chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The vaccine was opened today and had has been in the fridge unpunctured.; an expired dose of the Moderna COVID-19 vaccine was administered; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (an expired dose of the Moderna COVID-19 vaccine was administered) and PRODUCT STORAGE ERROR (The vaccine was opened today and had has been in the fridge unpunctured.) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 058A22-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jul-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (an expired dose of the Moderna COVID-19 vaccine was administered). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vaccine was opened today and had has been in the fridge unpunctured.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (an expired dose of the Moderna COVID-19 vaccine was administered) and PRODUCT STORAGE ERROR (The vaccine was opened today and had has been in the fridge unpunctured.) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. The number of doses per vial was1 dose from 1 vial administered. Vial was open today and it was brand new. The vial was initially stored in the refrigerator on 24 May 2022 The vial did not undergo any temperature excursions. No treatment reported
Hospitalized 01/19/2022-still currently admitted; COVID-19 positive 01/19/2022; fully vaccinated plus booster  ASSESSMENT / PLAN: COVID Acute hypoxic respiratory failure secondary to above              COVID positive 1/19              Asymptomatic; per facility have not noted any symptoms either              CT thorax does not show findings of COVID              Decadron 6mg daily              Remdesivir contraindicated due to renal function              Supplemental O2 PRN; currently on 3L, wean as able Admitted with COVID-19 pneumonia and acute hypoxic respiratory failure.  On 3 L by nasal cannula.  Started on Decadron.  Unlikely to benefit from Remdesivir.  Wean off O2 as able.  CT thorax does not show findings of COVID however the patient is wheezing and hypoxic.  He also has right lower extremity cellulitis and nonhealing 2nd toe amputation.  Had a recent angioplasty of the right lower extremity with vascular surgery.  Will start the patient on vancomycin and Zosyn. Heparin drip in place of Xarelto for now. MRI to rule out osteomyelitis.  Vascular surgery consult.  Consider podiatry consult pending MRI findings.  The patient also has acute encephalopathy likely toxic metabolic in the setting of cellulitis and COVID.  Monitor for now.  Patient has acute on chronic anemia.   01/23/22 notes: COVID pnuemonia. Acute hypoxic respiratory failure secondary to above -resolved              COVID positive 1/19              Asymptomatic; per facility have not noted any symptoms either              CT thorax does not show findings of COVID              on room air now. Will stop decadron in case that is causing agitation.   01/31/2022 notes: Acute hypoxic respiratory failure resolved COVID-19 pneumonia resolved Currently on room air  Disposition:  awaiting placement to skilled nursing facility
Suspected vaccination failure/Gave my children flu vaccine, let them deal with it; Gave my children flu vaccine, let them deal with it; Get sick and worse; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in an unspecified number of patients who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received Flu vaccine. On an unknown date, unknown after receiving Flu vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), influenza and sickness. The patient was treated with vitamins nos (Vitamins). On an unknown date, the outcome of the vaccination failure, influenza and sickness were unknown.   The reporter considered the vaccination failure, influenza and sickness to be possibly related to Flu vaccine.     Additional Information: GSK receipt date: 5-Jan-2023 Reporter's comment: The case was received from the patient's parent via interactive digital media. The reporter reported that he/she gave his/her female children flu vaccine before, but they still get sick and worse, so he/she stopped them. The reporter stated that let them deal with it but giving them healthy foods and plenty of water and giving vitamins. The reporter think that the event might have been related to the Product/Device. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of influenza were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Patient presented with acute onset of hypotension diaphoresis and altered mental status that was acute in onset.  Also reports diffuse abdominal cramping and multiple episodes of diarrhea.
Pt reports that he woke up Saturday morning after the flu shot w/severe dizziness and nausea that lasted the entire day. He then woke up Sunday am w/ mild Flu like Symptoms that lasted the entire day. As of Monday 9/21/2020 he is feeling at baseline. Patient is very concerned about severe dizziness.
Information has been received from a registered nurse via a company representative referring to an 80 year old male patient. Information regarding concomitant medication, medical history and drug reactions/allergies was unknown. On an unknown date (reported as "a few years ago"), the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration date, dose and route were not reported). On an unknown date, the patient was diagnosed with shingles. The patient contacted the nurse seeking medical attention. Treatment was given for the event and the patient recovered on an unknown date. The causality between the event and ZOSTAVAX was not reported. Additional information has been requested.
This spontaneous report as received from a physician (the patient's mother) via company representative refers to her daughter 13 year old female patient. In approximately 2008, when the patient was 13 years old the patient was vaccinated with a dose of GARDASIL (dose, lot# and expiration date were not reported). There was no concomitant medication reported. The physician stated that her daughter had a reaction to the GARDASIL, physician explained that after the vaccination, her daughter was dizzy and had to lay down in the car. The outcome of dizziness was reported as recovered/resolved on an unspecified date. Additional information is not expected since there is not permission to contact the physician.
