chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case number PHEH2015US026828 is a spontaneous report initially received from a nurse on 22 Dec 2015. This report refers to a 22 years old female patient. Medical history and concomitant medications were not reported. The patient received FLUVIRIN (batch number: 1514501, expiry date: May 2016) into left deltoid on 29 Oct 2015. It was reported that FLUVIRIN administered to the patient had a temperature excursion of 34 degrees. The reporter stated that she did not know why the refrigerator was out of temperature range for an unspecified amount of time overnight. She checked the temperature before she left for the day and when she arrived the next day and the temperature was fine. It was a new refrigerator and there have not been any problems since the temperature excursion. No adverse reaction was experienced by the patient following the maladministration. No further information provided. Follow up information received from the nurse on 26 Jan 2016: Reporter's comment updated.
p/vax pt devel chickenpox w/approx 100 lesions reported by the pt mom;
pt recvd vax & 34 days later devel a 2nd HIB infection; 34 days p/2nd HIB infect devel a third HIB infect of which pt succumbed; COD was fulminant meningitis; Anti-PRP antibody concentrations were nearly undetectable, indicating no response
got them after the vaccine/suspected vaccination failure; got them; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient got them two after the vaccine but it was not as bad, thank God. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting. No contact details were available.
Pt recvd 1st dose of Pneumovax vax 01NOV90; On 02NOV90 exp pain & erythema in lt deltoid muscle; dx cellulitis; tx Keftab; MD felt exp related to vax;
pt recvd vax; 24 hrs later c/o rt arm swelling, redness & throbbing; referred to md
I hardly felt the injection at 10:15am at 6pm my arm was sore at the injection site, by 7:30 pm pain radiated down my left arm into my hand. At 8:30 pm I was feeling tired, cold, sick and dizzy and was starting to get a headache. My temp was increasing a few points of a degree every 15 min. The soreness now radiated down the whole left side of my body. Right side had no pain. I drank a bunch of water and went to bed around 9:30pm. At 5:30 am my temp was 102.4 . I took ibuprofen.  I still felt exhausted. I had the worst headache of my life. The room was spinning if I lifted my head. I fell back asleep and woke around 1pm my fever was down to 99.9 by 2:30pm my temp was normal. I still have a headache and my left side is still very sore. I still feel exhausted. It's now 5:30pm and I am starting to get the chills again. I will continue to monitor my progress.
Vomiting, fever, body aches, joint soreness, lack of energy. Duration of symptoms: approx 4 days. Pt saw Dr. at approx. 1 week after vaccination given.
On 8/26/08 client received 1st dose of all needed vaccines including DTAP.  Client also mistakenly received TD/Adult dose and mother was notified to watch for possible adverse effects.  Instructed to give anti pyretic every 4-6 hours to minimize fever.  On 8/27/08 tc with mother, child somewhat fussy but slept well and no fever.  Told to continue anti fever meds x 24 hours.  On 8/28/08 mother called stating she fed client formula on pm of 8/27/08 but she "spit up clear liquid and turned blue when positioned on back" and "not breathing".  Took baby to walk in clinic who advised to "watch her".  No further symptoms but intending to take to pediatrician today for follow up.  8/29/08 spoke to mom - no return call for follow up information.
Hives and itching over abdomen about 1-2 hours, post vax. About 5 hours, post vax, pt had itchy eyes.
dministered dose of improperly stored PROQUAD; This spontaneous report was received from office manager and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 21-JUN-2022, the patient was vaccinated with improperly stored 1 dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin) (PROQUAD) subcutaneous injection, lot # U017140, expiration date: 28-NOV-2022 (strength, and route of administration were not provided) administered for prophylaxis (product storage error).  This is one of the several reports received from the same reporter (link reports # 2206USA007281, 2206USA007312, 2206USA007229).; Sender's Comments:  US-009507513-2206USA007281: US-009507513-2206USA007312: US-009507513-2206USA007229:
2 days of tender mass or lymph node in lt neck,pain over lt side of face,low grade cough w/small amount of yellow,hoarseness;discomfort in lt ear when pt chewed;devel non-itching rash,awful w/no energy;flu;viral illness not related to vax;
Hives in the face and throat; Swelling in the face; Swelling in the throat; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives in the face and throat), SWELLING FACE (Swelling in the face) and PHARYNGEAL SWELLING (Swelling in the throat) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced URTICARIA (Hives in the face and throat), SWELLING FACE (Swelling in the face) and PHARYNGEAL SWELLING (Swelling in the throat). At the time of the report, URTICARIA (Hives in the face and throat), SWELLING FACE (Swelling in the face) and PHARYNGEAL SWELLING (Swelling in the throat) outcome was unknown.    No concomitant medications were provided. Treatment medications were unknown. Action taken with mRNA-1273 in response to the events was not applicable.
