chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. No Medical History information was reported. On 02-Mar-2021 at 1:14 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 02-Mar-2021 at 1:14 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown. Not Provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The age of patient was provided as 74.14. Concomitant products were not provided. On 02-Mar-2021, excursion time was 09 AM, 10 AM, 11AM, 12AM, 2PM and 3PM,  and temperature was 27, 29, 32, 33, 35 and 36 respectively, total doses given for the day was 177, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 24-Feb-2021, vial was moved to clinic on 02-Mar-2021. 16 vial was moved to clinic on 02-Mar-2021. Vaccine BUD date was 26-Mar-2021. Vial was stored on cooler 1, on 02-Mar-2021, Excursion duration At, 9 AM: 27, 10 AM: 29, 11 AM: 32, 12 AM: 33, 1PM : 36, 2 PM : 35, 3 PM: 36, 4 PM: 37 and 5 PM : 37. The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a Fisherbrand traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature. It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F. Treatment medications were not reported.
This patient had probable seizure activity, eyes stared, decreased tone, voided for 3 minutes duration. Had Prevnar injection 4 days prior to event. History of fever, vomiting, diarrhea, URI sickness.
Chills Slight Headache 100.5  Fever  I took 2 (325mg ea.) tablets of Tylenol 1 time. This is the only treatment I took.
Information has been received from a physician via field representative referring to an 83 year old female patient. Information about medical history and drug reactions or allergies was not reported. On an unknown date the patient was vaccinated with ZOSTAVAX (1 shot, lot number, dose and route were unknown). Concomitant medications were unspecified. After receiving ZOSTAVAX, on an unknown date, the patient developed a case of the shingles. The patient sought medical attention via office visit. The outcome and causality of the event was unknown. Additional information has been requested.
I administered 0.25 mls of Moderna vaccine at approximately 2:45 pm to patient in the pharmacy. She remained in the pharmacy for 15 minutes for post-vaccination observation. She felt like she was having what she described as "heartburn" and asked my technician for some water while I was counseling another patient.  Soon after, she said she had shooting pain radiating from the left side of her chest to the right. She started to complain of jaw pain. I took her blood pressure. It was 150/91. She remained calm and conscious. She continued to talk to me and I repeated her blood pressure and it was 140/93. She became pale in color and her skin was cool to the touch. I called emergency and gave her 4 tablets of chewable Aspirin 81mg.  While we waited for the paramedics to arrive, she continued to talk to us but became dizzy. We had her sit on the floor with her back resting on a chair.  We continued to monitor her blood pressure. The paramedics arrived and performed an EKG in the ambulance. It came back ABNORMAL ATRIAL FLUTTER. They proceeded to take her to the Emergency Room at Hospital to do lab work and give her a complete assessment.
Baby arched back and went limp, barely breathing. Bleeding on the brain, bleeding behind the eyes.  9/18/07 Received ER medical records which reveal patient arrived in ER on 7/21 07 w/CPR in progress after being found by parents vomited & with agonal respirations.  Transferred to higher level of care.  10/2/07 Received hospital medical records which reveal patient experienced cardiopulmonary arrest at outlying ER.  Resuscitated, intubated & transferred for higher level of care.  Admitted to PICU 7/21-7/31 then transferred to peds unit from 7/21-9/4/2007 when transferred to LTC.  Neurosurg, neurology & ophthalmology consults done.  Left SDH drain placed on 7/21.  Required resuscitation again after left SDH drain placed.  Right SDH drain placed 7/22. Severe bilateral retinal hemorrhages c/w non accidental trauma.   Multiple seizures & tx w/antiseizure meds. LOC improved w/drainage but strong concerns about functional neuro status.  Failed extubation trials multiple times due to stridor & airway edema while on steroids until finally stable on extubation 8/18/07.  Multiple episodes of bradycardia believed to be CNS in origin.  Received PEG tube feedings.  Right SDH drain pulled on 8/2.  VP shunt placed.  Received IV antibiotics only after csf (+) on 8/2.  Patient is in custody of DSS in LTC. 11/2/07 Reviewed vax record from pcp & VAERS database updated w/same.
11 cm x 9.75 cm area of erythema/edema (R) deltoid.
