chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical histories provided. On 31-MAY-2016, the patient was vaccinated with an improperly stored dose of VARIVAX lot # reported as M000995, expiration date reported as 06-JAN-2018 (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of -8.4 degrees Celsius for 17.5 hours. There was previous excursion of -8.5 degrees Celsius for 37 hours. Data logger was involved. This is one of several reports received from the same reporter. Additional information has been requested.
This case was reported in a literature article and described the occurrence of Bell's palsy in a 26-year-old subject of unspecified gender who was vaccinated with HPV vaccine (manufacturer unspecified). No past medical history, the subject was healthy. On an unspecified date, the subject received an unspecified dose of HPV vaccine (administration site and route unknown, batch number not provided). At an unspecified time after vaccination with HPV vaccine, the subject experienced Bell's palsy. This case was assessed as medically serious by GSK. At the time of reporting, the outcome of the event was unspecified. This case has been linked to case B0739797A: same literature article. Summary of the literature article: In 2004 the Clinical Consult Case Review (CCCR) working group was formed within the CDC-funded Clinical Immunization Safety Assessment (CISA) Network to review individual cases of adverse events following immunizations (AEFI). Cases were referred by practitioners, health departments, or CDC employees. Vaccine Adverse Event Reporting System (VAERS) searches and literature reviews for similar cases were performed prior to review. After CCCR discussion, AEFI were assessed for a causal relationship with vaccination and recommendations regarding future immunizations were relayed back to the referring physicians. In 2010, surveys were sent to referring physicians to determine the utility and effectiveness of the CCCR service. CISA investigators reviewed 76 cases during 68 conference calls between April 2004 and December 2009. Almost half of the cases (35/76) were neurological in nature. Similar AEFI for the specific vaccines received were discovered for 63 cases through VAERS searches and for 38 cases through PubMed searches. Causality assessment using the modified WHO criteria resulted in classifying 3 cases as definitely related to vaccine administration, 12 as probably related, 16 as possibly related, 18 as unlikely related, 10 as unrelated, and 17 had insufficient information to assign causality. The physician satisfaction survey was returned by 30 (57.7%) of those surveyed and a majority of respondents (93.3%) felt that the CCCR service was useful.  The author's conclusion stated that the CCCR provides advice about AEFO to practitioners, assigns potential causality, and contributes to an improved understanding of adverse health events following immunizations.
This initial spontaneous case, was received from other health professional (nurse) on 20-Sep-2017, concerning a 19-year-old, adult female patient. The patient's historical procedures included removal of pancreatic tumor (on an unspecified date in May-2017) and appendectomy (on an unspecified date in Jul-2017). On 28-Aug-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5 ml, anatomical location: left deltoid, route of administration, batch number and expiry date: not reported). After 2 weeks of vaccination, the patient complained of bursitis, tendinitis, and difficulty in raising arms, which affected her tasks such as dressing herself and was treated with ice packs, ibuprofen and unspecified steroids. At the time of this report, the outcome of the events was not recovered (ongoing). It was reported that, the patient described that she has no pain when her shoulder was rotated actively but, she has pain when her shoulder was rotated passively. It was also reported that, the physician thought it would be related to muscle as opposed to bursitis or tendinitis. The reporter assessed the report as non-serious. Follow-up received from the reporter on 13-Oct-2017: The patient's age, historical procedure, anatomical location were updated. Narrative amended accordingly. Follow up received on 27-Oct-2017: The onset latency from 1 week to 2 weeks were updated. The narrative was amended accordingly.
