chrisvoncsefalvay/vaers-outcomes huggingface dataset:
On 2/14/22, burning sensation started an hour after injection. Also. rashes on both arms and legs. The burning sensation began in the left arm and spread to my chest, right arm and both legs. The strong burning sensation was without a fever and it continued until 2/17 along with body aches, headaches, chills.  On 2/18/22, the aches went away with daily naproxen. The burning sensation subsided expect for a slight burning sensation on my legs. However, the rashes continued to spread on both arms and legs. Additionally, I became very dizzy and had diarrhea. Which made me go to my local Urgent care.
arm swelled up 2/3 the length of my humerus and developed pealing itchy rash and,    Large ecchymosis to multiple body areas (especially the vax arm and right lower leg, and mild petechiae to trunk)
has a cold; congestion; sinus issues; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (has a cold), NASAL CONGESTION (congestion) and SINUS CONGESTION (sinus issues) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced NASOPHARYNGITIS (has a cold), NASAL CONGESTION (congestion) and SINUS CONGESTION (sinus issues). At the time of the report, NASOPHARYNGITIS (has a cold), NASAL CONGESTION (congestion) and SINUS CONGESTION (sinus issues) outcome was unknown. Not Provided      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.
Uveitis flare up. Light sensitivity, pain and discomfort. Prescribed treatment Prednisolone AC 1% Eye Drop. Treatment is currently ongoing.
Pt received a dose of Pfizer (0.2mL dose, 10mcg) in error. Medical Director, contacted immediately. Per CDC guidelines for administration errors, MD called for an adult dose of Pfizer (0.3mL dose, 30mcg) to be injected into opposite arm. Pt monitored in observation area following administration and had no immediate adverse reaction.
Developed raised blister like lesions with erythema base at site of injection (clustered), then dried and became flesh colored. No fever, no other lesions. No crusted scab, scaling skin flakes.
This spontaneous report as received from a registered nurse (R.N.) refers to a patient of unknown age. On 19-JUN-2007, the patient was vaccinated with GARDASIL (lot # not reported) (strength and total daily dose not reported). On 07-SEP-2010, the patient was vaccinated with another dose of GARDASIL (lot # not reported) (strength and total daily dose not reported). No adverse effect was reported. It was unspecified whether the patient sought for medical attention. The outcome was unknown. Additional information has been requested.
Initial report received from a health care professional on 26 Jan 2010: This patient was vaccinated with FLUVIRIN (batch number unknown) on an unspecified date in Sep 2009. The patient developed pharyngitis in Jan 2010 which progressed further to weakness in the abdomen and extremities. There was a suspicion of GUILLAIN-BARRE syndrome as a possible explanation of the patient's symptoms but no definitive diagnosis was made. Outcome of the events was not reported.
Pt performed TV with PCP on 2/24/21. Per PCP " She relates that yesterday morning (2/23/21) she got her 2nd COVID-19 vaccination by Pfizer. She had no ill affects until approximately 10:30 p.m. yesterday (2/23/21) at which time she developed chills her symptoms worsened and by midnight she could not move her arms or her legs and her arms and legs felt numb. She did not have any difficulty breathing. She did not have any numbness in her chest and she did not have any shortness of breath. She did not have any rash and she did not have any swelling or have any headache. She relates that she is better now (2/24/21) although she does still feel like she has weakness of her arms and legs she is now able to walk. The only remaining parenthesia is a little bit of tingling in her right arm. She is still experiencing significant fatigue".
She was taken to the hospital for respiratory distress, she was turning purple. She dies arriving at the hospital.
This prospective pregnancy case was reported by a consumer (subject) and described the occurrence of injection site pain in a 41-year-old female subject who was vaccinated with FLUARIX quadrivalent (GlaxoSmithKline) during pregnancy. A physician or other health care professional has not verified this report. The subject had no previous pregnancies. The subject was not using contraception and the conception was normal. There was no evidence of defect from prenatal testing. There was no maternal and paternal history which may have an impact on the outcome of this pregnancy. On 16 September 2013 the subject received a dose of FLUARIX quadrivalent (.5 ml, unknown route, left arm) and experienced vaccine exposure during pregnancy the 3rd trimester of pregnancy. The gestational age at the time of vaccination was calculated to be 36 weeks. The date of last menstrual period was not reported. The estimated date of delivery was reported as 10 October 2013 per the subject. At the time of reporting, the pregnancy was ongoing. On 16 September 2013, less than one day after vaccination with FLUARIX quadrivalent, the subject experienced injection site pain. On 23 September 2013, 7 days after vaccination with FLUARIX quadrivalent, the subject experienced injection site discoloration (described as "a ring formed around injection site and was discolored") and injection site pruritus (described as "the ring and discoloration were associated with itching"). It was unclear from the report whether the ring formed on 23 September 2013 or 27 September 2013. At the time of reporting the event of injection site pain was resolved. At the time of reporting, the events of injection site discoloration and injection site pruritus were unresolved per the reporter. 31 January 2014 - No further information was provided; patient lost to follow-up.
