chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient was given Pneumococcal Pneumovax 23 on 10/09/2012 SQ in right arm, also TIV Fluarix IM in right deltoid. Injections were given at least 3 inches apart.   Called office 10/11/12 reporting possible Cellulitis, seen in ED and given IV and Oral Antibiotics.  Seen in Drs office on 10/12/12 for follow up, much improved, area marked by ED went 3 inches below the elbow up to armpit, but was shrinking away from marks post treatment.  Patient feeling better.  Advised to return if area gets worse or changes in any way.
expired dose of ActHib was administered with no adverse event; Initial and additional information received on 14-Jun-2021 regarding an unsolicited valid non-serious case received from other health professional via physician via Regulatory authority (Reference number- 00639997 and 00640595).  This case involves a 4 months old male patient who administered 0.5 ml dose of HIB (PRP/T) VACCINE [ACT-HIB] (lot UJ316AA and expiry date: 08-Jun-2021) via intramuscular route in right thigh for prophylactic vaccination on 14-Jun-2021 for prophylactic vaccination (expired product administered).  Relevant medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  This was an actual medication error case due to expired vaccine used (latency was same day).  It was reported that nurse administered Acthib to a patient and noticed that the dilute and vaccine has two completely different expiration dates. The powder/vaccine portion expired 6 days ago on June 8 2021 and the dilute expires Jan 2022. A caller calling back in to get an answer to how to proceed after an expired dose of ActHib was administered. The caller reported that it was unknown to the clinic that the two components of the ActHib have different expiration dates. The clinic would have administered Pentacel but the family wanted individual vaccines; that the clinic does not usually administer ActHib alone; and that the family were very cautious of vaccines for their children. Diluent: LOT: U6849AB and expiry date:22-Jan-2022 Hib Portion: LOT: UJ316AA and expiry date: 08-Jun-2021.  At the time of reporting, no adverse event 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.
experienced a redness all over his body; his left arm became itchy and swollen; his left arm became itchy and swollen; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (experienced a redness all over his body), VACCINATION SITE SWELLING (his left arm became itchy and swollen) and VACCINATION SITE PRURITUS (his left arm became itchy and swollen) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013m20a) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced ERYTHEMA (experienced a redness all over his body), VACCINATION SITE SWELLING (his left arm became itchy and swollen) and VACCINATION SITE PRURITUS (his left arm became itchy and swollen). On 25-Feb-2021, ERYTHEMA (experienced a redness all over his body), VACCINATION SITE SWELLING (his left arm became itchy and swollen) and VACCINATION SITE PRURITUS (his left arm became itchy and swollen) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient take "pills for itchiness" and "pills for something else" patient was unsure about the medicines that were prescribed to him
itchy rash on trunk of body, cheek of face 1 and 2 days after injection, no redness or swelling at injection site
Headache, Myalgia,  fatigue shortness of breath numbness to lower extremities unsteady gait  Narrative: employee remains with unsteady gait, numbness to lower  extremities, fatigue. was started on Parkinson's medications. Under care of Dr
Redness; Pain at injection site; Itching; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE PAIN (Pain at injection site) and VACCINATION SITE PRURITUS (Itching) in a 92-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE PAIN (Pain at injection site) and VACCINATION SITE PRURITUS (Itching). At the time of the report, VACCINATION SITE ERYTHEMA (Redness), VACCINATION SITE PAIN (Pain at injection site) and VACCINATION SITE PRURITUS (Itching) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Treatment information was not reported.