Hep A vaccine was administered. Patient however received the adult dose which shouldn't be administered until patient is 19 years of age or older. Patient is only 18 years old. Contacted Merck and report issue.
he took second dose of Pfizer Vaccine on Friday evening (6/4/2021 around 5.30 pm) and following day (Saturday 6/5/2021) he had fever of around 101 degrees and he took tylenol and it made him better.  on 6/6/2021 he woke up he had swollen eyes, see below picture.Just wanted to let you know that this might be an allergic reaction to the vaccination so it can be recorded. He does not have any fever (his current body temperature is 97.7) and is able to breathe normally.- family called patient's uncle who is a physician, instructed to give Claritin in AM & PM 6/6/2021, on 6/7/2021 eyes still slightly swollen but improved
New onset Afib with RVR, chest pain and severe shortness of breath, woke from a sound sleep 3.5 weeks after second vaccination. Isolated incidence, no previous cardiac issues.
Fatigue, headache, slight dizziness, fever 2 days of 103, pain, myalgia.
This case was reported by a healthcare professional, via a sales representative, and described the occurrence of fainting in a subject of unspecified age and gender who was vaccinated with Boostrix for prophylaxis. On an unspecified ate the subject received unspecified dose of Boostrix (unknown). At an unspecified time after vaccination with Boostrix, the subject experienced fainting, joint pain and dizziness. This case was assessed as medically serious by manufacturer. At the time of reporting the outcome of the events were unspecified.
Pt was inadvertently vaccinated with the first dose of pneumococcal vaccine in the left arm, which expired on 5/1/99. Same day post vax, the pt experienced local swelling, pain, and warmth of the arm, along with flu-like symptoms. He was treated with Tylenol and an ice pack.
After receiving both shots, the patient fainted for 15 seconds. She came to feeling lethargic and nauseated. She was awake but closed her eyes. Her skin became cool and clammy. Pulse was weak. After about 20 minutes, 911 was called.
I had my 2nd vaccination over a week ago and since then I've had some symptoms that concern me; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (I had my 2nd vaccination over a week ago and since then I've had some symptoms that concern me) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (I had my 2nd vaccination over a week ago and since then I've had some symptoms that concern me). At the time of the report, VACCINATION COMPLICATION (I had my 2nd vaccination over a week ago and since then I've had some symptoms that concern me) outcome was unknown.            Concomitant product use was not provided by the reporter.  Action taken with mRNA-1273 in response to the events was not applicable.  Treatment information was not provided.
I was working at a university and that is why I got the shot there.  30 minutes after my 2nd shot, I was driving home and my heart started beating rapidly and it felt like I was having a asthma attack. I drove the apartment and laid down. I had the rapid heart beat and tiredness for several days. I had days where I was so exhausted I called in sick or worked from home. I still get tired easily , have rapid heart beats for up to an hour at a time and some days just take it easy.  I resigned from my job because I felt I could not function and I wanted to be closer to home where my doctors were located. I had only taken a day or two sick leave before my injection, but took many days after the shot.  I feel much better other than what I described above. I am reporting this because all news is talking about younger individuals. But I had/have the same symptoms and over 65.
INDIVIDUAL PRESENTED TO EVENT REQUESTING SECOND DOSE OF MODERNA SERIES. SHE STATED ON HER CONSENT THAT SHE HAD ONLY RECEIVED ONE DOSE PREVIOUSLY AND THAT SHE BROUGHT HER VACCINATION CARD WITH HER.  SHE RECEIVED SECOND DOSE. UPON ENTERING VACCINATION DATA, THERE WAS A RECORD OF HER HAVING RECEIVED 2 PREVIOUS DOSES 6/16/21 AND 7/12/21, THEREFORE THIS DOSE WOULD BE HER BOOSTER AND HALF-DOSE AMOUNT.
27 patients from 2 months -12 YO got Kinrix; This case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 7-Feb-2023 Reporter's comment: The reporter reported that total 27 patients of varying ages from 2 months through 12 years old received Kinrix. Exact ages correlating to number of patients was unavailable at this time.  The reporter did not had additional adverse event information at this time.  The reporter gave consent for safety team follow up. Additional supportive information: The patient received a dose of Kinrix at inappropriate age, which led to inappropriate age at vaccine administration. This was 1 of 27 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023019066:Same reporter/source case
Information has been received from a healthcare worker referring to multiple, unspecified patients of unknown age and gender. Information about patients' concomitant medications, concurrent conditions and medical history was not reported. On unspecified dates the patients were vaccinated with improperly stored doses of GARDASIL (dose and route not reported, lot # K010215 with expiration date 05-MAY-2017). No adverse effects were reported. This is one of two reports received from the same reporter (other linked case # 1603USA000669). Additional information has been requested.
