chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I actually felt bit sick after first dose, with pain, chills, numbness to my nerves in my body. I started to notice that I was feeling more sick. I went to see a doctor which I told her about my symptoms. I told the doctor I experienced hip pain radiating to my thighs and up to my shoulders with numbness sensation. I could not shrug my shoulders and my pain went up to my head. I have been using use crutches to ambulate due to my hip and leg pain. The doctor said she did not find any correlation with the vaccine and to wait it out for 90 days to see how I would be feeling and this it was up to me to take the second vaccine. I then went to get my second shot 05-01-21, I again felt the numbness again to my left ear, neck and headaches. My head hurts, on the left side and my jaw and ear go numb. I got lab work and they told me I have inflammation in my body. I got my vaccine on the right shoulder and again experienced ear pain and numbness and excruciating headaches. I also felt numbness to my right leg, calf and down to my big foot. I also had a small ball size lump to my right toe. I also have a small ball size lump to my right hand, index finger.  My forehead hurts, my shoulders hurt and I can not lift anything. I can not sit for too long periods of time. I am still using the crutches to ambulate daily. I can not sleep at night and I can not lie down on the left side, back due to my head pain. My head pain now radiates to the front side of my face, left side since receiving my second vaccine. I sleep 2-4 hours a day at night every day. Both of my legs feel inflamed. I have taken Ibuprofen medication after my vaccine and today I still continue with the face numbness, headaches to the left side of my face and hip and leg pain. I have not recuperated from my symptoms.
Information has been received from a consumer concerning her son who on approximatelt 04/09/01 was vaccinated with MMRII. In 04/01, the patient experienced fever, chronic diarrhea, slept a  lot and was very tired" additional information has been requested.
I tested positive for Covid-19. My symptoms included a sore throat, headache, runny nose, sneezing, achiness, and coughing. The sneezing is gone, but I have an occasional cough and I have a lot of phlegm in the back of my throat. And the headaches are gone as well. I received a 5-day course of Paxlovid from my doctor.
After receiving the vaccine on 1/5/2021 I had no symptoms initially and for then next 2 days.  On 1/8/21 at around 10:00am I got a headache of moderate severity behind my right eye and at right temple.  It was associated with nausea and fatigue.  I took 800mg ibuprofen and 4mg zofran.  At 12:00 I left work and went home and slept for 4.5 hours between 12:30 and 5pm.  I woke up at 5pm and had minimal residual headache in the right temple.  After going to sleep from 8pm to 6am, I awoke on 1/9/21 and my headache was completely resolved.    I do have a history of migraine headaches.  This headache and associated nausea felt like my previous migraine headaches and the course was similar to my previous headaches.
Patient started having an immediate reaction to the vaccine, he started shivering, coughing and complained of a hot sensation in his chest. We took him to the ER and in route he had c/o SOB and nausea and difficulty swallowing.
Diagnosed with/ tested positive for COVID-19; Lack of drug effect; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (Diagnosed with/ tested positive for COVID-19) and DRUG INEFFECTIVE (Lack of drug effect) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026B21A and 027A21A) for COVID-19 vaccination.  Concurrent medical conditions included Allergy to antibiotic (Amoxicillin), Hypothyroidism since 30-Jul-2021, Obesity since 17-Jul-2020 and Bladder neoplasm (bladder tumor) since 25-Nov-2019. Concomitant products included LEVOTHYROXINE SODIUM (LEVOTHYROXINE [LEVOTHYROXINE SODIUM]) from 30-Aug-2013 to an unknown date for Hypothyroidism.  On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 31-Jan-2022, the patient experienced COVID-19 (Diagnosed with/ tested positive for COVID-19) and DRUG INEFFECTIVE (Lack of drug effect). At the time of the report, COVID-19 (Diagnosed with/ tested positive for COVID-19) and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown.  DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Jan-2022, SARS-CoV-2 test: positive (Positive) Positive; Type of test at home.  For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  The patient received third dose of mRNA-1273 (Spikevax vaccine) of 0.5mL on 03-Mar-2022 at 09.45am, via intramuscular route on right deltoid (RD). No treatment information was reported.  Company comment: This is case of drug ineffective for this 69-year-old female patient with medical history of bladder tumor, who completed a two-dose primary series of mRNA-1273 vaccine with an interval of 28 days between doses and experienced non serious event of COVID-19 which occurred approximately 9 months after the administration of second dose. SARS-CoV-2 test result was positive; no further details regarding clinical course or treatment performed were disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2022-503778 (Patient Link).; Sender's Comments: This is case of drug ineffective for this 69-year-old female patient with medical historyof bladder tumor, who completed a two-dose primary series of mRNA-1273 vaccine with an interval of 28 days between doses and experienced non serious event of COVID-19 which occurred approximately 9 months after the administration of second dose. SARS-CoV-2 test result was positive; no further details regarding clinical course or treatment performed were disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
vaccine was expired, no temperature excursions occurred and Moderna determined the vial "maintained the activity necessary to protect against the SARS Co-V2 virus at the time of administration".  Patient reported no adverse reactions.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021 at 2:30 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On 03-Nov-2021 at 2:30 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 76.30.  No concomitant medications were reported.  Product moved to clinic on 03-Nov-2021.  Batch number 035C21A underwent temperature excursion on 03-Nov-2021 with temperature 35 degrees Fahrenheit at 10:00 AM. This vial was moved to fridge on 05-Oct-2021 and beyond use date for the vial was reported as 05-Nov-2021.   Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  No treatment medications were reported.
