chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Osteoporesis in hips; Sleeplessness/Lack of sleep; Injection site papule/Injection site red bump on stomach; Injection site itching/Injection site red bump on stomach with itchiness; Body Ache and Lack of sleep caused more pain; Injection site redness/Injection site red bump on stomach; Fatigue; Fever/Chills; Fever/Chills; This spontaneous case was reported by a consumer and describes the occurrence of OSTEOPOROSIS (Osteoporesis in hips), INSOMNIA (Sleeplessness/Lack of sleep), VACCINATION SITE PAPULE (Injection site papule/Injection site red bump on stomach), VACCINATION SITE PRURITUS (Injection site itching/Injection site red bump on stomach with itchiness) and PAIN (Body Ache and Lack of sleep caused more pain) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for an unknown indication.    No Medical history was reported.  Concomitant products included CURCUMA LONGA (TURMERIC [CURCUMA LONGA]) and CINNAMOMUM CASSIA (CINNAMON [CINNAMOMUM CASSIA]) for an unknown indication.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Dec-2021, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free. On an unknown date, the patient experienced OSTEOPOROSIS (Osteoporesis in hips), INSOMNIA (Sleeplessness/Lack of sleep), VACCINATION SITE PAPULE (Injection site papule/Injection site red bump on stomach), VACCINATION SITE PRURITUS (Injection site itching/Injection site red bump on stomach with itchiness), PAIN (Body Ache and Lack of sleep caused more pain), VACCINATION SITE ERYTHEMA (Injection site redness/Injection site red bump on stomach), FATIGUE (Fatigue), PYREXIA (Fever/Chills) and CHILLS (Fever/Chills). The patient was treated with DICLOFENAC at an unspecified dose and frequency. At the time of the report, OSTEOPOROSIS (Osteoporesis in hips), INSOMNIA (Sleeplessness/Lack of sleep), VACCINATION SITE PAPULE (Injection site papule/Injection site red bump on stomach), VACCINATION SITE PRURITUS (Injection site itching/Injection site red bump on stomach with itchiness), PAIN (Body Ache and Lack of sleep caused more pain), VACCINATION SITE ERYTHEMA (Injection site redness/Injection site red bump on stomach) and FATIGUE (Fatigue) had not resolved and PYREXIA (Fever/Chills) and CHILLS (Fever/Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was reported that second dose of moderna caused fever/chills, osteoporesis in hips, fatigue, lack of sleep caused more pain, injection site red bump on stomach with itchiness, second dose of moderna caused body ache. The patient was treated with Diclofenac  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   This case was linked to MOD-2022-592782 (Patient Link).
patient warned me she was a fainter/ needle phobic.  After dose she got very dizzy and pale.  Got to the point she was seeing spots and feeling flushed.   Patient laid down on the floor and given cold paper towel for neck. Offered juice/ cookie but the food was declined.  Monitored closely for 5 to 10 minutes.  Patient recovered 10 minutes or so after laying on floor and left with her boyfriend to continue to monitor at home.
A report has been received from a Health Professional via Medical Representative concerning, patients with unknown number and gender, who had been receiving Nasal FLUMIST Quadrivalent (Intranasal), 0.2 Milliliters, Unknown. FLUMIST Quadrivalent (Intranasal) started on an unknown date. The nurse reported that the Doctor was not taking the clip off the FLUMIST when administering to patients. The outcome of the event of Doctor not taking clip off FLUMIST (Half-Dose) is unknown. The report was considered to be non-serious by the company physician.
