chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Per mom patient was crying a lot after vaccine. Not wanting to eat refused bottle. Pt had a seizure a day after vaccine. No fever. Mid November had an episode of vomiting, acting weak, seemed limp. 12/1 was seen her for f/u and got flu vaccine, next day had GI sx, Mom layed down with him to take a nap, his whole body began shaking, everything deviated to the left, arms went up and to left, eyes looked to left, purple lips, lasted 2 minutes. Called 911 and transported to hospital, admitted, did an MRI and EEG, both came out normal.
Ichy following vaccine infection both at the injection site and other parts of body, 9 days after noticable round ( looks like a target ?? ) mark showed up that is sore to the touch, firm (compared to the surrounding soft squishy skin) and was incredibly itchy at injection site.  I have not made a doctor's appointment yet but may do so in the coming days.
This spontaneous report has been received from a 65 year old female patient, who was reporting on herself. The patient reported no pertinent medical history and drug reactions or allergies. Concomitant therapy was not reported. On 04-OCT-2016, the patient was vaccinated with PNEUMOVAX 23 (dose, lot#, expiration date were not reported, route of administration was not reported as intramuscular or subcutaneous). On 12-OCT-2016 (also reported as a week later), the patient experienced a rash on her arm (unspecified arm) and fever. The patient went to her physician who treated her with an unspecified anti-inflammatory medicine. No labs were performed. She stated she will see her physician again in a week (unspecified date) for further treatment, if her symptoms don't clear up. The patient did not recover from the event, at the time of the report. There was no product quality complaint involved. The patient stated that her physician was uncertain if PNEUMOVAX 23 was the cause of her rash. The relationship between the event and PNEUMOVAX 23 was not reported. Additional information has been requested.
Enlarged left axillary lymph nodes; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in 2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. It was unknown whether the patient received any other vaccines within four weeks prior to the vaccination. On an unknown date in May2021, the patient experienced enlarged left axillary lymph nodes. The event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, it was unknown whether the patient had been tested for COVID-19. It was unknown if any therapeutic measures were taken as a result of the event. The clinical outcome of the event enlarged left axillary lymph nodes was unknown at the time of this report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
This case was reported by a physician and described the occurrence of bordetella pertussis in a 6-month-old subject of unspecified gender who was vaccinated with PEDIARIX (GlaxoSmithKline). On unspecified dates the subject received 1st dose, 2nd dose and 3rd dose of PEDIARIX (unknown). Less than one year after vaccination with PEDIARIX, the subject experienced Bordetella pertussis, Bordetella pertussis test positive and vaccination failure. The physician inquired about storage/ transportation recommendations and reported a subject tested positive for Pertussis after being vaccinated with PEDIARIX. The subject was 6-months old and had just received the 3rd dose of PEDIARIX. At the time of the report no additional information was available. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the Bordetlla pertussis and Bordetella pertussis test positive was unspecified. The physician reported another case of Bordetella pertussis test positive, for that subject please see case A1024573A.
Patient reports started feeling "sick" the next morning. Reports could not go to work Saturday,  Sunday, Monday. Reports "chest hurts, back hurts, left arm is numb, right arm hurts, stomach upset, headache, 101.3 fever".  Reports has been taking "Back and Body" which contains aspirin and caffeine.  Denies shortness of breath, rash
GANGLIOS LINFATICOS INFLAMADOS  DOLOR EN EL LUGAR DE LA INYECCION COVID ARM
sore shoulder; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (sore shoulder) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, the patient experienced ARTHRALGIA (sore shoulder). At the time of the report, ARTHRALGIA (sore shoulder) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient is mother in law of the reporter. Concomitant drug information not provided. Treatment was unknown.   This case was linked to MOD-2021-062307, MOD-2021-062340 (E2B Linked Report).; Sender's Comments:  MOD-2021-062307: MOD-2021-062340:
I could no longer stay awake after receiving the vaccine. I felt tired all the time and lost all energy. I went from a healthy 30 year old to feeling 80 overnight. I ended up hospitalized with a severe stomach infection called c. difficile. The doctors did not understand how I acquired this when I wasn't elderly and did not receive antibiotics recently. While I was sick I learned antibiotics are in vaccines. A fact we were never taught in nursing school..