At 1005 Patient, a 56 yo Male was sitting in a 15 minute observation after receiving a first dose Pfizer (Lot EP7534 Expiring  07/31/2021) five minutes prior. Patient  reported feeling lightheaded and feeling a "heart warmth".  Client reported past medical history of Neuropathy, Mechanical mitral valve replacement, aortic valve repair, hyperlipidemia, coronary artery disease,  hypertension, DMII, dyspnea, obesity, depression and pulmonary hypertension. Client denied any allergies to medication, food or seasonal allergies. Client stated he last ate at 1030pm on 3/14/2021. Denied having any food,  drink  or diabetic medication this morning. Client rated the severity of heart warmth as a 2/10. Client stated warmth in his heart was similar to the sensation he had when doing a heart stress test. Client denied chest pain, shortness or breath, blurry vision, dizziness, headache, nausea, vomiting, diarrhea, recent illness or lifestyle changes. At 1018am client had water and ate a fruit bar he had. At 1022am client stated the warm sensation had diminished and he felt better after eating and drinking. Client denied dizziness, blurry vision and chest pain. Site offered to call 911 to have an ALS assessment. Client declined further evaluation and care. At 1045am Client was able to ambulate without assistance and had a steady gait as he left the observation site.
10cm reaction on upper/outer arm; area is red, swollen, & warm to touch; pt stated area was not painful;
Information has been received from an article on the internet, from a consumer concerning her daughter who on an unspecified date was vaccinated with a dose of GARDASIL. The mother stated that her daughter was always healthy before the vaccination and was so ill now. This is one of several cases from the same source. Attempts to verify the existence of an identifiable patient have been unsuccessful.
One week after dose 1 of the Moderna COVID-19 vaccine, area around injection site has become red, splotchy and hot to the touch. A little soreness when touched.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 65-year-old female patient received BNT162b2 (BNT162B2), on 31May2021 as dose 1, single (Lot number: EL9264), in left arm, on 30Jun2021 as dose 2, single (Lot number: EN6202), in left arm and on 06Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Early COPD" (unspecified if ongoing); "Osteoporosis" (unspecified if ongoing); "Failure to empty bladder" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Codeine, reaction(s): "known allergies Codeine", notes: known allergies Codeine. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Course: Patient also reported as after completion of Paxlovid treatment from 01Jun2022 to 05Jun2022 which was very successful, and after feeling fully recovered with no continuing symptoms other than lower energy level.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient has described soreness, pain, and stiffness in injection site and deltoid muscle since the vaccination, which was on 9/10/17. It has almost been three months since the vaccination and he says it was right after the vaccine that he felt this. He has stated that it is getting better lately.
Swollen, painful lymph nodes in left side of neck and left occipital node stolen to marble- grape size. Extremely painful to the touch. Several smaller lumps spread over left side of scalp.  Radiating, sharp/burning nerve pain over left side of scalp.
Tried Multiple times to report this.  since 1 day after vaccine i started feeling short of breath and for several weeks suffered multiple asthm attacks and at one point i was hospitalized for a week my lungs have been partially collapsed and have had pneumoni in both lungs later this month i will start seeing pulmonolgist. I cannot walk long distances without becoming short of breath now. I have a detailed timeline of the events that have happened since the vaccine. I have tried multiple times to report this online and kept getting errored out and have left a few messages with the VAERS phone number no call back. I pray this goes through nd that someone ccontacts me
No additional AE reported; A HCP called to report that an expired dose of VARIVAX was administered to a patient on 12/6/2019. No adverse effects were reported. No additional information was provided to further clarify any details. No additional AE reported. No PQC.; This spontaneous report was received from a nurse and refers to a 12-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 06-DEC-2019, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 ml/once, lot number N034558, expiration date: 05-DEC-2019, administered for prophylaxis (strength, and route of administration were not provided) (expired product administered). No additional adverse event was reported (no adverse event).
Initial report was received on 18 July 2012 from the Investigator participating in the post-marketing observational surveillance study under the reference number M5A16. A case of pertussis disease in a 4-year-old male subject was identified by the investigator based on review of data from the Electronic Disease Surveillance System (EDSS) database. The subject had received 3 doses of TRIPEDIA: lot number U2289CA on 21 August 2007, lot number U2291BA on 20 November 2007, lot number U2291BA on 22 January 2008 and a dose of DAPTACEL, lot number C2953AA, on 29 September 2008 (route and site of administration not reported). The subject developed catarrhal illness on 12 May 2012, nearly 4 years after the last dose. On 14 May 2012, the subject developed a paroxysmal cough (without whoop). The subject also experienced posttusive vomiting. Laboratory testing included positive PCR on 17 May 2012. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of azithromycin starting on 17 May 2012 for five days. The subject was not hospitalized. At the time of final contact on 04 June 2012, the subject's cough was still persisting. The duration of the cough reported at that time was 23 days. According to the investigator, this case was epidemiologically linked to a laboratory confirmed case. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Urinary tract infection; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (Urinary tract infection) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 012L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Jan-2021, the patient experienced URINARY TRACT INFECTION (Urinary tract infection). At the time of the report, URINARY TRACT INFECTION (Urinary tract infection) outcome was unknown.        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.   Concomitant medications were not reported. No treatment information was provided.  Company Comment: This case concerns a 69-year-old female who experienced NS unexpected event of urinary tract infection.  Event onset occurred the same day as the first dose of mRNA-1273. Treatment not reported. Event outcome unknown. Based on 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.; Reporter's Comments: This case concerns a 69-year-old female who experienced NS unexpected event of urinary tract infection.  Event onset occurred the same day as the first dose of mRNA-1273. Treatment not reported. Event outcome unknown. Based on 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.
