chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fever; chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 14Oct2023 at 16:00 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 4; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: PYREXIA (non-serious) with onset Oct2023, outcome "unknown", described as "Fever"; CHILLS (non-serious) with onset Oct2023, outcome "unknown".  Additional information: It was reported that the patient did not take any other vaccine in four weeks and was not tested covid prior and post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Within a few weeks of her second dose of vaccine, patient developed intermittent heart palpitations and chest pain along with inflammatory pain at her ankle, shoulder, and neck
This case was reported by a other health professional via sales rep and described the occurrence of myalgia in a 64-year-old male patient who received SHINGRIX (batch number TZ9L5, expiry date unknown) for prophylaxis. On 10th October 2018, the patient received SHINGRIX. On 26th October 2018, 16 days after receiving SHINGRIX, the patient experienced myalgia, hives and fatigue. On an unknown date, the outcome of the myalgia, hives and fatigue were unknown. It was unknown if the reporter considered the myalgia, hives and fatigue to be related to SHINGRIX. Additional details were provided as follows: The patient experienced myalgia, hives and fatigue after receiving a dose of SHINGRIX. It was unsure if issues were related to SHINGRIX vaccine. The reporter was agree to follow up from GlaxoSmithKline.
There was NOT an adverse event, but an administration error did occur.  The administering nurse, RN, first intradermal injection of Jynneos did NOT produce a visible "wheal", so she had to administer a second intradermal injection to patient.  The second injection did produce a wheal per the administering nurse.
Pentacel comes in a 2 vial dose that needs to be constituted together for single administration. Once green cap vial (HIB) and one blue cap vial (DTaP-IPV).  It was discovered on 12/22/2022 that there was one blue cap vial in the box missing it?s companion green cap vial. It is assumed that one of 5 patients did not receive the blue vial (DTaP-IPV)
On the 21st, my rib muscles on left side - spasms - hard to breathe or take a deep breath.  About month ago left foot and left hand - was start to numbness  - moving up my calf a little bit - doctor thought it was a nerve impeachment.  About two weeks ago,  Breathing with rib muscles are starting to be better - it's not gone however. The last couple of days, I have had a little numbness in my right foot and then it went away.
Intense and incapacitating fever (103°-105°) starting about 8-12hrs after vaccination. Fever was dangerous and the worst I've ever experienced. Fever lasted for over 24hrs. The worst of the fever was about 12 hrs after the shot and lasted 6-8hrs. Acetaminophen 500mg helped momentarily quell the fever for about 1hr after each dose. Nausea increased as the fever decreased. As an otherwise healthy adult, this vaccine could easily cause serious complications due to high fever in others who experience the same symptoms. It is unlikely I will ever get a similar vaccine again. The effects were TERRIBLE.
approx 4:00 seen in MD office w/warm, red swollen area @ inject site of rt leg; no fever nor crying; TC to mom @ 7:00; doing markedly better mom did not reutrn to MD office 7JUN94; pt OK
PATIENT WAS GIVEN A BOOSTER DOSE OF 0.5MLS INSTEAD OF 0.25MLS FOLLOWING THE JANSSEN VACCINE. PATIENT REPORTED FEVER THAT NIGHT AND BODY ACHES FOR A DAY.
This case was reported by a other health professional via sales rep and described the occurrence of pain in arm in a female patient who received S for prophylaxis. On 7th September 2018, the patient received SHINGRIX. In September 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm and influenza-like symptoms. On an unknown date, the outcome of the pain in arm was unknown and the outcome of the influenza-like symptoms was recovered/resolved. It was unknown if the reporter considered the pain in arm and influenza-like symptoms to be related to SHINGRIX. Additional details were reported as follows: This case was reported by Medical Assistant. The age at vaccination was not reported. The sales representative reported the adverse events he heard the day before reporting, by email. The reporter had a patient and reported incidents on 9th September 2018 to the clinic. It was stated that, the patient's arm where she received the vaccine hurt very badly. The patient also mentioned that, on the night of vaccination (on 8th September 2018), she experienced flu like symptoms and was bed ridden for 3 to 4 days. She recovered from the flu like symptoms. This case was linked with US2018167182, reported by same reporter.
