chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Woke from sleep at 8pm/screamed and cried and inconsolable x 3+ hours/ refused all attempts at comforting / very hot and sweaty and hands/arms shaking are red back and went limp and fell asleep in mothers arm/ next day seemed fine, tired and clingy.
expired dose of menactra with no adverse event; Initial information received on 17-May-2022 regarding an unsolicited valid non-serious case received via consumer/non-hcp.  This case involves a 31 years old female patient who experienced expired dose of menactra with no adverse event while receiving vaccine meningococcal a-c-y-w135 (d conj) vaccine (Menactra).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (Tdap) for Prophylactic vaccination.  On 16-May-2022, the patient received a dose of suspect meningococcal a-c-y-w135 (d conj) vaccine lot U6691AA via intramuscular route in arm for immunization.  Reportedly an expired dose of meningococcal a-c-y-w135 (d conj) vaccine was given to a patient yesterday (expired product administered), 16-May-2022, manger did not know which arm the dose was administered, she did not provide the NDC number as she was at a different medical office.   Action taken: not applicable.  Outcome: 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.
fever of 100.6, muscle cramp in calves, headache, chills, tiredness
Received flu shot 10/08/2010. Both her & her husband got fevers after getting flu shot. Has had high of 103, 101 yesterday without/body aches. Most miserable three days of her life. Will not be getting another flu shot again. Not actually likely due to shot but more likely that they were exposed to viral illness or even flu and has an infection. Fever is rare reaction - IF still sick, would like to see for flu test. -Seeing kids in office today with similar symptoms - who have not yet had their flu shots - discussed with patient and she is adamant that she did not go out of her house for 2 weeks prior to the vaccine and couldn't have been exposed to anyone. -"not event to grocery store" - states no other symptoms except for fever. Does not want to come in and fever has resolved.
Extra dose administered; This spontaneous report was received from a certified medical assistant referring to an 18 year old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.  On an unspecified date in 2016, the patient was vaccinated with the first dose of hepatitis a vaccine, inactivated (VAQTA) pediatric dose, for prophylaxis (strength, route of administration, anatomical location, lot # and expiration date were unknown). Then, on an unspecified date in 2017, patient received the second dose of hepatitis a vaccine, inactivated (VAQTA) pediatric dose, (strength, route of administration, anatomical location, lot # and expiration date were unknown).  On 27-OCT-2020, a third adult dose of hepatitis a vaccine, inactivated (VAQTA) 1 mL, lot #T014590 , expiration date on 15-APR-2021, (strength, route of administration and anatomical location were unknown) was given to the patient. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); devicelotnumber: T014590; expirationdate: 15-APR-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
My periods are usually an average flow and happen once monthly with average to moderate cramping. Following vaccination, I've had two menstrual cycles in September and two menstrual cycles in October. In September, my second menstrual cycle carried with it intense and unbearable cramping followed by heavier than normal menstrual bleeding. In October, I've had intense cramping once again (moreso than what is normal) and the heaviest menstrual flow for a period that I've ever had in my life.
faints during medical procedures.  9:55 patient had tonic clonic movement of both upper extremities and lower extremities almost immediately after the vaccine was injected for approximately 30 seconds.  patient vomited and reported feeling light headed and nauseous.  patient appeared pale and was diaphoretic.  vitals BP: 102/60, SPO2: 98%, HR 68, RR 24.  patient placed on cot and in recovery position.  juice provided, vitals remained stable.  patient reported feeling better and requested to leave at 10:15.  Patient A&O x3.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Additional Details: Patient fainted while sitting in seat.  He fell forward, resulting in \"rug burn\" type abrasions across side of face.  Patient's nose was bleeding as well
Patient has induration, redness, causing cellulitis, gets worst everyday. Also causing fever.
Pt broke out in a pimple-like rash on forehead and temple regions. Pt took Benadryl and the redness and bumps diminished.