This spontaneous report as received from medical assistant (other health professional) refers to an unknown number of patients of unknown age. Pertinent medical histories, current conditions and concomitant medications were not reported. On an unknown date, the unknown number of patients received improperly stored doses of GARDASIL 9 (dosage regimen were not reported) (lot # M013636, expiry date: 15-FEB-2018). No adverse effects were reported. The outcome of incorrect product storage and no adverse event were unknown. No Product quality complaints (PQC) were not involved. Additional information has been requested.
MODERNA EUA--The patient complained of having a rash on her face the day after receiving her first Moderna dose on 031621. She denied any fever, itching, shortness of breath or wheezing. She was also noted to have some bruising under her left eye. The initial encounter with the healtcare provider occurred two days post-vaccination via virtual visit on 031321. She was followed up in person on 031921 at which time her rash was improved after taking Benadryl. She reported some pain of her lower left eyelid that continued but no vision changes. Another virtual visit was conducted on 032621 at which time all symptoms had resolved without further sequelae.
Dose 1 given 1/30/2021 Pfizer lot # EN9581  Pt was hospitalized for Covid19
Patient broke out in hives, starting where the injection was given.  The hives continued to  spread over his whole body.  Mom states that she noticed the hives about an hour after child received immunization.  Client was taken to the emergency room and mom states that client was treated with some medication and sent home with oral benadryl.  Mom states that client is doing well today.  Mom states that ER physician told her that it could be a reaction to the eggs found in the flu vaccine.
Dizzy, Nauseous, Headache, Dry Mouth, Fatigue and barely able to walk...  Weakness, Dehydration, Low Magnesium at 1.6 and Sodium at 131 also High BP and a lowered pulse rate...
2nd day post vaccine - enlarged lymph node under same arm as injection site. Stomach pains, lower back pain. Leg pain. 4th day post vaccine - appendicitis.  Ongoing nerve pain & lethargy post operation to remove appendix. Leg pain, strange sensation in legs.
Temperature 103.8 orally. Return ER visit. IV fluids and Toradol given. Sent home. Return visit 8/2/13 for cellulitis of right arm. Prescribed Bactrim and Keflex.
Shot given to 17 year old girl. Ohio Department of Health was contacted and gave guidance on return vaccination. She will get the Pfizer vaccine at a minimum of 28 days after the 03/23/2021 Moderna shot. Father was contacted (who signed the consent form on his daughter's behalf). Copy of report will also be faxed to Moderna.