This is the eighth day of  a headache.  Actually, it's a skull ached.  The painful points are on the skull right behind the middle of each ear.   Occasionally, it seems like a regular headache--in the forehead--but most hours of the day and night, it's in the skull as described.  Motrin 800 helps.
She received H1N1 injectible vaccine from Health department, they came to her apartment buliding and administered the shot in her right arm on 1/8/2010. The next morning she woke up with nausea and vomiting, she took her temperature with a thermometer but she had no fever.  The vomiting lasted in her words for "a DAY OR TWO , THEN WENT AWAY".  She did not contact her private doctor about these symptoms.
Patient received a 3rd dose of PEDVAX at 6 months of age. This is an extra unneeded dose.
Pt called 11-8-21 reporting of hypotensive event on 11-7-21 to the point of being lathargic. She reported falling from her chair and needed help back up. No other events were reported on the phone call following these events listed. I recommended patient get checkied out physicians office ASAP to address possible underlying conditions or adverse reaction.
Pt presented today complaining of red, swollen area around injection site. Area warm (not hot) to touch. Area of involvement is approx 4 inches in diameter. I recommended cold compress and antihistamine. I called the patient's PCP and arranged for patient to be seen today (11:45 appt).
Patient was dizzy, spiked a fever of 101.8, slurring words, and "passed out" on mom. Mom was directed to take the patient to the Emergency Room immediately.
Received rabies pre-exposure #3 on 8/5/09 at 1030. Around 1930, she had fever to 105.3 and felt chills. Took tylenol and cool bath. Was seen in ER and felt related to vaccine. She had fever with nausea and vomiting after 2nd dose, but also had braces adjusted that day
Vomiting since the 24th, cannot keep food down. Officially 2 days since second dose of vaccine. initial symptom at dinner time.
Patient was provided with no observation at administering vaccination. Upon leaving pharmacy pt experienced symptoms of Anaphylaxis.  Symptoms worsened over a course of 2 hours.  First 5-15 minutes developed scratch/sore throat, ill feeling.  Pulsation in head and neck. 30-45 minutes post injection developed rash covering face, neck, back, stomach, and extremities.  Red face, swelling in face and neck, change in voice, tingling in mouth and lips.  Pt developed mild wheezing and sensation of some air way constriction.  Symptoms constant and worsening, Benadryl administered upon arrival home, EPI pen administered upon arrival to home upon observation, immediate transport to ER, Medications administered at ER IV, Pepcid 20mg , Benadryl  25mg, Solu-Medrol 125 mg, Sodium Chloride .9% Bolus 1000mL, discharged to home, prescribed prednisone 50mg oral x 5 days,  replacement EPI pen .3mg
1st dose 2 years ago, 2nd not received; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 79-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 2 years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 29-NOV-2022 Reporter's Comments:  This case was reported by the patient' brother.  The patient stated that 2 years ago the patient received only one single dose of Shingrix. The patient stated received the shot in the arm. The patient was never informed that Shingrix was given in two doses series; hence, they never received a second Shingrix dose.  The patient declined consent for safety follow up with healthcare professional.  The patient declined to provide date of birth and age instead.  The patient declined to provide relatives information and age.  The patient could not provide Shingrix lot, expiration date information, dosage or route of administration. No additional information provided.  The reporter did not consent to follow up.  This case had been linked with US2022178660, US2022AMR179084, US2022AMR179087, US2022AMR179086 same reporter. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.; Sender's Comments:  US-GSK-US2022178660:Same reporter US-GSK-US2022AMR179084:Same reporter US-GSK-US2022AMR179086:Same reporter US-GSK-US2022AMR179087:Same reporter
Chills , fever 99.3 ( my norm 96.3-.7) , tired, slight nausea, headache
Woke up with really bad vertigo this morning, was very difficult to walk, and vomited multiple times as a result. It has gotten better over the course of the day but not totally gone. If I am still experiencing this tomorrow I will go to an urgent care.
