chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Administered vaccine from a vial that was punctured more than 12 hours; Administered an expired dose of the Moderna COVID-19 vaccine from a vial that was punctured more than 12 hours; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered an expired dose of the Moderna COVID-19 vaccine from a vial that was punctured more than 12 hours) and PRODUCT STORAGE ERROR (Administered vaccine from a vial that was punctured more than 12 hours) in a 91-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 033K21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Apr-2022 at 12:30 PM, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 12-Apr-2022,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered an expired dose of the Moderna COVID-19 vaccine from a vial that was punctured more than 12 hours). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine from a vial that was punctured more than 12 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered an expired dose of the Moderna COVID-19 vaccine from a vial that was punctured more than 12 hours) and PRODUCT STORAGE ERROR (Administered vaccine from a vial that was punctured more than 12 hours) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The vial was initially stored in the refrigerator on 24-Mar-2022. The vaccine was punctured on 11-Apr-2022 at 12:54 pm. Post puncture the vail was stored in refrigerator. The vial did not undergo any temperature excursions.   No Treatment medications were reported.
began covid-19 symptoms on 6/15/2021 and tested positive for covid-19 on 6/18/2021
felt worse as the day has gone on; chills; high temperatures that went from 100.8 to 101 F; body aches; fever; racing heart rate; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (racing heart rate), PAIN (felt worse as the day has gone on), CHILLS (chills), PYREXIA (high temperatures that went from 100.8 to 101 F) and MYALGIA (body aches) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 06-Apr-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) (Intramuscular) 1 dosage form. On 07-Apr-2021, the patient experienced TACHYCARDIA (racing heart rate), CHILLS (chills), PYREXIA (high temperatures that went from 100.8 to 101 F), MYALGIA (body aches) and PYREXIA (fever). On an unknown date, the patient experienced PAIN (felt worse as the day has gone on). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) ongoing since an unknown date at a dose of UNK dosage form. At the time of the report, TACHYCARDIA (racing heart rate), PAIN (felt worse as the day has gone on), CHILLS (chills), PYREXIA (high temperatures that went from 100.8 to 101 F), MYALGIA (body aches) and PYREXIA (fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: 100.8 (High) 100.8 to 101 F and 101 (High) 100.8 to 101 F.         Concomitant product use was not provided by the reporter. Treatment information included aspirin.
I received the Moderna Bivalent booster for COVID-19 on 11/4/2022. On 12/5/2022, I had a tickle in my throat. I took a lozenge, and it went away. I also had some scratchiness on the side of my throat. I have GERD, so I assumed that it was caused by that. On 12/6/2022, I took a home antigen test upon waking up, because I had just visited a heavily populated area. The result was positive, to my surprise. I self-isolated for 10 days. I called my doctor, and I was prescribed Paxlovid and promethazine DM. He instructed me to wait until 12/8/2022 to begin taking the Paxlovid. He told me that if I didn't feel better by then, I could go ahead and start taking it. I didn't feel very bad, but I decided to start taking it anyway on 12/8/2022, and I finished it 12/12/2022. On 12/12/2022, I tested negative for the first time since getting sick. I stayed in isolation until 12/16/2022. I tested myself daily, and the results were negative from 12/12/2022 until 12/18/2022. However, I tested positive again on 12/19/2022. I called my doctor, who asked me to come to the practice. When I got there, I was tested for COVID-19 and the flu. The results of the clinical tests for both COVID-19 and the flu were negative. My blood pressure, my oxygen, and my temperature were all good. The only symptoms of COVID-19 that I had were fatigue and an occasional slight cough. The fatigue got worse on the afternoon 12/19/2022. I also developed a headache and nasal congestion. I continue to have these symptoms at the time of this writing, and when I tested myself again this morning, the result was still positive.
Subsequent to receiving one dose of varicella virus vaccine live the pt experienced chickenpox with 20 - 30 crusted over lesions on face, arms and diaper area.
107 patients who were administered with the vaccine past the published expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (107 patients who were administered with the vaccine past the published expiry) in a 77-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Nov-2021 at 12:49 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 11-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (107 patients who were administered with the vaccine past the published expiry). On 11-Nov-2021, EXPIRED PRODUCT ADMINISTERED (107 patients who were administered with the vaccine past the published expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment information was reported by reporter.
