chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case reported by a consumer, describes the occurrence of cerebrovascular accident (bilateral stroke) and thrombosis (blood clot) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 063C21A and 037A31B) for COVID-19  immunization. No medical history reported. On Apr 13, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On May 11, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. October 2021, patient experienced thrombosis/blood clot (prolonged hospitalization and medically significant). On Oct 21, 2021, patient experienced cerebrovascular accident (bilateral stroke) (prolonged hospitalization and medically significant). At the time of the report, cerebrovascular accident (bilateral stroke) and thrombosis (blood clot) outcome: unknown. No concomitant medications or treatment information provided. Patient has been in the hospital for the last two weeks. Sender's comments: This case concerns a 65-year-old, female patient with no medical history reported, who experienced the unexpected events of cerebrovascular accident and thrombosis. The events occurred on an unknown number of days after the second dose of mRNA-1273. The rechallenge was not applicable since the events happened after the second dose. The benefit-risk relationship of mRNA-1273 not affected by this report.
An expired Ipol was administered to patient; Initial information regarding an unsolicited valid non-serious case was received from a other health care professional via Medical Information (Reference number- 00360159) and transmitted to Sanofi on 16-Nov-2020.  This case involves a 10 years old female patient who was administered an expired 0.5 ml fifth dose of suspect IPV (VERO) [IPOL] (lot P1E70, expiry: 09-Nov-2020) via intramuscular route in the left deltoid on 16-Nov-2020 for prophylactic vaccination (Expired product administered)  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, TETANUS VACCINE TOXOID (BOOSTRIX) and INFLUENZA VACCINE for prophylactic vaccination.  It was of actual medication error due to Expired vaccine used (latency same day).  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.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent condition, or concomitant medication. On or about 01-JUL-2011, the patient was vaccinated with ZOSTAVAX (lot number, dosage and route of administration not provided) at physician's office, as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 27-OCT-2017(conflicting dates), 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. On or about 06-NOV-2014 (conflicting dates), the patient received subsequent medical treatment from the physician for ongoing and worsening symptoms of shingles. On or about 14-NOV-2014,(conflicting dates), he was again treated by the physician for uncontrolled symptoms of zoster, at which time his medications were changed in attempts to curb his symptoms. The patient has been prescribed valacyclovir (VALTREX), acetaminophen and hydrocodone (NORCO), and gabapentin(NEURONTIN) for management of his painful symptoms.  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.
Pain from the original shot didn't go away. At night I was unable to sleep on the right shoulder. Over a few months the pain got worse and started to impact daily routines. By December range of motion in shoulder is severely limited.
pt. recvd. vax & later developed diffuse lymphadenopathy w/ palpable nodes in inguinal,occipital,& cervical areas.
This literature marketed report was received and refers to a 3 year old female patient. The patient had no significant medical history. Her family history included mother with positive antinuclear antibody (ANA) and alopecia areata (AA) and a sister with positive thyroid antibodies. Antinuclear Antibody (ANA), complete Blood Count (CBC), erythrocyte sedimentation rate (ESR), C-reactive protein (CRP) and rheumatoid factor performed on an unspecified date were normal. On an unknown date, the patient was vaccinated with her third dose of hepatitis b vaccine (recombinant) (manufacturer unknown) (dose, route, anatomical place of vaccination, lot # and expiration date were not provided), for prophylaxis. On an unknown date (also reported as "4 days after receiving the third dose of hepatitis b vaccine (recombinant) (manufacturer unknown)), the patient experienced alopecia areata (AA). Physical examination performed on an unknown date showed widespread and well demarcated alopecic patches on the scalp without scarring, erythema, or scale. There were no nail changes. Therefore, the patient was prescribed with clobetasol with tacrolimus. At 6 weeks on an unspecified date, her scalp examination was largely unchanged and therapy was continued. After 2 months, an ophiasis pattern had developed, in addition to persistent alopecia on the crown. Clobetasol and tacrolimus were discontinued, and tretinoin was applied, with which there was minimal response over 4 months. Five months later, at which time the patient had stopped al prescription medication and had started a herbal remedy, examination revealed diffuse new hair growth on the scalp of a few inches in length, with one patch of alopecia on the right scalp and some irregularity of the hair line. The reporter considered alopecia areata to be related to Hepatitis B Vaccine (Recombinant) (manufacturer unknown). This is one of several reports from the same reporter. Sender's Comments: US-009507513-1803USA003425.
