chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Nov-2021 at 2:51 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 04-Nov-2021 at 2:51 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) and PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. The vial undergone temperature excursions for 1 month. The vial was in frozen state at the time of the excursion (Vials in question stored in a super cold Freezer) and minimum reached temperatures was negative 82 degrees Fahrenheit. The patient was given dose from vial that was stored in an ultracold freezer which was colder than it should have been. The vial moved from freezer to refrigerator on 19-Nov-2021, it was a day when the Moderna Covid-19 vials went from the super cold freezer to the refrigerator. The vials were returned to the freezer/refrigerator, or maintained at room temperature. The reporter stated that total 70 vials were still in the ultra cold freezer and 8 vials were in the refrigerator. No vaccine state changes were noticed. The vaccine was never refrozen. None of the vials were punctured. No Previous temperature excursions was reported.  Total 280 patients received Moderna Covid 19 stored at minus 82 degrees Fahrenheit. The patient was administered vaccine that was stored at temperature between minus 80 degree F to minus 84 degree F. No treatment medication information was provided.   This case was linked to MOD-2021-402935 (Patient Link).
headache 2-hours post vaccination chills, low grade fever, tired (next day 24-30 hours post)  swelling in arm at injection location, red, raised 2-3 days, took Benadryl that night  chills and achy feeling (days 1-4)  bruised and sore at injection site still (5 days later)  No longer feel achy, on day 5 post injection. Still feel tired.
Patient returned from deployment complaining of numbness of fingers and joints (including shoulders and hips), weakness, fatigue, slight memory loss, intermittent pain beginning within 24 hours of receiving vaccination. Seen initially by Dr. regarding symptoms and was referred to Orthopedic Specialist, Neurologist, and Immunologist.  Seen by Ortho on 25 May 2007, Impression: Polyathralgia, Bilateral rotator cuff tendonitis, muscle fasciculation; referred to neurology. Seen by  Neurology 7 Jun 2007, results pending; seen by Immunology 12 Jun 2007 results pending.
Patient came in on 4/26/2021 and received a second dose of Moderna too early.  His first dose was given on April 5th, 2021.
2 days post vax, child got big red blotch on lower thigh. Fever started 1 day post vax. Tylenol given for discomfort, child came back next day for 2/22/03 for 104 fever and redness of leg. Came back 2/24/03 for cough and congestion. Told child had viral syndrome and to drink lot of fluids and rest.
Information has been received from an office manager concerning a 29 year old male with no pertinent medical history, no known allergies and his prior vaccination history was unknown who on an unspecified date was vaccinated with a dose of MMR II (LOT# not reported). On 14-OCT-2010 the patient had titers drawn for measles, mumps and rubella antibodies. The office manager further reported that the patient tested negative for measles antibodies, while having appropriate levels of mumps and rubella antibodies. As any vaccinations were administered by a former healthcare provider, the office manager was unable to provide any details of prior vaccinations. Office Manager did not know if the patient received MMR II as a child. The patient sought medical attention by office visit. At the time of this report, the patient was recovering. Additional information has been requested.
SLEEPINESS; FATIGUE; This spontaneous report received from a consumer concerned a female of unspecified age. 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, administered on 03-APR-2021 08:15 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 04-APR-2021, the subject experienced sleepiness. On 04-APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fatigue and sleepiness was not reported. This report was non-serious.
Client received first dose Moderna and second dose as Pfizer.  Client experience no adverse reaction.  Vitals signs taken on site and eveluated by EMT.  Client A&Ox3.  Stayed on site for 45 minutes. Checked on client 24 hours later, reports no adverse reaction.  Waiting to speak with PCP.
17 year old received the vaccine; A spontaneous report was received from a pharmacist concerning a 17-year-old patient who received Moderna's COVID-19 vaccine (mRNA-1273) resulting in the event, 17 year old received the vaccine.  The patient's medical history was not provided. No concomitant medications were reported.   On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the deltoid for prophylaxis of COVID-19 infection.   On 04 Jan 2021, the 17-year-old patient received the mRNA-1273 vaccine. The patient did not experience any symptoms and did not receive any treatments.   Action taken with mRNA-1273 in response to the event was unknown.  The event, 17 year old received the vaccine, was considered resolved on 04 Jan 2021.; Reporter's Comments: This report refers to a case of 17- year-old female patient who received the mRNA-1273 vaccine (Inappropriate age at vaccine administration)  Lot # was not provided. There were no reported AEs associated with this case of Incomplete dose administered
Patient received Vaccine Booster (Dose 3) which had hindsight was expired past 10 weeks in refrigerator temperatures.  (10 days Past date) Called Patient 5/13/22 disappointed  but appreciated the transparency. Will consider revaccination.