Nausea; Vomiting; I am sick in my stomach; This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via unspecified route single dose for COVID-19 immunization on 05Apr2021, 9 o'clock (reported as today). Medical history and concomitant medication were not reported. The patient was sick in stomach, vomiting. The patient had nausea and vomiting. Outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
The pt noted redness, warmth and tenderness at the injection site for 3-4 days. No swelling. The symptoms cleared spontaneously.
no adverse symptoms were reported; Multiple patients received improperly stored doses of VARIVAX; This spontaneous report was received from a medical assistant referring to multiple patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions or concomitant medications were not reported.  On 07-AUG-2020, a patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # T002845 (expiration date: 23-JAN-2022) for prophylaxis (additional dosage regimen information was not reported). No adverse symptoms were provided.  The vaccine was exposed to a temperature of 6 to 14 Fahrenheit degrees (7.7 Fahrenheit degrees), for a timeframe of 2 hours and 8 minutes. There was no previous excursions and it was found because of a digital data logger.  This is one of several cases from the same reporter.; Sender's Comments:  US-009507513-2008USA010124: US-009507513-2008USA010123: US-009507513-2008USA010126: US-009507513-2008USA010125: US-009507513-2008USA010122: US-009507513-2008USA010000: US-009507513-2008USA010134: US-009507513-2008USA010121: US-009507513-2008USA010127: US-009507513-2008USA010136: US-009507513-2008USA010137: US-009507513-2008USA010128:
Initial unsolicited literature report received on 10 Feb 2015. Abstract: Introduction: Observational studies of influenza vaccine effectiveness often study persons seeking medical care for acute respiratory infection (ARI). We conducted a pilot study to determine if vaccine effectiveness could be estimated in the general population with a novel rolling cross-sectional survey sampling design and laboratory confirmation of influenza. Methods: Cross-sectional samples were selected weekly from defined populations from January through April, 2011 (12 weeks). Persons were telephoned and asked about the occurrence of ARI in the past week. Nasal and throat swabs were obtained from consenting individuals with ARI and tested by real-time reverse transcription polymerase chain reaction (RT-PCR). Vaccine effectiveness (VE) was defined as (100 x [1 OR]) for vaccination in a logistic regression model that adjusted for age, calendar week, and site. The comparison group included all study participants without RT-PCR confirmed influenza, including those who were not ill. Results: Study personnel contacted 9537 (62%) of 15,303 persons sampled; the primary analysis included 5678 subjects. Of these, 193 (3%) reported an ARI and agreed to be tested for influenza; 13 (7%) were influenza positive. The adjusted effectiveness of the influenza vaccine was 1% (95% confidence limits 239-70%). Conclusions: The rolling cross-sectional design is methodologically feasible and may be useful as a complement to clinic-based VE studies. This pilot study did not have sufficient power to detect significant vaccine effectiveness during a mild influenza season, but this approach may facilitate rapid estimation of VE in a pandemic setting when normal patterns of health care utilization are disrupted. It was reported that acute respiratory illness was identified in 94 patients, out of which 6 were influenza positive whose medical history and concomitant medication were not reported, had received a dose of Seasonal influenza vaccine (batch number, route and site of vaccination was not reported) on an unspecified date. On an unspecified date, 6 patients were identified as influenza vaccine positive. Corrective treatments and laboratory investigations were not reported. At the time of this report, the outcome of the event was reported as unknown. List of documents held by sender: None.
5 patients received full Moderna COVID-19 dose in error/5 patients should have received half dose booster; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL OVERDOSE (5 patients received full Moderna COVID-19 dose in error/5 patients should have received half dose booster) 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 22-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Oct-2021, the patient experienced ACCIDENTAL OVERDOSE (5 patients received full Moderna COVID-19 dose in error/5 patients should have received half dose booster). At the time of the report, ACCIDENTAL OVERDOSE (5 patients received full Moderna COVID-19 dose in error/5 patients should have received half dose booster) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not provided.
Rash on abdomen and neck, shoulders 2/8/05 fever 101-102 F.
