chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient was administered the Hib portion of PENTACEL that was mixed with a sterile water diluent rather than the DTaP-IPV diluent,with no reported adverse event; Initial information received on 16-Mar-2023 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 2 months old male patient and reporter reported that he was administered the hib portion of diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine [pentacel (VERO)] was mixed with a sterile water diluent rather than the dtap-ipv diluent,with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included hepatitis B vaccine for Immunisation; pneumococcal vaccine CONJ (pneumococcal conjugate vaccine) for Immunisation; and rotavirus vaccine (rotavirus vaccine) for Immunisation.  On 13-Mar-2023, the patient received 0.5 ml (milliliter) (dose 1) (once) of suspect diphtheria/tetanus/5 hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) vaccine, suspension for injection, (strength: standard) (lot UJ678AA, expiry date: 09-Sep-2023) via intramuscular route in the right vastus lateralis for immunization.  On 13-Mar-2023, the patient was administered the hib portion of pentacel that was mixed with a sterile water diluent rather than the dtap-ipv diluent with no reported adverse event (product preparation error) (latency: same day).  No lab data were reported.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for an event.   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 the guidelines. 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.
* note. I run 97-98 for my normal temp  Immediately after the vaccine I got nauseated sweaty hot and light headed and lost consciousness. The nurse took my BP and it was low. They gave me an ondansetron.  I drive home. My arm swelled and  was very painful at the injection site.    3 pm body achy   4 pm temp of 101.2 Took  200 mg ibuprofen  Ate food urinating every 10 minutes  6  pm Temp 102.8  Heart racing  Feels trembly in my body  Took benadryl 25 mg Drinking  LOTS of water Bath 9 pm 100.8 swollen atmpit left side (arm with vax) and  aches all over. Headache and fever tired and cotton mouth  Cant sleep all night Heart still race/ pound and  nauseated Entire body hurts Migraine headache (which I have never had in my life)  3 am  fever 102.7. Achy whole body especially left lats 9 am fever breaking sweaty 99.0. Better but shaky still By  3 pm temp  back to normal 97.9 and i feel better. Just sore body
tinnitus constant ringing in left ear. Occasional ringing in right ear. Ongoing since onset.
COVID rebound after Paxlovid. 7 days after completion; This spontaneous case was reported by a non-health professional and describes the occurrence of COVID-19 (COVID rebound after Paxlovid. 7 days after completion) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient previously received a COVID-19 Vaccine.     On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-May-2022, the patient experienced COVID-19 (COVID rebound after Paxlovid. 7 days after completion). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 13-May-2022 to 18-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID rebound after Paxlovid. 7 days after completion) outcome was unknown.            The patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment.   No concomitant medications were reported.  Device Date was 26-May-2022.  Company comment: This is a spontaneous case concerning a patient of unknown age and gender with no reported medical history, who experienced the unexpected non-serious event of Covid-19. The event occurrence was unknown with respect to the third dose of mRNA-1273 vaccine administration. The event was described as, on unknown date patient experienced Covid-19. Patient took Nirmatrelvir + Ritonavir (Paxlovid) as treatment for Covid-19. It was reported that the patient experienced rebound Covid, 7 days after completion of Nirmatrelvir + Ritonavir (Paxlovid). No other information surrounding the event was reported. The outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Sender's Comments: This is a spontaneous case concerning a patient of unknown age and gender with no reported medical history, who experienced the unexpected non-serious event of Covid-19. The event occurrence was unknown with respect to the third dose of mRNA-1273 vaccine administration. The event was described as, on unknown date patient experienced Covid-19. Patient took Nirmatrelvir + Ritonavir (Paxlovid) as treatment for Covid-19. It was reported that the patient experienced rebound Covid, 7 days after completion of Nirmatrelvir + Ritonavir (Paxlovid). No other information surrounding the event was reported. The outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
ATE FOOD 20 MINUTES AFTER TAKING VIVOTIF; This spontaneous case report (PVX2019-2924) was received from a consumer on 26-Nov-2019. It described a 42-year-old male consumer who "ate food 20 minutes after taking Vivotif" (PT: Product administration error). He was receiving oral Vivotif for a typhoid fever.  Case report: The consumer took his first dose of Vivotif and then ate food 20 min later.  Action taken with Vivotif with respect to the reported event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "ate food 20 minutes after taking Vivotif" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "ate food 20 minutes after taking Vivotif" was considered as not applicable.
