chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This initial spontaneous case, was received from other health professional (registered nurse) on 01-Jun-2017 and concerns students in an academic campus, who received flu vaccine. This case deals with third of 23 reports. From 03-Oct-2016 to 04-Oct-2016, 176 students were vaccinated with FLUCELVAX in the total of 258 students in the campus. In the spring of 2017, an outbreak of the flu occurred and lasted for approximately 10 days. The reporter stated that, from 13-Apr-2017 to 18-Apr-2017, they treated 22 students with flu and among them 5 students had the vaccine on campus. In the beginning of 18-Apr-2017, they treated another 23 students with flu symptoms and only 3 of those had not received the flu vaccine. The students were tested positive for influenza A via rapid flu test with nasopharyngeal swab. This case concerns a 17-years-old patient of unspecified gender. On 03-Oct-2016, the patient received FLUCELVAX QIV (dose, route of administration and anatomical location: not reported, batch number: 185888, expiration date: 31-May-2017). On 17-Apr-2017, the patient was tested positive for influenza A via rapid flu test with nasopharyngeal swab (characterized as vaccination failure). Based on the investigation performed, it can be concluded that FLUCELVAX 185888 was manufactured in compliance with the approved internal procedures and in accordance with the quality requirements. No evidence was found that the LOE complaint was the result of the Fill Finish or Bulk manufacturing process and no trends were identified for the batch, or any other FLUCELVAX QIV batches from the 2016-2017 FLUCELVAX Commercial season. Therefore, no internal root cause could be confirmed. Outcome of Influenza A virus infection and vaccination failure was not reported. The reporter did not assess the seriousness and did not provide the causality between events and suspect vaccine. The reporter stated that, the students received flu vaccine had less severe symptoms than those who had not received the flu vaccine. Batch review report (reference number 1022277) received from quality assurance department on 29-Jul-2017: The QA investigation report result of the batch: 185888 was received and narrative was amended accordingly. Non significant case correction received on 10-Aug-2017: Narrative was corrected.
About 2 weeks after vaccine I noticed Monocular Diplopia in my eyes & I saw double of everything so I contacted a dr.
Tested negative for antibodies; This spontaneous case was reported by a consumer and describes the occurrence of ANTIBODY TEST NEGATIVE (Tested negative for antibodies) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ANTIBODY TEST NEGATIVE (Tested negative for antibodies). At the time of the report, ANTIBODY TEST NEGATIVE (Tested negative for antibodies) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported. Treatment information was not provided. Company comment:  Based on the known information of the vaccine, post-vaccination antibody test results will be negative in individuals without a history of previous natural infection if the test used does not detect the type of antibodies induced by the vaccine. This can be natural and thus assessed as not related to the vaccine.; Sender's Comments: Based on the known information of the vaccine, post-vaccination antibody test results will be negative in individuals without a history of previous natural infection if the test used does not detect the type of antibodies induced by the vaccine. This can be natural and thus assessed as not related to the vaccine.
Bilateral joint Pain in hands, then 3 days later on 11/03/16 developed rash bilateral feet medial aspect that is when she reported symptoms to clinic. By that time the painful joints were resolving without treatment.
28nov89 pt vax hepta B pt ex pain at inject site. pt vax 2nd hepta B on 28dec89. pt ex prolonged pain and tenderness at the inject site which continued for 2 days to one week.  pt recovered.
I never felt well after my 2nd vaccination.  My head always having a dizzy feeling.  I thought this feeling would go away.  It gradually worsen.  Extreme dizzy feeling in head.  Pressure on right side of head especially near right ear and right eye.  My vision got blurry.
The Fluzone HD shot was given to the patient instead of the Fluzone. Patient is under 65 years old and should not have received the FLuzone HD. Patient will be notified.
