chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a licensed practical nurse referring to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies and concomitant medication were not provided. On unknown dates in 2016, the patients were vaccinated with unspecified improperly stored doses of PROQUAD (lot # M014301, expiration date 22-SEP-2017; dose and route were unknown) for prophylaxis. No adverse effects were reported. The excursion temperature included 9.9 Fahrenheit degree for 30 minutes on 10-AUG-2016 and 24.4 Fahrenheit degree for 1 hour and 30 minutes on 25-AUG-2016. Data logger was involved. No product quality complaint (PQC) was involved.  Albumin status for PROQUAD M014301 is rHA (recombinant human albumin). As of 21-DEC-2016, all telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.; Sender's Comments: , MERCK 1610USA009666:Mfr number.
Expired Bexsero administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 16-year-old female patient who received Men B NVS (Bexsero) (batch number unknown, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 21st July 2022, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 21st July 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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: 22-Jul-2022 Reporter's comment: The pharmacist reported that they had a customer (patient) who got Bexsero vaccine one day before the reporting date and after they gave the shot, they realized the vaccine was expired. The reporter did not had date of birth or lot number at time of interaction. The reporter consented to follow-up via postal. Additional supportive information: The patient received an expired dose of Bexsero, which led to expired vaccine used.
Patient was administered the adult pfizer vaccine in error. Patient reported fever, fatigue, sore arm for the next 2 days, and improvement of symptoms on the 3rd day.
Extreme fatigue for two weeks; This is spontaneous report received from consumer (Patient). A 69-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: Not reported), via an unspecified route of administration on 07Feb2021 at 2:00 PM (at the age of 69-years-old) as dose 2, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. Historical Vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EL3247), via an unspecified route of administration, administered in left arm on 20Jan2021 at 2:00 PM (at the age of 69-years-old) as dose 1, single for COVID-19 immunisation and experienced more intense fatigue. On an unspecified date after second dose, the patient experienced extreme fatigue for two weeks. The patient stated that the fatigue was more intense with the first vaccine. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Fever/chills, decreased appetite.   ED visit for chest pain day 3 post vaccination
This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, 2 days after receiving SHINGRIX, the patient experienced influenza-like symptoms, nausea, chills, pain and joint pain. On an unknown date, the outcome of the influenza-like symptoms, nausea, chills, pain and joint pain were recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms, nausea, chills, pain and joint pain to be related to SHINGRIX. Additional details were provided as follows: This case was reported by patient's husband. The age at vaccination was not reported. Few days ago, from the date of reporting, the patient received SHINGRIX and experienced flu-like symptoms, aching, joint pain, chills and nausea. The symptoms lasted for approximately 1 day. The reporter did not wish to provide any additional details. The patient wished to remain anonymous and did not wish to provide any additional details regarding the vaccine or event. This case has been linked with the case US2018195288 (patient's husband), reported by same reporter.
On 4/21 Vaccine transported refrigerated and upon arrival to the clinic, vaccine placed in freezer.  On 4/28 vaccine placed in refrigerator and 6 patients received vaccine.  Per manufacturer, patients that received the vaccine is within the excursion allowance  as well as the time period it was stored. Temps ranges from -50 c to -15 c  (freezer) storage between 24 and 2 weeks is a supported excursion.   Per manufacturer, remaining doses are not recommended to be used and will be discarded with wastage reported in immunization information system,
Rash occurred (B) thighs with (R) worse than (L) 3 days after vaccine administration. Rash is erythematous with <1 mm papules.
This case was reported by a consumer and described the occurrence of rigidity in a male patient who received BOOSTRIX for prophylaxis. On an unknown date, the patient received BOOSTRIX at an unknown dose. On an unknown date, unknown after receiving BOOSTRIX, the patient experienced rigidity (serious criteria hospitalization), high temperature and allergy. BOOSTRIX was discontinued. On an unknown date, the outcome of the rigidity, high temperature and allergy were unknown. It was unknown if the reporter considered the rigidity, high temperature and allergy to be related to BOOSTRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient's mother reported that the patient was deathly allergic to the pertussis vaccine. She was asking did this was taken into account for people like patient. The patient wound up in the hospital with an extremely high temperature and rigidity. The patient tested for meningitis but the test results was showed to be negative. The reporter said, the patient would never have the shot for pertussis ever again, not even the booster shot. Lab Comments: On a unknown date, the patient did laboratory test.
