chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Under-age patient was vacccinated. Patient was discovered to be under the minimum approved age for this vaccine after the injection was given. No signs or symptoms of adverse effect were detected during the 15 minute post-injection observation period.     Our Covid vaccination clinic screens patients for qualifying and disqualifying factors, including age, immediately before they receive a vaccination. Screeners are responsible for this. Patients who pass screening are then sent to a vaccinator.  Vaccinators do not re-screen patients in the course of administering the injection.     This event occurred because a mistake was made during the screening process.
This spontaneous report as received from a nurse practitioner refers to a 53 year old male patient with hypertension and depression and with no drug reactions or allergies. On 27-MAR-2015, the patient was vaccinated with a 0.65 ml dose of ZOSTAVAX (lot # reported as K020186 exp date 27-JAN-2016) subcutaneously. Concomitant therapies included atenolol and CELEXA. The nurse reported that on 28-MAR-2015, the patient experienced a two red circle with minor irritation and itching at the site of injection after being administered with ZOSTAVAX. The patient did not receive treatment for the adverse events. There were no Lab diagnosis or studies performed. On 31-MAR-2015, the patient recovered from the adverse events. Additional information has been requested.
10.5 cm x 10 cm area of induration/cellulitis, warmth. Given 7 d of antibiotics and 3 days steroids.
titers were found to be "low"; This spontaneous report was received from a pharmacist referring to a female patient in late twenties. The patient had never had chicken pox. The patient's concomitant medication and current condition were unknown.  At unspecified times in her youth, the patient had childhood vaccination with 2 doses of varicella virus vaccine live (oka/merck) (VARIVAX) (strength, frequency, route, lot# and expiration date unknown) with sterile diluent (MERCK STERILE DILUENT) (lot# and expiration date unknown) for varicella prevention.  In approximately May 2019 (reported as around time of delivering baby near 8 months ago), the patient was tested was tested for immunity (titers), and titers were found to be "low" (not defined) (antibody test abnormal).  The Pharmacist considered it was suspected that the patient did receive 2 doses of varicella virus vaccine live (oka/merck) (VARIVAX). No follow up titers had been drawn. No other symptoms was reported. The outcome of titers low was reported as recovered.  The causality between suspect therapies and titers low was not reported.
Moderna Bivalent Booster was given to patient but only half dose was given 0.25mcg. Patient was to receive 0.5mcg.
Patient with past medical history of CAD, CKD, sCHF, LGL Leukemia admitted to Hospital on 1/19 with pleural effusion. Pt expired on 2/1/2021. Hs of essential HTN, complete heart block, T2Diabetes,thyroid issues, stroke, papillary CA of thyroid, dyslipidemia, anemia, hypercalcemia, pulmonary nodule, hypoparathyroidism, pacemaker, bilat carotid stenosis, afib, pleural effusion, pancytopenia, cardiomyopathy, severe aortic stenosis, sick sinus syndrome, Dressler syndrome, empyema, ESRD
The patient is a 75-year-old man who was admitted with a change in gait. He received a flu shot approximately 4 to 6 weeks ago. He then began to have progressive ascending neuropathy with paralysis beginning in his feet that was ascending and progressive. He had some pain. He subsequently presented to the emergency department. The patient was noted to have bilateral lower extremity weakness. He was admitted. He subsequently developed almost complete paralysis of his lower extremities bilaterally. He had an extensive work up and evaluation by Infectious Disease and Neurology. Multiple MRI scans and CT scans were performed with results. The lumbar puncture was performed. His CSF protein was markedly elevated at 136 with a glucose of 78. In light of his presenting symptoms in the face of receiving a seasonal influenza shot and CSF results, it was deemed that the patient has a form of Guillain-Barre syndrome. He was subsequently given intravenous immunoglobulin for approximately 5 days and tolerated that relatively well. Fortunately, he had minimal results. He remains essentially paraplegic with minimum movement of his lower extremities. He has had episodic hypertension and sedatives to help him sleep at night, have caused some mild confusion. During the day, he is incredibly lucid and conversive. We have had other issues with hyponatremia, which has markedly improved with a free water restriction. On the day of discharge, the patient is eating. He is only ambulating via wheelchair. He does have issues with constipation, which seemed to be improving with regular scheduled stool softeners, but he is vitally stable, and he is very eager to begin rehabilitation and get back to his normal, usual state of health.
