chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No immediate adverse events or signs/symptoms post vaccination. On 12/14/21 resident c/o chest pain and was sent to Hospital ER for further evaluation. He was subsequently admitted to hospital where he remains to trend Troponin levels after slight elevation noted. Prior to this resident began exhibiting a change in mental status with hallucinations and delusions which started around 12/08/2021. He has been on several antibiotics for COPD exacerbation, UTI, chronic abscess to coccyx bone in the time frame of 1 month prior to vaccination to current date. He was admitted to acute care at Hospital on 12/14/21 for chest pain, elevated troponin (0.06), hypokalemia, and confusion. He was started on IV antibiotics for UTI infection and deep coccyx wound. Troponin again elevated in subsequent lab collection (0.11 from 0.05). Post admission diagnoses UTI with Sepsis, Chest pain with history of coronary artery disease, Stage 3 pressure ulcer of coccyx, Congestive Heart Failure - stable. Follow-up progress notes from 12/16/21 indicate UTI treated with IV Invanz, coccyx wound treated with IV vancomycin, improvement of hallucinations/confusion, Atrial fibrillation with RVR, hypokalemia, urinary retention. Transitioned to skilled care at Hospital.
Patient had equivocal titer. Given vaccine on 8/19/19. Lesion developed left lower face, near but not touching lip on 8/20/19, progressed to lesion inside of left nose, swelling/itchiness under left eye  itchiness, redness left upper gum near tooth #12, and left earlobe swelling/redness/itchiness. Seen initially for symptoms on 8/23/19 in my office, separate from site of immunization. Referral to ED, given Valtrex 1 gram po tid x 7 days. Follow up same day from this office. Ordered CT left orbit, CT brain without contrast, referral to Opthalmologist - test and specialty visit done same day 8/23/19. F/U 8/26/19 in office, improved. Given Bactroban, bid x 5 days for lesion inside of left nose.  F/U 8/30.
Around 1am (~13 hr after vaccination) I began experiencing severe joint pain in my ankles, knees, hips and spine. Enough to wake me up from my sleep. The pain was also accompanied by chills.  I took Tylenol for the symptoms but the pain did not subside. This morning, at 8:30am the joint pain is still very strong.
Booster Shot Within 5 minutes I could feel a burning sensation traveling through my arm and through my body.   My entire body got extremely hot and blazing red.  Big welts of skin, itchy.  I don?t know if my heart rate jumped up from anxiety or the shot.   I felt as if my body had hot lava traveling through me.
Headache, Myalgia, Arthralgia, chills, sweat Narrative:
Headache; Mild nausea; Muscle ache; This is a spontaneous report from a contactable consumer. A 45-years-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: Not reported) via an unspecified route, administered on 22Feb2021 (age at vaccination 45 years) as dose 2, single for COVID-19 immunization. Historical vaccination included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: Not reported) via an unspecified route, administered on 01Feb2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications was not reported. On 23Feb2021 the patient experienced headache, nausea, muscle ache. It was unknown that patient was received any treatment for events. The events accessed as a non serious. The outcome of all events was reported as not recovered.  Information about lot/batch number cannot be obtained. No further information expected.
Within 24 hours of receiving the vaccine, she developed muscle aches, felt feverish, had nausea and loss of appetite.   These symptoms have subsided except that she still has some nausea and loss of appetite, but it is not as bothersome.     About 24 hours after she got the injection, at the injection site, she also developed swelling of her arm, induration at the injection site, redness, itching.  She is still having these symptoms.
pt felt exposed to varicella while pregnant recv varicella instead of varicella zoster immune globulin by mistake;ultrasound @ 11.5 weeks gestation revealed that the fetus had died;the ultrasound inidcated that the fetus was devel to about
Dx: Intestinal infection enteritis due Rotavirus, vomiting and diarrhea and dehydration - that required four days of hospitalization - Child was positive for Rotavirus.  Follow up from admission for rotavirus Viral GE with vomiting and diarrhea.  Sx. have resolved s/p admission.  Pt. doing much better now.