Bruising and hematoma at injection site, approximately 4.5" in diameter. Not resolved after 12 days. Rectal bleeding on 3/12, 2021, Gum bleeding twice in 12 days. Bruise on left forearm.
PASSED OUT IN OUR LAB, BLOOD PRESSURE DROPPED VERY LOW, TRANSPORTED TO HOSPITAL.
Hives on neck, chest, back, arms, abdomen, and legs. On 9/20/2013 very tired and @ 2:00 PM ran temp. or 101.2. Took Benadryl for hives and Tylenol for fever.  Feeling better on 09/21/2013 but still very blotchy and a bit fatigued.  Had both the flu and pneumo on same day, but different arms.
it hurts; This case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingles vaccine.     Linked case(s) involving the same patient: US2022AMR052502  Additional details were reported as follows: The case was self reported by the patient. The age at vaccination was not applicable. The patient just got his/her second shot of Shingles vaccine and mentioned it hurts, but nothing like getting shingles. This case was linked with US2022AMR052502 reported by same reporter for same patient for different dose.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR052502:same report, other dose
I contracted COVID-19 on 07/21/2022 with symptoms of headache, sore throat, fever, runny nose, and congestion. I was not prescribed any medications. I was ill for 5 days before my symptoms began to resolve. I feel fully recovered with no lingering symptoms.
Pains at lower stomach; hips pain; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Pains at lower stomach) and ARTHRALGIA (hips pain) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2021, the patient experienced ABDOMINAL PAIN UPPER (Pains at lower stomach) and ARTHRALGIA (hips pain). At the time of the report, ABDOMINAL PAIN UPPER (Pains at lower stomach) and ARTHRALGIA (hips pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No treatment information was provided.
Patient is a 61 y.o. female who received the Janssen Covid vaccine Lot# 1805020 on 3/12/2021.  The patient experienced the following reaction(s) during the immediate   of observation:  Dizziness  Patient was treated/managed as follows:   Given Gatorade and VS taken: 12:16pm: BP-180/90 HR: 71 RR:18 O2: 98%  12:26pm: BP: 180/90 HR: 73 RR: 18 O2: 97%  Pt states she has not taken BP meds this morning.  Pt reports feeling better Patient given educational material regarding vaccine and advised to continue to self-monitor per the CDC guidance. Pt escorted to car by Site Lead
vaccination failure; Shingles; rash; sensation was described as electric shocky; This case was reported by a pharmacist via call center representative and described the occurrence of vaccination failure in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number C7B9P, expiry date 27th February 2021) for prophylaxis.   On 26th September 2018, the patient received the 1st dose of Shingrix. On 11th January 2019, the patient received the 2nd dose of Shingrix. On 25th September 2019, 364 days after receiving Shingrix and 257 days after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, rash and electric shock sensation. The patient was treated with azithromycin and valaciclovir hydrochloride (Valacyclovir). On an unknown date, the outcome of the vaccination failure, shingles, rash and electric shock sensation were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, rash and electric shock sensation to be related to Shingrix and Shingrix.  Additional details were provided as follows: The patient experienced a rash on her right buttock. The sensation was described as electric shocky. On 28th September 2019, the patient was seen by a doctor who diagnosed shingles. The patient was prescribed azithromycin 250 mg for 5 days and  valacyclovir 1 gram three times daily. At the time of reporting, it was not known if the patient has improved. The reporter consented to follow up.
2 weeks later and I am still having pain and tenderness in arm, arm feels heavy and sometimes I have weakness. There is no rash or swelling
Infant did not normally drop heart rate, did have an episode at 6pm on 2/12 before shift change but was able to be recovered. at 9pm infant had episode of heart rate drop that required intebation, made npo, placed on vent, septic work up done to rule out sepsis. Infant was on room air breathing on own before this. no growth from cultures so far. infant received prevnar on 02/11/11 in am
On 8/27/18, patient came by the pharmacy to pick up an Augmentin RX. Upon counsel, she stated she was receiving this antibiotic due to an allergic/infective response following her Shingrix vaccine that was administered 8/22/19.   She stated on the morning of 8/23/19, she began having a low grade fever and the injection site was sore. By Sunday 8/25, she stated the arm was swollen with a red splotchy area, and was warm to the touch. She visited her PCP that prescribed the Shingrix today 8/27, and he gave her a 7 day course of Augmentin. She states it is better now than it was this weekend, but she will still be taking the antibiotic course. It has a visible red splotchy area. Patient has been advised by her PCP not to get the 2nd Shingrix vaccine of the series due to her reaction.