10/27 Fever 104.5 Chills. Severe headache. SOB. Began 3-4 hr after Flu shot. Wen to Hospital Tx-O2 and IV. Sent home with Rx for Tylenol #3 ER physician stated was Rx to Flu vaccine.
Patient states after getting vaccinations she passed out at home and called EMS. Patient states having muscle spasm come/go for past couple weeks .. not severe.. past week they have gotten worse.
Pharmacy staff tried to contact patient to confirm appointment for second dose. Patient's sister answered the phone and stated that the patient had a stroke on 03-16-2021, that he was in the hospital.  She could not discuss it further because the patient's mother was next to her, and did not know that her son went to hospital. Patient's mother received vaccine the same day.
Fever low grade, glassy eyed x 48 hours. Mom did not report till she returned for 4 month visit.
Information has been received from a pharmacist concerning a male physician's assistant with history of chickenpox who was in next room where a dose of zoster vaccine live (Oka/Merck) was administered. It was reported that he never administered the vaccine. On 8-SEP-2007 the patient developed about a dozen clusters of lesions in the S1 dermatome (right side). The patient self-diagnosed himself and also went to the local clinic and the ER physician confirmed it was herpes zoster. The patient was treated with valacyclovir hydrochloride (VALTREX). The patient complained about small amount of pain. At the time of report the patient had not recovered. A product quality complaint was not involved. This is one of several reports received from the same source. Additional information has been requested.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 74-year-old female patient received BNT162b2 (BNT162B2), on 16Feb2021 as dose 1, single (Lot number: EL3249), in left arm, on 09Mar2021 as dose 2, single (Lot number: EN6208), in left arm and on 20Oct2021 as dose 3 (booster), single (Lot number: FH80220) at the age of 74 years, in left arm for Covid-19 immunisation. The patient had no relevant medical history. The patient had no Known allergies. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID-19". Adverse event: Ill with symptoms for 5 days. 2 negative tests on 6th day and 9th day. Relapsed with symptoms on 10th day. Tested positive on 11th day. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (May2022) Negative, notes: 2 negative tests on 6th day and 9th day; (May2022) Negative, notes: 2 negative tests on 6th day and 9th day; (May2022) Positive, notes: Tested positive on 11th day. Therapeutic measures were taken as a result of vaccination failure, Covid-19. Treatment started on 27Apr2022 and stopped on 01May2022.
The pt started spotting, then started cycle within 12 hours of vax. This was only after 12 days from previous cycle.
