chrisvoncsefalvay/vaers-outcomes huggingface dataset:
felt feverish; nausea that resolved the next day; she had fatigue; experienced injection site pain that lasted for several days; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19-JUN-2023, the patient received the 1st dose of Shingrix (intramuscular, unknown deltoid). On 19-JUN-2023, immediately after receiving Shingrix, the patient experienced injection site pain (Verbatim: experienced injection site pain that lasted for several days), nausea (Verbatim: nausea that resolved the next day) and fatigue (Verbatim: she had fatigue). On an unknown date, the patient experienced fever (Verbatim: felt feverish). The patient was treated with ibuprofen (Motrin). On 20-JUN-2023, the outcome of the nausea was resolved.  On 22-JUN-2023, the outcome of the fatigue was resolved. The outcome of the injection site pain and fever were resolved.   It was unknown if the reporter considered the injection site pain, fever, nausea and fatigue to be related to Shingrix.     It was unknown if the company considered the injection site pain, fever, nausea and fatigue to be related to Shingrix.   Additional Information: GSK receipt date: 03-JUL-2023 The reporter was the patient.  The patient received her first Shingrix dose and immediately experienced injection site pain that lasted for several days. She treated the pain with Motrin.  The evening of the vaccination she had nausea that resolved the next day. Beginning on the date of vaccination she had fatigue and felt feverish, which both resolved. Nothing else was reported. The reporter did not consent to follow-up.
Pt was standing in the checkout line after receiving a vaccination and felt light-headed and then fainted. Patient refused ambulance. Patient sat down and rested and said he was feeling better. Pt said this sometimes happens when he gets his blood down. Patient also said he has diabetes, but it was under control when I asked if he had checked his blood glucose.
I had a fever, chills, headache, aches and fatigue. Pain at the injection site and the area was warm to the touch. This happened around 2:00 am post COVID-19 vaccination.
fever that lasts overnight after vaccination, pain in the left hand where the vaccine was administered, dizziness and headache
Arm began to hurt. Developed cough. 10:30 PM unable to move arm, swollen and red from injection site near the left shoulder to the left elbow. Extreme pain and headache lasting 3 days. Arm remains red, swollen, painful and hot.
Partial loss of vision in left eye follow up with ophthalmology and cardiology at this time undergoing tests and treatment?s
I went to the doctor's office to confirm my COVID-19 and I tested positive. I was told to quarantine for ten days. After quarantine I was fine and back to normal. It was a very mild case.
Roughly 24 hours after the shot (not sure which shot) 4 year old has a swollen left arm. Arm is warm to touch, red and hard.
AFTER PATIENT RECEIVED VACCINE, SHE FELL TO FLOOR, HITTING HER HEAD SLIGHTY AND STARTED SEIZING. THE SEIZURE LASTED ABOUT 10-15 SECONDS.  I PROTECTED PATIENT DURING INCIDENT TO FURTHER INJURIES. I STARTED TALKING WITH PATIENT. SHE WAS NOT COMPLETELY ALERT OR ORIENTED. I ADVISED PHARMACY STAFF TO CALL 911 ASAP. AFTER ABOUT 2 MINS, PATIENT WAS ABLE TO COMMUNICATE WITH ME AND ANSWER QUESTIONS. I REMAINED WITH PATIENT UNTIL EMS ARRIVED.
Excrutiating pain thoughout arms and into lower back, fever, chills, dizziness, headache, swelling by injection spot.
The evening after my second dose Pfizer, I had fever and chills all night long.   I felt like I was outside in a freezer.  I was running a fever and it lasted at least 12 hours.  I took Tylenol to reduce my fever and my aches and pains.  I got plenty of rest.  I am better now.
