chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Seizures and tremors (less than 48) hours after vaccines. Increased to 50 or more a day. No fever. His seizures are better, but his encephalopathy has evolved into Tourette's syndrome they feel now. You may have access to medical records- already signed release form to you. Follow up report received on 01/25/2005 indicates patient has not recovered still has tics, ocd's, siezures, adhd, general anxiety, learning disability, aggression, angry, irritable. Had streop (scarlet fever) in May 2003, strep was still in his system at time of vaccines, MMR and strep don't mix and triggered his PANDAS.
At about 10:25 am  itching of neck and face. At about 10:40 am mild cutaneous swelling of lip.  Symptoms rebounded overnight
father called this AM stating gave APAP pt last noc pt was crying & c/o severe abdo pain all noc; told to stop APAP & contace MD to r/o other causes of abdo distress; 230PM states pt improved;
Localized reaction at injection site; red, slightly swollen and slightly hard. Icepack applied, with instructions for patient to continue applying ice at home; to be seen at the health center primary care provider for reassessment of injection site. Size of localized reaction measured for baseline.
Moderna vaccine taken out of freezer on 20-Apr-2022, out of freezer expiration date was 20-May-2022 and administered on 20-May-2022; On 24-May-2022 patient was given (4 days expired) Moderna vaccine, with manufacturer expiry date 10-Jul-2022, beyond 30 days duration; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (On 24-May-2022 patient was given (4 days expired) Moderna vaccine, with manufacturer expiry date 10-Jul-2022, beyond 30 days duration) and PRODUCT STORAGE ERROR (Moderna vaccine taken out of freezer on 20-Apr-2022, out of freezer expiration date was 20-May-2022 and administered on 20-May-2022) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033K212A, 013M20A and 037k20A) for COVID-19 prophylaxis.     Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 24-May-2022 at 3:15 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 24-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (On 24-May-2022 patient was given (4 days expired) Moderna vaccine, with manufacturer expiry date 10-Jul-2022, beyond 30 days duration). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Moderna vaccine taken out of freezer on 20-Apr-2022, out of freezer expiration date was 20-May-2022 and administered on 20-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (On 24-May-2022 patient was given (4 days expired) Moderna vaccine, with manufacturer expiry date 10-Jul-2022, beyond 30 days duration) and PRODUCT STORAGE ERROR (Moderna vaccine taken out of freezer on 20-Apr-2022, out of freezer expiration date was 20-May-2022 and administered on 20-May-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information provided
second dose wasn't fully administered; Part of the vaccine spilled out down her arm; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (second dose wasn't fully administered) and INCOMPLETE COURSE OF VACCINATION (Part of the vaccine spilled out down her arm) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005C21A and 021B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-May-2021, the patient experienced UNDERDOSE (second dose wasn't fully administered). 03-May-2021, the patient experienced INCOMPLETE COURSE OF VACCINATION (Part of the vaccine spilled out down her arm). On 03-May-2021, UNDERDOSE (second dose wasn't fully administered) and INCOMPLETE COURSE OF VACCINATION (Part of the vaccine spilled out down her arm) had resolved. Not provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Patient received pfizer vaccine on 2/17/21. Presented to ER on 7/12/22 and found to be COVID positive. Patient presented from home, she reports she lives with her daughter. Patient was brought emergency room for evaluation of shortness of breath.  Patient reports she started to feel short of breath all of a sudden today.  Patient reports she is on chronic home oxygen 2 L. And she is not feeling well. Denies fever chills nausea vomiting.  Denies cough phlegm production. In the course of hospitalization, patient was  managed with azithromycin, ceftriaxone for suspected bacterial pneumonia,  DuoNeb treatments, methylprednisolone.  Clinically, she has improved. patient is stable at this time and will be discharged to a skilled  nursing facility on 7/22/22.
