chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient had an episode of V-tach which deteriorated to V-fib. He ended up getting CPR and cardioversion and at the time was posturing after being resuscitated. He did arouse eventually after that, but he had underlying dementia previously and this appeared to have worsened. He was already pretty much requiring total care from his wife. He did really improve, was unable to take p.o. Initially all of his medications were changed over to IV and they were continued, but the patient really did not improve. He had a couple of runs of V-tach again which terminated spontaneously after two and three minutes. He just did not really improve and was placed on comfort care.
Got extremely tired; This spontaneous case was reported by a non-health professional and describes the occurrence of FATIGUE (Got extremely tired) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history.).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Got extremely tired). At the time of the report, FATIGUE (Got extremely tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Fever; chills; aching; sweating; headache; This is a spontaneous report received from a contactable pharmacist via Pfizer sales representative. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on an unspecified date as a dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced fever, chills, aching, sweating, headache. The reporter clarified that the adverse event took place after Pfizer product use. The outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Started with mildly itchy rash/blisters on left side of torso 2/2/17.
Patient went off period at 53 years of age and period has returned now she is 58 years old; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUAL DISORDER (Patient went off period at 53 years of age and period has returned now she is 58 years old) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MENSTRUAL DISORDER (Patient went off period at 53 years of age and period has returned now she is 58 years old). At the time of the report, MENSTRUAL DISORDER (Patient went off period at 53 years of age and period has returned now she is 58 years old) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. Treatment medication was not provided.  Patient states her period went off when she was 53 years old and after receiving injection it has returned.
Given yellow fever and #1 Havrix around 15:00.  Between 8-9 pm, noticed itching all over.  10pm noticed hives on arms, trunk and legs.  Reported to Medical clinic 01/07/04 @ 13:30.  Hives disappearing and not as itchy.
5/26/11 4pm:Large hives over half of neck and back.  Difficulty breathing.  Solumedrol shot given at dr.s w/Prednisone 20mg tablets at home. 5/27/11 2pm:Large hives over other side of front of neck and stomach.  Difficulty breathing.  Solumedrol shot given at dr.s 5/27/11 10pm Large hives all over body & front of neck.  Difficulty breathing.  Taken to Emergency.  Prednisone, Benadryl, Pepcid through IV.  Kept for hours. 5/28/11 to present.  Hives on legs, arms and feet.  Extreme itching.  Still on 20 mg Prednisone 3x a day for 10 days.
Patient states she noticed pain in her right shoulder same evening of injection. Patient states that she had limited range of motion. Patient states that pain was so bad she stated that it was hard to "even dress her self for the next day."
Pt received two doses of Rotateq. Pt was sent to hospital on 5/28/07 for excessive vomiting. It was concluded that pt had intussusception.  6/22/07 Received PCP med recs which included hospital D/C summary & vax record which confirms RO lot & dose number as reported & includes other vax received same date.  VAERS database updated w/same. D/C Summary reveals patient admitted 5/28-5/29/07 for vomiting & abdominal pain.  Progressed we// & d/c to home. LABS: abdominal x-ray.  air contrast barium enema + for IS. FINAL DX: Intussusception.  07/27/07 Received hospital medical records which reveal patient experienced fever, vomiting, heme (+) stool & abdominal pain.  Admitted 5/28-5/29/07 for observation s/p reduction of intussusception by air contrast barium enema. FINAL DX: Intussusception.
3-16-21 2:11PM PT STATES 'CHEST DISCOMFORT AND FELT HOT FOR 1 MIN AFTER GETTING SHOT'.  STATES 'NO PAIN OR DISCOMFORT NOW'. A/O, PINK, W/D, RESP REG WITH EASE. AMBULATORY TO EXIT - GAIT BRISK AND STEADY. HOME WITH WIFE. NO ACUTE OR OBVIOUS DISTRESS. 3-17-21 1:28: PT STATES HE 'WENT TO THE ER WITH CHEST TIGHTNESS AND LIGHTHEADED. WAS THERE 5 HR AND WAS CHECKED OUT - EVERYTHING WAS OK'.
Low-grade fever 100.5 with face/cheek rash spreading to arms/legs. 5/15/06 Pt seen. No conjunctivitis, no cough, no fever, no cough but head covered with pink papular rash.