her sister got her shot yesterday and she had ringing in her ears/ringing in her head; This is a spontaneous report from a contactable consumer or other non-HCP (patient sister) via Medical Information Team. A female patient of an unspecified age received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number-UNKNOWN) via an unspecified route of administration on 22Mar2021 as dose 1, single for COVID-19 immunization. Patient medical history included ongoing ascending aortic aneurysm from unspecified date. The concomitant medications were not reported. Investigations were not provided. Sister had been encouraging her to get the vaccine. She stated her sister got her first dose yesterday and called her and said that the caller was not going to believe this but as soon as she got it, there was a ringing in her head on 22Mar2021. She had ringing in her ears immediately upon getting the shot. She stated her sister said an hour after she got the shot, her ringing had stopped. It went away by the time she got home. Stated she wanted her sister to get it because of where she works. She stated that her sister had the exact same aortal aneurysm as she does. It was reported that her sister had the same ascending aortal aneurysms that she had. She stated that she had not talked to her today to see about her symptoms because her sister was going to funeral. Sister stated that she was interested to see if her sister had any permanent stuff going on and she was going to give her the number for the people to report it to. She stated that she had wondered if there was a possibility that has to do with aortal aneurysms. Stated they created circulatory and vascular issues that maybe she had her experience because of her pre-existing condition. Stated that it was funny that she experienced it as well. She stated her sister said it was weird and said it went away. She stated her sister (patient) said she was not sure that she would have alcohol. She stated that she will tell her sister (patient) to call. Stated it was an immediate reaction within a few minutes. She stated that her sister was in so she probably did not have the same batch. She states it was an interesting anecdote. Stated her sister said she was not going to believe this but within a couple minutes her head started ringing so loud and it would not go away and some other person had to drive. Stated she will have her call if it was continual. The reporter asked could this be related. She had researched and found that some people are deciding not to get the second dose. Are we tracking the people who are specifically having hearing difficulties, specifically tinnitus. If she got the second dose will that be permanent.  She did not want a second shot if this could become a 24/7 type of thing. She has heard via news reports based on CDC data that 30 percent of reactions were related to hearing. Some have completely lost their hearing. The outcome of event was resolved on 22Mar2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 003B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Feb-2021 at 1:01 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 21-Mar-2021 at 12:50 PM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 40.72 and 40.82.  Concomitant products were not provided.  On 14-Feb-2021, Excursion time was 09 AM, 10 AM, 11 AM, 02 PM, 03 PM temperature was 32, 32, 32, 35, 35 total doses given for the day was 162, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09-Feb-2021, vial was moved to clinic on 13-Jan-2021. 30 vials were sent to clinic. Vaccine BUD date was 10-Mar-2021.  On 21-Mar-2021, Excursion time was 09 AM, 10 AM, 11 AM temperature was 32, 34, 32 total doses given for the day was 94, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 16-Mar-2021, vial was moved to clinic on 21-Mar-2021. 10 vials were sent to clinic. Vaccine BUD date was 15-Apr-2021.The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Information has been received from a mother concerning her 9 year old son with no pertinent medical history who in 1995 was vaccinated with a dose of varicella virus vaccine live. There was no concomitant therapy. The patient's mother reported that on 09-Oct-2003, the patient developed over 100 chickenpox lesions. Unspecified medical attention was sought, but no treatment or laboratory/diagnostic tests were required. At the time of this report, the patient ws recovering with sequalae (unspecified). A nurse in the patient's physician's office indicated that the office had seen two similar cases that same week and that four other children in the patient's class also developed chickenpox that same week as well. Additional information has been requested.
Child was given HepA vaccine on 1-31-08 - should have been given HepB vaccine.  The nurse reported the error the the MD and clinical manager immediately.  The clinical manager called the nurse consultant with the state.  All internal protocols followed.  MD educated parent on all possible side effects.  MD gave parent a VIS for HepA and instructed parent to call with any symptoms of reactions or concerns. We will call and check progress of child at 1 day, 2 day and 1 week after vaccination date.  Progress checks on 1-31-08, 2-1-08, 2-2-08, 2-8-08 & 2-7-08 - child doing well no reactions or complications.
WOKE UP DAY AFTER VACCINATION WITH FLU LIKE SYMPTOMS. LETHARGY AND MALAISE. SCRATCHY THROAT, STUFFY NOSE. LETHARGY AND MALAISE SYMPTOMS WORSENED. NO FURTHER "COLD LIKE" SYMPTOMS. SEEN BY DR. ON 3/25/03. HAD CBC AND MONONUCLEOSIS TEST. MONO NEGATIVE. CBC WITHIN NORMAL LIMITS. SAW FAMILY PHYSICIAN ON 3/27. NO SYMPTOMS OF ANY "BUGS" CURRENTLY BEING EXPERIENCED IN OUR AREA. B-12 INJECTION GIVEN.
TASTE SENSATION,  CRAMPING IN BACK, LIGHT HEADDED ,  COLD SWEATS, MALISE
Information has been received from a registered nurse referring to a patient of unknown age and gender. On 01-JUN-2016 the patient was vaccinated with fourth dose of RECOMBIVAX HB (dose was unknown, lot # L048236, expiry date: 31-MAR-2018 intramuscular) (extra dose administered). No adverse effects were reported.
