chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tongue numbness and sensitive; Tongue numbness and sensitive; This is a spontaneous report from a contactable nurse (patient) and a physician. A 31-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EK5730) intramuscular on17Dec2020 13:30 at a single dose on right arm as COVID-19 vaccine. Medical history was not reported. The patient had no known allergies to medications, food, or other products. Concomitant medications were not reported. On 17Dec2020, she received the vaccine and an hour after getting it, her tongue went numb and became sensitive (tongue numbness and sensitive on 17Dec2020 14:00). Today, it was not as numb feeling but was still sensitive. The events were assessed as non-serious, did not result in death, not life threatening, did not cause/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. Treatment was not received for the adverse events. The patient was not pregnant at the time of vaccination. The facility where the most recent COVID-19 vaccine was administered was noted as other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. There was no expiry date for the vaccine. The card she has, only has the received date: 17Dec2020 and when to return for the second dose: 07Jan2021. She had submitted a claim about the side effects experienced but it wasn't clear what would happen next. The patient inquired if someone would reach out to her and would there be a follow-up. She wanted to know what the process would be regarding reporting. The outcome of the event 'numbness of tongue' was recovering while 'sensitive tongue' was not recovered.
Patient has a knot in his lymph node area under the arm in which he received the PREVNAR vaccination.
He was having trouble breathing.; Tone went limp; Was lethargic; This non-serious case was received during the monitoring on 11-APR-2022 with the following Primary ID 2180696-1. The original narrative from the sender is as below:  While sleeping the night after the vaccines, mom woke to him gasping. He was having trouble breathing. Tone went limp. Was lethargic. Responded after mother provided stimulation. Similar issues occurred after 4 mo vaccinations.  Lab data included none this time. After 4mo vaccinations, he was evaluated by neuro and seizures were ruled out.  Current illness included mild viral URI the week prior.  Adverse Events After Prior Vaccinations included similar issue after 4 mo vaccinations.  Medications At Time Of Vaccination included Peanut allergy supplementation.  No allergies. No medical history.
This spontaneous report as receipt from a pharmacist refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medications were not reported. On 10-MAY-2016, the patient was vaccinated with RECOMBIVAX HB lot # K008986, expiry date 01-APR-2016 (dose, route and site of administration were not reported) which was 10 days past its expiration date. No adverse effects were reported. Additional information has been requested.
Received vaccines 12/23 and 1/13. Conceived 3/13. Diagnosed with symptomatic (bleeding) placenta previa 6/8. No risk factors present.
7pm.. chills, mild body aches, 8pm.. worsening chills, headache and moderate body aches 9pm-2am....  chills, headaches, moderate body aches 7am..  mild bodyaches, headache 11:15....  sx gone MILD body aches the next morning.... of note  hx of  COVID dx 9/2020
Extreme soreness in arm. Pt required steroid pack.  Vaccine was given to high on arm and given near shoulder bone which is probably reason for reaction.
Experience side effects: tiredness, soreness, shakes, headache, nausea. Resolved after 24 hours.
Within 48 hours after receiving DTaP/IPV in (R) deltoid pt developed redness / tenderness & multiple large fluid filled blisters.
Had irritability and low grade fever up to 101 for 2 days, then developed lethargy, poor eating, diarrhea with orange stool, vomiting, abdominal pain, episodic pallor. On exam had significant abdominal tenderness but by the time patient saw me he had already improved and the severe lethargy and orange stools resolved.
THREE DAYS AFTER THE VACCINE SHE DEVELOPED PAIN AND TENDERNESS FROM HER LEFT NECK AND SHOULDER DOWN THE ARM TO THE WRIST.  THE SYMPTOMS PEAKED IN THE FIRST 2-3 DAYS, THEN SUBSIDED SOMEWHAT BUT STILL PERSIST TO DATE.  WE'LL CONTINUE TO FOLLOW HER.