Depression; Major depressive disorder; Felt painful and a little bit sour on the left arm; headache; This spontaneous case was reported by a consumer and describes the occurrence of MAJOR DEPRESSION (Major depressive disorder), DEPRESSION (Depression) and HEADACHE (headache) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A and 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical history was not reported.  Concurrent medical conditions included Penicillin allergy, Depression (major depressive disorder) and Psychosis. Concomitant products included ZOLPIDEM for an unknown indication.   On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2021, the patient experienced DEPRESSION (Depression) (seriousness criterion hospitalization). On 28-Apr-2021, the patient experienced MAJOR DEPRESSION (Major depressive disorder) (seriousness criteria hospitalization and medically significant) and HEADACHE (headache) (seriousness criterion hospitalization). On an unknown date, the patient experienced MYALGIA (Felt painful and a little bit sour on the left arm). The patient was hospitalized from 28-Apr-2021 to 30-Apr-2021 due to DEPRESSION and HEADACHE, and then from 30-Apr-2021 to 14-May-2021 due to MAJOR DEPRESSION. The patient was treated with FLUOXETINE HCL at a dose of 20 mg; OLANZAPINE at a dose of 10 mg once a day; TRAZODONE ongoing since an unknown date at a dose of 50 mg once a day and PAROXETINE (oral) from 05-Apr-2021 to 28-Apr-2021 for Depression, at a dose of UNK, qd. At the time of the report, MAJOR DEPRESSION (Major depressive disorder) had not resolved and DEPRESSION (Depression), HEADACHE (headache) and MYALGIA (Felt painful and a little bit sour on the left arm) had resolved.            Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded   This case was linked to MOD-2021-221026 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-Jul-2021: Follow up received on 05 JUL 2021 and Contains was updated patient details, vaccine details, and additional narrative information.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
Information has been received from a physician concerning a female who on unknown dates was vaccinated with full series of GARDASIL (lot # not reported). Subsequently the patient was "diagnosed with HPV". At the time of reporting, the patient didn't recover. Pap smear was performed with no results provided. The patient sought unspecified medical attention. Additional information has been requested.
Dizziness, Headache, Myalgia, Arthralgia, chills, fatigue Narrative:
Day after receiving injection developed swelling, pain and redness of upper arm (circumferentially) with chills, no fever documented. Seen in ER 2 days after receiving injection given morphine, Ancel IV and Rx'd po cephalexin.
Information has been received from a medical assistant concerning an approximately 8 year old female who on 8/24/04 was vaccinated with a dose of varicella virus vaccine live. The reporter indicated that in approximately August 2004, the patient developed a generalized rash after receipt of the vaccination (exact onset unknown). Unspecified medical attention was sought. A product quality complaint was not involved. Additional information has been requested.
heart palpitations chest pain dizzy headache  Feeling as if I was suffering the effects of "severe dehydration".  This all came on very sudden, as opposed to a slow onset if I was actually dehydrated.
Swelling to lips, eyes, cheek. Benadryl given. awaiting outcomes.
MOM STATES HER DAUGHTER REPORTED SORENESS TO THE LEFT ARM ALL WEEK. SATURDAY, RED "SPLOTCHES" BEGAN APPEARING BELOW THE INJECTION SITE, "ABOVE AND BELOW THE ELBOW." THERE IS NO DRAINAGE OR SWELLING NOTED. MOM STATES THESE SPOTS BEGAN TO APPEAR WORSE ON SUNDAY, BUT SEEM TO HAVE MAINTAINED THEIR APPEARANCE TODAY. SORENESS IS STILL PRESENT; OTC ANALGESICS HAVE NOT SEEMED TO HELP.  IT WAS ADVISED BY THIS NURSE AND RN TO USE HEAT TO HELP ALLEVIATE PAIN AND USE OF DIPHENHYDRAMINE. IF THE AREA CONTINUES TO GET WORSE OR DOES NOT IMPROVE, SEEK MEDICAL ATTENTION FROM PRIMARY CARE.   I ALSO TALKED TO MOM ABOUT PATIENT'S SECOND DOSE. IT WAS ENCOURAGED FOR HER TO HAVE A DISCUSSION WITH PATIENT'S PRIMARY DOCTOR  IF HE FELT THE BENEFITS OUTWEIGHED THE RISKS OF RECEIVING THE SECOND DOSE. OF COURSE, PATIENT AND HER MOM ALSO HAVE THE OPTION TO REFUSE THE 2ND DOSE OF BEXSERO ALTOGETHER WITHOUT CONSULTATION. SHE WAS ALSO INFORMED TO CALL IF SHE HAD ANY ADDITIONAL QUESTIONS OR CONCERNS.
Infant developed hives 1 hour after vaccines given. Went to emergency room. Received Benadryl PO and steroid injection. Hives cleared.
Guest passed/expired within 10 days of dose #2 of COVID-19 vaccine series. Began transitioning on 9/27/21-- 5 days s/p Dose #2. Guest was a hospice resident prior to COVID-19 vaccine and overall was having  general decline prior to vaccination. Signed on to hospice on 8/6/21.  Had active diagnosis of adult failure to thrive and hx of gastric CA--declined PEG tube.  Only acute side effect 2 days s/p dose 2 noted was fatigue. No side side effects were reported with dose #1.
Patient began seizing after several hours of fever of >100 degrees F, post-vaccination. He was transported by ambulance from his home to the Emergency Department where he experienced another seizure. Patient was hospitalized overnight and discharged with medication for control of seizures.
