chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 02-Oct-2018 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 71 years old male patient who experienced the patient felt that he did not receive the entire 0.5ml dose and little bit leaked out of the injection site (right deltoid) and ran down his arm, while he received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ038AA via unknown route in the right deltoid. It was also a case of actual medication error due to Vaccine underdose and exposure via skin contact. (Other relevant tests included No lab test). Final diagnosis was little bit leaked out of the injection site (right deltoid) and ran down his arm and the patient felt that he did not receive the entire 0.5ml dose. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Not Applicable for little bit leaked out of the injection site (right deltoid) and ran down his arm and as Not Applicable for the patient felt that he did not receive the entire 0.5ml dose. 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.
This was a very unusual event for me 2 weeks after getting the vaccine. Extremely heavy menstral cycle this lasted 15 days. Heavy clotting dropped my blood pressure extremely low and my iron count. 3 days into the event, I was extremely weak, nauseated, sweating and clammy. I was so tired I couldn?t get out of bed due to the extreme bleeding. I have no pre-existing health conditions, am generally in good health, rarely get sick and I've been on birth control for over 20 years. I rarely ever get a period and when I do, it's very light. I've never had a period like this in my life and then I get the vaccine and two weeks later, the worst period of my life to where I considered going to the ER several times because of unusually heavy bleeding.
Presenting to ED on 12/06/2021 with falls, productive cough, congestion, dyspnea, subjective fevers, chills, body aches, weakness.  In ED patient hypoxic, and placed on 2LNC, COVID positive.  Patient admitted to floor and placed on heparin, dexamethasone, azithromycin, and Rocephin for superimposed bacterial PNA.  Patient was a DNR/DNI and developed bradycardia and expired.
shingles; This spontaneous report was received from a lawyer referring to a patient (pt) of unknown age and gender. Information regarding current condition, historical condition or concomitant medication was not provided. In 2014, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (strength, route, dose number, batch/lot# and expiration date were unknown) by a healthcare provider (HCP) in a clinic for the long-term prevention of shingles and zoster-related conditions. On an unknown date, subsequent to zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by a HCP for shingles. As a direct and proximate result of the pt's use of the zoster vaccine live (ZOSTAVAX) vaccine, the pt had and would continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs included care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of shingles was unknown. The reporter considered shingles to be related to zoster vaccine live (ZOSTAVAX).
Patient received Moderna COVID vaccine on 1/23/21 (lot # 042L20A), 2/23/21 (lot # 002A21A), 11/24/21 (lot # 065F21A). On 6/2/22, patient admitted to our inpatient facility (med/surg unit) with acute respiratory failure with hypoxia and COVID19 pneumonia. Patient was discharged home earlier today on 6/6/22.
headache; stomach cramps; feel hot; burning sensation in chest; burning sensaton in arms; disorientation; A spontaneous report was received from a consumer concerning a 86 year old female patient who received Modern's COVID-19 vaccine (mRNA-1273) and experienced disorientation, headache, stomach cramps, feeling of warmth, chest burning and feeling pain.  The patient's medical history were not reported and concomitant medication were Plavix, Januvia, Simvastatin, Progesterone, Vivelle.  06Jan2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: Not reported) via intramuscular rout for prophylaxis of COVID-19 infection.  On 08Jan2021, the patient experienced disorientation. On 12Jan2021, the patient experienced headache, stomach cramps, feeling of warmth, chest burning and feeling pain. No Laboratory details provided.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.  At the time of this report, the outcome of the events disorientation, headache, stomach cramps, feeling of warmth, chest burning and feeling pain is Unknown.