Fever over 104 degrees, vomiting, body shakes, hallucination, muscle pain
Headache, Myalgia, Fever, NauseaVomiting, Chills Narrative:
This spontaneous report as received from a registered nurse refers to a 15 month old patient of unknown gender. The patient's concurrent conditions, medical history and drug allergies were not reported. On 01-NOV-2016, the patient was vaccinated with improperly stored LIQUID PEDVAXHIB (dose and route not reported) from lot # M025192, expiry date: 21-MAR-2019, for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous temperature excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information is not expected as all follow up information has been received; Sender's Comments: US-009507513-1610USA014705: US-009507513-1610USA014706: US-009507513-1610USA008140:
Received Pfizer booster shot Aug. 19,2021 and suffered an ischemic stroke on Sept. 1, 2021 which resulted in 25-30% permanent vision loss.
administered an expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 1-month-old male patient who received HBV (Engerix B) (batch number 5295P, expiry date 27th December 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 11th January 2023, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On 11th January 2023, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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: 11 JAN 2023 Reporters comment: The reporter reported that the patient received today an expired dose of Engerix B on 11th January 2023 expiry date 27th December 2022. The reporter consented to follow up. Additional supportive information: As patient received the expired vaccine which led to expired vaccine used.
Lethargy, stiffness in limbs, inability to swallow, labored breathing, spitting white foam, lack of appetite. Autopsy Report received on 12/10/2003 states COD was bronchial pneumonia.
A non-serious report of viral infection with wheezing, fever, runny nose and congestion was received from a consumer in the USA concerning a four-year-old female.  This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FluMist.  No medical history was reported.  However, the child received four other vaccines at the time of Flumist administration.  The patient received FluMist on 22Oct2007.  Four days after receiving FluMist and four other vaccines, the child experienced runny nose, congestion, cough, and wheezing with fever.  Per the parent, the pediatrician believes her daughter has a viral infection and is treating the child with nebulizers and steroids.  The symptoms improved but the child still had intermittent episodes of wheezing with fever.  No dechallenge or rechallenge occurred.  The reporter provided no causality assessment for the event.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.
After the first 4 weeks of having the first dose I experienced my first ever seizure out of the country as I was on holiday. Then 4 weeks after my second one I had another seizure.  Ever since they haven't stopped and have continued to get worse.
pt was seen in the doctor's office earlier in the week and diagnosed with pneumonia  (COVID test was negative)before being seen in the ED on 8/27; presented to ED after falling 3x in past 24hrs;  c/o weakness x 1 wk and cough, pt admitted; condition worsened; COPD exacerbation with sepsis due to COVID; pt passed away in the hospital
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Mild
5"x6" swelling on arm with dark center core 2"x2" - hot and tender - location of VARIVAX sub q. administration.
There was no adverse event. The nurse was informed by email that she needed to complete a vaers form because the bud date had expired.  The expriration date in the immunization registry stated unspecified date which is the manufacturers expiration date.  The bud date was 01/03/22.
did not feel too well; feeling quite poorly; nauseous; Had trouble with his temperature; had a bad headache; Was not energetic; did not sleep well; needed to pee a lot; Itching on his face; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (did not feel too well), MALAISE (feeling quite poorly), NAUSEA (nauseous), BODY TEMPERATURE ABNORMAL (Had trouble with his temperature) and HEADACHE (had a bad headache) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced PRURITUS (Itching on his face). On an unknown date, the patient experienced MALAISE (did not feel too well), MALAISE (feeling quite poorly), NAUSEA (nauseous), BODY TEMPERATURE ABNORMAL (Had trouble with his temperature), HEADACHE (had a bad headache), ASTHENIA (Was not energetic), INSOMNIA (did not sleep well) and MICTURITION URGENCY (needed to pee a lot). At the time of the report, MALAISE (did not feel too well), MALAISE (feeling quite poorly), NAUSEA (nauseous), BODY TEMPERATURE ABNORMAL (Had trouble with his temperature), HEADACHE (had a bad headache), ASTHENIA (Was not energetic), INSOMNIA (did not sleep well), MICTURITION URGENCY (needed to pee a lot) and PRURITUS (Itching on his face) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant history was not provided by the reporter , no lab data was reported .   The treatment taken by the patient was ibuprofen.   Reporter did not allow further contact
Pfizer Vaccines: 1/14/2021--Headaches, fatigue; 1/25/2021--Headaches; 12/1/2021(booster); started having unexplained headaches with increase fatigue and balance issues. End of February 2022 diagnosed with Shingles. Beginning in March 2022 noticed frequent headaches, altered gait, unexplained dizzy spells which continued into April 2022.  May 2022 increase dizziness and unsteady gait, fell on right side. June diagnosed with Bell's Palsy.