Sore shoulder both arm right and left arm; pain scale 5/10 Narrative:
This is one case out of a cumulative total of 215 cases solicited from a database during the surveillance period from 01 January 2010 to 15 October 2013. These 215 cases represent children who received 3 or more doses of sanofi pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not reported as per study protocol. Initial report received on 15 October 2013 from the Investigator participating in a post-marketing observational surveillance study. A case of pertussis disease in a 3-year-old female subject (initials not collected) was identified by the investigator based on review of data from the state Electronic Disease Surveillance electronic database. The subject had received 4 doses of PENTACEL; lot number C3294AB received on 13 July 2009, lot number C3378AA received on 15 September 2009, lot number C3365AB received on 16 November 2009 and lot number C3615AA received on 29 July 2010 (routes and sites of administration not reported). The subject developed cold-like symptoms on 27 August 2013, approximately three years after the last dose. On 27 August 2013, the subject developed a cough and paroxysmal cough on 06 September 2013 with a whoop. The subject also experienced post-tussive vomiting, sleep disturbance and apnea. Laboratory testing included positive PCR on 08 September 2013. Chest x-ray findings were unknown for pneumonia. Corrective treatments consisted of azithromycin starting on 06 September 2013 for 3 days. The subject was not hospitalized. At the time of final contact on 12 September 2013, the subject's cough was still persisting. The duration of the cough was reported at that time as 16 days. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Loss of hearing in left ear and starting same in the right as of today (11/10/2022).   Urgent care physician recommended fluticasone nasal spray and Pseudoephedrine  No changes in symptoms
Patient too young, family aware and will follow up with Peds for further guidance on second dose.
Almost immediately after patient sat down in observation chair after vaccine administration, he stated he was feeling extremely dizzy and light-headed. He also became extremely sweaty and cold/clammy to the touch. Took his blood pressure and it was 80/56 mmHg. HR was 49 bpm. Grabbed him some cool cloths to apply to his face/head/neck. He stated he was extremely anxious about the vaccine as he has an extremely phobia of needles & thought this may have contributed to the event, but was not sure. After a few minutes, he began to feel better. He stopped sweating, skin warmed up and he was no longer dizzy or light headed. By the time his 15 minutes were up, he was back to normal again.
Information has been received from a medical assistant referring to a patient of unknown age and gender. The patient's concurrent condition or medical history was unknown. On 31-JUL-2017 the patient was inadvertently vaccinated with an expired dose of GARDASIL (lot # M014929 with expiration date 27-MAY-2017, dose and route unknown) for prophylaxis.
2 days after injection right arm injection site was hot itchy! Painful and hard. No improvement until started prednisone taper 04/27/13 and doxycycline BID x 10 days. Neck swelling on right side noted as well.
Information has been received from a school nurse concerning a patient who 10-15 years ago (approximately 1993), was vaccinated with pneumococcal 23v polysaccharide vaccine (lot #, dose and route not reported). The nurse reported that 10-15 years ago when the pneumococcal 23v polysaccharide vaccine was given, the patient broke out in hives. The nurse had no further information. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with an expired dose of PNEUMOVAX 23 on 23-OCT-2012 (lot# 669776/0614AA; expiration date 27-SEP-2012; dose and route not reported). No other co-suspects were reported. No concomitant medications were reported. No adverse symptoms were reported. Additional information has been requested.
Body aches, fever, chills, headache.  Came on approximately 4 hours after vaccination, subsided approximately 24 hours after vaccination.
Mood swings that were once controlled by medication returned. Easy aggravation that was controlled by medication returned after the vaccine on the 13th. Depression worsened, focus and interest declined started the 14th.  I couldn't sleep the night I received the first dose. I have lost a total of 3 full nights of sleep since I got the vaccine. I am still having mood swings as of April 23rd. I still feel generally ill, fatigued, and all over muscle pain as of April 23rd, it started the 14th. Increase in anxiety after experiencing the mental health side effects of the vaccine. I also experience clear UTI symptoms but had a negative result test.
I got COVID-19 01/20/2021 and one week later I received an Antibody treatment before I got my COVID-19 vaccines and I waited 90 days afterward to get my shot. Two days after I got my vaccine every single joint in my body became inflamed. The pain was severe. I also had cellulitis around my body that was very painful if someone touched me. I went to the ER and I ended up being hospitalized for one week. I was then transferred to a rehabilitation center for two weeks. I was then transferred to another hospital for one week after that. The pain persisted all over my body. No one could even touch me. I recovered over the next couple of weeks after I was discharged. I was referred to a rheumatologist by my PCP. I got the second dose, and I did not have the same symptoms. My joint pain still flares up briefly sometimes.
vaccine brand other=Moderna as dose 3; COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing). The patient has no known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Feb2023, outcome "unknown" and all described as "COVID 19 Treatment"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "vaccine brand other=Moderna as dose 3". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative, notes: day 6; Negative, notes: day 7. Therapeutic measures were taken as a result of drug ineffective, covid-19 including Paxlovid from 10Feb2023 to 14Feb2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: A contributory role of BNT162B2 to event CIVID-19 treatment cannot be excluded based on temporal association and available information.