Initial misuse report received from a healthcare professional on 06 February 2014. A patient had received a dose of ADACEL intramuscularly in deltoid when she was supposed to get TST on an unspecified date. No adverse event was reported. List of documents held by sender: none.
Approximately one week after vaccine (21 January 2022), experienced unusual fatigue and irregularities with chest/possible heart issues.  I was experiencing intermittent chest discomfort before this (beginning on/or about 3 Jan 2022), so unsure if the issues experienced beginning 21 January are a continuation of existing conditions or possibly related to booster vaccine (Moderna).  Cardiac-type events increased over the weekend and into this week that could be classified similar to heart palpitations (stops/skipping beats).
approx 35min p/vax given pt & father returned w/child eyelids swollen, red w/hives around neck & upper lids, wheezing devel;
Pt was bitten by dog on Sat 8/14. To ER on Sun 8/15 & rec'd 1st vaccine. ER doctor gave script for rest of vaccines ordering 2nd vaccine on Tues 8/17.
Moderate to severe generalized body and joint aches, sore throat that started 8-10 hours after initial injection. Waxing and waning symptoms since that time but progressively worsening.  Patient is seeking treatment in clinic for symptoms with me today, was unsure whether it was reaction to vaccine vs. other etiology.
This case was reported by a nurse via call center representative and described the occurrence of generalized edema in a 54-year-old male patient who received SHINGRIX (batch number EK279, expiry date 31st March 2020). On 21st May 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 26th May 2018, 5 days after receiving SHINGRIX, the patient experienced generalized edema. On an unknown date, the outcome of the generalized edema was unknown. It was unknown if the reporter considered the generalized edema to be related to SHINGRIX. Additional information was received as follows: The patient received SHINGRIX on the left arm. The patient experienced generalized edema, especially in the hands, arms, feet and face.
This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown ages and genders. From 13-FEB-2014 to 14-MAR-2014, doses of LIQUID PEDVAXHIB injections (lot #, expiry date, dose, route and indication unknown) that were exposed to temperatures outside of the prescribing information, might have been administered to the unspecified number of patients. No adverse events were reported. This is one of several reports received from the same source. Additional information has been requested.
Telephone call from Mom with concerns of 101 degrees temp. after HepB booster. At this time denies any fussiness, tugging at ears or any symptoms besides fever. Advised by nurse to monitor, give TYLENOL 145mg 4-6 hours (based on wt.) Friday 102.9 temp., Sunday rash on head & spread to torso.
My son was given the PEDIARIX shot and developed an all over body rash. I took him back to the doctor and he had a negative Strep test. No fever and no one at his school had these symptoms. Doc said it was a reaction to vaccine and to treat with BENADRYL. It took a few weeks to completely go away.
Inappropriate schedule of vaccine administered; Flare up of pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Flare up of pain) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) for Rheumatoid arthritis.    No Medical History information was reported.   On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) at an unspecified dose. On 03-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). In September 2021, the patient experienced PAIN (Flare up of pain). In September 2021, PAIN (Flare up of pain) had resolved. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) outcome was unknown.            Concomitant medication was not reported.  Patient had a flare up of pain after taking her 2nd covid vaccine. Treatment details were not reported.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Information has been received from a LPN and certified MA concerning a 15 day old female pt who was born with respiratory distress, who on 07-JUN-2005 or 012-Jun-2005 was vaccinated (grandmother also reported immediately at birth) with the first dose 0.5 ml dose of hepatitis B virus vaccine rHBsAg (yeast) and then transferred that same day to another hospital because of the respiratory distress problem from birth. On 20-JUN-2005 at the other hospital the pt received a second vaccination of hepatitis b vaccine. The nurse reported that the pt's grandmother had reported the event but did not mention to the nurse that there were any medical problems as a result of the two doses of vaccine. It was reported that the pt was hospitalized for the respiratory distress she had at birth (worsening) and there was no relation between the respiratory distress and vaccination. No further information regarding the adverse event or the pt's outcome was available at the time of this report. There was no product quality complaint reported. Additional information has been requested.
Immediate  fever , nausea , weakness , chest pain .  Fever lasted up to 4 days . Pain lasted for couple of weeks. Weakness of left shoulder and arm still in place to the date .
