chrisvoncsefalvay/vaers-outcomes huggingface dataset:
extra heavy periods; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A female patient 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: HEAVY MENSTRUAL BLEEDING (non-serious), outcome "unknown", described as "extra heavy periods".  Additional Information: Male patient himself does not want to be contacted about this by Pfizer. He shared that he experienced back pain and herniated disc after Pfizer COVID vaccine and his wife had extra heavy periods after her COVID vaccine. Yes this happened after Pfizer vaccine Pfizer COVID vaccine   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Mom states that eve after a shower noted area was red & swollen with a pinpoint flat rash that extended down from injection site 3 fingers width.  C/o being itchy & warm to touch.  Gave BENADRYL that evening and in AM with ice to area.  In AM, looked the same but improved over the day - It took a couple days to totally resolve.
Dizziness occurred 1-2 minutes following administration of FluMist. Lasted approximately 4 minutes.
Initial information received on 28-Mar-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 7 months old female patient received vaccine PENTACEL. The patients past medical history and family history were not provided. Concomitant medications included PREVNAR 13, HEPATITIS B VACCINE and ROTAVIRUS VACCINE on 27-Mar-2019. On 27-Mar-2016, the patient received a third dose 0.5ml of suspect PENTACEL lot C5590AA, expiry date 18-Oct-2019 via intramuscular route in the left arm. It was an actual medication error due to incorrect product storage and wrong technique in product usage process. It was reported that patient received an invalid PENTACEL which was reconstituted on 26-Mar-2019 and given on 27-Mar-2019. The patient did not experience any adverse reaction after the injection. 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 and Module VI of the 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.
SIGNIFICANT Pain in upper left arm and shoulder... MUCH more severe than the level of pain I often have after vaccinations. Severe enough 2nd and 3rd nights after vaccination to WAKE ME FROM SLEEP multiple times during the nights, despite having taken Aleve and even Hydrocodone.   Pain level reaching 8-9 on pain scale 1-10.  (I am usually pain tolerant, having been through surgeries such as rotator cuff repair, achilles tendon repair and a spinal fusion, but THIS level of pain --especially during the nights--has been almost unbearable.   (Stiffness in arm,.but that is what I often have after vaccinations.  It's the PAIN ACUITY THAT IS MUCH WORSE.
Patient was 2 years old and had 1st dose Pfizer 6mons-4yrs on 9/14/22. Patient was due for the 2nd dose but was accidentally given the Pfizer 5-11yrs vaccine on 10/11/22 instead of the baby vaccine. There were no side effects. Patient was observed for 30 minutes. Parent notified their doctor. No treatment needed.
Extreme fatigue and headache for a few days so I was unable to complete my daily tasks. I received a call from someone at CDC asking me to fill this out.   I am currently pregnant, 12 weeks along at time of injection. Due date is 07/10/21
This spontaneous report as received from a Physician refers to an unspecified number of patients of unknown age and gender. On unknown date, the patients were vaccinated with improperly stored doses of ROTATEQ oral, lot number reported as: M019690, expiration date on: 02-NOV-2017 for prophylaxis. The administered doses of the vaccine were exposed to a temperature excursions of 32 °F (degrees Fahrenheit) to 35°F (degrees Fahrenheit) for 123 hours and 31 °F (degrees Fahrenheit)  for colder for 35 hours (coldest 26 °F) A digital data logger was involved. No adverse events were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter.; Sender's Comments: US-009507513-1707USA006851: US-009507513-1707USA013064:
Unknown exact onset of symptoms believe it was on 10/10/23.  Have not spoken with patient, but her fellow coworkers report she has no pain at site, but can't lift her arm.
Herpes zoster diagnosis in two-dose varicella vaccine recipient. Symptoms include: rash, unilateral, painful.
MULTIPLE SUBSEGMENTAL PULMONARY EMBOLI WITHOUT ACUTE COR PULMONALE ACUTE HYPOXEMIC RESPIRATORY FAILURE ACUTE PULMONARY EMBOLISM
One day post vax, the pt developed generalized swelling over her body. She was seen in an ER and treated with epinephrine and Benadryl. The infant recovered. This is considered "medically important". F/U info rec'd from the physician on 4/5/01 indicated that the infant developed diarrhea on the night of vaccine. Informaton regarding Prevnar (pneumococcal 7-valent conjugate vaccine (diphtheria crm197 protein) injection) was received from a pediatrician regarding a 5-month old female who experienced generalized swelling, diarrhea and hives. At 5 months of age, the infant received the second dose on 14-Feb-2001. On 2/17/01 she developed generalized swelling over her body (swelling) and hives (urticaria). The infant was seen in an emergency room and treated with epinephrine and Benadryl (diphenhydramine). The infant recovered. The pediatrician indicated that the infant has received one additional "booster" with no side effects. (OMIC)
Started between the night of the vaccine, flu like symptoms, chills, extreme headache that floored me, cold sweats, fever, I couldn't eat or drink, and because  of extreme exhaustion could not get out of bed and I ended up going to the ER Monday night I had an itchy throat and my arm was swollen, red and itchy.