pregnancy; This spontaneous prospective pregnancy case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EXPOSURE DURING PREGNANCY (pregnancy) 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 (No medical history reported).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (pregnancy). The delivery occurred on an unknown date, which was reported as Unknown. For neonate 1, The outcome was reported as Unknown. At the time of the report, EXPOSURE DURING PREGNANCY (pregnancy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.; Sender's Comments: This is a case of product exposure during pregnancy with no associated adverse events for this female patient. Patient will continue to be contacted for further monitoring of adverse events during the pregnancy.
Pt. received vaccines (MMR & Varicella) on 3/6/12. On 3/25/12 was found dead in crib (still waiting for autopsy results).
8 hours after vaccine administration I was awoken with severe chills (the quest on my life). My teeth were chattering and my body was shaking. I put on additional cloths and went back to sleep. An hour later I awoke and was extremely hot. I had 102.9 fever (which was probably the highest fever I ever had). I took most of my clothes off and tried to go back to sleep. By the morning the fever was down to 100. During the next day o slowly got my strength back.
The patient, was thought to be the incorrect name and spelling.  Due to this she received the Adult Pfizer Vaccine instead of the Pediatric Pfizer Vaccine.  This error was identified at store 36 when the patient and her father showed up for a pediatric bivalent booster vaccine.  We asked the father for her COVID card and her insurance information. He stated he didn't have either.  When we added her into the system we searched and generated her information and he admitted she did have insurance.  Once entering the Pediatric Bivalent booster I searched for the patient and could not find her primary pediatric series.  I asked her father again if he had any evidence of her primary series and he then produced her COVID card and it had the incorrect spelling and DOB.  I explained the error to the father and at this point we decided to give her the Pediatric Pfizer booster.  It is unclear if the father purposefully filled the patient's information incorrectly or if this was truly and accident.  The father stated he did not give us the INS information because he heard on the news that it was better if they did not present the INS information.
After vaccine forearm began to swell, egg shaped raised skin, warm to the touch and redness. Swelling measurements are 7in in length and 5 inches wide. Continuing to swell outside these dimensions.
On 2/9/21 09:30 headache, at 1800 chills, at 1900 body aches, extreme fatique, at 21:00 fever, at 01:30 T-101.5. 2/10 7am to 2pm symptoms continue, add migraine.  On 2/11/21 symptoms subsided, but developed fever blister.  All symptoms resolved by 2/13/21.  Took Tylenol with relief and rested.
Extreme injection site soreness; Low grade fever; Body aches; Fatigue; This is a spontaneous report from a non-contactable consumer (patient). A 46-year-old male patient received BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration, administered in the left arm on 25Feb2021 at 10:00 (Lot Number: EL3247) as dose 2, single for COVID-19 immunization.  Medical history included high BP on an unknown date. The patient had no known allergies. The patient did not have COVID prior to vaccination. Concomitant medication included amlodipine besilate (NORVASC) taken for an unspecified indication, start and stop date were not reported.  The patient previously received the first dose of BNT162B2 on 04Feb2021 at 10:00 (lot number: EL3247) on the left arm for COVID-19 immunization (at 46-years-old). The patient was not tested for COVID post vaccination. On 25Feb2021 at 22:00, the patient experienced extreme injection site soreness, low grade fever, body aches and fatigue. The patient did not receive treatment for the events. The events recovered on Feb2021.   No follow-up attempts are possible. No further information is expected.