Since I have had the booster shot for Moderna Covid, I have a very sore arm and sharp pain that make it where I can not use my arm.  This has been going on for 4 months about and my doctor does not know what to do to stop it. He has done two treatments
no serious adverse event; expired dose of vaqta was inadvertently administered to patient; This spontaneous report as received from a pharmacist refers to a 7 years old patient. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported.  On 20-MAY-2020, the patient was inadvertently vaccinated with an expired dose of hepatitis a vaccine, inactivated(VAQTA) pre-filled syringe of strength 25 units/0.5 milliliter, (lot # S021092, expiry date : 18-MAY-2020, anatomical location was not reported) for prophylaxis (expired product administered). The patient had no adverse event. No product quality complaint (PQC) was involved. The outcome of expired product administered and no adverse event was unknown. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S021092; expirationdate: 18-MAY-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Initial unsolicited report received from a consumer on 29 April 2015. A 19-year-old female patient, whose medical history was food allergies and concomitant medications was not reported, had received a second dose of IMOVAX (batch number, expiry date, dose and site of administration were not reported) on an unspecified date (09:00 hours). Patient's mother reported that at around 09:00 hours and at 19:00 hours at night patient developed mild facial swelling and started feeling like she was having difficulty in swallowing. Patient took BENADRYL and EPIPEN and then went to emergency room and received no further treatment at emergency room. It was reported that, vaccinations within four weeks of vaccinations were not provided and patient had one previous dose of IMOVAX. Patient had no illness at the time of vaccination. It was also reported that, pre-existing physician diagnosed allergies, birth defects, medical conditions were severe food allergies. Laboratory investigations were reported as none. At the time of this report, patient had recovered. Documents held by sender: none. Follow-up information received from a physician on 08 June 2015. A 19-year-old female patient had received a 1 ml of IMOVAX (batch number: KI079-1, expiry date: 14 February 2016) via intramuscular route in left deltoid on 16 April 2015 at 09:00 hours. Also, the patient had received ADACEL (batch number: C4765AA), TYPHIM VI (batch number: K1200-1), FLUZONE (batch number: UI197AB), IXIARO (manufacturer: Novartis, batch number: IEV14B59E) [expiry date, dose, dose in series and route of administration were not reported for all] all in left deltoid on 16 April 2015 and Influenza vaccine (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on 16 April 2015. The vaccine was purchased with private funds and was vaccinated at private doctor's office/hospital. Reporter causality was not reported. Documents held by sender: none.
Around 6:30 PM patient complained his legs where itchy, upon inspection we discovered hives and took him to ER.
REC'D VACCINE ON 1-19-20. ON 1-20-21, STARTED WITH FEVER AND CHILLS. TEMP 101.1. TOOK TYLENOL. HAD SORENESS AT IJECTION SIT, ALL OVER BODY ACHES AND JOINT DISCOMFORT. HEADACHE, SHIVERING, FATIGUE. ON 1-21-21, PATIENT STATES SHE HAS BEGUN TO FEEL BETTER. TEMP 98.8. STILL ACHY
Lethargy, blistering rash (ZOSTER); lasted through December.  Patient still experiences postherpetic neuralgia.
Patient reported redness and swelling at the site starting on 10/31/23 up until 11/17. As well as pain and a bad burning sensation in the arm occasionally going up to the shoulder.  Also, her legs are experiencing severe trolly horses especially at night involving my entire legs. It is both of them sometimes a burning.
Vaccines were not required based on the CDC catch-up schedule. Attempted contact to guardian (father) but unable to leave message. No adverse events were reported to Health Department. This RN had given catch-up vaccines at the request of school nurse and reviewed CDC catch-up schedule (Persons aged 4 months through 6 years).  After vaccination this RN realized that there were notations of using  this table "in conjunction with Figure 1 and Footnotes" that explained after 59 months 2nd doses are not required unless specific medical conditions are present.
Muscle pain at injection site that quickly became a "frozen shoulder."  Frozen shoulder has not yet resolved (still frozen).  considerable discomfort still in the area where the shot occurred.
Next day, client felt nauseated.   Each day afterward symptoms worsened until after one week, client got dizzy when she sat up or opened eyes. She got prescription for zofran twice a day for two weeks. Client felt better after 4-5 weeks post-vaccination with zofran. At 4 week point, client spoke with her primary care doctor who recommended benadryl every 6 hours for 5 days, then once daily. Client felt fully better with benadryl.   PCP felt the reaction was due to the Moderna and alpha-gal. Client requested and received Janssen/Johnson and Johnson for second and final vaccine.