A large blood blister formed on my tongue within an hour of receiving my vaccine. It was the size of a cherry tomato
Patient complained of dizziness was sweating, clammy, shaking, and pale.  Vitals were taken; BP 70/43, O2 97%, respiration 12, temp 96.8.  Cold compression was placed with LVN by his side.  Patient ate breakfast bar and orange juice.  EMS was called due to possible hypoglycemic event.  Upon EMS arrival; RN reported patients condition.  EMS assessed, vitals were back to normal, patient felt better.  EMS cleared patient; no other treatment needed per EMS.  RN advised patient to eat and stay hydrated, see PCP,  go to ER if symptoms persist.
Fever, chills, aches, tired, diarrhea, redness swelling in arm, headache. 2 days
FATIGUE, SORE THROAT, REDNESS AT INJECTION SITE-ABOUT THE SIZE OF YOUR PALM.
joint stiffness and swelling right hand >left; joint stiffness and swelling right hand >left; streak of rash dorsal hand/Scattered red non raised rash up arms and less so on chest; dorsal hand with edema and some loss of coordination and strength; some loss of coordination and strength; some loss of coordination and strength; This is a spontaneous report from a contactable nurse (patient herself). A non-pregnant 80-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), dose 1 intramuscular, at age 80 years (as reported), administered in Arm Left on 23Feb2021 10:30 (Batch/Lot Number: EL9264) as DOSE 1, SINGLE for COVID-19 immunisation. Relevant medical history includes scoliosis and paranoid schizophrenia. No COVID prior vaccination. No known allergies. Concomitant medication(s) included diazepam (VALIUM); temazepam; codeine phosphate, paracetamol (TYLENOL WITH CODEINE); and quetiapine; all taken for an unspecified indication, start and stop date were not reported.  No other vaccine in 4 weeks. On 06Mar2021 at 06:00 PM, the patient complained of joint stiffness and swelling right hand >left, streak of rash dorsal hand with edema and some loss of coordination and strength Scattered red non raised rash up arms and less so on chest. It was unknown if treatment was received. COVID was not tested post vaccination. Facility vaccine type was at a hospital. The outcome of the events was not recovered.    No follow-up attempts are possible. No further information is expected.
diarrhea; she has lost 8 or 9 pounds; Initial information received on 16-Oct-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-healthcare professional.  This case involves a 62 years old female patient who experienced diarrhea and she has lost 8 or 9 pounds, after receiving vaccine Influenza Quadrival A-B Vaccine [Fluzone Qiv].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Covid-19 Vaccine (Covid-19 Vaccine) for Prophylactic vaccination.  On 11-Oct-2023, the patient received a  dose of suspect Influenza Quadrival A-B Vaccine, suspension for injection (strength: unknown) (lot number, expiry date: not reported) via intramuscular route in the left deltoid for prophylactic vaccination (immunization).  On 11-OCT-2023 the patient developed diarrhea (diarrhoea) and she has lost 8 or 9 pounds since this started (weight decreased) (latency: same day) following the administration of Influenza Quadrival A-B Vaccine.  No lab data reported.  Action taken: not applicable.  The patient was treated with Loperamide Hydrochloride (Lomotil) and Loperamide Hydrochloride (Imodium) for Diarrhoea.  At time of reporting, the outcome was Not Recovered / Not Resolved for the event diarrhea.
Within around an hour of the injection, patient started having numbness on ride side of body (including face down to toes) which lasted approximately 2 days.  Around 3 days after injection, she developed a bright red rash down her right leg which lasted approximately 2 or 3 days.  She also had chills and felt feverish for 4-5 days.  All symptoms resolved without treatment.  Patient did speak with one of her doctors who advised her to not take second dose.
1st vaccine on 05/22/2018 and it in the pharmacy today for 2nd dose; This case was reported by a pharmacist and described the occurrence of incomplete course of vaccination in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (1st dose received on 22nd May 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: The age at vaccination was not applicable for this report. On the day of reporting, the patient was in pharmacy to receive 2nd dose.  The reporter asked Medical Information to see if it was safe to administer 2nd dose or whether the patient had to restart the series. Till the time of reporting, the patient did not receive the 2nd dose of the Shingrix, which led to incomplete course of vaccination. The reporter did not had lot number and expiration date for 1st dose. The reporter consented to follow up.