feels like getting Covid-19 infection; chills; Severe body aches/muscle pains; fatigue; headache; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (feels like getting Covid-19 infection), CHILLS (chills), MYALGIA (Severe body aches/muscle pains), FATIGUE (fatigue) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in December 2020. Concomitant products included FAMOTIDINE, IBUPROFEN (DUEXIS) for an unknown indication.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced COVID-19 (feels like getting Covid-19 infection), CHILLS (chills), MYALGIA (Severe body aches/muscle pains), FATIGUE (fatigue) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 24-Mar-2021, COVID-19 (feels like getting Covid-19 infection), CHILLS (chills), MYALGIA (Severe body aches/muscle pains), FATIGUE (fatigue) and HEADACHE (headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
From phone contact received at manufacturer on 8/21/02, it was reported that an 18 y.o. male received Menomune A/C/Y/W-135 on 8/16/02. On 8/18/02, the PT developed chills, fever of 103 deg F, headaches, body aches, vomiting, and loss of appetite. The PT was seen by an MD on 8/21/02. The Sx's were unresolved at that time.
Date of 1st dose 2May2021 patient has not received 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Date of 1st dose 2May2021 patient has not received 2nd dose) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 02-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-May-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Date of 1st dose 2May2021 patient has not received 2nd dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Date of 1st dose 2May2021 patient has not received 2nd dose) 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 product : Herbs
Presented with enlarged lymph nodes which began 3 days following vaccination with Pfizer booster. Patient also had swelling under left arm which was painful, along with a low grade fever after injection. Noted a more prominent right breast, with a lump in that breast.
Fever chills, fever, swelling and soreness to injection site Narrative:  States that she had first vaccine on 12/28/20. On day 2 (12/29) she  states that she noticed soreness and swelling to injection site, chills, and fever. On day 3 (12/30), states resolution of symptoms. No further report of symptoms at this time.
Aseptic meningitis. Hospitalized x 5 d. 12/21/09 Hosp records received for date 9/30/09 to 10/5/09. DX: viral syndrome. Pt c/o HA, pain in knees and feet, chills beginning 9/26/09. Fever on 9/27/09. HA worsening thereafter and vomited. Pt admitted through ER. Assessment: tonsils mod enlarged, (+)neck tenderness. At time of dc sx resolved. 1/4/2010 DC summary for 9/30-10/5/2009, DC Dx Viral syndrome.
This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/ allergies and concomitant therapies were not reported. In July 2016, the patient was vaccinated with the first dose of GARDASIL Lot number: M014929 (expiration date, strength, dose, frequency and route of administration were not reported) for prophylaxis. A year later, in July 2016, the second dose of GARDASIL was administered to the patient, Lot number: K010215 (expiration date, strength, dose, frequency and route of administration were not reported) for prophylaxis. Also, the nurse stated that the patient did complete the third dose with GARDASIL 9 (lot number, expiration date, strength, dose, frequency nd route of administratio were not reported). In September 2016. No adverse effects were reported. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
After felt uneasy after 5 min of getting shots. Feel nauseated and complained for uneasiness. Asked to call 911, medical responder came and spoke to him. After 15-20 min patient walked out of the pharmacy.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2014, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. In 2016, the patient was treated by a physician for a blistering vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
ADMINISTRATION OF JANSSEN COVID 19 VACCINE THAT EXPIRED BY TWO DAYS; This spontaneous report received from a health care professional concerned a 56 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A, and expiry: 14-DEC-2021) dose was not reported, administered on 16-DEC-2021 for prophylactic vaccination. No concomitant medications were reported.  On 16-DEC-2021, the patient experienced administration of janssen covid 19 vaccine that expired by two days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of janssen covid 19 vaccine that expired by two days was not reported. This report was non-serious. This case, from the same reporter is linked to 20211240774.