Hemorrhagic Cerebrovascular Accident (Cva) (Cms-Hcc)Acute Loss of Vision, Left; Hemorrhagic Cerebrovascular Accident (Cva) (Cms-Hcc)Acute Loss of Vision, Left; Hemorrhagic Cerebrovascular Accident (Cva) (Cms-Hcc)Acute Loss of Vision, Left; This is a spontaneous report from a contactable consumer. This 61-year-old male consumer (patient) reported for himself that he received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EN6204) via an unspecified route of administration on 16Mar2021 at 15:00 hours on left arm (at 61-year-old) as dose 1, single for COVID-19 immunization. Medical history included cardiac failure. The allergies were reported as none. Concomitant medications included sacubitril valsartan sodium hydrate (Entresto) taken for an unspecified indication, carvedilol taken for an unspecified indication and spironolactone taken for an unspecified indication. On 18Mar2021 at 10:00 PM the patient experienced loss of vision, cerebrovascular accident and hemorrhagic stroke. The patient required emergency room visit and was hospitalized for 3 days. Therapeutic measures were taken with nir angiogram cerebral. The event outcome was unknown. It was mentioned that no other vaccine was received in four weeks, patient had no covid prior vaccination and was not tested for covid post vaccination. The device date was 03Jul2021.
Sweating, lightheadedness, nausea - occurred 6-8 hrs post vaccination.
Splotchy rash around injection site. Approximately 3 in x 3 in area. No swelling.
I attended a wedding on 6/19/2022. On 6/21/2022, I returned home late from a trip and got only about 3 hours of sleep. I woke up feeling achy and I had a persistent cough with a little bit of congestion. I did a neti pot to cleanse my sinuses, and it helped me sleep. I took an at-home test for COVID on the afternoon of 6/22/2022 after learning that some other wedding guests had tested positive. The test yielded a positive result. I called my doctor to inform her of the test result, and she prescribed me Paxlovid. I haven't yet picked up the prescription. In the meantime, I have been isolating at home, wearing a mask, having chicken soup, and taking mostly vitamin C and vitamin D supplements. At the time of this writing, I feel a little better than I did at the beginning. I now have mostly fatigue and a light cough.
light headed, site burning sensation, felt dehydrated, lethargic, sore throat, disoriented, body aches, brain fog
I went for a low dose lung cancer screening. When results came back they told me my lymph nodes were swollen and i needed to follow up for more screens. The doctor was concern but I came back for another CT scan and sonogram. They said that it was a expected side effect for the vaccine. And everything did come back fine in the end
Left arm presented red swelling, cellulitis, pain radiating to the fingers and left side of the shoulder and neck areas.
redness on arm immediately after vaccine (dime size) gotten larger the following day (quarter size) rash, hot and itchy
Fluzone High Dose administered to a 6 month old patient / no AE; Fluzone High Dose administered to a 6 month old patient / no AE; Initial information received on 04-Oct-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 6 months old female patient who received 0.5 ml dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] lot UJ284AA (Expiry date 25-May-2020) via intramuscular route in the right thigh on 04-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) and DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (PEDIARIX).  It was an actual medication error case due to inappropriate age at vaccine administration and overdose.   At a time of reporting no adverse event was reported.  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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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 and chills and headach starting approx 8 hrs after booster vaccine. Body aches, extreme muscle soreness (full body), fatigue, skin hurts to the touch all over, neck pain.
9:15 AM: ITCHING ON AND AROUND INJECTION SITE SPREADING TO MY NECK, RED/HOT SKIN ON AND AROUND INJECTION SITE, NAUSEA, HEADACHE, MENTAL FUZZINESS. TAKEN TO EMERGENCY DEPT, GIVEN BENADRYL. ITCHING STILL OCCURING ON BODY.
This spontaneous report as received from a nurse via field representative refers to a patient of unknown age and gender. The patient's current conditions, pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with ROTATEQ (strength, dose, frequency,lot/batch # and expiration date were not reported) by mouth for prophylaxis and shortly "threw it up" (underdose). On an unknown date(reported as"few days later", the patient was administered with second dose of ROTATEQ (strength, dose, frequency, lot/batch # and expiration date were not reported). No symptoms were reported. No additional adverse event information was provided. No product quality complaint (PQC) involved. The outcome of the events was unknown. The causality assessment of the ROTATEQ with the event "threw it up" was not provided by the reporter.
patient received a Menveo dose that was reconstituted using sterile water; patient received a Menveo dose that was reconstituted using sterile water; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 12-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA748A, expiry date 30-NOV-2023) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: patient received a Menveo dose that was reconstituted using sterile water) and inappropriate dose of vaccine administered (Verbatim: patient received a Menveo dose that was reconstituted using sterile water). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: Receipt date: 14-Aug-2023 A pharmacist asked for guidance on this situation. The reporter did not consent to follow-up. The patient received a dose of Menveo that was reconstituted using sterile water instead of the supplied meningococcal CYW-135 (MenCYW 135) liquid conjugate vaccine component, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Pt recvd MMR vax on 6JAN92 &  w/in 10 mins pt devel wheal, erythema & induration of 4 to 5 cm @ inject site; wheal inc to a dime size w/several smaller wheals on periphery; w/in 1/2 hr of vax area swollen & erythemateous;
I suffered an incident of Vertigo (intense dizzyness and vomiting) lasting approximately 48 hours that required a trip to the ER. Physical Therpay was prescribed and done for a period of one week or until symptoms are no longer present. I feel fine now.
