chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt complained of dizziness and nausea, Has a HX of hypotension. Had pt lay down flat, pt was alert and oriented x4. Vitals were taken 147/82, HR78 and RR 18. Mrs. advised to see PCP for higher BP. Monitored pt for an extra 15 minutes and she left with friend after she fully recovered
On 11/2/13, slight to moderate itching resolved by rubbing. Site felt raised. On 11/3/13, itching became moderate. At 8:30 pm patient looked at the area and noticed a 2 x 3 in. raised, red rash. Patient took one ALLEGRA 180mg and Vitamin C 500mg and did a 5 minute cool compress. Itching size and redness has subsided.
This spontaneous report was received from a certified medical assistant and 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, the patients were vaccinated with the improperly stored doses of RECOMBIVAX HB lot number: K02144, expiration date on 17-SEP-2016 (strength, dose number, route and anatomical location were not provided). No adverse events were reported. This is one of several reports received from the same source. Additional information has been requested.
The day after receiving the meningococcal vaccine (she also received HPV,Hep A & Tdap at the same time)she woke up not feeling well.  As the day progressed she got a 102.5 fever, chills, headache, whole body ache, difficulty breathing and her hands felt numb at times.  This lasted until the next day.  She felt better the next day but still felt tired, some what achy and dizzy at times.  By the next day she felt normal again.  I gave her ibuprofen, which brought the fever down some and somewhat helped with the aches.  I did not take her in to the doctors office.     She received two shots in the left arm and two in the right (which ones in each, I do not know).  I clicked unkown manufacturer below, because I do not know what was used.
Redness and swelling at site of injection, hoarseness, wheezing intermittent for 2-3 hours.
Reaction to ZOSTAVAX vaccine. Rash (itchy, swollen, hard spot around injection site).
Heart coming out of throat, BP 128/84, P98, dyspnea, R arm warm to touch, dizziness, skin blotchy, diarrhea.
Patient reported shortness of breath, swelling at site of injection, slight fever, and lethargy.
Just learned of VAERS. No previous hip medical history. Felt healthy before the vaccine. The same vaccine day, in the evening, felt an intense pain so hard in my left hip that felt like a ball of fire. The next day, I could not put weight on it. That day, the chiropractor found that my hip was out of place. Have to go everyday to put the left hip back in place. It is pain from the toes at the left leg going up to the left ribs. Symptoms: pain in the hip area, chills at any time, lost about 15 lbs, pain in the joints, mobility decreased, hip area very tender, prone to injury. As of today, going to physical therapy every day since then. Life has changed since then.
Information has been received from a physician concerning a 6 month old patient who on 21-SEP-2006 was vaccinated with a first dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human bovine). No adverse events were reported. Unspecified medical attention was sought. No product quality complaint was involved. Additional information has been requested.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 54-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Oct2022 as dose 5 (booster), single (Lot number: GH9703) at the age of 54 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "kidney stones" (unspecified if ongoing); "GERD" (unspecified if ongoing). Concomitant medication(s) included: ACETAMINOPHEN; ATORVASTATIN CALCIUM; BUPROPION; DULERA; CHOLECALCIFEROL; FLUTICASONE; LORATADINE; TIZANIDINE; PANTOPRAZOLE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Treatment medicine was Paxlovid.
Blotchy rash and puffiness on face, muscle twitching face, arms, legs, felt tight, twitching feeling and tightness resolved with Benadryl all Sx resided with in 2 days.
pt rt leg swelled 4" around site of inject; inconsolable crying for 8 hrs;
Pt found unresponsive & not breathing after nap.  Resuscitated by EMS & in ER, never regained consciousness & later died in PICU at hospital.  Intracranial bleed on head CT.  10/9/2008 Forensic Autopsy Summary Sheet received, COD pending further studies.  Infant found unresponsive and transported to ER & dx with subdural hematoma.  Transferred to higher level of care.  Despite resuscitation efforts, infant pronounced dead.  Autopsy findings of 2 small abraded contusions to L side of head, subdural hematoma overlying the L temporal lobe.  Marked brain edema and pulmonary edema. Otherwise unremarkable
Kinrix given to 10 month old infant; should have been Pediarix.  Phone call placed to mom to discuss error.  Mom returned to office to Receive Hep B vaccine (for after 6 months).