Aching all over. I have fever, chills, cough, fatigue, muscle aches, diarrhea headache.
PATIENT FELT FAINT APPROXIMATELY 3-5 MINUTES FOLLOWING 2ND DOSE OF PFIZER COVID VACCINE. PATIENT BEGAN TO FAINT AND FATHER LOWERED HIM TO THE FLOOR. PATIENT QUICKLY REGAINED CONSCIOUSNESS, BUT FELT FAINT AFTER GETTING BACK IN A CHAIR. PATIENT WAS LOWERED TO FLOOR AGAIN AND WAITED FOR EMS TO ARRIVE. EMS ARRIVED A FEW MOMENTS LATER (3:15PM) AND ASSESSED THE PATIENT.
Initial report received from a health care professional on 31 August 2011. A 70-year-old female patient received a right deltoid intramuscular injection of FLUZONE HIGH-DOSE No Preservative 2011-2012, sanofi pasteur Inc. lot number UH436AB, on 30 August 2011. The patient had an allergy to fish. She took no concomitant medications, had no illnesses at the time of vaccination and had no other vaccines within 4 weeks of the FLUZONE HD. The patient had received previous flu shots yearly. On 30 August 2011 and 45 minutes post vaccination, the patient felt her throat beginning to tickle then close, an area around eyes began to swell. She also had a headache. The patient was seen in the Emergency Department (ED). She was treated with BENADRYL and epinephrine. The patient was discharged on BENADRYL. The outcome was reported as recovered. Documents held by sender: None.
Patient woke at midnight after receiving vaccine with fever of 100.1*, chills, shivering,  loss of bladder control and difficulty with balance. Patient took Tylenol and was able to return to sleep. She woke to resolution of fever and improvement of bladder control. At 4 days post vaccination patient still feels tired, weak, and difficulty with balance.
Patient complained the following day she got the shot saying her arm is itching and red. I counseled her to apply BENADRYL/ZnO cream but she didn't feel well the 2nd day. Visited her PCP who diagnosed her with cellulitis and allergic skin reaction followed vaccine. Treated with CIPRO 500 mg tab for 1 week and fluconazole 150 for 1 day.
Redness and swelling at site. Fever 101.1. Nausea, vomiting, diarrhea. Apply cool compress to site, Ibuprofen for inflammation and fever.
The Pfizer Covid vaccine has caused severe radiating arm pain throughout my left arm. My arm constantly falls asleep and it is very painful. I've been waking up every night from my arm pain. I will get random sharp pains and constantly feel like I can feel something in my arm. After getting the covid shot the whole inside of my arm was bruised black from my armpit to half o my bicep. My arm experiences such great pains now that I'm changing careers. I can't be a certified dental assistant anymore due to the pain. This is criminal, I was forced to get this to work. Now I'm in constant pain.
High fever, lethargy, intense body pain, abdominal pain, nausea, chills
Employee had low grade fever and 15 x 30 mm raised rash at vaccine site.
On day 10 after vaccine I had an episode of Trans global Amnesia. These are usually triggered by elevated heart rate or intense physical activity. This episode lasted about 15 minutes. COVID-19 infection was due to exposure to daughter and grandson, they were symptomatic in the few days prior to my testing positive. Day 1 I had a scratchy throat. Within 24 hours I had a fever 99.6 at the highest and a runny nose. The fever lasted 3 days. On the 8th day I lost my sense of smell and taste, but they returned after 2 days.
Worsening sore arm, body aches, 101.1 temperature, increased fatigue
mom states child devel itching rash & hives on the way home from clinic;mom called local ER;pt had rash around neck, underarms & in groin area w/in 30min;pt exp diff swallowing;
Off label use- started to give half doses of Moderna as boosters to staff; -started to give half doses of Moderna as boosters to staff; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of OFF LABEL USE (Off label use- started to give half doses of Moderna as boosters to staff) and UNDERDOSE (-started to give half doses of Moderna as boosters to staff) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced OFF LABEL USE (Off label use- started to give half doses of Moderna as boosters to staff) and UNDERDOSE (-started to give half doses of Moderna as boosters to staff). At the time of the report, OFF LABEL USE (Off label use- started to give half doses of Moderna as boosters to staff) and UNDERDOSE (-started to give half doses of Moderna as boosters to staff) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.
2 week post MMR atypical measles  Morbilliform rash neck and trunk.  Advised to use tyn/ibu PRN.  Avoid exposure to pregnant females.  Avoid exposure to unvaccinated people.
Tingling, numbness, burning in toes of both feet. Ringing on and off in right ear.
