antibiotic for seven days.