chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I had a low grade fever, sneezing, coughing, nasal discharge, and body aches. I also was pregnant and I tested positive for COVID-19. I am due July 5th 2022.
Developed Guillain-Barre Syndrome. Hospitalized on 8/30/2018. Treated with IVIG. Currently completing a course of biweekly IVIG and is gradually improving. Ambulating with a cane and experiencing decreased paresthesias.
Muscular Weakness, Extremities Pt presented to Valley Medical Center with c/o weakness in legs, hands, and muscle soreness throughout back.
1242: Vaccine administered.   1255: RN called to assist with patient. Caregiver stated that the patient reported that he "felt funny" and "feel like I can't breathe." Caregiver stated that the patient was no longer responding to questions being asked. Caregiver reported not being able to arouse the patient after shaking his leg twice an no response. Caregiver stated that excess secretions from mouth is normal.    1255: Patient responding to questions being asked. Heart rate 123 beats per minute and oxygen saturation level 99% on room air via pulse oximeter. Lungs clear to ausculation. Patient sitting power chair.   1257: Apical heart, regular with a rate 100 beats per minute.   1258: Unalbe to obtain blood pressure in left arm due to tone.   1259: Blood pressure in right arm 168/92.   1303: Blood pressure in right arm 158/98.   1309: Patient reports feeling better at this time. Patient with caregiver. Caregiver verbalized appreciation.
He took the booster dose; Pain is in the joint of his shoulder and arm/pain in those areas were bad again; Pain is in the joint of his shoulder and arm/pain in those areas were bad again; pain in lower part of his neck; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 75 year-old male patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) at the age of 75 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "spine surgery" (not ongoing), notes: Caller reported he had spine surgery.; "had surgery on his neck", start date: 03Feb2021, stop date: 03Feb2021, notes: Caller states he had surgery on his neck before getting the vaccines. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose), administration date: Mar2021, when the patient was 75 years old, for COVID-19 immunization, reaction(s): "Pain is in the joint of his shoulder and arm", "Pain in his neck", "Pain is in the joint of his shoulder and arm"; Bnt162b2 (Second dose), administration date: 2021, when the patient was 75 years old, for COVID-19 immunization, reaction(s): "Pain is in the joint of his shoulder and arm", "Pain in his neck", "Pain is in the joint of his shoulder and arm". The following information was reported: IMMUNISATION (non-serious) with onset 2021, outcome "unknown", described as "He took the booster dose"; ARTHRALGIA (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 2021, outcome "recovering" and all described as "Pain is in the joint of his shoulder and arm/pain in those areas were bad again"; NECK PAIN (non-serious) with onset 2021, outcome "recovering", described as "pain in lower part of his neck". The events "pain is in the joint of his shoulder and arm/pain in those areas were bad again", "pain is in the joint of his shoulder and arm/pain in those areas were bad again" and "pain in lower part of his neck" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient reported the pain was in the joint of his shoulder and arm and has been going on for 8 months. He took the booster dose and it got worse again but now it was better again but it never goes away and he sees a therapist. He told the therapist at the beginning of therapy his pain was a 10. And his last appointment was today and his pain is now 1-2. Patient wanted to know if other people have reported pain in the shoulder after the vaccines. Wanted to know how long does it last and was it going to go away. He asked could it be nerve issue. Caller states after the booster, the pain in those areas were bad again, but now it is 75% better. Caller states he has spoken to his doctor and he was scheduled for an MRI.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Pt recvd vax & devel burning sensation upon inject as well as soreness & or an aching sensation in the arm; Pt felt heaviness in the arm;
Child has juvenile diabetes mellitus, dx'd 8/8/94. He was not our pt then. Parent requested dates of immunizations to be sumitted to correlate shots & onset of JDM, esp Hep-B vaccine.
He didn't feel anything; Bled a little after the injection; Worried that he didn't received the full dose; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (He didn't feel anything), VACCINATION SITE HAEMORRHAGE (Bled a little after the injection) and UNDERDOSE (Worried that he didn't received the full dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 011M20A) for an unknown indication.     No Medical History information was reported.   On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Apr-2021, the patient experienced FEELING ABNORMAL (He didn't feel anything), VACCINATION SITE HAEMORRHAGE (Bled a little after the injection) and UNDERDOSE (Worried that he didn't received the full dose). At the time of the report, FEELING ABNORMAL (He didn't feel anything), VACCINATION SITE HAEMORRHAGE (Bled a little after the injection) and UNDERDOSE (Worried that he didn't received the full dose) outcome was unknown.            Concomitant medication was not provided.  Treatment information was not provided.