Headache and discomfort for duration of initial day. Itching and rash on site and on arm/hand where shot was given.    Following day(Sunday) experienced more headache and muscle aches and joint pain. fatigue. Some abdominal discomfort and intestinal distress.These symptoms lasted ino Monday.  Monday did not work, continued to experience flu-like symptons. felt chills but did not have fever above 99 during any of time.  Abdominal discomfort continued through Tuesday
Moderna COVID- 19 Vaccine  After the 15 minute monitoring period after vaccine administration, patient complained of abdominal itching, no throat itching, no swelling, no difficulty breathing. Patient was given diphenhydramine 25mg oral liquid and asked to stay for additional 15 minutes of monitoring. After additional 15 minutes, patient stated that itching has improved.
Beginning 1/10/2009, red bumps appeared on back of hands + face -  total E2Y changed to  - 5 pustules resolved after one week
A vaccine that experienced a supported temp excursion was administered to patients; This non-serious spontaneous safety report was received with reference numbers 02202377/02202359 on 11-JUL-2022 and forwarded. on 12-JUL-2022 from another health care professional.   The causal relationship between Vaxelis and the reported event of "Vaccine that experienced a supported temp excursion was administered to patients; Temperature 35.1F" was assessed as not applicable due to the nature of the event.  Further information is expected.
adipose necrosis-1x1cm <less;pt exp dimpling of thigh p/vax;dimpling is a result of necrosis of fatty tissue
Swollen, very itchy, red, circular rash near the injection site. I have been taking allergy medication, applied calamine lotion, as well as hydrocortisone cream to reduce the itching. The red rash mainly disappeared but is still itchy. I am afraid to scratch it believing the rash will come back and become even itchier. The itching was so back that it woke me up last night/early morning (1/28) and I had to apply hydrocortisone cream to relieve the itching. The itchy will go away for a day then return and this has been going on for a week.
24 hrs after shot  i ran low fever and head ache. i had fatigue,  But then i started 2ays later feeling like i had inflammation in my butt, external in vaginal area and was hard to use the restroom and back of thighs area. felt like a had a rash but there was nothing there. like it was burning.  it just felt inflamed.  It felt good to apply cold to it.  it lasted until the next day.
redness-heat 7x10cm rt deltoid area; low grade templ discomfort @ site;
Body aches; throat closing up; This non-serious case was reported by a consumer and described the occurrence of general body pain in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced general body pain (Verbatim: Body aches) and throat constriction (Verbatim: throat closing up). The outcome of the general body pain and throat constriction were resolved.   It was unknown if the reporter considered the general body pain and throat constriction to be related to Shingrix.     It was unknown if the company considered the general body pain and throat constriction to be related to Shingrix.   Additional Information: GSK Receipt Date: 01-OCT-2023 This report was submitted via the online direct entry reporting system.  The patient reported after administration of first dose she had bad reaction of throat closing up. The reaction has been worst. In addition, she also had body aches which was no surprise. The symptoms were not treated. She wanted to get information on efficacy after just having the first dose of Shingrix. The pharmacist thought she had heard 65 percent efficacy and her MD refused to provide more information or advice. The reporter gave permission to contact on her mail address.
This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA (lot # K010577, expiration date 22-SEP-2016, exact doses and route of administration were not reported). The vaccines were exposed to temperature of 28F during cumulative of 8 hours, which was recorded last week of January 2016. Previous temperature excursion was reported and doses reached then 32F for near 1 hour (date was not provided). No adverse effects were reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same source. Additional information has been requested.