High nuchal translucency/ potential cystic hygroma.  I am currently 14 + 3 and baby is measuring at 15 +1. At 11 +5 babies nuchal translucency measured 8.4 mm, at 12 +6 - 5.4 mm, and at 13 + 0 - 4.5mm. We have another week before the CVS results come back. Im 26 y/o , it's septated, generalized to the neck alone, and so far no other issues seen on the level 2 ultrasound. I have two healthy daughters 1 y/o and 3 y/o with no known issues and no issues during pregnancy.  My estimated due date is January 29, 2022.
This spontaneous report was received from Registered Nurse (R.N.), via a company representative, referring to a male patient of unknown age. The patient was allergic to NEOSPORIN. Other relevant medical history was not reported. In approximately June 2016 (reported as 1 to 2 months ago), the patient was vaccinated with the first dose of GARDASIL 9. Dose, route, lot # and anatomical location were not reported. It was stated that later that night the patient became very weak and sick to his stomach and vomited twice. The patient's parent sought medical attention and called the physician. It was not a product quality complaint involved. At the time of reporting the patient had no recovered from events. The causality assessment between the events and the suspect therapy was not reported. Additional information has been requested.
Temp 102 - lethargy - body aches (L) arm "red and sore".
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 30-JUN-2008, the patient was inoculated with ZOSTAVAX by a physician as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On or about 08-Sep-2015, the patient was treated bya physician for a vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment.  As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.  The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Information has been received from a nurse concerning a "few" female patients, demographics not provided, that had complained their arm had gone numb at the injection site where GARDASIL was received (unspecified dose and date of vaccination); however, no additional AE information was provided.  Additional information is not expected.  This is one of several reports from the same source.
3-6 hours post injection, hives, pruritis, and mild SOB developed.  Left arm (injection site) became very swollen and indurated and warm.  Benadryl and prednisone dispensed and most symptoms abated except still pruritis at injection site.  Nurse follow up on 10/30/04 states: "Nausea; vomiting; allergic reaction."
Information has been received from a nurse practitioner concerning an approximately 9 week old female patient with history of being premature baby and pneumonia and others unspecified who on approximately February 2009 (at 2 months) was vaccinated orally with her first 0.2 ml dose of ROTATEQ. In approximately February 2009 (a week later) the patient came down with the rotavirus. The patient sought unknown medical attention. Lab diagnostic tests were performed: unspecified which ones. The patient recovered on an unspecified date. The patient still finished the series and was fine after the rest of the doses of ROTATEQ. No further information provided. Follow up information has been received from a physician concerning the 9 week old female patient with prematuration and no illness at time of vaccination who on 02-DEC-2008 was vaccination orally with the first dose of ROTATEQ (Lot # 663234/1473X). The patient's sibling developed diarrhea at 7 years old without vaccination. On 06-DEC-2008 the patient developed diarrhea. Stool sample was sent for rotavirus ova and parasite examination on 09-DEC-2008 and antigen was positive on 10-DEC-2008. The final report verified at 10:55 on 10-DEC-2008 was antigen detected. The patient recovered on 08-DEC-2008. Additional information is not expected.
Stage IV small-cell lung cancer with brain mets, malignant receiving treatment spiked a fever and tested for COVID
Patient received his booster around 1pm on Monday, January 3rd. His wife said he was still in bed at noon on Tuesday and had severe muscle weakness. He could not get out of bed at all. He then started with severe, uncontrolled diarrhea. He was so weak that he could not get to the bathroom or out of the bed. Wednesday morning the diarrhea had continued and the patient fell. His wife came to the pharmacy around lunch time to report his reaction. She had called his PCP and was told to get Imodium and feed him a bland diet.
Since starting the COVID-19 vaccine in January 2021, I started having heart issues. I have a heart attack in May of 2022.It was mild, but I wasn't thinking much. I got a stint in place and been under cardiac care and they changed my blood pressure. I have been taking medicines for 6 or 7 months. Lately I have been declining in my health. I recently checked my blood pressure, and it was high, but I felt fine. This morning it was extremely high 189/185. I was scared and went on about my morning. I took my meds blood pressure and blood thinner. I have had another change in my health, a constant state of dizziness and this erratic blood pressure. This all very strange.