No adverse event; Patient received her first dose of Moderna Covid-19 vaccine on 06-Jan-2022 and would like to receive her second dose of the Moderna Covid-19 vaccine on 19-Jan-2023; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (Patient received her first dose of Moderna Covid-19 vaccine on 06-Jan-2022 and would like to receive her second dose of the Moderna Covid-19 vaccine on 19-Jan-2023) and NO ADVERSE EVENT (No adverse event) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Jan-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (Patient received her first dose of Moderna Covid-19 vaccine on 06-Jan-2022 and would like to receive her second dose of the Moderna Covid-19 vaccine on 19-Jan-2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (Patient received her first dose of Moderna Covid-19 vaccine on 06-Jan-2022 and would like to receive her second dose of the Moderna Covid-19 vaccine on 19-Jan-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTRATION INTERRUPTED (Patient received her first dose of Moderna Covid-19 vaccine on 06-Jan-2022 and would like to receive her second dose of the Moderna Covid-19 vaccine on 19-Jan-2023).    No concomitant medication information was provided.  It was reported that patient received her first dose of Moderna Covid-19 vaccine on 06-Jan-2022 and would like to receive her second dose of the Moderna Covid-19 vaccine on 19-Jan-2023. No lot number is known by the Pharmacist as the patient received this vaccine in another pharmacy. No adverse reactions to the first dose are known of.  No treatment medications were provided.
fainting from sitting position preceded by dizziness and nausea. Returned to lying down and did not reoccur
Woke up the morning after my second injection feeling slightly ill, maybe 75% of what I normally feel like.  Did a two mile walk instead of my 4 mile run and continued the day as usual although somewhat subdued.  I did have chills off and on all day and a temperature of 99.2 which is high for me.  Went to bed and slept 11 hours and I am back to 100% this morning.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Feb-2021 at 2:54 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 14-Feb-2021 at 2:54 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 84.89 years.  No concomitant product use was reported.  It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  On 14-Feb-2021, Excursion temperature at 09 AM was 32, at 10 AM was temperature 32 , at 11 AM was temperature 32, at 02 PM was temperature 35, at 03 PM was temperature 35,total doses given for the day was 162 condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 09-Feb-2021, vial was moved to clinic on 13-Jan-2021. 30 vials were moved to clinic. Vaccine BUD date was 10-Mar-2021.  Temperature recordings were taken by using a traceable temperature monitor at every hour.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  No treatment information was provided.   This case was linked to MOD-2022-566976 (Patient Link).
Stiff arm; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231), via an unspecified route of administration in the right arm on 26Jan2021 08:30 at a single dose for COVID-19 immunisation. The patient's medical history included hyperactive thyroid, psoriasis, and prostate disorder. Concomitant medications included methimazole (tablet) for hyperactive thyroid, apremilast (OTEZLA, tablet, lot number: 1121523) for psoriasis, and tamsulosin (capsule, lot number: KP7571, expiration date: Apr2022) for his prostate to help him urinate. The patient experienced stiff arm on 27Jan2021. Day 4 after he had the first dose of the vaccine, he has had no side effects. He wants to double check his medications since he is taking three different medications. He wants to check his meds so he will not have adverse effects on the vaccine's ability to work for him. Outcome of the event was unknown.
This is a historical event per patient. Pt states she recieved Hep B vaccine (Manufacturer: Glaxosmithkline, Lot: 4T4GJ) in R Deltoid and numbness, paresthesia, and weakness occured immediately in R side of face and RUE. Traveled to L side of face only within 2 minutes. Pt states she informed primary care of event as it was happening and it resolved within 45 minutes.
pt recvd vax 18JAN95 & exp scarlet fever w/(sand paper-like) rash;18JAN95 had pharyngitis presumed to be strep-no culture was done;23JAN95 exp hundreds of edematous,pruritic,papulo-vesicles;dx papular acrodermatitis of gianotti-crosti;
Sore arm started about 6 hours after the vaccination and lasting about 24 hours. Fever, chills,  severe body aches, severe headache lasting about 9 hours starting at midnight following the vaccination.