COVID Arm.  Large red lump at injection site and itchy.   My legs have been itching at night also, but maybe that is more heat rash, but thought it worth mentioning.
shingles; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (002191). The reporter is the patient.  A 70 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HERPES ZOSTER (non-serious), outcome "unknown", described as "shingles". Therapeutic measures were taken as a result of herpes zoster.  Additional information: Patient had not had the shingles vaccine. She took a seven day cycle of valacyclovir and she finished it seven days ago. Patient wanted to know if the effectiveness of the booster dose would be affected by the Valacyclovir or how long should she wait before having the booster dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt. came in on 7/4 concerned that the rash on her Lt. arm might be Assc. with the recent SHINGRIX vac. The rash appeared patchy and raised - no itchiness or pain - she also complained about asthmatic Sx (wheezing/coughing) 7/2. No treatment at this time.
A company representative reported that a 5 year old child was admitted to the hospital with a diagnosis of pneumococcal meningitis. No further information was available at the date of this report.
She was cold; Nose running; Diarrhea; Vomiting; Back ache; Fever; A spontaneous report was received from a reporter concerning a 71-year-old, female patient who received Moderna (mRNA-1273) and experienced a cold, her nose running, diarrhea, vomiting, back ache and a fever.    The patient's medical history was not provided. No relevant concomitant medications were reported.   On 06 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On 07 Jan 2021, in the middle of the night, the patient experienced a cold, her nose running, diarrhea, vomiting, back ache and a fever.  No treatment was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the events a cold, her nose running, diarrhea, vomiting, back ache and a fever, were considered unknown.; Reporter's Comments: Based on the current available information and a temporal association between the use of the product and the start date of the reported events, a causal relationship with the events cannot be excluded. Fever and vomiting are consistent with the known safety profile of the vaccine.
significant vaginal bleeding, nausea, extreme body ache, difficulty breathing, small seizures, dizziness, light headed,
On 7-1-07 mom picked up patient at volleyball practice with HA and tremors.  Mom states since then patient has had severe HA right behind eyes, mouth sores, tremors on a daily basis.  She has also had severe joint pain and swelling.  Recently had appendix removed. 8/29/08 Reviewed neuro medical records of 7/9-8/4/2008. FINAL DX: migraine headaches; benign familial tremor. Records reveal patient experienced severe HA & shaking x 1 year, localized behing eyes & relieved only by sleep.  Tx w/meds.   9/12/08 Reviewed PCP medical records of 6/21/07-7/31/2008. FINAL DX: none provided Records reveal patient experienced good health on day of vaccination.  RTC 6/23 for HA which caused visual loss & jittery/shaking spells.  Referred to Neuro.  RTC 11/8 w/abdominal pain esp in RLT & anorexia.  Admittd for Surgical consult & appendectomy done 11/8/2007.  RTC 1/15/08 for HA x 3 wks, mouth blisters, tired, excessive sleeping, generalized aching. HA resolved w/antibiotics for sinus infection. RTC 7/31/08 for migraines being f/u w/neuro, canker sores & sports injuries of foot pain & swelling & knee pain. 1/26/2010 Follow-up: Patient still with tremors. Negative EEG/MRI per patient's mom.
Patient received pediatric dose instead of Adult Pfizer dose. Mother called and scheduled children for the pediatric clinic. When documenting in system noted that patient was 16.
I had a horrible headache almost immediately after the injection. I also had nausea. The headache subsided a bit towards the end of the day.  I went to be and woke up during the night with my throat feeling tight, like I might be coming down with something. The next morning I was debilitated. Everything from my eyes to my skin and joints  ached. I was down  all the next day, absolutely exhausted and not able to function normally.  I had a flushed face nausea and loose stools for about 3 days after. I am just about 10 past having had the shot and am now feeling normal.
Right side axillary enlarged lymph nodes noted 5 months after vaccine. Abnormal lymph nodes per mammogram and ultrasound .  Biopsy recommended per primary.
About 2 weeks after vaccination child had presumed positive for COVID-19. Had fever, runny nose, decreased appetite  and congestion. Gave TYLENOL for fever.
Had Covid 19 December 2020 with severe Total Body Aches, Headache, fatigue.  Recovered after 4 weeks bedrest.  I had no pain at injection site till the next morning.  I also felt I had Covid 19 all over again with fever 100.3 X 3 days. Tylenol would not take the symptoms away.
Nurse administered both shots in left arm causing me to have low fever, achiness, headaches, nausea for 5 days, area was red, & slightly swollen.