Bone pain; Pain in reproductive organs (uterus); Pain in reproductive organs (ovaries); Pain in reproductive organs (lower abdomen); Abdominal cramping; Headache starting the evening of the second vaccine to current date of this report 8/19/2021, still unresolved.; This is a spontaneous report from a non-contactable nurse, the patient. A 38-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA7485) via an intramuscular route of administration in the left arm on 09Aug2021 at 16:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. The patient did not take any concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0198) via an intramuscular route of administration in the left arm on an unknown date in Jul2021 at 17:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. On 09Aug2021 at 20:00, bone pain, pain in reproductive organs (uterus, ovaries, lower abdomen), abdominal cramping and headache starting the evening of the second vaccine to current date of this report 19Aug2021. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events bone pain, pain in reproductive organs (uterus, ovaries, lower abdomen), abdominal cramping were resolved with sequelae on an unknown date in Aug2021; while that of the event headache was not resolved at the time of this report.  No follow-up attempts are possible. No further information is expected.
Rapid heart rate - my heart started racing non stop for hours, at least 4+ hours at night  Hyperactive (non stop talking) - an hour after getting the shot, lasted hours, from  about 5:30pm to 11pm   And just to let it be known, I had taken my inhaler around 10pm  but I've never had my inhaler act like that before. (Xopenex)
Patient received expired vaccination. ProQuad expired on 3/16/2022. Vaccine given on 3/22/2022.
08/05/04-10:30PM high pitch scream, sleeping a lot. No swelling at injection site. 8/6/04 9:30AM ate ok no fever or other symptoms. 8/9/04 100.8 temp crying when child is moved, Dr. Sent to ER -4AM. Blood culture done neg. 08/10/04 per mom 102 temp off and on since 8/5/04.
Covid19 breakthrough.  1st vaccine received on 01/09/2021, 2nd on 01/30/2021, and 3rd on 09/03/2021.  76 y/o female with PMHx of Diabetes, HTN, and chronic renal insufficiency presents to the ED with c/o SOB, Cough, Mold Exposure, nausea, vomiting and low grade temps.  Temp 100.0, room air sat 100%.  Chest Xray-normal chest.  Pt treated with steroids.
bloody spot on arm and inner lip; fever; arm pain; This is a spontaneous report from a contactable consumer (patient reported for herself).   A 28-years-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Mar2021 (Batch/Lot Number: EN6206) as SINGLE DOSE for covid-19 immunisation.  Medical history included penicillin allergy from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported.  The patient previously took olive (olea europaea) and experienced drug hypersensitivity.   The patient experienced bloody spot on arm and inner lip (purpura) (non-serious) on an unspecified date with outcome of unknown , bloody spot on arm and inner lip(non-serious) on an unspecified date with outcome of unknown , fever (pyrexia) (non-serious) on an unspecified date with outcome of unknown , arm pain (pain in extremity) (non-serious) on an unspecified date with outcome of unknown.
This spontaneous report as received from a pharmacist refers to an unknown number of patients of unknown ages. On unknown dates the patients were vaccinated with ZOSTAVAX (lot # not reported) (strength and total daily dose not reported). It was reported that an unknown number of vials of ZOSTAVAX underwent unknown excursions, which might not be supported. Pharmacist reported that it was possible that some of these vials of ZOSTAVAX might have been administered to the patients. No adverse effects were reported. It was unspecified whether the patients sought for medical attention. The outcome was unknown. Additional information is not expected.
Same day had pain in both arms with Lt. > Rt., Lt arm numbness & tingling, headache, facial hives, episodes of sweating, and subsequent 2-5 days also URI symptoms. Pt self treated with Theraflu - Seen in E.R. & discharged with Tylenol & Antihistamine.
This spontaneous report was received from a registered nurse referring to a 89 year old female patient. The patient's concurrent conditions included hypothyroidism and breast cancer in remission. On 13-SEP-2016, the patient was vaccinated with PNEUMOVAX 23 (which had the lot # reported as M027552, expiration date and dose were unknown) intramuscular route. Information regarding concomitant medication was not provided. On 13-SEP-2016 in the evening, the patient developed small bruising at the site, redness and swelling below the site, cellulitis and a 3-4" area of redness and swelling up the arm. The patient received treatment for the adverse events. At the time of reporting, the outcome of cellulitis, redness, swelling and bruising was reported as recovering. The causality assessment between the events and PNEUMOVAX 23 was not provided. Upon internal review the event cellulitis was determined to be medically significant. Additional information has been requested.