PATIENT RECEIVED FLUZONE HD ON 9/24/20, RETURNED TO PHARMACY THE NEXT DAY 9/25/20. PATIENT COMPLAINED OF REDNESS (SIZE OS A HAND) ITCHINESS AND HEAT AROUND THE SITE.  PATIENT WAS ADVISED TO TAKE OTC ANTI HISTAMINE, USE HYDROCORTISONE CREAM AND COLD COMPRESS AND MONITOR.  PT WAS ADVISED TO CONTACT DR IF SYMPTOMS DON'T IMPROVE OR WORSENS.
Information was received on 11-JUL-2017 from a registered nurse who was reporting on a 4 year old patient of unknown gender. No medical history or concomitant medications were reported. On 11-JUL-2017, the patient was vaccinated with an improperly stored dose of PROQUAD (Lot N008824, expires 28-AUG-2018) that was reconstituted with properly stored sterile diluent MRK (lot number expiration unknown). No adverse effects were reported. The vaccine PROQUAD was at a temperature of 5.9 degrees F. for 18 minutes, as per a data logger. Additional information has been requested.
7 days after INFLUENZA vaccine developed progressive fasciculations and numbness over last 2 months. Is being followed by neurology for same.
Information has been received from a licensed practical nurse concerning an 12-month-old female who on 01-DEC-2000 was vaccinated SC with a 0.5 mL dose of Varivax. Concomitant vaccination on the same day included a dose of MMR, a dose of PEDVAX HIB, and a dose of diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid. On an unspecified date in 2001, the patient experienced atopic dermatitis. On 30-JAN-2006, the patient presented to the office with a "significant outbreak." There were ulcers on the legs and arms, but no ulcers on the trunk or face. Soaks were ordered and a vesicle culture was done with the result positive for "herpes simplex". The child recovered, but several chickenpox scars were still visible at the time of the report. A product quality complaint was not involved. Follow-up information from the licensed practical nurse indicated that on 07-DEC-2000 the patient developed a rash on her body that the provider determined to be a reaction to amoxicillin. On 30-JAN-206 the patient developed herpes zoster with ulcers noted on leg and arms. There were none on the patients trunk or face as of 30-JAN-2006. They were vesicular per provider. The patient's temperature and other systemic symptoms were not documented. The patient recovered. There was no history of chickenpox or recent exposure to chickenpox or herpes zoster. There was no documentation of a direct fluorescent antibody being performed. A specimen was not collected for PCR and a photo was not taken. Additional information is not expected.
After shot, just felt like someone took a bat to my arm.  However, yesterday I noticed a slight itching and bump on left arm by injection site when I was teaching.  This morning I woke up and noticed it is red, itchy, little swollen and the arm is sore.  I have also had a headache the past 2 days and slight dizziness/unfocused visual effects this morning.
a patient received improperly stored vaccine; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  The reporter stated that 23-APR-2019, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated(VAQTA) one dose, for prophylaxis, lot # S002459, expiration date: 15-MAY-2020, (frequency and route were not provided) (product storage error). It was stated that the vaccine was under a temperature excursion of 52.5 F, during 4 hours 40 minutes. There was not previous temperature excursion. Data logger was positive.
She mentioned she will be receiving her 3rd vaccination this Saturday; No additional adverse effects reported; she found out she was pregnant on Oct 15, 2021; She mentioned she will be receiving her 3rd vaccination this Saturday; This spontaneous prospective pregnancy report was received from a consumer referring to herself, a female patient who was 30 years old at the time of the report.  The patient pertinent medical history, previous drug reactions or allergies, and concurrent conditions were not reported. The patient's concomitant vaccines included COVID-19 vaccine (manufacturer: Pfizer).  On 02-JUL-2021, 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) (dose, route of administration, anatomical site of vaccination, lot number and expiration date were not reported) for human papillomavirus (HPV) prevention.  On 15-OCT-2021, the patient found out she was pregnant (maternal exposure before pregnancy). Moreover, the patient mentioned that she would receive the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) on 22-OCT-2021 (circumstance or information capable of leading to medication error, exposure during pregnancy).   The pregnancy gestation or last menstrual period was in October 2021 (reported as "less than a week"). The estimated date of delivery was not reported. The pregnancy outcome is pending, and the fetal outcome is unknown. No additional adverse effects reported (no adverse event).
Inconsolable crying ceasing for brief periods only when the baby passed out from exhaustion. The crying lasted 5 hours.