**SEVERE LEFT ARM PAIN (05/07/2021 TO PRESENT) OTC NSAID, TYLENOL, INDOMETHACIN 25, OXYCODONE/ACETAMINOPHEN 5-325, BACLOFEN 10MG, TIZANIDINE HCL-4, PREDNISONE, LIDOCAINE PATCH 5%, STERIOD INJECTION (03/07/2022)  **FEVER 101+ 05/07/2021-05/10/2021 (TYLENOL)  **HIVES LOWER EXTREMITIES 05/10/2021-05-13-2021 (BENADRYL)  **INTENSE NAUSEA/FATIGUE/ABDOMINAL PAIN (05/07/2021 TO PRESENT) OTC FAMOTIDINE, AMOX, CLARI, METRONIDAZOLE, ONDANSETRON 4MG, DIETARY RESTRICTIONS **JOINT PAIN (04-16-2021 FIRST VACCINE TO PRESENT)  **DELAYED MENSES (04-16-2021 FIRST VACCINE TO PRESENT) **LOWER BACK PAIN (05/13/2021-11/15/2021) SAME MEDS AS LEFT ARM
This spontaneous report as received from a Registered Nurse refers to a patient of unknown age. ON 12-AUG-2013 the patient was vaccinated with a dose of expired VARIVAX (Merck) (dose, frequency and route unknown) (lot# was reported as 10888AA which was confirmed as not valid for VARIVAX (Merck), Exp 06-JUL-2013). There was a little redness at the injection site after administration. It was unknown if the patient had sought medical attention. The outcome of the event was unknown. Additional information has been requested.
Swelling at injection site, itching, redness, throbbing, redness travelling toward elbow; treated with benadryl  still taking it
Sudden onset of severe vertigo and vomiting lasting several weeks, 2 Ed visits, one hospitalization. Multiple physician evaluations with neurology, cardiology,ENT. Diagnosed with vestibular neuritis. Continued dizziness and significant gait issues to date. Currently in vestibular rehab PT.  Onset 12/09/2021-to present 2/28/2022.
Large approximately 2? in diameter at this time , red, hard itchy spot at injection sight. Warm to the touch  Appeared a few hours after receiving  injection.
p/vax pt noted numbness/tingling in finger tips rt hand x4hr; site of inj tender to touch rt arm;
pt recv vax & grandma noticed pt not using lt leg properly;MD noted dec use of leg;referred to ped neuro-MD told parent legs is flaccid;pt to have MRI & further studies;
I had a rash on my face and neck (started on my neck and crept up to my face). This began ~ an hour after I got the vaccine. I called my primary care provider and they advised me to take an antihistamine which calmed it down. They also advised that I take an antihistamine prior to my second dose. I did and had no such reaction the second time.
Vomiting around 30 times in 48 hours. Seen in ER 11/4/04 pm and given 1.5L IV fluid. Mother notified us 11/5/04. Mother states child had low grade fever 100-104. 1 Loose stool. Illness resolved by 11/5/04.
CAME DOWN WITH A CASE OF SHINGLES ABOUT 2 WEEKS POST VACCINE THAT WAS MORE PAINFUL AND A WORSE RASH THAN SHE'D EVER HAD BEFORE.
Information has been received from a physician via company employees and a practice manager referring to a patient of unknown age and gender. On 03-MAY-2016 the patient was vaccinated with an improperly stored dose of (wistar ra 27-3) M-M-R II (rHA (recombinant human albumin), lot #L003856, expiration date 05-FEB-2017, strength, dose and route were unspecified). This specified lot number vaccine was exposed to temperature twice. The total cumulative excursion time of the first time was 904 hours with the lowest recorded temperature of 34 Fahrenheit degree. The total cumulative excursion time of the second time was 168 hours with the lowest recorded temperature of 32 Fahrenheit degree. The storage criteria of this vaccine was refrigerator/freezer (R/F) and the type of excursion was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source.
