chrisvoncsefalvay/vaers-outcomes huggingface dataset:
only received the diluent and not the powder of 2 vial Menveo; only received the diluent and not the powder of 2 vial Menveo; This non-serious case was reported by a nurse via sales rep and described the occurrence of inappropriate preparation of medication in a adolescent male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: only received the diluent and not the powder of 2 vial Menveo) and inappropriate dose of vaccine administered (Verbatim: only received the diluent and not the powder of 2 vial Menveo). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 16-Aug-2023 The patient was coming in on 17th August 2023 to get entire vaccine. The reporter consented to follow-up. The patient only received the diluent and not the powder of 2 vial of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Fatigue; Chills; Shaking; Body aches; Muscle pain; Nausea; Initial MOD-2020-001401  A report was received from a physician concerning a male patient of unknown age and race participating in the mRNA-1273 Emergency Use Program and experienced fatigue, tiredness, muscle pain, body aches, chills, shaking, feeling cold, nausea, achy, and the verbatim term of "felt run down".  The patient's medical history was not provided.  No relevant concomitant medications were reported.   On 23 December 2020 at 4pm prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (BATCH# 011J20A) by injection for prophylaxis of COVID-19 infection.     Patient experienced fatigue, tiredness, muscle pain, body aches, chills, shaking, feeling cold, nausea, achy, and the verbatim term of "felt run down", on the same day as the injection start date. It is unknown if patient has recovered from the events. No treatment was administered to treat the events.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events fatigue, tiredness, muscle pain, body aches, chills, shaking, feeling cold, nausea, achy, and the verbatim term of "felt run down" was not reported.   The causality assessment of the reported events fatigue, tiredness, muscle pain, body aches, chills, shaking, feeling cold, nausea, achy, and the verbatim term of "felt run down", is unknown to the study drug.; Reporter's Comments: This case concerns a male patient of unknown age. The patient's medical history was not provided. The patient experienced the expected event of fatigue, myalgia, chills, nausea and unexpected event of Pain, tremors, feeling cold and feeling abnormal. The event occurred the day the first dose of mRNA-1273 (BATCH# 011J20A) was administered. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
At 11:39am, patient & wife mention that patient has history of passing out. Then suddenly, patient started to feel lightheaded & dizziness. Patient loss of conciousness and was lay down to the floor assisted. Patient was diaphoretic, loss of conciousness for about 1 to 2 mins, VS#1 130/90, 68 & 98%. Patient regain conciousness, alert & oriented. At 11:46am, VS#2 132/100, 96% & 71 sitting down. Transfer to wheelchair & monitored for 30mins, 11:54 VS#3 130/70, 97% & 66. At 1209, VS#4 140/90, 97% & 67 on standing position, denies dizziness, lightheadedness, SOB & with steady gait. Patient able to go home with wife. No s/sx of distress.
Since the beginning of September I have extreme issues with my menstrual cycle.  I have always been "normal".  Now I have had 5 periods since September.  They come and go from being light to extremely heavy in flow.  The cramps are very severe.  These symptoms are not normal for me.
Sore arm first evening then it went away, it did wake me up that night; Sore arm first evening then it went away, it did wake me up that night; The caller's friend then tested positive for Covid 19 on 24Jan2021./The caller has had a rapid Covid test and xray in the ER and both were neg for Covid 19; This is a spontaneous report from a contactable consumer.  A 78-year-old female consumer reported that she received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number unknown), at single dose on 07Jan2021 for COVID-19 immunization. She is due for her 2nd dose 30Jan2021. Medical history and concomitant drugs were unknown.  Following the 1st vaccine dose she had a sore arm first evening then it went away, it did wake her up that night.  In addition she reported that has friend she took to the ER with rectal bleeding on 23Jan2021. and the caller spent the whole day with ''in a couple feet" of her friend. The caller's friend then tested positive for Covid 19 on 24Jan2021.  The caller has had a rapid Covid test and xray in the ER and both were neg for Covid 19. She is wondering if this can effect her getting her 2nd shot. Further the caller is "suppose to take someone in for a hip replacement tomorrow am and then pick up 1-3 days and she was supposed to stay at her house following surgery. She wondered if it is safe to take care of her. The friend  having surgery received her first vaccine shot 07Jan2021.  Information on the lot/batch number has been requested.