3RD DOSE MODERNA COVID VACCINE GIVEN 11/24/2021, #065F21A; pt to hospital with worsening SOB, cough and wheezing; found to be positive for COVID; duo nebulized; methylprednisone; DNR/DNI; worsening respiratory status; transitioned to comfort measures and pt passed away in the hospital
hasn't been feeling well since getting the first dose of the vaccine; Nausea; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (non-serious), outcome "unknown", described as "hasn't been feeling well since getting the first dose of the vaccine"; NAUSEA (non-serious), outcome "unknown", described as "Nausea".  Additional information: The patient was not related to a study or programme. It was reported that the patient was scheduled for second vaccine tomorrow. It was reported that, the patient had not feel well since getting the first dose of the vaccine. The patient wanted to know anything that she can take for nausea. Patient want to know if she can reschedule her appointment, how long would wait to get the second dose. She heard that the second dose would be worse. She had spoken to a pharmacist and was not told anything.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
On 9/17/2016 child with fever and cellulitis of hand. Started on cephalexin 9/20 seen again for otitis media and sinusitis 9/24 seen for rash, sent to ER and diagnosed with leukemia and vaccination induced varicella.
Hard time falling asleep last night; Right away post injection, in the first fifteen minutes, there was a metallic taste in my mouth, a weird taste; increase in the vibrations of my tinnitus, my ears got full and it's very difficult to manage, My ears were full blast, i have it in both ears,unbelievable ringing like sounds in both ears/now have this unbelievable ringing again; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Right away post injection, in the first fifteen minutes, there was a metallic taste in my mouth, a weird taste   ), TINNITUS (increase in the vibrations of my tinnitus, my ears got full and it's very difficult to manage, My ears were full blast, i have it in both ears,unbelievable ringing like sounds in both ears/now have this unbelievable ringing again) and INSOMNIA (Hard time falling asleep last night) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Aug-2021, the patient experienced DYSGEUSIA (Right away post injection, in the first fifteen minutes, there was a metallic taste in my mouth, a weird taste   ) and TINNITUS (increase in the vibrations of my tinnitus, my ears got full and it's very difficult to manage, My ears were full blast, i have it in both ears,unbelievable ringing like sounds in both ears/now have this unbelievable ringing again). On an unknown date, the patient experienced INSOMNIA (Hard time falling asleep last night). At the time of the report, DYSGEUSIA (Right away post injection, in the first fifteen minutes, there was a metallic taste in my mouth, a weird taste   ), TINNITUS (increase in the vibrations of my tinnitus, my ears got full and it's very difficult to manage, My ears were full blast, i have it in both ears,unbelievable ringing like sounds in both ears/now have this unbelievable ringing again) and INSOMNIA (Hard time falling asleep last night) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Follow-up received on 06-Aug-2021: New event was updated.
FEVER THE NIGHT; SOME FATIGUE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced fever the night, and some fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever the night, and some fatigue. This report was non-serious.
3 RED "WELTS" ON LT ARM TOWARDS THE OUTSIDE-MENACTRA GIVEN IM ON OUTER ASPECT OF DELTOID MUSCLE & HEP A GIVEN TOWARDS INNER ASPECT OF DELTOID
Swollen lymph nodes in armpit and back of neck on right side.; This is a spontaneous report from a contactable consumer, the patient. A 44-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the right arm on 31Mar2021 at 15:15 (at the age of 44-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient was allergic to codeine. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration on 10Mar2021(at the age of 44-year-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 01Apr2021 at 00:00, the patient experienced very swollen lymph nodes in armpit and back of neck on right side. The adverse events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. The patient did not receive any treatment for the events.  The clinical outcome of the event swollen lymph nodes in armpit and back of neck on right side was not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
very tender, slightly swollen, red in two spots, now filled in for a 3" circle, stomach ache
7/31/19-day after vaccine - headache when woke up took 1000mg acetaminophen - extreme fatigue by noon - needing to go to bed, woke up about 2 hrs later with shaking chills, headache and a temp of 101.3,  took 1000mg  acetaminophen and water and back to bed, got up 2 hrs later still tired, headache, not feeling well, sat around and back to bed about 3-4 hrs later til the next morning (took 1000mg acetaminophen q 6 h) was already taking Mobic for back pain next day-8/1/2019 worn out and fatigued all day needing naps during the day Aug 2 , 2019-head felt woozy- sort of off balance- rested- home all day Aug 3- back to normal This also happened with the first vaccine back in December 2018 but only lasted 2 days as I remember
At approximately 2AM on Thursday, a severe headache (I would term a migraine based on prior experience) woke me. I had no apparent fever, but my body was stiff and I felt my heart rate was elevated. I drank some water, in case it was dehydration-related, but was unable to fall back asleep. I also experienced some nausea at breakfast but ate toast and had some (caffeinated) tea about 6 AM. Around 7 AM I took two (2) ibuprofen, which dulled the headache slightly. However it persisted into early/late afternoon hours on Thursday. (My customary activities were curtailed somewhat.) Since I have had migraines in the past, I treated this as I treated those: hydrating, taking pain medication as required, remaining quiet, reducing exposure to light and sound, etc. I continued taking two (2) ibuprofen periodically as I felt the need through bedtime Thursday night.  Friday I had periodic headaches (again, attributed them to rebound migraines or just headaches), felt tired, and been a bit 'out of it'. But my systems did not prevent me from functioning. I did repeat the two (2) ibuprofen on Friday night at bedtime.