Flu-like symptoms, aching, chills, weakness, lethargy, very swollen glands in neck, sore throat lasting about 4 days - white spots on throat.
First vaccine 3/24/21 Second vaccine 4/14/21 In early may, mom can't remember date, patient c/o left  leg and foot pain. Went to podiatrist - no diagnosis made - was told to monitor. Mid to late May developed dry cough. Not seen for this. On June 10 taken to ED lower left leg extremely painful and swollen and mom reported discoloration to back of leg. Diagnosed with DVT and put on blood thinner Xeralto and discharged. A week later went to hematologist who said to continue Xeralto and monitor.  A week after seeing Dr. and two weeks after initial ED visit, on a Wednesday, patient started to cough up blood. Went back to Dr. and patient was taken off of Xeralto. PE scan ordered.  The next day patient developed chest pain and went to ED. PE scan done and diagnosed with two PE's on right lung. Was informed had six blood clots in lower left leg. Admitted to ICU. Was an inpatient for 5 days then discharged.  Now patient is taking Lovenox injections twice daily.
Patient received 4 years vaccines on AM of 4/22/2010, presented to ER with elevated heart rate 270's at 9pm on 4/22, went to hospital.
presented to ER t105, hx of 1 min sz @ home; vomiting, diarrhea that day; adm spinal tap; blood cultures-no info on results of testing during hospitalization;
Noted angry red rash on bilateral Achilles heels on 1/30/2021. Rash was very red and itchy.  Tx with Benadryl 25 mg 2-3 times a day and Hydrocort 10 cream as needed. This lasted approximately 1 1/2 weeks. I woke up on 2/13/2021 with pain in both wrist joint, all my finger joints as well as swelling so that I couldn't close my fingers. This is still going on.  Today (2/17/2021) I noted joint pain in both my knees and shoulders. I have not had any problem with either my knees or shoulders prior to this.
This spontaneous case reported by a consumer, describes the occurrence of pain in extremity (sore right arm) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 024M20A) for COVID-19 immunization. No medical history reported. On Feb 9, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced pain in extremity (sore right arm). At the time of the report, pain in extremity (sore right arm) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information. This case linked to MOD-2021-404586, MOD-2021-404698 (patient link).
10APR98 body aches, gen, lymphadenopathy, loss of appetite, fever to 104 & gen body rash on 15APR98;
Pt was given MMRV in error. The intended vaccine was MMR. Pt was also administered the varicella vaccine on the same day. Will not allow the MMRV vaccine to be reported, producing the error message "A vaccination from the same family as MMRV is recorded for the same day". To document accurately and remove the administered vaccine from our stock, I need to have this resolved. Please help.
Headaches 2 days after injections - total body weakness, had to remain in bed. 3rd day - jumpiness - nervous mood swings - (NEVER had high blood pressure). Went to pharmacy took it 161/110. Went to urgent care - followed by internist psychiatrist visits.
Lost feeling in left leg, night sweats , cold sweats, nausea, diarrhea, long sleep times, no energy, slightly short of breath
flu like sx-muscle aches, fever, vomiting for 24 hrs w/in 1 hrs p/receivng inject;
Swollen lymph node near left collarbone and rash, hardness and hot skin around injection site. Follow up with doc in four weeks, hopefully symptoms will cease.
Information has been received from a nurse practitioner concerning a 17 year old female patient with no pertinent medical history who on 21-JUL-2010 was vaccinated with a second dose of GARDASIL (Lot# unknown). The nurse reported that on 21-JUL-2010 after receiving the vaccine, the patient fainted. She stated that even after the patient woke up, the patient experienced the dizziness and nausea for an hour. There were no laboratory tests or diagnostic studies performed. The patient recovered from fainted, dizziness and nausea on 21-JUL-2010. The patient sought unspecified medical attention. Follow-up information has been received from a nurse practitioner concerning 17 year old student female with no pertinent medical history, drug reactions or allergies reported who on 19-JUL-2010 (previously reported as 21-JUL-2010) was vaccinated into the left arm at 15:30 pm. The reporter stated that the patient went to grocery store within 20 minutes of getting the second dose of GARDASIL and passed out. EMT's were called. The patient complained of dizziness and nausea for one hour. Blood pressure was 120/60. On the same date, the patient fully recovered and went home from ambulance. Patient was not transported to hospital. Additional information is not expected.