Encephalitis,  cried NON STOP for 3 days, body was extremely stiff, no appetite,  no energy to nurse, vomited the bit she ate, fever, didn't sleep,  extremely irritable, could not move, would not calm down at all. Took over a week to recover.
Subsequent to an Acel-Imune injection, pt developed an injection site reaction characterized by swelling, redness and warmth extending to the elbow.
Injection site swelled (4" diameter), was extremely hot to the touch, and very painful start about four hours after the shot. By that evening, I was extremely achey and feeling flu-like symptoms. Extreme headache began next day and lasted for 1.5 days. Fever was never confirmed, but I had chills and could not warm myself. Swelling and redness lasted two days. Swelling was circular around injection site--still swollen now/4 days after. Aches lasted about 2 days. Once the redness subsided, the injection site became extremely itchy and still is to date.   Please note, I am 10 months postpartum and still breastfeeding.
2-3 days after Pedvax Hib, Prevnar, and Pediarix she got a rash that covered both legs and feet that lasted a little over 24 hours she was not taken to the doctor. She also ran a fever but didn't take a temperature. She did have pertussis at 2 months of age.
Tenderness at the injection site; Terrible headache the day after; muscle achiness; tiredness; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site tenderness in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced injection site tenderness (Verbatim: Tenderness at the injection site), headache (Verbatim: Terrible headache the day after), muscle pain (Verbatim: muscle achiness) and tiredness (Verbatim: tiredness). The outcome of the injection site tenderness, headache, muscle pain and tiredness were not reported.   It was unknown if the reporter considered the injection site tenderness, headache, muscle pain and tiredness to be related to Arexvy.     It was unknown if the company considered the injection site tenderness, headache, muscle pain and tiredness to be related to Arexvy.   Additional Information: GSK Receipt Date: 17-OCT-2023 This case was reported via (Open field AE monitoring) interactive digital media. The follow up would not possible as no contact details were available.
Patient called and reported sweating, throwing up, swelling in injection site, and injection site was warm for 24 hours.
six days post vaccination, there is a large lump at injection site. warm and cold compresses has been applied since vaccination. my child is irritable from the lump. This is his third dose of this vaccine and has all required vaccines to date. He has not reacted to any vaccine such as this.
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication use was reported.
Flu-like symptoms; soreness in the arm; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Tetanus NVS (Tetanus vaccine) for prophylaxis.   On 18th August 2020, the patient received the 1st dose of Shingrix (intramuscular) and Tetanus vaccine. In August 2020, less than a week after receiving Shingrix and Tetanus vaccine, the patient experienced influenza-like symptoms and pain in arm. On an unknown date, the outcome of the influenza-like symptoms and pain in arm were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms and pain in arm to be related to Shingrix and Tetanus vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced flu-like symptoms for 1 to 2 days after the 18th August 2020 the injection of the first dose of Shingrix.  The patient also stated he had soreness in the arm but he also had a tetanus shot at the same time. All symptoms resolved in 2 days.  The reporter did not consent to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020170267:same reporter
I had a hard, warm bruise on my arm the day after my shot. It has grown  to about 3 inches wide and is warm to the touch and ichy. I have had severe headaches and felt very congested since the vaccination
Body aches, nausea, lethargy, decreased appetite, possible fever, sleeping difficulties approx. 24 hours
About 4 hours after my 2nd dose, I was driving on my way home and all of a sudden I felt like I was hallucinating. I saw what looked like a bug infestation coming across my vision line. It was a swarm of black spots. I had to stop and re-evaluate my situation on the way home. When I gained control again, I realized it wasn't a hallucination. It was my actual vision. When I got home I basically crashed for the rest of the day. The next day I contacted my optometrist and I went in for an evaluation. They said it was a cloud of floaters. I asked if there was any chance that it was a side effect of the vaccine. They told me no. They sent me to an ophthalmologist. He told me that it will never go away. I went back to my optometrist and they said it would go away. All that they could come up with is that it is a coincidence. I have also had dizzy spells. They weren't strong, but it was like a constant dizziness. I still have all of the symptoms going on. The floaters in my eye seem like they are starting to dissipate. I have had some mild nausea. I can take a nap and it seems like it dissipates. This all came on at one time. I have been extremely tired lately. I take 2-3 naps a day and that is just not like me. It's like the feeling of being hungover, but I haven't had a drink in months.
