chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Lack of response - Information has been received from a registered nurse concerning a 52 year old caucasian female patient who was vaccinated sc with the first and second dose of varicella virus vaccine live (lot 631171/0879J) on 01 Jun 1999 and 19 Jul 1999 respectively in the right arm.  Subsequently the patients laboratory results indicated a lack of serocoversion.  It was indicated that an additonal patient waes 00051818 had a similar experience.  No further information is available.
My daughter was hospitalized with a temp of 106.8 for RSV.  The Dr said RSV rarely hospitalizes children and asked if she'd had any shots recently.  I had told him about her flu shot and he explained it had weakened her immune system allowing the RSV to get so bad as to need hospitalization.
Patient received this year's flu vaccine on Sept 8, 2017 while in training. She was revaccinated due to a clerical error. She had no SE to date. Designated Medical Officer and Regional Pharmacy Executive were notified of incident.
Tingling like limbs going to go to sleep from neck down. More so in hands, arms, legs and feet. Completely uneasy feeling, restless and in pain. Through out next 2 weeks tingling was more apparent on left side, including left hand, arm, leg and foot.  Then moved to just left foot to which I?m still experiencing numbness. Numbness meaning I can feel touch, but foot feels ?dead? almost heavy. Has a cool sensation to it, feels asleep without tingling sensation. A lot of pain came with this in my muscles and achy in bones. Hands still feel weak.
Employee received .2 cc of Pfizer instead of .3 cc which was inadvertently administrated by vaccine nurse.   NO ADVERSE REACTION, just reporting medication error.   after speaking with CDC and other source, we decided to offer the employee an additional COVID-19 vaccine dose.  Thanks.
was so sick like if I had the covid same symptoms or worse; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.  Additional details were provided are as follows: The age at vaccination was not reported. The patient had a shot and on 2nd dose was sick like if he/she had the covid symptoms or worsen. No further information was reported.
Alzheimer's dementia for several years, had shown significant improvement; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A 95 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "non-Alzheimer's dementia" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG EFFECTIVE FOR UNAPPROVED INDICATION (non-serious), outcome "unknown", described as "Alzheimer's dementia for several years, had shown significant improvement". Additional Information: When (Name) visited her mother in March, (Name) was alert, smiling and articulate in short sentences. She even read the aid's name tag aloud.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Confirmed Breakthrough Case  COVID-19 (Moderna) 1  03/27/2021 Medical Center Moderna 017B21A   COVID-19 (Moderna) 2  04/23/2021 Medical Center  Moderna 025B21A
Within a few weeks after the booster I developed flashing light floating in my right eye. Then on three occasions each maybe a week or two apart I almost fainted. I was sitting down when the near fainting happened. Things went dark, yet I could hear surroundings. Also I had a rise in heart rate separate from the fainting. After these events no more issues have occurred. But the events have initiated a trip to my primary care doctor who in turn suggested a battery of tests. Stress, EKG. Neurologist, cardiologist and optometrist appointment. Also had a brain MRI. After the news on January 18, 2023 reported a connection with stroke and the Pfizer vaccine that was given to people 65 or older.
2-5hrs p/receiving dose 1 & 2 of hep B pt developed a dizzy lightheaded feeling enough to make him afraid to drive his car; Rxn subsided w/in 3-4hrs;
11/23/2005 received 2nd dose of Twinrix. Noticed rash 11/23/05 pm. 11/26/05 went to walk in clinic received cortisone shot and PO antihistamines. Client states very rapid resolution of rash. States they were slightly reddened hives that itched. 11/28/05 client followed up with his primary physician, no further treatment or Meds given.
pt recv vax;1 1/2 hr later felt hot,fussy & irritable;flailed arm upward & clutched;to er;baby turned red & did not breathe;to er for 24 hrs of observation; no further problems;
I developed oligohydramnios. I was approximately 35 weeks pregnant at the time. My amniotic fluid fell to low levels which was detected on November 5th during regular follow up with maternal fetal medicine doctors. I was then followed closely as an outpatient. Over the next week my amniotic fluid continued to drop. I was admitted to Hospital on November 11th for IV hydration and the amniotic fluid level dropped to a level consistent with oligohydramnios on November 12th per ultrasound. The amniotic fluid did not respond to IV hydration and continued to decline. I was induced for four days and delivered my son prematurely at 36 weeks via vaginal delivery who is healthy.