This is a non-serious spontaneous case, initially received from other non-health professional on 24-Jan-2018, concerning a male patient of unspecified age. The patient's medical history was not reported. On an unspecified date, the patient was administered with non-company suspect COSENTYX solution (dose: 300 mg, route of administration: subcutaneous, frequency, once every two weeks (qow), batch number and expiry date: not reported) which was explicitly reported as off label use. On an unspecified date (while patient was on the COSENTYX medication), the patient was vaccinated with influenza vaccine (dose, route of administration, anatomical location, batch number, expiry date, trade name and manufacturer: not reported). It was reported that, the last time the patient took the flu shot, he was under the medication of COSENTYX and on unspecified date after taking flu vaccine he got really sick. Outcome of the event was not reported. The reporter did not provide the seriousness assessment.
arm has been hurting / when she moves it, it hurts; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2020, the patient received the 1st dose of Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional information was provided as follows: Since the patient got the vaccine, her arm has been hurting. She stated that if she did not move her arm, its fine, but when she move it, it hurts and has done so for 5 months. The patient did not want to get the second dose of shingrix. She did not want to provide HCP (Health Care Professional) information until she went to an appointment The reporter did not consent to follow up.
Turned "grey" 1-2 hrs p/shot; lasted about 1hr;
Initial information received on 26-Jul-2018 regarding an unsolicited valid non-serious case received from a Nurse. This case is linked with 2018SA208858, 2018SA208860, and 2018SA208862 (same reporter). This case involves a 12 months old patient who was vaccinated with 0.5 ml fourth single dose expired dose of vaccine ACT-HIB lot UI719AAA (expiry date: 18-Oct-17), in the right thigh on 25-Jan-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS A VACCINE for Immunisation; PREVNAR 13; and VARICELLA VACCINE. It was a case of actual medication error due to expired vaccine used and drug dose administration interval too short (patient took fourth dose at 12 months only). It was unknown whether patient experienced any adverse event to product. 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. Document held by sender: None
shoulder achy; This case was reported by a pharmacist via call center representative and described the occurrence of shoulder pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced shoulder pain. On an unknown date, the outcome of the shoulder pain was recovered/resolved.   It was unknown if the reporter considered the shoulder pain to be related to Shingrix.  Additional details were provided as follows: The age and age group of the patient was not reported, but taken as an adult as per vaccine indication. Pharmacist reported a group of patients experienced an achy feeling in their shoulders for 24 to 48 hours after receiving one or both doses of Shingrix. The patient experienced an achy feeling in their shoulders for 24 to 48 hours after receiving Shingrix vaccine. This was the same reporter but different patients reported on the same day to different agents.
nausea; tightness in the chest; lightheadedness; headache; fatigue; body aches; Initial information regarding an unsolicited valid non-serious case was received from a Consumer/non-hcp (Healthcare professional) via Medical Information (Reference number- 00722010) and transmitted to Sanofi on 12-Aug-2021.  This case involves a female patient who experienced body aches (pain), nausea, tightness in the chest (chest discomfort), headache, fatigue and lightheadedness (dizziness), after receiving vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history included Exposure to SARS-CoV-2 on 08-AUG-2021. The patient's past medical treatment(s), vaccination(s) and family history were not provided.   On 09-Aug-2021, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number and expiry date not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On 10-AUG-2021 the patient developed a non-serious body aches (pain), headache, and fatigue, next day following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  On 11-AUG-2021 the patient developed a non-serious nausea, tightness in the chest (chest discomfort) and lightheadedness (dizziness) 2 days following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  It was reported that I'm wondering if the symptoms I'm experiencing are normal? I'm most concerned about the tightness in my chest.  Relevant laboratory test results included: Electrocardiogram - On an unknown date with unknown result. SARS-CoV-2 antibody test - On 09-Aug-2021: Negative  The patient was given inhaler.  At time of reporting, the patient was not recovered from the events.