Information has been received from a 37 year old female registered nurse with multiple sclerosis and allergy to ibuprofen who on 23-OCT-2007 was vaccinated with her first dose of Pneumovax 23, 0.5 ml, IM left deltoid.  Concomitant therapy included FLUZONE, which was given the same day, and BETASERON.  On 23-OCT-2007 the patient experienced erythema, swelling, and pain at the injection site after her first dose of Pneumovax 23.  She also had a fever and was unable to move her arm for three days.  On 07-DEC-2007, she began experiencing pain in her hands and seizures.  She was admitted to the hospital on 09-DEC-2007 and was diagnosed with thrombotic thrombocytopenic purpura.  She was released from the hospital on 08-JAN-2008, and was recovered.  The registered nurse considered thrombotic thrombocytopenic purpura to be disabling, immediately life-threatening and an other important medical event.  Additional information has been requested.  9/2/08 Reviewed hospital medical records of 12/09/07-01/07/2008. FINAL DX: refractory thrombotic thrombycytopenic purpura Records reveal patient experienced HA, numbness of arm & leg, difficulty ambulating, fall, reduced oral intake, decreased vocalization, fever, & confusion worsening over 2 days time.  Seen at outlying ER & transferred to higher level of care.  Admitted to ICU. ID, neuro consult done.   Tx w/plasmapheresis QD during hospitalization.  Also tx w/rituximab x 3 doses & high dose steroids & Imuran.  Treated briefly for presumed UTI.  Developed fever & had partial complex seizures 12/17/07 followed by postictal confusion. Plasmapheresis was increased to BID.  Very gradually improved & d/c to home
On Friday 12/5 small rash broke out on entire body after shower. Very ichy! saturday and sunday rash spread became larger and became more ichy. finally on sunday night after tring cortizon cream I became so ichy I went to clinic. Dr gave me IM shot of some type of steroid and another IM shot of some form of antihistamine. symptoms were gone by the time I got home. I was presribed Methylprednisolone 4MGUD and hydroxyzineHCL 25MG 1 every eigt hours for iching. the meds work but every morning after shower rash comes back and tkes most of the morning to subside.
I had vaccination on 09/13/2022. I felt flu like symptoms on 09/19/2022 sluggish for couple days. On 09/21/2022 I had lunch and didn't feel well. I slid to the floor at 01:00PM ET my heart stopped pumping blood to the rest of the body. I could not talk but was conscious. The medics could not find a blood pressure. They got me to hospital and I spent several hours in pericardial state. The heart was blocked and they could not get in a position to get the needles in and took about 15 attempts. They took me into surgery and after period of time managed to get the needle in to drain the blood away. During the process I had collapsed lungs and they had to drill a hole in my chest to fix the lung. I got out of the hospital on 09/27/2022. Diagnosed with Pericardial Tamponade.
First Dose on 3/18/21: Several very painful, weeping,  dime-sized blisters on my left side.  Second Dose: I had the same symptoms, but with a single blister, on my face, occurring 36 hours after my  dose of the Moderna vaccine.  Second dose was 4/15/21, with blister arising at 6 a.m. on 4/17/21.  Blisters lasted 3-4 days.  Symptoms similar to shingles.
Patient complained of dizziness, numbness to fingers and toes, blurred vision. Patient anxious. Vital signs taken and stable. Fingerstick 137.
On Day 10, the arm of the injection site was swollen, red, itchy, and very warm to the touch.  Discovered in the morning and as day progressed spread down the entire forearm, but stopped at the elbow.  Lasted about 10 days, but diminished some each day.  Was gone entirely after 2 weeks.
Case previously recorded as MA2009-4289. Initial case report received from a physician on 04 NOV 2009. A 9 month-old female patient was vaccinated with 0.5 mL of FLUVIRIN 2009/2010 (batch no. 100813) i.m. on 04 NOV 2009. No adverse events were reported. Reference no: NA09-007607.
Patient came into pharmacy on 4/17/19 complaining of sore, red, hot, and swollen arm. She said it started the day before and the swelling has gone down some she said since 4/16/19. Was advised to see doctor today.