Patient received 2nd dose on 3/15/22. On 3/31/2022 patient returned to the office with complaints of R should pain and unable to elevate arm. Patient reports she believed this was due to the injection, x-ray obtained at this time that resulted with no acute process Patient had a subsequent appointment on 4/5/2022 with no relief, cortisone injection given at this time. As of today, 4/8/2022 patient reports her pain continues.
After second dose  high fever for 36 hours, sore arm, ringing in ears. Ringing in ears has been persistent. 4 weeks later  had significant hearing loss in right ear.
Friday day of vaccine caused nausea, fever headache until Sunday, then Sunday I had swelling under my left armpit felt like swollen lymph node lasted thru Monday 3/14, then by 3/21 I had red painful bumps and bruises on both leg shine area, by Tuesday 3/22 I went to the er due to pain swelling and more red swollen nodes on my shines which is where I was diagnosed with erythema nodosum.
Immediate loss of consciousness/death at 3 pm on 11/16. No symptoms leading up to event. Husband of patient witnessed the event and said it was immediate. Patient was laying down when event occurred.  Asystolic when checked by EMTs 10 minutes after. Declared dead.
Information has been received from the health professional referring to an unspecified number of patients of unknown demographics. Relevant medical history, concurrent conditions and drug reactions/allergies of these patients were not reported. On unknown dates, these patients were vaccinated with improperly stored (Oka/Merck) VARIVAX (lot # K021936, expiry date: 10-NOV-2016; lot # L001327, expiry date: 13-JAN-2017; lot # L010144, expiry date: 24-MAR-2017). Concomitant medications were not reported. No adverse effects were reported. This is one of the three reports received from the same reporter. Additional information has been requested.
significant area of indentation @ site of inj when seen on 30NOV95;almost fist sized;unk if had any other sx @ time of inj;all fatty tissue involvement, no loss of muscle;
pt fainted x 2, 5min p/vax;amb called but pt refused to to to ER MD called;
This spontaneous report as received from a nurse refers to a patient of unknown age. The patient was vaccinated with PNEUMOVAX 23 on 06-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. On 11-OCT-2012 the patient inadvertently received another dose of PNEUMOVAX 23. Additional information is not expected.
Received vaccine 3/31/03. Reaction onset. 4/2/03 woke middle of night left arm/shoulder in pain. By 4/5/03 all joints in body hurt (legs, back, both arms, etc). Saw physician 4/7/03, prescribed Vioxx.
Large rash formed on Left arm, slightly distal to injection site. Started about 16 hours after 2nd dose of vaccine, expanded/worsened 36-48 hours after second vaccine dose. Non-tender, non-pruritic, blanching rash, similar to a sunburn.
pt recv vax 1OCT98 9AM & c/o itching all over & rash under breast;also c/o onset of diarrhea;advised pt to see MD or go to urgent care;
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Nov-2021 at 4:48 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 16-Nov-2021 at 4:48 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported.   The patient was given dose from vial that were stored in an ultracold freezer which was colder than they should have been. The facility had a temperature excursion for the Moderna COVID-19 vaccine and the patient was administered the vaccine underwent temperature excursion.  Excursion duration was 1 month; on 19-Nov-2021, the vial moved from super cold freezer to the refrigerator; 70 vials were still in the ultra-cold freezer and 8 vials were in the refrigerator; no vaccine state changes were noticed; none of the vials were punctured and no previous temperature excursions.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-402935 (Patient Link).
