chrisvoncsefalvay/vaers-outcomes huggingface dataset:
1 dose of IPOL was administered with highest temperature reached 46.6 F and the total excursion lasted 20 minutes  with no reported adverse event; Initial information received on 22-May-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves patient of unknown demographics and 1 dose of IPV (VERO) [IPOL] was administered with highest temperature reached 46.6 f and the total excursion lasted 20 minutes  with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect IPV (VERO) Suspension for injection strength, dose: not reported lot V1B891M expiry date: 01-Jun-2024 via unknown route in unknown administration site for prophylactic vaccination (immunization).  On an unknown date the patient developed a non-serious 1 dose of ipol was administered with highest temperature reached 46.6 f and the total excursion lasted 20 minutes with no reported adverse event (poor quality product administered) on the same day following the administration of IPV (VERO).  It was reported "Caller reported a temperature excursion due to a power outage that occurred on 19MAY2023. The highest temperature reached 52.3 F and the total excursion lasted 2 hours and 20 minutes. The products have not been administered since the excursion occurred on 19MAY2023. Caller noted a previous excursion on 11MAY2023. The highest temperature reached 46.6 F and the total excursion lasted 20 minutes. The caller stated that they reported this information and were told that the products were suitable for use. The IPOL was open at the time of this excursion. 1 dose of IPOL was administered after 11MAY2023 but prior to 19MAY2023. The caller did not have the patient specific information available at the time of the caller".  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event 1 dose of ipol was administered with highest temperature reached 46.6 f and the total excursion lasted 20 minutes  with no reported adverse event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sore arm; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PAIN IN EXTREMITY (Sore Arm) in an 89-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.  No Medical History information was reported.  On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore Arm). At the time of the report, PAIN IN EXTREMITY (Sore Arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided.  Treatment information was not provided.   This case was linked to MOD-2021-059651 (Patient Link).
hives on stomach & chin, arms;DPh 1/4 tsp PRN;
Breakthrough COVID first dose 4/7/2021 75-year-old woman Patient was off long-term resident in another skilled nursing facility but she recently was diagnosed with COVID-19 infection for which they needed to transfer the patient to a facility that accepts patients with COVID-19 infection.  She was transferred to skilled nursing facility just 24 hours ago.  Patient spent only a day at facility in were they found that she was having hypoxia for which they decided to bring the patient to the hospital for further evaluation and treatment
Patient received the Shingrix vaccine and complained of arm pain 30 minutes after. Patient was instructed to take ibuprofen to alleviate pain. Patient ended up having to go to ED for extreme arm pain and loss of some mobility. Patient was started on Norco and deltasone to help with pain. May potentially follow up with an orthopedic specialist.
Initial unsolicited misuse report received from a non-healthcare professional on 17 September 2015. This case involves a 68-years-old male patient who was vaccinated with 0.1 ml of IPOL (batch number: K1330-1, expiry date: 20 June 2016, dose in series, route of administration were not reported) in left forearm on 14 September 2015 instead of TUBERCULIN PPD (TB Test) in error. The patient's Illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) reported as none. Concomitant medications were not reported. On 15 September 2015, one day following the vaccination, the patient had developed slightly less than a dime size raised red area where the vaccine was administered. The patient required ER/doctor visit. It was a wrong vaccine administered and vaccine administered at inappropriate site. Relevant diagnostic tests/laboratory data was reported as none. Corrective treatment was not reported. The patient was not recovered from the event. Follow-up information received from a physician on 13 November 2015. It was reported that Tuberculin TB was given in right forearm (batch number: 725986, expiry date: June 2016) which was to be read in 72 hours. The patient had recieved IPOL intradermally. It was reported that the patient had developed 6cm area or redness, slightly red and minimally warm at medial forearm (no evidence of ulceration, vesicles or skin sloughing) and had minimal discomfort with no ithching. The outcome of minimal discomfort was not reported. List of documents held by sender: none.