DID NOT CONTINUE THE VIVOTIF AFTER TAKING FIRST DOSE; A spontaneous case report was received from a nurse on 25-Oct-2019 for two consumers.  Based on the information obtained from the nurse two individual case safety report PVX201910-000826 (PVX2019-2664; first consumer) and PVX201910-000829 (PVX2019-2665; second consumer) were created and cross-linked in the database.  This case (PVX2019-2664) described a female consumer who "did not continue the Vivotif after taking first dose" (PT: Incomplete course of vaccination), while being on oral Vivotif for typhoid fever prophylaxis.  Case report: The consumer took the first dose of Vivotif on 24-Oct-2019. It was reported that she was traveling on 29-Oct-2019, so she will be receiving the injectable typhoid vaccine instead and not continuing the Vivotif.   Action taken with Vivotif with respect to reported event was not applicable.  The clinical outcome of the reported event was unknown.  Company's Comment: The causality of the event "missed the second dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "missed the second dose" was considered as not applicable. US-PaxVax Berna GmbH-PVX201910-000829:
12 days post vaccination, circular rash appeared around injection site (potential delayed type hypersensitivity reaction); Rash is sensitive to touch; 12 days post vaccination, circular rash appeared around injection site (potential delayed type hypersensitivity reaction); Rash is sensitive to touch; low grade fever; chills; headache; injection site pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 12 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 13May2021 16:45 (Lot number: EW0168) at the age of 12 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: VACCINATION SITE RASH (non-serious), HYPERSENSITIVITY (non-serious) all with onset 25May2021, outcome "not recovered" and all described as "12 days post vaccination, circular rash appeared around injection site (potential delayed type hypersensitivity reaction); Rash is sensitive to touch"; PYREXIA (non-serious) with onset 13May2021, outcome "recovered" (May2021), described as "low grade fever"; CHILLS (non-serious) with onset 13May2021, outcome "recovered" (May2021), described as "chills"; HEADACHE (non-serious) with onset 13May2021, outcome "recovered" (May2021), described as "headache"; VACCINATION SITE PAIN (non-serious) with onset 13May2021, outcome "recovered" (May2021), described as "injection site pain". Therapeutic measures were not taken as a result of vaccination site rash, hypersensitivity, pyrexia, chills, headache, vaccination site pain.  Follow-up attempts are completed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: suspect vaccine Route captured, Event's coding updated, Final sentence and clinical information updated.
The patient felt dizzy and also felt like fainting but she sat down and drank some water and was fine afterwards  The paramedics came to observe her
5/27/02 Felt pain Left side of head down to shoulder and upper back to point of waking from sleep. Pain on and off since 5/27. Relieved with APAP, ibuprofen and Alleve.
Pt recv vax on 11/5/98; 12 hr post vax pt exp fever, hallucinations, drug interaction
Experienced pain in (R) arm 6 hours after vaccine. On 3/26/15, pain of (R) arm, especially with lifting arm. (+) chills. T max 3/27/15 early AM-101 degrees F. (+) nausea, abdominal unsettling feeling. 3/27/15 pain (R) arm improving. Exam (R) arm swelling, warm, erythema around site of injection. TX: NSAIDS, EMETROL for nausea.
patient experienced tightness in chest and difficulty breathing, requested staff call 911 for squad. Did not want to have personal EPI pen administered. EMS arrived 10 minutes after onset and was taken to ER. Rec'd call from pt. at vaccine site on 3/11/21 (day after vaccine administration)  stating she was given EPI 3x in ambulance and transferred to ICU.
Rash and hives starting on torso and spreading to entire body. Patient first sought treatment at the pharmacy and was given diphenhydramine to be taken orally on 12/28/18. Patient then sought further treatment at the ER and was given a MEDROL Dose PAK prescription on 12/29/18 after given prednisone in the ER. No resolution of rash yet as of 12/29/18.
Information has been received from a physician concerning a 12 year old female patient who on 14-FEB-2011 was vaccinated with the first dose of GARDASIL (Lot# 666929/0331Z) intramuscularly. Concomitant therapy included MENACTRA on the same day. On 14-FEB-2011 the patient felt dizzy, nauseous, complained of a headache, and appeared flushed with red cheeks, shortly after receiving the vaccines. The physician reported that the patient was allowed to rest and observed for 15-20 minutes prior to leaving the practice. On 14-FEB-2011 the patient recovered from the events. The patient sought medical attention in the office. Follow up information was received from a health professional reported that the patient was a female student with seasonal allergy who on 14-FEB-2011 at 2:39 PM was vaccinated with the first dose of GARDASIL, intramuscularly on right deltoid. Concomitant therapy included the first dose of MENACTRA (lot number U3544AA), intramuscularly on left deltoid on the same day at 2:40 PM. Shortly after shot at 2:45 PM, the patient became dizzy then developed headache and nausea, cheek were red a flushed looking. Then the patient was told to lie down and be observed. No diagnostic tests were performed. 30 minutes after, the patient recovered. No further information is expected.
RespDepression concern for pharyngeal edema, shortness of breath with exertion and low oxygen saturation Narrative:  56 yo female employee who developed sensation of "lump" in her throat the evening of 1/6/21. She woke up and still had same feeling of lump in her throat and feeling she had "difficulty getting her lungs to expand fully". She is a very active patient who runs-reports this am had some shortness of breath with walking up a few stairs. She was noted to have a drop in her oxygen saturation to 88% with ambulation-she was sent to the Emergency Department for further work-up.