9/10/2021 - COVID POSITIVE AND HOSPITALIZED WITH SOB & COUGH, DIAGNOSED WITH SEVERE COVID PNEUMONIA
Sunday, June 5, 2022 late that night I had a scratchy throat. Monday I had to start blowing my nose a lot, and developed a cough that increased throughout the day. On Wednesday I took a home COVID-19 test in the morning it came back positive, I retested in the afternoon it also came back positive. After the second test came back positive I called my Primary Care Physician, after a series of questions he prescribed PAXLOVID that I am currently taking. I started taking this yesterday so I cannot give information on the efficacy of the medication.
more somnolent since vaccinations,  decreased oral intake and unable to take medications, presented to ER on 12/9, admitted with altered mental status, weakness, and possible UTI, no improvement with antibiotic, hydration, and administering Parkinson's medications via NG tube, discharged on hospice care 12/8.
This was my 2nd injection (first was done in 05/23).  The following morning I awoke with the feeling that I had a stroke.  I was lying in bed and initially ould not move my extremities.  I had to use my left (stronger) arm to lift my right arm.  Injectioin was in the left arm.  I had an "electrical zapping" pain in the back of my head.  I could not walk for quite awhile due to significant pain and stiffness.  I had nausea, fever, lungs hurt.  only muscle pain persists and is constant
patient return for the second dose past the 28 days recommended so patient was advice to start the series over; patient got 3 full Moderna vaccines; Off label use; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient return for the second dose past the 28 days recommended so patient was advice to start the series over), EXTRA DOSE ADMINISTERED (patient got 3 full Moderna vaccines) and OFF LABEL USE (Off label use) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040B21A, 002B21A and 030M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Apr-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient return for the second dose past the 28 days recommended so patient was advice to start the series over), EXTRA DOSE ADMINISTERED (patient got 3 full Moderna vaccines) and OFF LABEL USE (Off label use). On 23-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient return for the second dose past the 28 days recommended so patient was advice to start the series over), EXTRA DOSE ADMINISTERED (patient got 3 full Moderna vaccines) and OFF LABEL USE (Off label use) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Treatment medication information was not provided.   This case was linked to MOD-2022-455788 (Patient Link).
Rash over mid back, started this morning, covering 50% of back, itchy, no oral swelling/difficulty breathing
On March 18 sore on the right arm, 3/19 chills,fever, cough, taste was off by salty every tasted like pure salt even a piece of candy. Back pain on lower back and stomach pains and inflammation of the stomach.  Started with very painful back pain went to the doctor and gave him antibiotics and pain medicines and since he was not recovering with the medication they admitted him to the hospital on 4/9 with a blood clot in the portal vain causing no draining from liquids  to the intestines and was placen on blood thinners
Knee pain resulting in limping, inability to walk without pain. spoke with nurse regarding status of patient, improving with decreased complaint of soreness and stiffness. No complaints of weakness or neurological symptoms.   11/3/06-records received from physician office support phone conversation of 11/2/06.
On July 3rd I woke up with a burning throat, sneezing and coughing so I took an at home COVID-19 test that was positive.  I went to urgent care that afternoon and had a rapid test in the office that was also positive.  The doctor gave me a 5 day prescription for Paxlovid which I started that same day.  I did have coughing and sneezing all night last night but around lunch time today my symptoms are gone.
Nausea, vomiting, diarrhea, clammy feeling, sweats, headache The nausea lasted for about four days and I was prescribed zofran which didn?t really help at all I was even given it through IV which did not help
Initial light headed, dizzy, 1.5 hour later flushed feeling, chilled, nausea, headache, hot, cold, sweaty, photophobia, phonophobia, achiness