chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a licensed clinical social worker referring to an unspecified number of patients of unknown ages and genders. The patients' medical history, concurrent condition and concomitant therapy were not reported. On unknown dates, the patients might have been administered improperly stored GARDASIL (lot # M014929, expiration date 27-MAY-2017; dose and route were unknown). The vaccines were stored under temperature 11 Celsius degree for 17 days. There was no previous temperature excursion. Digital data logger was involved. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Hospitalist Discharge Summary    76 y.o.    Admit Date:  7/14/2022   Discharge Date:  7/25/2022    Principal Dx/ Final Dx: COVID-19 virus infection   Relevant Inpt Dx: Principal Problem:   COVID-19 virus infection Active Problems:   Generalized weakness   Parkinson disease       Follow-up Recommendations: #1 please take medication as prescribed #2 please keep follow-up appointments   HPI: As per Dr's Note:  "Patient is a 76 y.o. male with Parkinson's who came to the ER due to worsening generalized weakness. He usually moves around with a walker but now feels weaker than usual. He required full assistance in the ER. UA (-) for infection. Mg and BMP are normal. He tested (+) for Covid-19 infection, He had received the Covid-19 vaccine. He has been admitted."   Hospital Course:   Patient presented with generalized weakness. He was found to have COVID-19 infection. He was started on Remdecivir and he completed the full treatment. He was also evaluated by neurology for weakness due to underlying history of Parkinson disease. He was seen by physical therapy and they recommended placement which was arranged with the help of social services. Patient was recommended to follow-up with the neurology as an outpatient.     Unresolved issues requiring follow up (w/ labs or studies): None      @HOSPDCED@   Consults:   IP CONSULT TO NEUROLOGY IP CONSULT TO SOCIAL WORK IP CONSULT TO WOUND CARE   Significant Diagnostic Studies:    Positive COVID-19 test   Operations:  None    Wound care recs: None    Disposition:  SNF   Discharge Condition:  good
Arm became extremely sore on day 8, felt like I had been punched. On day 9, a red raised rash appeared that?s warm to the touch and feels like a bruise.
Patient stated that she was given the SHINGRIX vaccination in her left upper arm, at pharmacy, near the end of May. She states the day after the vaccination her arm at the site of the injection was red and painful. She states her symptoms have progressively become worse, and she can see where the needle entered her arm.
Rash on chest. Spread to abdomen. I took 20mg of prednisone I had on hand. Rash has not subsided
elevated levels of chromium; This is a spontaneous report from a contactable other HCP (patient).  A 39-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, NDC: 59267-1000-02), dose 2 intramuscular, administered in arm right at the age of 39-year-old on 07Jan2021 (Lot Number: EJ1685) as single dose for COVID-19 immunisation, tocopherol (VITAMIN E), route of administration, start and stop date and dose were not reported for an unspecified indication. Medical history included NASH (non-alcoholic steatohepatitis) from 2015 and ongoing. There were no concomitant medications. The patient previously took first dose of bnt162b2 (lot number: EJ1685) in left arm at the age of 39-year-old on 18Dec2020 for COVID-19 immunisation. Had elevated levels of chromium on 31Mar2021 and only took the vaccine and vitamin E during this period of time. It was asked if it was something related to the vaccine. Caller states she had two rounds of Pfizer COVID-19 vaccine on 18Dec2020 at 10Am and 07Jan2021 sometime in the afternoon. Caller states that all of a sudden come up with an extremely abnormal amount of chromium in her body. Caller states she just found out yesterday (31Mar2021) and the test was performed on 02Mar2021. Causality: Unknown. Caller states she has not taken anything else in the previous 90 days prior to the vaccine. No medications or supplements or anything, which is why they are concerned this is from the vaccine. Reporter seriousness for abnormal amount of chromium in her body was Medically significant. The patient underwent lab tests and procedures which included blood chromium: 2979 ug/kg on 02Mar2021, blood chromium: elevated/abnormal amount on 31Mar2021. The action taken in response to the event for tocopherol was unknown. The outcome of the event was unknown.; Sender's Comments: Based on known drug profile it is unlikely that the reported blood chromium: elevated was causally  related to bnt162b2.  This is probably an intercurrent  medical condition.  Case will be reassessed if additional information is received.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Patient presented to hospital on 7/22/08 with complaints of vomiting and diarrhea, temp 99.9 x 2 days.  Patient received Rotavirus vaccine on 7/18/08 at hospital, on 7/22/08 diagnosed with Rotavirus reaction vs viral, no treatment given.