Fever (100.9), headache, dizziness, blurred vision, swelling, redness, warm to touch at injection, nausea, vomiting, diarrhea, and weakness.
Initial report received from a nurse on 23 July 2010. A 58-year-old female patient, who had no concurrent illnesses, no known allergies and medical history of right breast cancer, ovarian cancer and DJD (degenerative joint disease) had received a first intramuscular left deltoid injection of H1N1 (lot number UP075AA) on 07 January 2010. One day following vaccination the patient complained of pain and limited range of motion in the left arm. She also had redness and bruising at the injection site as well. She was evaluated in the physician's office in May, June and twice in July 2010 for this complaint. Per the reporter, an MRI will be done. At the time of this report, the patient had not recovered. Documents held by sender: None.
Anaphylatic reaction: Initially, dizziness /light-headed which progressed to shortness of breath, sweating, syncope (within 5 minutes).  Required 1 dose of Epipen 0.3mg and EMS transport to hospital.   11/16/09 Medical records and discharge summary received for DOS: 11/12/09. Final DX: Allergic reaction to vaccine. C/o dizziness/wooziness s/p vaccine. Throat tightness. Diaphoresis. Epi in office. ED visit. Benadryl. D/C to home.
Body temperature of 102.3deg F; Arm was sore; Injection site is warm; Bodyache; Chills; Headache; Tired; Injection site is red; A spontaneous report was received from a a 62-years old female patient concerning herself, who received two doses of Moderna's covid-19 vaccine (mRNA -1273) and experienced the events, sore arm(pain in extremity), chills(chills), body ache(myalgia), headache(headache), body temperature(pyrexia), injection site warmth(injection site warmth), red(injection site erythema) and feel tired(fatigue).  The patient's medical history was not provided. Concomitant medications were not reported.  On 08 Jan 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 027120A) via unknown route for prophylaxis of COVID-19 infection.  On 08 Jan 2021 in the afternoon, the patient experienced the event sore arm, later in the night she had chills, body ache and headache. On 09 Jan 2021, the patient had a rise in body temperature and on 10 JAN 2021, the patient reported that injection site is warm and red, and she is tired. On 09 Jan 2021, the lab tests performed included body temperature 102.3. Treatment for the events included acetaminophen.  Action taken with mRNA-1273 in response to the events was unknown.  The events, sore arm, chills, body ache, headache and body temperature were resolved on 10 Jan 2021. At the time of this report, the outcome of the events, injection site warmth, red and feel tired were considered to be not resolved.; Reporter's Comments: This case concerns a 62-year-old female who experienced nonserious events of unexpected pain in extremity, injection site warmth and expected fever, chills, fatigue, myalgia, headache, and injection site erythema.  Event onset the same day as the first dose of mRNA-1273. Treatment with acetaminophen. Events ongoing. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Local reaction of redness and swelling to (L) upper arm to elbow. Required Cephalexin 500 mg 1 BID and BENADRYL 25 mg 1 PO BID x 5 days.
