chrisvoncsefalvay/vaers-outcomes huggingface dataset:
CONFIRMED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a 63 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: cancer. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1085029 expiry: UNKNOWN) dose was not reported, 1 total administered to left arm on 14-MAR-2021 for prophylactic vaccination. Concomitant medications included bnt 162 for prophylactic vaccination. On 26-AUG-2021, he did an antibody test and it was negative test (confirmed immunological vaccine failure). After received the vaccine he had no side effects at all. The patient's arm was not even hurting from the injection. He could not even tell which arm he got the vaccine. He drove for a couple of hours to get the vaccine and on his way back he drank a couple of bottles of electrolytes as he was advised that this will help after getting the vaccine. The patient's doctor suggested to get another shot of Pfizer Covid-19 vaccine which he received on August 26th, 2021. The patient was not on any other medications other than OTC pain killers and vitamins. Laboratory data included: Antibody test (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a regulatory authority: 90000191530. This case, from the same reporter is linked to 20210860607 and 20210860781.; Sender's Comments: V0; 20210860500-COVID-19 VACCINE AD26.COV2.S-Confirmed Immunological Vaccination Failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Pt vax w/ 1st dose Hepta B 28JAN91. Developed dizziness&gastrointestinal cramps.11May91 2nd dose of vax developed local rxn,urticaria,edema&chest pain.To ER-DX:serum sickness.Developed bilat knee effusion&handgrip weakness.DX:carpel tunnel
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 62-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (in January 2016). On 26th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In September 2018, less than a day after receiving SHINGRIX, the patient experienced pain in arm, injected limb mobility decreased, influenza-like symptoms, chills and fever. On an unknown date, the outcome of the pain in arm, influenza-like symptoms, chills and fever were not recovered/not resolved and the outcome of the injected limb mobility decreased was recovered/resolved. It was unknown if the reporter considered the pain in arm, injected limb mobility decreased, influenza-like symptoms, chills and fever to be related to SHINGRIX. Additional details were received as follows: The patient received SHINGRIX in the left arm. The patient had SHINGRIX vaccine which hurt very bad. The patient could not lift her arm for approximately 4 to 5 days due to the arm pain. That night after receiving the SHINGRIX vaccine, several hours after vaccination the patient developed flu-like symptoms, including chills and fever. She was sick for two days and the symptoms resolved. The reporter consented to follow up. For tolerance, refer case US2019027669 for 2nd dose. This case has been linked to US2019027673 (husband's case), reported by the same reporter.
VAXELIS administered since temperature excursion above 8.5° (10 mins)/Previous temperature excursion on 12-APR-22 above 8° (10 mins); This non-serious spontaneous report with reference numbers 02197725 / 02197588 was received by partner on 05-JUL-2022 and forwarded on 06-JUL-2022 from a consumer.    The causal relationship between Vaxelis and the reported event "multiple doses of VAXELIS administered since temperature excursion" was assessed as not applicable due to the nature of the event.    Further information is expected.  FOLLOW-UP INFORMATION was received by a partner on 01-AUG-2022 and forwarded on 03-AUG-2022, from a HCP. The case is maintained as non-serious.  The reporter confirmed that there were no Adverse Events following Vaxelis administration to the patient.  Due to the nature of the event, the causality between the event "VAXELIS administered since temperature excursion above 8.5° (10 mins)/Previous temperature excursion on 12-APR-22 above 8°C (10 mins)" and Vaxelis remained not applicable.  For reference purposes this case is linked to MCM-003724, MCM-003725, MCM-003726, MCM-003724, MCM-003734, MCM-003735, MCM-003737, MCM-003738, MCM-003739, MCM-003740, MCM-003741, MCM-003742, MCM-003743, MCM-003744, MCM-003747, MCM-003749, MCM-003751, MCM-003752, MCM-003753, MCM-003757, MCM-003760, MCM-003761, MCM-003763, MCM-003766, MCM-003767, MCM-003769, MCM-003770, and MCM-003772, due to same reporter.  No further information is expected.
Tdap administered 10/15/09. Pt reported reaction on 10/23/09 follow 10/29/09. Pt states following occurred after receiving vaccine. Left arm hurting later in evening which continued to get worse "throbbing, swollen, warm and red". 10/16/09 went to class and hurting really bad, sick to stomach, continued to feel worse, clammy, light headed, sweating, pale, BP "low", felt like going to pass out when stood up. Went to Emergency Room, was told had reaction to Tdap given ibuprofen and PHENERGAN. Pt states went home continued to get worse, "redness spread from shoulder to elbow, feet hot "feverish", "achy and cold", seemed to be getting worse". Went to urgent care 10/19/09. States doctor said did not get all of vaccine in muscle. States was given "shot of steroid" and prescription of PREDNISONE 20mg BID 10 tablets 10/20/09 "started to getting better, swelling and redness started going down".
