chrisvoncsefalvay/vaers-outcomes huggingface dataset:
17 year old male fainted on the 2rd dose of GARDASIL 9; Information has been received from a physician, referring to a 17 year old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported On an unknown date, the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot number, expiration date, anatomical location and administration route were not reported) for prophylaxis.        On 26-NOV-2019, the patient fainted (syncope) on the second dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9). The outcome of syncope was unknown.       The casuality assessment between the syncope and the vaccination with the third dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was not reported. Upon internal review, the fainted was considered as a medically significant event.  This is one of three reports received from the same source.; Sender's Comments:  US-009507513-2010USA004817: US-009507513-2010USA006059:
Right middle finger became blue and very painful to touch. Swelled up and became very hard and crusty. Tip of finger very cold
This spontaneous report as received from a pharmacist refers to a 59 years old female patient. The patient was vaccinated with ZOSTAVAX on AUG-2011 [Lot# unspecified]. No other co-suspects were reported. No concomitant medications were reported. On 17-NOV-2012 the patient experienced shingles outbreak with a rash around her abdomen. Treatment with anti-viral medication was received. The outcome of shingles outbreak is unknown. The relatedness for shingles is unknown for ZOSTAVAX. Additional information has been requested.
Tiredness in the afternoon. Injection arm pain and soreness in the afternoon after shot. Extreme nausea started around 10 pm, 12 hours after injection,  fever and chills soon to follow, 3:00 AM on 4/20, diarrhea and itching skin, 4:00AM vomiting. Body went through on and off fevers, nausea, diarrhea, vomiting, extreme tiredness and headaches through the  next day 4/20. 4/21 symptoms have subsided, general aches still.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 01-SEP-2015, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown), as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. During March of 2016, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
vial was initially stored in the refrigerator on 4Jun2022 and administration of vaccine on 30Jul2022; No adverse event; Administered the vaccine to 346 patients after the 30 day by used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 4Jun2022 and administration of vaccine on 30Jul2022) and NO ADVERSE EVENT (No adverse event) in a 66-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058A22-2A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 30-Jul-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 30-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 4Jun2022 and administration of vaccine on 30Jul2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 4Jun2022 and administration of vaccine on 30Jul2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered the vaccine to 346 patients after the 30 day by used) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 4Jun2022 and administration of vaccine on 30Jul2022).    Concomitant medications were not reported.  Patient received half dose. They administered the vaccine to 346 patients after the 30 day by used and total Number of vials was 35. The vial did not undergo any temperature excursions. Treatment medications were not reported.
The patient was given the Pfizer Monovalent vaccine instead of the Pfizer Bivalent Vaccine. No adverse signs or symptoms to vaccine.
Patient reported matted eyes/red eyes, bleeding nose, coughing, runny nose and headaches.
I got shingles rash and it was painful.  I see the doctor and I was diagnosed with it. I was put on antivirals. Also happened with the second vaccine.
04/23/2021 09:00PM 6 hours right side of face, body down to leg went numb. Sick in bed no energy, fatigue, and headaches throughout the weekend. Two weeks later she was feeling off and foggy with her mind set on Friday night exactly two weeks from vaccination had pain in chest and back and could not catch her breath and was taken to the hospital by her husband over the weekend. High blood pressure sent her home on Sunday. Tuesday to hospital to do a D-dimer. Was out of work sick for a week. Friday heart condition May, June, July for high blood pressure. Possible breast cancer with biopsy. Still having side effects.
FEELS SPACEY; DIZZINESS; PAIN FROM HEAD TO TOE; NAUSEA; DRY THROAT; EYEBALLS WERE HURTING; FEELING HOT; FELT LIKE RUN OVER BY A MACK TRUCK; CHILLS; HEADACHE; HOT SWEATS; STOMACH ACHE / BELLY MUSCLE ACHE; INCREASED GAS; BURPING; SWOLLEN THROAT; THROAT IRRITATION; This spontaneous report received from a patient concerned a 62 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: UNKNOWN) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the subject experienced increased gas. On 07-APR-2021, the subject experienced burping. On 07-APR-2021, the subject experienced swollen throat. On 07-APR-2021, the subject experienced throat irritation. On 08-APR-2021, the subject experienced stomach ache / belly muscle ache. On 08-APR-2021, the subject experienced hot sweats. On 08-APR-2021, the subject experienced dry throat. On 08-APR-2021, the subject experienced eyeballs were hurting. On 08-APR-2021, the subject experienced feeling hot. On 08-APR-2021, the subject experienced felt like run over by a mack truck. On 08-APR-2021, the subject experienced chills. On 08-APR-2021, the subject experienced headache. On 08-APR-2021 03:00, the subject experienced dizziness. On 08-APR-2021 03:00, the subject experienced pain from head to toe. On 08-APR-2021 03:00, the subject experienced nausea. On 09-APR-2021, the subject experienced feels spacey. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from stomach ache / belly muscle ache, increased gas, burping, headache, swollen throat, dizziness, nausea, pain from head to toe, chills, hot sweats, feels spacey, throat irritation, dry throat, eyeballs were hurting, feeling hot, and felt like run over by a mack truck. This report was non-serious.