Rec injection lt  deltiod and child suddenly threw arm upward near the end, there was y a very tiny amount of vaccine left in syringe, As the syring was moving to come out tiny amount appeared to have been injected into the subcut area, small wheel developed with redness and warmth to the lt deltoid area immediately. Reddness extended downward of arm and small amount across back of shoulder blade. Child extremely upset and guardian indicated when child gets upset will redden with flushed face and upper extremities. No rash noted on trunk or back region, no facial swelling or rash to face, tongue with no swelling, airway patient, no hoarseness noted, child with easy work of breathing without wheezes noted.  child easily consoled per guardian. Observed for approx 10 minutes in exam, no change in condition, Medical director notified of situation,, status update given and inform parent to monitor closely at home. Condition of extremity improved prior to leaving clinic. Parent contated later in afternoon, child active and playing , child wanting to go to school, parent reports redness and small wheel presentation almost completely resolved. Spoke with MD again, recommendation discussed with parent for repeat dose and follow up with Pediatrician within 24-48 hours.
Shortly after receiving COVID vaccine, I got pregnant.  I suffered a miscarriage on Jun 28th 2021.   I was approximately 7 weeks pregnant.  The date of my last period before pregnancy was May 11, 2021.
On the same day that I received the injections, in the afternoon, around 3 p.m., started to get very cold,  started shivering and my teeth were chattering.  I assumed it was from the air conditioning.  Later at dinner, around 5:30, in a different location, I two cups of hot tea to try and warm myself, with no luck.  After returning home I went to bed around 9 pm, still feeling extremely cold and shivering.  I slept poorly.  I felt very achy.  I awoke around 5 a.m. feeling very hot.  My husband took my temperature and it was 101.8 degrees.  He gave me two extra strength acetaminophen, which helped bring my fever down and relieved some of my aches.  However, all day that day (Sunday, Sept. 29, 2019) I was extremely tired and fatigued and the aches returned, but not the fever.  Today, Monday, Sept. 30, 2019, I have no fever or aches, but am extremely fatigued.
Dizziness and nausea around 8pm, 12 hours after vaccine. Effects lasted 1.5 days. No treatment
After the first 2 doses, (1/2/21 and 2/1/21) I experienced severe vaginal bleeding and my OBGYN could not identify the cause, bleed heavily for close to 5 months. Hound out that that the vaccine was a potential cause. I just had a booster on 12/15/21 and vaginal  bleeding started 12/19/21 and still Ongoing as at 1/2/22 and now I am convinced it?s the Moderna
After receiving the vaccine, I had a sore arm for a day. On 12/03/2022 I went to the emergency room for a gastrointestinal bleed. I had no prior pain or symptoms. I was in the hospital for six days. As of today, I continue to be anemic.
Patient presented to pharmacy approximately 28 hours post-injection and showed me that her left arm had a light pink circle around the injection site approximately 2 inches wide. Area shown did not appear red as a rash would. Patient says it was a little sore but pink area (not red) has not spread out. I recommended the patient to use 1% hydrocortisone to reduce the pinkness of the area and to report to her physician in 24 hours if the symptoms don't decrease. Patient was well and alert; no limitation of arm movement. This was patient's 2nd vaccination of SHINGRIX to complete the series.
I still get tiredness; Feeling unwell; This is a spontaneous report from a contactable consumer (patient). An 82-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number was not reported), on 14Feb2021, via unspecified route of administration, at a first dose single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient still got tiredness and was feeling unwell. The patient stated that she got the vaccine on 14th February and she wanted to know if she still supposed to get a reaction. She still got tiredness and was really feeling unwell. She asked if she was still supposed to get the vaccine. The patient was informed about the role of Pfizer. The patient said that it is said in the paper that if you have any questions about the vaccine or if you have side effects then let us know, that is why I called. In response to question regarding Lot number, she mentioned that she did not see the lot number. Further probing could not be initiated as the patient was unwilling to further answer the questions. Hence, Limited information was available over the call. The outcome of the events was unknown.   No follow-up attempts are possible. Information on the lot/batch number cannot be obtained.
Red rash developed the next day on her upper chest (below neck and above breast) along with headache at the back of her neck/head. The following day it subsided but is still noticebably red.
One week after receiving the vaccine I started experiencing a mild allergic reaction on the skin surrounding the injection site, about 3 inches by 3 inches. The area was red, itchy, hard, and felt warm.  It was uncomfortable, but not painful and it went away on its own after 2 days.
Pt recvd 1st & 2nd dose of Engerix-B &/or Recombivax & 1st dose was uneventful; about 1 hr p/2nd dose became very ill, inc temp, clammy, hot & lightheaded;
slight cough; Sore arm at injection site; fatigue; headache; This is a spontaneous report from a contactable consumer (patient). A 31-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3247), dose 1 via an unspecified route of administration, administered in arm right on 10Mar2021 11:00 (at the age of 31-years-old) as dose 1, single for COVID-19 immunisation. The patient medical history was none (No known allergies and no other medical history). The patient's concomitant medications were none as no medications in two weeks. No other vaccine in four weeks. No Covid prior vaccination and no Covid tested post vaccination. On 11Mar2021 20:00 (the evening after the injection around 8PM), the patient started having symptoms of sore arm at injection site, fatigue, headache, and slight cough. No treatment received for the events. The outcome of events was recovering.  No follow-up attempts are needed. No further information is expected.