4/16/21 short of breath while gardening. Came to ER, diagnosed with Bilateral Pulmonary Emboli
Severe swelling and redness around the site of injection. Blister like appearance 3 inches around injection site. Breakout around neck, spottled looking.
This spontaneous case was reported by a medical assistant and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Patient received a vaccine that underwent a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received a vaccine that underwent a temperature excursion) and NO ADVERSE EVENT (No adverse event) in a 3-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 prophylaxis. No Medical History information was reported. On 13-Aug-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Aug-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Patient received a vaccine that underwent a temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received a vaccine that underwent a temperature excursion) and NO ADVERSE EVENT (No adverse event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Patient received a vaccine that underwent a temperature excursion), PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received a vaccine that underwent a temperature excursion) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Patient received a vaccine that underwent a temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received a vaccine that underwent a temperature excursion). The patient weight was 34.3 (unit not specified). No concomitant medication was reported by reporter. The vaccine administration location was on (unspecified). It was reported that, some vaccines were stored in the freezer and other vials in the refrigerator. The excursion occurred on 7-Aug-2022 and was picked up by local review of the temperature data logger 2 weeks later after the excursion. Total 38 patients received this. One refrigerated vial was with lot number AS1412B and expiration date 10-Feb-2023. Maximum or minimum temperatures reached was 14 degrees Celsius for 3hr 5min. Vial was moved from refrigerator on 8-Aug-2022. Those were administered or discarded. Proposed desired used by date was 18-Aug-2022. Patient did not have any side effects. No treatment medication was reported by reporter.
Tested NAAT positive for COVID-19 10/31/21 after being fully vaccinated.
Hives, Increased Blood Pressure, Increased pulse, Rapid/Shallow Breathing, Dry Mouth, Red & Blotchy Skin.
A couple of minutes after the vaccine I started to have a little migraine. I felt pressure in my head. Then 30 min later I started to have an anaphylactic reaction. I stayed for 2 hrs in a half until I was able to drive. When I left I got to my friends house and I started having another reaction there but I took lots of Benadryl and that helped me.
Initial unsolicited report received from a consumer on 24-Oct-2017. This case involves a 90-year-old male patient who was vaccinated with a 0.5 ml single dose of FLUZONE HD (batch number, expiry date and site of administration were not reported) via intramuscular route on 18-Oct-2017. The patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient experienced severe ringing in ears which resolved and now has a persistent buzzing in his head. The patient's laboratory data and corrective treatment were not reported. On an unknown date the patient was recovered with sequelae from events. List of documents held by sender: none.
Light headed; wheezing; pressure in chest; trouble breathing; soreness in vaccinated arm; headache; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Light headed), WHEEZING (wheezing), CHEST DISCOMFORT (pressure in chest), DYSPNOEA (trouble breathing) and VACCINATION SITE PAIN (soreness in vaccinated arm) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] for an unknown indication.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced DIZZINESS (Light headed), WHEEZING (wheezing), CHEST DISCOMFORT (pressure in chest), DYSPNOEA (trouble breathing), VACCINATION SITE PAIN (soreness in vaccinated arm) and HEADACHE (headache). At the time of the report, DIZZINESS (Light headed), WHEEZING (wheezing), CHEST DISCOMFORT (pressure in chest), DYSPNOEA (trouble breathing), VACCINATION SITE PAIN (soreness in vaccinated arm) and HEADACHE (headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information not provided.   This case was linked to MOD-2021-043718 (Parent-Child Link).   See case MOD-2021-043718 for details regarding the child case.  Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Outcome and reporter causality of events updated.
the next day, had unwitnessed syncopal episode, hitting head, no other symptoms.