This spontaneous report as received from a nurse refers to unspecified number of patients. Their pertinent medical history, concomitant medications, drug reactions and allergies were not reported. On unspecified dates, the patients were administered improperly stored doses of ROTATEQ, orally, lot# M007311, expiration date 30-NOV-2017 (dose was not reported). Vaccines were stored at the temperature of 8.5 Celsius degrees for 30 minutes. There was no previous temperature excursion. Digital data logger was involved. No adverse effects were reported. This is one of several reports from the same reporter. Additional information has been requested.
Received influenza vaccination, approximately 20 to 30 minutes later, experienced itching, SOB, Hives/rash, first noted on arms, left than right and than located on neck and face.
injection site is swelling and the pain; injection site is swelling and the pain; arm was stiff and that is what happened after the first shot also; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (Patient) reported for a female patient of unspecified age received bnt162b2 (Pfizer-Biontech covid-19 vaccine, Formulation: solution for injection) via unspecified route of administration on unspecified date as 1st dose single dose for COVID-19 immunisation. The patient's medical history included ongoing Crohn's disease (worse flare ever had in 35 years). Concomitant medication was not reported. On an unknown date, the patient experienced injection site swelling and pain. The patient also stated she experienced arm stiff after getting first dose. The patient had history of Crohns disease and having a whole problem with that at the moment. Outcome of the events was unknown.  Information on the lot/batch number has been requested. Follow-up attempts completed. No further information expected. Decision made to close the case.
Unusual "ladder" of painted ellipses developed adjacent to injection site. No systemic symptoms (see enclosed drawing from office note). 11-13-06 Pneumox .5ml IM Left deltoid. 11-15-06 reaction to Pneumovax. Temp 96.9, P 80AP BP 110/80. By last RN noted redness, soreness close to site of Pneumovax. No temp/dysponea/ or rash elsewhere. Some of 3 erythmeatous ellipses with slight induration, tenderness, blanchable, positive mild tenderness of anterior axillary fold no palpable node. Also no left epitrochlear node.  Unusual local response to Pneumovax. Ice for 24 hours, expect improvement within few days, recommend avoid future Pneumovax.
Patient receive flu shot in right deltoid on 10/18/2004 at 2 pm. Patient reported no reaction at that time. Patient awoke on the morning of 10/20/04 with pain in right arm in the triceps , redness, swelling and tenderness. On exam, 45mm x 25mm area of redness, nickel-sized bruise at injection which was rather high for an IM injection in the deltoid, no palpable induration ,or warmth at site. Patient will take Tylenol every 4 to 6 hours for pain. Will follow up with health department if symptoms do not resolve.
wrist joint paint / hip joint pain; temperature reached 101.6 degrees; chills; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), FATIGUE (fatigue), ARTHRALGIA (wrist joint paint / hip joint pain) and BODY TEMPERATURE INCREASED (temperature reached 101.6 degrees) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced CHILLS (chills) and FATIGUE (fatigue). On 29-Jan-2021, the patient experienced ARTHRALGIA (wrist joint paint / hip joint pain) and BODY TEMPERATURE INCREASED (temperature reached 101.6 degrees). At the time of the report, CHILLS (chills), FATIGUE (fatigue), ARTHRALGIA (wrist joint paint / hip joint pain) and BODY TEMPERATURE INCREASED (temperature reached 101.6 degrees) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Jan-2021, Body temperature: 101.6 (abnormal) Abnormal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
1 mm blanchable erythematous lesions diffusely scattered on torso, legs, arms and face, sparing the palms and soles. Large wheal of 10 cm in width and 15 cm in length noted on the ant. aspect of the R thigh that during visit is dynamic in intensity of erythema. Benadryl dose of 4 mlo every 6 hrs to 12 hrs.