chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Wrong Drug Administered; administered PROQUAD and VARIVAX together; No additional information; This spontaneous report was received from a consumer via a company representative referring to a 22 years old patient of unknown gender. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.  On an unknown date the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) and varicella virus vaccine live (oka/merck)(VARIVAX) together by error when it was intended the patient receive measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) and varicella virus vaccine live (oka/merck)(VARIVAX) independently (Inappropriate schedule of product administration, wrong product administered). Dose, route, lot# and expiration date for all vaccines were not reported and used for prophylaxis. No additional information.
Headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and PYREXIA (Fever) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, the patient experienced HEADACHE (Headache) and PYREXIA (Fever). At the time of the report, HEADACHE (Headache) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product used was not provided by the reporter.  Patient was allowed to take Tylenol as treatment.
This spontaneous report has been received from a pharmacist referring to a patient of unknown age. On 23-NOV-2015 the patient was vaccinated with improperly stored MMR II (dose and route not reported, lot # L024264, expiration date: 01-JUL-2017). No adverse effects reported. This is one of several reports from the same reporter. Additional information has been requested.
A report was received from a health professional on October 22, 2001 concerning a 40 year old male patient who experienced lethargy and headache after receiving Fluvirin in October 2000. 20 minutes after the vaccination the patient complained of a "tight ring around head" and having a "cotton wool head".  The patient had also been feeling lethargic and listless, especially after exercise.  The patient had not recovered at the time of reporting. There was insufficient information to assess the reporter's causality.
The patient is only four years old and received a the first dose of the Pfizer Pediatric Covid Vaccine that is approved for children age 5 to 11 years old only.  Upon inquiring, it was discovered that the child mother gave a false date-of-birth in order for the patient to receive the vaccine.  At this time, the parents have not reported any adverse reactions however, the Immunization Registry and the child's pediatrician have both been notified.  The mother was also contacted to let her know that we would not be able to administer the second dose of the vaccine.
muscle aches; headache; chest pains; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (muscle aches), HEADACHE (headache) and CHEST PAIN (chest pains) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 086M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, the patient experienced MYALGIA (muscle aches), HEADACHE (headache) and CHEST PAIN (chest pains). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, MYALGIA (muscle aches), HEADACHE (headache) and CHEST PAIN (chest pains) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Relevant concomitant medications were not reported. Patient thinks it was due to her shoveling snow but wasn't sure.
about 12 hours after the shot, I got a week headache and was very restless and couldn't get comfortable going to sleep. Took 600 mg of IBprophen which helped.  When I woke up at 7:30 next morning, I didn't feel good...my skin hurt to touch (like when you have the flu), nauseated and felt weak.  This ended around 8pm of 4/6.
This prospective pregnancy case described the occurrence of heartburn in a neonate. the 30-year-old mother was a subject enrolled in an open label study: a prospective, exploratory, cohort study to detect and describe and abnormal pregnancy outcomes in women intentionally or unintentionally vaccinated with either FLUARIX or FLUARIX QUADRIVALENT or FLULAVAL or FLULAVAL QUADRIVALENT during pregnancy or within 28 days preceding conception. The subject received Flu Seasonal QIV Dresden .5 ml on 26th September 2014. The mother's last menstrual period was on 23rd March 2014 and estimated date of delivery was 28th December 2014. The neonate was exposed to Flu Seasonal QIV Dresden at week 26 of gestation and during the second trimester of pregnancy. The neonate was diagnosed with heartburn. Additional event(s) included gastroesophageal reflux disease, crying, colic and maternal exposure during pregnancy, second trimester. The outcome of heartburn was recovered/resolved. The outcome(s) of the additional event(s) included gastroesophageal reflux disease (recovered/resolved), crying (recovered/resolved), colic (recovered/resolved) and maternal exposure during pregnancy, second trimester (unknown). It was unknown if the investigator considered the heartburn, gastroesophageal reflux disease, crying and colic to be related to Flu Seasonal QIV Dresden. See case US2015GSK002902 for details regarding the mother case. Additional details provided are as follows: The infant was fine initially, but after an unspecified time experienced heart burn, bad reflux, horrible crying and colic for the first 6 weeks of life. It was unspecified whether, the patient experienced colic or reflux.
Fever, shaking uncontrollably, body aches, tiredness, nausea, loss of appetite. Symptoms lasted 48 hours.
Right after the vaccination, I began to swell in my feet and face. Then, I developed rashes and hives. I still have these affects after 10 months I now have developed an auto immune disorder. I take herbs to help w/the symptoms of each. I never signed a paper before taking this. It was pushed to take it.