pt recv vax & devel muscle aches, pain & cramps in both legs, especially calves, which lasted for 3 wk; pt recovered; pt recv 2nd dose of vax w/o problems;
This case was reported by a pharmacist and described the occurrence of bruise injection site in a subject of unspecified age and gender who was vaccinated with FLUARIX. On 11 October 2013 the subject received a dose of FLUARIX (.5 ml, subcutaneous, unknown arm) and experienced inappropriate route of vaccination. FLUARIX should be administered as an intramuscular injection and not injected subcutaneously. In October 2012, less than a week since vaccination with FLUARIX, the subject experienced bruise injection site, and swelling injection site. The reporter was not able to provide specific details as to the onset of the adverse events. At the time of reporting the outcome of the events was unknown. The pharmacist reported four cases with inappropriate route of vaccination, bruise injection site and swelling injection site. The pharmacist did not know if there were more than four employees that were given FLUARIX by subcutaneous route versus intramuscular route. See cases A0998033A, A0998039A, and A0998040A.
poor quality vaccine administered (with no reported adverse event); Initial information received on 19-Apr-2023 regarding an unsolicited valid  non-serious case received via physician.  This case involves Infant and unknown gender to whom poor quality vaccine hib (prp/t) vaccine [Act-Hib] administered (with no reported adverse event)  The patient's past medical history, medical treatment(s), concomitant(s) and family history were not provided.   On an unknown date, the patient received  suspect hib (prp/t) vaccine Powder and solvent for solution for injectionat dose of 0.5 ml (strength, batch number, expiry date: unknown) via unknown route in unknown administration site for prophylactic vaccination (immunization)  On an unknown date, vaccine act-hib  poor quality was administered (poor quality product administered) (same day latency) with no reported adverse event  Action taken was not applicable.  At time of reporting, the outcome was Unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. 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.; Sender's Comments:  01582774: 01576636:
first date vaccine in left arm .  Hurt arm after 2 days then stopped.    2nd vaccine right arm ok  1 week later 2 /26/21 left arm pain started . No physical injuries to left arm.  Dr said Mystery.  Had xray 2/18
Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. No information has been received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 16-SEP-2012, the patient was inoculated with ZOSTAVAX at a pharmacy for routine adult health maintenance and the intended purpose for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, the very virus the ZOSTAVAX vaccine is intended to prevent. On or about 30-JUN-2014 the patient was treated by a 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 reporter considered the events to be related to ZOSTAVAX. The outcome of the events was unknown. Additional information has been requested.
Patient developed seizures and ADEM.  8/21/207 ID consult sent from CDC dated 6/25/2007 for F/U of Acute demyelinating encephalomyelitis and possible vaccine reaction.  Infant presented to MD with fever and was prescribed abx for OM.  Received 4 month vaccines that day.  Fever continued for several days when a purplish discoloration was noted on the child's head.   TXd with steroids and abx.   8/27/2007 MR received for DOS 5/22-29/2007 for initial c/o fever and increased sleepiness. Child also had decreased po intake.  Continued decreased activity as well as development of choreiform movements noted during admission.  Discharge DX:  Acute Demyelinating Encephalomyelitis, 2' to unknown cause.  Pretreated CSF Pleocytosis.
Shortly after receiving flu immunization patient experienced extreme pain in his back. He sat down and continued to have pain. He walked into an exam room to lay down. He was examined by a provider. After 10 minutes the back pain was no longer present.
Broke out in hives on  evening of 1/15. Treated with Benadryl at home.  Hives continued the next day. After taking more Benadryl, felt lightheaded and faint. Went to Urgent Care and was given 3 day course of prednisone. Hives began to come back 1/21. Continuing to treat with hydrocortisone cream and occasional benadryl.
A non-serious spontaneous report of dizzy and lightheaded has been received from a registered nurse/health professional concerning a 47-year-old male, subsequent to H1N1, Intranasal. Neither relevant medical history nor concomitant medications have been reported for this patient. On 17-Dec-2009, the patient received H1N1, Intranasal, for an unknown indication. Few minutes after receiving H1N1 vaccine, the patient experienced dizzy and lightheaded. The patient was doing better at the time of report. The outcome for the reported adverse events was resolving at the time of reporting.
Information has been received from a registered nurse concerning a patient of unknown age and gender. Patients' pertinent medical history, drug reactions or allergies were not reported. On 30-DEC-2015, the patient received an improperly stored dose of PROQUAD (Merck) with the lot # L032761, expiration date 24-FEB-2017 and (dose, route and anatomical location of administration were not reported). The condition storage was 7F for 10 minutes. There was previous temperature excursion with 8F for 40 minutes and 18.2 F for 5 minutes. No concomitant therapy was provided. No adverse effects or reactions to this vaccines were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Sweating, nausea, dizziness. BPs 88/60 (pulse 72), 104/90 (pulse 68). Water given. O2 sats 100%.