Extra dose of Hepatitis A vaccine was given.  It was marked to be given on the child immunization  consent, however it was not needed.
48hrs post-vaccine began with polyarthralgia, progressed to myalgias, arthritis, weight loss, abdominal pain/diarrhea, mucosal ulceration, and dyspnea, now admitted for evaluation which is suggestive of systemic lupus erythematosus.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 58-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included back disorder (back issues). Concomitant products included SHINGRIX. On 6th July 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 7th July 2018, 1 days after receiving SHINGRIX, the patient experienced pain in arm. In July 2018, the patient experienced fatigue, pain in hip, shoulder pain and back disorder. On an unknown date, the patient experienced muscle pain and white blood cell count increased. The patient was treated with non-drug therapy (Physical Therapy (Nos)). On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the fatigue, muscle pain, pain in hip, shoulder pain and back disorder were not recovered/not resolved and the outcome of the white blood cell count increased was unknown. It was unknown if the reporter considered the pain in arm, fatigue, muscle pain, pain in hip, shoulder pain, back disorder and white blood cell count increased to be related to SHINGRIX.  Rerun: Additional details were reported as follows: The patient received SHINGRIX on the left arm. The patient experienced soreness in her left arm that lasted for approximately 1 week. Two weeks after she received the 2nd dose of SHINGRIX, the patient started experiencing fatigue, muscle aches, and joint pain. She stated that most of the joint pain was in her left hip, right shoulder and both knees. The patient underwent physical therapy for the pain and that had not helped. The patient stated that it hurts the most when she moved from sitting position to standing position and sometimes when rolling over in bed. The patient had a history of back issues, however, she had not had any problems with her back recently until after receiving the 2nd dose of SHINGRIX. The patient stated that approximately 2 weeks after receiving the 2nd dose of SHINGRIX, she could hear every vertebrae in her spine move and crack whenever she moved. A few weeks after receiving the 2nd dose of SHINGRIX, the patient had some blood work done and the results showed an increase in her white blood cell count. The patient had denied permission to contact their physician. For tolerance after 1st dose of SHINGRIX, refer US2018GSK186424.
Dull headache, on 3-15 had rash on forehead neck front chest. On 3-16 rash had seemed to clear on neck and forehead and had moved to cheeks. Rash did seem to disappear on 3-17.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old male patient received BNT162b2 (BNT162B2), on 20Oct2021 as dose 3 (booster), single (Lot number: FE3592) at the age of 41 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown). The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "obesity" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11Jul2022) negative, notes: Antigen testing was negative starting 11Jul2022; (14Jul2022) positive, notes: but testing was positive on 14Jul2022 until the present day; (15Jul2022) positive, notes: but testing was positive on 14Jul2022 until the present day; (16Jul2022) positive, notes: but testing was positive on 14Jul2022 until the present day. Therapeutic measures were taken as a result of covid-19, drug ineffective.  Additional information: Report about covid treatment: Yes If vaccine received: Yes, Other medication in 2weeks: Yes, COVID symptoms resumed after completing Paxlovid course. (08Jul2022). Antigen testing was negative starting 11Jul2022, but testing was positive on 14Jul2022 until the present day. Mild symptoms resumed (coughing, runny nose) and now seem to be in remission. If treatment ae: No.  No follow-up attempts are possible. No further information is expected.
Pt has allergy to wheat and asthma. Mom reports after receiving her Hep B #2 imm at 1600 hours. the child had a sudden onset of asthma occuring at 04:00 hours on 2/26/02. This sudden onset atypical.
Vaccines given 8/8/03 AM. Fever 101 degrees and hives all over, very tired. By Saturday AM rash all over her body. Rx 80 mg Depomedrol, Ataraz, Prednisone.