Chills; I was very weak; Headache; Palpitations; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 05Mar2021 (Lot number: EN6202) at the age of 78 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "have a pace maker" (unspecified if ongoing), notes: "I have a pace maker and I also have a clip. I have a micro valve leakage and they put a clip in.". The patient's concomitant medications were not reported. The following information was reported: CHILLS (non-serious), outcome "unknown", described as "Chills"; ASTHENIA (non-serious), outcome "unknown", described as "I was very weak"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; PALPITATIONS (non-serious), outcome "unknown", described as "Palpitations". Therapeutic measures were taken as a result of chills, asthenia, headache, palpitations.  Additional information- It was reported that the patient received treatment with Tylenol.  No follow-up attempts are possible. No further information is expected.
From injection site to right elbow, from anterior to posterior arm was red, hot swollen, painful, burning for two days on day three it started to resolve with the application of warm soaks. Saw the Workers Comp doctor and my PCP.
Patient reported upper arm pain the day after the vaccine was administered. The vaccine was administered subcutaneously over the elbow. He is still having upper arm pain as of 4/1/17, but he thinks it could also be related to a shoulder injury.
I was feeling fatigue night after injection. Next morning I passed out, woke up sweaty. Then started vomiting and having severe leg cramps. Called employee health and they said to go to emergency department.
hives on my neck and on my upper torso; This is a spontaneous report from a contactable nurse reported for herself. A 39-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration in right arm on 26Jan2021 12:15 as single dose for covid-19 immunisation. Patient had historical vaccine BNT162B2, first dose for COVID-19 immunisation. The patient was allergic to seafood. The patient's concomitant medications were not reported. The patient had not received any other vaccine prior to the COVID vaccine and not tested for COVID-19 after vaccination. The patient experienced hives on her neck and on her upper torso on 27Jan2021 19:00. No treatment received for the reported adverse event. The outcome of the event was unknown.  Information on the Lot/Batch Number has been requested.
pt recvd MMR 25MAR93 seen in office 7APR93 w/measle like synd-rash neck to groin (macular), conjunctivitis injected, koplick spots;
About 3 days after vaccination, patient developed redness near the injection site. It started about an inch below the injection site and covered an area about 3 x 5 inches. The arm had some soreness as expected, but nothing abnormal.  I spoke to her 7 days after the injection. Red area still visible but it was improving according to the patient.
After receiving shot, patient experienced redness and swelling at injection site immediately.  She only reported allergies to penicillin or dye.  With further questioning she said she was allergic to latex.  We immediately had patient place a cold compress on the swelling.  She felt better within 20 minutes.  She was instructed to take BENADRYL OTC 25mg q6h if needed. A follow up call to patient was made 3 hours later.  She said the arm felt fine but fir a small bump.  The Pharmacist wore latex gloves and the patient was allergic to latex.  The VAER may have been from the latex gloves and not from the flu-shot.
Slight fever 1 point elevated. Muscle, body aches, fatigue, tiredness, slight headache, joint pain, sore Rt. arm, sore injection site. Side effects have subsided after approximately five (5) days.  None of the side effects were considered severe!
One day after my vaccine, I started spotting and by 2 days my period was the heaviest bleeding I have ever had for 4 days going through a tampon more frequently than ever hour as well as additional amount on overnight pad. My perioid has been every 21 days regular and I had just finished my period on 3/30 so I was not due. Of note, 8 hours after vaccine I had fever, sweats, headache and nausea with muscle aches which resolved (except muscle aches) within 24 hours
Initial report received on 21 September 2009 from a health care professional. A three year old patient with no reported past medical history developed GUILLAIN BARRE Syndrome 34 days after receiving FLUZONE 2009-2010 (lot number U3189AA) intramuscularly in the left deltoid on 17 August 2009 during a check up visit. On 18 September 2009 and 19 September 2009 the patient returned to the physician's office with complaints of leg pain and weakness. On 20 September 2009 the patient was diagnosed with GUILLAIN BARRE Syndrome. As a result, the patient was hospitalized for two days and received intravenous immunoglobulin G (IV IgG). The patient did not recover. No further information was provided. List of Documents held by Sender: none.  10/28/09:  Hospital records and discharge summary received for dates of service 9/19/09 to 9/24/09.  Final Dx:  Guillain-Barre Syndrome, Peripheral Neuritis, Back pain.  Assessment:  Admitted for worsening back pain, leg pain and weakness following a viral illness two weeks prior and flu vaccine 1 month prior.  MRI-abnormal; consistent with neuritis. IVIG administered over 4 days. Developed urinary retention and distension described as hydroureternephrosis,  requiring a foley catheter.   Voiding on own for 24 hours prior to discharge.  Discharged on Neurontin and scheduled to follow up with rehabilitation service on 9/29/09.
