chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse concerning a 14 year old female who on 15-JAN-2007 was vaccinated, intramuscularly with the first dose of HPV vaccine (yeast), (lot # 654389/0961F). On 15-JAN-2007 the patient fainted after receiving the vaccination. The patient was seen in the Emergency Room (ER) following vaccination and "no problems were found".  At the time of the report, it was unspecified, if the patient recovered.  Additional information was received on 11-APR-2007. The registered nurse indicated that on 15-JAN-2007 the patient's blood pressure was 56/72 and heart rate was 104. On 15-JAN-2007, at 15:10, the patient was vaccinated with her first dose of Gardisil intramuscular (left deltoid), became pale immediately, laid down for approximately 5 minutes, got up, started walking down the hall, and passed out. The patient was taken to an ER, oxygen saturation was 99% (no other vital signs were taken). It was noted that the patient did report nausea. The patient did not experience rashes, hives, or difficulty breating. The patient was not ill at the time of vaccination. Additional information is not expected.
12 year old who was paralyzed/paralyzed from the waist down; seizures; Severely injured; memory loss; feeding tube; stomach ache; The initial case was missing the following minimum criteria: Reporter cannot be identified for direct/private contact (internet source). Upon receipt of follow-up information on [18Feb2023], this case now contains all required information to be considered valid.  This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP).  A 12-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: PARAPLEGIA (medically significant), outcome "unknown", described as "12 year old who was paralyzed/paralyzed from the waist down"; SEIZURE (medically significant), outcome "unknown", described as "seizures"; INJURY (non-serious), outcome "unknown", described as "Severely injured"; AMNESIA (non-serious), outcome "unknown", described as "memory loss"; FEEDING TUBE USER (non-serious), outcome "unknown", described as "feeding tube"; ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "stomach ache". Clinical course: This reported was received from a Pfizer-sponsored program Corporate (Pfizer) Social Media Platforms. Patient was paralyzed by Pfizer vaccine in Pfizer trial doing, reporter asked for any update and would she walk again. Product was Pfizer Covid Vaccine - BNT162b2. It was reported that once- healthy 12yr old was volunteered by her family for Pfizer trial after 2 doses she was paralyzed from the waist down, in a wheelchair, had seizures & memory loss her remorse-filled mom said, "we just wanted to show we believed in The Science". Social Media Channel and report type stated as Pfizer AE. Upon follow-up query to RA, it was confirmed that Reporter was working on behalf of Vendor, the vendor was a measurable supplier and Supplier name (unspecified).  Follow-up attempts are completed. No further information is expected.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 63-year-old female patient. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not provided. On an unknown date in May 2015, the patient was vaccinated by a pharmacist with ZOSTAVAX (dose, route of administration, lot number and expiration date were not provided) for long-term prevention of shingles and zoster-related conditions. On an unknown date, the patient experienced heart failure and other Zoster related injuries and was treated by a healthcare provider. The patient claims damages as a result of: injury to herself, loss of consortium, loss of services, and economic losses. The outcome of the events is unknown. The reporter considered the events to be related to ZOSTAVAX. Upon internal review, the event heart failure was determined to be medically significant. Additional information has been requested.
Patient had swelling of the arm that was the size of the tennis ball that gave her a lot of pain.   It was also red and hot to the touch.  She reported of pain radiating down the upper arm.  There was a certain area around the site of injection that was very hard to the touch.
tightness in chest, a little harder to breathe, lower back, hips in pain, temp. of 102.85 after tylenol was taken, head hurting, freezing with trembling, sweating, sick at stomach,weak, unsteady,  this all the same day and evening into night, couldn't really go to sleep till way up the next morning, felt bad day after didn't want to do anything. Felt better by late evening of 10/25/2023.  But don't look forward of ever receiving any more flu shots!
Swelling, redness patient also experience itching, without fever.  Onset 24hrs after injection .
