chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Inappropriate vaccine dose administered due to early retraction of needle. Pt did not receive the full dose. Gave patient the full dose after event.
pt recvd vax & exp arthritis & arthralgia w/ both arms & legs;
pt recvd vax 7OCT95 & 8OCT95 pt devel a low grade fever & the following day numbness of the feet & chest, dec resp & a rash on onse side of the rib cage; pt was admitted 9OCT95 to hosp tx IV's  & released;exp vertigo after hospital stay.
Onset began on evening of injection. Pt. states arm started to swell and fingers became numb and tingling. Pt called clinic 11/16/2010 pt stated swelling is getting worse but the numbness and tingling has improved. No signs of fever, SOB, CP or rash. She was advised to use ice for swelling and come into the office to be seen. Pt did not want to. She was advised to go to a walk in clinic.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 16-APR-2013 the patient was vaccinated with a dose of M-M-R II that was reconstituted with sterile diluent that had expired. Lot number strength, and dose of M-M-R II were unknown. Lot number of sterile diluent was 6104Y. Per reporter sterile diluent had expired on an unspecified date in February 2012. Per manufacturer records lot 6104Y of sterile diluent has an expiry date of 20-FEB-2013. The M-M-R II had not expired. No adverse symptoms were reported. This is one of multiple reports from the same reporter (other case IDs 1308USA013861 and 1308USA014141). Additional information has been requested.
Patient came in for vaccines that were due. 11/21/19 vaccines were prepared and verified by LVN. Gave patient (3 dose) Flu vaccine on same arm about an inch apart. Notice there was bleeding and immediately the site began to get swollen, the area became red. Apply gauze to stop bleeding, after gave ice pack to place over the Left deltoid. About 10 min later patien bump went down. Patient was also given Hep A vaccine 2 dose.
Shingles / Suspected Vaccination Failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Shingles / Suspected Vaccination Failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 22-Apr-2023 This case was reported by a patient via interactive digital media. The patient received the Shingles vaccine but still had a shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
No additional AE; HCP reported an adverse event for PROQUAD. Caller explained the PROQUAD was administered after a temperature excursion. No additional AE or PQC reported. No additional information provided.  ?    Names of vaccines involved (including lot/exp): PROQ; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 06-APR-2022, the patient was vaccinated with an improperly stored of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) 0.5 milliliter, for prophylaxis (lot # U039254 has been verified to be a valid lot number measles, mumps, rubella and varicella (oka-merck) virus vaccine live, expiration date reported and establish as 09-JUN-2023) (strength, route of administration and anatomical location were not provided).  The temperature of storage and time frame of the excursion were 12.95° Fahrenheit (F) for 21 hour and 15 minutes respectively.  If a digital data logger was involved was not reported.  The vaccine did not experience a previous temperature excursion.  No adverse event reported.
Pfizer Dose 1 3/25/21 (ER2613) Pfizer Dose 2 4/16/21 (ER8729) COVID Positive 1/20/22  1/20/22: 84-year-old female with dementia, esophageal stricture, breast cancer, interstitial lung disease, hypothyroidism and hypertension  Patient presented to the ED with altered mental status of 1 day.  Patient stated that did not know anything was able to no herself when she arrived in the hospital  Patient currently complains of left hip and right knee pain.  Patient does not remember having any fall down  EMS noted that patient was lethargic with GCS of 13 on arrival.  Also noted she has also over her arm which could be possibly from fall.  In the emergency room patient noted to have elevated glucose, BUN and creatinine of 29/2.28.  Urinalysis noted for infection.  CT head without contrast was unremarkable  1/26/22: Pt is 84-year-old female with dementia, esophageal stricture, breast cancer, interstitial lung disease, hypothyroidism and hypertension  Patient presented to the ED with altered mental status of 1 day.  Patient stated that did not know anything was able to no herself when she arrived in the hospital  Patient was then admitted with metabolic encephalopathy from UTI on top of chronic comorbidities.  Patient was found to be COVID positive; required initial oxygen supplementation 2 LPM which was titrated down.  Patient noted to have fluid overload on chest x-ray and required IV diuretics with improvement clinically.  Patient oxygen supplementation was weaned down to room air.  Patient noted to have loose bowel movement with foul-smelling stool C diff was positive and started on p.o. vancomycin.  Patient will be discharged home with to continue her 24 hours care follow-up with PCP as outpatient
NONE COVID VACCINE EXPIRED 11/22/2022 GIVEN: 01/11/2023
This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 41-year-old female patient who received HAV (Havrix) (batch number 4H37Y, expiry date 8th November 2020) for prophylaxis. Co-suspect products included Hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis. On 20th December 2021, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 20th December 2021, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were reported as follows: The patient was inadvertently administered with an expired dose of Havrix. The reporter consented to follow up.