Increased pain at site: warmth, erythema, inflammation at injection site-erythema 9cm x 8cm; inflammation is 6cm diameter. Body aches; temp 99 degrees. Td given 8/20/02. Seen 8/23/02.
after the 1st dose she had a rectal rash that was "very bad." /then got the same rash on her inner elbow of the injection arm; taking an antibiotic for a recurrent urinary tract infection; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (BNT162B2, Solution for injection) via an unspecified route of administration on 05Jun2021 (Batch/Lot Number: EW0186) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. Two weeks after the first one, the patient had a rectum rash really bad. She also had a rash on her inner elbow on the same arm the vaccine was given on. The patient was taking an antibiotic for a recurrent urinary tract infection on an unspecified date. She stated that she was currently taking an antibiotic for a recurrent urinary tract infection she had and wanted to make sure it was okay to get the vaccine as scheduled this weekend while taking her antibiotic. She just wanted to know if these were side effects. She asked that do they have to eat certain foods or eliminate prescriptions after getting the vaccine. The outcome of the events was unknown.  Information on batch/lot numbers are available. Further information has been requested
I am not 100% certain of this event being related to the vaccination with the Moderna COVID19 shot or not.  However, in the interest of completeness and for investigative purposes, I am reporting to you the event in relation to the vaccination as the patient reported to me.  She received the vaccination on 2/14/2021 and became very confused.  She had significant left arm swelling much worse than when she had her first vaccination.  Her husband brought her to the emergency room and she was eventually discharged, but she went on to develop significant hypertension and she reported that her blood pressures were normal prior to the vaccination.  She had an emergency room visit in which her systolic pressures were well above 240.  She revisited the emergency room and had elevated blood pressures of 240 and was diagnosed with hypertensive encephalopathy and later found to have posterior reversible encephalopathy syndrome or PRES.  We have started the patient on medications, and started laboratory work-up for secondary hypertension and her blood pressures have improved with treatment.  We discussed the case with the neurologist, who suggested that we repeat MRI scan to make sure that her punctate lesions noted on MRI on this admission on 2/25/2021, have resolved.  It was advised that if they had not resolved that we should call neurology again.  Hypertensive encephalopathy is rare and press syndrome as a result is also rare.  It is for this reason that I am reporting this event as again, I am not trying to mislead anyone or distort information, but should this be an adverse effect of the vaccine I wanted to make sure that this was reported as the patient's history prior to the vaccination and developing this complication post vaccination are temporally related at a minimum.  The patient is a known smoker but quit on the 14th of this month.
Patient was given VZV vaccine after she answered no to pre-screening questions. However, a urine pregnancy test done after vaccine given was positive. (few days after). Pt is about 5 weeks pregnant. Denies any reaction.
Patient had flu like symptoms for first few days then resolved. 1 week later developed warmth, redness and induration around the site. Tender,.  No fever, cough or SOB just tenderness and induration
PATIENTS BLOOD PRESSURE WENT VERY HIGH, SHE GOT DIZZY AND HAD MUSCLE PAIN IN THE NECK AND IN THE BACK
Information has been received from a 72 year old female patient with allergy to sulfa medications and sulfides and penicillin who on 30-DEC-2011, was vaccinated with a second 0.5ml dose of PNEUMOVAX 23 (Lot # 671554/1297AA). In 2002, the patient received the a first dose of PNEUMOVAX 23 without incidence (dose, route and lot# were not reported). Concomitant therapy included gabapentin and baclofen and "provacol". On 30-DEC-2011, right after receiving the vaccine, the patient experienced "soreness at the sight" and on 30-DEC-2011, that night, the patient noticed redness in her arm. On 31-DEC-2011, in the morning the patient developed " a prickly heat like pimply rash". On an unknown date the patient started to have pain in her left groin, which turned into weakness in her left side. The pain was to the point that the patient did had to lift her legs manually to tie her shoes this pain began within the last few days. It was reported that routine tests were done before adverse event took place. The patient's treatment included BENADRYL. The patient did not seek medical attention. At the time of the report patient's outcome was not recovered. Upon internal review, Weakness in left side was determined to be an other important medical event. Additional information has been requested.
No side effects with the exception of minor irritation at injection site, until 96 hours later, sever flu like symptoms, chills, nausea - which lasted around 1 day.  Feeling much better at this point but the delayed response was unexpected.  I'm fairly sure there wasn't another event that prompted the symptoms but anything's possible.
injection site pain 5 weeks after getting 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (injection site pain 5 weeks after getting 2nd dose) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 036A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INJECTION SITE PAIN (injection site pain 5 weeks after getting 2nd dose). At the time of the report, INJECTION SITE PAIN (injection site pain 5 weeks after getting 2nd dose) outcome was unknown.            Concomitant medication was not provided. Treatment information was not provided.    Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: NNI
Information has been received from a pharmacist concerning multiple unspecified patients of unknown age or gender. No concurrent condition, medical history and concomitant therapies were reported. On unspecified dates in 2016, the patients received doses of improperly stored M-M-R IK subcutaneous Injection (lot # L026553 with expire date of 16-JUL-2017, dosage and route not provided). The vaccine was stored under was 9 C for 27 hours. The excursion was started on 19-APR-2016. Previous temperature excursion was included in hours assessment. No adverse effects were reported. Additional information has been requested.
Patient was given a Pfizer 12+ Bivalent booster. Patient waited in the exam room for 20 minutes+ after receiving this vaccine. Provider was notified, attempted to contact patient's guardian to notify - left a voicemail for them to please contact our office. Occurrence report and VAERS complteted.
After receiving the flu shot in the afternoon she was fine then at night she starts having fever >101, nausea, chills, headache, increase heart rate and noticed her veins/blood vessels swollen. She felt very sick and went to ER.
Site following day became sore, redness, and arm aches. Had read info form so felt mild reaction. Iced site and took some TYLENOL. Next day called health dept. unable to get through. Redness increased, hardness at site, warmth, swelling, itchy increased (no fever). Health dept. reached Dec. 16 - related symptoms to staff. May need to contact doctor. Spoke to Dr. prescribed Cephalexin 500 mg. Skin cellulitis. 7 days/reaction symptoms improved. Site center darkened appearance. Tiredness remained into January. Never had vaccine reaction before! Had to pay for antibiotic. Hopefully my insurance will pay health dept for vaccine.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 16-NOV-2018, the patient was vaccinated with a dose of PROQUAD lot # N028445 with expiration date on 09-APR-2019 (exact dose, dose number and route of administration were not reported) . The vaccine was reconstituted with a sterile diluent. On the same day, he patient was concomitantly vaccinated  with a dose of VARIVAX lot# 006221 with expiration date on 29-FEB-2020 (exact dose and route of administration were not reported), for prophylaxis. No adverse effects were reported.
10 year old female with swelling/redness over L deltoid began on 2/12/10. Approx 4.5x2.5cm. Non-tender. Advised cool compresses and TYLENOL as needed. Pt seen in clinic on 2/13/10.
Fever which peaked at 101.1°, chills, body/head ache for duration of weekend from 12/3 PM through night of 12/5 into early morning of Monday 12/6.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 27-JUN-2013, the patient was vaccinated with VARIVAX (Merck) (dose strength and route was not reported) (lot # H018796 and expiry date: 24-OCT-2014) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting VARIVAX (Merck), nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for VARIVAX (Merck). This is one of the several reports from the same reporter. Additional information has been requested.
sinus infection; pretty sick; "horrible burning sensation" in head; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 16Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious) with onset 23Mar2021, outcome "unknown", described as "pretty sick"; BURNING SENSATION (non-serious) with onset 23Mar2021, outcome "unknown", described as ""horrible burning sensation" in head"; SINUSITIS (non-serious), outcome "not recovered", described as "sinus infection".  Additional Information: The patient was reported to be prone to sinus infections this time of year and reported it to be particularly bad. His doctor recommended taking antibiotic and asked if it was okay to take it in between the COVID-19 vaccine doses. The second dose was scheduled on 08Apr2021. The patient mentioned that if he did not take anything within 5-10 days, it's going to be so bad and he will be running a fever and did not think he would even be eligible to take the second dose. He wanted to know his options.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a physician concerning a 14 year old female patient with conjunctivitis at the time of vaccination, no pertinent medical history and no drug reactions/allergies, who on 28-SEP-2009 at 9:15 am was vaccinated in her left arm with the second dose of series of GARDASIL (lot # 662300/0100Y). The same day, at the same time the patient was vaccinated in the right arm with a dose of influenza virus vaccine (Novartis, lot # 96037). The Physician reported that within two minutes of receiving GARDASIL the patient became syncopatic and had tremors for one minute. The patient then stayed in the office for fifteen minutes to recover, which she had, and then was able to leave.  The patient's symptoms improved on therapy. The patient sought unspecified medical attention in the office. No laboratory diagnostics studies were performed. Additional information is not expected.
pt recv vax 19AUG98 & 21AUG98 pt exp migraine h/a;8SEP98 pt exp fever, migraine, & visual hallucinations in rt eye;MRI indicated occipital lobe lesions post inflammatory, maybe infarct;pt hosp;LP nl;
t106 R; APAP given, to ER there t102 R shot given 21JAN92; sx occurred 24JAN92;
received 1st dose of Moderna vaccine under 18 Years of age; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (received 1st dose of Moderna vaccine under 18 Years of age) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044B21A and 033c21a) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (received 1st dose of Moderna vaccine under 18 Years of age). On 17-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (received 1st dose of Moderna vaccine under 18 Years of age) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication provided.  No treatment details were provided.   Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Non significant follow up received on 21-05-2021, patient ethnicity updated.
Within minutes of receiving vaccine, pt complained of Nausea, proceeded to loss consciousness. Paramedics were called vitals were monitored and were normal, once Paramedics arrived pt gained consciousness. At hospital pt was diagnosed with anemia and incident was not related to vaccine.  11/30/06 Received medical records from hospital which reveal patient admitted 11/15/06 & d/c to home 11/17/06.  Had vasovagal syncope & was admitted to telemetry to r/o cardia arrhythmia. Also had complaints of abdominal pain for about 1 week prior to admit with diarrhea & black stools.  GI consult & EGD done & received transfusion x 1. PMH: rheumatoid arthritis, NIDDM, HTN Final DX: anemia, hiatal hernia, gastritis/ss
pt recvd vax & exp urticaria & petechiae p/dose 1 the same day; no react was reported p/dose 2;
Nearly uncontrollable shivering, redness at injection site, general muscle aches, tiredness
Acute Pancreatitis, liquid diet with close monitoring. Toradol IM for pain
Asleep all day, slept for 2 days after; Fever; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (Asleep all day, slept for 2 days after) and PYREXIA (Fever) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 026A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced HYPERSOMNIA (Asleep all day, slept for 2 days after) and PYREXIA (Fever). At the time of the report, HYPERSOMNIA (Asleep all day, slept for 2 days after) and PYREXIA (Fever) had resolved.            The concomitant medication was not provided.  The treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Follow up received on 10-JUN-2021. Added information include patient race and  outcome of the events was updated from unknown to recovered/resolved.
Pt turned white face to feet within seconds of IPV, Dtap, Comvax given. Prevnar was given 4th but by then pt turned white.
Information has been received from a vaccine specialist and a nurse practitioner (N.P.) concerning a female who on an unspecified date was vaccinated with a dose of GARDASIL. Subsequently, on an unspecified date following vaccination with GARDASIL, the patient fell into a coma. The outcome of the patient was not reported. Upon internal review, coma was determined to be an other important medical event. No further information is available.
Product storage error; Doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date) and PRODUCT STORAGE ERROR (Product storage error) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Nov-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Product storage error). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date) and PRODUCT STORAGE ERROR (Product storage error) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  Date the vial was initially stored in the refrigerator was 04-Nov-2021. There was no temperature excursion. The reporter reported that that there was a confusion between the expiration date printed in the carton and the expiration date when the QR code was scanned.  The patient did not experience any adverse event.  No treatment information was provided by the reporter.
Pt w prolonged diarrhea including bloody and mucus stools after Rotateq vaccine.  Pt was required ER visit and subsequent hospitalization.  She was managed by pediatric GI and underwent a endoscopy which showed general inflammation.  The overall consensus was this reaction may have been due to the Rotateq vaccine. Subsequent doses were held and symptoms have not recurred.