chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report has been received from a physician via a company representative referring to a patient of unknown age (the neighbor of the physician's mother). The patient's medical history and concurrent condition were not reported. On an unknown date the patient was vaccinated with an unidentified Merck HPV vaccine (name and lot number not provided) (GARDASIL or GARDASIL 9 could not be ruled out). Concomitant therapy was not reported. It was reported that on an unspecified date the patient was "paralyzed" after being administered the vaccine. The outcome of "paralyzed" was unknown. It was unknown if the patient sought any medical attention. Upon internal review, the event of "paralyzed" was considered to be medically significant and resulted in disability. Additional information has been requested.
This case involves patient of unknown demographics who reported got sick right after it while receiving vaccine INFLUENZA VACCINE. The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided. On an unknown date, the patient received an unknown  dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, formulation, frequency,  lot number and expiry date was not reported via unknown route in unknown administration site) for prophylactic vaccination. On an unknown date the patient developed a non-serious event "got sick right after it" (illness) (unknown latency) following the administration of INFLUENZA VACCINE. It was reported" I got mine 8 years ago got sick right after it. Haven't had a shot since and haven't had the flu ." Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable. It was not reported if the patient received a corrective treatment for the event (got sick right after it). At time of reporting, the outcome was Unknown for the event got sick right after it.
Redness and swelling in left delotoid 50x50mm. Advised to use cool compresses and tylenol.
For about 24 hr - chills, widespread muscles aches, sensation of "skin hurting" - took acetaminophen, recovered about 48 hr after the injection. Painful area of heat, edema, erythema about 10 cm X 9 cm at injection site. Still there at this time, but less swollen. Painful to touch and itchy, but probably resolving. No signs of allergic reaction (I, the patient, am an RN).
Systemic: Cardiac Disorder (diagnosed by MD)-Mild, Systemic: Chest Tightness / Heaviness / Pain-Mild, Additional Details: patient was diagnosed with mild pericarditis following chest xray and given antiinflammatory medications and order to avoid exercise until feeling well.
Pt states that it started being sore and painful the night after receiving the vaccine. High fever, Soreness, redness and itchiness spread away from the injection site and we went to her Dr. Dr informed her that it's cellulitis from the Prevnar shot and will require antibiotics. she also had to take Benadryl because it was severely itchy.
Bilateral Red rash covering upper torso; Painful, burning sensations throughout effected area; Painful, burning sensations throughout effected area; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old female patient received bnt162b2 (BNT162B2) (Lot number: FC3183) at the age of 49 years as dose 2, single and (Lot number: FC3184) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: RASH ERYTHEMATOUS (non-serious), outcome "recovered", described as "Bilateral Red rash covering upper torso"; PAIN (non-serious), BURNING SENSATION (non-serious), outcome "recovered" and all described as "Painful, burning sensations throughout effected area". The events "bilateral red rash covering upper torso", "painful, burning sensations throughout effected area" and "painful, burning sensations throughout effected area" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of rash erythematous, pain, burning sensation.   Additional information: It was reported hospitalization prolonged no. Patient received treatment for AE was oral corticosteroids. No covid prior vaccination. It was reported covid tested post vaccination: yes. The patient was not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not received any other medications within 2 weeks of vaccination. Device date was 22Dec2021.  Follow-up attempts completed. No further information expected.
This spontaneous report as received from a physician refers to an unknown number of patients. Case 1 of 6 of the same reporter (related cases 1211USA005837, 1211USA005838, 1211USA005839, 1211USA005840 and 1211USA005841). An unknown number of patients was vaccinated with VAQTA in 2012. No other co-suspects were reported. No concomitant medications were reported. The patients were administered vaccines that had been improperly stored for the last six months. No treatment information was reported. No adverse event was reported. Additional information has been requested.
Patient came to the clinic van to receive his COVID-19 booster. The Pfizer booster (0.3ml dose was given however, the vaccine was not correctly prepared. The vial was diluted with 0.6ml of 0.9% of sodium chloride instead of 1.8ml. The error was noted after the administration of vaccine. The provider, patient, Pfizer manufacture and medical organization was made aware. Pfizer emailed directives/information regarding this incident and advise patient be monitored. The patient stated no signs on 12/16/21and 12/17/21. Patient will continue to be monitored for the next 48 hours. Patient also advised of ER precautions. Medical organization has began their post-investigation of incident and will implement appropriate actions with staff who committed error.