PT STATES EVERY TIME HE RECEIVES ANTHRAX VACCINE SINCE 1999, HE SUFFERS TEMPORARY MEMORY LOSS. HE RECEIVED 5 SERIES OF VACDCINE APR 1999-APR 2000, AND ANNUAL SINCE 2006. MEMORY LOSS BEGIGS WITHIN 24HR OF VACCINE, AND LASTING SEVERAL MONTHS.IN 2008, IT TOOK ALMOST 9-10MONTHS UNTIL BACK TO NORMAL.i WILL GIVE HIM A MEDICAL PERMANEMT EXEMPTION TO ANTHRAX VACCINE. THANK YOU.
Hospitalized and death; symptoms include fever, rhinorrhea, sore throat, cough, shortness of breath, chest pain, headache, fatigue, diarrhea, congestion, and loss of taste/smell.
About 8 hrs. after receiving the shot. I could not get warm had a bad headache & my whole body ached so bad I could hardly move in bed. Was tired the next day because I couldn't sleep but symptoms had passed.
Vertigo/dizziness causing vomiting and affecting activities of daily living. Ongoing after 1 week and not responding to Meclizine or Ondansetron.  Originally had mild fever for one night, then brain fog and night sweats for approximately five days
Tested positive with covid-19; A spontaneous report was received from a pharmacist concerning an unspecified age male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and tested positive with covid-19(covid-19).  The patient's medical history was not provided. No relevant concomitant medications were reported.    On an unknown date, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (lot unknown) via unknown route for prophylaxis of COVID-19 infection.  On an unknown date, the patient tested positive with covid-19.   No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.  The seriousness criteria of event was non serious.  The outcome of the event tested positive with covid-19 was unknown.; Reporter's Comments: Based on reporter's causality ,the event SARS-CoV-2 test positive is assessed as unlikely related to mRNA-1273.
presents to hospital with 6 days of worsening SOB/Dyspnea. Patient reports he was tested for COVID at PCP office. Patient is not vaccinated and is immunocompromised r/t chemotherapy and steroid usage. Patient was found to be hypoxic and tachypneic by EMS, placed on CPAP with improvement in respiratory work.  Tested positive on 11/22/2021
Dtap and IPV component of the Pentacel was administered to the patient and not the ActHib component of pentacel, no AE; Initial information received on 11-Sep-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 4 years old male patient who received 0.5 ml dose of DTAP AND IPV component and not ACT-HIB component of the IPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (batch number: U6327AA and expiry date: 19-Sep-2020) via intramuscular route in right leg, on 11 Sep 2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation.  It was an actual medication error due to inappropriate reconstitution technique. It was reported that 4 year-old patient came in and the Dtap and IPV component of the Pentacel was administered. The ActHib component was not administered. It was 4th IPV and 5th Dtap dose.  At the time of reporting the patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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.  List of documents held by sender: none.
On June 19, 2022 my husband tested positive for COVID-19. I tested negative until June 23, 2022 and I had a cough, fatigue and it settled in my chest. I called my doctor and had a telemedicine visit. He prescribed Paxlovid that I started taking that evening. I am feeling so much better and am very thankful and glad that I am symptom free.
Information has been received from a physician concerning a 12 month male patient who on 28-SEP-2009 was vaccinated with a first dose of VARIVAX (Merck) (dose, route and lot# not report). The physician stated that on 11-NOV-2010 the patient was diagnosed with varicella. At the time of the report the patient had recovered. The patient sought unspecified medical attention. This is one of several reports received from the same source. Additional information has been requested.
Pain at injection site for a couple days. 7 days later pain became worse.  10-12 days later pain became worse in arm and shoulder region and could not lift arm all the way. Patient went to family doctor. Physician sent patient for an MRI.  MRI showed problems with shoulder.
Information has been received from a nurse concerning a female (age not reported) who on 09-MAY-2007 was vaccinated with a 0.5 mL dose of Gardasil (lot unavailable).  Concomitant vaccination included unspecified "tetanus vaccine".  On 09-MAY-2007 the patient "got dizzy after receiving Gardasil.  The patient sought unspecified medical attention.  On 09-MAY-2007, the patient recovered.  There was no product quality complaint.  Additional information has been requested.