Patient c/o of heart palpitations to observation RN. Patient escorted into triage area with observation RN. Charge RN and on-site provider notified.    @1130AM BP 135/90 HR 69 RR 16 O2sat 100% AOx4. Assess by observation RN- Patient denies chest pain N/V, headache. SOB. Patient reported having an anxiety to needles and feeling cold, was provided jacket by husband. Pt reported consuming 2 cups of coffee prior to time of vaccination and has not had any other drinks. On site provider recommended extended observation. Patient given 1 water bottle.   @1204PM BP 119/88 HR 67 RR 16 O2sat 100% AOx4, VSS. Patient fully drank 1 water bottle. Patient denies chest pain N/V, headache, and no longer feels palpitations, and SOB. On site provider recommended pt follow up with PCP.   Patient educated to call 911/ER services for any worsening symptoms. Patient verbalized understanding. Pt d/c @1204PM to home with husband.
Sudden onset tinnitus. No prior history of tinnitus previously. Tinnitus is constant ringing/droning in both ears exacerbated by laying down.
2/22/2021 1st Dose: Within 2 hours: severe pain from neck to fingertips on L arm. Lasted approximately 4 days. Within 4 hours: severe headache, took 2 500mg Tylenol about 3-4 times over the course of 48 hours. Headache subsided on 3rd day.  3/15/2021 2nd Dose: Within 1 hour: weakness, pain from neck thru fingertips in L arm, throat swelling, came home took 2 Tylenol 500mg gel caps at 4:00pm. Napped until 7:00pm. Temperature was 97.5. Thought I was feeling better. Went to bed at 11:00pm. By 2:30am I was awaking, restless sleep, pain all over body, every joint. Finally got out of bed at 11:30am today. Nerves and joints feel as tho on fire. Both arms and hands very swollen. Toes swollen. Nauseous. No appetite. Hurts to move, sit or lay down. Have rested all day. 6:40pm temperature is 99.8. Feel awful. Shooting pain like electricity down both arms into hands extremely sensitive to cold - feels like fire.
p/vax pt exp streptococcal pneumonia & sepsis (cult from blood);pt hosp; Annual follow-up dated 3/28/01 states that the record was voided as the pt did not receive a Merck vaccine. Information has been received from a physician's assistant concerning a 73 year old female with a history of chronic obstructive pulmonary disease who in approximately 1991 was vacinated with PNEUMOVAX 23. In approximately 1999 then patient experienced streptococcal pneumonia and sepsis (cultured from blood). The patient was hospitalized. Another patient was reported with a similar experience (WAES99091806). No further information is available.
hemorraging; Period was late; nausea; fatigue; headaches; irregular period; Erythema multiforme major; I broke out with multiple sores all over the left Breast; a strange Blister was on my left breast; Pain; This is a spontaneous report from a contactable consumer. A 41-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 08Mar2021 10:00 (Batch/Lot Number: EP6955) as SINGLE DOSE for covid-19 immunisation. The patient has no medical history. Concomitant medication(s) included alprazolam (XANAX).  On 08Mar2021 21:00, the patient became sick 11 hours after first dose and was ill for two days took a full week for nausea and fatigue and headaches to improve. On March 19th my period was late and by the 22nd when it started I had to be hospitalized for hemorraging and a strange Blister was on my left breast over the next two weeks I broke out with multiple sores all over the left Breast and still am and was diagnosed with Erythema multiforme major from an autoimmune response to the vaccine. Multiple ER and urgent care visits resulted as I was first misdiagnosed with Shingles. Then, I started bleeding again only 14 days after my period ended again. The pain and bleeding are as intense. I have never had irregular period in my life until the vax. The patient was hospitalized for hemorraging from 22Mar2021 to an unknown date for 1 days. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 31Mar2021 covid test type post vaccination=Nasal Swab,  covid Test name post vaccination=Pi  xel by lab,  covid test date=31Mar2021, covid test result=Negative.  The patient did not receive treatment for the events. The outcome of the events hemorraging, Erythema multiforme major, I broke out with multiple sores all over the left Breast, a strange Blister was on my left breast was not recovered, while recovering for the events nausea, fatigue, and headache, and unknown for the rest of the events. The patient second shot on March 29th and the skin lesions and sores continue to appear as well as fatigue, headache and joint pain. I was in good health before receiving the vaccine and never had skin issues or irregular or painful periods with this much bleeding.