Ringing ears, splitting headache, fever, dizzy, body aches, extreme fatigue.
unable/hardly to raise arm; little soreness; 1st dose in 2021, has not yet received 2nd dose; This case was reported by a consumer via call center representative and described the occurrence of injected limb mobility decreased in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu unspecified (Flu vaccine) for prophylaxis and Herpes zoster (Shingrix) for prophylaxis.   In October 2021, the patient received the 1st dose of Shingrix and Flu vaccine. On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and Flu vaccine and not applicable after receiving Shingrix, the patient experienced injected limb mobility decreased, pain and incomplete course of vaccination. The patient was treated with diclofenac. On an unknown date, the outcome of the injected limb mobility decreased was not recovered/not resolved and the outcome of the pain and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the injected limb mobility decreased and pain to be related to Shingrix and Flu vaccine.     Additional Information: GSK Receipt Date: 06-DEC-2022 Reporter's Comment: The reporter was the patient. The patient received her first dose of Shingrix over 1 year ago, in October 2021.  The patient also received a Flu vaccine (unknown manufacturer) at the same time.  The patient received the Shingrix vaccine in one arm, the Flu vaccine in the other.  The patient did not recall which vaccine was given in which arm.  The patient states after she received the vaccines, she was unable to raise either arm. Currently, the patient can raise her left arm, but can hardly raise her right arm.  The patient experiences a little soreness.  The patient was recently prescribed Diclofenac 50 mg to alleviate symptoms.  The patient had follow up with her doctor in February 2023.  At the time of the call, the patient has not yet received her second dose of Shingrix. The reporter consent to follow up. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
5 hours after vaccines given, left thigh was red and swollen, warm to touch. Able to move leg freely. No fever. Recommended cool compress and TYLENOL PRN. To call back if worsens or new s/s develop.
Per patient, itching started 5-6 hours post injection. When area was checked swelling and redness noted presenting like hives. Denies any fever/chills, pain and/or any other complain. Symptoms resolved in 2 days.
H1N1 mist administered. Pt c/o heart palpitations, arms feeling heavy, B/P 160/110, P 80. Pt to clinic for evaluation by MD.
The day I got it I was fine, I had no problems, the next day I worked hadn't drinking much water and really taxed my body and then the next day I had flu like symptoms and what concerned me was I was having heart palpitations that kept me up, and symptoms last for 5 days.
swelling of my feet and legs; Sat 4/17 I went to the beach for 2 hours. By Sunday 4/18 I had patches and streaks of red like sun burn and severe swelling of my feet and legs. This has continued with the swelling decreasing but sti; This is a spontaneous report from a contactable consumer (herself). A 43-years-old non pregnant female patient received second dose bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 15Apr2021 06:00 as DOSE 2, SINGLE for covid-19 immunisation (at the age of 43 years). The patient medical history was not reported. The patient was unaware of allergies to medication, food, or other products. The patient's concomitant medications were not reported. Not pregnant at the time of vaccination. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. And no list of any other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. The patient experienced on 17Apr2021 that sat 4/17 i went to the beach for 2 hours. by sunday 4/18 she had patches and streaks of red like sun burn and severe swelling of her feet and legs. This has continued with the swelling decreasing but still present w the redness, swelling of my feet and legs. The patient underwent lab test Ultrasound of legs to review if a blood clot which resulted negative. The patient received treatment. The patient visited doctor or other healthcare professional office/clinic visit. The clinical outcome of the events were recovering/ resolving.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
pt recv vax in 1991 & devel an inj site abscess which ruptured on it sown, & drained a large amount of fluid;the event resolved but it is unk if further tx was required;reporter has no further info about this rxn;
I had early signs of arthritis, but when going to see my local doctors and orthopedic and have received injections on my knees and ortho said that my arthritis is advanced and so far no results have been figured out. All symptoms started after  the injection. My magnesium and potassium was also very low when blood work was done.
pt recvd vax & w/in 24 hrs p/vax had vomiting & diarrhea x 24 hrs; The reporting MD dx pt's sx as gastroenteritis; sx subsided;
ARM HURTS FROM COVID BOOSTER; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (ARM HURTS FROM COVID BOOSTER) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 21-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In 2021, the patient experienced VACCINATION SITE PAIN (ARM HURTS FROM COVID BOOSTER). At the time of the report, VACCINATION SITE PAIN (ARM HURTS FROM COVID BOOSTER) was resolving.            This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  No concomitant medication information was  provided. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No treatment medication information was provided.   This case was linked to MOD-2021-623130 (Patient Link).
