chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 16-Nov-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves an 8 years old male patient who received vaccine DAPTACEL. The patients past medical history, concomitant medication and family history were not provided. On 31-Jan-2011, the patient received a First dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE Suspension for injection lot number not reported via unknown route in unknown administration site. On 01-Mar-2011 he also received a second dose of the same vaccine with an unknown batch number via unknown route in unknown administration site. On 02-Mar-2012 he also received a third dose of the same vaccine with an unknown batch number via unknown route in unknown administration site. On 19-Oct-2018 he also received a fourth dose of the same vaccine with an unknown batch number via unknown route in unknown administration site. It was an actual medication error due to inappropriate schedule of vaccine administered. It was reported that eight year old child received his fourth DAPTACEL at age 2, he missed his fifth dose. It was unknown whether patient experienced 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 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. List of documents held by sender - none.
1: 12/20/20: 4:30pm: headache, injection soreness, tiredness, feeling worn out: started around 8pm lasting through next day  2: 1/9/21: 9am: headache, injection soreness, tiredness, feeling worn out, chills, body aches, chest tightness: started around 8pm lasting to next day (today)
I took the Janssen COVID-19 vaccine on Monday morning at 0905 hours. Right after the injection, my left arm was sore in some areas and numb around the injection site. At around 1900 hours I started to have an extremely bad headache which persisted for over 48 hours. On Tuesday, I had diarrhea the entire day with approx 8 bowel movements. Additionally, I had muscle cramps in my chest and back. The diarrhea subsided after I slept most of the day Tuesday. Most of my symptoms subsided on Wednesday evening. However, it is now Thursday and I still have numbness around the injection site and pain in my back along with tiredness. My heart rate is also 20 bpm above the average when resting, walking, or exercising. I would like to be checked for blood clots as the result of this vaccine.
1/22/22 - sudden onset headache after day with grandchildren and supper with son and daughter in law. COVID positive 1/23/22 after sleeping most of day. Basically like a cold for the next week, did the usual to prevent cold complications - Flonase and Q-var inhaler. 4/7/22 - ongoing sinus problems, ( nose burns because of coldness, causes headaches requiring Excedrin 1-2 times a day. No congestion, no fever, no sinus pressure, no sinus tenderness) Augmentin Rx x 10 days after video visit. Burning coldness quit after 2 doses, and resumed the day following completion of Augmentin on 4/15.  MD appt 4/19 with Keflex ordered x 10 days. Burning coldness stopped after 2 doses, resumed 4/24.
5 hours after receiving DTaP #1, IPV #1, Hib #1, Prevnar #1, Rotateq #1 pt had 20 minute episode of acute pallor, cyanosis, and was limp. Evaluated at ER, transferred to hospital. Observed overnight, tests normal. Patient reviewed fully to date.  0/30/07 Reviewed pcp records which consisted of vax records, ER records & hospital records.  Vax record confirms dose & lot #s as reported.  ER records indicate patient seen in ER on 10/22/2007 for ALTE.  Awakened from nap, turned pale w/cyanotic lips, eyes that were not alert, limp body, not reponsive to stimulation followed by slow improvement back to normal.  Transferred to higher level of care & kept in observation overnight.  No further episodes & was d/c to outpatient f/u.  Seen by pcp on 10/24 & f/u CXR, EKG & EEG to be done. FINAL DX: ALTE. 1/7/08 Reviewed additional hospital records received.  No new information.
High fever of 102+ for 5 days, fatigue, loss of appetite, and all over rash showing on 4th day and continuing for 5+days
Slight cough, cold symptoms before vaccine became EXTREME cold/flu/pneumonia symptoms less than 24 hours after being vaccinated,  including nausea, coughing, pain, body aches, weakness, fatigue, difficulty moving, difficulty breathing, lack of appetite, extreme headaches, 102 fever for 5+ days, etc.;  Emergency Room visit 03/08/2021, 4:00 AM - 36 hours after being vaccinated
increased serum calcium levels; This case was reported by a consumer via call center representative and described the occurrence of serum calcium increased in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 26th July 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a month after receiving Shingrix, the patient experienced serum calcium increased (serious criteria hospitalization). On an unknown date, the outcome of the serum calcium increased was not recovered/not resolved.   It was unknown if the reporter considered the serum calcium increased to be related to Shingrix.  Additional details were provided as follows: The patient received shingrix on left arm. In August 2019, the patient was hospitalised for increased serum calcium levels. This case was linked with US2019AMR189454 having same reporter and same patient (dose 2)
The vaccine was given to the patient past the beyond use date. The clinic is currently working on creating guidelines and processes so that this doesn't happen again.
pt came to the office w/fever; pt then got mottled, cyanotic from feet to neck w/30 seconds; pt had elevated HR, thready pulses; poor capillary refill; pt recvd oxygen, blood culture & was adm to hosp;
Protocol for Moderna vaccine is 18 years and older.  Patient was only 17. Need to get contact information for patient from school.