pt devel rash in diaper area about 24 hrs p/inject; spread to entire body even ear; given DPH; no relief taken to ER; given steroid inject & put on Pediapred;
she had rash that came up on her body on several places; This is a spontaneous report received from a contactable reporter(s) (Consumer) from medical information team. The reporter is the patient.  A 74-year-old female patient received BNT162b2 (BNT162B2), 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: RASH (non-serious), outcome "not recovered", described as "she had rash that came up on her body on several places". Additional information: Caller is a consumer. Caller reported that after one and a half month after her first Pfizer covid-19 injection she had rash that came up on her body on several places and up until now the rashes are still there. Caller asked if there is a possibility that the rash could be caused by the vaccine. Caller clarified that she received 4 Pfizer covid vaccines including the bivalent booster.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
My daughter received her first dose of Gardasil on April 19, 2007 she felt feverish minutes after and developed a sore throat the same day. The next day she complained of a headache and contined to complain of headaches for the next 2 months. Also my daughter had a large decrease in appetite, dizziness, nausea and fatigue that she had never felt before.  On June 13, 2007 my daughter had the second dose of Gardasil. She again felt feverish, tired and complained of a sore throat once again. The headaches increased within a few days of the second shot. She also told me she felt "slower" than normal and that she had to think about things before doing them, like typing and using her cell phone. On July 1, 2007 my daughter said she had a "horrible" headache, with in 15 minutes of saying this she fainted and stopped breathing. I had to give her mouth to mouth to get her breathing again. My daughter then had 2 back to back seizures. Her entire body became rigid with her hands and arms raising and all her muscles contracting. Her eyes seem to pop out of her head. She began to choke and was unable to breath. I again gave her a breath of air and she then began to vomit and a few minutes later she came to. An ambulance took her to the hospital where a cat scan, MRI/MRA and EEG tests were negative. Blood work showed a slightly raised potassium level and small amounts of Vicodin (last dose taken 3 days before seizure) which she was taking for an unrelated arm injury. Urine tests were also normal and a strep test was negative. There is no family history or seizures and my daughter was healthy until she received the Gardasil shots.  07/16/2007 MR received for o/n hospital stay 7/1/2007 for c/o generalized tonoclonic seizure activity seen after pt fell to floor.  Pt c/o post-ictal H/A as well as H/A prior to seizure.  PE WNL.  Neuro consult with Impression of new Onset Seizure Disorder, etiology not clear.
Recent EKG 1st since vaccine showed abnormal reading 1st time I have had one Moderate left Acis deviation  -30 deg. = < QRS axis < -20 deg Recommended to see  Cardiologist  Scheduled Cardiologist appt for Oct
Over 101 fevers, headaches, nausea, vomiting, body aches, heart racing, exhaustion, diarrhea.
3/28/2021   (patient) was observed post Covid-19 immunization for 30 minutes based on pre-vaccination screening .  During the observation period, she experienced an adverse reaction with the following symptoms:  Hot, jittery.   Assessment : Time of assessment 1332 Alert and oriented. And anxious   Actions taken: VS taken at 1332, BP- 199/147, P- 123, O2- 100%,placed on stretcher, offered water and drinking, patient reports that she took her BP meds late today, VS recheck at 1344- BP- 182/73, P- 90, O2- 100%, symptoms residing, daughter in room. 1350 BP- 175/72. P- 89, O2- 100%, at 1400, BP- 174/89, P- 64, discharge with daughter at 1402.         Medications administered: No medication administered.   Disposition: Reports no further symptoms of adverse reaction after observation for 30 minutes. Discharged home.     Immunizations Administered    Name Date Dose VIS Date Route   Pfizer COVID-19 Vaccine 3/28/2021  1:27 PM 0.3 mL 12/11/2020 Intramuscular   Manufacturer: Pfizer, Inc   Lot: ER8733
Case number PHEH2017US005237, is an initial spontaneous report received from a pharmacist on 16 Feb 2017. This report refers to a 18 years old male patient. Medical history was not reported. Concomitant medication was not reported. The pharmacist reported that, the temperature excursion was occurred in Jan for 10 hours, maximum temperature of 51.8 Fahrenheit and the patient was vaccinated with FLUCELVAX Quadrivalent (batch number: 186867, expiry date: May 2017) at a dose of 0.5 ml, intramuscularly on 05 Feb 2017, following the temperature excursion. No adverse event was reported following this medication error (incorrect storage of drug).
PATIENT FAINTED FOR 3-4 MINUTES...CALLED 911..PATIENT WAS TAKEN TO HOSPITAL
Patient complained of not feeling well and fatigued hours after receiving her 2nd dose of the Covid vaccine. Patient stated that within 36 hours after receiving the vaccine that she fainted, had two bloody noses, multiple muscle cramps in her hand and legs, headaches, and swollen lymph nodes throughout body.
Complaint of cough, chills, headache, runny nose/congestion, and malaise.
Apparently a spike in D Dimer score, though Dr. will be making further assessments.
Soreness at first in Arm. 12:30 PM General feeling of extreme fatigue 2:45PM Aching Joints in arms and legs. 5:00PM Chills 6:30PM High Fever of 103 8:00PM Dizziness 8:00PM Headache 8:00PM  Used Ibuprofen to reduce fever and for body aches at 9:00PM Fever seemed to break around 1:00AM All associated symptoms seemed to wane around the same time. Only a soreness in lower back remained through the next evening before it dissipated as well.