Dizziness, Headache, malaise, pain and limited ROM in injected arm Narrative:
Episode of possible apnea associated with cyanosis; HOSPITAL COURSE: Because this child was presumed to be in life-threatening event at home, he was admitted and observed in the hospital. Earlier that day of admission he had been given an immunization series. Because of the temporal relationship between the two events he was admitted. He had no further apnea while observed in the hospital. He was discharged home without any medications to have an EEG as an outpatient.  1/24/08 Medical records that accompanied report reveal that on 10/16/07 patient experienced crying out followed by cyanosis, pale, blank stare, head tipped back.  EMS found O2 sats decreased to 80's.  ER O2 sats 90-100% on RA.  Admitted 10/16-10/17/07.  No further episodes of apnea while hospitalized.  D/C to home. FINAL DX: Apnea. Per 60 day follow up: Vaccinations were given on 03-4-08 with no adverse reactions. PEDIARIX, Hib, PREVNAR
I went to hospital 8/6/07 with my husband - we are traveling overseas next month - the dr. recommended we get hepatitis A - tetanus shots - Ok and suggested we take the oral vivotif berna - typhoid vaccine - we both did beginning 8/07/7 - using the information given we took each capsule 1 day apart - completing the dosage of 4 capsules - about 6/08 I didn't even realized I was having a reaction - I felt itchy all over my body - scalp, hands, legs, genital area, trunk, etc. all over - like creepy crawly itching sensation that would not cease with cold shower, powder etc. of course I could not sleep - I honestly did not take into consideration that I was having a reaction as we were instructed to expect nausea or vomiting or queasy stomach - I did not have the sense to inquire -??? however, after many nights - of lack of sleep on 8/16 I went to my internist who informed me that - he said - I bet those were manufactured out of the country - I said yes, I even saved the box - and he continued to instruct me that I was having a serious allergic reaction to a preservative used in the manufacture - he prescribed allegra to calm the symptoms and told me to drink tons of water to flush it out of my system - today 8/18 - I am almost symptom free - he said it would take a few days so there is my story - the preservative was the culprit and not the medication - I was sorry that I didn't save the insert or view expected complications - but when I went on the website for vivotif-berna - it took me a while to find that itching was a possible serious side effect - the process is listed on how they manufacture and bind the bacteria - lactose and magnesium stearte - ascorbi- amino acid lactose - I think it was the magnesium stearate that did it - I will contact my internist and have him delineate the exact cause Follow-up: I stopped itching 10-02-07. I also met a woman with the same complaint whose symptoms lasted for almost a yr. Prior to going on Safari she took same live oral stuff the dr's biopsied. Small white bumps like I had and came up with "allergic".
Post vax, the pt experienced intermittent fevers for 8 days, as high as 40 degrees C with no other physical findings. Twelve days after vax, he had onset of pruritic rash beginning on his back and extending to the posterior portion of his left arm. When seen by a physician three days later, he was afebrile, complained of nausea and vomiting for 3 days and had a vesicular rash in a left second thoracic dermatome pattern on his back and extending to the posterior aspect of his left arm. Treated with prochlorperazine for nausea and ibuprofen for mild pain. Nine days later there was complete crusting of all lesions, resolution of pain and no further complaints.
The patient called the COVID19 hotline. He noted difficulty swallowing starting shortly after he received the vaccine. As well he notes his entire upper arm on the vaccinate side was red and swollen,
This spontaneous report was received from a medical assistant and refers to a 65 year old patient of unknown gender. On 12-MAY-2015, the patient was vaccinated with an expired PNEUMOVAX 23 (dose, route of administration were not reported, lot number: J013555, expiry date: 02-MAY-2015). No adverse effect was reported. Additional information has been requested.
Pt received dose of Moderna on 4/15/2021. After vaccine, she stated that she felt dizzy 5 minutes later. Pt was given water, sprite, ice pack. She did not pass out. Pt started feeling better in about 15 minutes. She had stable vitals and had transportation home.
Patient sent to the ED by pulmonologist for evaluation.  Patient had shortness of breath, left chest pain, and cough.  Patient admitted to the hospital for Covid pneumonia and treated with remdesivir.
I had pain in my left leg primarily in my calf that was pretty constant. I went to Urgent Care two weeks later. They were not concerned about a blood clot since the time had passed. I contacted my Doctor and he did not feel that it was necessary to be concerned because I am male which was no cause to worry.
"red itchy spot" next to the injection site, around the size of a quarter; She specified it doesn't itch all the time but "itches and stop, itches and stops".; This is a spontaneous report from a contactable consumer (patient) via Medical Information team. A 71-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: unknown) dose 2 via an unspecified route of administration on 08Feb2021 (at the age of 71-year-old) as single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. She received the second dose of the Pfizer-BioNTech COVID-19 vaccine on Monday (08Feb2021). In Feb2021, she has a "red itchy spot" next to the injection site, around the size of a quarter. She specified it doesn't itch all the time but "itches and stop, itches and stops". The outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.