Fine vesicles around injection site at (L) lower upper arm - larger vesicle in center oozing clear fluid. Entire area of vesicles slightly raised (treated with Atarax topically).
Associate became lightheaded and lost her balance.  B/P 135/105.  By the time the ambulance arrived she had hives to her chest, neck and forehead.  She was "seeing black spots".
Itching of hand; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching of hand) in a female patient of an unknown age 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Itching of hand). At the time of the report, PRURITUS (Itching of hand) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.
Information has been received from an administrative assistant and a medical assistant concerning multiple unspecified patients of unknown age and gender. On unknown dates these patients received VAQTA (lot#, dose, route not reported) that were improperly stored. Concomitant medications were not provided. No adverse effects were reported. This is one of several reports from the same source. Additional information has been requested.
On 2/10/01, rash started on trunk (red and raised) and progressed to entire body. On 2/11/01, facial swelling and knees swelling. Took to ER and was dx'd with urticaria. Placed on Prelone and Atarax.
Headache, neck pain and fever following administration of HPV vaccine on 7/28/17.
Started wuth pain on right leg and itching the day after. Five days later gave shingles
2 cm mild swelling/induration around injection site shortly after vaccination. No symptoms. Monitored 10 min - improved. On repeat exam in office 10 minutes later.
This case was reported by a pharmacist via call center representative and described the occurrence of headache in a 76-year-old male patient who received SHINGRIX (batch number 3AF9E, expiry date 2nd February 2021) for prophylaxis. On 26th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 27th June 2018, 1 days after receiving SHINGRIX, the patient experienced headache, maculopapular rash and pruritus. On an unknown date, the outcome of the headache, maculopapular rash and pruritus were recovering/resolving. It was unknown if the reporter considered the headache, maculopapular rash and pruritus to be related to SHINGRIX. Additional details were provided as follows: The patient received the vaccine in the left deltoid. The patient experienced macular or papular rash. The patient had been in an out of doctor's office getting tests done for the symptoms he had experienced. No further details were provided. This case has been linked with case US2018124902 (wife's case), reported for by the same reporter. The reported batch number 3AF99 for Shingrix did not exist and updated to 3AF9E as per sales database.
aching lymph nodes; burning sensation inside of body; blisters all over right side of body; swollen lymph nodes; swelling at injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a 34-year-old male patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Concurrent medical conditions included factor v leiden mutation.   On 4th September 2019, the patient received the 1st dose of Boostrix (intramuscular). On 4th September 2019, less than a day after receiving Boostrix, the patient experienced injection site swelling. On 9th September 2019, the patient experienced blister, enlargement of lymph nodes, lymph node pain and burning sensation. On 9th September 2019, the outcome of the injection site swelling was recovered/resolved. On an unknown date, the outcome of the blister, enlargement of lymph nodes, lymph node pain and burning sensation were not recovered/not resolved.   It was unknown if the reporter considered the injection site swelling, blister, enlargement of lymph nodes, lymph node pain and burning sensation to be related to Boostrix.  Additional details were provided as follows: The patient received a dose of Boostrix in the right arm. On 9th September 2019, 5 days after receiving a dose of Boostirx the patient experienced blister, enlargement of lymph nodes, lymph node pain and burning sensation. The patient planned to continue follow-up with his physician on an unknown date. The reporter consented to follow up. The case was linked with the case US2019170062, reported by same reporter. There was discrepancy in the outcome of the events blister, enlargement of lymph nodes, lymph node pain and burning sensation, in the source document outcome was reported as recovering/ resolving and in the database outcome reported as not recovered/not resolved.
Pt admitted 2/26 with past medical history of hypertension, COPD, obesity, multisubstance drug abuse presented with acute respiratory distress, shortness of breath, which then led to cardiac arrest while she was in the emergency room.  Pt was intubated, but the patient's weaning process was difficult. Pt was unresponsive and condition was worsened.  Several diagnoses while pt was hospitalized including anoxic hypoxic encephalopathy, asthma, COPD exacerbation, poorly-controlled hypertension, as well as COVID-19 infection confirmed 3/6, Strep pneumoniae as well.  Family elected to transition over hospice and she was transferred 3/9. Patient was placed on comfort measures, and expired on 3/12.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age. On 22-MAY-2013 the patient was vaccinated with the first dose of GARDASIL (Lot # not reported) (dose, route unspecified by the reporter). No other co suspects were reported. No concomitant therapy was reported. The reporter stated that the patient was vaccinated with the second dose of GARDASIL on 20-JUN-2013. No adverse effect was reported. Additional information has been requested.