pt recvd vax & w/in 24 hrs pt devel redness, induration, swelling & warmth @ site of inj;
swelling; chills; nausea; aches; tiredness; stomach upset; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th June 2019, the patient received the 1st dose of Shingrix (intramuscular). On 11th June 2019, less than a day after receiving Shingrix, the patient experienced injection site swelling, chills, nausea, pain, tiredness and upset stomach. The patient was treated with ibuprofen (Advil). The action taken with Shingrix was unknown. On an unknown date, the outcome of the injection site swelling, chills, nausea, pain, tiredness and upset stomach were not recovered/not resolved.   It was unknown if the reporter considered the injection site swelling, chills, nausea, pain, tiredness and upset stomach to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose in left arm at doctor's office. On the same day night, the patient started to experience swelling on his left arm, chills, nausea, aches, tiredness, and stomach upset.  On 11th June 2019, the patient did take an Advil. The patient could not provide address and first name of the physician. There is a discrepancy in the reporting the outcome was reported in the structured field as not recovered/not resolved, but the outcome reported in the source document recovering/ resolving, however outcome is retain as per database fields. The reporter consented to follow up.
At 11:00 pm the evening the vaccines were given the patient began to experience fatigue. The fatigue progressed into chills and nausea. These symptoms were still present through at least the next morning at 10 am. The patient took tylenol and ibuprofen to treat symptoms.
1/9/03 phone call from mother reported fever 103-104 since early Wed. morning No other concerns. No vomiting or neuro changes. Will cal nurse back if seeks medical attention. Continued giving Tylenol alternating with Motrin as medicine directs. Support offered.
This case was reported by a nurse and described a 47 year old male pt who did not respond to Twinrix. On 4/26/02, the pt received the 1st dose of Twinrix (HAB218B6. Concurrently, the same day, the pt also received TD. On 6/3/02, the pt received the 2nd dose of Twinrix (HAB218B6). Concurrently, on the same day, the pt received IPOL. Approximately 7.5 months later, on 12/16/02, the pt received the 3rd dose of Twinrix (HAB222A6). This administration is later than the recommended interval of 6 months between the 1st and 3rd doses of Twinrix. Approximately 28 months following the administration of the 3rd dose of Twinrix, on an unspecified date in 4/05, a hepatitis B surface antiboy titer was "negative". The nurse reported on follow-up received on 5/16/05, that she, "offerred to give the pt a dose of hepatitis B vaccine to see if his body would produce antibody response. The pt was not interested in doing this. We accepted that his body now has immune memory to hepatitis B".
I'm miserable; suspected vaccination failure; had shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included COVID-19 VACCINE MRNA (MRNA 1273) (MODERNA (MRNA RIBONUCLEIC ACID VACCINE)) for covid-19 prophylaxis.   On an unknown date, the patient received Shingles vaccine and the 2nd dose of MODERNA (MRNA RIBONUCLEIC ACID VACCINE). In May 2021, less than 2 years after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the patient experienced feeling miserable. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and feeling miserable were not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and feeling miserable to be related to Shingles vaccine.  Additional details were provided as follows: This case was reported by the patient himself/ herself. The age at vaccination was not reported. The patient got the Shingles vaccine last year and had shingles since May. The patient got them after his/her second Moderna vaccine. The patient was miserable. The patient had started a new round of treatment as they didn't quite go away. The patient stated that he/she wouldn't wish this on anybody. It was unknown if the reporter considered the vaccination failure, shingles and feeling miserable to be related to Moderna vaccine. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule and laboratory test confirming shingles were unknown at the time of reporting.