Bumps first appeared on 8/28/05 with increase temp (102) then major breakout on 8/29/05 am.  Missed school from 8/29-9/6/05.  Given Zovirax- took x 1 week.
A little ringing in the ear after booster Shot; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (A little ringing in the ear after booster Shot) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 17-Jan-2022, the patient experienced TINNITUS (A little ringing in the ear after booster Shot). At the time of the report, TINNITUS (A little ringing in the ear after booster Shot) outcome was unknown.            No Concomitant medication reported. No Treatment medication reported.   This case was linked to MOD-2022-504241 (Patient Link).
This spontaneous report as received from a nurse refers to unspecified patients of unknown age and gender. On an unknown date these patients were vaccinated with a dose of PNEUMOVAX 23 (lot#, dose, route, indication not reported). Concomitant medications were not reported. On an unknown date these patients developed redness that was the size of a "half dollar" after receiving PNEUMOVAX 23. But the nurse stated that this was "rare". Outcome of the event was unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Patient presented to the ED for low hemoglobin, anemia and was subsequently hospitalized within 6 weeks of receiving covid vaccination.
p/vax pt lab tests revealed no varicella antibodies;pt sought unspecified medical attention;
Approximately 5 mins post injection of influenza and varicella vaccines, patient developed syncope, parent reported shaking of upper extremities for a few seconds, patient unresponsive and eyes rolled back.  Patient responsive within approx. 30 seconds of nurse/provider coming into room, diaphoretic, no cyanosis, no incontinence, no labored breathing.  Blood sugar and vital signs monitored and WNL, 2 L oxygen applied, patient reported tongue tingling but no difficulty breathing.  Paramedics were called, arrived at clinic and assessed, and patient discharged home with mother, with instructions to follow-up with PCP.
A report was received from an observational study. This is a Phase IV safety study using Adenovirus Type 4 and Type 7 Vaccine, Live, Oral. There were 55,989 in the exposed cohort and 55,989 in the unexposed cohort. The date of the surveillance of the exposed group was Oct 2011 to July 2012. The date of the surveillance of the unexposed group was Oct 2010 to July 2011. 8 Patients in the exposed cohort experienced thyrotoxicosis, while 5 of the unexposed cohort experienced thyrotoxicosis. Of the 8 patients in the exposed group age: 6 were in the age group 19-24; 2 were 25-29. Sex: 7 female, 1 male. Of the 5 in the unexposed group age: 4 were in the 19-24 age group; 1 from 30-34 age group. Sex: 2 female, 3 male.
There have been two, Joint pain in the left knee, felt like I hyper extended it which started the next day after the shot and lasted about two days. No known activity that would have made me have knee pain. Second event started 4/8 as a rash in both arms. None around the shot site but more on both forearms. I have no food allergies and did not eat anything that I haven't eaten before. I've taken Benadryl to ease the condition and will continue to monitor it.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 16-SEP-2015 the patient was vaccinated with an improperly stored dose of GARDASIL9 (0.5 ml; lot # K026247, expiration date: 29-JAN-2017; dose, frequency and route unspecified). No adverse effects were reported. This specified lot number vaccine was exposed to temperature excursion 4 times. The storage criteria was refrigerator (R). The total cumulative excursion time (hour), the lowest recorded temperature (Fahrenheit degree/ Celsius), Celsius conversion of the lowest recorded temperature (Fahrenheit degree/ Celsius) and the type of excursion (R/F) for each time were 120, 29, -1.666666667 and R; 24, 33, 0.555555556 and R; 272, 31, -0.555555556 and R; 112, 32, 0 and R. This is one of several reports received from the same source. Additional information has been requested.