This spontaneous report as received from a certified medical assistant, via a company representative, refers to unspecified number of less than 10 patients of unknown age and genders. No information on their medical history, concurrent conditions or concomitant drugs was provided. On an unknown dates, reportedly between 01-MAY-2014 and 01-JUL-2014, the patients were vaccinated with GARDASIL which was improperly stored (lot # J009788, expiration date 17-MAR-2016) (doses, administrations sites and routes unspecified). This is one of several reports from then same reporter. Additional information has been requested.
This spontaneous report was received from a registered nurse referring to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories. From 19-MAR-2017 through 27-MAR-2017, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot # M042322 with expiration date of 21-FEB-2019; strength, dose, route and anatomical location were not provided), for prophylaxis. It was also reported that the administered doses experienced a temperature excursion during 7 hours at a temperature from 47 degrees Fahrenheit to 77 degrees Fahrenheit on unspecified date. No previous temperature excursion was reported. In addition, a data logger issue was involved. No adverse effects and no product quality complaint were reported. Additional information has been requested.; Sender's Comments: US-009507513-1703USA013210: US-009507513-1703USA014483: US-009507513-1703USA014485: US-009507513-1703USA014486:
pt received flu shot on 10/2. 10 days later reports pain in legs and side. progressively got worse. went to urgent care 10/17 then hosp 10/18 to 10/22. Hosp ruled out everything else. Hosp says it was Guillen Barr. Pt still has nerve related symptoms.
I started to develop the following symptoms fever,  joint pain, shortness of breathe, fatigue, confusion, muscle pain by 7:00 AM on Saturday 6th, and subsequently they increased until the only thing I could to was only lay in bed, during the night the shivering awfull, there was a point when my whole body was stiff and I wasn't able to move (or at least that was my perception at that point) the fever, joint pain, shortness of breathe, fatigue, confusion, muscle pain increased and by 3 AM I was vomiting. I took medication for the pain but the symptoms were lessened not for much, I remained in bed until 2:30 PM on Sunday 7th. I am still weakened, fatigued and with a slight shortness of breath, I am assuming by tomorrow I will be feeling better. No regrets whatsoever.
Pregnancy was unknown to patient as it was only 2-3 weeks along. Spotting began on March 26, 2021, patient wasn't concerned as the pregnancy was till unbeknownst. Pre period type symptoms continued throughout the next 2 weeks: cramping, bloating, fatigue, dizziness, light and inconsistent spotting. Home pregnancy test was taken on April 4, 2021. Discovery of a possible pregnancy postponed the 2nd dose of the vaccine, by the vaccine clinic, until getting a doctor's permission. An official pregnancy test was done April 5, 2021.  Confirmation of said pregnancy was made with internal ultrasound and blood work. Based on the ultrasound results and physical exam, Doctor (no longer at the stated medical  facility), gave permission to receive the 2nd dose around April 10,2021. 2nd dose was completed on April 13, 2021. Light cramping and discomfort began April 22, 2021. April 29, 2021 ultrasound confirms no heartbeat. Miscarriage completed naturally on May 4, 2021
I didn't verify the age of the patient before giving the Pfizer Covid-19 (adult) vaccine to him. I spoke to the father about his son (the patient) about him receiving the wrong vaccine. At this time there was no adverse event.
Vaccine was injected on left arm- by 4:00 PM my arm began to hurt and I can't move the arm. The arm was flushed to my body and I can't raise it, hold anything with my hand. By 7:30PM the pain increased, I developed some fever, not to high but warm enough I knew I was getting fever. I developed some bumps on my face, above the right eye, and I had difficulty breathing. Again, not to the point where I can't breath, but I was not my normal self. I was trying to yawn and my throat felt dry and no air going into my lungs. I did some deep breathing exercises and walked around. This helped. The pain continue for few more hours. I placed an ice bag on my arm, on and off, for several hours and this seemed to help. I couldn't sleep. Close to 3:00 AM the pain diminished and I was able to sleep few hours. By 8:00 AM, I was feeling better. I called the DR. and they asked me to come in. The Dr. said I can take Ibuprofin 600 mg.. I did and it helped. Tuesday night I was able to sleep and Wednesday I went back to work.
Fever; chills; body aches; headache; general tiredness; This is a spontaneous report from a non-contactable consumer. A 24-years-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot/batch no: unspecified) via unspecified route of administration in left arm, as single dose on 02Mar2021 09:45 for COVID-19 immunization (at the age of 24-years). Historical vaccine included first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot/batch no: unspecified) via unspecified route of administration as single dose on an unspecified date for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took nortriptyline and experienced drug hypersensitivity. Prior to vaccination, it was unknown if the patient was diagnosed with COVID-19. Since the vaccination, he has not been tested for COVID-19. On 02Mar2021 20:30, the patient experienced fever, chills, body aches, headache and general tiredness. The patient did not receive any treatment for the events. The clinical outcome for the event was recovering.  No follow-up attempts are possible. Information about lot/batch number cannot been obtained. No further information is expected.