Out of 126 police & fireman vaxed w/Engerix-B, 39 pts have neg anti-HBS titers (titers less than 10);
Experienced fatigue following adm of 1st two doses of Hepatits B vaccine; 1 month following 3rd dose, pt developed poss peripheral neuropathy;
The day after getting the vaccinations, I woke up with swelling hands and extremely fatigued.  I kept falling asleep all day and don't remember much.  I was rushed to the ER that night with a 104 degree fever and was diagnosed with pneumonia.  The joints in my hands, wrists, elbows, knees, ankles and feet were all swollen so I could barely walk.  I was put on antibiotics and two days later I was admitted into the hospital.  It took weeks for the swelling to go down and I need physical therapy to regain full motion.
Starting having tongue pain and swelling 2 days after second vaccine shot, felt like my throat was swelling up as well. Have been diagnosed with geographic tongue, which there is no cure for. Its been 3 weeks and my symptoms have not improved.
She got her 4th vaccine, she had no reaction.  Went to bed and around 3:00 AM she woke up nauseous and started dry heaving over the toilet.  She then also got a headache, severe.  She started to feel a little better.  She was talking on the phone in the morning and touched her neck a day or two after and noticed a lump on her neck on the right side.  She called her doctor, he went to see him and felt it and that her lymph node was swollen on the right hand side.  He sent her for an US which was done on 5/3/22 (today), and was informed that she did not have anything to worry about.  She was also informed that other people had a similar reaction.  She has a history of lymphoma and was concerned, and then went home and relaxed.   The doctor is going to call her with the results, but the tech had told her there was nothing to worry about.  Her PCP also felt that it was coming from the vaccine, and that if it was not it would have gone into both sides.
6/20/2023 Patient was seen yesterday where an order for a COVID Pfizer booster was ordered by provider. Patient was given pfizer bivalent 6m-4yr instead on accident. The entire multidose vial (10 doses) was given without diluent.   Spoke to patient's daughter this morning to make sure patient doesn't have adverse reactions. Patient's daughter stated the only symptom patient reported before bed was a arm soreness, no S/S of infections. But patient is still currently sleeping so patient's daughter will check on patient when she wakes up.   6/21/2023 - patient experienced mild fatigue, otherwise no other symptoms
I went to the clinic to get my Covid Shot waited 15 mins and went home feeling well. In January 2022 I new I had been in contact with someone but did not get symptoms for a couple days. Started with headaches, dizzy, very fatigue, I couldn't walk. I went to the urgent care got tested for Covid and went home. They called me 24hrs later that I was positive. I was with Covid for 5 to 7 days. Same symptoms the fatigued lingered on for awhile. I quarantine for 15 days. I do not feel anymore symptoms.
On 10/8/00, the pt had a 30 second seizure, whole body shaking and eyes rolled to back of head. On 10/16/00, the pt had a 3-5 minute seizure. On 10/17/00, pt experienced seizure during EEG.
Subject developed fever and redness at vaccination site.  Subject reports development of a secondary bacterial infection with abscess formation and sepsis.  Hospitalized for five days.  Treated with parenteral antibiotics and incision and drainage.
Is it normal to have her numbers (blood sugar) high 274 Saturday night; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patients daughter) reported for a 82-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number& Expiry date not reported) via unspecified route of administration on 06Feb2021 (at age of 82-years-old) as single dose for COVID-19 Immunization. Patient medical history includes diabetes from unknown date. Patient concomitant medications not reported. On 07Feb2021, one day after vaccination, patient experienced blood sugar was high 274 on saturday night. Patient daughter reported that it was never that high then this morning sunday it was 176 and that is still high. She enquired, is that due to the vaccine, would you know. She takes her at night and then in the morning, the sugar, she is diabetic, the blood sugar was very high, so she checks got her injection for her diabetes not clarified. Reporter stated,  want to know is that due to the Covid-19 vaccine. Reporter was informed about the role of Pfizer Drug Safety. Reporter stated need answer to this question or is myself I can answer for her. Treatment received for the event. Patient underwent lab test and procedures include blood sugar test was 274 (high) on unspecified date. The Outcome of event was unknow.   Information on the lot/batch number has been requested.   Follow-up (14May2021): Follow-up attempts completed. No further information expected.
Sore arm with swelling. During nighttime, woke with violent shivering, goosebumps, headache and nausea.
My flu like symptoms started on 12/10/2022 in the morning at 08:00AM. I woke up with a stuffy nose, itchy throat, headache, dry cough, body aches, nausea, diarrhea, fever, ear infection on the right, and chest pains. I did a telehealth with my doctor on 12/29/2022. He prescribed me with methylprednisolone 4mg for 6 days. I took DAYQUIL and NYQUIL from 12/10/2022-12/29/2022.