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The nurse reported that a patient was administered a first dose of VARIVAX on 15-JUL-2009. On 17-JUL-2013, patient received the first dose of ZOSTAVAX (lot number not provided) 0.5 ml subcutaneously instead of the intended VARIVAX. Concomitant medications were not provided. No adverse effect reported. No further information provided. Additional information has been requested.
Allergic reaction on her arm; It's a bit warm; Reacting like a wasp type thing where it's a 3 by 3 large red circle pink in the center.; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (Allergic reaction on her arm), VACCINATION SITE WARMTH (It's a bit warm) and VACCINATION SITE ERYTHEMA (Reacting like a wasp type thing where it's a 3 by 3 large red circle pink in the center.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced HYPERSENSITIVITY (Allergic reaction on her arm), VACCINATION SITE WARMTH (It's a bit warm) and VACCINATION SITE ERYTHEMA (Reacting like a wasp type thing where it's a 3 by 3 large red circle pink in the center.). At the time of the report, HYPERSENSITIVITY (Allergic reaction on her arm), VACCINATION SITE WARMTH (It's a bit warm) and VACCINATION SITE ERYTHEMA (Reacting like a wasp type thing where it's a 3 by 3 large red circle pink in the center.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment information was provided.
Started having ringing in ear 12 hours after shot which affected sleep; light tingling in feet 3 days after; hypervigilant; Last night (5 days after shot) had extreme tingling in lip/mouth; Started having ringing in ear 12 hours after shot which affected sleep; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 23Jul2021 09:00 (Lot number: ew0177) at the age of 29 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "heart murmur" (unspecified if ongoing), notes: other medical history none/ possible heart murmur when very young. There were no concomitant medications. The following information was reported: TINNITUS (non-serious) with onset 23Jul2021, outcome "recovering", SLEEP DISORDER (non-serious) with onset 29Jul2021 20:00, outcome "recovering" and all described as "Started having ringing in ear 12 hours after shot which affected sleep"; PARAESTHESIA (non-serious) with onset 29Jul2021 20:00, outcome "recovering", described as "light tingling in feet 3 days after"; ANXIETY (non-serious) with onset 29Jul2021 20:00, outcome "recovering", described as "hypervigilant"; PARAESTHESIA ORAL (non-serious) with onset 29Jul2021 20:00, outcome "recovering", described as "Last night (5 days after shot) had extreme tingling in lip/mouth". Therapeutic measures were not taken as a result of tinnitus, sleep disorder, paraesthesia, anxiety, paraesthesia oral.  Additional Information: The patient Started having ringing in ear 12 hours after shot which affected sleep. Semi-loud ringing continued for 3 days and is has gotten better since. Also have had some light tingling in feet 3 days after but not sure if a true reaction due to being hypervigilant due to the ringing. Last night ( 5 days after shot) had extreme tingling in lip/mouth that lasted for ~20 minutes however no swelling occurred. This event was quite disturbing which has prompted this report. It was unknown if covid was prior vaccination. The patient did not test for Covid post vaccination. Facility type of vaccine was Hospital. There was no other vaccine in four weeks. There were no other medications in two weeks.  Follow-up attempts are completed. No further information is expected.
Shortly after receiving his vaccines he was sitting on a chair and then started to pass out and fell to the floor.  He was out for about 5 seconds.  Pharmacist caught him and had him sit on the floor with his back to the wall, asked him questions such as name, where he was, who he was with.  Provided water and a granola bar and had them stay in the pharmacy for an additional 30 minutes.  Child was able to get up on his own and could walk by himself with no issues.  Went home with family.
Pt. fainted approximately 5 mins after the 2 shots given that lasted around 10 seconds. Regain & became exhausted.