Pt reported fever and N/V on day following vaccine. At one point he fainted for about 5 minutes and was taken to the ER after that. He recovered completely.
Seizure-DIASTAT given. # didn't take all of AM DEPAKOTE per dad.
It looks like patient had an allergic rxn to PNEUMOVAX vaccine. He (R) upper arm was red / blue and swollen. Recommended that pt. takes ADVIL for inflammation.
Immediately after the injection, I had a strong taste of metal in my mouth that lasted for over 24 hours. Within five minutes of injection, I had a warm burning sensation from head to toe. The burning sensation settled down into a pins and needles sensation throughout my body that has continued for the past 48 hours. I have never had an adverse reaction to any vaccine, and I have no underlying medical conditions that would cause a pins and needles sensation.
deafness in her left ear; Initial information received on 08-Nov-2019 regarding an unsolicited valid serious case received from a consumer.  This case involves female patient who experienced deafness in her left ear (deafness unilateral) while she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 15-Oct-2019, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UJ210AA (Expiry date 30-Jun-2020) via unknown route in unknown administration site.  On 19-Oct-2019, the patient developed a serious deafness in her left ear (deafness unilateral) 4 days following the administration of INFLUENZA QUADRIVAL A-B VACCINE. This event was assessed as medically significant.  (Other relevant tests included no lab data.)  Final diagnosis was deafness in her left ear.   It was not reported if the patient received a corrective treatment.  The event outcome is reported as Unknown for deafness in her ear.; Sender's Comments: This case involves female patient who experienced deafness in her left ear, while she received vaccine Fluzone Quadrivalent. The time to onset is compatible with the role of the vaccine. Moreover, patient's medical history, medical condition at time of vaccination and lab test ruling out alternate etiologies were not reported.
Severly ill with COVID 19.  Tested positive 8/13/22.  In hospital since 8/14/22.
Pt recd 3rd dose of Hep B 21OCT91; on same day, pt exp "sick serum synd", sx included discomfort, swelling of knees, legs & ankles, rash on back, joint pain; rx: epi @ ER; swelling worsened; rx: steroid therapy;
This spontaneous report received from a patient via social media from a company representative concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. The patient's past medical history included: breast cancer survivor. On an unspecified date, the patient previously received Covid-19 vaccine ad26.cov2.s (dose number in series 1), (unspecified manufacturer) (suspension for injection, route of admin, batch number and expiry were not reported) dose was not reported, administered 1 in total for prophylactic vaccination. No adverse events reported following vaccination with Covid-19 vaccine ad26.cov2.s (dose number in series 1).   The patient received Covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose, start therapy date were not reported administered 1 in total for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On 04-MAR-2022, the patient experienced ear bleeding (dose number in series 2). On an unspecified date, the patient experienced heart flutters, hair falling out, skin like its sunburn feeling, inside of mouth always feels sore, skin thickening, both breasts have issues, legs hurt, headaches, and weaker (dose number in series 2). It was reported that "I wish I was as fortunate. No problems with the regular shot, however, with booster my hairs falling out, my skins like its sunburn feeling and thickening, inside mouth now always feels sore, heart flutters, and legs hurt. Yesterday one ear was bleeding, now left ears bleeding not a little blood comes out of my ear so Monday it begins again I am off to Dr. again. Also I am a breast cancer survivor and both breast have issues now as well as headaches many other things. I am trying to get thru but each day I get weaker". The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from ears bleeding on 05-MAR-2022, had not recovered from inside of mouth always feels sore, both breasts have issues, and weaker, and the outcome of hair falling out, skin like its sunburn feeling, heart flutters, legs hurt, headaches and skin thickening was not reported. This report was serious (Other Medically Important Condition). Sender's Comments: V0: 20220313818-Covid-19 vaccine ad26.cov2.s-heart flutters. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Nauseous; Headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nauseous), HEADACHE (Headache) and FATIGUE (Fatigue) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, the patient experienced NAUSEA (Nauseous), HEADACHE (Headache) and FATIGUE (Fatigue). At the time of the report, NAUSEA (Nauseous), HEADACHE (Headache) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Patient is 62 years old and received a Fluzone Quad High Dose vaccine. According to CDC:  Fluzone High-Dose Quadrivalent vaccine is approved only for people 65 years and older. Fluzone High-Dose Quadrivalent is not approved for people younger than 65 years or for people of any age with a history of severe allergic reaction to any influenza vaccine or to vaccine components other than eggs. Information about vaccine ingredients is located in the manufacturer?s package insert.