Within 5 minutes post injection, pt reported dizziness, tachycardia ("heart beating out of chest"), pain & tingling radiating through injection arm & through left side of neck, acute flushing, hypertension, and disorientation. Thought she might have been feeling her throat swell but wasn't sure since she has severe anxiety and recent neurological symptoms (ocular headaches). Suggested to administer IM diphenhydramine 50 mg but since pt stated that she has phobia of needles so IM injection may exacerbate symptoms. Since pt's airways were clear, administered PO benadryl 50mg. After 10 mins, pt reported pain & tingling, extreme tachycardia had subsided but was starting to feel abdominal pain radiating to back. Still felt disorientation. Continued to monitor. After 20 mins post vaccination, decision was made to call EMS (pt previously refused since it was unclear which party would be responsible for EMS services). EMS arrived less than 5 mins later, took BP, and suggested to go to ER. Pt declined being taken by EMS and instead had her mother drop her off. The next day, pt's mother came back to pharmacy to indicate that pt was treated with additional diphenhydramine and was stable.
Moderna COVID-19 Vaccine EUA (2nd shot) Severe lightheadedness for 1.5 hrs. beginning 2 hours after shot Fever (101.4) and chills beginning 2 hours after shot lasting 2 days Stomach pain after eating lasting 4 days Diarrhea beginning 9 hrs. after shot, lasting 10 hours
Patient came to pharmacy on the evening of 2-13-18 at approximately 7 pm. She stated that the evening that she received shot she experienced extreme pain in her arm and was hardly able to lift it. This progressed to large area of redness from the deltoid to about half way down to the elbow. Area was hard with constant itching. When she came to the pharmacy she stated that she had gone to see her doctor because she was concerned that it was still red so long after the shot. She said her doctor told her to come to our pharmacy and have us fill out this report. She also stated that the doctor had recommended she use cold compress and BENADRYL for itching.
Information has been received from a health professional concerning an approximately 41 month old female who on 12/31/2003, at 10:15am, was vaccinated with a first dose in the left arm of varicella virus vaccine live (lot 646535/0575N). Concomitant vaccine administered at the same time included a third dose in the left arm of Pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (PREVNAR) and a fourth dose in the right arm of diphtheria toxoid + pertussis acellular Biken vaccine + tetanus toxoid Tripedia. it was reported that the patient now, on approximately 5/23/2005, has chickenpox characterized by 50 to 250 lesions and a fever of 100.1F. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Follow up information from a health professional indicated that the patient recovered. Additional information is not expected.
No Adverse event. On 11/03/2021 the Vaccine Refrig data logger showed a temperature excursion occurred on 10/29/2021 at 10:48 a.m. of +50.7 (F). The timeframe documented is 13 mins with n 5 min alarm notification totaling 18 min. The vaccine providers were not aware that the vaccine needed to be used within a 24 hour timeframe of the excursion prior to discussion with the health department on 11/3/2021. A clinic was scheduled for Moderna Booster doses at a High School (AIM) for their employees for 11/1/2021. This clinic did occur with the Moderna Vaccine with Lot # 076C21A between the hours of 3:00-5:00 p.m. A total of 16 people received Moderna Booster shots 0.25ml.The vaccine provider learned on 11/3/2021 in conversations with the health department that due to the excursion, the vaccine should be discarded if not used within 24 hours of the temperature excursion. With the instructional education provided via the health department, all remaining doses of Moderna with Lot# 076C21A was wasted.
Received vaccines at 2:30 pm office visit on 5-13-09. By 8:30 pm child had facial swelling and eyelid swelling. Poor feeding, swelling of injection site. And was taken to ER where child was given BENADRYL. No labs done. Swelling decreased in 45 min-1hr.
COVID Arm      3-4 Inch red, swollen, hive with itchiness'.
Onset of fever 102.5 and cough within hours of administration of flu vaccine. States something happened with administrate of 2016-2017 vaccine w/associated vomit at that time.
Information has been received from a pharmacist concerning a 65 year old female with no known allergies and arthritis, who on 29-AUG-2007 was vaccinated with Zostavax (Oka/Merck) (Lot# 658081/0743U) subcutaneously in the left arm. There was no concomitant medication. A couple of days after receiving the vaccination, the patient experienced odd pain in the jawline (which side unspecified) up to the ear (unspecified). The patient took amoxicillin on 03-SEP-2007 for what was thought to be an abscess. The patient saw a dentist who could not find a problem. An X-ray showed the nerves seem irritated. The X-ray showed "blackened" and cloudy appearance around the nerve. As of 10-SEP-2007, the patient's pain was better but still present. Additional information has been requested.
