chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Covid symptoms; after second vaccine patient had fever for about a week; This spontaneous case was reported by a consumer and describes the occurrence of SUSPECTED COVID-19 (Covid symptoms) and PYREXIA (after second vaccine patient had fever for about a week) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037A21B and 010A21A) for COVID-19 vaccination.     The patient's past medical history included Bullous disorder and Acid reflux (esophageal). Concurrent medical conditions included COPD and Emphysema. Concomitant products included ALBUTEROL [SALBUTAMOL] for an unknown indication.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SUSPECTED COVID-19 (Covid symptoms) and PYREXIA (after second vaccine patient had fever for about a week). At the time of the report, SUSPECTED COVID-19 (Covid symptoms) outcome was unknown and PYREXIA (after second vaccine patient had fever for about a week) had resolved.            Concomitant medication also include trilogy once daily. Treatment includes antibiotics and steroid pack Patient also had both lungs altered, a third of each was taken out. Patient stated that her doctor said to her that she had the same Covid symptoms as the doctor had, when the doctor had Covid. The patient had two Covid tests done on 06June2021.  Patient stated results were that she had no antibodies.; Sender's Comments: This case concerns a female patient with relevant medical history of COPD, Emphysema, Bullous disorder and Acid reflux (esophageal)., who experienced the unexpected event of suspected COVID 19 and expected event of pyrexia. The event of suspected COVID 19 occurred on an unknown date while pyrexia occurred after the second dose of Moderna COVID-19 Vaccine. Patient stated that her doctor said to her that she had the same Covid symptoms as the doctor had, when the doctor had Covid. The patient had two Covid tests done and results were that she had no antibodies. The rechallenge was not applicable. Based on the current available information, the mRNA-1273 does not contain a virus capable of causing COVID-19 infection after vaccination. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.
little bit of pain in the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (little bit of pain in the arm) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 013A21A) for COVID-19 vaccination.     Concurrent medical conditions included Cancer and Immunodeficiency.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (little bit of pain in the arm). At the time of the report, PAIN IN EXTREMITY (little bit of pain in the arm) outcome was unknown.            Concomitant medications were not provided. Treatment information was not provided.   This case was linked to MOD-2021-403258 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 30-Nov-2021: Non-Significant Follow up-Document attached
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about concomitant medications and pertinent medical history reported. On 16-JUL-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck) (dose, route, site, lot# and expiry date were not reported). No adverse effect was reported. Additional information has been requested.
While the vaccine was being administered the needle fell off the syringe with needle still in the patient's arm.  Person giving the vaccine didn't feel the patient received any of the vaccine.
patient was administered the TDAP vaccine in the early weeks of her pregnancy with no adverse event; Initial information was received on 16-Feb-2023 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 29 years old female patient who was exposed to vaccine DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE in context of patient was administered the tdap vaccine in the early weeks of her pregnancy with no adverse event.   Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known.   The reported patient was administered the TDAP vaccine in the early weeks of her pregnancy with no adverse event occurred at unknown gestation period the gestation period at onset and gestation period at exposure data needs to be populated, if available  The date of last menstrual period was not reported. The estimated due date was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had unknown previous pregnancy/ies.    On 19-Aug-2022, the patient received a  dose of suspect DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE produced by unknown manufacturer (dose, formulation, strength, and expiry date: unknown) via unknown route in unknown administration site for prophylactic vaccination (Immunisation).  On 19-AUG-2022 the patient developed a non-serious patient was administered the tdap vaccine in the early weeks of her pregnancy with no adverse event (exposure during pregnancy) (latency same day).  it was reported " Pharmacist mentioned that the patient may have been in the early weeks of gestation back in 19Aug2022 when she received a dose of the TDAP, and wonder would that be harmful to the patient or fetus? Patient has not received the vaccine yet. She states the patient's OBGYN sent in a prescription for a TDAP vaccine. Patient received a dose of TDAP back on 19Aug2022 and may or may not have been in the early weeks of her pregnancy".   Relevant prenatal testing after exposure included   Action taken with DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE) was not applicable.  At time of reporting, the outcome was Unknown for the event patient was administered the tdap vaccine in the early weeks of her pregnancy with no adverse event.  Additionally, at time of reporting, the outcome of the pregnancy is unknown.