I received the flu shot this morning, and around 0900 I started noticing a hive on my left wrist that itches. A hive on the left hand and on the under side of the right arm. After monitoring it throughout the day the one on the Left wrist got bigger and was itching.
Rash at injection site for influenza vaccine. Pt prescribed cephalexin 500 mg q.i.d. by another physician.
The pt experienced a fever, extreme irritability, decreased appetite, decreased fluid intake, maculo-papular rash on trunk and neck, and pharyngitis.
Patient developed left leg swelling and pain.  Ultrasound performed showing superficial thrombophlebitis of L posterior tibial vein.
Approximately 10 minutes after receiving flu shot patient got lightheaded & fainted, and fell to floor, bumping his chin on way down, resulting in laceration. EMS responded but pt refused to go to ER.
Initial report received on 25 August 2008 from an other manufacturer who had received the original report from their company representative who had obtained the report from a health care professional. An 11-year-old male patient had received "T-Dap" (Trade name not provided), and MENACTRA vaccine on an unspecified date. The lot numbers, routes and sites of administration were not provided. The patient returned to the physician's office a couple of days after receiving the vaccine complaining of fever, diarrhea and lethargy. It was not reported whether the patient received any treatment, or had diagnostic tests completed. The recovery status of the patient was not reported. No further information was provided.
Employee indicated that immediately after receiving vaccine felt a sensation go up the right side of her neck followed by tingling and numbness in bilateral hands, blurred vision and nausea. Employee placed on stretcher for recovery, Benadryl 25 mg PO administered. Employee continues to voice complaints of numbness and tingling in hands, with discomfort in feet 4 days post receiving vaccine.
Pain/stiffness (1) starting in left groin area then over next 30-45 days, spreading and intensifying (2) to right leg (behind knee and down through calf); (3) to left leg (behind knee and down through calf); (4) to left shoulder and lower arm; (5) to right arm; and (6) to back of neck.  Diagnosed as Polymyalgia Rheumatics (PMR).  Treatment of symptoms: Prednisone, 20 mg daily beginning 12/6/2012.
1626-Patient c/o injection site itching, patient had been scratching a little.  Site was red around injection site. Doctor inspected that site as well. Claritin 10mg PO was given for localized reaction.     BP 107/59, HR 62, RR 20, RA O2 sat 97%   1634, itching seems to be better, will monitor for 15 more minutes for a total of 30 minutes.   1645- itching much better BP 99/53, HR 58, O2 sat 97% on RA.  NO c/o SOB, swelling of throat or chest pain   Patient states BP runs low
High temp 103 F rectally, non confluent maculopapular rash over face, trunk and back. Tylenol as needed.
Patient was standing outside the exam room and stated he felt he was tired. I helped him to the ground to lie down. He laid there for 5 minutes BP 119/71. He sat up BP 107/55. Gave patient water and had him lay back down for another 5 minutes. He stated he felt better and sat up BP 94/74. Patient did not eat in the morning. I explained to mom to have him eat something and if got worse take him to emergency. I walked patient to the car.
devel 4 raised red papules w/surrounding redness (shoulder, chest, face, abd;no tx given;
Have huge lymph nodes react and arm pits hurting-read this was fairly common as a matter of fact was told not to get mammogram for at least one month after as nodes could be read as potential cancer when not
CONFIRMED IMMUNOLOGICAL VACCINATION FAILURE; This spontaneous report received from a parent concerned a female of unspecified race, ethnic origin and age. Initial information was processed along with the additional information received on 17-MAY-2021 and 19-May-2021. 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: Unknown) dose was not reported, 1 total administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On MAY- 2021, the subject experienced confirmed immunological vaccine failure.  On MAY-2021, Laboratory data included: COVID-19 antibody test (NR: not provided) None. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of confirmed immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). The suspected product quality complaint has been confirmed to be not voided (meet PQC criteria). This report was associated with product quality complaint number:90000179791 The investigation has been reviewed and the root cause and disposition determinations were documented properly. the investigation is approved and closed. based on the PQC evaluation/investigation performed.; Sender's Comments: V0:20210527212-covid-19 vaccine ad26.cov2.s-Confirmed immunological vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS