chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age.  The patient's medical history, concurrent conditions and concomitant medication were not provided. It was alleged that the patient was inoculated with a dose of ZOSTAVAX vaccine (dose, route, lot # and expiration date were not provided) on or about 25-JAN-2013 at a clinic, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 24-FEB-2014, the patient was treated by her physician at a clinic for a painful rash that was diagnosed as herpes zoster, or shingles. The patient was prescribed valacyclovir (VALTREX) for treatment and management of her symptoms. As a direct and proximate result of these malfunctions, 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, pain and suffering and other damages. Additional information has been requested.
Admitted to hospital 9/21/2021 with cough, fever, SOB, acute hypoxemic respiratory failure. Placed on oxygen, plan for Remdesivir, Solumedrol, cefepime or azithromycin.  Client vaccinated for Covid - Pfizer 2/10/2021, 3/3/2021 and booster 9/15/2021. Flu vaccine reportedly also given 9/15/2021.  Submitter does not have access to information on further hospital course, discharge date, or outcomes. If further information is needed, please contact admitting hospital:
Initial solicited report received on 01 April 2016 from a research analyst participating in the below-mentioned study. This case involves an unknown age, race and gender subject who had a reaction of an unknown descriptions. Medical history and concomitant therapies details were not reported. A doctor during research commented that a subject had called him on a Saturday night claiming that the subject had an influenza shot of unknown manufacturer, which was not administered by the doctor. The subject had received the immunization at an unknown location, probably a grocery store, and administered by an unknown heath care professional at an unknown time. The subject was claiming to have a reaction of an unknown description. The doctor told the subject that he would not take responsibility or advice care as he had not administered the vaccine. The type of reaction was unknown. The manufacturer, brand and presentation of vaccine was unknown to the physician. The lab data and corrective treatment details were not reported. The outcome of "reaction of an unknown descriptions" was unknown at the time of report. Relationship to investigational product according to company: not associated. Relationship to investigational product according to reporter: not reported. List of documents held by sender: none.
reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (reaction). At the time of the report, VACCINATION COMPLICATION (reaction) outcome was unknown. Not Provided          Concomitant medications were not provided. Treatment details were not provided; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Exactly 24 hours after vaccine received, symptoms started and then continued for exactly 12 hours: - Mild Nausea - Headache -102 degree fever - Severe chills and sweats
patient had three anaphylactic reactions in 2021, patient did not share this information prior to vaccination.  No contraindication boxes were checked on the consent form. throat felt funny, epi given in vaccine clinic and patient taken to the ED.  pre-medicated with 50mg benadryl at 0700, solumedrol and benadryl given.  Lab staff member. HR 87, SpO2 100 monitored in the ED.  Additional EPI given.  Admitted as observation.
Welts on my other arm; This case was reported by a consumer via interactive digital media and described the occurrence of welts in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced welts. On an unknown date, the outcome of the welts was unknown.   It was unknown if the reporter considered the welts 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 and had welts on other arm.
A few minutes after receiving the vaccine, patient complained of feeling dizzy, nauseated, having chills, and of her heart beating too fast. Patient alert and oriented. She called her mother to tell her how she was feeling. Heart rate increased from 100 to 150 five minutes later. EMS services called. Patient left via ambulance to hospital accompanied by a friend.
left arm red; left arm itchy; vomiting two times; slit rash over her body, pink, little thing in the skin; Nausea; Chills; feverish; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Feb-2021 and was forwarded to Moderna on 08-Feb-2021.    This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Feb-2021 and was forwarded to Moderna on 08-Feb-2021.    A spontaneous report was received from a consumer concerning herself, who is a 81-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events left arm red, left arm itchy, vomiting two times, slit rash over her body, pink, little thing in the skin, chills, nausea, feverish.  The patient's medical history was blood pressure, also allergic to panicillin. Concomitant medications reported were blood pressure medicine.  On 29 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) through unknown route in the unknown location for prophylaxis of COVID-19 infection.  On an unknown date, 8 days later after first dose the patient experienced the events left arm red and itchy , color, collapse two times, slit rash over her body, pink, little thing in the skin. After taking paracetamol patient experienced chills, nausea and feverish.  Treatment details included paracetamol.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events left arm red, left arm itchy, vomiting two times, slit rash over her body, pink, little thing in the skin, chills, nausea, feverish was unknown.
Started with a minor head ache at about noon. By 6pm I had a severe back ache and the headache increased to heavy. As the evening progressed I developed chills, but also massive sweating; my clothes and sheets were soaked. My whole body ached and I was unable to sleep. I was dizzy upon standing. Chills and sweating lasted until about 9am the next morning. Headache and body ache has continued throughout the next day.
Symptoms include: vaginal spotting (blood) (not on period at the time), headache, urinary tract infection
This case was reported by a other health professional via call center representative and described the occurrence of shingles in a female patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter had a patient who experienced shingles shortly after vaccination. The reporter attempted to research if she should still get the 2nd dose of the vaccine and if so at what point but was unable to locate any pertinent information regarding this. The reporter was asking for this information. No additional information was provided.
This case was reported by a consumer via call center representative and described the occurrence of irritability in a 4-month-old male patient who received PEDIARIX (batch number XT73A, expiry date unknown) for prophylaxis. Co-suspect products included INFANRIX (batch number 2N43Z, expiry date 4th December 2020) for prophylaxis. On 31st December 2018, the patient received PEDIARIX .5 ml and INFANRIX. On 31st December 2018, unknown after receiving PEDIARIX and INFANRIX, the patient experienced overdose. On 1st January 2019, the patient experienced irritability. On an unknown date, the outcome of the irritability and overdose were unknown. It was unknown if the reporter considered the irritability to be related to PEDIARIX and INFANRIX. Additional details were provided as follows: The physician said the patient was a healthy 4 month old as far as any medical history. Mother of the patient reported that the patient received a PEDIARIX dose as well as a INFANRIX on the same day, which led to an overdose of DTaP component. On 1st January 2019, 1 day after receiving PEDIARIX and INFANRIX, the patient experienced irritability. The physician called back on 4th January 2019 and stated that he followed up with the mother of the patient and the patient did experience some irritability the next day.
This case was reported by a nurse and described the occurrence of injection site reaction in a 4 year old male pt who received DTAP (Infanrix) for prophylaxis. The vaccine provider submitted this report directly to the local health department. On 05/07/03 the pt received the 5th dose of Infanrix in the left arm. On the same date, he received an injection of IPV in the left arm and MMRII in the right arm. On 05/08/03, 24 hours post-immunization, the pt experienced an injection site reaction characterized by pain, swelling and inflammation. The pt also experienced irritability and low-grade fever. The events resolved by 05/10/03.  The nurse considered the events were related to vaccination with Infanrix.
Patient called on 6/19/18 and reported that the injection site was very itchy and experience hives around the site. She applied BENADRYL cream and took an oral BENADRYL. No shortness of breath reported. She reported that she felt better after using the BENADRYL.
pt recv vax in 1987 & devel numbness in temples & difficulty swallowing; pt did not cont the series; subsequently exp a lack of response following vax w/4 doses of Hep B-MSD & 1 dose Engerix-B
I experienced intermittent chest pain  a few days after receiving the shot lasting around  4 or 5 days afterwards.    I checked my pulse and it seemed steady.  Since it was intermittent and didn't stay and my pulse seemed steady  I didn't seek medical care.
Received by error Havrix pediatric formulation instead of Engerix-B; 6 month male baby, received by error Havrix pediatric formulation instead of Engerix-B; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 6-month-old male patient who received HAV (Havrix pediatric) (batch number 9R5LC, expiry date 24-NOV-2024) for prophylaxis.   Previously administered products included Hepatitis B vaccine (1st dose received on an unknown date) and Hepatitis B vaccine (2nd dose received on an unknown date).   On 23-JUN-2023, the patient received Havrix pediatric. On 23-JUN-2023, an unknown time after receiving Havrix pediatric, the patient experienced wrong vaccine administered (Verbatim: Received by error Havrix pediatric formulation instead of Engerix-B) and inappropriate age at vaccine administration (Verbatim: 6 month male baby, received by error Havrix pediatric formulation instead of Engerix-B). The outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   Additional Information: GSK receipt date: 27-JUN-2023 The patient had no previous hepatitis A vaccination. The reporter consented to follow up. 6-month patient received by error Havrix pediatric formulation instead of Engerix-B, which led to wrong vaccine administered and inappropriate age at vaccine administration.
DTAP given on 1/14/02. On 1/19/02, had a bright red area at vaccination site, which enlarged over several days; felt warm and firm. On 1/19/02 through 1/23/02, had hives scattered on her trunk. Exam on 1/21/02 of vaccination site showed a 6cm X 5cm area of redness with central 2cm X 2 1/2cm of cleared skin, whole lesion mildly raised, small firm nodule but no diffuse induration. Non-tender. Stopped Amoxicillin/Augmentin; trail of these drugs again on 2/13/02 with no reaction.
Thrombocytopenia with bruising and mild epistaxis and petechiae likely ITP.
headache, congestion, Fatigue, body aches, cough COVID-19 +
Pt came in on 8-27-2017 and complained right arm where ZOSTAVAX injection given very red, swollen, and warm to the touch. Started day after injection and became worse. Pt is following up with MD to see if any follow up treatment is required.
Breakthrough COVID Case: Symptoms started May 7th with a sore throat that kept getting worse. I took multiple rapid tests that came back negative. The night of the 12th, I had a fever and coughing that kept me awake and a negative rapid test. On the 13th, I went to Urgent Care to get a strep test. Strep test was negative. They gave me a PCR test. They also gave me a steroid for my throat. The PCR test came back positive Saturday, the 14th. The sore throat got better over the next couple of days. The cough got worse for a couple of days. I also had a slight fever on the 15th. Tested negative on the 20th with a rapid test.
Pt recvd vax 5JUN92 & exp low back pain, uneasiness when still, nerovus energy which classified as an anxiety type reaction; also had difficulty resting or sleeping;
Suspected vaccination failure; had 4 episodes of Shingles; This serious case was reported by a other health professional via call center representative and described the occurrence of vaccination failure in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included psoriatic arthritis, cholecystitis, psoriasis, vocal cord paralysis, episcleritis, thyroiditis and immunocompromised. Additional patient notes included Current condition was reported as crones.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: had 4 episodes of Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 30-OCT-2023 Reporter was a healthcare professional calling as a customer. The reporter stated that after receiving the Shingrix Vaccine she had 4 episodes of Shingles. Shingrix vaccine series was given as per PI instructions in the year 2021. Concomitant product included tumor necrosis factor Medication. The reporter was an immunocompromised patient who called today to inquire about clinical study information and how to become a participant in clinical studies. The reporter consented to follow up. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Info has been received from a male pharmacist who on 12/03/2002 was vaccinated in the left deltoid with a dose of pneumococcal vaccine 23 polyvalent (Lot #643251/0445M). Post-vaccination the pt experienced left arm pain, redness, and swelling from the deltoid to the elbow. It was unknown if medical attention was sought. A product quality complaint was not involved. Additional info has been requested.
client came in with mother presented Id, client was vaccinated and sent to observation area. left deltoid injection tolerated well, no issues to report monitored for 40 minutes and released after reporting no issues. mom aware of vaccine restrictions.