MMR #1 given 1/6/04. Fever with maculopapular erythema (rash) on 1/11/04. Rapid strep (-) not on antibiotics. Pt was seen on 1/15/04 with the rash.
tired; weak; This is a spontaneous report from a contactable consumer or other non hcp (Patient).  A 65-years-old male patient received bnt162b2 (BNT162B2, PFZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as unknown, single dose for covid-19 immunization. No medical history and no concomitant medications were not reported. It was reported that patient stated since the vaccine dose he has felt weak and tired and patient wanted to know how long will it last. He was so tired, he need to rest when he is working. Patient asked for recommendations on any medication he can take for the symptoms. Reported seriousness was reported as non-serious. The outcome for the events was reported as unknown at the time of this report.   Information about batch/lot number has been requested.  Follow-up (23Aug2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
URI  fatigue, a small cough and a headache/dizziness that comes and GOES
[April 10; Evening]: Headache with small pounding feeling, a slight fever. [April 11, Morning]: Slight pressure on injection sight, weak limbs, vomiting, fatigue. [April 11, Evening]: Unconsciousness, nausea, delirious, fever. [April12-14]: Extreme Migraines, dizziness, loss of balance while walking, unconsciousness, loss of appetite. Took Pedialyte and liquid pain reliever everyday.
pediatric patient inadvertently received an adult dose of Havrix; Pediatric patient received Havrix adult dose; Expired Havrix administered; This case was reported by a nurse via call center representative and described the occurrence of accidental overdose in a 22-month-old male patient who received HAV (Havrix adult) (batch number 72T95, expiry date 9th August 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 31st August 2022, the patient received Havrix adult and Havrix Pre-Filled Syringe Device. On 31st August 2022, unknown after receiving Havrix adult and Havrix Pre-Filled Syringe Device, the patient experienced accidental overdose, adult product administered to child and expired vaccine used. On an unknown date, the outcome of the accidental overdose, adult product administered to child and expired vaccine used were 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: 31-AUG-2022  Reporter's comment: The nurse reported that pediatric patient inadvertently received an adult dose of Havrix.  The reporter consent to follow up from agency via email would be okay. Additional supportive information: The patient received an expired dose of adult Havrix, which led to expired vaccine used. The patient was inadvertently administered an adult Havrix dose, which led to adult product administered to child and accidental overdose. This case is linked with US2022AMR126800, reported by same reporter for different patient.; Sender's Comments:  US-GSK-US2022AMR126800:Same reporter
Patient had the same vaccine on 10/03/18 and got the same vaccine 10/23/18. Patient did not have any adverse events.
Pt was vaxed w/pneumococcal vax & devel a local reaction which consisted of cellulitis & swelling of the entire arm; pt recvd inject of cortisone & w/in 3 to 4 days sx subsided; No further details were provided;
Information has been received from a licensed visiting nurse concerning a 66 year old female with no allergies or medical history, who on 07-SEP-2006 was vaccinated IM with a 0.5 ml dose of PNEUMOVAX (lot# 651319/1007P).  There was no concomitant medication.  Within 24 hours later, the patient developed swelling and a rash at the injection site from her shoulder to her elbow.  It was noted that the swelling has mostly resolved, however, a marble sized area of swelling has remained.  The patient was treated with ice for the swelling.  No other symptoms were reported.  At the time of this report, the patient was recovering.  No product quality complaint was involved.  Additional information has been requested.
Swelling and redness at injection site of PREVNAR 13. Given on 11-12-2015.
got really ill; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 25 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "got really ill".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021447082 same drug/AE, different patient
Throat swelling, Itchy throat, hoarse voice after 7 minutes of 2nd dose of vaccine Benadryl 50mg PO given 10minutes after reaction started Patient symptoms revolving after 15 minutes of giving Benadryl. Hoarseness , swelling and itchiness resolving
headache,pain,swelling,chills,fatigue my whole shoulder in pain bad headache feverish fealing  started around 1am could not sleep due to pain took exedrin pain was reduced still had chills lasted all the next day 2days now over just a little soreness in arm,1st dose no side effects just sore arm.