right shoulder severe tendonitis, limited mobility and severe pain starting 2 days after vaccine given in same arm
This spontaneous report as received from a registered nurse refers to a 14 month old male patient with ano history of drug reactions or allergies. On 12-MAY-2011, the patient was vaccinated with MMR II (lot # 669200/1346Z, exp date: 13-OCT-2012)(0.5ml, subcutaneously in the right arm, dose and frequency unknown). Other suspect vaccines administered to the patient on the same day (12-OCT-2011) included (Oka/Merck) VARIVAX (lot # exp date: unknown)(strength, dose, frequency and route of administration: unknown, in left arm also reported as "in a separate arm" (than MMR) and HAVRIX. No concomitant medication was reported.  On 12-MAY-2011 also reported as "that night" the patient's mother went to change his diaper and noted the patient's  scrotum area was red and swollen. The reporter stated that the patient was prescribed loratadine (manufacturer unknown) (syrup) on 12-MAY-2011. The reporter was not sure if the patient's mother gave him loratadine (manufacturer unknown) (syrup). The patient's mother sought medical attention on 12-MAY-2011 via the telephone and she ws informed by the "on-call" physician to administer BENADRYL to the patient. . No lab diagnostics studies were performed. The outcome of "the patient's scrotum area was red and swollen" was reported as recovered/resolved on 13-MAY-2011. Relatedness between "the patient's scrotum area was red and swollen" and MMR II, (Oka/Merck) VARIVAX and HAVRIX was not reported. Additional information has been requested.
Whelps on left arm, left eye was swollen.  1 Benadryl for treatment.
Hives all over body, head to toe. Currently 5 weeks from the start of the hives.  Hives are not gone as of yet.  Steroid shot was given 3/15/22, only helped for 2 days. Currently on oral prednisone 10mg 2 a day for 5 days then stepping down from there. Also, loratadine 10mg 4 a day and famotidine 20 mg 2 a day.
Severe swelling to left arm. Went to personal MD, prescribed BENADRYL and topical cortisone cream. Improved by 5/2/12.
pt suddenly broke out in hives approx 8-10hr p/vax; temp was 102 ear;pt had high pitched cry 15-20min;phone call to ER felt may be allerg rxn; aunt called 911 seen in ER T100.8 no other signs pt release T99 that noc;
Adv eff bact vac NEC/NOS on 2014-04-01.
17 year old patient received a dose of Flublok Quadrivalent, no AE; Initial information received on 24-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to cases 2019SA304586, 2019SA304587, 2019SA304588, 2019SA304589, 2019SA304590, 2019SA304591 and 2019SA304580 (same reporter).  This case involves 17-year-old patient (gender not reported) who received a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV](lot-QFAA1938 and Exp-30Jun2020) on an unknown date (reported as multiple patient's received a dose of FLUBLOK on 01-Oct-2019, 02-Oct-2019 and 03-Oct-2019 at the immunization fair).  Medical history, medical treatments, vaccinations and family history were not provided.  It was an actual medication error due to Inappropriate age at vaccine administration.  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.
Pt. had fever in evening after immunization given, and was given Ibuprofen. Pt. no longer has fever. Pt. also has local redness at injection site. L. thigh: 10x8, R. thigh 3x3 cm. Advised ice and antihistamines. Informed to f/u w/any more fever.
p/vax pt exp h/a; sore throat, low grade; lt arm erythema; very warm; firm @inj site; red; itchy patch; approx 16x12cm min tenderness; joint pain to include elbow; shoulder; wrist; fingers of lt arm, moderate w/movement;
SWELLING, HARD KNOT, AND ITCHING ABOUT 5 INCHES IN DIAMETER.  ALSO, TEMPERATURE UP TO 102 DEGREES WITH CHILLS.
Patient received vaccine while breastfeeding 2 month old infant. Patient had no adverse reactions. Infant one week after first injection began showing blood in stool. Initially blood was believed to be an allergen received in breastmilk but infant later tested for elevated CRP with symptoms of colitis and possible early onset IBD. Further diagnoses and treatment plan still being evaluated.
Vial was unlabeled. In the future I will check for label before administration. Patient was notified and declined to return return for repeat dose.
