chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a female who on 05-JUL-2007 was vaccinated with Gardasil (Lot # not reported). Suspect secondary therapy included Varivax (Oka/Merck). On 03-SEP-2007 the patient came back into the office with headache, bodyache, and tingling in hands. She then came back in on 10-SEP-2007 and 11-SEP-2007 with more pronounced symptoms of dizziness and ataxia. She had an MRI and was diagnosed with multiple sclerosis with transverse myelitis. On 13-SEP-2007 the patient was hospitalized, length of hospitalization was not provided. The patient's multiple sclerosis persisted. Multiple sclerosis was considered to be disabling. Additional information has been requested.  8/14/2008 MR received for DOS 9/13-17/2007 with D/C DX:  Multiple Sclerosis (most likely dx, monophasic at present). Pt presented with 1 week hx of generalized weakness and numbness in the bilateral fingers, 1 episode of urinary retention requiring catheterization and ataxia beginning 9/10/07.   On exam, dysmetria, ataxia, R lower extremity weakness and nystagmus, pupillary defect (R>L) noted. Tx with solumedrol with improvement in dysthesias and strength. F/u as outpt.
Sore arm at injection site; This is a spontaneous report from a contactable consumer (patient). A 42-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EL3247), via an unspecified route of administration in the right arm, on 02Feb2021 at 10:00 (at the age of 42-years-old) at a single dose for COVID-19 immunisation. Medical history included asthma, allergy to animals, allergy to pineapple, and allergy to raw onion. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications, taken within two weeks of vaccination, included levocetirizine dihydrochloride (XYZAL).  The patient previously took ibuprofen (MANUFACTURER UNKNOWN) and experienced allergy. The patient experienced sore arm at injection site on 02Feb2021 at 17:00. The event was reported as non-serious. The patient did not receive any treatment for the event. The clinical outcome of sore arm at injection site was unknown. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Hives on neck, flushed cheeks and neck for about 1-2 hours.
Patient received vaccine on 9/21, no significant adverse events noted at time of immunization. On the following day the patient started to notice swelling, erythema, and pain at the injection site which continued to increase over the course of the day. Patient reported reaction to pharmacy on 9/23.
ActHIB lypholized powder was mixed with Sterile Water Diluent  from Merck Sharp and Dohme and administered to the patient. The mistake was discovered approx 90 minutes after the event. The patient's primary care physician  was immediately notified. The event happened late on a Friday afternoon so the  Public Health vaccine nurse was notified the next Monday  7/1/2019. Upon the advice of the immunization nurse who  utilized the website information site, the dose needed to be repeated. Pt was  re-vaccinated on 7/5/19.
Patient had an itchy arm in the night 8 days after the vaccine, she scratched it, the site of the injection became hot, raised, and red
Dizzy shortly after vaccine, complained of headache, "wobbly", off balance. Sore muscle (left deltoid) -administration site; Dizziness and headache persist >24 hours after administration of vaccine
Nausea, tightness in chest from nausea  BP  106/70 (P) 61           @ 1015 am BP  100/68 (P) 60            @1025 am monitored for 40 mins; nausea improved  Returned to work
Arm swelling, redness and pain; chills, weakness, nausea, feeling faint- symptoms lasted for 48 hours.
Nausea, shortness of breath, body aches, headache, hives started on day 6
Within 15-20 minutes of receiving vaccine, I felt something in my chest. A slight pain or pang for a few seconds then it went away. The next day, I had noticeable visible swelling of my left breast and  lymph nodes under my left armpit even though injection was on rt arm. This was checked out by radiologist with a mammogram/ultrasound and lefts side looked fine, right side was suspicious of a legion which was biopsies and turned out to be fibrosis. Don?t know if there?s a connection to vaccine or not.  What was equally if not more concerning were the chest pains which returned a few more times getting stronger  that first week after the vaccine. It was a pulling sensation on the left side of my chest that, if 10x stronger, would feel (or be?) a heart attack. And that was after the 1st dose, so I am extremely hesitant to take the 2nd dose should those particular side effects intensify. I have googled it and can find no information about chest pains after the vaccine.  On a side note, my first cousin went into cardiac arrest after receiving his vaccination. He was dead and they brought him back. I?d like to avoid this.
the third dose one year and 10 months later; second dose one week earlier than recommended; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, HAB (Twinrix) for prophylaxis and hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (1st dose received on 4th September 2019).   On 27th July 2019, the patient received the 3rd dose of Twinrix. On 27th July 2021, the patient started Twinrix Pre-Filled Syringe Device. On 26th September 2021, the patient received the 2nd dose of Twinrix. On 26th September 2019, the patient started Twinrix Pre-Filled Syringe Device. On 26th September 2019, not applicable after receiving Twinrix and Twinrix Pre-Filled Syringe Device, not applicable after starting Twinrix and Twinrix Pre-Filled Syringe Device and unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too short. On 27th July 2021, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too short and drug dose administration interval too long were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 2nd dose of Twinrix one week earlier than recommended from 1st dose, which led to shortening of vaccination schedule. The patient was received 3rd dose of Twinrix (one year and 10 months later), later than the recommended interval, which led to lengthening of vaccination schedule. No adverse event details was provided even though it was requested. The reporter did not consent to follow-up.