This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (found out after they gave the 2nd shot that it has only been 14 days or 2 weeks ago that the patient received the 1st shot) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050C21A and 022B21A) for COVID-19 vaccination. No Medical History Information was reported.  On 20-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (found out after they gave the 2nd shot that it has only been 14 days or 2 weeks ago that the patient received the 1st shot). On 04-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (found out after they gave the 2nd shot that it has only been 14 days or 2 weeks ago that the patient received the 1st shot) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication were reported. No treatment information was reported. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 04-Jun-2021 and was forwarded to Moderna on 05-Jun-2021. This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (found out after they gave the 2nd shot that it has only been 14 days or 2 weeks ago that the patient received the 1st shot) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050C21A and 022B21A) for COVID-19 vaccination.  No Medical History Information was reported. On 20-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (found out after they gave the 2nd shot that it has only been 14 days or 2 weeks ago that the patient received the 1st shot). On 04-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (found out after they gave the 2nd shot that it has only been 14 days or 2 weeks ago that the patient received the 1st shot) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication were reported. No treatment information was reported.
This spontaneous report was received from a licensed practical nurse referring to multiple patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On multiple unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 for prophylaxis, (route, dose, lot and expiration dates were not reported). No adverse effects were reported. There were no previous temperature excursions; the data logger reported: "traceable Min. and Max." There was no Product Quality Complain (PQC) involved. This is one of several reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA012322: US-009507513-1612USA013204: US-009507513-1612USA013205: US-009507513-1612USA013206.
This spontaneous report as received from a 71 years old male patient with diabetes and no drug reaction/allergy. The patient stated after having shingles, he received ZOSTAVAX on 07-JUN-2011 (lot# and route were unspecified) to prevent shingles a second time, and it did not work, the shingles came again sometime in February-2012. Concomitant medications included metformin and glyburide (reported as glybride). Valacyclovir and acyclovir were given for the events. Lab diagnostic study included blood work, and no result was reported. The patient was not recovered. The patient sought medical attention via office visit. Additional information has been requested.
This spontaneous report as received from a nurse refers to a 74 year old female patient. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (route, dose and lot # were unknown). The patient had pneumonia two times on unspecified dates. The outcome of event was unknown. The relationship between event and PNEUMOVAX 23 was unknown. Additional information has been requested.
damage shoulder for having jab; This case was reported by a consumer via interactive digital media and described the occurrence of shoulder injury 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 shoulder injury. On an unknown date, the outcome of the shoulder injury was unknown.   It was unknown if the reporter considered the shoulder injury to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient damaged to his/her shoulder for having that Shingles jab and would never outweigh. The patient inquired what his/her immune system could have done, the patient so regret taking the shot, government push and hate that he/she caved to it. The follow up would not be possible as no contact details were available.
I started having  a reaction to the vaccine about 1pm in the afternoon. I found a big RED mark where the injection was put in along  with my arm being sore and swollen I was not able  to raise my hand about my head. Getting dressed is very difficult because putting my right arm in the sleeves is very painful. I cant  sleep on my side because of the pain and I have a pain in my neck that is also very bothersome.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No medical history and concurrent conditions were reported. On an unknown date the patient was inadvertently vaccinated with PROQUAD (lot # L046507, expiry date unknown) (dosing regimen and frequency unknown) subcutaneously and VARIVAX (lot number and expiry date unknown) (dosing regimen and frequency unknown) (overdose). No concomitant medications were reported. No adverse effects were reported. The action taken with the suspect therapy was unknown. The outcome of the events was unknown. There was no product quality complaint reported. Additional information has been requested.
Varicella  Information has been received from a physician concerning a 5 year old female who on 12-Oct-2000 was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). On 20-Aug-2004 the patient was diagnosed with chickenpox, 7 lesions were noted. The child was well otherwise. Unspecified medical attention was sought. there was no product quality complaint involved
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Medical problems) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product INFLUENZA VACCINE (FLU) for an unknown indication. No Medical History information was reported. On 05-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form and INFLUENZA VACCINE (FLU) (unknown route) at an unspecified dose. In November 2021, the patient experienced VACCINATION COMPLICATION (Medical problems). At the time of the report, VACCINATION COMPLICATION (Medical problems) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were provided. No treatment medications were reported. Reporter did not allow further contact.