Recurring hives all over body; This is a spontaneous report from a contactable consumer (patient). A 59-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: not reported) via an unspecified route of administration in the left arm on 23Apr2021 (at the age of 59-year-old) as a DOSE 2, SINGLE for COVID-19 immunisation. The medical history included blood pressure high, hypothyroidism, gluten sensitivity, penicillin allergy, egg allergy and fruit allergy (olive). Concomitant medications included levothyroxine and lispersl. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/ Lot Number: not reported) via an unspecified route of administration in the left arm on an unknown date as a DOSE 1, SINGLE for COVID-19 immunisation. On 03May2021, the patient experienced recurring hives all over body. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event recurring hives all over body was not resolved at the time of this report.  The batch/lot number for BNT162b2 were not provided and will be requested during follow up.
Patient was seen in office 6/3/2021 with complaints of a site reaction to the COVID-19 vaccine; arm swelling near the site and warm to the touch
Rash on both arms and upper back; itching on arms and upper back; pain in same arm; This spontaneous case was reported by a patient and describes the occurrence of RASH (Rash on both arms and upper back), PRURITUS (itching on arms and upper back) and PAIN IN EXTREMITY (pain in same arm) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced RASH (Rash on both arms and upper back) and PRURITUS (itching on arms and upper back). 10-Feb-2021, the patient experienced PAIN IN EXTREMITY (pain in same arm). The patient was treated with LORATADINE (CLARITIN [LORATADINE]) at an unspecified dose and frequency and CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) on 16-Feb-2021 at an unspecified dose and frequency. On 11-Feb-2021, PAIN IN EXTREMITY (pain in same arm) had resolved. At the time of the report, RASH (Rash on both arms and upper back) and PRURITUS (itching on arms and upper back) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported
L arm 4-5 inch area of warmth, redness, mildly indurated - non-tender - Non- itchy, developed approximately 24 hours after injections - treated with ice, Ibuprofen.
This spontaneous report was received from a certified medical assistant, referring to a patient of unknown age and gender. The patient's medical history or concurrent conditions were not reported. On 11-MAY-2016, the patient was vaccinated with a dose of ROTATEQ (which had the lot number of K015816, expiration date 20-MAY-2016) (strength, dose, route and anatomical site of vaccination were not reported). Information regarding concomitant medication was not provided. No adverse effects were reported. Furthermore, the vaccines experienced temperature of 18.49F, the time frame was 30 days (1137 hours). The call was because a "data logger". There was not previous temperature excursion. And there was not product quality complaint involved. This is one several cases from the same reporter. Additional information has been requested.
c/o itchy rash, body aches, joint pains mild, abdo discomfort; PE gen macular urticaria; no angioedema;
Lips started to tingle when got home- was itchy on back- not raised but light pink- no trouble breathing;  tip of nose started getting numb; legs getting itchy- took Benadryl-  did not help after 30 min so went to ER- received IV Benadryl and steroids- monitored for at least hours- discharged with prednisone and Benadryl meds for weekend
Non-Hodgkins Lymphoma; I became very ill; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: (RA). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 immunization; Bnt162b2;bnt162b2 omi ba.4-5 (DOSE NUMBER UNKNOWN (BOOSTER), SINGLE), for Covid-19 immunization, reaction(s): "I became very ill", "Non-Hodgkins Lymphoma". The following information was reported: NON-HODGKIN'S LYMPHOMA (medically significant), outcome "unknown", described as "Non-Hodgkins Lymphoma"; ILLNESS (non-serious), outcome "unknown", described as "I became very ill". Therapeutic measures were taken as a result of non-hodgkin's lymphoma. Clinical course: Patient's last two booster shots caused lymph nodes to swell, some for over a year. Patient became very ill. Patient was currently receiving chemo treatments.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300126869 same reporter/patient /AE different dose number;
COVID-19; COVID-19; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43-year-old male patient received BNT162b2 (BNT162B2), on 21Sep2021 as dose 2, single (Lot number: Cw0170), in left arm and on 03Nov2021 as dose 3 (booster), single (Lot number: 33068D) at the age of 42 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SERTRALINE. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 26Sep2022, outcome "not recovered" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (26Sep2022) Positive, notes: I originally tested positive and started taking Paxlovid that same day. Therapeutic measures were taken as a result of drug ineffective, covid-19.