The initial case was missing the following minimum criteria: unidentifiable patient. Upon receipt of follow-up information on 14Sep2015, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable medical assistant on behalf of physician, via a Pfizer sales representative. The medical assistant reported for 6 patients. This is the first of the six reports. A 18-year-old female patient of an unspecified ethnicity received second dose of TRUMENBA (Lot# J28923, exp date Jun2016), intramuscular in the right deltoid, on 18Aug2015 at 10:11 am, at 0.5 ml single. Relevant medical history was not reported. Concomitant medication included JUNEL FE from 04May2015 and ongoing daily, for birth control. The patient previously received first dose of TRUMENBA, intramuscular in the right deltoid, on 02Jun2015, at 0.5 ml single. On 18Aug2015, approximately 2 hours after receiving vaccine the patient experienced dizziness, headache (severe), chills, shaky feelings and vomiting. She was advised to increase hydration and lay down/sleep. Events recovered on 19Aug2015. Then on an unspecified date the patient had extreme pain in the arm where the vaccine was injected, like to the point that could barely lift the arm and described it as dead arm; these events lasted about 7 to 10 days after the injection and recovered on an unspecified date. The reporter considered that the adverse events were due to TRUMENBA. Patient will receive TRUMENBA in Dec2015. Follow-up (01Oct2015): New information from the same healthcare professional on behalf of physician includes: vaccination history/scheduling, event details, concomitant.
It's a facial spasm on the left side close to my left eyebrow. The same side as my Bell-s palsy. And it was initially intermittent and then became more persistent and by late April my Doctor prescribed me a 6 day steroid. And it has since become intermittent again. So it's better but still present. I was referred to a Neurologist and just completed an MRI.
Injection likely in joint w/severe pain/for 7-10 days. Followed-up with wife 11-16-10. Almost resolved with small amount of residual pain. However he had difficulty sleeping for several nights and flu-like symptoms for at least a week.
It is alleged that the aforementioned vaccines were contaminated and adulterated with mercury based thimerosal. It is also alleged that the pt was first diagnosed and discovered to have mercury poisoning and related mental, physical and neurological injuries less than one year from 8/21/01. This was considered to be an "other medical event". No further information is available.
within 2 minutes of receiving (covid) vaccine. mild rash and pruritus. poss. allergic reaction. all symptoms resolved within 10 mins. Elevated BP, recommend that she follow up with PCP. monitor for any return of symptoms over the next 4 hours. 11:30 174/89 p92 r20 o2 100% 11:51 178/96 p80 r16 o2 100%
took paxlovid as they had covid-19 even though they have the 2 vaccines and a booster from Pfizer; took paxlovid as they had COVID-19 even though they have the 2 vaccines and a booster from Pfizer; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 78-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single for covid-19 immunisation; 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's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "took paxlovid as they had covid-19 even though they have the 2 vaccines and a booster from Pfizer"; COVID-19 (medically significant), outcome "unknown", described as "took paxlovid as they had COVID-19 even though they have the 2 vaccines and a booster from Pfizer". Therapeutic measures were taken as a result of drug ineffective, covid-19. Consumer also stated: that her husband had a mild headache but he took aspirin. She also took Paxlovid and had a headache and the also took an aspirin for it. She states that she suffers from headaches from time to time, but not her husband even though he I 78-years-old. He is always in good shape. They both took Paxlovid as they had COVID-19 even though they have the 2 vaccines and a booster from Pfizer.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300038589 same reporter/product/event, diff patients;
MY WHITE BLOOD CELLS AND PLATELETS DROPPED TO CRITICAL LEVELS AND I HAVE BEEN IN AND OUT OF THE HOSPITAL MANY TIMES FOR PLATELET TRANSFUSIONS. MY PAST LAB RESULTS HAVE SHOWN NORMAL LEVELS. I HAVE BEEN A SYSTEMAIC HOWVER DO SHOW SIGNS OF BRUSING AS MY PLATELETS FALL INTO CRITICAL NUMBERS. THIS HAS BEEN GOING ON SINCE LATE MAY UNTIL CURRENT DATE. DUE TO ALL THE TEST COMING BACK NEGATIVE I HAVE BEEN DIAGNOSED WITH ITP. AND IS BELIEVED TO HAVE OCCURED FROM THE VACCINE SINCE NO PRIOR HISTORY
Pt recvd vax & was found to be pregnant; exp a miscarriage; MD did not consider this event out of the ordinary for this pt;
PT REACTED TO ANTHRAX VACCINE AFTER 4 DAYS OF RECEIVING THE IMMUNIZATION. PT WENT TO THE ER FOR COMPLAINS OF HIVES AND WAS GIVEN ATARAX AND PREDNISONE.