Sept 25 4 hrs after vaccine feeling tired-then at 8:30 pm driving home from dinner my right hip had much pain and then my right leg would not move and pain traveled down leg to toes, about 6 minutes later the left one did the same from hip to toes--I had to pull off the road and massage both limbs for about 10 minutes  had a hard drive rest of the way home  my drive should have taken 10-12 minutes it took me 25 minutes.  On September 27, 2022 at about 3am I developed a horrendous cough, still have the cough today and will see Pulmonologist on January 17, 2023 to find out why this cough iss lingering--it is not Asthma nor am I wheezing. October 5, I developed a rash on my face, face bright red, and then Oco I then developed white heads where all the red blotches and rash was  Saw Dr., Dermatologist on Dec 5 and dx with Rosacea Scripted Doxycycline orally and Metronidazole topically. Saw Dr. for f/u on 05JAN23 and face had cleared  d/c Oral med and continue for another week or two with Topical.  Cough Still remained so not an infection.  Adverse reaction on April 13, 2022 woke up middle of night not feeling well sat up in bed and became lightheaded thought my electrolytes were low got out to walk to kitchen took me 30 minutes and drank Powerade zero and stayed in the family room adjacent to the kitchen.  all resolved by 10 am on April 14,2022
pain in her left arm pit (injection site was left arm)/ in her left armpit the lymph node; pain in her left arm pit (injection site was left arm)/ in her left armpit the lymph node; feeling really weak; chills that alternated with feeling very hot; chills that alternated with feeling very hot; tense upper back and muscle aches/ muscle ache in her upper back; tense upper back and muscle aches/ muscle ache in her upper back; muscle aches/ muscle ache in her upper back; This is a spontaneous report received from a contactable consumer from medical information team. The reporter is the patient.  A 66-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), intramuscular, administered in the left arm, administration date 23Mar2021 (Lot number: ER8730) at the age of 66 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Blood pressure" (unspecified if ongoing), notes: controlled by the medication (oral pill), on medication for years; "tested COVID positive", start date: Nov2020 (unspecified if ongoing). The patient took concomitant medications. The following information was reported: ASTHENIA (non-serious) with onset 24Mar2021, outcome "recovered" (24Mar2021), described as "feeling really weak"; FEELING HOT (non-serious), CHILLS (non-serious) all with onset 24Mar2021, outcome "recovered" (24Mar2021) and all described as "chills that alternated with feeling very hot"; BACK PAIN (non-serious), MUSCLE TIGHTNESS (non-serious) all with onset 24Mar2021, outcome "recovered" (24Mar2021) and all described as "tense upper back and muscle aches/ muscle ache in her upper back"; MYALGIA (non-serious) with onset 24Mar2021, outcome "recovered" (24Mar2021), described as "muscle aches/ muscle ache in her upper back"; AXILLARY PAIN (non-serious), LYMPH NODE PAIN (non-serious) all with onset 25Mar2021, outcome "not recovered" and all described as "pain in her left arm pit (injection site was left arm)/ in her left armpit the lymph node". The events "feeling really weak", "chills that alternated with feeling very hot", "tense upper back and muscle aches/ muscle ache in her upper back", and "pain in her left arm pit (injection site was left arm)/ in her left armpit the lymph node" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of asthenia, feeling hot, chills, back pain, muscle tightness, myalgia, axillary pain, lymph node pain.  Additional information: The patient spoke with her MD and they directed her to not receive the second dose because of the side effects. The patient mentioned she has blood pressure and that was controlled by the medication. She stated she's on medication for years (oral pill).  No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a pharmacist refers to a patient of unknown demography. The Pharmacist reported that improperly stored ZOSTAVAX (dose, route and frequency were not reported) may have been administered to the patient on an unknown date. It was reported that the ZOSTAVAX was stored with dry ice in January 2014. No adverse event reported. No other information was reported. It was also reported that the professional information request has been sent. Additional information is not expected.
Vaccination underdose; Some white liquid that was cold running down; A spontaneous report was received from other health care professional concerning a  73Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced event some white liquid that was cold running down/ Vaccination site discharge, Incorrect dose administered.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 12-JAN-2021 , prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 041L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 22-FEB-2021 , prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 031L20A) intramuscularly in the left deltoid.  On 22-FEB-2021, The patient experienced some white liquid that was cold running down.   Laboratory details were not provided.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   On 22-FEB-2021, the outcome of the event some white liquid that was cold running down was resolved.; Reporter's Comments: This report refers to a case of Vaccination site discharge and vaccination underdose for mRNA-1273, lot # 031L20A,  with no associated AEs.
Intensive pain & tingling in vaccinated arm.  8 hours later, can not move left arm without severe pain.  Swelling & heat at injection site.  Pain kept me awake most of the night.