Patient felt dizzy after dTaP, Varicella, and HPV administration.  She had a syncopal episode lasting seconds, immediately recoverd with stable vital signs.  To note patient has a past medical history significant for syncope and did not take her atenolo that morning.  She was sent to the ER for fluids and further monitoring.
Next day (Dec. 1st, 2021) body aches, day after (Dec. 2nd, 2021) not as bad but still debilitating and has not improve to this day (Jan. 27th, 2022).
pt recv vax 17OCT95 & w/in 2 days devel arm pain,tingling in hand & fingers & no strength in fingers 4 & 5;saw neurologist on 15NOV95 who allegedly told pt there was no nerve involvement;dx muscular pain d/t vaccine;
Approximately 8 days after the vaccination (1/22/21), patient experienced a large, raised rash on her arm. She received dose number 2 in the series as scheduled.
patient received the bivalent booster dose for their first dose of their primary series.; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (patient received the bivalent booster dose for their first dose of their primary series.) and NO ADVERSE EVENT (No adverse event) in a 23-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (patient received the bivalent booster dose for their first dose of their primary series.) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (patient received the bivalent booster dose for their first dose of their primary series.) 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 assessment was provided for WRONG PRODUCT ADMINISTERED (patient received the bivalent booster dose for their first dose of their primary series.).    No concomitant medications was reported. No treatment medications was reported.
Persistent pain for two weeks post vaccination.  Left Deltoid. Post-immunization brachial plexius?
Severe joint pain and stiffness upon waking, peaking approximately 20 days post-vaccination but still persistent.  Diagnosed with rheumatoid arthritis 9/22/06.
Right after vaccination, patient was really nervous and anxious.  After sitting for a couple minutes, she proceeded to walk from the vaccination room to the chairs located on the outside of the room.  She then slumped over on the counter then sat down with the help of another member.  She then was assisted over to a chair and sat until EMS arrived.
Rash on the arm, pain in left arm and travels to neck, hair loss, unable to control bladder and bowel movements, numbness in hands.
Acute tinnitus in both ears. Mostly left ear.   Onset approx 2 days 8 hours after injection
Had HPV and Menactra on 4-5-07 on 4-10-07 began to have chest and abdomen pain then had seizures (abd) a few days later which have developed into grand mal seizures. 7/5/07-records received for DOS 4/16-5/29/17-seen by cardiologist on 4/16 for C/O chest pain, experiencing chest pain for several months, 3-5 times per day last from 1-3 minutes, occasionally becomes nauseous with pain. Associated sharp abdominal pain at time, left sided. Impression: experiencing noncardiac chest pain. Seen by neurologist on 5/4/07- with C/O seizures versus migraines verus other. Having intermittent apells that are confusing in spite of multiple work ups and evaluations. Episodes occur any time night or day, woken the patient up twice. Seem to be somewhat progressive, patient first complains of chest  pain and this occurs in epigastric region radiating to left chest and patient may tense up, episodes now described as being normal and then 5-10 minutes spaces out. Seems to be in a trance and is amnesic and may fall to floow with cold sweats and cries and screams may ball up into fetal position. Has had 4 back to back. Always happen on the left. Two weeks prior to onset of symptomatology patient had HPV vaccine and meningiococcal vaccine. Follow up visit on 5/30/07-Currently all spells have been on Friday and Saturdays and consisting of trembling, shaking all over, both hands are fists, she becomes stiff her eyes are squeezed tight. Ususally an aura of nausea prior to event. EEG normal and 6 hour vido EEG was normal. Assessment: paroxysmal spells would could represent complex parital seizures versus nonepileptic events.
Injection site on left arm swelled immediately to golf ball size lump that was hard to the touch. Pt was given 2 x 25 mg Diphenhydramine and was observed for 1/2 hours for adverse signs. Swelling started to go down & pt left store with instruction to call Dr if SOB or increased swelling.