This spontaneous report was received from a medical assistant and refers an unknown number of patients of unknown demographics. The patients' pertinent medical history, drug reactions or allergies and concomitant medications were not reported. The reporter stated that an unknown dates since 12-JAN-2017, the patients received an improperly stored doses of ROTATEQ orally (lot # L046318 with expiration date at 28-SEP-2017 and lot # reported as M014755 with expiration date at 30-OCT-2017; dose was not reported) for prophylaxis. The administered doses of vaccine were exposed to a temperature of 46 and 77 (unit not provided) for 39 minutes. No previous temperature excursion was reported. Data logger was used to track the temperature. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA000822: US-009507513-1702USA004072: US-009507513-1702USA004069: US-009507513-1702USA004070: US-009507513-1702USA004071: US-009507513-1702USA004066: US-009507513-1702USA004068.
ACUTE HYPOXEMIC RESPIRATORY FAILURE  11/24/2022 -- RECURRENCE OF SAME SYMPTOMS
On 04/10/2021 I had a severe pressure headache that lasted the entire day which led me to tears.  The headache was so severe I felt if you drilled a hole in the top of my head air would spew out.  Additionally, on 04/10/21 I had soreness in the injection site, some pain in the right shoulder blade which felt like an inflamed bursa, some fatigue,+ dehydration (cotton mouth-dry tongue). After 04/10/21-todayI have had mild headaches occasionally during the week. I had started to have a mild cough since 04/22/21.
Patient reports 4 days post vaccination after injection of pneumovax reaction.  Arm on back of left arm, not injection site, became reddened, some swelling and tender to touch x 2 days ago, then resolved.  No other symptoms to report.
HEART PROBLEM CAUSED BY THE VACCINE; This spontaneous report received from a consumer via a social media concerned a patient of unspecified age, sex, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 1 in total, dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced heart problem caused by the vaccine. On an unspecified date, the patient died from heart problem caused by the vaccine. It was unknown if an autopsy was performed. The reporter stated, " I have a relative who has passed away of heart problem caused by the vaccine as the forense reported". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).  Version created to amend previously reported information on 08-FEB-2022. Upon review the following information was amended: Amendment Adverse Event (the case validity assessment was updated to valid from the previously incorrect assessment of non-valid).; Sender's Comments: V1 - Version created to amend case validity assessment to valid from the previously incorrect assessment of non-valid. This does not alter previous causality assessment of the reported events  20220220915 -COVID-19 VACCINE AD26.COV2.S- Heart problem caused by the vaccine. 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). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: HEART PROBLEM CAUSED BY THE VACCINE
Friday evening, had itching and bumps around the injection site. Saturday, redness at the site. Later, it became warm to the touch and red. Saturday night, called nurse at the clinic, thought it was an infection. Called doctor, had a televisit. Told to take Benadryl, Tylenol and apply ice.
I am getting a shingles rash on my chest and back; I am getting a shingles rash on my chest and back; This case was reported by a consumer and described the occurrence of shingles in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, 20 days after receiving Shingrix, the patient experienced shingles and rash. On an unknown date, the outcome of the shingles and rash were unknown.   It was unknown if the reporter considered the shingles and rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received Shingrix about 20 days before the date of reporting and now experiencing shingles rash on chest and back.  The reporter asked if this was normal. No further information would be available.