Elevated heart rate at rest and active Fatigue Dizzy Out of breath We had him rest - lasted 3 days
Fever: 2 days  Severe chills and body aches, very painful skin to the touch: 3 days  Fatigue: 4 days  Severe knee and ankle pain that limited ability to walk: 8 hours  Fainting: 1?event  Brain fog: started on day 4
Patient entered Nursing Rehab center (1/29/2021) after hospital discharge because of recent falls, swallowing difficulty. J&J vaccine given to residents 03/30/2021. OK the next day (03/31/2021), but in extreme pain by second day - 04/01/2021. He kept saying he never felt so terrible in his whole life. I asked the nurse to please go down the hall and check on him, which she did, but do not think any medical procedure was performed. This was about 8:00am, I checked back again about an hour later and he said he was VERY tired, just wanted to sleep. Again nothing was done for him. I received a call from the home about midnight saying when the nurse checked on him there was no response and that he had passed.
08/29/03 Three days after 2nd Prevnar and first Chicken Pox vaccination (08/26/03), child awoke in a dazed state and remained that way for 5 1/2 hours, her eyes were open, but she was unresponsive to any stimulus; she did not make any vocalization in those hours( very unusual for our baby), she was listless and her body was limp with a rapid heart beat, labored breathing and pallor of the skin- this same reaction happened at 9 mos. after first dose of prevnar- our doctors have dismissed the coincidence and have ordered further testing assuming that she had sustained a seizure- bloodwork and urine came back fine- no infections, no fever. She bounced back by the evening. When we initially called our Ped. 1 1/2 hours into the episode, right off the idea that this was vaccine related was dismissed as it did not occur in the normal 24-48 hours.
Information has been received from a physician concerning a 10 yr old white female with a history of acute lymphoblastic leukemia in remission in Jan 1997 and off all treatments in Mar 1999, who on 11Jul03 was vaccinated SC in the right arm with a second dose 9date of first dose not reported) of 0.5mL dose of varicella virus vaccine live (Lot644974/0196N). There was no concomitant medication. The physician reported that a few weeks ago in approx May 2005 (also reported as 10Jun05), the pt came into the office with a full case of chicken pox although varicella virus vaccine live was given. The physician reported that the pt had a rash with erythematous papular lesions (20), pruritic, fever and had nasal congestion. The physician did not have any additional information regarding the adverse experience or the pt's outcome at the time of this report. There was no product quality complaint reported. Additional information has been requested.
Arm ached; delayed reaction; Warm to touch at injection site; Arm inflammation; Bumps at injection site / beacme inflammed with raised itchy bumps.; severe itching at the vaccination site on left arm; Swollen at injection site; Redness at injection site; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Jan-2021. The most recent information was received on 28-Jun-2021 and was forwarded to Moderna on 28-Jun-2021.    This spontaneous case was reported by a patient and describes the occurrence of PAIN (Arm ached), HYPERSENSITIVITY (delayed reaction), VACCINATION SITE WARMTH (Warm to touch at injection site), VACCINATION SITE INFLAMMATION (Arm inflammation) and VACCINATION SITE INDURATION (Bumps at injection site / beacme inflammed with raised itchy bumps.) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Sulfonamide allergy. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) for High cholesterol, VITAMIN D NOS for an unknown indication.    On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced PAIN (Arm ached), HYPERSENSITIVITY (delayed reaction), VACCINATION SITE WARMTH (Warm to touch at injection site), VACCINATION SITE INFLAMMATION (Arm inflammation), VACCINATION SITE INDURATION (Bumps at injection site / beacme inflammed with raised itchy bumps.), VACCINATION SITE PRURITUS (severe itching at the vaccination site on left arm), VACCINATION SITE SWELLING (Swollen at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site). On 29-Jan-2021, PAIN (Arm ached), HYPERSENSITIVITY (delayed reaction), VACCINATION SITE WARMTH (Warm to touch at injection site), VACCINATION SITE INDURATION (Bumps at injection site / beacme inflammed with raised itchy bumps.), VACCINATION SITE PRURITUS (severe itching at the vaccination site on left arm) and VACCINATION SITE SWELLING (Swollen at injection site) had resolved. At the time of the report, VACCINATION SITE INFLAMMATION (Arm inflammation) and VACCINATION SITE ERYTHEMA (Redness at injection site) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information  included icepack and antihistamine.  EpiPen was ordered incase of emergency.   This case was linked to MOD-2021-239110 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: Non Significant follow-up (Reporter's e-mal updated) no new information is added. On 28-Jun-2021: Follow up is significant containing information of patient demographics, concomitant drugs, vaccine batch number, additional event-inflammation(for the first dose of vaccine).