Severe local reaction at injection site within 36 hr. 8cm raised indurated lesion on (R) thigh with vesicles in center more raised area
Dtap given right thigh, Hib given left thigh 8 days ago.  Swelling and lump on right thigh about 3 cm   with less swelling and lump on left thigh (1.5 cm) with bruising on both thighs  No fever, sterile abscess,  no treatment needed.
It started with a cough, sore throat, a little fever, congestion, and really bad wheezing.
This spontaneous report as received from a healthcare worker regarding a patient of an unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 04-MAY-2015, the patient was vaccinated with VARIVAX (Merck) (lot # K011082, expiry date 08-AUG-2016) which was exposed to temperature excursion of 25F for 41 hours. No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Needlestick; Initial Report Received on 07-Jun-2022  An adult nurse practitioner in the reported that 23-year-old female patient (race and ethnicity unknown) received a needlestick while emptying a garage can 2 weeks after her last dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  No medical history at the time of vaccination was reported.   No concomitant medications at the time of vaccination were reported.  On 07-Apr-2022, the patient received the first dose of HEPLISAV-B (Lot # 937231, expiration date 30 Jan 2023, NDC # and route unknown) in the left deltoid.   On 25-May-2022, 49 days after receiving the first dose of HEPLISAV-B, the patient received the second dose of HEPLISAV-B (Lot #, expiration date, NDC #, route, and injection site unknown).   On an unspecified date in Jun-2022, approximately 2 weeks after the last dose of HEPLISAV-B, while emptying the garbage can, the patient received a needlestick.  The patient did not report any adverse effects.  No additional information was provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Emp with severe hearing impairment since 2003. She states that she developed tinnitus for 2 days then developed even more profound hearing loss/ almost none at all upon day 3 after vaccine. Hearing is starting to improve. Not back to her baseline yet though.
Admitted on 2/17/2021 2nd dose injected on 2/20/2021 Shortness of breath died on 03/04/2021
Starting 06/18/2022, I had congestion which worsened and then included coughing, wheezing and a fever of 101 for a few days and body aches. I tested positive on 06/18/2022. The body aches were the worst around Tuesday 06/21/2022 to the point where I didn't want to move and my joints hurt a lot as well. My congestion gradually got better up until yesterday. My aches are becoming more infrequent. My fever has resolved. I still have coughing spells and have only needed to use my inhaler 1x or 2x. I have been taking mucinex to help with congestion and staying hydrated. On day 5, I still tested positive. I will go back this coming Tuesday (07/05/2022) and I am still experiencing fatigue, feeling out of breath if I exert myself and coughing spells. I am continuing mucinex to keep the mucous thin so that I don't have trouble breathing. My congestion is not fully resolved but its getting better and the mucinex is helping that. Also, all the food I ate tasted metallic and as of today its better but still present. Also, my face was very sensitive and my normal face wash bothered my skin.
how long the soreness lasts after the shot?; This case was reported by a consumer via call center representative and described the occurrence of pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd March 2020, the patient received the 1st dose of Shingrix. In March 2020, less than a week after receiving Shingrix, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group of the patient was not provided but selected as an adult as per vaccine indication. The patient reported that, after vaccination had soreness and asked how long it would last.
Caller is an HCP reporting an expired dose of MMR II (Lot: T033814, Expiration Date: 5OCT2022) was accidently administered to a patient.; This spontaneous report was received from a nurse and referred to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On an unknown date in October 2022, the patient was accidently vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) subcutaneous injection (0.5 milliliter (ml) /once, strength, anatomical site of vaccination and route of administration were not reported, lot #T033814, expiration date was reported and validated as 05-OCT-2022) for prophylaxis (expired product administered). No additional clarifying statements or details were provided.  This is one of two reports from same reporter.; Sender's Comments:  US-009507513-2211USA005029:MSD
Anaphylaxis; This serious case was reported by a other health professional via call center representative and described the occurrence of anaphylaxis in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced anaphylaxis (Verbatim: Anaphylaxis) (serious criteria GSK medically significant). The outcome of the anaphylaxis was resolved.   It was unknown if the reporter considered the anaphylaxis to be related to Shingrix.     It was unknown if the company considered the anaphylaxis to be related to Shingrix.   Additional Information: GSK receipt date: 29-Jun-2023 The field staff reported a case of anaphylaxis after Shingrix immunization for a staff member of a client. The reporter learned of the event while taking with office staff of one of her contacts. The event happened perhaps as much as a year ago and the patient reported it at the time. The patient was not hospitalized, but there were no lasting effects. The patient wished to be remain anonymous and did not provide consent to contact her physician because this was a long time ago and she already reported. The reporter did not consent to follow up.