Itchy; Rash on the site of the vaccination and about 7 inches long and 4 or 5 inches wide, very irregular; Swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE RASH (Rash on the site of the vaccination and about 7 inches long and 4 or 5 inches wide, very irregular) and VACCINATION SITE SWELLING (Swollen) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy. Concomitant products included LEVOTHYROXINE for Thyroid disorder, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) and MULTIVITAMIN [VITAMINS NOS] for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE RASH (Rash on the site of the vaccination and about 7 inches long and 4 or 5 inches wide, very irregular) and VACCINATION SITE SWELLING (Swollen). At the time of the report, VACCINATION SITE PRURITUS (Itchy), VACCINATION SITE RASH (Rash on the site of the vaccination and about 7 inches long and 4 or 5 inches wide, very irregular) and VACCINATION SITE SWELLING (Swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment related information has been reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-101746 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Patient's contact details, action taken, Product-Event details tab with action taken, Dechallenge and rechallenge was updated. Extra Events with same PT was deleted and were merged together into single event (Vaccination Site Rash) and Patient's Date of birth was added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-101746:2nd dose
Patient was given Moderna 0.5ml IM in error. The vaccination was given by an MA in the clinic without a visit. The MA is Patient's mother, and the dose was administered in the care. CDC was called for guidance.  To complete the series she would need to receive the age appropriate Pfizer dose 28 days after the Moderna was given. NO adverse effects noted from receiving this vaccination in error.
Rheumatoid arthritis, which had been well controlled, suddenly worsened after my second dose of Moderna COVID vaccine, lot# 027A21A, received on 03/06/2021. At the time I thought it may just be coincidence. My Rheumatologist prescribed a series of Prednisone, and increased my Methotrexate to the maximum dose of 1 ml by injection, weekly. It helped some, but symptoms remained. After receiving the Moderna COVID booster on 11/17/2022, my symptoms worsened again, more than after the second dose. I contacted my Rheumatologist and again completed a series of Prednisone steroids. This time the Prednisone did not help and the RA pain is now disabling. She also told me she has received similar reports from several patients.
Inflammation of the vaccination site (redness, warm skin) with a diameter of about 4 inches.  Patient reported that the inflammation was worse yesterday than today.
patient received the 1st dose of Moderna Covid Vaccine. Patient informed EMT she was feeling numbness to lower lip and headache. PHN joined EMT. First vitals 1530: blood pressure 140/90, pulse 73, oxygen 99%. Alert and oriented, history of allergy to penicillin. Per patient began feeling numbness within first 20 mins of receiving vaccine. Patient stated had botox 1 month ago. No other relevant medical history or medications. 1536 vitals: blood pressure 150/80, pulse 83, oxygen 99%. Per patient headache pain 6/10, lip still numb, feeling swelling up and having a "sour" taste in mouth. Patient denied shortness of breath. PHN  offered patient Benadryl, patient accepted, did not want injection, wanted oral. Benadryl 50mg oral given at 1538. Vitals 1541: blood pressure 140/96, pulse 74, oxygen 99%. Headache minimal, lip swelling same and numbness. Vitals 1546: blood pressure 125/90, pulse 76, oxygen 100%. Per patient headache gone, lip sensation returning, stated feeling drowsy. Patient's husband present, would drive patient home. Vitals 1551: blood pressure 125/90, pulse 75, oxygen 100%. Per patient lip sensation feeling better, no headache. 1555 vitals: blood pressure 125/90, pulse 75, oxygen 99%. Patient stated lip sensation returning, felt improvement. Vitals at 1602: blood pressure 120/80, pulse 73, oxygen 99%. Per patient all previous complaints resolved. No headache, sour taste gone and lip swelling and numbness gone. ER precautions given and advised to follow up with provider before second dose. Patient left facility with steady gait at 1612
This spontaneous prospective pregnancy report was received from a registered nurse and refers to a 17-year-old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patient was vaccinated with the first dose of VARIVAX (dose, route of administration, lot# and expiration date were not reported). On 26-OCT-2016, she was vaccinated with the second dose of VARIVAX (dose, route of administration, lot# and expiration date were not reported).  On an unknown date in 2016, the patient became pregnant with last menstrual period (LMP) in November 2016. Estimated date of delivery (EDD) was not known. She discovered that she was pregnant on an unknown date in 2016 (reported as "recently"). The patient sought medical attention - she was seen at clinic. No product quality complaint (PQC) was involved. No other information was available at the time of reporting, as the patient did not see her physician yet. The pregnancy outcome was pending. Additional information has been requested.
The second shot felt wrong almost immediately. Sharp pain started shooting down my arm. Temp started being very noticeable. My arms started tensing up. Then my whole body has felt like it was totally having  charley horses. I laid in the fetal  position and cried. Temp wouldn?t go down it was 103.4 at its highest. Yesterday slept most of the day. The pains keep coming back. Temp came back 101.7. So then my skin burned. Every single part of me felt like my bones and muscle is going to burst thru my skin. Severe headache unlike even a migraine. Temp today is 99.4 but now I try to walk in my house and stumble. Can?t stay awake. Shortness of breath started just about an hour ago. Severe stomach pains. Continued can?t keep thought.