Around four days after the second Moderna shot, woke up to tinnitus in both ears. Tinnitus has been unrelenting since onset. Visited urgent car on Jun 6th since the tinnitus was unrelenting. Saw ENT Jun 9th. Had hearing test on June 10th and saw audiologist after hearing test. Nothing was prescribed. Visited primary care on July 9th and was prescribed venlafaxine, partly due to anxiety / depression following symptoms. Visited with tinnitus specialist on September 1st 2021 and again on October 20th 2021. Have another visit scheduled with same specialist on April 20th 2022.
Patient was admitted 4/13/2021 to the hospital, tested positive 4/14/2021 for COVID. He received Pfizer vaccination on 2/24/21 & 3/17/2021
Aches all over her body; Low grade Fever; Mild Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Aches all over her body), PYREXIA (Low grade Fever) and HEADACHE (Mild Headache) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (Past medical history not provided).    On 27-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On an unknown date, the patient experienced PAIN (Aches all over her body), PYREXIA (Low grade Fever) and HEADACHE (Mild Headache). At the time of the report, PAIN (Aches all over her body), PYREXIA (Low grade Fever) and HEADACHE (Mild Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications taken by the patient were not provided. Treatment information was not provided.
Narrative:  94yo male patient who resided in nursing home moved to facility hospice care on 10/21/2021. Pt died on 11/1/2021. Pt's problem list below: 11 Active Problems PROBLEM LAST MOD PROVIDER Osteoarthritis of knee (SCT 239873007) 08/02/2017 (ICD-10-CM M17.0) Benign prostatic hypertrophy without outflow 08/01/2016 obstruction (SCT 254902007) (ICD-10-CM N40.1) Degeneration of cervical intervertebral disc 07/30/2015 (ICD-9-CM 722.4) (ICD-9-CM V45.81); Postsurgical Aortocoronary 05/02/2006 Bypass Status (ICD-9-CM V45.81) (ICD-9-CM 562.10); DIVERTICULOSIS OF COLON 05/08/2003 (ICD-10-CM I25.10); Coronary artery disease 8/01/2016 (SNOMED CT 53741008) (ICD-10-CM I10.); Benign essential hypertension 08/01/2016 (SNOMED CT 1201005) (ICD-10-CM K21.9); Gastroesophageal reflux 08/01/2016 disease (SNOMED CT 235595009) (ICD-9-CM 607.84); IMPOTENCE, ORGANIC ORIGN 05/13/2002 (ICD-10-CM E78.2); Mixed hyperlipidemia (SNOMED 08/01/2016 CT 267434003) (ICD-9-CM 715.00); OSTEOARTHROSIS, GENERALIZED 05/13/2002 Pt had been given covid vaccines on 1/12/21 & 2/9/21. Likely pt's death is not related to covid vaccines given pt's advanced age, comorbidies, and long length of time between death & date of vaccine administrations.
Local side effect (greenish bruise about 1 cm) on left side of outer arm, redness raised above the skin and feel hot, feel tired - tongue enlarge w/ discoloration, dry blood around the mouth.