Three to four days post vax, the pt developed prodromal symptoms consisting of myalgia, sore throat, and fatigue. These symptoms lasted three days and then resolved. The pt sought unspecified medical attention. Two weeks later, the pt developed extreme fatigue, hypersomnolence, and nausea. On 7/4/00, the pt's mother noted that she was jaundiced. The pt reportedly remained "ill" and was seen by her physician on 8/22/00, at which time she complained of myalgias, anorexia, nausea, fatigue, hypersomnolence, and headaches and was seen by a physician. The pt also experienced a 19 pound weight loss and amenorrhea. The pt denied acholic stools or dark urine.
Starting in the middle of February 2021, my menstrual cycle has been drastically changed, and has still not gone back to normal. My menstrual cycles my entire life have been light and only would last 2-4 days at the longest.  This year I have had extremely heavy periods that have lasted up to 6-8 weeks at a time with only a few days break before it would start again.  This has slightly improve in the last couple of months, but the most recent 2 periods I've had have lasted 8 days and have been far heavier than normal.
pt became limp & unresponsive for few minutes while in daycare p/vax ( 4 hrs); came to & brought to a office for eval w/o need for med intervention; pt slightly drowsy & admitted for ovservation;
Chills; headache; muscle ache; fatigue; Like a bad hangover; Feel crappy; This is a spontaneous report from a contactable nurse. A female patient of an unspecified age (Age: 62, Unit: Unknown) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 date single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced chills, headache, muscle ache, fatigue, like a bad hangover, feel crappy. Outcome of events was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
On the day of the shot (1/15/21), I had arm pain.  Next morning (1/16/21), I still had arm pain and my left arm was not as flexible.  By 5:00 p.m., I had chills, felt like a low grade fever, and ached all over.  By 6:30 p.m., very chilled, lymph node swollen on left side, no energy.  Fever of 100.4 at 8:00 p.m.  Tylenol lowered fever to 99.9 at 9:15 p.m.  On 1/17/21, normal temperature and chills gone.  Still tired.  By 9:45 p.m., rash from armpits to outside of breasts and around neck.  It did not itch.  On 1/18/21, rash still present at 7:00 a.m.  Nausea started at 8:00 a.m.  Still tired.  By 9:30 pm., rash better but still present.  Still nauseous.  1/19/21, rash better but still present.  Still nauseous.  Still tired - but a little more energy.
I had a breakthrough case of Covid between dose 4 and 5. So runny nose, fever, congestion, cough, joint pain, feeling crappy, shortness of breath.
rash all over body itchy papular skin colored rash w/pruritus;avoid hep b;DPH given; pt still w/rash;
Information regarding Flumist (2003-2004 Formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a father regarding his 5 year old daughter who experienced fever, weakness, tiredness, runny nose, sore throat, and swollen throat.  At 5 years of age, the pt received a dose on 12/10/03.  The pt had no relevant medical history.  Indication for Flumist (2003-2004 formula) was immunization.  Product was administered on 12/10/03.  Dose regimen was 1 dose 1 time per day (IN).  Pt was not taking concomitant therapy.  On 12/11/03, the pt was sent home from school due to weakness and tiredness.  Later that same day, she developed a runny nose, sore throat, and swollen throat.  That night she woke up with a fever of 103 deg F.  As of 12/12/03, she still had a fever of 99 deg F, runny nose and sore, swollen throat.  No additional information was available at the date of this report. Follow-up information received on 16-Jan-2004 from the reporter provided the child's birth weigh, sibling information, previous vaccine adverse event history, and recovery status. The child's father indicated that more than half of the patient's classmates had become ill with the flu at the time his daughter was ill. The reporting father indicated that his daughter's pediatrician commented that it was likely she had already been exposed to the flu prior to FluMist adminstration. Through the course of her illness she experienced high fevers of 104 deg. F. for several days, and was well by the fifth day.
numbness and tingling in hand in left hand that she says she felt start right away after the vaccine. It has been mild and she states the numbness is not debilitating.