I don't remember the exact time of onset but that afternoon I felt very fatigued, so I went to bed, and everything felt heavy to lift like my arms and legs. I went to bed and the next day I was still tired and had that feeling of heaviness in legs and it lasted most of that day and towards the evening I started feeling a little better and on the third day I was okay.
Pt. left without stating she was in pain, but the next day (11/13), about 24 h. later, she said the pain started right after the shot, & she was in alot of pain that night.  She also had some bleeding that soaked thru the bandaid.  On 11/13 at 2 pm she still had pain in upper arm and left side of neck. Now (11/14 at 10 am) she states there is no more discomf, in her arm, but mild discomf. in neck with movement.
This spontaneous report was received from a physician via company representative, concerning a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 08-JAN-2016, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (lot number L024129; expiration date 21-JAN-2017) "10 PK 0.5 ml SD-PFS LLok w tip" (route of administration and anatomical location were not reported). On an unspecified dates, the PNEUMOVAX 23 had one temperature excursion of 120 hours. The lowest recorded temperature was 34 F. No adverse effects reported and no product quality complaint was involved. The vaccine status was reported as "in excursion". The vaccine storage criteria and the storage type of excursion were reported as "Refrigerator(R)". This is one of several cases from the same reporter. Additional information has been requested.
Patient came to the vaccination site to receive a second dose in their Moderna vaccine series. Due to the patient having severe special needs and being very anxious and agitated, redundancy was overlooked and the patient was given a Pfizer dose.
This spontaneous report as received from a pharmacist via a company representative refers to a female patient of unknown age. On an unknown date the patient was vaccinated with expired PNEUMOVAX 23 (lot# 669379/0453AA). No adverse event was reported. It was unspecified whether the patient sought for medical attention. The outcome was unknown. Additional information is not expected.
Narrative: patient experienced dizziness and nausea 7-8 hours after receiving the COVID vaccine.
Patient was brought to EMS room due to stating history of dizziness with first covid vaccine, as well as shakiness and anxiety. At 1627 c/o shakiness and mild dizziness. 1700 states patient states she feels much better, sat on cot w/o dizziness, stood and tolerated well.
On 10/18/16 reported persistent pain from shoulder to elbow in left arm and decreased range of motion in left arm since receiving influenza vaccine in left arm, required physical therapy for improvement of symptoms.
Developed a fever of 102F and a generalized macular rash.  Otherwise well.  No URI symptoms.
This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a female patient who received SHINGRIX. Concomitant products included Valacyclovir. 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 injection site swelling, influenza-like symptoms and injection site erythema. On an unknown date, the outcome of the injection site swelling, influenza-like symptoms and injection site erythema were recovered/resolved. It was unknown if the reporter considered the injection site swelling, influenza-like symptoms and injection site erythema to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. On an unknown date, approximately two months ago, the patient received a dose of SHINGRIX vaccine in right deltoid and experienced redness and swelling at the injection site and flu like symptoms that all lasted for three days and then resolved without need for any treatment or intervention. The patient notified her physician of the events and was counseled by the physician to call them back if symptoms had not resolved within the week. The limited report was filed with available information. The reporter declined to provide further details for the report.
Immediately after receiving the vaccine, patient developed sensation of throat numbness in the back of the throat. Patient denied SOB, wheezing, throat swelling, stridor, rash, chest pain, tongue swelling. One dose of diphenhydramine 25 mg PO suspension and referred to the Mount Sinai emergency department. Sensation resolved after a total of 30 minutes (10 minutes after receiving diphenhydramine). Vital signs and physical exam were WNL with the exception bilateral submandibular adenopathy. Patient was observed in the ED for approximately one hour with no clinical change and was subsequently discharged home.
Systemic: light headed and fell in parking lot after wating 15min in the store. bruised right knee-Mild, Additional Details: ems called by bystander. she was here with daughter. ems checked bp, sugar, temp. all were within normal limits. rph called to check on her at 2.15pm. no response. eill call again. ems think she missed her step and fell. she had not eaten  by 1230 when fall happened. on bp med. no injection site rxn. picked redness because i had to pick one
Patient described chills and achiness, as well as, right legs soreness and pain. Enough pain that the patient had to stay off the leg. The leg pain had been occurring since the vaccine was given the other symptoms subsided. The patient did indicate there was a previous injury to this leg years ago.
This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) Batch/lot number: EK9231, intramuscularly into the left arm on 05Jan2021 at single dose for covid-19 vaccination. Medical history included in Dec2020 around 23Dec2020 she tested positive for Covid-19. There were no concomitant medications. Patient said that because of the time of her retirement, she went to the VA and got the vaccination the first week of Jan2021. She said that with the first vaccination she said that she had chills, fever, and her arm hurt real bad. She said that her symptoms came on during the night. She mentioned she had experienced some side effects which went away after a few days. She had herself tested last 06Jan2021 (also reported as 07Jan2021, pending for clarification) for Covid-19 antibodies which turned out positive and PCR which turned out negative. The outcome of the event "Covid antibodies which turned out positive" was unknown, while outcome of other events was recovered in Jan2021.
Patient reports sore throat and runny nose, which has subsided. He also reports fatigue, which is mild, he states all symptoms have been mild.
large raised red rash on left arm. appeared in ~24 hours, lasted for ~4 days
This case was reported by a pharmacist and described the occurrence of nausea in a 30-year-old female patient who received HAVRIX 360 Junior. Co-suspect products included Thyroid Tablets for an unknown indication. On 3rd December 2014, the patient received the 1st dose of HAVRIX 360 Junior. On 2nd December 2014, the patient started Thyroid Tablets (oral) at an unknown dose and frequency. On 3rd December 2014, less than an hour after receiving HAVRIX 360 Junior, the patient experienced nausea (serious criteria disability), vomiting, cramp, abdominal pain and underdose. The patient was treated with invert sugar, EMETROL. On an unknown date, the outcome of the nausea, vomiting, cramp and abdominal pain were not recovered/not resolved and the outcome of the underdose was unknown. It was unknown if the reporter considered the nausea, vomiting, cramp and abdominal pain to be related to HAVRIX 360 Junior. Additional details provided: The pharmacist who reported the incident was also the patient. The events required medical attention at the doctor's office. The reporter was not aware of any adverse events following previous vaccinations.
Complex Partial Seizure. Drool. I have epilepsy. However I was six free on the current medication and I started to have them regularly.
In addition to the known side effects of fever, chills, body aches, headaches, and brain fog, my menstrual cycle occurred about 10 days post what it should have started in February.  In March menstrual cycled started about 5 days later than in February. On April 3, 2021 started to have eye pain, was diagnosed with a chalazion cyst on April 7.  Cyst is on the eyelid of left eye.  I have never had issues with cysts or swelling of any kind.
Twelve hours after vaccine I felt like I was freezing and hot at the same time. I had muscle cramps and complete body fatigue and felt like I had the flu. I couldn't get up and do my usual thing, I'm really afraid to take the next shot if it's going to be worse than the first one.
sepsis; surgery to put stent in; Blood pressure dropped to 70/20; kidney stone; A spontaneous report was received from a consumer who is an 80-years-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced sepsis, kidney stone, stent replacement and ended up in ICU and blood pressure dropped to 70/20.    The patient's medical history included 6 months of chemo and cataracts surgery in both eyes (not specified).   The concomitant product was not provided .   On an unknown date prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: Unknown) in the right arm and patients second dose was scheduled on 25-Feb-2021 for prophylaxis of COVID-19 infection.  On an unknown date, after vaccination patient experienced sepsis, put the stent in and ended up in ICU and blood pressure dropped to 70/20/ blood pressure low (18-Jan-2021) and kidney stone.  The patient was hospitalized for sepsis,  stent replacement and ended up in ICU and blood pressure dropped to 70/20/ blood pressure low.  On 04-Mar-2021, she was going to have surgery to have kidney stone which was 9cm long removed and to have stent replaced.  Treatment information was not provided.  Action taken with respect to  mRNA-1273 in response to the events.  The outcome of the events was not reported for all events.; Reporter's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested. However, the events of kidney stone and stent replacement are unlikely because the kidney stone was preexisting  and the procedure of stent replacement was planned for a later date.
10/21/09 Received DTaP, HIB, Polio, S. Pneumonia & Rotavirus Vaccine   10/21/09  Significant swelling at injection sights on both thighs.  Awoke screaming and could not console for 30-40 minutes.  10/23/09  11:00pm  awake and suddenly started screaming for no apparent reason. Screamed as if in pain for an hour.  Started to show signs of respiratory problems. Sneezing, dry hacking coughing, slight clear nasal discharge.  Also showed signs of digestive discomfort. Excessive gas. Refused normal amount of formula, from 5oz to 1-2oz.  10/24/09  Morning, Diarrhea. Formula consumption still off.  Breathing raspy.   10/25/09  Taken to pediatrician due to respiratory problems. Pediatrician states airway is swollen and is being treated with Predisone.
Over 24 hours after vaccination, patient reported to primary provider with complaints of facial swelling, dyspnea, and cough. Was then admitted to hospital for close airway monitoring