Patient received second Moderna vaccine on 3/25/21. Presented to ER on 4/23/21 0739 with stroke symptoms, stroke code activated. Last known well was 4/23/2021 at 0200. MRI indicated abnormality in thoracic spinal cord that appeared to be vascular in nature. Due to proximity in time to Moderna vaccination, concern regarding this being vaccine related injury.   Hospitilized 4/24-28 acute inpatient  Transfer to inpatient rehab 4/28/21
spinal pain; 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 SPINAL PAIN (spinal pain) in a  patient of an unknown age and gender 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SPINAL PAIN (spinal pain). At the time of the report, SPINAL PAIN (spinal pain) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medications provided. No treatment information provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-116616, US-MODERNATX, INC.-MOD-2021-116654, US-MODERNATX, INC.-MOD-2021-116661 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-116616:Crosslinked with daughter case US-MODERNATX, INC.-MOD-2021-116654:Cluster case for other people having spinal pain US-MODERNATX, INC.-MOD-2021-116661:Cluster case for other people having spinal pain
This spontaneous report was received from a pharmacist concerning a 65 year old female patient. The patient's concurrent conditions included allergy to codeine. On 03-DEC-2015, the patient was vaccinated with a dose of ZOSTAVAX (lot # L029482, expiration date: 06-NOV-2016), dose and route were not reported. Other suspect therapies included FLUZONE and PREVNAR 13; both administered on 03-DEC-2015 at an unknown dose and unknown route. On 12-DEC-2015, the patient began to experience "painful, itchy spots" on her torso and on the following morning (reported as 14-DEC-2015), the spots like "pimples", remaining mostly on the torso. She sought medical attention by calling the pharmacy. The pharmacist reported that as of 15-DEC-2015, the patient stated that the spots have mostly crusted over. The pharmacist stated, that the patient has not visited her primary care physician yet, and probably would not. No treatment was given for the events. The outcome of the events was not reported. The relatedness between the events and ZOSTAVAX, FLUZONE and PREVNAR 13 was not provided. Additional information has been requested.
Chills, body aches approx. 4 hrs after eyes bloodshot & felt swollen (did not take mpi) weak & nauseated - went to bed today to sleep it off. Still a little achy on 10/28 & 10/29
Inner arm swollen, red and warm to touch. Not near injection site. Stated started 1 day after vaccine.  Pt. does not believe due to injection, just wanted RPH to look at it. Says might have bumped arm somewhere. Informed pt. to go to MD to have looked at.
After Injection #3 - Extreme pain when injected, the following morning I awoke to swelling and pain in the injection area.  Pain and swelling stayed for about 2 weeks, then pain radiating in the forearm and upper arm of the started.  Still continues thru today.  I frequently have difficulty getting dressed and/or putting shoes on with my right arm.  Occasional pain in the area of the injection will reappear.  I seldom can lift my right arm over my head, lift any object, or straighten my right arm without discomfort, sometimes extreme pain occurs.  It also affects my sleep.  No reactions to Injections #1 or #2.
Erythema, swelling, hot to touch, stiffness, itching and pain at site.  Measures 150mm x 200mm today, but states it was bigger yesterday.
The pt developed swollen, red area below deltoid muscle above elbow. He also felt feverish and was slightly nauseated immediately after the injection. He also had a flew shot the same day.
This spontaneous report was received from a licensed practical nurse and refers to a 2 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 19-OCT-2015, the patient was vaccinated with a dose of GARDASIL 9 (lot # L007560, expiration date, exact dose, route of administration and anatomical location were not reported), that had experienced a temperature excursion. No adverse reaction was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from a registered nurse concerning a patient who on 27-MAY-2008 was vaccinated subcutaneously with a 0.5 ml dose of ZOSTAVAX (Oka/Merck) instead of VARIVAX (Oka/Merck) due to a medical error. The patient was not experiencing any known symptoms. The nurse stated that the error was her fault. It had nothing to do with packing or anything else. The nurse was disturbed several times while dispensing the medication and she didn't even realize that she grabbed the wrong one until later that evening when she was doing the charts. She has since separated the two products in their freezer, in the hopes of preventing others in the office from doing it again. She also stated that the patient was in the office on 30-MAY-2008 and the patient looked and acted fine. The patient's siblings also had an adverse experience with ZOSTAVAX (Oka/Merck) (WAES# 0805USA05808 & 0806USA07718). Additional information has been requested.
Information has been received from a physician concerning a 47 year old white male who on 10/18/99, was vaccinated IM with a 2nd dose of pneumococcal vaccine 23 polyvalent, in the left deltoid. On 10/19/99, the pt woke up complaining of not being able to move his arm and a large swollen knot to the deltoid area approximately the size of a nickel. The pt noted "entire arm is swollen including fingers." The pt was seen by a physician and treated with Benadryl and alternating ice and heat compresses. On 10/20/99, the pt recovered. No further information is available.
1/28/2021 About an hour after my vaccination, I became very dizzy. I had to sit down, and it resolved. Then it began happening periodically. I went to the doctor, and she referred me to an ENT doctor. I saw the ENT doctor and had various tests. He was unable to find anything but did note I was having dizzy spells. I went to an audiologist, and everything was normal for my age. These dizzy spells still continue to come and go and it is unexplained vertigo. The last one I had was in January 2023.