Headache, Myalgia, Arthralgia, Fever, FATIGUE, INJECTION SITE PAIN Narrative:
Parent contacted school to excuse student due to illness.  Fever, headache, and runny nose reported by parent.
Pt. was a routine checkup to have his physical form signed for college. The nurse practitioner told him that he had only received one dose of the chicken pox vaccine (varicella) and told him he needed another dose.  This information is not accurate. The dr's office has record that pt. received his first dose of varicella on 10/14/05 and his second dose of varicella on 4/29/09 as recommended by the CDC. The dose that was administered by the nurse practitioner on 4/19/23 was pt.'s third dose of the varicella vaccine.  The dr was called concerning the third dosage.  The nurse took a message and said she would pass it on to the dr to see if there was anything we should do since pt. was administered a third dosage of varicella.  The dr never called back as of 9:30pm on 4/19/23.
CERVICAL RADICULOPATHY IN LEFT ARM; This spontaneous report received from a patient concerned a 57 year old male. The patient's weight, height and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 expiry: unknown) dose was not reported, 1 total, administered on 12-MAR-2021 at left arm for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date in 2021, the patient experienced severe pain in the shoulder where he got the injection, later diagnosed as cervical radiculopathy in left arm, and was hospitalized for 3 weeks (date unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from cervical radiculopathy in left arm. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0- covid-19 vaccine ad26.cov2.s -Cervical Radiculopathy. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
24 hours - flu like Fever of 100.8  Chills Body aches  Headache Stomach cramps - no vomit or diarrhea
Tested positive for COVID-19 on 02/05/2021 Became sick with influenza like symptoms accompanied by high fever April, May and June.
Arm sore, abdominal swelling significant, gravel throat, tiredness, some wheezes
This case was reported by a pharmacist via call center representative and described the occurrence of vomiting in a infant patient who received ROTARIX. On an unknown date, the patient received ROTARIX (oral). On an unknown date, less than a day after receiving ROTARIX, the patient experienced vomiting and accidental underdose. On an unknown date, the outcome of the vomiting and accidental underdose were unknown. It was unknown if the reporter considered the vomiting to be related to ROTARIX. Additional details were reported as follows: The age at vaccination was not reported. After receiving ROTARIX vaccine, the patient vomited the vaccine, which led to accidental underdose. The healthcare professional did not have patient or product infection. The reporter had very limited information. The healthcare professional was informed that someone might reach out for additional information.
swelling; tenderness; a red lump at the injection site; a red lump at the injection site; This is a spontaneous report from a contactable other healthcare professional (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: Unknown), via an unspecified route of administration on 30Dec2020 at a single dose for COVID-19 immunization. The patient was Covid 19 positive in Aug2020. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced swelling, tenderness, and a red lump at the injection site. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Vaccine was given at approximately 0930. 30 minutes after vaccine injection (10:00am) patient noticed her face starting to itch.  This eventually progressed to a rash on the anterior, upper legs.  At 12:50pm patient returned to speak to RN who gave the injection.  Pt stated the rash on legs had subsided but face still felt slightly itchy.  At 12:55pm patient was given 25mg Benadryl with water.