This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with the improperly stored doses of GARDASIL 9 (dose, route, lot # and expiration date were not reported) for prophylaxis. The vaccines were reconstituted whit a properly stored sterile diluent (DILUENT MRK) (lot # and expiration date were not reported). There were no adverse effects reported. Administered doses of vaccines experienced the temperature excursion of 9 degrees Celsius for 56 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA015113: US-009507513-1704USA015115: US-009507513-1704USA015112: US-009507513-1704USA015114.
A physician reported the occurrence of a positive antibody to Hep B core antigen in an adult female of unspecified age who received Hep B vaccine recombinant (Engerix-B) for prophylaxis. The subject's medical history, concurrent conditions, and concurrent medications were not specified. On an unspecified date approximately 4 or 5 yrs ago, the vaccinee received her first injection of Engerix-B. The subject did not complete the immunization series. In Oct. 02, a Hep B panel was performed. Serology revealed that antibodies to Hep B surface antigen were greater than 140, while antibodies to Hep B core antigen were reactive. No Hep B infection was reported.  Follow up on 01/16/02: "The reporter stated the events were unrelated to the Engerix-B vaccine."
Large red itchy spot on arm. Thought it was a bug bite at first. No treatment as I?m currently breastfeeding.
Breakthrough case after 3 vaccines Moderna 3/3/21 NO LOT #;  8/12/21 Moderna Lot# 050C21A ; Moderna 9/13/21 Lot# 049E21A
Nurse administered vaccine, within 1-2 mins the patient became drowsy, drooping head forward, closing eyes, and slurring speech.  Patient lost consciousness and slumped into chair, EMS on site, administered IV fluids and transported to hospital.
Soon after the shot I had a big headache, almost like a migraine headache; I am having tough time right now; Soon after the shot I had a big headache, almost like a migraine headache; I am having tough time right now; I have slight fever 99.6; Muscle ache; This is a spontaneous report from a contactable healthcare professional, the patient.  A 58-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK55730), via an unspecified route of administration on 17Dec2020 at 13:00 (at the age of 58-years-old) as a single dose for COVID-19 immunization.  Medical history included high blood pressure, lupus, stroke, and diabetes.  Concomitant medications included lisinopril (MANUFACTURER UNKNOWN).  On 17Dec2020, soon after receiving the vaccine, the patient experienced a big headache, almost like a migraine headache; slight fever of 99.6 (no units provided), and muscle ache. The clinical outcomes of slight fever of 99.6 and muscle ache were unknown; while that of the big headache, like a migraine was not recovered.
Dizziness; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received first single dose of BNT162B2 (Solution for injection, lot number: EL9263, exp date not reported), via an unspecified route of administration (anatomical location: arm left) on 02Feb2021 11:00 as treatment first dose (COVID-19 immunisation). Vaccination Facility Type: at the mall. Vaccine was not administered at military facility. Medical history included diabetes type 1, from late 30s or 40s; and she had a stroke when she was 53 years old. Family history included sister with type 1 diabetes, other sister with hypogammaglobulin anemia. Concomitant medication included ongoing oral ramipril taking since she was 53 because she had a stroke as blood thinner. The patient had no prior vaccinations within 4 weeks. She thought she got Moderna but they sent her home with Pfizer paper. Asking how can she know which vaccine she had? Then states now she sees the name Pfizer on her vaccine card. Mentions that she had some dizziness in the last half hour on 02Feb2021. She was scheduled to receive the next dose of the vaccine 23Feb2021. No investigation assessment performed. The outcome of dizziness was recovering (ongoing at the time of reporting).
Patient received Ipol instead of Prolia injection/No AE; Initial information was received on 31-Jan-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves a 50 year old female patient who accidentally received IPV (VERO) [IPOL] instead of DENOSUMAB [PROLIA].  Medical history, medical treatment, vaccination and family history were not provided.   On 30-Jan-2020, the patient received a 0.5 ml first dose of suspect IPV (VERO) (lot P1F541M, Expiry date 07-Dec-2020) once via intramuscular route in the left deltoid in error.  It was a case of an actual medication error due to wrong product administered. Nurse stated that a 50 year-old patient came in for her Prolia injection, but the Medical Assistant administered Ipol. Consumer did receive Prolia afterward.  At the time of report, 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.