2 year old was administered Kinrix; Kinrix dose instead of Pentacel; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-year-old female patient who received DTPa-IPV (Kinrix) (batch number G9N2M, expiry date 14-APR-2024) for prophylaxis.   On 06-MAR-2023, the patient received Kinrix. On 06-MAR-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: 2 year old was administered Kinrix) and wrong vaccine administered (Verbatim: Kinrix dose instead of Pentacel). The outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 17-MAR-2023 The licensed practical nurse (LPN) called to enquire, regarding any information on any harm to the patient. The reporter asked would the patient need another DTap or how to proceed. The LPN reported a 2 year old patient was inadvertently administered a Kinrix dose instead of Pentacel, at an alternate office listed on HCP account. The reporter consented to follow up.         The patient was inadvertently administered a Kinrix dose instead of Pentacel at inappropriate age, which led to inappropriate age at vaccine administration and wrong vaccine administered
arm stiffness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21Mar2021 11:30 (Lot number: EP7534, Expiration Date: 21Mar2021) at the age of 36 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Obesity" (unspecified if ongoing); "COVID-19 during Mar2020", start date: Mar2020 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: MUSCULOSKELETAL STIFFNESS (non-serious) with onset 13Apr2021, outcome "not recovered", described as "arm stiffness". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of musculoskeletal stiffness.  Additional information: The facility type vaccine was Pharmacy or Drug Store. No other vaccine was given in four weeks. No other medications were given in two weeks. It was unknown whether the patient had COVID prior vaccination. COVID not tested post vaccination. The patient was tested for common allergies and had no known allergies.  No follow-up attempts are possible. No further information is expected.
got first dose / 16 months ago and has not gotten the second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received intramuscularly, 16 months ago of the reporting date).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows:  The age at vaccination was not applicable for this report. Till the time of reporting patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not consent to follow up.
Inappropriate age at vaccine administration; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration) in a 17-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-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 ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment information in response to events was not provided.   This case was linked to MOD-2021-059995 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Apr-2021: No specific follow-up information recorded.; Reporter's Comments: This report refers to a case of Product administered to patient of inappropriate age, for mRNA-1273, lot # unknown, with no associated AEs.; Sender's Comments:  MOD-2021-059995:Crosslinked case
Client reported "tingling in back of tongue and throat."  Sensation lasted 15-20 minutes.  Resolved without medication intervention.  Client reported, "Sensation is gone.  I feel okay now."
Chest Pain in the morning after sleep Occurred twice before going to Emergency Dept. administered EKG and other test to rule out heart problems. They were in fact ruled out. Heart is in great condition.  Third episode of chest pains 3 days later and I now have Dr  appt in 48 hours
This past Sunday I was having chest pain with a burning sensation. I did not think much of it but the next morning when I got up my resting heart rate was 155BPM. I looked up a heart hospital and went to the ER there. They did a ton of tests EKG; CT Scan with Contrast; Ultrasound; and lab work. They did also give a medication to get my heart rate down. They found inflammation of sac around the heart and diagnosed me with Pericarditis. I was admitted to the hospital for four days and three nights. They put me on four new medications, and I have a follow up appointment in ten days.
Per student- " I got Hives over the weekend all on my arms and back, I had to put ice."  According to student, hives self resolving/improved and student did not seek treatment or take any medications.
Palpitations, HYPERtension, Tachycardia,  FLUHSED Narrative:  Employee had sudden onset flushing and palpitations. Initial vitals 186/96. P 92, Pulse Ox 100% at 10:20. Ice pack given and employee closely monitored. Repeat at 10:23 158/90, 86 and 100%. Repeat at 10:30 136/80, 81 and 99%. Repeat at 10:37 147/84, 77 and 99%. Employee reports all symptoms completely resolved. Has history of isolated HTN. Elected to return to work. Knows to contact occupational health if any new symptoms develop or symptoms return. Also knows ER is an option if needed.
This spontaneous report has been received from a certified medical assistant (C.M.A.) referring to an unspecified number of patients. On unspecified dates since 02-JUN-2015, these patients were administered an unspecified number of improperly stored doses of PROQUAD (Merck) (lot # K025760) subcutaneously (incorrect product storage). No adverse effects were reported. This is one of the two reports received from the same reporter. Additional information has been requested.