This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On 13-MAR-2017, the patient was vaccinated with an expired dose of VAQTA lot # L027735, expiration date: 12-JAN-2017, as prophylaxis (Strength, dose and route of administration were not reported. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
My arm has been sore for 3 weeks , can?t lift my arm past my shoulder without pain. Constantly feel a full ache.
Vomiting for 2 days post vaccine. Went to doctor weakness in legs, unable to urinate or defecate. Admitted to hospital 6 days later with progressive weakness in legs and body. Was hospitalized for 7 days. Diagnosed with acute disseminating encephalomyelitis. Discharge summary states paresthesia, nausea, vomiting, tremors. msv
Breakthrough case admission after 4 vaccines Pfizer 2/10/21 Lot# EL9267;  Pfizer 3/3/21 Lot# EN6205;  Pfizer 11/29/21 Lot# FJ1620;  Pfizer 1/11/23 Lot# GL0447
Right corner of eye appears to have a burst blood vessel causing the inner area of right sclera to be bloodshot.
Unusually stiff and sore at injection site (left shoulder) shortly after injection; felt like shoulder had received a very strong punch unlike other years' flu injections. The stiffness and soreness then spread to the forearm (left) and hand starting at 4:30 pm (90 minutes after injection.) Thirty minutes later, stiffness and soreness spread to left leg (top). Was difficult and very uncomfortable to fully raise left arm overhead. Noted that I was not able to do so until some time later that evening. Stiffness/soreness in mentioned sites continued eight hours later until I went to sleep at midnight. Soreness/stiffness had lessened some by morning, but remained noticeable at all sites mentioned. Soreness did not abate until later that day. Injection site remains lightly sore at touch today, five days later.
I WILL NOT BE GETTING THE SECOND SHOT.  YOU DON'T CARE ABOUT THE SEVERITY OF "SIDE EFFECTS." (YEAH, WHAT ELSE IS NEW.) YOU MUST STOP MAIMING AND TORTURING PEOPLE WHO'VE ALREADY HAD COVID. YOU ARE LITERALLY KILLING US WITH YOUR "SIDE EFFECTS."   SEVERE, ROCK-HARD, CONSTANT PAIN, HEAT AND SWELLING AT INJECTION SIDE. SEVERE WEAKNESS AND MUSCLE PAIN. I'M GOING ON MY FIFTH DAY OF THIS. COVID ONLY TOOK ME DOWN FOR A DAY AND A HALF. IF YOU HAD YOUR WAY YOU'D TORTURE ME WITH "IMMUNITY" UNTIL YOU PUT ME IN A HOSPITAL. WHAT IS WRONG WITH YOU PEOPLE? I'M HOPING AND PRAYING I'LL GET BACK NORMAL USE OF MY ARM. IT'S BEEN ROCK HARD FOR DAYS! HOW MUCH EVIDENCE OF IMMUNITY DO YOU NEED?
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient passed out for just a few seconds   he was confused briefly   he waited here with both parents  911 was called but mom decided that they did not need to come     he was given water and they left after his parents were confident that he was fine
Redness/swelling at site within 24 hours after injection. Recommended ice packs four times a day for 15 min. Ibuprofen with complains of pain.
Client was administered Janssen COVID-19 vaccine after stating she had an allergic reaction to a Moderna COVID19 vaccine administered earlier this year in January, she would not state location/exact day. No previous COVID-19 vaccine documented in of this clients Moderna vaccination. Janssen COVID-19 vaccine provided per clients request, no documented or reported adverse reaction.
Pt recv vax on 9/17/98; on 9/18/98 pt exp tender, red &swollen injection site area (LA), fever.  Pt tx for cellulitis.