I woke up with swollen lymph node in my neck and my arms pits; Elevated pulse; Sweating; Severe sore throat; weakness; Body ache; I couldn't even function and get out of bed; I am still kind of feeling off; Fatigue; I couldn't swallow; This is a spontaneous report from a contactable consumer (patient).  A 36-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK5730 and expiration date Mar2021), intramuscular on 17Dec2020 16:00 at single dose for prevention of COVID-19 at a outpatient clinic. The patient's medical history and concomitant medications were not reported. It was reported that the patient got the vaccine on the 17th he got the vaccine around 4 o' clock and later that evening about 11 o'clock at night he woke up with swollen lymph node in his neck and his arms pits, with a elevated pulse and sweating and a severe sore throat where he couldn't swallow and body ache and that subsided in a couple of hours after that. But he was with body ache and weakness for almost three days after that to a point where he couldn't even function and get out of bed still with sore throat and after three days it subsided. But he was still kind of feeling off and general weakness. The patient had had blood work, which he did not know the specific name of test that he had done, it was for a physical, it was just regular laboratory work. The result of the blood work was unknown. No treatment was received for the events. Also reported that for the most of above events improved, just the fatigue was persistent. The outcome of the event fatigue was not recovered, for the rest of events was unknown.
BODY ACHES; CHILLS; SORE ARM; MILD FEVER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. 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: Unknown) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAR-2021, the subject experienced body aches. On MAR-2021, the subject experienced chills. On MAR-2021, the subject experienced sore arm. On MAR-2021, the subject experienced mild fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, chills, sore arm, and mild fever on MAR-2021. This report was non-serious.
This case was reported by a consumer and described the occurrence of injection site rash in a 12-year-old female patient who received MENVEO for prophylaxis. Co-suspect products included BOOSTRIX for prophylaxis and FLULAVAL QUADRIVALENT (2018-2019 season) for prophylaxis. On 21st December 2018 16:15, the patient received MENVEO, BOOSTRIX and FLULAVAL QUADRIVALENT 2018-2019 season. In December 2018, 15 hrs 15 min after receiving MENVEO, BOOSTRIX and FLULAVAL QUADRIVALENT 2018-2019 season, the patient experienced injection site rash, injection site hives, injection site itching, injection site pain and injection site erythema. The patient was treated with ZYRTEC and BENADRYL. On an unknown date, the outcome of the injection site rash, injection site hives, injection site itching and injection site pain were unknown and the outcome of the injection site erythema was recovering/resolving. It was unknown if the reporter considered the injection site rash, injection site hives, injection site itching, injection site pain and injection site erythema to be related to MENVEO, BOOSTRIX and FLULAVAL QUADRIVALENT 2018-2019 season. Additional information was provided as follows: The patient received 3 shots at her 12yr annual exam on 21st December 2018 at 4:15pm. She received two shots in her left arm and on shot in her right arm. There were no issues during the 15-minute wait and no issues through the night. In December 2018, 15 hrs 15 min after the patient experienced injection site rash, injection site hives, injection site itching, injection site pain and injection site erythema. The patient received MENVEO,BOOSTRIX and FLULAVAL QUADRIVALENT. The records are unclear as to which vaccine was placed in each arm and on her left arm had a rash the size of two silver dollars and two hives at the site where she received the two shots. The area was itchy and painful. The patient called the Dr. who recommended ZYRTEC or BENADRYL. The patient administered one pill of ZYRTEC 10mg at about 9:00 am on 22nd December 2018. The redness seemed to be clearing.The patient would continue to monitor.
Information has been received from a physician concerning a now 29 year old female patient who was diagnosed with Bell's palsy 2 days after receiving her first dose of VARIVAX (Merck) 10 years ago in 1999 approximately at age of 19 year old. There was no concomitant medication. The symptoms resolved after 6 months (date unknown) and the patient fully recovered. Unspecified medical attention had been sought. Upon internal review, bells palsy was determined to be an other important medical event. Additional information has been requested.