Aches, fever, exhaustion. Approx 24 hours beginning 8 hours after receiving shot.
On Sunday, January 17, 2021 I started having severe joint pain in my wrists, elbows, knees, hips and shoulders. Along with aching all over. Over the course of the day, I started to feel bad. Then on Monday January 18, 2021, in addition, to the joint pain, I started feeling disoriented, dizzy like spells of vertigo.  I went to my PCP who did lab work and all was normal. He said it muse be delayed reaction to the vaccine. Later in the day, I was having difficulty putting words together and more dizzy and very lethargic. I laid down and slept until the next morning. (Tuesday 1/19/21) On Tuesday 1/19/21, they symptoms were improved but still had some dizziness. On Wednesday 1/20/21, the symptoms have improved except for an occasional dizzy spell.
This spontaneous report as received from a registered nurse refers to a 4 month old patient. The patient's concurrent conditions, medical history and drug allergies were not reported. On 10-NOV-2016, the patient was vaccinated with improperly stored ROTATEQ, oral, (dose not reported) from lot # M014544 with expiry date: 27-NOV-2017 for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information is not expected as all correspondence has been received. Sender's Comments: US-009507513-1610USA008140: US-009507513-1610USA014705:
Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium
This spontaneous report was received from a registered nurse and refers to multiple unspecified patients of unknown age and gender. The patients' concurrent conditions and medical history were not provided. On unknown dates, the patients were vaccinated with improperly stores doses of M-M-R II, lot numbers L015280, expiry date 30-APR-2017; L026553, expiry date 16-JUL-2017; L027432, expiry date 22-JUL-2017 and L032181, expiry date 25-AUG-2017; (doses and routes were not reported). Concomitant therapies were not provided. According to the reporter, the vaccines were stored at a temperature of 11.1 degrees Celsius for 1 hour and 36 minutes and also at a temperature of -12.3 degrees Celsius for 1 hour and 33 minutes (excursion dates were not reported). No adverse symptoms were reported. No product quality complain (PQC) was involved. Additional information has been requested.
DTaP given 4/15/03. In health unit on 4/17/03; left deltoid red, swollen with induration 2.75"x2.75". Small amount bumps in inner at injection site about .5" diameter. Arm warm to touch; no fever.
Now in full-on menopause after my doctor tested my TSH and FSH in March 2021 and said my #s were good.
Pt scheduled an immunization online, didn't have covid card and got a second bivalent booster
Patient was brought to pharmacy by nursing home for second covid shot. The facility did not have COVID card and were going to bring it up after getting the patient returned. Intern confirmed with nurse aid and patient this was 2nd dose of Moderna Vaccine. Intern did not check the system and when nurse aid brought COVID card back to pharmacy to be completed, the patient had received first dose of Pfizer vaccine in March 2021. Went ahead and completed card for second dose and Moderna information, spoke with nursing director and advised to watch for any signs and symptoms of reaction, but felt that there was minimal risk since patient was past due on the Pfizer series.
My daughter began feeling dizzy immediately after flu mist vaccination was administered.  Within 10 minutes, she had a severe headache. Within 15 minutes, she had a slight fever, which escalated to 102.9 within 1 hour.  She was treated with ibuprofen and aceteminophen (alternately) to bring her fever down and lessen her headache pain.  We returned to the doctor's office where they took her temperature and blood pressure and gave her a dose of ibuprofen. They told us that the onset of her symptoms and the administration of the flu vaccine was "coincidental".
I received the flu vaccine at primary's office to my (R) deltoid and within 45 mins-1 hour I started feeling pain to my (R) arm that progressed to my shoulder joint area. I thought it was expected discomfort from injection, but its been almost 2 months and the pain is worse. It's constant pain that affects my sleep and ADL's.