Per mother, patient received 2 month immunizations on afternoon of 9/9/05, was given dose of tylenol after shots.  Went home, had feeding before bed for the evening and was acting normally.  Patient did not wake up for 4 am feed, and then had to be woken up for 8 am feed.  She did take the bottle, but then was floppy and difficult to keep awake.  Fever upon arrival to ER, was admitted for septic workup which was negative. Follow-up report states: 9/23/05 Medical records x 15 pgs received and reviewed. Final diagnosis was "fever, congestion, and decreased po intake after having received 2 months vaccinations on the day prior to admisson." Septic workup was negative. It was noted that infant had frontal skull bone fracture on 8/31 from falling from bed, with no neurologic sequelae. Also infant had prenatal cocaine expose. To follow up with peds primary care on 9/19/05 and neurosurgery on 9/15 (previously scheduled FU for depressed skull fracture). There were no medications prescribed. Pt was discharged in good condition. Records submitted for scanning. No additional COSTARTS. Case marked complete/closed and paper report filed/sem.
Discharge Provider: MD Primary Care Provider at Discharge: Alternate MD  Admission Date: 10/31/2022 Discharge Date: 11/2/2022  PRESENTING PROBLEM: Mild persistent asthma with exacerbation [J45.31] Acute asthma exacerbation [J45.901] COVID-19 [U07.1]   HOSPITAL COURSE:    Patient is a 78 y.o. female  who presented to Health hospital on 10/31/2022. The patient states that she has been having coughing and shortness of breath since about 10/20. She presented with fevers and chills and presented to the hospital with worsened shortness of breath and coughing.  Chest x-ray was performed in the emergency department which shows no acute chest process.  She has leukocytosis of 18 upon admission she recently completed a oral steroid taper.  Given persistent fever. A film array was ordered to rule out a secondary viral infection due to a negative procalcitonin suggesting no secondary bacterial pneumonia.  The patient was also encouraged to use incentive spirometry and started on supportive care with cough suppressants and Mucinex.  While hospitalized she was treated with nebulizer treatments, IV Decadron and azithromycin.  She has not required supplemental oxygen during the hospital stay. Will continue robitussin with codeine for cough suppression and azithromycin for antiinflammatory properties. Recommend post-hospitalization follow-up with PCP in 1-2 weeks. Of note the patient has leukocytosis which is likely steroid induced. Recommend follow-up CBC with diff in 2 weeks.
Patient received 2nd dose of Moderna vaccine on March 12th in the early afternoon and started experiencing intermittent itching, swelling and redness below the injection site (left tricept) that started Saturday March 13th.
I'm still experiencing COVID-19 symptoms. I had a lot of fatigue, coughing fits; severe head congestion which I still have. I flew and felt sick and my wife felt sick too so as soon as we got home we tested and it was positive right away. I was given antiviral 4 tablets for 5 days, it was not Paxlovid.
This spontaneous report as received from an office supervisor  medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history and concomitant therapies were not reported. On unknown date in 2017, the patient was vaccinated with an incorrect storage dose of GARDASIL 9 (lot # M036059 with expiration date of 03-JUN-2019; strength, dose, route and anatomical location were not provided), for prophylaxis. The vaccine was exposed from 47 degrees Fahrenheit to 77 degrees Fahrenheit for 12 hours. There was no previous temperature excursion. The call was made because there was a "data logger".  No adverse effects were reported. No product quality complain was involved. This is one of several reports from the same reporter. Sender's Comments: US-009507513-1707USA006643.
Swollen and sore left underarm area. Tender when arm is lowered to resting position.
After patient left it was discovered the he was given 0.2cc  of adult Pfizer vacccine.  He should have been given covid 19 mRNA 5-11 yr old. Patient waited the 15 min protocol for all patients without a reaction noted. I notified my director who notified doctor. Members weight is 76# >120days noted in chart. Age 10yrs.
15 minutes after vaccine of Hepatitis B, employee started experiencing muscle spasms in left arm and left leg.  Employee's joints in affected arm became stiff and edemitis.  Vital signs within normal limits took employee to local physician and he diagnosed her with a  moderate reaction to vaccine and treated it with steroids (intramuscular at office and 10 day supply of Prednisone)