11 year old patient was given Pediarix; 11 year old patient was given Pediarix instead of Boostrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 11-year-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 4N2PM, expiry date 28-MAR-2025) for prophylaxis.   On 10-MAR-2023, the patient received Pediarix. On 10-MAR-2023, an unknown time after receiving Pediarix, the patient experienced inappropriate age at vaccine administration (Verbatim: 11 year old patient was given Pediarix) and wrong vaccine administered (Verbatim: 11 year old patient was given Pediarix instead of Boostrix). The outcome of the inappropriate age at vaccine administration and wrong vaccine administered 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: 10-MAR-2023 The reporter was a medical assistant. The reporter was consented to follow up. The 11 year old patient was given Pediarix instead of Boostrix which led to inappropriate age at vaccine administration and wrong vaccine administered.
Neurological  Numbness feet hands ,JAW PAIN Dizziness,Weird migraines  ACUTE Weakness  Epstein bar virus flare up Double and blurry vision  ACUTE BACKPAIN
No adverse outcomes. I called guardian letting her know what happened, what to watch for and to present to ED if any of these happen. I made follow up call to guardian and patient was fine with no adverse reactions.
her eyesight got even worse; she felt like very dizzy; This spontaneous case was reported by an other health care professional and describes the occurrence of VISUAL IMPAIRMENT (her eyesight got even worse) and DIZZINESS (she felt like very dizzy) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012F21A, 013M20A and 029L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VISUAL IMPAIRMENT (her eyesight got even worse) and DIZZINESS (she felt like very dizzy). At the time of the report, VISUAL IMPAIRMENT (her eyesight got even worse) and DIZZINESS (she felt like very dizzy) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment drug details were reported. Patient was in contact with an ophthalmologists.   This case was linked to MOD-2021-417751 (Patient Link).
Pfizer-BioNTech COVID-19 Vaccine EUA: pruritic rash at injection site (localized), appeared 10 days after first dose
long COVID symptoms; long COVID symptoms; encephalitis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "long COVID symptoms"; ENCEPHALITIS (medically significant), outcome "unknown". Therapeutic measures were taken as a result of covid-19, encephalitis.  Clinical course: After experiencing long COVID symptoms after the vaccine and some signs of encephalitis, it was Vistaril and decongestants which have changed everything. Benadryl was decent in helping but higher doses of Vistaril changed a lot. Looking at research and with patient background in animal science, the patient think it's blocking the H1 histamine receptor as it's known for. Allowing the body to block virus binding.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
COVID; COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 22Nov2022 as dose 4 (booster), single (Lot number: GH9703) for covid-19 immunisation; BNT162b2 (BNT162B2), on 27Jan2021 as dose 1, single (Lot number: EN6198), on 20Feb2021 as dose 2, single (Lot number: EN6198) and on 15Oct2021 as dose 3 (booster), single (Lot number: 8020FH) for covid-19 immunisation. The patient's relevant medical history included: "Rash" (ongoing). Concomitant medication(s) included: CARVEDILOL, start date: 11Sep2018 (ongoing); LIOTHYRONINE, start date: 01Jan1990 (ongoing); HYDROXYCHLOROQUINE taken for rash, start date: 06Sep2022 (ongoing). The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID". Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid from 09Jun2022 to 15Jun2022.
pt recvd 1st dose of Engerix-B 21AUG92 & 24 hrs later pt exp tongue numbness, postural hypotension, insomnia & diarrhea; no tx was given; events resolved;
Initial information received on 30-Nov-2018 regarding an unsolicited valid non-serious case received from a other health care professional. This case involves a 12 years old male patient who was vaccinated with a 0.5 ml dose of FLUZONE QUADRIVALENT (Batch number: UJ087AA, expiration date: 30-Jun-2019, route: intramuscular and site of administration: right deltoid) on an unknown date. The patient's medical history and concomitant medications were not reported. It was an actual medication error due to incorrect product storage. Shipping delivery delay causing invalid dose of FLUZONE QUADRIVALENT which was administered to 12 year old male. It was unknown whether patient experienced any adverse event following vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.