Arm swollen, hard and pink around injection site.  Disappeared in a couple of days.
PT recd vax 11MAY91 ? & 11JUN91 @730; 1 hr p/2nd dose (830) exp'd h/a, neckache, hand shake, trembling, & shoulders ached;
23JUL94 began running high temp 101-103; 25JUL94 notified CNS that pt was running fever, hallucinating & vomiting; t103; also c/o sore lt knee & back hurting; to MD , to ER temp inc to 105.3; adm to hosp for tests, rx IV therapy
Dizziness. Extreme, could not stand, began after awaking from a nap. Still occurring 12 hrs after vaccination.
This case was reported by a consumer via call center representative and described the occurrence of elevated liver enzymes in a female patient who received Hepatitis A vaccine for prophylaxis. On an unknown date, the patient received Hepatitis A vaccine at an unknown dose. On an unknown date, unknown after receiving Hepatitis A vaccine, the patient experienced elevated liver enzymes. On an unknown date, the outcome of the elevated liver enzymes was unknown. It was unknown if the reporter considered the elevated liver enzymes to be related to Hepatitis A vaccine. Additional details were provided as follows: The age at vaccination was not reported. The patient was not certain that she received HAVRIX. She only knows that it was a Hepatitis A vaccine. The patient experienced her liver enzymes were elevated. The patient refused to answer any questions. The time frame was unknown. Lab Comments: On an unknown date, the patient's liver enzymes were elevated.
HEAVY MENSTRUATION; IRREGULAR SPOTTING; NAUSEA; This spontaneous report received from a patient concerned a 27 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: 23-JUN-2021) dose was not reported, administered on 11-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 19-MAY-2021, the subject experienced heavy menstruation. On 19-MAY-2021, the subject experienced irregular spotting. On 19-MAY-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from nausea on 20-MAY-2021, had not recovered from heavy menstruation, and the outcome of irregular spotting was not reported. This report was non-serious.
Infant found deceased in crib. Follow up: this report was received from the Centers for Disease Control and Prevention in response ot Freedom of Information by GSK. This case was reported by the CDC and Prevention and described the occurrence of death in a 2month old male patient who received diphtheria and tetanus toxois and acellular pertussis adsorbed , hepatitis B recombinant and inactivated poliovirus vaccine combined. On 13JULY2004, the patiet received the first dose of Pediarix. On the same day, the paitent also received injectons of Haemophilu influenzae type b conjugate vaccine and 7 valent pneumococcal conjugate vaccine. Approximately eight days following the receiipt of the immunizations, on 21JULY2004, the patient was found dead in his crib. It is unknown whether an autopsy was performed.  Autopsy report received which reveals COD as unexpected death of infant while cosleeping.
Information has been received from a licensed visiting nurse concerning a patient who since Jan 2005, was vaccinated SC with a 0.5ml, dose of varicella virus vaccine live. Between 1/1/2005 and 6/29/2005, the patient developed a full blown case of chickenpox. The patient has fully recovered. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
24-30 hours after vaccination was administered I experienced terrible pain in my left shoulder and upper arm. I went to doctor two weeks later when it wasn?t any better. He put me on inflammatory pills which didn?t help and then he did a Cortizone shot and physical therapy those also did not help. From there we did an x-ray and an MRI and we found there was a full rotator cuff tear.
rash, myalgias, nausea, low grade fever 36hr p/vax;possible viral illness;
8NOV96 sz p/2nd dose of vax occurring several hr later;multiple sz over past 3mo nl EEGx3, nl development;
About 18 days after shot, I noticed pain on my left side in evening after sitting in bed two hours watching TV.  Turning or changing position hurt but passed if I held the position.  It affected my sleep a bit more as the days past.  But during the day, I could dance, move with no or sometimes, a tiny bit of pain in my side or back.  Because it got more painful at night and early mornings when I got up I decided I better contact you and delay the second dose which is scheduled for Friday, 4/23/2021 at l:00 pm.  Should I take Tylenol in the meantime at night.  Again I feel fine during the day when I am moving around.  But there is a reminder from time to time.
A non-serious spontaneous report of administration of expired FLUMIST was received from a health professional concerning a 35-month-old female. Neither the patient's past medical history.