Patient was given incorrect vaccine. Suggested vaccine by provider was T-dap and patient received Td vaccine instead.
This spontaneous report was received from a nurse and refers to an 18 month old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions, concomitant medications or drug reactions/allergies. On 27-MAR-2019, the patient was vaccinated with an expired dose of VAQTA, intramuscular, R010369, expiration date 25-MAR-2019 for prophylaxis (dose was not reported) (expired product administered). No adverse effects were reported. The outcome of the event expired product administered was not reported.
Patient received product 8 days past the beyond-use-date. Manufacturer contacted to review product stability.
Shortness of breath Narrative: Patient is a 74 yo MALE with PMHx significant for tobacco use, COPD, h/o polysubstance use, and PTSD. Pt received Pfizer COVID-19 vaccine dose #1 and dose #2 on 1/30/2021 and 2/20/2021 respectively. Shortly after second COVID-19 vaccination, pt developed some lightheadedness and SOB. Evaluated by clinic provider at12:30PM, vital signs were stable, had coarse breath sounds (consistent COPD), no wheezing, and had good air movement: pt observed for an extended period of time. No rash or lip swelling noted. Repeat vitals at 1:15PM, BP 145/76, HR 70, O2 Sat 97%. Pt used his inhaler and SOB resolved, dizziness dissipated; reported SOB symptoms were consistent w/ his COPD and response to inhaler was similar. Per clinic provider's assessment, dizziness and SOB unlikely to be related to the vaccine. S/p inhaler use, symptoms resolved; pt had stable gait, breathing was unlabored, and cognitive status was good. Pt left of his on accord w/ instruction s on symptoms that would require immediate medical attention.
Immediately following vaccination I developed at the injection site a hard mass that was very red and hot to the touch. Mass dissipated over 7-10 days. Early January I began developing rashes all over my body. They were raised, very itchy, and painful at ties. Went to allergist/dermatologist on January 30th and he stated he had several patients present with the same thing following the Moderna booster. Put me on an acid reflux medicine and another medicine I can't recall. Symptoms lasted until mid May when it finally cleared and stayed clear.
hives the noc of shot & unconsolable;low grade fever;lump @ inj site;given DPH PRN rash & APAP
p/vax devel poss sz activity;pt slept p/vax until 1PM;vomit 9-10x;became lifeless, eyes rolled back & arms straight out in tonic posture, then flaccid;lethargic;dx=metabolic acidosis, post urethral valves, infect gastroenteritis, convuls
Employee received vaccine on 10/27/06 after having a bone scan with contrast.  She reports becoming extremely ill 3 hours after administration of the vaccine.  Began vomiting and was examined in ED--received IV fluids and Magnesium.  Her PCP examined employee and states the illness may have been caused by the Influenza vaccine.
A non-serious spontaneous report of flu like symptoms manifested by fever, body aches, chills and runny nose has been received from a health professional concerning a four-year-old male, subsequent to FLUMIST. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age. Neither relevant past medical history nor concomitant medications had been reported for this patient. On 21-Oct-2011, the patient received FLUMIST. After receiving FLUMIST, the patient had fever and flu like symptoms two days later. The event of flu like symptoms was recovering.
56 yo male patient reports his left deltoid feels like a muscle strain after receiving his first dose of the shingles vaccine on 19 Oct 2020. He received his second dose today.
started 1/08/2021 at 18:00,tired, dizzy, weak, fatigue, 99.4, slept 1/9
Information has been received from a physician concerning a 2 month old female who on 18-APR-2007 was vaccinated with Rotateq (lot # 656195/0025U) 2 mL po. Concomitant therapy included Hepatitis B virus vaccine inactivated USP, (therapy unspecified TETNA") and PedvaxHib. The physician reported that the patient was fussy and constipated on 27-APR-2007 after getting the vaccine. The physician did not provide further explanation of "fussy" (later reported as fussy). The physician reported that the patient was seen approximately 10 days (also reported as onset of 29-APR-2007) after being vaccinated with complaints of constipation increased crying and fussy. The stool pattern was slowed but no hard stools. The physician reported that the diagnosis was gastroenteritis and the patient was treated with Pedialyte for two to three feedings. Over the weekend the patient had a fever of 101.8 degrees on 30-APR-2007 and went to the emergency room on 01-MAY-2007 with a fever of 101.3. The patient was hospitalized for 24 hours under observation; for observation and bowel rest secondary to fever and fussing. The physician reported that the patient recovered on 03-MAY-2007 after therapy was discontinued. Lab and diagnostic test done were reported as" KUB with no evidence of obstruction, increased bowel gas: CBC/BMP normal and blood culture and urine culture: no growth. Additional information is not expected.