I get very sick; Initial information received regarding this unsolicited valid non-serious case received from a consumer (patient) and transmitted to Sanofi 29-Oct-2020.  This case was linked to cases 2020SA306292, 2020SA306293, 2020SA306294, 2020SA306276, 2020SA306296, 2020SA306297, 2020SA306298, 2020SA306299, 2020SA306300, 2020SA306301, 2020SA306302, 2020SA306303, 2020SA306304, 2020SA306305 and 2020SA306306.  This case involved a patient of unknown demographics who got very sick, while the patient received vaccine INFLUENZA VACCINE.  Relevant medical history, past medical treatment, vaccination, concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient got very sick (illness), 3 to 5 days (as reported) following the administration of INFLUENZA VACCINE.  Relevant laboratory test was not reported.  Final diagnosis was illness.   It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome was unknown for the reported event.  There would be no information available on batch number for this case.
every day, specifically on one side of her head/ headache radiates from her eye to back of the head; 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 25-year-old female patient received BNT162b2 (BNT162B2), on 16May2022 as dose 1, single (Batch/Lot number: unknown) at the age of 25 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset May2022, outcome "not recovered", described as "every day, specifically on one side of her head/ headache radiates from her eye to back of the head".  Additional information: The patient was trying to get in contact with her doctor, but hasn't been able to reach anyone.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
I had a possible exposure to Rabies as there was a bat in my attic. This happened over Thanksgiving. I received Rabies immunoglobulin and a series of IMOVAX rabies vaccination shots over the course of December. My first shot was December 14, my last shot was December 29. After the immunoglobulin I began experiencing migratory arthralgia and myalgia.  By Christmas I began experiencing severe paresthesias and burning in my arms and legs. My muscles fatigue so easily I can hardly carry my handbag. After visits to Clinics, I finally found a neurologist who feels I have autoimmune related neuropathy secondary to the vaccination. I am on gabapentin, CYMBALTA, and ATIVAN with a very little relief of symptoms. I am devastated.
3 hours after her flu shot she started with tickle in throat and cough x 45 min hoarseness, headache -> intense -> like someone was kicking her in the head. Extreme nasal congestion and red eyes - achy.
"I feel short of breath, palpitations and I feel dizzy." RN put Client supine in gravity chair.  RN provided juice and a protein bar. After 3 minutes, Client stated, "I feel better now, they symptoms are gone."
5 MINS AFTER SHOT ADMINISTERED PT GOT LIGHT-HEADED, DIZZY AND SWEATY. HE VOMITED AND WAS GIVEN SOME WATER. WAS ASKED IF HE NEEDED 911 SERVICES. HE SAID NO. TOLD TO REST FOR 30 MINS AND AFTERWARDS FELT BETTER. NO SIGNS OR SX OF ANAPHYLAXIS AND MOTHER TOLD TO MONITOR HIM FOR 48 HRS. THEY LEFT PHARMACY AFTER 30MINS.
myocarditis; This literature-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (myocarditis) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   LITERATURE REFERENCE: Myocarditis following immunization with mRNA COVID-19 vaccines in members of the US military. International peer review. 2021     No Medical History information was reported.   In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced MYOCARDITIS (myocarditis) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (myocarditis) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Troponin: elevated (High) elevated.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered MYOCARDITIS (myocarditis) to be possibly related.    No concomitant medication was reported. Patient received supportive care. Reportedly patient visited hospital for chest pain.  Symptoms begun few days after receiving the product.  Patient presented with acute onset of marked chest pain Infectious, ischemic, or autoimmune etiologies was not identified for myocarditis. Patient was physically fit by military standards and lacking any known history of cardiac disease, significant cardiac risk factors, or exposure to cardiotoxic agents. No structural abnormalities were noted on echocardiogram.  Company Comment: Based on the current available information and temporal association between the use of the product, and the start date of the event, a causal relationship cannot be excluded.   Author comment clinical course suggests eosinophilic hypersensitivity myocarditis as described in the context of other drug-associated and vaccine-associated myocarditis.   This case was linked to MOD-2021-284001, MOD-2021-284002, MOD-2021-284003, MOD-2021-284004, MOD-2021-284005, MOD-2021-284006, MOD-2021-245527, MOD-2021-284008, MOD-2021-284009, MOD-2021-284010, MOD-2021-284011, MOD-2021-284012, MOD-2021-284013, MOD-2021-284014, MOD-2021-284015 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Jul-2021: Follow up received by safety 07-Jul-2021 included the full text article added with no new information. On 07-Jul-2021: Follow up received by safety 08-Jul-2021 included the full text article added with no new information.; Sender's Comments: Based on the current available information and temporal association between the use of the product, and the start date of the event, a causal relationship cannot be excluded.
pt recvd vax;exp shoulder discomfort,lasted a couple of days;2 days p/ dose 3,exp arm swelling;tx w/ ATB;MD felt sxs have nothing to do w/ hep B vax;dx as a "fatty tumor" that found passage through muscle & appeared superficially;
Was requiring high FiO2 and NIPPV support, with further worsening of the respiratory status. Was transferred to ICU. Upon d/W Dr. in ICU, family decided to proceed with only comfort care measures. NIPPV was DCed today and patient was kept comfortable. Patient was also followed by Dr., Palliative care. Patient was comfortable and passed away on 9/4/21
Patient was inadvertently given a pediatric dose of HBV vs adult dose. No adverse reactions observed.