I have had no adverse effects from the Moderna Covid Vaccine.  The reason I am using this form of reporting is that I have not been able to use the every day or every week online text  reporting system since the link sent to me by text does not work.. I have tried typing it in manually and it does not work that way either.  I just wanted to report that there were no adverse effects so that you would have some sort of feedback from me.  Thank you.
Received Varicella vaccine at approximately 11 AM on 11/01/2006.  At 6:30 PM, complained of chills, muscle aching of the arms and legs, and abdominal cramps. Diaphoretic, vomited twice.  No diarrhea. Was sick throughout night. Did not go to school today, feeling weak but "better".
After 48 hrs.  Sleepy. 4 hours of cold shakes and sweating. Next day 99.3 f fever and headaches.
57-year-old female who lives in an assisted living/skilled nursing facility, from where she was transferred to the hospital because of suspected stroke.  Subsequently, the patient was undergoing workup and result for COVID-19 test came back positive. The patient denies cough, fever, chills. Denied any history of cough, fever, chills, or shortness of breath.  She is a known diabetic and kidney failure.  The patient suffers from morbid obesity also, and has gait and mobility disorder.  The patient has a history of acute onset dysphagia and mental status changes. Tested positive for COVID on 5/16/2021.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 49-year-old female patient who received SHINGRIX (batch number 5Z5LX, expiry date 30th October 2020). Concomitant products included CENTRUM MVI and Vitamin B Supplements. On 13th December 2017, the patient received the 1st dose of SHINGRIX (intramuscular). On 14th December 2017, 1 days after receiving SHINGRIX, the patient experienced injection site pain, shivering, weakness generalized, cough nonproductive, lymphadenitis cervical, nausea and malaise. On an unknown date, the outcome of the injection site pain, shivering, weakness generalized, cough nonproductive, lymphadenitis cervical, nausea and malaise were not recovered/not resolved. The reporter considered the injection site pain, shivering, weakness generalized, cough nonproductive, lymphadenitis cervical, nausea and malaise to be probably related to SHINGRIX. Additional details were provided as follows: The patient reported for herself. The patient received CENTRUM and Vitamin B supplements. The patient felt like she had been 'run over by a truck' and was 'sick as a dog'. When the patient woke up to go to work, she experienced uncontrollable shivering, malaise, general weakness, soreness at injection site, inflamed cervical lymph nodes on the left side, nausea and non-productive cough. The patient described that the shivering 'comes and goes'. The patient had denied permission to contact their physician.
After my 3rd dose  of  the Moderna COVID-19 vaccine. My adverse event started on 12/12/2021. The Lymph nodes  on the right side was more swollen than the left.  I couldn't sleep at night. My left side of my armpit was swollen, and  painful.  I am not taking any medications at all.   I had a regular mammogram at my doctors office as well as an Ultra Sound   On 10/10/2022  my doctor  told me that both of my armpits were swollen  according to the Ultra Sound but I feel pain more on the left side of my armpit. The pain comes and goes.
Information has been received from a 76 year old female with no pertinent medical history or drug allergies, who on 15-OCT-2007 was vaccinated with a single dose of zoster vaccine live (Oka/Merck) (lot number unknown). Concomitant drug therapy included Advair, Zyrtec and Levothroid. On that same night the patient developed extreme inflammation covering a large portion on her left arm and left arm also itched. No medical attention was sought. No labs or diagnostic studies were performed. The patient was not recovered. There was no product quality complaint. No further information is available.
A nurse reported the occurrence of an injection site reaction in a 4 year old male who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed for prophylaxis. The vaccine provider submitted this report directly to VAERS.  The subject had no known allergies, adverse experiences following receipt of previous immunizations, concurrent conditions, or concurrent medications. The subject received his fifth injection of Infanrix on 31Mar2003 into his right arm. He also received injections of inactivated poliomyelitis virus vaccine and measles, mumps and rubella virus vaccine into his left arm. On 01APR2003, the subject presented to the local emergency room with redness and swelling of his entire right arm. The emergency room physician made a diagnosis of cellulitis and prescribed an unspecified antibiotic. On 02APRIL2003, the subject was seen by the vaccine provider, who thought the events represented "just a local reaction to the vaccine." The vaccine provider discontinued antibiotic therapy. The events resolved.
swelling about 10 centimeters wide around the injection site.; redness; rash; This case was reported by a physician via sales rep and described the occurrence of extensive swelling of vaccinated limb in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2020, the patient received the 2nd dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb, injection site erythema and injection site rash. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site erythema and injection site rash were unknown.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site erythema and injection site rash to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix and experienced swelling, redness and a rash about 10 centimeters wide around the injection site. No hives or facial, lip or other swelling nor other systemic.
Had a retinal check in December 2020 no changes stable. Retinal changes in eyes after vaccination