Developed petechia about 10/10/03. Seen in office 10/13/03 with platelet count of 8000. Admitted. The medical records received on 11/20/03 states immune thrombocytopenia purpura.
Arm hurts so bad; Chills; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurts so bad), CHILLS (Chills) and HEADACHE (Headache) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in November 2020. Concurrent medical conditions included Blood pressure high.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm hurts so bad), CHILLS (Chills) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (Arm hurts so bad), CHILLS (Chills) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  Treatment of these events were not reported.; Sender's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Approximately 24 hours  after secondPfizer dose, 17 year old male awoke in the morning and was complaining of intense throat pain radiating into the upper chest  relieved by sitting up.  NSAIDS not helpful, went to narcotic med to relieve, which it did with single tab of medication.  Other symptoms, fatigue, body aches, low fever.  Waxed and waned over 48 hour time period from onset, with another intense episode  of throat/chest pain 24 hours in from onset requiring narcotic pain med to relief.   Again this was in the morning.  One episode of vomiting during second intense period with what looked like water that just hadn't gone down his throat, and following this he reported some relief from what he described as a radiating burning sensation up under the lower jaw and radiating into the upper chest.  No shortness of breath ever.   Burning sensation in throat and chest resolved by 72 hours with no more episodes of the acute throat and chest pain after the two episodes.  While ED was considered due to the distress being experienced, we decided against since the narcotic med was helping and no shortness of breath was being experienced.  I did try to get on with the CDC to report my concerns when it was happening to see if others were reporting this, then because it was a concerning reaction, but site was difficult to navigate and I was trying to monitor.  I did not call the pediatrician at that time as I am a health care worker and felt I could assess and make decisions based on findings.   Following the recent reports of myocarditis in teens, especially males, I felt obligated to report this experience.   This child has no history of heart ailment.  No tests were done to assess what might have been the cause.  I assumed it was an outside-the-box reaction to the second Pfizer dose.
1. Large red, swollen, itchy, and painful rash on the top part of my left arm.  Started around day 4 after shot and lasted a couple weeks. Pain lasted longer than the rash.   2. Period cycle has been irregular with Longer, more painful cramping and heavier bleeding.  Period cycles have been regular my whole life until after the moderna vaccine. Now 3 cycles later and still irregular, longer, painful and heavier bleeding.
Woke up on 5/22 with complaints of left arm stiffness and soreness, barely able to lift arm.  Fatigue, total body aches, fever 100.8,  back pain and stinging sensation on skin on back  5/23 large lump at injection site. no bruising or redness 5/24 lymph nodes under left arm enlarged and tingling sensation in armpit area, flushed feeling
Throat Closed "tightness; This spontaneous case was reported by a consumer and describes the occurrence of THROAT TIGHTNESS (Throat Closed "tightness) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (penicillin and sulfa).    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced THROAT TIGHTNESS (Throat Closed "tightness). On 09-Jan-2021, THROAT TIGHTNESS (Throat Closed "tightness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication included diphenhydramine twice daily.
Vertigo when I woke up.  Woke up at 5am to run a half marathon, when I rolled over my head was spinning. When I tried to stand up I fell back on the bed.  Had to sit still for 10 minutes until the spinning stopped.  Moved carefully for a few hours.  Ran a half marathon.  After the half, if I turned my head quickly, I felt the vertigo return but it was not as bad as when I woke up.