This spontaneous report as received from a medical assistant refers to a female patient of unknown age. On 03-APR-2014 the patient was vaccinated with PNEUMOVAX 23 (lot # J010396, 0.5 ml, IM) for vaccination. On an unknown date in April 2014 the patient experienced pain at the injection site. The patient was called the office for medical attention and was suggested to use ice compresses and ibuprofen. None lab was performed. The outcome of the adverse event was unknown. This is one of the two reports from the same source. Additional information has been requested.
Sore arm after second dose; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE PAIN (Sore arm after second dose) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 025L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore arm after second dose). At the time of the report, VACCINATION SITE PAIN (Sore arm after second dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications information was not reported No treatment medications were provided   This case was linked to MOD-2021-352613, MOD-2021-352623, MOD-2021-352994, MOD-2021-352991 (Patient Link).
Scattered dizziness and nausea; Scattered dizziness and nausea; This is a spontaneous report from a contactable nurse, the patient.  A non-pregnant 63-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EK4176), via an unspecified route of administration in the right arm, on 13Jan2021 at 07:00 AM (at the age of 63-year-old) as a single dose for COVID-19 immunization. Medical history included high  cholesterol, regurgitation.  Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medication taken within two weeks of vaccination included sertraline hydrochloride (ZOLOFT), rosuvastatin calcium (CRESTOR), omeprazole (PRILOSEC).  The patient previously took erythromycin and experienced drug hypersensitivity. The patient has allergy to penicillin. The patient did not receive any other vaccines within four weeks prior to the vaccination. Historical vaccine included Dose 1 of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EH9899), right arm  on 23Dec2020 for COVID-19 immunization.  On 15Jan2021, the patient experienced scattered dizziness and nausea. The patient did not receive any treatment for the events. The clinical outcome of the scattered dizziness and nausea was not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
0920 Cleared to leave 0930  Started feeling tired /fatigued  1900 Arms started to become sore, Migraine Headache 2330 Took Tylenol PM 0100 -0300 Restless sleep , body temperature hot & cold but no fever;  arm sore; took ibuprofen   Sun, 31 Jan 21 0900 Woke up with Migraine headache, arms still sore , tired ..stayed in bed all day Mon, 1 Feb 21 Feeling much better; no migraines
Developed hives to right arm, mandible, and right breast. Right arm swollen and red.
Child developed bilateral buccal mucosa swelling 7 hours following MMR vaccine. swelling is non tender and only from the inside. no visible external cheek swelling. shotty occipital LNs. no gum lesions. otherwise acting normal. swelling hasn't regressed at time of visit to After hours clinic.
Symptoms started 8 hours after injection--started slowly with overall body fatigue, hazy mind, sore injection site. Then progressed to body aches, severe chills, headache and high fever( 101) and joint pain.
patient that received a tenivac vaccine that was two days past its expiration date with no reported adverse event; Initial information received on 26-Jun-2023 regarding an unsolicited valid non-serious case received from an other health professional.  This case involves a 65 years old female patient where she received diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] vaccine that was two days past its expiration date with no reported adverse event.  The patient's past medical history, medical treatment(s) and family history were not provided.  No concomitant vaccines were administered.   On 26-Jun-2023, the patient received 0.5 mL (TOTAL) Booster dose of suspect diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult Suspension for injection single-dose prefilled syringe (batch number- U7092AA and expiration date- 24-Jun-2023) via intramuscular route in the left deltoid (strength: not provided) for Immunization.  On 26-Jun-2023 the patient received a tenivac vaccine that was two days past its expiration date with no reported adverse event (expired product administered) (latency- same day) following the administration of diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult.  Action taken- not applicable.  At time of reporting, the outcome was Unknown for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
I started getting episodes of vertigo in January.  The episodes were not long - less than a minute but I was getting them 3-4 times per week by February when I went to the doctor.  I had never had vertigo prior to this.    As time has gone on the episodes have become less frequent.
Information has been received from a registered nurse regarding a patient of unknown age and gender. On 09-APR-2012, the patient was administered with a dose VARIVAX (Lot # 670851/0869AA, expiry date 26-JUL-2013) (Route, dosing regimen and frequency unknown) which was exposed to a temperature excursion of up to -3 degrees Centigrade. No adverse events were reported. No product quality issue was reported. This is one of the many reports received from the same source. Additional information has been requested.
?Pfizer-BioNTech COVID-19 Vaccine  Began shortly after injection. Fatigue, confusion (minor), Injection site pain (moderate to severe, mild with tylenol, ice, and heat), increased cardiac PVCs.