BRIEF OVERVIEW: Admission Date: 7/5/2023 Discharge Date: Jul 6, 2023 Discharge Disposition:  Home with services - Occupational therapy and Physical therapy    DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Weakness [R53.1] Acute cystitis without hematuria [N30.00] COVID-19 [U07.1]   HOSPITAL COURSE:   Patient is a 61 y.o. male with traumatic brain injury from MVA with subsequent seizure disorder who presented to ED with generalized weakness associated with falls. On admission family reported they had just returned from a family vacation.  Since then he has had progressive weakness x5 days associated with cough and daily falls.     In ED VS/Labs were stable. Due to URI symptoms resp panel ordered and positive for covid. Admitted to medicine for generalized weakness. Pt did not require 02 and satted >92%. He was monitored and worked with pt/ot which recommended home w hh services. Repeat labs wnl and pt stable for discharge on 7/6. VS remained stable. Pulm rehab was ordered for new cpap mask to use at home. Pt safely discharged home.
Sudden onset of Severe Shaking Chills, Fever 102.5, Severe HA, Nausea, Vomiting, Incontinence of Urine, Indescribable Body Pain, so much so I could not get out of bed, nor walk. I almost called the ambulance to go to the hospital. Thank God I had some family home to help me. Plus I have a huge bump at the site.  Did not experience anything that severe with my first two doses. Today I am only slightly improved. I am a nurse practitioner and most of my patients had side effects but nothing like this.  Pretty bad and frightening, but I seem to be  improving, so I am not going to the Emergency Department.
Customer received the Moderna bivalent booster instead of the primary dose. He came in asking for the most recent dose and since only Bivalent was available he said he wanted the booster thinking that if he got the booster then he would not need the primary. Upon enquiring for the primary vaccine record he said he did not have it in his possession. As a result the pharmacist assumed that he has had his primary doses and gave him the Bivalent booster. His physician asked him to get another dose for which he came to pharmacy and that is when this got discovered that he never got the primary dose. Pharmacist looked up a pharmacy location nearby which had the primary Moderna doses using vaccine finder and referred the customer to that location to get the second dose of the monovalent (primary series).
Narrative:  Patient received first dose of Pfizer COVID19 vaccine on 2/18/21. No adverse reactions reported. Received second dose 3/11/21. Patient called clinic 4/30/21 reporting intermittent, generalized rash. Described rash as raised, reddened and itchy. Reported taking OTC diphenhydramine, dose and frequency unknown. Patient was traveling and unable to come to clinic or complete virtual visit for evaluation. Was instructed to report to local urgent care if additional care needed.
Client reports numerous episodes of diarrhea x 4 days after receiving vaccine on 12-30-15. Client states was unable to go to work and was bedridden. Denies vomiting, fever, etc.
This spontaneous case reported by a consumer, describes the occurrence of influenza-like illness (like he had the flu), hyperhidrosis (chills/sweating lasted all night), pain in extremity (right arm shoulder was sore and is still sore), chills and pyrexia (fever) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch# 040B21A) for COVID-19 immunization. The occurrence of additional events detailed below. The patient's medical history included neck surgery (4 discs removed) on Mar 30, 2021. On Apr 29, 2021, at 8:45 am, patient received first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Apr 29 2021, patient experienced pain in extremity (right arm shoulder was sore and is still sore). On Apr 29, 2021, at 10:00 pm, patient experienced influenza-like illness (like he had the flu), hyperhidrosis (chills/sweating lasted all night), chills, pyrexia (fever) and nausea (tried to throw up). On May 1, 2021, influenza-like illness (like he had the flu), hyperhidrosis (chills sweating that lasted all night), chills, pyrexia (fever) and nausea (tried to throw up) resolved. At the time of the report, pain in extremity (right arm shoulder was sore and is still sore): unresolved. The action taken with mRNA-1273 (Moderna COVID-19  vaccine), intramuscular: unknown. No concomitant medication or treatment information reported.