This report was received from an unspecified reporter via a Market Research. The reporter stated, that '20 years of lab studies in mice, and human observational data, suggested that the PNEUMOVAX 23 might be protective against heart attack and stroke'. Additional information has been requested.
This spontaneous report was received from a nurse prescriber via a company representative, who referred to a female patient of an unknown age. No information regarding the patients pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 18-MAY-2017, the patient was administered ZOSTAVAX subcutaneously (formulation, dose, anatomical location, lot# and expiration date were not reported) for prevention of herpes zoster (shingles). On 19-MAY-2017, the patient reported to the nurse prescriber that she experienced an unspecified injection site reaction to ZOSTAVAX. The patient sought medical attention by visiting the nurse prescriber's office on 22-MAY-2017 (reported as today) to be examined. No product quality complaint (PQC) was involved. The outcome of the unspecified injection site reaction was unknown. The relatedness between the event and ZOSTAVAX was reported as related. Additional information has been requested.
Ongoing sudden flashes of hot sensations that move down my legs and occasionally my arms. They're more dominantly on my left side but have felt them on my right leg on occasion since Sunday following my injection.  These are reoccurring sensations all day/night.    I have not had it checked out by a doctor. I started a new job and cannot afford the time off or a dr visit.
T104.6 R, nausea & vomiting, crying, irritable; started evening of immun consulted MD by phone; tx PAPA supp; was better 13MAR92 but still st 14MAR92 101; Seen by MD 14MAR92 & was treated for ear infect;
very high blood sugar in the 450-500 range that persisted for 2.5 weeks; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received BNT162B2  (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: ER8731), via an unspecified route of administration, administered in left arm on an unspecified date in May2021 12:00 (at the age of 57-year old), as dose 1, single for COVID-19 immunisation.  Medical history included patient was diabetic and had known allergies to Keflex. Prior to vaccination, the patient was not pregnant, not diagnosed with COVID-19, and did not receive any other vaccines within 4 weeks. The patient received unspecified concomitant medications given within two weeks of vaccination. Another unspecified vaccine with lot number ER87311 was given on the same date of vaccination in May2021 (pending clarification). On 04May2021 12:00, the patient reported that she was diabetic, but the shot gave her very high blood sugar in the 450-500 range that persisted for 2.5 weeks. In other times, her sugar levels were in control. She used a tracking app for her food, so she knew what her numbers were on and verified this with finger sticking. The adverse event resulted in doctor or healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measure taken as a result of the event included additional use of insulin glargine. The outcome of the event was recovered in May2021.  The lot number for BNT162B2, was not provided and will be requested during follow-up.
Left leg localized cellulitis. Treated with warm compress, Keflex, Motrin.
The patient came with a brochure for the RSV vaccine and asked if it was recommended to be given to her. The pharmacist stated that the RSV vaccine is recommended for her since she is over 60 years old and has asthma. The vaccine was processed through the insurance for zero copay and there was no rejection stating it was a duplicate. After the vaccine was administered and the patient left the store, it was found in the health tab that she already received the vaccine on 9/1/23. The patient was contacted to inform her of the error. The patient has not reported any adverse side effects from the duplicate dose.
pt started constant crying & drawing up legs; pt could not be consoled starting about 4PM, 1/2 hr p/vax until 730PM when was still fussy but was able to sleep in one position;
I started having frequent trips to the bathroom to urinate, some burning sensation. I called to make an appointment with my doctor. I had a urinalysis test during my visit with the doctor visit where it was determined I had an UTI infection. I was prescribed medication for the UTI that I was able to start immediately.
The patient was given expired Daptacel; Initial information received on 28-Oct-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 3-year-old patient (gender unknown) who was administered with an expired dose of diphtheria-15/tetanus/5 ac pertussis vaccine [Daptacel] (PT: expired product administered).  The patient's past medical history, medical treatment, vaccination and family history were not provided.  Concomitant vaccinations included hepatitis A vaccine.  On 24-Oct-2019, the patient received expired diphtheria-15/tetanus/5 ac pertussis vaccine (lot number: C5281AA; expiry date: 05-Oct-2019), at a dose of 0.5 ml via intramuscular route, in left thigh, for prophylactic vaccination (PT: expired product administered).  At the time of this report, no adverse event was reported.  Information on the batch number is available.  d 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 Directive and Module VI of the 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