Patient's symptoms started 2 hours after administration of vaccine and included shortness of breath, headache, blurry vision, generalized numbness and weakness, couldn't walk. Went to hospital where no treatment was given. Symptoms fully resolved by midday.
Tetanus/Diptheria Toxoid 0.1ml given subcutaneously, right arm - 03/09/2005 - causing immediate itching and redness.  Treated with ice pack, hydrocortisone cream, and claritin.
I began spotting heavily as if I had my period almost instantly. I never ever get my period early or spot unless I miss a birth control pill which I did not. I also got intense back pains, what I felt when I am about to get my period, which I was not going to get for 2 weeks. Again, I?ve had a very exact schedule for 10+ years. Very concerning.
Severe Pneumonia; Sepsis; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 vaccine), dose 1 via an unspecified route of administration, administered in Arm Left on 02Apr2021 14:00 (Batch/Lot Number: EW0750) as 1st dose, single for covid-19 immunisation. Medical history included asthma and GERD (gastrooesophageal reflux disease). Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The patient's concomitant medications were not reported. The patient previously took pencillin and sulfa [sulfanilamide] both which patient experienced allergies. On 28Apr2021, the patient experienced severe pneumonia and sepsis with symptom of fever which began around 29Apr2021. The events required hospitalization from 05May2021 to 09May2021. The patient was treated with IV and oral antibiotics, oxygen and breathing Tmt. The patient underwent lab tests and procedures which included nasal swab on 26Apr2021 which result was negative. The outcome of the events was recovering.  Follow up needed, further information has been requested.
Tested positive for covid; Tested positive for covid; Wet cough; diarrhea; chills; stuffy nose; body aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 23 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 24Mar2021 (Lot number: EP6955) at the age of 22 years as dose 2, single and administered in arm left, administration date 03Mar2021 (Lot number: EL3248) as dose 1, single for covid-19 immunisation. Relevant medical history included: "known allergies:Penicillin products" (unspecified if ongoing), notes: known allergies: Penicillin products. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 30Dec2021, outcome "recovering" and all described as "Tested positive for covid"; COUGH (non-serious) with onset 26Dec2021, outcome "recovering", described as "Wet cough"; NASAL CONGESTION (non-serious) with onset 26Dec2021, outcome "recovering", described as "stuffy nose"; DIARRHOEA (non-serious) with onset 26Dec2021, outcome "recovering", described as "diarrhea"; CHILLS (non-serious) with onset 26Dec2021, outcome "recovering", described as "chills"; PAIN (non-serious) with onset 26Dec2021, outcome "recovering", described as "body aches". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (30Dec2021) positive. Therapeutic measures were not taken as a result of vaccination failure, covid-19, cough, nasal congestion, diarrhoea, chills, pain.  Additional information : patient did not receive any other vaccine in four weeks, Patient did not receive any treatment for AE. prior vaccination patient not tested covid positive , post vaccination Patient tested covid positive . patient have Penicillin products allergies
bad head ache that no medicine stops. survive pain in eyes when i bend over and almost feel like I'm passing out when i bend over. I have body ache but not real bad.
Got my second shot on 30 November 2019 around 11:30 am.  Experienced stronger side effects than from the first shot.  The initial side effects were the ones documented as common; muscle and joint pain, fever, headache, tired, loss of appetite, swollen glands in neck (flue like symptoms).  These started early afternoon on the 30th.  The fever subsided around 2 am on Dec 1st.   I then started to experience a side effect I did not see identified for this vaccine.  I noticed on Dec 1st that my urine was darker in color than normal.  It was more yellow / brown in color.  At first, I did not pay much attention as I figured that because the vaccine caused me to lose my appetite I had not been eating or drinking as much.  I figured my urine was just more concentrated due to drinking less water although it did have a slightly brown tinge rather than just a darker yellow that is more characteristic for me when I start to get dehydrated.   The next morning, December 2nd my urine was a very dark (slightly reddish) brown color.  (It may have been this color during the night but I did not check when emptied my bladder at night as only have a night light in the bathroom at night so don?t turn on a room light.)  I did not feel like I was dehydrated or thirsty.  I was still drinking some water because that is what I normally do but not as much as I was not thirsty.  I did not feel the urge to urinate as frequently that day.  When I urinated late afternoon, my urine was still a very dark (slightly reddish) brown color.  After urinating the water in the bowel looked like the color after having diarrhea (but of course no solid matter in this case).  At that point I started drinking much more water regardless of thirst.   I am continuing to monitor the situation and if it has not cleared up by the end of the day on December 3rd, I will go to see a doctor on December 4th.  It is my assumption that I have blood in my urine (but it is not fresh red) or perhaps bilirubin.  Unfortunately, I did not think to get a urine sample for testing (I don?t have a sterile container to collect it in).  I have not experienced pain or discomfort when urinating.  I have no health problems and am not on any medications.  So far on December 3rd my urine color has not been the very dark brown.  It has lightened to more of a dark yellow brown.  I am continuing to hydrate more heavily.   NDC number: 58160-0823-11  Expiration date of lot is 04/24/2022.