About 6 hours after shot left ear plugged. 24 hours after shot severe vertigo sensation lasting about 2 hours. 48 hours after shot same experience. Went to urgent care was prescribed meclizine for nausea. Ear still plugged 5 days after shot, no other cold symptoms. Multiple minor vertigo episodes. No resolution as of yet.
Info has been received from a physician concerning a male who was vaccinated with a dose of varicella virus vaccine live. Subsequently, the pt experienced rash. Additional info has been requested.
pt recv vax & 2 days post vax pt exp sudden onset of chest tightness, SOB, rhinitis, coughing w/clear expectoration;had no fever;;ER or MD visit was required;tx ATB, ventolin, steroids, azmacort, Vancenase;
PT. DID EXPERIENCE SOME VOMITING, SWEATING AND SHAKING SEVERAL MINUTES AFTER VACCINES WERE GIVEN.
pt recv vax 12JAN98 & 24JAN98 pt devel less than 15 chickenpox lesions on arms, face  & neck;the lesions were vesicular, red & itchy;
This case was reported by a consumer via call center representative and described the occurrence of herpes simplex keratitis in a 67-year-old female patient who received SHINGRIX for prophylaxis.  The patient's past medical history included herpes simplex keratitis (usually affected patient's right eye). On 8th March 2019, the patient received the 1st dose of SHINGRIX. In March 2019, less than a month after receiving SHINGRIX, the patient experienced herpes simplex keratitis (serious criteria GSK medically significant) and rash. The patient was treated with acyclovir. On an unknown date, the outcome of the herpes simplex keratitis was recovering/resolving and the outcome of the rash was unknown. It was unknown if the reporter considered the herpes simplex keratitis and rash to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient's husband. The age at vaccination was not reported. The patient received a dose of SHINGRIX on the left side. The patient had history of herpes simplex keratitis that usually affects her right eye. After receiving the SHINGRIX vaccine, she developed very similar symptoms of the same but affecting her left eye. The patient also experienced rash break out on her scalp on the top of her head on the left side, the same side she had received her vaccine. The patient did not contact the physician for the adverse events. The reporter stated that on the day of reporting, the patient began taking Acyclovir orally per a previously prescribed from her physician, and the symptoms in her left eye were improving. The reporter was advised to contact the physician to let him know what had occurred with the first SHINGRIX vaccine. The reporter wanted to know, if this was a expected side effect.
Fainted; Disoriented and didn't know what was happening; Feels a little dizzy; Lethargy; Tenderness in the arm; A spontaneous report was received from a consumer who was a 36-year-old, male, patient, who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced fainted, tenderness in the arm, lethargy, disoriented and didn't know what was happening, and feels a little dizzy.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 14 Jan 2021, prior to the onset of events, the patient received the first of two planned doses of mRNA-1273 (Lot number: 25L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On the evening of 14 Jan 2021, the patient had tenderness in the arm and felt lethargic.   On 15 Jan 2021, the patient fainted when he woke up in the morning. The patient's legs gave out and he fell into the wall. The patient was disoriented and didn't know what was happening. The patient reported the event as happening pretty quick and described it as "like he had very low blood sugar". The patient reported that sometimes when he gets up too quickly, he feels a little dizzy. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, fainted, tenderness in the arm, lethargy, disoriented and didn't know what was happening, and sometimes when he gets up too quickly, was unknown. The event, feels a little dizzy, was considered not resolved.; Reporter's Comments: This spontaneous report refers to a case of a 36-year-old male patient who experienced events of fainted, tenderness in the arm, lethargy, disoriented and didn't know what was happening, and feels a little dizzy.  The events developed on the following day after the administration of the mRNA-1273 vaccine (Lot # 25L20A, expiration date-unknown). No treatment was reported, and outcome is resolved for dizziness and unknown for all other events.  Based on the information provided which includes a temporal association, a causal association cannot be excluded
Information has been received from a medical assistant concerning a 34 year old female patient with no known drug allergies or pertinent medical history who on 07-OCT-2009 was vaccinated with a first dose of PNEUMOVAX 23 (lot # 665402/1339Y), 0.5 ml. There was no concomitant medication. ON 08-OCT-2009 the patient developed an erythematous area at the site of injection after administration of PNEUMOVAX 23. The area now extends down her arm. The physician did not think it was cellulitis. Lab diagnostics studies were not performed. The patient sought medical attention at office visit. At the time of this report, the patient was not recovered. This is one of several reports received from the same source. Additional information has been requested.