1 DAY AFTER 2ND INJECTION: EXTREME FATIGUE, BODY ACHES, HEADACHE 2 DAYS AFTER 2ND INJECTION: HEADACHE, INJECTION SITE RED, SWOLLEN, ARM ACHES
Rebound effect. Felt great after day 7 of infection. Then tested positive again and symptoms returned until day 18; Rebound effect. Felt great after day 7 of infection. Then tested positive again and symptoms returned until day 18; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31-year-old male patient received BNT162b2 (BNT162B2), on 26Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 31 years for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose Number:1 , Manufacture unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 2, Manufacture unknown), for Covid-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 28Mar2022, outcome "unknown", SUSPECTED COVID-19 (medically significant) with onset 28Mar2022, outcome "recovered with sequelae" and all described as "Rebound effect. Felt great after day 7 of infection. Then tested positive again and symptoms returned until day 18". The patient underwent the following laboratory tests and procedures: Tested: (28Mar2022) positive. Therapeutic measures were taken as a result of suspected covid-19.  Clinical course: Drug(s) Information: Characterization of drug role: Suspect Proprietary medicinal product name: Paxlovid Indication for use in the case: Treatment of COVID-19 Date of start of drug: 23Mar2022 Date of last administration: 28Mar2022  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Did not get the full dose; Syringe and needles did not connect correctly; A spontaneous report  was received from a nurse, concerning a male patient of unknown age, who experienced a medication error where he did not get the full dose/MedDRA PT: underdose, and syringe and needles did not connect correctly/MedDRA PT: device connection issue.  The patient's medical history was not provided.  No concomitant medications were reported.   On an unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: Unknown) intramuscularly for prophylaxis of COVID-19 infection.   Nurse reported that the equipment came in from the state and some of the syringes and needles did not connect correctly.  The patient did not get the full dose because where the syringe and needles did not connect right and during administration, the majority of the vaccine came out of the connection and not into the patient's muscle.  No treatment information was provided.   Action taken with second dose of mRNA-1273 in response to the event was not reported.  The event, medication error of underdose and device connection issue,  was considered as resolved.  The nurse reported the same event for two different patients so an additional case created for each of the 2 separate reports, one for each patient.; Reporter's Comments: This case concerns a 77-year-old male who experienced NS unexpected events of Incomplete dose administered and Device connection issue without associated adverse events.  The events occurred the same day as the first dose of mRNA-1273 (lot # unknown).  Events resolved. Further information requested.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-014294:same reporter, different patient
15 minutes after dose she was "jittery".  Had had feeling before in the past. Pt states She has a horseshoe kidney and as a result is sensitive to medications. Denies cardiac issues, but later stated she had a longstanding hx of sinus tachycardia for which she had workups by her PCP and cardiologist.  Did have two cups coffee prior to injection.  pulse 130, saturation and BP WNL, LS CTA, heart tachy but regular.  EKG done ST rate=105.  Monitored closely until HR was 110.  Sent home after rest to FU with PCP and with  ED precautions (to go to ED if worse).
Our Pfizer Covid-19 vaccine was placed in the fridge in a bag with the date 2/5/22 for dilution and beyond use. We did not use the vaccine for several days. On 2/6/22 the vaccine was not pulled from the fridge and an intern utilized the vial for two vaccines, one being this one. We contacted Pfizer and they said that off label the vaccines have appropriate integrity for 45 days after placing in the fridge. They did not recommend revaccination. We contacted the patient and let them know. They were ok with this information and appreciated us letting them know. The patient has not experienced any other issues
24 hours later I had inflamed lymph node on right armpit, tenderness, extending down the left inner arm several inches and remain approximately 1 week, fatigue and general achiness, flu like symptoms that lasted a few days.