This serious initial spontaneous case, received from other non-health professional (consumer) on 22-Nov-2017, concerns a 45-year-old adult female patient. The concomitant medication was not reported. On 14-Nov-2017, the patient was administered with FLUVIRIN (dose: 0.5 ml, route of administration: intramuscular, batch number: 170103P, expiry date: May-2018 and anatomical location: left arm). On next day (on 15-Nov-2017), the patient developed Bell's palsy. Her physician was aware of this adverse event and treated with acyclovir, prednisone and physical therapy. At the time of the report, the event Bell's palsy was persistent (not recovered).
Ten days post second vax, on 05/23/99, pt experienced joint stiffness, arthralgias, and myalgias. He was diagnosed with polymyalgia rheumatica. The pt was first seen by physician on 07/01/99 and was treated with steroids (nos) and NSAIDS (nos). He was subsequently treated with prednisone (5 mg curretnly) and Vioxx (12.5 mg currently). Physician reported that the pt was doing better. The most recent information, received on 09/27/99, reports the condition of the pt is not yet resolved.
"Event Description: Patient came in to get a HAVRIX vaccine. After administration, the patient had a vasovagal syncope. I ran to go get help and by the time I returned to the patient she woke up. She was out for about 15 seconds and then slowly came back to consciousness. She explained to me after the fact that she used to have these episodes as a child but hasn't had one in years. She thinks it may be caused by a fear of needles as a child. I sat with her for 10-15 minutes and she seemed to be ok and I explained to her to let us know if she has any other issues."
Right upper arm swollen, reddened, hot with approx 50mm patch of blistering. No signs and symptoms infection. Child not uncomfortable according to mother. Child taken to medical clinic 7/28/07.Child brought back to HD 7/2/07 RA swelling gone, area of blisters now, dry, peeling skin.
She experienced normal soreness the same day. The pain persisted and worsened until one week later when she could no longer lift her right arm over her head. She visited and orthopedist who diagnosed her with adhesive capsulitis ("frozen shoulder") that the doctor said can be caused  vaccine. The pain has continued but improved. On 10/29/09 she reported being about 90% recovered. Requested vaccine without thimerosal.
From 1:00 am I had chills, headache and fever. I took panadol every four hours until the morning.
hallucinating; cancer for the fourth time.; cannot walk; cannot talk; This spontaneous case was reported by a patient family member or friend and describes the occurrence of HALLUCINATION (hallucinating), NEOPLASM MALIGNANT (cancer for the fourth time.), WALKING DISABILITY (cannot walk) and APHASIA (cannot talk) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L02A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HALLUCINATION (hallucinating) (seriousness criteria disability and medically significant), NEOPLASM MALIGNANT (cancer for the fourth time.) (seriousness criteria disability and medically significant), WALKING DISABILITY (cannot walk) (seriousness criterion medically significant) and APHASIA (cannot talk) (seriousness criterion medically significant). At the time of the report, HALLUCINATION (hallucinating), NEOPLASM MALIGNANT (cancer for the fourth time.), WALKING DISABILITY (cannot walk) and APHASIA (cannot talk) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Caller said that her mother cannot walk, cannot talk, and going to be dead in a month, she was hallucinating, and has cancer for the fourth time. No treatment information was reported.  Company Comment: This is a Spontaneous case reported by a patient family member, concerning a 71-year-old female patient, with no medical history reported, who experienced the unexpected and serious (due to disability and medically significant) events of Hallucination and Neoplasm malignant, and the unexpected and serious (due to medically significant) events of Aphasia and Walking disability, which occurred on an unknown date related to the first dose of mRNA-1273 vaccine. Since no vaccination nor events dates were provided, temporal association and latency cannot be properly assessed. As reported, the patient cannot walk, cannot talk, and is going to be dead in a month. She was hallucinating, and has cancer for the fourth time. No information disclosed about diagnostic tests performed or treatments received. At the time of the report, the events had not resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.