Woke up feeling light-headed and dizzy. Called Doctor's office at 11:20 AM. Took pulse with wrist heart rate monitor, and it was 98-102 bpm. Temperature of 99.5. Couldn't bend over as would get very dizzy. Large rash the size of two silver-dollars where the injection site was. Injection site hot to touch, entire upper arm sore and tender. Laying down caused heart rate to return to normal. Doctor prescribed 6 day dose of Prednisone and taking BENADRYL in addition to already taken daily ALLEGRA dose. Had to call off work due to side effects.
Patient received bivalent preparation of Moderna vaccine as her second dose.  No adverse events were noted/documented.
arm felt tingly when shot went in and immediately started to hurt on forearm between elbow an wrist. immediately that area swelled up and turned red. today (4/22) it is still significantly swollen, though swelling has decreased. also immediately felt "spacey" and feet and forehead felt tingly. within 30 minutes it felt odd to walk because legs/feet felt a bit numb. the spacey feeling  stayed for 6 full days during which i felt exactly the same as i had when i had a concussion  about 6 years ago. i could think but i couldn't multi-task, communicate well, focus well, speak normally. it's hard to explain but it felt like  i had a concussion and it was really scary. i tried to drive at day  6 and realized i could not do it. by day 7, my head started to clear up and i felt better mentally.
achiness; Fatigue; patient was administered 0.3ml of undiluted covid vaccine intramuscularly.; patient was administered 0.3ml of undiluted covid vaccine intramuscularly.; This is a spontaneous report from a Pfizer-sponsored program, IBCC (Inbound Call Center for HCPs). A contactable pharmacist reported that a 28-year-old female patient received bnt162b2 (BNT162B2; lot number: EH9899; NDC number of Covid vaccine: 59267-1000-1 Expiry Date of Covid vaccine: Mar2021), intramuscular on right deltoid on 18Dec2020 at 0.3 mL for COVID-19 immunization. There were no medical history and concomitant medications. On 18Dec2020, a patient was administered 0.3ml of undiluted covid vaccine intramuscularly. The patient experienced achiness, fatigue. The patient received the covid vaccine injection Friday afternoon. When querying seriousness regarding the patient receiving the undiluted dose, he states she has not had very many side effects from it thus far. Clarifies that achiness and fatigue were her main side effects which started Friday night and continued into Saturday. Treatment: She received IV fluids this weekend in the ER as a precautionary measure He does not have time to continue with report and requested to be transferred. No further details. The outcome of the events was unknown.
Fatigue after vaccination; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "Fatigue after vaccination".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient states that on the night of vaccination (3/23/21) she started feeling badly with flu-like symptoms. Her temperature is running 103 F, has a headache, and very severe joint pain (which she states is her worst symptom). Not much improvement today 3/24/21. She is going to keep in touch and go to dr or ER if symptoms worsen.
Pain at injection site, significant swelling and redness below injection site, muscle soreness and tenderness.
The vial was initially stored in the refrigerator on 17-Sep-2022 and admistered on 18-Oct-2022; No Adverse event; Patient administered an expired (30 day use by) bivalent vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered an expired (30 day use by) bivalent vaccine), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 17-Sep-2022 and admistered on 18-Oct-2022) and NO ADVERSE EVENT (No Adverse event) in a 67-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7147B) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Oct-2022 at 10:30 AM, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 18-Oct-2022 at 10:30 AM,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered an expired (30 day use by) bivalent vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 17-Sep-2022 and admistered on 18-Oct-2022) and NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient administered an expired (30 day use by) bivalent vaccine), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 17-Sep-2022 and admistered on 18-Oct-2022) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient administered an expired (30 day use by) bivalent vaccine) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 17-Sep-2022 and admistered on 18-Oct-2022).    No concomitant medication information was provided.  Reported that Vial size was 2.5 ml. The vial was initially stored in the refrigerator on 17-Sep-2022 and 30 day use by date was 17Oct2022. The vial did not undergo any temperature excursions.  No treatment medication were provided.   Most recent FOLLOW-UP information incorporated above includes: On 18-Oct-2022: Live follow up received contains significant information: Updated patient demographics.
Information has been received from a registered nurse referring to a patient of unknown age and gender. On 02-MAR-2015 (reporting day) the patient was vaccinated with an expired dose of RECOMBIVAX HB (strength: 10 (unit was not reported); dose, route were not reported, Batch #: H010671, lot #: 0334AE, expire date: 28-FEB-2015). No adverse events were reported. Additional information has been requested.
Injection given on 1/14. I noticed only tenderness at the site the first two days. Six days later I became aware of warmth on my are and a defused rash. Today, 13 days later, the rash is totally red with defined edges and larger in area than last week. It is not totally painful, but I feel it, am aware of it on my arm. It itches slightly and feels good to be gently rubbed.