Pt symptomatic with "fevers, cough, SOB, HA and Body Aches" with possible occupational exposure on 07/27.2021 and tested positive for Covid on 08/06/2021 with anterior nares swab.
has not received the second dose yet; This case was reported by a consumer and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on December 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The reporter was the patient. The age at vaccination was not applicable for this report. The reporter stated that, till the time of reporting, the patient did not receive 2nd dose of shingrix, which led to incomplete course of vaccination. The reporter declined to provide his date of birth or health care professional information. The reporter did not consent to follow up.
Report 20010039191 describes an upper respiratory infection in a 53 year old female who received hepatitis B vaccine (brand name unknown). This report was received from the pt and has not been verified by a physician or other health care professional. Medical history included yeast infections. Concurrent medical conditions and medications were not provided. The pt received her first injection of hepatitis B vaccine (brand name unknown) on 01/11/2001 at her place of employment. She had no adverse experience following receipt of this injection. The pt received her second injection of hepatitis B vaccine (brand name unknown) on 02/08/2001 at her place of employment. The pt stated that she "was fighting a cold" at the time of immunization. Later on 02/08/2001, she "got sicker." She experienced flu-like symptoms and stated that she had an "upper respiratory infection." The pt did not seek medical attention. Her symptoms persisted as of 02/13/2001.
Nerve pain in her mouth and teeth; This case was reported by a consumer via call center representative and described the occurrence of nerve pain in a 88-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th August 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In September 2020, between 1 and 2 weeks after receiving Shingrix, the patient experienced nerve pain. On an unknown date, the outcome of the nerve pain was not recovered/not resolved.   The reporter considered the nerve pain to be unrelated to Shingrix.  Additional details were provided as follows: The reporter stated that her mother received her first dose of Shingrix in right arm. The reporter stated that 1.5 to 2 weeks later the patient developed nerve pain in her mouth and teeth.  The patient had gone to the physician about this pain, and the physician stated it was not related to the Shingrix vaccine. The reporter stated that the pain had decreased, but still had not resolved. The reporter did not consent to follow up.
Blurred vision; fatigue, dizziness, headaches; fatigue, dizziness, headaches; fatigue, dizziness, headaches; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (Blurred vision), DIZZINESS (fatigue, dizziness, headaches), FATIGUE (fatigue, dizziness, headaches) and HEADACHE (fatigue, dizziness, headaches) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included High cholesterol since an unknown date. Concomitant products included IBUPROFEN for an unknown indication.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, the patient experienced VISION BLURRED (Blurred vision), DIZZINESS (fatigue, dizziness, headaches), FATIGUE (fatigue, dizziness, headaches) and HEADACHE (fatigue, dizziness, headaches). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VISION BLURRED (Blurred vision), DIZZINESS (fatigue, dizziness, headaches), FATIGUE (fatigue, dizziness, headaches) and HEADACHE (fatigue, dizziness, headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment medications included Acetaminophen.  Concomitant medications included an unknown cholesterol medication.
Covid monitoring documentation. PT admitted 1/6/22 documented to have positive covid. PT received Pfizer 2/4/21 Lot EL1284 for dose 1. Dose 2 was Pfizer given on 3/4/21 Lot EL1685. PT received Pfizer Booster on 11/17/21 Lot FH8020.
No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manager and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 10-AUG-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 1 injection, lot # 1621929, expiration date: 06-DEC-2021 (injection site, route of administration were not provided) for prophylaxis.  On 04-AUG-2020, the administered dose experienced a temperature excursion of below 2 degrees Celsius (C) (1.1 C) for 27 hours and 45 minutes and above 9 degrees Celsius (9 C) for 1 hour and 15 minutes. The digital data logger was involved. No previous temperature excursion had occurred. No further adverse events (AE) were reported.  This is one of multiple reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: 1621929; expirationdate: 06-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other;  followupadditionalinfo :Yes; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:
Patient called to report that sense of smell has not returned since receiving the 2nd dose of COVID-19 vaccination. Patient had COVID on Dec 10th 2021 and never loss sense of smell or taste at that time.  Patient tests weekly for job and is negative every time. Patient is following up with PMD at this time.