Covid 19 Pfizer Gray Top was diluted with 1.8 ml of diluent in error Patient received diluted dose
about 24 hrs after receiving my 2nd pfizer covid vaccine, I developed hives across my face, neck and chest. I took benadryll to alleviate the itchiness, and ended up being ok a few hours after taking the benadryll. the hives were relatively small (1-2cm wide) and pretty itchy. My mom and 1 other female cousin from my mom's side also had the same reaction so i kind of knew that the same would happen to me too
Arm swollen taking Ibuprofen for swelling-tender, and heated to touch, local soreness.
pt recv varicella in 10/4/95 & in 4/12/98 pt exp severe chickenpox w/greater than 300 vesicles.
Erythema on (R) UE extending down to antecubital region, circumventing entire upper arm. Also c/o headache.
1st dose Jan2022, no other dose yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 69-year-old male patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (On an unknown date in January 2022, received 1st dose).   On an unknown date, the patient did not receive the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date:15-Dec-2022. Reporter's Comment: The reporter consented to follow-up. Additional Supportive Information: Till the time of reporting the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Patient was only 4 years old and received vaccination indicated for 5-11 years old.
Pfizer 2nd dose was given prior to the 21 day dose interval.  To the best of our knowledge, the 2nd dose was due 4/23/21 but was administered on 4/15/21.
Pt came to clinic and received vaccines. Vaccine expirations were checked before drawing up vaccines. Pfizer vaccine expirations must be calculated and calculation in the med room was written as 12/30/2022. Pt received HepB Vaccine and also second dose of Covid-19 Pfizer Vaccine for ages 5-11 per mother request. Pt given vaccines and pt tolerated well with no complaint. Upon clerical staff putting in Covid-19 vaccine in the system, it was found that COVID-19 Vaccine expiration was actually 11/30/2022 (yesterday). Mother called and informed of situation. Mother denies any adverse signs and symptoms.
Seizure/fainting 3-5 min after injection. Lasted about 1 min. Called 911 they checked her out she walked out of store 30 minutes said she was ok. They did not transport to hospital.
Its hot to touch; Arm started itching; I developed a really big rash around the Vaccine area; Burns to touch; Spreading and going down and towards the inside of the arm. ,I still have the rash today; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE WARMTH (Its hot to touch), VACCINATION SITE PRURITUS (Arm started itching), VACCINATION SITE RASH (I developed a really big rash around the Vaccine area), VACCINATION SITE PAIN (Burns to touch) and RASH (Spreading and going down and towards the inside of the arm. ,I still have the rash today) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, the patient experienced VACCINATION SITE WARMTH (Its hot to touch), VACCINATION SITE PRURITUS (Arm started itching), VACCINATION SITE RASH (I developed a really big rash around the Vaccine area), VACCINATION SITE PAIN (Burns to touch) and RASH (Spreading and going down and towards the inside of the arm. ,I still have the rash today). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) for Itching, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Its hot to touch), VACCINATION SITE PRURITUS (Arm started itching), VACCINATION SITE RASH (I developed a really big rash around the Vaccine area), VACCINATION SITE PAIN (Burns to touch) and RASH (Spreading and going down and towards the inside of the arm. ,I still have the rash today) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.
pt recv vax & pt devel an allergic rxn w/flushing & edematous condition of the face, bronchospasm or congestion & coughing;sx prompted a 911 call;pt was tx w/DPH; & epi was taken to ER for a few & then released to go home;
Parent provided date of birth on vaccine administration/consent form for both girls (they are twins) as 7/22/09, making them 12 years old. When vaccination data was submitted to state IIS, it was discovered that their actual DOB was 9/22/09 making them 11 years and 10 months old.
The evening p/receiving vax pt had t103.6 R & unconsoleable cry for seven hrs; The next day pt was fine w/sl elevated temp;
One day after receiving vaccine pt developing progressively worsening pain in L deltoid, at the site of the injection. He also had one episode of numbness/parasthesias in the left upper extremity. Presented to clinic 14 days after vaccine, where he had pain severely limiting his arm abduction (almost none, due to pain upon active abduction) due to pain experienced at the mid-L deltoid. Denied fever, nausea or vomiting, hematuria, dizziness; pain or weakness in any other extremity. On exam had mild edema to the area without erythema, induration, fluctuance, or tenderness. He was advised to take Motrin q6h, ice, and rest. Seen for follow up 7 days later, with significant improvement in pain, though active ROM still limited to approx 100 degs of midline due to pain.
Patient became ill at school on 8/8/22 complaining of tiredness and stomach pain and registering a low fever, and vomited twice.  He tested positive for COVID on an antigen home test on 8/9/22, fever continued, no more vomiting, runny nose.  Isolated at home for 5 days with no more fever or stomach symptoms, but runny nose continued.  Positive antigen home test on 8/13/22.  Negative antigen home test on 8/14/22.  Runny nose initially abated, then returned after negative test.  He returned to school on 8/15/22.