Constant high pitched ringing in ear. Doctor referred to it as Tinnitus probably caused by vaccine.
This non-serious spontaneous case, initially received on 19-Mar-2018, was reported by other health professional and concerns a 10-year-old, child of unspecified gender. It was reported that, on an unspecified date, the temperature of the refrigerator in which vaccine was stored dropped to 32 F and was out of range for a total of 1 hour off and on for 2 weeks. On 31-Jan-2018, the patient was administered with FLUCELVAX QIV (dose, route of administration: intramuscular, anatomical location: right deltoid, batch number: 195236, expiry date: 31-May-2018). No adverse event was reported. Follow-up report received from other health professional on 19-Mar-2018: The report type was changed from invalid to spontaneous report. The age of the patient, start date of the event (31-Jan-2018), route of administration (intramuscular) and anatomical location (right deltoid) were added. Narrative amended accordingly. Non-significant follow-up received from the reporter on 07-May-2018: No adverse event was reported upon administration of vaccine stored out of temperature. Narrative was amended accordingly.
Information has been received from a healthcare professional referring to an unspecified number of patients of unknown age and gender. Information about medical history, concurrent condition and concomitant medications was not reported. On unknown dates the patients were vaccinated with VAQTA lot # L008665 with expiration date of 10-FEB-2017; strength, dosage, frequency and route unspecified), which were post temperature excursion. No adverse effects were noted by any patients. This is one of several reports received from the same reporter. Additional information has been requested.
Flushing occurred about from 5-40 minutes after receiving vaccine Nausea began about 20 minutes after receiving vaccine and persisted intermittently for 48 hours afterwards Headache began about 20 minutes after receiving vaccine and persisted intermittently for 12 hours afterwards Muscle pain/aching in neck began about 40 minutes after receiving vaccine and persisted for about 12 hours afterwards Sore right deltoid (injection site) started about 6 hours after vaccine given and persisted for about 60 hours
extreme itching 1 week after shot, developed rash all over body, dermatologist suggested allergy specialist
Severe headaches/back of the head lower part by neck.  Also felt tingling and numbness in legs. Went to primary care physician on 10/21/2010 because of severe pain and numbness in legs and constant headache.  Physician instructed the patient to go to emergency room if symptoms persisted or if they got worse.  Next morning was in emergency room at 6 in the morning.
Itching at the injection site; shoulder and neck pain (on and off) (5 or 6 on pain scale); redness at the injection site,Size of red area reported to be approximately 2"X2"; Swelling at the injection site; Fatigue; Headaches (off and on); Muscle pain; shoulder and neck pain (on and off) (5 or 6 on pain scale); Chills (on and off); Nausea (on and off); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itching at the injection site), NECK PAIN (shoulder and neck pain (on and off) (5 or 6 on pain scale)), VACCINATION SITE ERYTHEMA (redness at the injection site,Size of red area reported to be approximately 2"X2"), VACCINATION SITE SWELLING (Swelling at the injection site) and FATIGUE (Fatigue) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure fluctuation, Arthritis, Acid reflux (esophageal) and Penicillin allergy. Concomitant products included OMEPRAZOLE for an unknown indication.    On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 28-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itching at the injection site), NECK PAIN (shoulder and neck pain (on and off) (5 or 6 on pain scale)), VACCINATION SITE ERYTHEMA (redness at the injection site,Size of red area reported to be approximately 2"X2"), VACCINATION SITE SWELLING (Swelling at the injection site), FATIGUE (Fatigue), HEADACHE (Headaches (off and on)), MYALGIA (Muscle pain), ARTHRALGIA (shoulder and neck pain (on and off) (5 or 6 on pain scale)), CHILLS (Chills (on and off)) and NAUSEA (Nausea (on and off)). At the time of the report, VACCINATION SITE PRURITUS (Itching at the injection site), NECK PAIN (shoulder and neck pain (on and off) (5 or 6 on pain scale)), VACCINATION SITE ERYTHEMA (redness at the injection site,Size of red area reported to be approximately 2"X2"), VACCINATION SITE SWELLING (Swelling at the injection site), FATIGUE (Fatigue), HEADACHE (Headaches (off and on)), MYALGIA (Muscle pain), ARTHRALGIA (shoulder and neck pain (on and off) (5 or 6 on pain scale)), CHILLS (Chills (on and off)) and NAUSEA (Nausea (on and off)) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other concomitant medication included unknown medication for mild to moderate blood pressure. Treatment information was not reported.