I noticed he used bivalent boosters instead of 1 monovalent booster and one bivalent booster. I wasn't sure if he had actually received 2 bivalent boosters; no adverse event; This spontaneous case was reported by a patient and describes the occurrence of CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (I noticed he used bivalent boosters instead of 1 monovalent booster and one bivalent booster. I wasn't sure if he had actually received 2 bivalent boosters) and NO ADVERSE EVENT (no adverse event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (I noticed he used bivalent boosters instead of 1 monovalent booster and one bivalent booster. I wasn't sure if he had actually received 2 bivalent boosters) and NO ADVERSE EVENT (no adverse event). At the time of the report, CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (I noticed he used bivalent boosters instead of 1 monovalent booster and one bivalent booster. I wasn't sure if he had actually received 2 bivalent boosters) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (I noticed he used bivalent boosters instead of 1 monovalent booster and one bivalent booster. I wasn't sure if he had actually received 2 bivalent boosters).    No concomitant medications were reported.     Patient noticed that they used bivalent boosters instead of 1 monovalent booster and one bivalent booster. The patient was not sure if he had actually received 2 bivalent boosters or if he was referring to both boosters just as both bivalent boosters because that was the most recent booster he had received or not.  No treatment medications were reported.   Reporter did not allow further contact
chest infection; Arm pain; cough; asthma attack; This is a spontaneous report from a non-contactable consumer (patient). A 45-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA6780), via an unspecified route of administration, administered in left arm on an unspecified date in Jul2021 (at the age of 45-years-old) as dose 2, single for COVID-19 immunisation. The patient previously took the first dose of bnt162b2 on an unsoecified date in Jul2021 and experienced arm pain and sick with flu like symptoms for 2 days. The patient medical history was not reported. The patient was not diagnosed with COVID before vaccination. Concomitant medication included multivitamin, vitamin d3, calcium and elderberry, all taken for an unspecified indication, start and stop date were not reported. On 28Jul2021 the patient experienced chest infection, arm pain, cough and asthma attack. It was reported that began with a cough, and it triggered a severe asthma attack by the second day after the vaccine. Patient has not suffered from asthma in 12 years until she took the covid shot. It became worse even after starting prednisone and taking prescribed cough medication. Ended up in the hospital for a chest X-ray and covid testing, all came back clear, no covid and no pneumonia. Just a severe chest infection that triggered outgrown asthma symptoms. Was them prescribed azithromycin and currently waiting to see if it will help with the reaction to the lungs and chest. Arm pain with both shots but worse with the first shot. The events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care visit. The treatment of events included ae treatment prednisone, Benzonatate and Azithromycin. On 02Aug2021 patient performed a covid test type post vaccination (Nasal Swab) with negative result. The outcome of events was recovering.    No follow-up attempts are possible. No further information is expected.
Per patient email report:  "I woke up last night with a severe, cramping stomachache, along with muscle/body aches that is not improving with ibuprofen and Tums. I am also developing a very itchy rash/allergic reaction on the sides of my abdomen. "
A 6 month old patient was given KINRIX (DTAP, IPV). The patient did receive the vaccine. Doses will count & not need to be repeated per CDC guidelines. No adverse reaction noted. Private office. Medications involved are DTAP-IPV combination and KINRIX. Injectable; 0.5 mL dose containing a suspension of DTAP antigens, and inactivated poliovirus. Error was discovered a 9 month well child check with immunization review. Recommended dosing age needs to be printed clearly on the front of the box. No adverse reaction noted. Error was discovered at 9 month well child check with immunization review. Recommended dosing age needs to be printed clearly on the front of the box.
No adverse event; Patients received a dosage of 0.2 ml of the bivalent vaccine dark pink cap with yellow border as their primary dose; This spontaneous case was reported by an other health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patients received a dosage of 0.2 ml of the bivalent vaccine dark pink cap with yellow border as their primary dose) and NO ADVERSE EVENT (No adverse event) in an infant patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Rotavirus (Rota tec), Pediarix, ACT Hib and PCV 13. Past adverse reactions to the above products included No adverse event with ACT Hib, PCV 13, Pediarix and Rotavirus (Rota tec). Concurrent medical conditions included Lactose intolerant and Cow's milk protein allergy.    On 19-Apr-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. On 19-Apr-2023, the patient experienced WRONG PRODUCT ADMINISTERED (Patients received a dosage of 0.2 ml of the bivalent vaccine dark pink cap with yellow border as their primary dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patients received a dosage of 0.2 ml of the bivalent vaccine dark pink cap with yellow border as their primary dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patients received a dosage of 0.2 ml of the bivalent vaccine dark pink cap with yellow border as their primary dose).    It was reported that patient received other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medications was reported. No treatment drug details was reported.  This case contains information for the 3rd patient out of 4 infant patients as described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-720512 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-720512:Infant Patient - 1 (master case)
Low grade fever, pain/redness at injection site of flu shot. Myalgias, induration of 2cm.
Fever, upper arm redness and warmth, instructed to use cold compress and take BENADRYL BID.
Pt reported headache shortly after receiving vaccine, and later that day and the  next day she experienced difficulty swallowing (choking) and hives. She took Benadryl which did not help much, then she talked to her doctor and took prednisone she had at home. She  feels better and wants to report the side effects. Very concerned about getting the second dose.
16 days after receiving ADACEL, complains of feeling pins and needles in her feet and numb sensation on both legs. MD notes state decreased sensation to light touch on both feet below the ankles.