Pt vaccinated with DTP/OPV found shortly after being put down for nap unresponsibe, apnea, blue & resuscitation unsuccessful. Verbal autopsey Dr SIDS.
Day 1 (day of vaccine) - sore, tight jaw Day 2 - pain, redness and slight swelling Day 3 - sharp pain, redness and increased swelling (on call doctor advise Ibuprofen and Benadryl) Day 4- sharp pain, redness, severe swelling under arm, cannot lift arm swelling in neck and head, chest tightness  Day 5 - saw doctor, increased pain, redness swelling up neck and head under arm, Chest tightness and itchy. prescribed steroid  Day 6 - swelling decreased but then by afternoon increasing, tightness of chest and tachycardia - admitted to hospital
Information has been received from a physician concerning a patient who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). Subsequently the patient experienced an allergic reaction (rash) at injection site. It was unknown whether medical attention was sought. The patient's outcome was not reported. No product quality complaint was involved. Additional information has been requested.
Pt. received immunizations at 1:30pm on 4/29/08.  Within 2 hours she had area at one injection sites that red and the size of a half dollar.  The next AM the area was softball sized, red & warm to touch.
Tiny bump; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Tiny bump) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     The patient's past medical history included Cancer (cancer survivor). Concurrent medical conditions included Diabetes and Blood pressure high. Concomitant products included VITAMINS NOS for Supplementation therapy, GLIPIZIDE, SEMAGLUTIDE (OZEMPIC), LOSARTAN and AMLODIPINE for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced SWELLING (Tiny bump). On 05-Mar-2021, SWELLING (Tiny bump) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
45 x 55 mm. erythema & induration tender. (R) upper arm.
Patient scheduled with the call center with the dob year as 2000. Patient came in and received the vaccine under the DOB year 2000 instead of the actual DOB year 2004. Moderna guidelines suggest patients receive the vaccine ages 18 & up.  The mistake was caught after the vaccine was administered, realizing that the patient was 17 years old instead of 18.   Per mother of the patient, an email was sent to her by the school board that suggested patients receive the moderna vaccine for patients 16 & up, which is why she didn't question it to begin with.   As per admin information was verified and patient confirmed. As per nurse administrating the vaccine the dob was verified again and the patient confirmed.  When the patient headed for the 2nd dose appointment, she told the admin staff that the birthday for her daughter was incorrect and the issue was escalated to the admin site lead in which she realized that the patient's correct DOB would indicate that the patient is 17 instead of 18.   Pt?s mom was informed of the issue and information. Per Dr, it was suggested that patient is eligible to receive the 2nd dose of moderna. Pt?s mother was also notified if there are any indications of signs and symptoms to report to the Emergency Room or their pediatrician. Mom also verbalized understanding.
Redness, swelling, pain at injection site beginning about 24 hours post vaccination. No systemic symptoms. Appears to be injection site reaction. Recommended acetaminophen for analgesic and ice to area. Recommended follow up with MD if symptoms worsen or fever develops.
Patient presented to the ER with pain in her arm of the injection and fever up to 102.0.
After receiving the COVID19 Janssen vaccine, I have had missed periods and irregular periods. I received the vaccine on 4/28/21 and should have started my period on May 1, 2021.  My period started extremely late, on June 5, 2021. My next period after June 5th started July 22, 2021.  I have not had another period since July 22nd (and it is currently Nov 8,  2021.) Prior to receiving the COVID19 Janssen vaccine, my menstrual cycle was 28-30 days long every month for many years.  I have never had a missed period unless I was pregnant.  (I am not currently pregnant and haven't been pregnant since before receiving the COVID19 Janssen vaccine.)
Fatigue, body aches, "puffy and swollen", edema +1. Treatment: antihistamines, NSAIDs. Dr. recommends no flu shots in future.
Pt received ADACEL injection on 1/23/12. By Friday 1/27/12 area was hard, swollen, red, burning. Pt could feel heat radiating through shirts. Having some headaches. She used Ibuprofen.