Received2nd Pfizer Covid vac on Saturday, April 17th, 2:45, Monday, April 19th morning swollen painful under arm on injection arm, still hurts Tuesday morning. Sunday, injection site is swollen and painful all day and evening Starting Saturday night, night sweats, no fever  Starting Saturday night, heart palpitations, occur in the evening continued with a less degree on Sunday and Monday evenings.
Menstrual cycle length and intensity changes ever since and hast gone back to its normal pattern; This is a spontaneous report from a non-contactable consumer, the patient. A 42-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 06Apr2021 at 08:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history includes allergy to sulfa drugs. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 06Apr2021, the patient experienced menstrual cycle length and intensity changes ever since and has not gone back to its normal pattern. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measure was not taken as a result of event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event menstrual cycle length and intensity changes ever since and has not gone back to its normal pattern was not resolved at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient received dose 2 on 3-27-2021. He was given the Pfizer vaccine instead of the Moderna he should have received. It was caught after the Pfizer was already given. He stated he feels fine and will notify the Health Department if he experiences any problems. Staff was counseled on checking shot record before giving any vaccine.
Information has been received from 2 healthcare worker referring to a patient of unknown age and gender. The patient's medical history was not reported. On 17-MAR-2015, the patient was received improperly stored (Oka/Merck) VARIVAX (lot # K007979, exp date 03-JUN-2016, dose and route unknown). Concomitant medications was not reported. No adverse effects were reported. No product quality issue (PQC) was involved. This is one of several reports received from the same source. Additional information is not expected since the reporter don't wish us to contact.
Information has been received from a registered nurse (R.N.) concerning a 13-month-female who on 18-JUL-207 was vaccinated subcutaneously with a 0.65 milliliter dose of Zostavax (Oka/Merck) (lot# 654604/1406F) instead of Varivax (Oka/Merck). It is reported that this occurred because one vial of Zostavax (Oka/Merck) was put into the Varivax (Oka/Merck) vial box by someone in the office. When the administering nurse grabbed the vial to inject the patient she did not look to make sure that it was Varivax (Oka/Merck), since it came out of the Varivax box. She did not realize this until after the patient was injected. It is reported that the patient is not experiencing any known symptoms. Unspecified medical attention was sought. No product quality complaint was involved. Follow up information received on 21-Aug-2007 indicated that the patient was a healthy black female with no illness at the time of vaccination. Secondary suspect vaccinations on 18-Jul-2007 included a first dose in the right thigh of MMR II (lot# 655410/1469F). Concomitant therapy included a fourth dose in the right thigh of PREVNAR (Wyeth) (lot# b08692F), a third dose in the right thigh of PROHIBIT (Aventis Pasteur) (lot# 1126F), and XOPENEX as needed. On 18-Jul-2007, the patient had a low grade fever which was treated with MOTRIN, and irritability which was treated with alternating TYLENOL and MOTRIN. No laboratory or diagnostic tests were ordered. No more information is expected.
5/4/2022-Presents to ED c/o weakness. Recently d/c from hospital one week ago for sepsis and E coli bacteremia. Afebrile, HR-121. 92% on RA.  CT multilobar pna. Covid + test. CRP-15.2. ALt-39. EKG-a fib RVR. WBC-22.6. Admit sepsis s/t bilateral multilobar pna likely hospital aquired immunocompromised. Zosyn, remdesivir and vanco ordered. Recent IP 4/16-4/26/2022 for EColi in bloodstream.  5/5/2022-HR increase jumpin into the 130's, IV dose Lopressor given. HR remianed in the 120's for most of day Lopressor PO increased to 50-75mg BID.  5/6/2022- ID consult Zosyn d/c, Flagyl and Cefepime started. Vanco continued.
I had headache; achiness under where got the needle.; rash under where got the needle.; This is a spontaneous report from a contactable consumer (Patient) via Pfizer sponsored program Covax Support. A 75-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Her second one was 27Mar2021 ("next Saturday"). The patient medical history was not reported. The patient's concomitant medication included took gamunex c every 4 weeks, last dose was received on 19Mar2021. The patient experienced headache, achiness, and a rash under where got the needle on an unspecified date. The outcome was unknown.  No follow up attempts are possible; Information about lot/batch number cannot be obtained.