On 1/6/00, the pt experienced left arm swelling all the way around which was red and hot. A fever, pain in the shoulder and a bad taste in mouth was experienced. The pt reported that she had to lie down most of the day. The pt sought medical attention and was treated with Benadryl and ice.
pt recvd vax; devel gen rash on his trunk, face, scalp,legs,arms,hands including palms & finger webs consisting of 100 or more lesions;most of lesions healed 1 wk later;
She is not sure if her son's vaccine was Moderna or Pfizer but he was at death's door.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A male patient received COVID-19 Vaccine - Manufacturer Unknown, as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Myasthenia gravis" (unspecified if ongoing), notes: myasthenia gravis for about 6 years. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 01 Manufacturer: Unknown), for COVID-19 immunization. The following information was reported: NEAR DEATH EXPERIENCE (caused and prolonged hospitalization, medically significant, life threatening), outcome "unknown", described as "She is not sure if her son's vaccine was Moderna or Pfizer but he was at death's door".  Clinical course: The reporter son had his second vaccine and ended up in a medical crisis in the hospital for a month. Caller declined to complete report for her son and states she was not sure if he had the Pfizer or Moderna covid vaccine and has no lot, expiry date or NDC to provide for his vaccine but she was with him when he went into acute medical crisis and he was a very very sick man with myasthenia gravis, clarified her son had myasthenia gravis prior to the covid vaccine and it was under control but it was after the covid vaccine when he went into medical crisis. Her son had myasthenia gravis for about 6 years. Her son has myasthenia gravis and got his second shot on her birthday date and that day he ended up in the hospital for the total of a month in a medical crisis. She was not sure if her son's vaccine was Moderna or Pfizer but he was at death's door.   The information on the batch/lot number for COVID-19 Vaccine - Manufacturer Unknown has been requested and will be submitted if and when received.
Severe swelling at the injection site. The size of a softball that encompassed his entire left thigh. Raised, red, hot to the touch. It went away after 2 days. I don't know what type of flu vaccine it was but he had received one 2 months prior that was not recorded so this was an unnecessary 2nd vaccination for flu. The office didn't save the shot into the system but once I got home and looked at the last print out they gave me and had them confirm in his medical records he was given one on 9/6/2018.
pt recvd vax;bilateral symmetrical swelling below auricles on angle of mandible passing earlobe upward extending anterior & posterior regions;
shingles; Information was received from a lawyer regarding a case in litigation referring to a 68 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In December 2010, the patient was vaccinated with zoster vaccine live(ZOSTAVAX)(strength, route, dosage schedule, lot number and expiration date were not reported) for prophylaxis. As a result of receipt of zoster vaccine live(ZOSTAVAX), also in December 2010, patient was caused to suffer shingles, including any and all of its sequelae. As a result of receipt of zoster vaccine live(ZOSTAVAX), patient has been caused to suffer severe personal injuries, pain, suffering, and emotional distress, as well as to incur substantial economic damages. The outcome of herpes zoster was unknown. The reporter considered herpes zoster to be related to Zoster Vaccine Live(ZOSTAVAX).  As a result of the foregoing acts and omissions, the patient was caused to suffer serious and dangerous side effects including shingles, as well as other severe and personal injuries which are permanent and lasting in nature, physical pain and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and/or medications.
"Covid Arm" post Covid Moderna Booster- persistent redness and itching with chills
Tension headache; This spontaneous case was reported by a consumer and describes the occurrence of TENSION HEADACHE (Tension headache) in a male 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 medical history reported.).   On 31-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced TENSION HEADACHE (Tension headache). At the time of the report, TENSION HEADACHE (Tension headache) outcome was unknown. Not Provided          Action taken with mRNA-1273 in response to the event was not applicable. Concomitant drug was not reported. Treatment for the event was not reported.   Reporter did not allow further contact
Administer Expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) in a 39-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine). On 22-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported .  The vaccines was stored in freezer and took out one to two vials and placed in fridge every day as needed.  No treatment information was provided by the reporter.
Spitting up blood and blood in stools. We were out of town, I took my son to urgent care clinic and they determined it was blood he was spitting up, he then was transported to the hospital via ambulance where he was examined again in the ER. They did x-rays but couldn't find the problem. We then went back to his pediatrician to be examined again three days later and then he ended up seeing a GI specialist, who determined it was caused from the Rotavirus vaccine.