Rec'd Fluzone 0.25 ml for firsts time. About 3 minutes after vaccination, client fainted - fell to floor- hit back of head. Had approximately 30 second seizure. Call to 911 - went to ER. Labs WNL - discharged to home. To follow up with MD today. MD doesn't feel vaccine was case of seizure. Is ordering sleep deprived brain wave test.
sweat profusely; feeling really weak; gets cold; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 22Sep2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPERHIDROSIS (non-serious), outcome "unknown", described as "sweat profusely"; ASTHENIA (non-serious), outcome "unknown", described as "feeling really weak"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "gets cold".  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Chills, headache, sore eyes, fatigue, diarrhea, loss of appetite - lasted in decreasing measure for three days.
Vaccine administered 1 day after the beyond use date. Pfizer corporation has been contacted in regards to stability issue, and the clinical coordinator on regard to revaccinate
This case was reported by a consumer and described the occurrence of tremor in a 7-month-old female subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix, GlaxoSmithKline) for prophylaxis. Th reported is the mother of the subject. A physician or other health care professional has not verified this report. The subject had no pre-existing medical conditions. There were no concurrent medications. On an unspecified date in July 2006 the subject received 2nd dose of Infanrix. On an unspecified date in either July 2006 or August 2006, 4 days after vaccination with Infanrix, the subject experienced tremor. The consumer reported that the subject, "would have a tremor every two or three days, then went for two weeks without a tremor, then she had a tremor and then none since." The subject was seen at a physician's office. The tremors resolved on an unspecified date in 2006.
patient evidently went  into anaphylaxis on the drive home (companion was driving, not patient); patient and companion had both received the vaccine and waited the requisite 15 minutes before leaving the area (reaction was delayed). When patient realized reaction had begun, companion drove her straight to the hospital  to receive treatment. She self-administered epi-pen on the way; was given Benadryl, Pepcid, and a steroid at the hospital. She has recovered.
FORGOT TO TAKE NEXT DOSES; This spontaneous case (PVX2019-797) was received from consumer on 02-Apr-2019. It describes a male consumer who "forgot to take next doses", while being on Vivotif for an unknown indication.   Case report: The consumer took the first dose of Vivotif on 28-Mar-2018 and then forgot to take the second dose till 02-Apr-2019.  Action taken with Vivotif was not applicable.   The clinical outcome of the event "forgot to take next doses" was unknown.  Company's Comment: The causality of the event "forgot to take next doses" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "forgot to take next doses" was considered as not applicable.
Sore arm late night of the Dec. 28th and morning of Dec. 29th - day after.  By 11:30am on the 29th i was leaving work - felt weak, extremely tired, muscles very sore, joints hurting, mild headache starting.  12:15pm, at home - very sore, changed into pjs and went to bed under extra blankets.  Very sore in all large joints, bad headache, cold chills, fever or 100 degrees.  Called Dr. office to be sure i was ok -- felt exactly like the first days of COVID -(I had it most of the month of August 2020 followed by pneumonia.)  I took Advil, went back to bed.  At about 46 hours post-vaccine it eased off and was shortly gone.  I stayed in bed, sleeping most of the time from early afternoon Tues, 12/28 until the morning of 12/30 when i returned to work.
Redness and tenderness on the injection site, swelling lymph nodes in the same arm as shot, fatigue, headache , chills, fever
This spontaneous report was received from a pharmacist who mentioned that two unspecified patients experienced redness at the site after administration of ZOSTAVAX. No further information was provided. At the time of the report, the patients' outcomes were unknown. No further information is available. This is one of the several reports from the same source.
No additional AE details provided.; 1 dose of PROQUAD stored outside of recommended range was administered to a patient.; This spontaneous report was received from a medical assistant concerning a 4-year-old male patient. The patient's medical history, drug reactions/allergies, concurrent conditions were not reported. Concomitant medication included sterile diluent (STERILE DILUENT).  On 22-JUN-2022, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) 1 dose (lot # U030588, expiration date: 29-MAR-2023; route and was not reported) for prophylaxis, which was stored outside of recommended range (product storage error). The details of the improperly stored temperature excursion: temperature minus 10 degrees Celsius up to 8 degrees Celsius (minus 8.8C) for 0 hours 45 minutes 0 seconds; minus 10 degrees Celsius up to 8 degrees Celsius (1.1C) for 0 hours 50 minutes 0 seconds. It was reported that there were no previous temperature excursions. No additional adverse event details (no adverse event).