Chills, Fever 103.6 for approx day and half,  bad headache, earache in right ear, fatigue approx 2 hours after injection
This case was reported by a physician and described the occurrence of Bell's palsy in a 16 year old male pt who received hep B vaccine recombinant (Engerix B) for prophylaxis. On 7/22/03 the pt received the 2nd dose of Engerix B. One day post-immunization, on 7/23/03, the pt presented to the physician with weakness in the left side of the face, including difficulty opening and closing the left eye and the inability to flex the left side of his forehead. He also had a "drooping smile." The physician made a diagnosis of Bell's palsy. The most recent info was received on 8/20/03. The Bell's palsy had improved by 8/14/03. The reporting physician considered the events were possibly related to vaccination with Engerix B, and the immunization series was discontinued. The reporter considered the Bell's palsy to be nonserious; however, the event is considered to be medically serious by manufacturer (OMIC).
pt mom called stated pt had hives on chest, fever, nausea, vomiting & fever;
This spontaneous report was received from a Licensed Practical Nurse refers to a 4 year old male patient. The patient previously received one dose of M-M-R, one dose of varicella virus vaccine live (unspecified), 4 doses of diphtheria toxoid pertussis acellular vaccine (unspecified) tetanus toxoid and 3 doses of poliovirus vaccine inactivated (unspecified). On 09-JUL-2018, the patient was vaccinated with PROQUAD from lot R003292 dose 1, intramuscular in the right deltoid for prophylaxis. On the same day, the patient was also vaccinated with KINRIX from lot 53NB2 dose 1, subcutaneous in the right arm for prophylaxis. The sterile diluent (manufacturer unknown) (lot# M012716 with expiration date 20-AUG-2018, lot # N030577 with expiration date 19-APR-2019, lot# N027783 with expiration date 17-NOV-2019,lot# M013220 with expiration date 24-SEP-2018, lot# M035268 with expiration date 19-APR-2019; lot # N006322 with expiration date 11-JUL-2019, lot # M012718 with expiration date 10-NOV-2018, lot # N004190 with expiration date 04-JUL-2019, lot # N022038 with expiration date 27-NOV-2019, lot# N030574 with expiration date 05-JUN-2020, lot# N030178 with expiration date 15-JUL-2020) used to reconstitute the vaccines was properly stored. The medical assistant was not sure which sterile diluent (manufacturer unknown) lot numbers were used. The vaccines were exposed to temperature excursion of -14 degree Celsius up to -10 degree Celsius for 5 hours total (including the previous exposure to temperature excursion). Data logger was involved. No adverse effects reported. No product quality complaint (PQC) was involved in this case. No symptoms were reported. This is one of the several reports linked via same reporter link. Sender's Comments: US-009507513-1807USA007589.
Patient began running fever at 9 PM the night of May 22nd. I checked it under his arm after he was screaming from his room and would not sleep. It read 104 under the arm. He would not respond to stimuli, was very still while holding him, and had body jerking. We gave him TYLENOL, although he didn't take it well, and took him to the ER. The ER and his doctor's office claimed he was fine as the TYLENOL brought his fever down slightly, and they told me the vaccines did not cause this. I left the ER and he was not seen due to me needing to be home with my other son as well. The ER was slow and did not process patient through in a timely manner. Patient slept next to me that night and ran fever the next day. His right thigh had a massive red mark from one of the injection sites, and it still has scarring two months later.
This case was reported by a nurse via sales rep and described the occurrence of injection site erythema in an unspecifed number of adult patients who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site erythema. On an unknown date, the outcome of the injection site erythema was not reported. It was unknown if the reporter considered the injection site erythema to be related to SHINGRIX. Additional details were reporter as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. It was reported that a few patients experienced redness at injection site after receiving SHINGRIX vaccine. This is 1 of the 12 linked cases, reported by same reporter.
Lightheadedness Tinlging in feet or head  Given water and a snack; symptoms resolved. monitored for 30 minutes.
Pt reported swelling, fiery red rash, itching and soreness peri-injection site approx 48 hours after receiving injection. Pt states she took BENADRYL at time reported - rash resolving.
This is a non-serious spontaneous case, initially received from other non-health professional on 03-Oct-2018, concerns a 31-year-old, adult pregnant female patient. The patient's concomitant medication included prenatal vitamins during pregnancy for an unknown indication. The patient's last menstrual period (LMP) date was 11-May-2018. On 03-Oct-2018, the pregnant patient (gestation period: 20 weeks) was administered FLUCELVAX QIVc (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number; 252656 and expiry date: 31-May-2019). No adverse reactions were reported after administration of the vaccine. The estimated date of delivery was reported as 15-Feb-2019. Follow-up received from other non-health professional on 21-Nov-2018: Added patient's last menstrual period (LMP) date (11-May-2018) in the patient tab and updated reference number (Med info number: SEQ18-06031) in the additional information tab. Narrative was amended accordingly.