Administerd vaccine that was not stored in recommended temprature; A report was received from a health care professional concerning a 47-year old patient participating in the mRNA-1273 Emergency Use Program who was administered vaccine that was not stored in recommended temperature.  The patient's medical history was not provided. No relevant concomitant medications were reported.   The patient received their first of two planned doses of mRNA-1273 (Lot 011J20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection on 21 Dec 2020. On the same day, the nurse noticed administered vaccine was not stored in recommended temperature. Temperature reading of -21.6 and -20.9 ranges were in Fahrenheit instead of Celsius as the freezer reading was set to Fahrenheit. The nurse called to inquire whether the vaccine is usable. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, administered vaccine that was not stored in recommended temperature, was unknown.   The reporter did not provide an assessment for the event of administered vaccine that was not stored in recommended temperature.; Reporter's Comments: This case concerns a 47-year-old patient who received their first of two planned doses of mRNA-1273 (Lot 011J20A), reporting Product storage error without any associated adverse events.
swollen, blotchy arm at injection site.... slightly itchy.... large red blotch that is hot to the touch
Pain on injection site in couple of days; tiredness; headache; muscle pain; joint pain; weakness; mild fever; sore throat; profused sweating; This is a spontaneous report from a contactable nurse. A 43-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 vaccine; lot EL0140, expiration date unspecified), via an unspecified route of administration on 29Dec2020 10:30 at single dose at left arm, for COVID-19 immunization. Medical history included allergies to seafoods occasionally. There were no concomitant medications. The patient was not pregnant at the time of vaccination. On 31Dec2020 23:00, the patient experienced pain on injection site in couple of days, tiredness, headache, muscle pain, joint pain, weakness, mild fever, sore throat and profuse sweating. Therapy for the events included Tylenol 500 mg. It was reported that the patient was vaccinated at the hospital. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine and no other medications the patient received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had been tested for COVID-19. The patient underwent a lab test and procedure which included nasal swab which was negative on 11Nov2020. Outcome of events was unknown.
3 days after receiving the shot, the child became more fatigued, weak legs, difficulty walking which was progressive until 10/11/19 when the child had difficulty standing and was short of breath when trying to stand. HR standing was in the 160s. Child was taken to walk-in clinic at pediatricians office where they observed all of the above and referred to cardiology. The child was seen by cardiology later that day and had ECHO, EKG, and 48 hour Holter Monitor was started. Cardiology testing was normal but this began a series of testing with multiple doctors in addition to cardiology including sleep disorders, ENT, and neurology. Testing included sleep study, trial of CPAP x 1 month, ENT exam, 48 hour inpatient seizure testing, tilt table testing. Child was diagnosed with dysautonomia and is in ongoing treatment for it.
A report has been received from a Physician concerning 11 patients. This case belongs to one of them. The patient with unknown gender had been receiving Nasal FLUMIST QUADRIVALENT. FLUMIST QUADRIVALENT (Intranasal) started on an unknown date. The patient received expired FLUMIST during 2014. The outcome of the event of received expired FLUMIST is unknown. The report was considered to be non-serious by the reporter.
Localized swelling and induration (L) anterior thigh. Onset 24 hours 7cm Treating with NSAID & Antihistamine.
Redness that night which turned to bruising and kept creeping down her arm over the next few days.  Area is 3" below injection site.  She came in 9/21 & talked to me.  Told her to ice it & use the Advil she had been using.  Called MD's office Mon 9/22 to let them know she had some bruising and may call them.  Whether brusing is related to shot or just a coincidence is unknown.
(L) arm developed round, red 5 x 5 cm raised area where vaccine given. Cool compress and Ibuprofen.
Diagnosed with COVID19 on 7/15/21, symptom onset 7/11/21. Confirmation w/PCR testing.
03/17: Got 2nd dose of Pfizer vaccine 03/23: Pain started in chest and leg 03/24: Pain forced her to go to ER where it was discovered that she had a clot in her lungs and leg.  Now on Xarelto
temperature excurtion for PROQUAD and VARIVAX / vaccines were administered to patients prior to having them evaluated; This spontaneous report was received from a office manager, referring to a patient of unknown age and gender. The patient's historical drugs, medical history, concomitant therapies and concurrent conditions were not reported.  On 25-JAN-2021, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live recombinant Human albumin (rHA)(PROQUAD) 0.5 ml for 1 dose, lot # T013540, expiration date 17-OCT-2021, for prophylaxis (strength, route and frequency were not reported) and varicella virus vaccine live (Oka/Merck)(VARIVAX) for prophylaxis (strength, dose, route, frequency, lot# and expiration date were not reported).  The cumulative and complete temperature excursion was unknown. It was  also unknown if a digital data logger was involved.