Initial misuse report received from a healthcare professional on 29-Aug-2013. A patient (no other information was provided regarding patient) had received  only the ACTHIB component reconstituted with sterile water still has the DTAP/IPV component As per CDC, any dose of ACTHIB reconstituted with a diluent other than DTAP-IPV or the specific ACTHIB diluent should not be counted as valid and must be repeated. Although not licensed, DTAP-IPV is immunogenic when administered without first reconstituting the ACTHIB component. For this situation pt. can be administered the DTAP/IPV component and a separate ACTHIB vaccine. if don't have separate ACTHIB vaccine, need to discard that extra DTAP/IPV component of PENTACEL and administer an appropriately reconstituted PENTACEL dose. No adverse event was reported. List of documents held by sender: none.
Patient missed second dose appointment; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient missed second dose appointment) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient missed second dose appointment). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient missed second dose appointment) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment information was reported.
within 10 minutes of vaccine administration complained of throat fullness, no difficulty breathing or swallowing, hives developed as well on upper torso and arms. no headache, no dizziness, no tongue swelling. Gave epi 0.3mg IM x 1 and diphenhydramine 50mg IM x 1, called 911, symptom improvement after medication administered.
received the adult version instead of the children's with no reported adverse event; received the adult version instead of the children's with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from the consumer or non-healthcare professional via Information (Reference number: 00845148) and transmitted to Sanofi on 05-Nov-2021.  This case involves a six-year-old male patient receiving INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] incorrectly and they received the adult version instead of the children (product administered to patient of inappropriate age and Wrong vaccine administered).  It was unknown if the patient had any medical history, concomitant disease or risk factor.  The patient past medical treatment, vaccination, concomitant medication and family history were not provided.  On 04-Nov-2021, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [Frequency: once, Dose = 0.25 mL to 2 mL for vaccines or 0.1 mL for tuberculin (TB) skin test, Frequency: once, lot number and expiry date not reported] via unknown route in the left arm for prophylactic vaccination.  It was an actual medication error case due to Inappropriate age at vaccine administration and Wrong vaccine administered (latency: same day).  It was reported "Caller stated that his son and daughter ages 11 and 6 received FLUBLOK was administered incorrectly and they received the adult version instead of the children and asking if we have any information regarding children receiving adult vaccine and what they should be concerned about."   At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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.  There will be no information available on the batch number for this case.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 29-SEP-2009, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided) at a medical clinic. On or about 03-MAR-2013, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive 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 including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death; aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
sore arm. Pain has spread to other parts of the arm. She has difficultly mobilizing it at times
I got the vaccine shot at 8:30 am on the morning of 1/22/21 and went back to work in the dairy dept at a grocery store for another 6 hours. By the time I was off, I was tired and had a migraine going. By 7:30 pm that night, I had a 100.5 fever, extremely exhausted, the chills and shakes, my whole body ached, and my upper left arm was red, swollen and hurt like heck. I also still had a migraine that last for four days after the vaccine shot. By 1 am on 1/23/21, I had a 101.7 degree fever, no energy/strength, and hurt all over. The fever broke below 100 on 1/24/21 by 3 pm and I finally was back to a normal temperature on the morning of 1/25/21.  I was finally able to go back to work on the morning of 1/26/21 but was exhausted and weak for the next two days.
This female subject was enrolled in an observer blind study. On 11 September 2013, she received a 1st dose of GSK PRIORIX or Merck's M-M-R II co-administered with GSK HAVRIX 720 Junior, Merck's VARIVAX and Pfizer's PREVNAR 13. On 29 October 2013, she received a 2nd dose of GSK PRIORIX or Merck's M-M-R II. On 16 April 2014, six months after the 2nd dose of Blinded vaccine, seven months after the dose of HAVRIX 720 Junior, seven months after the dose of VARIVAX, seven months after the dose of PREVNAR 13, this 22-month-old subject developed developmental delay. The event was disabling. The event was unresolved at time of reporting. The investigator considered that there was a reasonable possibility that the developmental delay may have been caused by the investigational product, HAVRIX 720 Junior, VARIVAX and PREVNAR 13. Relevant Risk Factors: Father: Bi-polar Disorder Father's side: Tourette's syndrome. Investigator Comments: Family non-compliant with well child exams. Last well child check was 12 month visit on 7-16-13. Subject missed both 15 month and 18 month well child check up visits. No 18 month MCHAT or ASQ developmental questionnaires to compare with 4-16-14 visit questionnaires. Physician deferred well child check due to traumatic events, head trauma 4-13-14 and diagnosis of undisplaced oblique fracture through the mid to distal right femoral diaphysis 13 April 2014. Subject failed ASQ across all domains on 16 April 2014. Subject will need further evaluation. 4/23/14: Investigator cannot rule out possible relationship of SAE to Investigational product. The subject's last dose of Investigational product was 29 October 2013. Last well child check was 16 July 2013 and developmental delay diagnosis was on 16 April 2014. The subject is scheduled to return on 30 April 2014 for follow up after hospitalization and to complete the well child check. The SAE relationship to Investigational product will be re-evaluated at that time.