Back of Rt arm red and edematous. Sl hard to touch, no cellulitis. OTC Benadryl elixir and cool moist compresses to site Q 4 hrs. RTC if SX worsen.
Rigors, fever, body aches, headache, nausea and vomiting.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 18-MAY-2015, the patient was vaccinated with ROTATEQ which had been improperly stored (oral, lot # K016314, expiry date: 05-JUN-2016, dosage not provided). The product had not been supported with in-house stability data. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Parent for patient stated minor child said that child had pain at the injection site after receiving a Pediatric first dose Pfizer.   Post injection the nurse practitioner was notified. Ice pack was applied to minor, and minor was monitored.  Nurse also noticed slight bleeding at the injection site.  After further monitoring the minor was cleared by the nurse.
Severe body aches, fatigue, fever, headache, nausea.  Symptoms lasted 4 days.  Oral fluids, ibuprofen, rest. Symptoms now resolved.
Other complications following immunization, not elsewhere classified, initial encounter on 2022-11-21.
She developed severe right arm pain a few hours after the shot. Had chills and continued arm pain. Developed a blotchy red indurated rash on right deltoid area. Was seen in urgent care on 11/12/08 and in the office on 11/14/08. I treated her with steroids and pain medication on 11/14/08. She had received flu shot in same arm as PNEUMOVAX.
Malaise, decreased appetite, erythematous, non blanching, discrete rash sparing palms/soles.
Patient presented to hospital on 06/12/2022 with c/o SOB.  Patient was placed on BiPAP via EMS.  On arrival to ED patient was intubated for continued hypoxia and distress.  CXR showed hyperdensity in left lung.  EKG showed atrial flutter with QTc 523.  Patient was admitted to the ICU.  Patient tested positive for Covid-19.  Patient was started on antibiotics and steroids.  Patient ultimately went into PEA arrest and full ACLS protocol was initiated.  Patient expired on 06/12/2022.
AT TIME OF INJECTION, PATIENT SAID THE AREA BURNED AND HURT. WITHIN 30 MINUTES, AREA WAS SILVER-DOLLAR SIZED AND RED AND INFLAMED. AT 3AM, PATIENT AWOKE WITH SORE QUADS AND SHOULDERS AND A RED, INFLAMED, HOT RASH ON THE DELTOID AREA (SITE OF VACCINATION). AFTER SPEAKING TO THE PHARMACIST, PATIENT WAS INSTRUCTED TO GO TO URGENT CARE WHERE SHE WAS DIAGNOSED WITH CELLULITIS. CURRENTLY RECEIVING TREATMENT WITH CLINDAMYCIN 300MG 4 TIMES DAILY FOR 10 DAYS.
Shot 1 - 12/20/20 - no adverse effects  Shot 2 -1/10/21 - 18 hours post vax became very suddenly sick w/ flu like symptoms for about 24 hours then just as quickly symptoms were gone. Right hip where hx of laberal tear repair continued to ache for about 6 weeks. Aprox 3 weeks later 2/1/21 had shingles outbreak that took 3 weeks of antiviral meds to clear.   Shot 3 - 2/8/22 - 12 hours post vax suddenly very very ill, worse then last time, horrible body aches, especially hips/knees/ankles/low back/shoulders were throbbing with horrible pain that was not relieved with Tylenol or Ibuprofen, nausea, dizzy, headache, fever.  lasted about 48 hours then suddenly gone.  right hip with laberal tear repair continued to ache consistently for about a months.  April 2022 woke up with bilateral knee pain and swelling, no trauma.  Continued increasing stiffness when swelling went away. Knees and lower extremities continued to be very sore/painful/stiff and would swell randomly then get better. By June i could not go up/down more then 3 stairs.   Saw Dr. of sports medicine. He had me start twice dialy Diclofenac which immediately made me almost better.  Continued for 2 months total along with exercises to help strengthen,  then dropped to 1x per day.  continued a few weeks then stopped Diclofenac.  Within a week  could not walk, lower extremity (hips/knees/ankles/feet) pain, swelling and stiffness so bad had to start up Diclofenac again.  Began to feel better within days.  Theory: we know the vax immunocompromised me leading to shingles twice.  while immunocompromised triggered an inflammatory response that my body cant get rid of.   PCP ran more labs, all normal.   referred to Rheumatologist as well as Immunologist. First appointment with Rheumatology was 2 weeks ago, intake, xrays, extensive labs drawn.  f/u appointment 2/13/23 to discuss results/whats wrong with me?  Intake/1st appointment with immunology 3/1/23.