Patient admitted 5/18 with complaint of SOB, epistaxis, and had a syncopal episode while at PCP office. Injury to lower left anterior ribs and INR was elevated.  COVID test came back positive 5/18. Patient continues to have occasional nose bleeds and continues to cough up scant amount of blood. Patient was seen and started on remdesivir and also on ceftriaxone. Patient did  complain of cough and shortness of breath denied any chest pain no nausea no vomiting no frequency urgency no dysuria hematochezia hematemesis melena no dizziness no diaphoresis no bleeding and no rash 5/23. Discharged home 5/25.
7 hours post-vaccination shot started to feel extremely fatigued and dizzy, progressed quickly to nausea then vomiting Muscle aches, chills and nausea through the 1st night post-shot Next day: fatigue and nausea, muscle aches, chills 2 days later: finally resolved Adverse Events  At time of vaccination, 30 weeks pregnant due 7/19/2021; did not deliver yet
I was fully vaccinated with Pfizer vaccine back in April and I got positive with covid 2 weeks ago.; I was fully vaccinated with Pfizer vaccine back in April and I got positive with covid 2 weeks ago.; This is a spontaneous report from a contactable consumer (patient). A 26-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EP7534) via an intramuscular route of administration in left arm on 16Mar2021 (age at vaccination 25-year-old) as dose 1, single and received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: EW0153; Expiration Date: 31Jul2021) via an intramuscular route of administration in left arm on 08Apr2021 (age at vaccination 25-year-old) as dose 2, single for Covid -19 immunization. Patient medical history was not provided. Patient concomitant medications were none. Patient was fully vaccinated with Pfizer vaccine back in April and on 11Apr2021 patient got positive with covid. Patient did not receive any treatment for covid because he had pretty minor symptoms, so he did not take any medicines. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 11Apr2021. Product quality group provided investigation results: Description of complaint: tested positive for COVID-19 on 11Apr2021 after receiving both doses of Pfizer COVID-19 vaccine on 16Mar2021 and 08Apr2021. Additional lot numbers: EP7534 and EW0153. The complaint for lack of effect of the PFIZER-BIONTECH COVID-19 VACCINE lot EW0153 was investigated. The investigation included a review of manufacturing and packaging batch records, deviation investigations, and an analysis of complaint history for the reported lot. The final scope included the reported finished goods lot EW0153, fill lot EP8692 and the bulk formulated drug product EW8071. A complaint sample was not returned, and photographs were not received. No related quality issues were identified during the investigation. There is no impact to product quality. No root cause or corrective/preventative actions were identified as the complaint was not confirmed. All release testing performed prior to the release of the reported batch was within specifications. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Felt light-headed on my way home  (after waiting 20 minutes). Got home and ate a sandwich then got real dizzy and my heart started beating real fast so I lay down. It lasted around 45 minutes and got better., but I felt weak the rest of the day
Information has been received from a nurse concerning a female patient (age not reported) with a history of flu vaccination site reaction who on 18-SEP-2007 was vaccinated with Zostavax (Oka/Merck) (Lot#658208/0886U). On 21-SEP-2007, the patient experienced redness, swelling, and warm to touch at injection site. No rash was noted. The size of the area was 3 inches by 3 inches. The patient sought unspecified medical attention. The patient's outcome was not reported. Additional information has been requested.
Arm pain/Pain in arm was so severe; Pain in arm was so severe I could not sleep; Extreme body aches the aches intensified throughout the day; Headaches; sore throat; head and chest congestion; head and chest congestion; This is a spontaneous report from a contactable other hcp (patient). A 49-year-old female patient received bnt162b2 via an unspecified route of administration on arm left, first dose on 16Dec2020 12:45 at single dose for COVID-19 immunization.  Other vaccine same date product included Pfizer-Biontech first dose on 16Dec2020 on left arm (pending clarification). Medical history included COVID-19 prior vaccination from an unknown date. Not pregnant at the time of vaccination. No known allergies. No other medical history. Concomitant medication included bupropion from 2020. No other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced arm pain. Pain in arm was so severe she could not sleep. Applied an ice pack throughout the night. Extreme body aches the aches intensified throughout the day. Headaches, sore throat, head and chest congestion. Adverse event start date was on 16Dec2020. The event was reported as non-serious. Therapeutic measures were taken as a result of arm pain/pain in arm was so severe, treatment included ice pack. No treatment was received for other events. The outcome of the events was recovering.  Information about Lot/batch no has been requested.