Intense lower back pain began about 9-10 hours after vaccine (2nd dose). Pain has continued for three full days now. Today, third day after vaccine, pain seems to be letting up a little bit. Correspondingly, the inflammation at the injection site is beginning to go down as of third day. The injection site is still tender, itchy and slightly red, and the size of the hard lump is down to about the size of a robin's egg. For the first two days the injection site was warm to the touch, quite sore and quite swollen -- what one might call a "goose egg" although not actually as big as an actual goose egg. Having had much experience with bee stings growing up, I would compare the condition of the injection site to that of a bee sting reaction. But the lower back pain is the worst I've ever experienced, more intense than the normal strain from shoveling snow or weeding, etc.. I think I did strain my back lightly an hour or two before the pain set in, but the acuteness of the pain was way beyond what the normal soreness should have been.  My observation is that my body's immune/inflammatory response to the vaccine somehow greatly amplified the inflammatory response to a slight muscle strain. I'm not a physician or scientist; this is my layman's sense of what is going on. I've not sought medical care -- assuming the muscle pain will subside in time; if it continues unabated into the next week then I may do so. In the meantime I am treating it with ibuprofen, ice and heat.  I just thought this reaction is abnormal enough that it should be reported.
11-11-2 11:43 am vomiting w/o fever or nausea x 12 hours. Pt called 11.14.12 back at school. Needed IV fluids & anti-nausea meds.
I got back pain, tiredness, thirst, and arm?s pain at the following day. Also, I got  chills about 30 minutes 24 hours later. I got the same  side effects with both doses, and they last in 24 hours.
both eyes swollen-no SOB noted-refer to MD; meds Epi & DPH
Day after shot given noted quarter size rash on left arm, site of varicella itchy. Using BENADRYL. Did feel nausea day of shot. Improving when called about shot.
Mom reports that he began to feel bad 11/30 (Day 4 post vaccines). On 11/30 he developed welts on side of face and ear was red. Lasted a few hours and went away on its own. Temp 99 at this time. Gave TYLENOL because he was fussy. No other rash developed. Drooling a lot. Teething. Continued to be fussy/irritable. On 12/7 (Day 8 post vaccines) ear temp 91, repeat ear temp 94 Checked under arm X 3, was 93. Appetite decreased. Sleeping normally. Extremely irritable and inconsolable since waking from nap in afternoon.
This initial non-serious spontaneous case, was received on 01-Nov-2017, from a physician, concerning an adult male patient of unspecified age. This case refers to 30th out of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in cooler with ice packs for 6 days and had reached unknown temperature during transport (explicitly considered as incorrect product storage) instead of storing at 36-degree F and 46-degree F (2-degree C and 8-degree C). And the same was administered to the patient (explicitly considered as drug administration error). The reporter stated that the temperature was not monitored on 24-Oct-2017 (could have been between 2-8C, but not certain) and there were no reports of adverse effect after vaccination (no adverse effect). The vaccine had been discarded. Follow up received on 09-Nov-2017 from a physician: Added event (no adverse effect) and reporter's comment. Amended narrative accordingly.
Fluzone High-Dose Quadrivalent given to a 63yr old female with no reported adverse event; Initial information received on 01-Nov-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 63 years old female patient who was administered Influenza Quadrival A-B High Dose Hv Vaccine [Fluzone High-Dose Quadrivalent] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received 0.7 ml total of suspect Influenza Quadrival A-B High Dose Hv Vaccine (lot number: U8162BA, Expiry date: 30-Jun-2024) (with an unknown formulation, strength) via unknown route in unknown administration site for immunization.  On an unknown date, the patient was administered Influenza Quadrival A-B High Dose Hv Vaccine with no reported adverse event (product administered to patient of inappropriate age) (latency: same day).  It was reported, Fluzone High-Dose Quadrivalent given to a 63yr old female what actions need to be taken. Primary physician has been contacted. This situation is reported as an off-label use as per local labelling due to patient age. No additional information available from this first contact.   Action taken was not applicable. Outcome was unknown.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.
2 Weeks after 2nd dose - calf soreness and toe pain (lasted 2 weeks ofs an on) 3 Weeks after 2nd dose - Burning middle back like pins and needles, chest pain, insomnia, racing heart feeling (lasted 2 weeks off and on) Additional neck and back pain 9 Weeks after 2nd dose - loose stools