Arm pain,  increased seizure activity day after, tired, aches, wheezing, headache, feverish
Patient developed 5 cm X 7.5 cm area of induration and erythema at injection site. C/O tenderness at site. Tender to light palpation.
fever, chills, body ache, headache, vomiting and diarrhea The fever, chills, body ache and headache started around 8 pm, diarrhea started at 9:00 pm and vomiting started at 10  pm.  The vomiting and diarrhea lasted until early morning hours (around 6:00).  The fever, chills and body ache ended the next day.  I took an Aleve around 10:00 am and the headache went away.
6:30 a.m. head ache, sore arm ,temp of 100.1 as of 5: 47 p.m. still running temp headache an sore arm.
This spontaneous report as received from a physician refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. On unknown dates between end of March 2016 and 23-MAY-2016, the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX lot # L035127, expiration date 14-SEP-2017 (dose and route of administration were not reported) as a part of immunization series. There was no adverse effect reported. Administered doses of vaccines experienced the temperature excursion of 12 degrees Fahrenheit for 2 months (1440 hours) cumulative time. Data logger was not involved, the excursion was recorded manually. Additional information has been requested.
Pt stated he developed an itchy throat about 30 min after receiving his vaccine. This resolved within an hour.
Patient recieved first dose of covid 19 vaccine (Pfizer) He recieved 0.1 mL dose vs 0.3 mL correct dose.
when arrived home after shot given developed headache, nausea, vomiting, abd pain, chills, diarrhea and dizziness. + myalgia in neck. No change in gait, numbness/tingling/neck stiffness
Friday, November 12, 2021 I arrived to the pharmacy to receive my Moderna COVID-19 booster vaccine with my husband as we both had appointments for our booster shots. I was first in the chair and the pharmacy tech proceed to wipe the lateral posterior of my left arm with an alcohol swab. I am a medical assistant and I have been giving injections both IM and Sub q for over 20 years. As soon as she wiped my arm with the swab my first thought is "why is she wiping the back of my arm with this alcohol swab?" Before I could say anything about it the needle was in and the injection being given. This was my 3rd Moderna vaccine and by far the most painful administration.  I knew immediately that the injection was given not in my deltoid as an IM injection, but in between my deltoid and tricep muscle in the subcutaneous space. I didn't say anything and just shrugged it off.   16 hours later on Saturday morning I awoke to the familiar sore arm but didn't think anything of it as I know this is a normal side effect to any vaccine given IM.  I did develop fever, chills, fatigue all of which I had with my second booster shot, so I just rested, took tylenol and slept.  Saturday night, 11/13/21 my arm was extremely sore, red, and hot to the touch. My armpit had also began to swell. Again, I chalked it up to a bad local reaction due to the vaccine not being given in the deltoid muscle.   Sunday morning 11/14/21 the pain was worse, the redness had started to spread and temp taken with a thermal thermometer over the injection site registered 101.4.  My overall fever, chills, etc had subsided but the injection site was getting worse. I took some tylenol, iced it and went about my day. Sunday night I noticed the redness spreading further, so I had my husband outline the red area with a marker so I could keep an eye on how much it was spreading.   Monday 11/15/21 I went to work at the Internal Medicine practice I work for and had one of the MD's I work with take a look.  The redness  and pain had spread beyond the marker outline and he determined it was heading toward a cellulitis and started me on Keflex 500 mg TID x 7 days.  As of tonight the cellulitis is still spreading, however I've stared the antibiotic and hope that will take care of it.   I am only reporting this because in my line of work I see medical professionals every day that are poorly trained on how to give a proper injection. Pharmacy technicians should not be giving injections to patients unless they are fully trained.  I'm not sure what type of training the technician that gave me my vaccine had, but this should be an industry standard.
Tremendous head pressure; Mental confusion and cloudy; Random sharp pain randomly throughout head; Dizziness; Headache; Nausea; Extreme exhausation; This is a spontaneous report from a contactable consumer (patient himself). A 32-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and expiration date was not reported) via an unspecified route of administration, administered in Arm Left on 25Jun2021 10:00 (at the age of 32-years-old) as DOSE 1, SINGLE for COVID-19 immunization. Medical history included COVID-19 from an unknown date and unknown if ongoing. Concomitant medication included cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) taken for an unspecified indication. The patient previously took cefazil and duracef [cefixime] and experienced drug hypersensitivity. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 28Jun2021 the patient experienced tremendous head pressure, mental confusion and random sharp pain randomly throughout head, dizziness, headache, nausea, extreme exhausation. Adverse events resulted in physician office visit. Therapeutic measures were taken as a result of adverse events as patient had received steroids. The patient underwent lab tests and procedures which included magnetic resonance imaging with unknown results on an unspecified date. Since the vaccination, patient has not been tested for COVID-19. The outcome of all events was resolved on an unspecified date in 2021.  No follow-up attempts are needed; information about lot/batch number can not be obtained.