Pt received GSK influenza quad inj Lot# 79XR9 on 10/04/2023 subsequently received an additional dose of the above vaccine at the school flu clinic on 11/02/2023. Parent erred in not notifying the school nurse the pt had previously received vaccine on 10/04/2023. If that had been done the pt consent form would have been pulled and this incident would not have happened.
Gait deterioration; slapping gait; speech deterioration and lethargy within 36 hours of vaccine.
sore left injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore left injection site arm) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 029L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Feb-2021, the patient experienced VACCINATION SITE PAIN (sore left injection site arm). At the time of the report, VACCINATION SITE PAIN (sore left injection site arm) outcome was unknown.            No concomitant medication details was reported. No treatment medication details was reported.   This case was linked to MOD-2021-403073 (Patient Link).
Vaccine administration complication: the vaccine syringe "clicked" as if the needle had retracted, so it was withdrawn, but the needle had not retracted and at least half the dose leaked onto the floor.  Patient was counseled by MD and pt chose to have a second full dose given
Rash redness at injection site  swollen lymph gland in same arm  painful  happened 9 days out and lasted more then 5 days
Per Note from ER physician: Pleasant 58 year-old male with rash on right arm and right chest for one day.  States he received his flu shot earlier today and then ~ 2 hours later noticed a rash on his right arm.  The rash has extended down his arm and onto his right chest.  Interestingly, he had his flu shot in his left deltoid. Macular rash with defined borders noted on proximal arm and plantar forearm with extension to right axillary/chest area. Impression: Exanthem, allergic eruption Plan: Dexamethasone 4 mg daily for 5 days.  Advised patient to return if symptoms worsen or do not improve following therapy.
Widespread body aches; Irregular menstrual cycles; Heavy menstrual bleeding; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0198) via an unspecified route of administration in the left arm on 27Jul2021 at 10:00 (at the age of 49-years-old) as a single dose for COVID-19 immunisation. Medical history included fibromyalgia and COVID-19. The patient had no known allergies. Prior to the vaccination, the patient was diagnosed with COVID-19.  The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. The patient received unspecified concomitant medications. On 28Jul2021, the patient experienced widespread body aches, irregular menstrual cycles and heavy menstrual bleeding. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event widespread body aches, irregular menstrual cycles and heavy menstrual bleeding were resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
2nd dose pfizer vaccine was given to patient on 07/08/2021. We found out on 07/09/2021 vaccine was stored outside the recommended 31 day expiration window. We reached out to pt on 07/10/21 to get the 1st dose again. Patient will return to the pharmacy to repeat dose on 07/12/21.
Soreness in left arm persists after two weeks and is worse when arm is raised laterally.
High fever - up to 103- March 13-14-2009 Full body rash- March 15-16-17-2009 MMR-given 3-02-09
Rash at injection sight.  Redness, itchy, warm to the touch. Looks like 2 large red rings
About 2 hours after receiving the vaccine, my right arm started throbbing from the vaccine site down to my elbow. Within 15 minutes the throbbing turned into excruciating pain. I could not move my upper arm without causing extreme pain. The pain continued to get worse and my upper arm muscle was hard as a rock until I received morphine about 2 hours later.  I took Flexeril 5 mg and Naproxen 500 mg for 4 days. Today is day 6 and I have about 90% of  my range of motion back but it's still very sore.  Using a heating pad, water fitness  and exercising my arm every day.  Note: Both Covid vaccines were in my right arm; the last one was one month before the Shingles shot. Is there a correlation? The Emergency Room Doctor told me this reaction was "not normal" for a Shingles vaccine adversity.
None. Patient said arm slightly sore evening of immunization but next day fine. Patient was given Tdap by mistake since it is only recommended at ages 10-64 (BOOSTRIX) and patient is 67 years old. Patient was due for Td.
On 09/16/2022 or within that week, I began to feel exhausted and had a fever and was achy.  I kept picking up viruses and my sinuses would get infected.  I would be in bed for three or four days and I still don't have the energy.
Pain in Left Shoulder where vaccine was given.  Soreness, red, swelling at injection site (hive).  Pain lasting two days and counting.