This spontaneous report was received from a physician via two company representatives and from a practice manager (support services director) and refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 13-MAY-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB 10 microgram/1 ml injection, lot # L044917, expiration date 05-OCT-2018 (dose, route and site of administration were not reported). The administered dose of vaccine was exposed to two temperature excursions (dates unspecified): one lasting for 144 hours, with the lowest recorded temperature of 34 degrees Fahrenheit (1.111111111 degrees Celsius) and another lasting for 72 hours, with the lowest recorded temperature of 31 degrees Fahrenheit (-0.555555556 degrees Celsius). The vaccine was stored in a refrigerator. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
Fever, extreme chills, sweating, extreme body ache, dizziness, nauseous. Could hardly walk, could not sleep, had headache for 3 days.  Every inch of my body was throbbing in pain. Tylenol did nothing to help. 3 days later broke out in itchy circular rash where vaccine given and have picture to document size each day. Still have red mark there. Got my  period today (week after vaccine) 8 days early?!
Information has been received from a company representative concerning a 7 year old healthy male who on 04/05/1999 was vaccinated with varicella virus vaccine live. In the first week of February 2002, the boy experienced varicella with more than 50 lesions. The physician indicated that it was a wild type varicella. The boy was treated with Benadryl, Aveeno, and Zyrtec. There were no complications and the varicella was reported to be "progressing well." The pt's sister (WAES0203USA02516) also experienced varicella following exposure to varicella virus vaccine live. It was also reported that the third sibling is 1 year old and received varicella virus vaccine live from another log on 11/07/2001 and has not developed any symptoms. No further info is available.
Dizziness for almost 18 hours- couldn?t open eyes or dizziness caused nauseous feeling.  After dizziness subsided, diarrhea &tired, but at least can sit, walk and not feel ill.
Bodily fatigue lasting until 6/28/2021. I had to make myself get out of bed each morning because I felt exhausted, even after 9 or more hours of sleep. I normally function best with 7.5-8 hours of sleep.
Retinitis found incidentally on regular optometry screening examination also confirmed but opthamology who suggested this may be vaccine related given timing. And that has been seen with multiple  other vaccines. Historically such as influenza and HPV. Pt has had all of those.  Not influenza this year due to fear of worsening the retinitis that is active.  On follow up visit there had been some resolution of inflammation on imaging. Have a follow up in March to see if there is full resolution. There was no vision loss noted just a large area of retinal inflammation.  No symptoms found incidentally.
Information has been received from a nurse midwife for GARDASIL, a pregnancy registry product, concerning a 31 year old female who on 05-AUG-2009 was inadvertently vaccinated SC in the left forearm with 0.1cc dose of GARDASIL instead of PPD vaccine. There was no concomitant medication. The patient was 11 1/2 weeks pregnant on 05-AUG-2009. The last menstruation period was 20-MAY-2009 and the estimated delivery date would be 24-FEB-2010. Client was seen for a follow up visit today and nurse stated she was okay. The left forearm had some hyperpigmentation but no ulceration. Client had dating sonogram performed on 29-JUL-2009 and was due on 24-FEB-2010. Follow-up information has been received from a nurse practitioner who indicated that on 04-AUG-2009 (also reported as 05-AUG-2009) the patient was accidentally vaccinated subdermal with GARDASIL (Lot # was not reported) in her arm. The whole dose was not given to the patient just partial dose because the office realized that this patient was not supposed to get the GARDASIL vaccine. Nurse reported that the patient developed redness and half centimeter pigmented skin on the injection site. At the time of report the redness and half centimeter pigmented skin on the injection site was not recovered. Follow-up information has been received from a certified nurse midwife who indicated that the female patient was inadvertently vaccinated intradermally with a 0.1cc dose of GARDASIL on 04-AUG-2009. Concomitant therapies included: vitamins unspecified, VISTARIL, MUCINEX, ferrous sulfate, calcium (unspecified). On 19-AUG-2009 the patient developed a 1/2 cm in diameter erythematous hyperpigmented area at the site of injection. There were no symptoms or signs of ulceration. Follow-up information has been received from a certified nurse midwife who indicated that the female patient had allergy symptoms at time of vaccination and had no pre-existing allergies, birth defects and medical conditions. Follow-up information has been received from another health professional indicated that the female patient with 3 previous pregnancies and 2 full term deliveries who on 24-FEB-2010 delivered a normal health female infant. The weight of infant was 3519 gm, the Apgar score of infant was 9/9, the birth date from LMP was 39.1 weeks. There were no congenital anomalies or other complications with the infant. Additional information is not expected.
Information has been received from a medical assistant concerning a patient who was vaccinated with ZOSTAVAX (Merck). The patient developed a mild case of shingles after receiving the vaccine. The patient had sought unspecified medical attention. On an unspecified date, the patient recovered from the mild case of shingles. No further information is available.