both his legs were swollen and also the middle of his foot; both legs around ankles were very swollen; sore shoulder; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program. A male patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number was not reported), via an unspecified route of administration on 27Apr2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Previously he received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 06Apr2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. It was reported he received his 2nd dose of the covid vaccine yesterday, Pfizers (On 27Apr2021). Then went shopping and about 6 hours later, both legs around ankles were very swollen. When he got home, both his legs were swollen and also the middle of his foot. Patient questioned whether his side effect swollen legs was related to the covid vaccine. No other reaction other than a sore shoulder. He put feet his feet up on high pillows all night long were still present this morning. Slightly more pronounced on left side, which is also the side he received the vaccine (27Apr2021). He wanted to question the fact that the left side, non-dominant side, is more swollen than the right, and this is also where he received the vaccine and stated he would like to know about the countermeasure injury compensation program. The outcome of all the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a pharmacist refers to an approximately 68 year old female patient. Information regarding the patient's pertinent medical history, drug reaction/allergies and concomitant medications was unspecified by the reporter. On 24-JUN-2015, the patient was vaccinated with the first dose of ZOSTAVAX (lot# L000449, expiration date: 08-MAR-2016) (dose and route of administration were not reported). On an unspecified date approximately in 2015, the patient experienced shingles. The patient sought medical attention via unspecified doctor's office. There was no product quality complaint. The outcome of the event was not reported. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
panic attacks; painful; depression; hot flashes; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Jul2021 (Lot number: Fa6780) at the age of 53 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Depression" (unspecified if ongoing); "migraine headaches" (unspecified if ongoing); "allergies: Yes, medications no foods" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN C [ASCORBIC ACID]; VITAMIN D NOS. Vaccination history included: Bnt162b2 (Dose number 1, Lot number EW0181, Administration time 10:00 AM, Vaccine location Left arm , ), administration date: 13Jun2021, for Covid-19 Immunisation, reaction(s): "muscles and joints pain scale a nine", "pain all over my body", "muscles and joints pain scale a nine".  The following information was reported: PANIC ATTACK (non-serious), outcome "not recovered", described as "panic attacks"; PAIN (non-serious), outcome "not recovered", described as "painful"; DEPRESSION (non-serious), outcome "not recovered", described as "depression"; HOT FLUSH (non-serious), outcome "not recovered", described as "hot flashes". The events "panic attacks", "painful", "depression" and "hot flashes" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were not taken as a result of panic attack, pain, depression, hot flush.  Additional information: Patient took second dose on 10Jul2021 and one week later she started to experience panic attacks and painful hot flashes and depression and patient's body was still experiencing pain all over. It was 21Jul2022 and patient was still experiencing all of these symptoms and they were all increasing. No report whether the patient took any other vaccine in four weeks. Patient had not been diagnose with Covid prior or post vaccination.  No follow-up attempts are possible. No further information is expected.
Information has been received from a physician concerning a 20 year old female with no allergies, who, on an unspecified date, was vaccinated with a dose of Gardasil.  There was no concomitant medication.  There were no illnesses at the time of vaccination.  It was noted that the reporting physician recommended the HPV vaccination to the patient but she was vaccinated at her college campus.  Three to four days post vaccination the patient experienced a high fever, headache, and blurred vision.  The patient went to the emergency room but was not admitted.  The patient then returned to the emergency room a second time and was admitted to the hospital for two days.  The patient was diagnosed with encephalitis.  At the time of the report, the outcome of the patient was unknown.  Additional information has been requested.
GOT A FINE RASH ON BACK, ARMS, FACE AND HANDS.
Initial report received from a health care professional on 18 January 2011. A female patient received on 15 November 2010 an intramuscular injection (site unknown) of FLUZONE SV 2010-2011, lot number UH223AC. The patient's medical history and concomitant medications were not reported. On an unknown date, the patient had a severe reaction to the vaccine. No further information was available. The outcome was reported as unknown. Follow-up information was received 04 February 2011 from a consumer, who is the patient. From new information received, it was determined this case meets seriousness criteria and this case has been upgraded from nonserious to serious. The patient was identified as a 63-year-old female who received FLUZONE as a first dose intramuscular right deltoid injection. On 16 November 2010, the day after vaccination, the patient "turned purple" and developed rash, itching and spastic uncontrollable movements which lasted for the next 30 days (previously reported as "severe reaction", coding removed as event now identified). She was evaluated by her health care provider on 18 November 2010 (results of evaluation not reported). She had a past history of breast cancer and allergies to penicillin, corn and peanuts. Concomitant medications consisted of Vitamin D, Calcium, iron, and vitamin B complex. The patient had not received any other vaccines within four weeks of FLUZONE SV 2010-2011. The patient's outcome was not reported and no additional information was provided at the time of the report. Documents held by sender: None.
Pt recvd 3 doses of Engerix-B & it was determined that pt had inadequate antibody titers about 6 mos p/last inject;
headaches, interrupted breathing , increased susceptibility to cold temperature, reduced stamina (new symptoms with this booster) memory loss, tremor arms and hands, tendency to fall asleep after closing eyes (symptoms worsened by this booster but beginning with first 2 vaccinations-all vaccinations moderna) I was sick with flu-like symptoms in addition to the above for 1 month following this booster dose.