At 7pm, on 3/16, the patient sat down to watch tv and was having difficulty seeing the tv. He then went to his computer and could not see the type on the screen. The loss of sight seemed to be in both eyes. The center of his eyes were blurry. His blood pressure was 190/110. This was the highest it had ever been. He went to urgent care and on his way, his sight returned. Sight had been altered for about 1/2 hour. An EKG revealed PVC. Urgent care sent him to the hospital, where his BP was 163/110 (higher than normal). ER doctor thought pt had a TIA. REturned home at 3:30am, slept most of 3/17. On 3/18 he felt better, but BP was higher than normal at 163/95
S: 29 y/o WM DOD IT Contractor seen FBVHC for evaluation of 2-day h/o "tiny red bumps" on neck, chest, arms, axillas, abdomen, back and near groin (not on palms of hands or soles of feet) which appeared on days #11-12 s/p receipt mandatory primary SPV in right upper arm on 29Oct09. Patient also received AVA #1, Hep A #3, Hep B #2 MMR #2 in left upper arm and Live Intranasal Influenza on 29Oct09. Patient alsow expressed concern re marked redness around primary SPV site (RUE), which he has been covering with and Occlusive Tegaderm bandage. He denied any chest pain or radiation to jaw or left arm. No acute, deep SOB. He denied any h/o eczema, psoriasis, atopic dermatitis or asthma, but he does take daily generic equivalent of Allegra for "allergies." Patient reported a h/o GERD, which has exacerbated with use of high does Ibuprofen 4 times a day s/p double, maxillary wisdom tooth extraction on 30Oct09. Patient has just finished a 10-day course of Clindamycin 300 mg po qd s/p dental extractions. Patient deploys on 12Nov09. O: Local erythema 9 cms X 10 cms RUE, surround 12 evolution. Center of pustule is still moist, secondary to occlusive tegaderm dressing-no eschar formation as yet. No red streaking or axillary LAD of rue. Fine prurtic follicular rash on neck, chest, arms, axillas, back abdomen, groin and upper inner aspect of thighs 11-12 days s/p primary SPV. Meds: Nexium 40mg po qd; allegra (generic) 180 mg po qd. Allergies: NKDA-parents both allergic to PCN PMH: significant for chronic sinus problems, IBS, GERD, tinea veriscolor, tubes in ears at 8 yrs of age, heart murmur as child. Hosp/Surgeries: Ganglion cyst removed right wrist at 17 yrs old, testicular cyst removed at 15 yrs old, Open Mumford Procedure left shoulder (2003) s/p soccer injury while AD. A: 1. Folliculitis-rash consistent with non-viral pustolosis s/p primary SPV (29Oct09); 2. Robust Take (RUE) "normal variant" s/p primary SPV 29Oct09. P: 1. Refer to WAMC DERM for consensus of opinion. Patient is already routinely taking Allegra 180mg po qd for allergies and has just finished a 10-day course of Clindamycin s/p dental extractions. 2. Reviewed site care primary SPV. Continue daily non-occlussive dressing changes-gave guaze and paper tape. If possible, leave open to air when alone in room in evening before hs. Continue OTC Ibuprofen 600-800 mg po bd with meals until erythema RUE has resolved. Continue daily Allegra 180 mg po qd as prescribed by MD. If any new onset, left-sided chest pain or deep SOB, seek medical care at ED or nearest civilian care center in theatre.
PNEUMONIA; SUSPECTED COVID-19 INFECTION; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a patient concerned a 43 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: bipolar, diabetic, high cholesterol, penicillin allergy, and sulpha allergy. The patient experienced drug allergy when treated with lamotrigine.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, and expiry: 21-SEP-2021) dose was not reported, 1 total, administered on 02-AUG-2021 for prophylactic vaccination. No concomitant medications were reported.  On 05-SEP-2021, the patient experienced suspected clinical vaccination failure as patient test positive for Covid-19. On an unspecified date, the patient experienced pneumonia, could not move, and could not do anything. Treatment medications (dates unspecified) included: lorazepam, and mirtazapine. Patient was administered Ativan and also treated with Remeron for 2 weeks. On 05-SEP-2021, the patient experienced weakness, and suspected covid-19 infection, and was hospitalized. The patient was hospitalized for 14 days and discharged on 18-SEP-2021. Patient felt week and deconditioned. They tied patient to the bed for 2 weeks. Patient stated that she could not move and could not do anything for herself and still can't but patient was trying. They did a ton of blood work but patient didn't remember any. Patient mentioned that she was really sick. Patient was calling to try to get Levaquin for pneumonia. Laboratory data (dates unspecified) included: Blood test (NR: not provided) with unknown result , and on 05-SEP-2021, COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure, pneumonia and suspected covid-19 infection was not reported. This report was serious (Hospitalization Caused / Prolonged). This report was associated with product quality complaint: 90000194723.; Sender's Comments: V0: 20210950464- Covid-19 vaccine ad26.cov2.s- Suspected clinical 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  20210950464- Covid-19 vaccine ad26.cov2.s- Pneumonia, suspected covid-19 infection. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).