Stroke?? Full Week in the hospital in two weeks at In patient Rehabilitation Hospital.   Outpatient hospital now definitely!
Hives to left arm approximately 1 hr. after vaccine administration to left arm. BENADRYL 25 mg PO x 1 with resolution of symptoms.
A Fib event and had to go to the emergency room and stayed over night. They gave me new medicines.
Fever 102.5 with diffuse erythematous rash day after vaccine given.
Expiration date was 26FEB2023 and date the vial was initially stored in the refrigerator on 14MAR2023; No adverse event; She had expired vaccine that was administered on March 15,2023 there was between 75 and 125 people that was vaccinated; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023 there was between 75 and 125 people that was vaccinated), PRODUCT STORAGE ERROR (Expiration date was 26FEB2023 and date the vial was initially stored in the refrigerator on 14MAR2023) and NO ADVERSE EVENT (No adverse event) in a 33-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 060B22A) for COVID-19 prophylaxis.     It was unknown if patient had ever been diagnosed with/ tested positive for COVID-19.     On 15-Mar-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 15-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023 there was between 75 and 125 people that was vaccinated). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expiration date was 26FEB2023 and date the vial was initially stored in the refrigerator on 14MAR2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023 there was between 75 and 125 people that was vaccinated), PRODUCT STORAGE ERROR (Expiration date was 26FEB2023 and date the vial was initially stored in the refrigerator on 14MAR2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (She had expired vaccine that was administered on March 15,2023 there was between 75 and 125 people that was vaccinated) and PRODUCT STORAGE ERROR (Expiration date was 26FEB2023 and date the vial was initially stored in the refrigerator on 14MAR2023).    Concomitant medication was not reported. Vial size was reported as 10 dose vial. The vial was initially stored in the refrigerator on 14-MAR-2023. The vial did not undergo any temperature excursions. It was reported that HCP stated that expired Moderna COVID-19 monovalent vaccine was administered to approximately 75-125 patients on 15-MAR-2023. There was potentially a second lot number that was expired and was administered to patients on 3-MAR-2023, but HCP did not had any details on that event at the time of report.   Treatment medication was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-716065 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716065:Master Case
NEUROPATHY 3/29/2023 ACUTE LOW BACK PAIN < 1 MONTH
Patient called about a week after receiving vaccination with complaint of an abnormally shoulder. Was advised to attempt reach out to PCP about pain in shoulder if not resolved within the next few days. Patient went to PCP and was diagnosed with a frozen shoulder.
Patient is complaining of multiple bruises. Bruises are appearing in multiple areas of the body including both arms and chest area. Unsure if related to bruises. Patient did report taking aspirin 81mg and has since stopped taking.
Approx 5 days p/flu vax pt devel cold sx from which pt never recovered; On 25OCT91 pt exp hematuria & hypotension & died following day; COD was not felt to be secondary to the flu vax;
Hospitalization: 4/25/2023 - 4/30/2023 (5 days) Presentation to the ED: mechanical fall. COVID + date: 4/29/2023 Treatment: supportive management with vitamin C  & Zinc. asymptomatic.  Discharge to: SNF.   006B21A 3/19/2021 037B21A 4/16/2021
About 2 hours post vaccination (shot 1 of 2):  Nausea, lightheadedness, exhaustion, left sided neck soreness. Tenderness at injection site.  Considering taking Tylenol but trying to wait it out in an effort to observe the immune response.
Fatigue and myalgias started approximately 2 weeks after the Vaccinia given.  Chest discomfort began approximately 2 weeks after the vaccine.
This spontaneous report as received from a nurse practitioner refers to multiple patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored VAQTA (lot # K005958, expiration date 09-FEB-2017). The excursion temperature was 33.8 degree Fahrenheit. The excursion time frames were 1 hour 69 minutes and 1 hour and 43 minutes. The temperature was back in range. There were no previous temperature excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
This 82 year old male received the Moderna Covid shot on  1/21/21    and went to the ED on  2/13/21     and was admitted  on2/16/21 with the following diagnoses listed below. I63.9 - CVA (cerebral vascular accident) (CMS/HCC) R29.90 - Stroke-like symptoms I63.9 - Cerebral infarction, unspecified
One week post injection numbness was noted on top of left foot. Numbness is still present as of filing.