This spontaneous report as received from a physician via a company representative refers to an approximately 14 month old male patient. It was reported that the patient did not have any concurrent condition or medical history. On 04-FEB-2016 the patient was vaccinated with VARIVAX (Merck) (lot # L034370, expiry date unknown) injection (dosing regimen and frequency unknown). The patient was not on any concomitant medications. On 06-FEB-2016 (also reported 2 days later) the patient experienced chicken pox (varicella). On approximately 08-FEB-2016 the patient's chicken pox was severe and had over 100 lesions. This had prompted an office visit with the patient's physician. There was no lab diagnostics studies performed. It was reported that the patient was treated with an unspecified anti itch cream. The action taken with the therapy with VARIVAX (Merck) was unknown. The outcome of varicella was reported as recovering. The relatedness of the events to the therapy with VARIVAX (Merck) was unknown. There was no product quality complaint reported. Additional information has been requested.
This spontaneous report as received from a physician via company representative refers to a female patient of unknown age. The patient's medical history and current conditions were not provided. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (lot number and expiration date were not reported) 0.65 ml, single injection, subcutaneous. Secondary suspects and concomitant therapies were not reported. The patient was diagnosed with shingles on three separate unspecified dates after receiving a vaccine injection of ZOSTAVAX. The outcome of shingles was unknown. The patient sought medical attention via contacting with physician. The relatedness shingles event and ZOSTAVAX was not reported. Additional information has been requested.
Severe body aches. Low grade fever, fatigue. Redness, swollen and warm injection site. Injection site is swollen and painful and itchy.
hard, swollen, hot injection site on upper right arm from meningococcal acwy vaccine.  lasted approximately one week. was asked to return for follow up. Different doctor on site requested we monitor and give pain reliever to child. Was told to also file this report by the clinic.
arm soreness; arm swelling; redness at the site of the injection; sick to her stomach; This case was reported by a consumer via call center representative and described the occurrence of stomach pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In May 2022, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced stomach pain, pain in arm, swelling arm and injection site erythema. On an unknown date, the outcome of the stomach pain was recovered/resolved and the outcome of the pain in arm, swelling arm and injection site erythema were not recovered/not resolved.   It was unknown if the reporter considered the stomach pain, pain in arm, swelling arm and injection site erythema to be related to Shingrix.     Additional Information: GSK Receipt Date: 29-JUN-2022 Reporter's Comment: The reporter is patient. The patient stated received first dose of Shingrix a month ago. The patient stated that felt sick to her stomach for about 3 days but that resolved. The patient also stated that she had arm soreness, arm swelling and redness at the site of the injection (left arm) which had not resolved after one month.
The pt experienced swollen knees, swollen hands, achy hands, fatigue, muscle twitches, stiff neck, sore and achey muscles, hip joints hurt, all symptom are on going for weeks starting in July, 00.
This spontaneous report was received from a registered nurse regarding a 26 year and 10 months old female patient. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown date, the patient started GARDASIL 9 series for prophylaxis (dosing details were not reported). No adverse effect reported. No product quality complaint was present.