Have not had a second dose/did not recomment to get the second dose since they were in error/deviation of the 21-42 day time frame; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Have not had a second dose/did not recomment to get the second dose since they were in error/deviation of the 21-42 day time frame) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Have not had a second dose/did not recomment to get the second dose since they were in error/deviation of the 21-42 day time frame). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Have not had a second dose/did not recomment to get the second dose since they were in error/deviation of the 21-42 day time frame) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatments were reported.   Most recent FOLLOW-UP information incorporated above includes: On 14-Sep-2021: Event verbatim updated.
PN given in right gluteal and area red and sore shortly after given. Seen Dr 11/18/2005 and given cortisone injection, increased redness and swelling this am.
This case was reported by a pharmacist via call center representative and described the occurrence of pruritus in a 33-year-old female patient who received TWINRIX (batch number Z75Y2, expiry date 15th March 2020). On 8th November 2017, the patient received the 1st dose of TWINRIX 1 ml. On 10th November 2017, 2 days after receiving TWINRIX, the patient experienced pruritus. On an unknown date, the outcome of the pruritus was unknown. The reporter considered the pruritus to be possibly related to TWINRIX. Additional details were provided as follows: The patient experienced itching. The reporter reported that patient also did hot yoga in the interim so registered nurse thought there were confounding factors and it might not had been due to the vaccine. It was asked (via phone) if issue had resolved and the health care professional stated that he was unsure. It was reported that he was not the person who administered the vaccine, so was gathering this information second-hand.
LEG CRAMPS; SLEPT ALL DAY; FELT LIKE LITTLE BRUISE; PAIN WHERE NEEDLE PUNCTURED  SKIN; TIRED/EXHAUSTED/NEEDED A NAP; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. 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: Unk) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers.   No concomitant medications were reported. On an unspecified date, the subject experienced leg cramps, slept all day, felt like little bruise, pain where needle punctured skin, and tired/exhausted/needed a nap. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pain where needle punctured skin, felt like little bruise, tired/exhausted/needed a nap, slept all day and leg cramps was not reported. This report was non-serious.
Received immunization at 14:00 on 01/07/2005 then at 16:00 developed screaming , blotchy rash on back of neck and chest. + scratching palms and soles lasted approx 6 hours. Treated with Tylenol and Benadryl. All symptoms resolved.
got her 1st dose at 11 yr of age and 2nd dose at 16 yr and now she was possible given another Menactra at 18 yrs/no side effects; received Menactra instead of Meningococcal B/no side effects; Initial information received on 26-Aug-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp and additional information recieved on 29-Aug-2019.  This case involves an 18 years old female patient who got her 1st dose at 11 yr of age and 2nd dose at 16 yr and now she was possible given another menactra at 18 yrs. no specific symptoms reported (extra dose administered) and received MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] instead of MENINGOCOCCAL VACCINE B (wrong vaccine administered) lot number not reported, via unknown route in left deltoid on 24-Aug-2019.  The patient's past vaccination(s) included first dose of MENACTRA at 11 year. The patient's past medical history, medical treatment(s) and family history were not provided.  No other vaccines were given on that day.  It was a case of actual medication error due to wrong vaccine administered and extra dose administered. It was reported that Caller stated that pharmacy stated that is what they gave her daughter but caller is not convinced. Caller stated her daughter did not need another meningococcal vaccine, just the B portion and she thinks her daughter was given the full meningococcal vaccine. The patient received a Menactra instead of a Meningococcal B.  The patient did not experience any adverse event following vaccination.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Batch number was requested.  List of document held: none.
Febrile convulsion on 12/27/00; seen in ER at 00:47. Return if fever persists or any other concerns or if has another seizure. Should see a doctor within 2 days.
quarter size ring on lt arm where DTP was administered; pt c/o pain in arm since vax was administered till 19APR94; most pain observed when arm kept immobile like p/sleeping all noc;
Initial report received on 24 August 2011 from a health care professional. This is a case of misuse where a patient inadvertently splashed vaccine in her eye while drawing a dose from a multi-dose vial. A female patient with no concurrent illnesses had been drawing up a dose of FLUZONE (lot number UH454AB) from a multi-dose vial on 24 August 2011 when she inadvertently squirted some in her eye. She flushed her eye, but an unspecified amount of time later, which was on the same day, she experienced burning in her eyes, and numbness of her tongue. At the time of this report, the burning in her eyes and numbness of her tongue had subsided, but she was experiencing a sore throat. It was not reported whether she required medication evaluation or not. The patient had not received any other vaccinations within 4 weeks prior to 24 August 2011. At the time of this report, the patient had not recovered. Documents held by sender: None.