On 3/29/21 left arm felt warm, hard, itchy. Noticeable rash 4" around site of injection.; Left arm felt warm, hard, itchy. Noticeable rash 4 around site of injection.; Left arm felt warm, hard, itchy. Noticeable rash 4 around site of injection.; Left arm felt warm, hard, itchy. Noticeable rash 4 around site of injection.; This is a spontaneous report from a contactable consumer, the patient. A 53-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration in the left arm on 26Mar2021 at 12:30 (at the age of 53-year-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient was not allergic to medications, food, or other products. Concomitant medications included progesterone (MANUFACTURER UNKNOWN) and unspecified vitamins (MANUFACTURER UNKNOWN). The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm left on 05Mar2021 at 15:15 as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 29Mar2021 at 10:00, the patient's left arm felt warm, hard, and itchy. On the same day, noticeable rash (reported as rash 4) was there around site of injection. Therapeutic measures were taken as a result of events and included treatment with topical analgesic and skin protectant. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events left arm felt warm, hard, itchy, and noticeable rash around site of injection was recovering/resolving.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
pruritic, maculopapular rash devel @ the site of DTAP w/in 24hr of inj;rash spread over several dasy across back, neck & eventually face;partially responded to med;
blood pressure went up considerably; Heart racing; suddenly felt very warm; This is a spontaneous report from a contactable consumer. A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular on 21Jan2021 at 14:45 (at the age of 67-years-old) as a single dose for Covid-19 immunization. Medical history included a history of asthma. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination or additional vaccines on the same day. On 21Jan2021 around a half hour after administration (also reported as within 40 minutes) the patient started having symptoms of suddenly felt very warm, her blood pressure went up considerably and her heart was racing. The patient went to Urgent Care and Urgent Care advised to take her to the Emergency Room as they did not have an EpiPen. The patient was advised to go to the Emergency Room and was in transit to the ER. The clinical outcome of the events blood pressure increased and palpitations was not recovered; for feeling hot it was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Client presented to Company Mobile event to receive Pfizer Booster. Client states that after Dose 1 and Dose 2 of Pfizer client developed painful fluid filled neck welts. Client didn't seek emergency care but went to her dermatologist. Client states Dr doesn't believe it was related to vaccine, but client states it's never happened before. Client states the welts come and go and feels a mass. A medical consult was submitted by RN to Clinical Project Coordinator. Client received approval to receive Pfizer Booster COVID vaccine by MD. Client received Moderna Booster Lot#FK9895. RN gave client Emergency precautions for recurring symptoms. Client verbalized understanding. Client refused to stay for observation time. Client left vaccination site in a steady gait.
68y.o. female with a PMH of bipolar affective disorder, HTN, HLD, anxiety, and depression who was transferred to (Privacy) from (Privacy) after concern for an episode of transient loss of consciousness it was felt that her symptoms were likely related to hypotension associated with Seroquel.  Medication was adjusted.  Symptoms resolved.  She did have intermittent bradycardia which was asymptomatic.  Echocardiogram did not show any significant findings.  She did test positive for COVID-19 virus on 1/4/2022.  She was asymptomatic.  She was accepted back to the general psychiatric unit for further management of her emotional/behavioral disorder. Time spent in care, counseling and discharge on date of discharge-33 minutes
This spontaneous report as received from a registered nurse refers to a female patient of an unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown date, the patient was vaccinated with the first dose of GARDASIL 9 (concentration, route of administration, lot# and expiration date were not reported). On an unknown date, approximately one year after the first dose, the patient was vaccinated with the second dose of GARDASIL 9 (concentration, route of administration, lot# and expiration date were not reported). No adverse effects were reported.
Sore Arm Temperature of 99.8 degrees all day Fatigue all day Difficulty in walking more than 15 mins without sitting down Legs felt very tired all day Lack of energy by 5:00 PM
Anaphylaxis (hives, throat tightening, chest pain, dizziness, nausea)  after booster dose with Pfizer-BioNTech COVID-19 vaccine.  Took patient to urgent care. Gave diphenhydramine 50 mg IV. Gave epinephrine and glucagon 1 mg IV. Contacted EMS. EMS gave additional dose of epinephrine and transported patient to ED. Limited data from outside ED, but looks like patient was discharged in stable condition with instructions to return if symptoms return. Given home EpiPen prescription.