Pt had febrile grand mal seizure, eyes rolling back lips turned blue, t105 w/seizure; no focus for febrile illness, occurred 28OCT91 PM; 7 days p/recvd DTP/OPV/HIB/MMR; sz witnessed by 11 y/o cousin lasted 10 min per cousin & 21 y/o brother
skin rash upper trunk/face; pruritic in nature, maculopapular involving scalp intertriginous area;
(L) arm red, swollen, warm 2 1/2 x 2 in cool compress, Motrin
Received first dose at 10am, complained of feeling dizzy and "can't feel anything" @ 10:03am.  Blood pressure 88/58, alert and oriented.  Client place in a zero gravity chair.  Client continued to feel dizzy and cold @ 10:10am, blood pressure 110/70.  Symptoms improved, drinking water by 10:25am.  Client states "I feel good" @10:40 am, instructed to follow up with primary care.  Discharged home with friend @1050.
Patient seen at Clinic on 3/16/2021 for left arm rash this is spreading, pain, and chills that started on 3/14/21. Patient treated for Cellulitis with Cephalexin 500mg antibiotic for 10 days.
Joint aches, high fever up to 102.5, weakness and some congestion within 24 hours after injection.  Felt like a flu, but no other COVID sysmptoms
I was informed  by the staff that pt. had fainted about 1/2 hour after receiving The Covid vaccine. The staff immediately called 911 & EMS arrived in about 15 minutes *Collapsed approx. 30 min after shot Arrived 11:45AM & she was responsive WEIGHT: 149.8 as of 12/20/20
feeling nauseous; high fever; chills; headache; slight joint aching; sick; This is a spontaneous report from a contactable consumer. This consumer reported for a patient (Reporter's colleague) that: A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number and Expiry date was not reported), via an unspecified route of administration, administered in Arm Left on 17Feb2021 as dose 2, single for COVID-19 immunization. The patient medical history was none and concomitant medications were not reported. Patient had no known allergies. Patient did not receive vaccine in four weeks. Patient did not have COVID prior vaccination. Patient was not tested COVID-19 post vaccination. It was reported that on 18Feb2021 03:00, the patient experienced feeling nauseous, high fever, chills, headache, slight joint aching, sick. Three other colleagues and my department out sick after second vaccine with same symptoms. Four of us all woke up between 2-3am with noticeable symptoms, including high fever and chills. We have all since recovered. The patient did not received any treatment for the events. The outcome of the events was recovered in 2021.  No follow-up attempts are possible. Information on lot number, batch number could not be obtained.
Patient received the 2nd COVID vaccine (Pfizer, lot #EW0182, use by 05/22/21 at 10:20am, expiration date 08/2021) at 1532. Client reported a tingling sensation in the L arm to employee at 1545. Employee immediately assessed client. The patient was A&O to person, time, place, and situation. No loss of consciousness or dizziness occurred. Vital signs were taken by EMT at 1545 with BP 155/45 in R arm sitting upright, HR of 78,  RR of 18, and O2 saturation level of 100%. At 1550 the patient denied numbness, tingling, or shortness of breathe. Vital signs at 1550 were BP 155/75 in R arm sitting upright, HR of 75, RR of 16, and O2 saturation level of 100%. At 1600 patient was talking in full sentences and sitting upright in zero gravity chair. Client reported medical history of hypertension. Client is taking BP medication but was not able recall name of medication. Vitals at 1600 were BP 150/80 in R arm sitting upright, HR of 70, RR of 16, and O2 saturation level of 99%. At 1605, patient was stable and employee educated about V-Safe information and advised patient to follow up with her PCP at Hospital. Educated about ER precautions. Patient left the site at 1615.
local rxn 10cm x 12cm from mid arm to elbow lt area;Ibuprofen;
1ST DOSE DATE ADMIN 10/01/22 TIME ADMIN 10:38AM  INTRADERMAL LEFT LOWER FOREARM HE SAID IT WAS NOT SO BAD BUT ITCHINESS FIRST TIME.  2ND DOSE ADMIN 10/25/22 TIME ADMIN 12:43PM INTRADERMAL RIGHT LOWER FOREARM
SOB, swollen face, wheezing, pruritus, red face; to ER given something to inhale w/02; unsure of what it is-DPH;