Patient presented to Unit Medical Personnel on 7/29/05 with reports of rash to body that started the previous day. Rash is present on both arms and legs. Also reports headache and weakness as well. Seen on 7/30/05 for same complaints. Claritin 10mg ordered on 7/30/05 for rash, Ibuprofen 400mg qid prn ordered for HA.
continuous low BP; continuous Low pulse rate; continuous cough and cold badly; continuous cough and cold badly; Subconscious the day i took medicine around 10.30 PM in rest room while using and felt and got hurt in neck; Wife took care and i dont remember anything during that time.; This is a spontaneous report from a contactable consumer or other non-HCP. A 47-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration, administered in Left Arm on an unspecified date (Age of vaccination: Unknown) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 17Apr2021. The patient did not receive any other vaccine in four weeks and no other medications in two weeks. The patient did not had COVID prior vaccination and post vaccination, patient had not tested with covid 19. No known allergies and other medical history reported for the patient. The patient experienced continuous low bp, continuous low pulse rate, continuous cough and cold badly, subconscious the day he took medicine around 10.30 pm in rest room while using and felt and got hurt in neck and wife took care and he dont remember anything during that time. The patient underwent lab tests and procedures which included blood pressure decreased: decreased on an unspecified date. The outcome of all events was not recovered.  No follow up attempts are needed. No further information is expected
Information has been received from a physician and a practice manger via company representative referring to a patient of unknown age and gender. On 31-MAR-2015 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23-10PK-0.5mlSD-PFS LLokwTip) (lot # K019386, expiration date 09-JUN-2016). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 24 hours with the lowest recorded temperature of 33 Fahrenheit degree. The total cumulative excursion time of the second time was 48 hours with the lowest recorded temperature of 32 Fahrenheit degree. The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effect was reported. This is one of several reports received from the same source. Additional information has been requested.
3/24/10 9:00 am felt headache, nauseated, diarrhea, arm sore after lump. 3/27/10 arm tender but felt better by Sat.
Back pain and weakness in lower back began on April 9th. This progressed to sciatica, numbness, weakness and inability to walk within 3 days. A facial rash was also present within 2 days. I had had a disc herniation in the year prior but I was symptom free since 3 months prior to the vaccine. The vaccine caused an immense increase in inflammation to the area. I have not been able to walk for almost 3 weeks.
Patient received vaccine on 09/15 and patient has reported shoulder soreness and discomfort on 01/05/22. Patient reports having to use physical therapy including pulleys, ropes, and exercises to help with this issue. The patient believes the shot might  have been given in the wrong area causing this issue.
10/28/09 Pt came into office today to get the H1N1. Pt was given by mistake 0.5 ml instead of the .25 ml. Called the Imm. program-stated to have pt come back in 1 month for the H1N1 .25. Dr. spoke with father-advised to watch for fever.
Initial report received from a healthcare professional on 11 July 2012. A 4-year-old male patient with no reported concomitant medications and no medical history, had received fifth dose of intramuscular DAPTACEL in left thigh (batch number: C4186AA) and Hepatitis B vaccination (lot number, route, dose, was not reported) in the right thigh on 3 July 2012. It was reported that, the patient received DAPTACEL vaccination on an 3 July 2012 and immediately following vaccination she developed 4 small hives lateral to injection site and small area of redness at injection site of thigh. It was reported that 20 minutes after vaccination the 4 small hives formed in to one large hive and red area became larger which was 3 x3 cm in size area at injection site with one large hive. The patient received ibuprofen as treatment and her mother administered BENADRYL at home 1 hour later. After 8 hours the patients mother reported that the injection site looked same no large. Details of laboratory investigations were not reported. The outcome of the event was recovered on an unspecified date. Documents held by sender: none.
Shot administered at 10:25 a.m. At 9 p.m. child began having chills followed by 20 hours of fever. The first day the fever averaged 102.4. The second day it was 103.4. The child shook significantly with his chills. Eyes were glassy and he looked tired and didn't have much of an appetite for about three days following shot.
mom noticed area of injection site redness and swelling in the evening of the 6/22/07. In office on 6/23/07 with "1/2 dollar size area of induration and redness at injection site". No fever noted.
Patient had fever of 101.2 starting in the evening. Took 2 tylenol at 8 12 and 4am. Temperature returned to normal at 9am on Friday.
Pt. developed burning, itching rash on both upper arms, chest and upper thighs over 3 day period post vaccination;   to Er on day 3 -received IV solumedrol 125 mg and Benadry 25 mg IV;  given prednisone # 8 to take  po BID x 4 days.