A non-serious report of fever, vomiting, and diarrhea has been received from a nurse concerning a six-year-old female.  No medical history nor concomitant medications were provided.  The patient received the initial FluMist dose out of the two dose series, on an unknown date.  Two days after the dose of FluMist, the patient had a low grade fever, vomiting, and diarrhea.  Outcome for the events was not provided by the reporter.  It is unknown whether the patient received the second dose of the two dose series of FluMist.  The reporter provided no causality assessment for the events.  The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable.
Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Additional Details: After patient recieved their shot they passed out.  Pt states that this has happened before after vaccination.  Paramedics were called and patient declined to go to the hospital.
may be Guillain Barre Syndrome; Lost the ability to walk; Lost the ability to get up; 3rd dose of Shingrix administered; first dose of Shingrix on 19-Sep-2019, a second dose on 17-Sep-2020; This case was reported by a pharmacist via call center representative and described the occurrence of guillain barre syndrome in a 73-year-old male patient who received Herpes zoster (Shingrix) (batch number LG2XJ, expiry date 10th September 2023) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (On19th Sep 2019 1st dose received).   On 21st September 2022 17:00, the patient received the 3rd dose of Shingrix. On 17th September 2020, the patient received the 2nd dose of Shingrix. On 17th September 2020, not applicable after receiving Shingrix and unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On 21st September 2022, the patient experienced guillain barre syndrome (serious criteria hospitalization and GSK medically significant), unable to walk (serious criteria hospitalization), mobility decreased (serious criteria hospitalization) and extra dose administered. On an unknown date, the outcome of the guillain barre syndrome, unable to walk, mobility decreased, extra dose administered and drug dose administration interval too long were unknown.   It was unknown if the reporter considered the guillain barre syndrome, unable to walk and mobility decreased to be related to Shingrix.     Additional Information: GSK receipt date: 22-SEP-2022 Reporters comment:  The patient received a first dose of Shingrix on 19th Sep 2019, a second dose on 17th Sep 2020 and a third dose on 21st Sep 2022 around 5 PM (local time). The patient remained in the pharmacy for 10 to 15 minutes after received the third dose and, as per the reporting pharmacist, was asymptomatic when leaving the pharmacy. The pharmacist also reported that around 6PM local time on 21st Sep 2022, the patient was rushed to the hospital by a life squad.  On 21st September 2022, less than an hour after shingrix 3rd dose, the patient experienced guillain barre syndrome, unable to walk, mobility decreased. According to the reporter, the patient´s daughter told the pharmacy staff that on 22nd Sep 2022, the patient had been hospitalized and had lost the ability to get up and walk and that it may be Guillain Barre Syndrome The reporter consent to follow-up. Additional Supportive information: Till the time of reporting, the patient received 3 doses of shingrix, which led to Extra dose administered and first dose of Shingrix received on 19th Sep 2019, a second dose on 17th Sep 2020 which led to lengthening of vaccination schedule.  As the patient received 3rd dose of shingrix which led to extra dose administered.
11April96 Pt recv 1 dose vax. 03Feb98 Pt devel "mild case breakthrough varicella. approx 30 lesions.
I am 19 weeks pregnant due August 19th. Side effects included migraine/headache and muscle/joint aches.
1-2 hrs p/vax twitching in the arm where administered; 1 wk p/vax severe twitching & tingling in both arms & both legs, certain movements w/hand or fingers not smoothe, weakness in rt foot & leg;
I don't know that adverse events occurred as a result of the vaccination.  I was told to submit if any events occurred after vaccination.  There is only one place to enter information but she had a second injection a month after the one listed in part 4 on April 17, 2021 at the same Moderna 007BZIA
Rebound 8 days after finished the 5 day course; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Rebound 8 days after finished the 5 day course) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039F21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer / BioNTech (Batch/Lot No: ER8732  Location of injection: Arm Left) on 24-Mar-2021 and Pfizer / BioNTech (Batch/Lot No: Ew0775  Location of injection: Arm Left) on 21-Apr-2021. Past adverse reactions to the above products included No adverse event with Pfizer / BioNTech and Pfizer / BioNTech. Concurrent medical conditions included Drug allergy (Sulfa). Concomitant products included LEVONORGESTREL (MIRENA) and TOPIRAMATE for an unknown indication.    On 04-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Rebound 8 days after finished the 5 day course). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 18-May-2022 to 23-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (Rebound 8 days after finished the 5 day course) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       It was reported that patient taking any other medication within 2 week of starting covid-19 treatment.  Company comment- This spontaneous case concerns a 42-year-old female patient with no relevant medical history, who experienced unexpected, non-serious adverse event of special interest Covid-19 which occurred at an unknown time with regards to the mRNA-1273 vaccination. The patient complained of rebound 8 days after finishing the 5-day course of Paxlovid. No further information was provided. The outcome of the events was reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Sender's Comments: This spontaneous case concerns a 42-year-old female patient with no relevant medical history, who experienced unexpected, non-serious adverse event of special interest Covid-19 which occurred at an unknown time with regards to the mRNA-1273 vaccination. The patient complained of rebound 8 days after finishing the 5-day course of Paxlovid. No further information was provided. The outcome of the events was reported as unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Vaccine administed to a 17 year old; A spontaneous report was received from a Certified in Public Health (CPH) concerning a 17-years old patient who was received Moderna's COVID-19 Vaccine (mRNA-1273) and who experienced the event, product administered to patient of inappropriate age.  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 on an unknown date, intramuscularly for prophylaxis of COVID-19 infection.  On 05 Jan 2021, the CPH reported that one of their local hospitals administered a dose of Moderna vaccine in error to the 17-years old patient.   No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The event, product administered to patient of inappropriate age, was resolved on unknown date.; Reporter's Comments: This case concerns a 17-year-old patient who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Product administered to patient of inappropriate age without any associated adverse events.
Initial visit. Patient is sitting up in bed drinking some juice. She is somewhat drowsy, drifting off to sleep when not directly engaged. PPS 30%; bedbound. Patient denies pain when asked; states she feels much better than last night. Son reports that she had a good deal of pain and anxiety last night, but it is much better this AM after she received some Roxanol and Ativan before bed. When she does have pain, it is in the perineum. Having copious amounts of thin, malodorous brown drainage/stool coming from the vaginal fistula. She often groans and grimaces when peri-care is performed. from Skin is intact and pale/cool to touch. Fingers and legs very cool to touch. Unable to obtain sats as fingers were cold to touch and unable to warm them up. Respirations unlabored at rest; labored if repositioned and with pain. LS diminished throughout. Edema 2+ BLE. BS active; having constant stool leaking. Discussed timeline, prognosis, and reviewed patient?s routine medications and CCK. Written instructions provided. Discussed POC with son. No refills needed. Instructed to call hospice with any changes or concerns. Visit made to pronounce death. Patient had no pulse or respirations at time of visit
Loss of some hearing in right ear.  Ringing, tinnitis possibly.  Moderna vaccine used.
Erythema, macular and blotchy and irregular in pattern extends approximately 2 inches in diameter. No warmth of skinat site left anterior thigh (not lateral) site of VARIVAX vaccine given 3-26-13. Pt is afebrile. Discomfort at site relieved with TYLENOL 1 dose.
1 hour after receiving the COVID-19 vaccine, I experienced a tingling sensation that started in my lips (right side only). This turned into an icy, burning sensation that traveled  up my right cheek, ear and scalp and stayed for 2 hours. The feeling returned that night at an unknown time and I felt fine the next day.
shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, immediately after receiving Shingles vaccine, the patient experienced shingles (Verbatim: shingles).  The outcome of the shingles was not reported.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 03-Mar-2023 This case was reported by a patient's friend via interactive digital media. The reporter reported that the patient received the shingles vaccine and came down with a horrible case of shingles right after that. The follow up would not possible as no contact details were available.
Vaccine administered on March 6.  Noticed small red rash (1 x 2") on upper arm just below injection site on Tuesday March 9th.  Each day after,  the rash continued to spread and area was warm to the touch.  By Thursday the 11th the rash became very itchy and eventually spread down to the bend in my elbow and in a triangular shape from the injection site to the total outside of my upper arm (5 x 7 ")  It remained very itchy for 3 days. I used antihistamine and cortisone creme do relieve itch.  That helped somewhat.  The rash has slowly disappeared with no more side effects.
Received Hepatitis A #1 vaccine on 8/5/09 in L arm around 7PM complains of tingling in R hand. Woke on 8/6/09 with red rash on face that extended to neck and antrum chest. Hive/ rash - No respiratory problems.
Few days after receiving PREVNAR, pt stated he started itching starting from midline and shoulder blades to lower back and front trunk and back of lower left leg. He also noticed some bumps on his body.