Narrative:  74yo male patient with the following active problems: PROBLEM LAST MOD PROVIDER Opioid dependence (SCT 75544000) (ICD-10-CM 02/06/2018 F11.20) Heroin Hernia of anterior abdominal wall (SCT 10/14/2014 414396006) (ICD-9-CM 553.8) (ICD-9-CM 366.17); Cataract, Mature 11/03/2009 (ICD-9-CM 365.63); Neovascular Glaucoma 11/03/2009 (ICD-9-CM 530.81); GERD * (ICD-9-CM 530.81) 03/27/2009 (ICD-9-CM 304.80); Polysubstance dependence 01/22/2007 (ICD-9-CM 304.80/304.90) (ICD-9-CM 722.6); DDD-DEGENERATIVE DISC DISORDER 05/07/2001 (ICD-10-CM E78.5); Hyperlipidemia (SNOMED CT 10/28/2015 55822004) (ICD-9-CM 607.84); IMPOTENCE, ORGANIC ORIGIN 05/07/2001 Chronic hepatitis C without mention of hepatic 10/28/2015 coma (SCT 128241005) (ICD-10-CM B18.2) Dental Caries (ICD-9-CM 521.0) 02/14/2000 Prolonged Posttraumatic Stress Disorder 01/06/1997 (ICD-9-CM 309.81) Viral hepatitis carrier, unspecified (ICD-9-CM 03/06/1996 V02.6), Onset 00/00/1995 Lumbosacral spondylosis without myelopathy 03/06/1996 (ICD-9-CM 721.3), Onset 00/00/1995 Cannabis dependence, continuous use (ICD-9-CM 03/06/1996 304.31), Onset 00/00/1995 Cocaine dependence, continuous use (SCT 10/03/2018 31956009) (ICD-10-CM F14.90), Onset 00/00/1995 Died on 11/15/2021. No information given on cause or place of pt's death. Pt had received covid vaccines on 2/24/21 & 3/24/21. This death is likely not related to the vaccinations due to patient's problem list, advanced age, and length of time from vaccine administration.
pt recvd vax; devel headache; arthralgia & malaise; w/ 2nd dose; same symptoms w/ nausea & hematemesis; pt devel inversion of right foot & dystonia w/ dorsaflexion of foot;
Red, sore, swollen arm at the site of the injection, mild body aches. Site is warm to touch with a 4" diameter erythema around injection site. Suggested ice to site and ibuprofen or other NSAID.
Since receiving the vaccine, patient has developed a severe egg allergy, which includes extreme nausea, vomiting and dizziness. On 9/1/17 she ate eggs and developed severe nausea and vomiting within a few hours. After this date, when eating products containing eggs, she developed nausea. On 9/18/17 she ate eggs and developed severe and prolonged nausea vomiting within 15 minutes, requiring BENADRYL, serious consideration of the use of her school's EPIPEN, and consultation with her doctor concerning treatment at the ER. She has since tested positive for an egg allergy and is now required to modify her diet by avoiding eggs and all products containing eggs, while also carrying an EPIPEN at all times. Prior to administration of the vaccine, patient could eat eggs or products containing eggs with no issues or problems, and did so on a regular basis.
L arm-upper painful, swollen and red - area of 7.5 cm x 7.5 cm measured and seen by provider 6/18/08. Advised ice packs/NSAIDS prn and return to clinic if worsens or not improved.
Initially, my reaction to the shot seemed to be normal and consisted of mild side effects. Towards the end of the first week I was feeling better. However, somewhere around 7-9 days after the first shot, I started having muscle weakness and a feeling of just not feeling well. Since some of my symptoms associated with my underlying condition lessened while my body was initially dealing with the vaccine, I thought that perhaps my immune system was having a strong reaction to the underlying condition and things would calm down.   Since then, I have been up and down, in that, I'll start to feel more normal, but then the muscle weakness and feeling of not feeling well will return. I began to wonder if maybe the vaccine exacerbated the underlying condition. However, that is not what this feels like. Today I wondered if maybe it is indeed a long-term reaction to the vaccine. I did a Google search just to see what I could find and it looks like others are having similar issues. I know anybody can make posts on sites like this, and certainly there could be other causes for their issues, but some of their stories are matching up, at least somewhat, with mine.  Unfortunately, I'm going to have to cancel my appointment for the second dose, as I don't think it's safe for me at this time. I'm hoping the symptoms will resolve soon and perhaps I can get a booster down the road.  For Item 21 below,  I checked "None of the Above" because I generally rely on prayer for healing. However, I am prepared to go to the hospital if things get to a point where my life seems to be in imminent danger.