chrisvoncsefalvay/vaers-outcomes huggingface dataset:
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 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Mar-2021 at 9:09 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Mar-2021 at 9:09 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (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.   No Concomitant product use was reported.  The age of patient was provided as 56.81.  It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  On 27-Mar-2021, Excursion time was 09 AM and 10 AM, temperature was 35 at both the times, total doses given for the day was 195, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 23-Mar-2021, vial was moved to clinic on 27-Mar-2021. 20 vials were sent to clinic. Vaccine BUD date was 22-Apr-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. The temperature recordings were taken by using a traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  No treatment information was provided.
Four days after injection patient became pale and lethargic - she kept falling and her arms couldn't hold her from hitting the floor.  Then on the 7th/8th day she got a fever of 104.6 - we put her in the bath and it rocketed down to 93.2. The doctor on call sent her to the ER where they took blood and said her platelets were so low she prob had leukemia - she didn't - it was from the vaccine and eventually her platelets went back up. But she stopped speaking, sleeping, walking straight and was quickly diagnosed as on the Autism spectrum.
This case was reported by a pharmacist via a pharmacy claims management company and described the occurrence of adverse reaction in a female subject of unspecified age who was vaccinated with BOOSTRIX, (GlaxoSmithKline). On 5 December 2013 the subject received unspecified dose of BOOSTRIX (unknown details). In December 2013, less than one month after vaccination with BOOSTRIX, the subject experienced adverse reaction. At the time of reporting the outcome of the event was unspecified.
Starting day after shot, patient experienced nausea, chills, and extreme fatigue to the point where she didn't go to work the next day and had to stay home. Patient recovered over the next 3-4 days without any medical assistance.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 06Mar2021 as dose 1, single (Batch/Lot number: unknown), on 27Mar2021 as dose 2, single (Batch/Lot number: unknown), on 30Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) and on 03Jun2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Post thyroidectomy" (unspecified if ongoing); "Sulfa allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Aug2023, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; positive. Therapeutic measures were taken as a result of vaccination failure, covid-19, including Paxlovid from 22Aug2023 to 26Aug2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
3 1/2 hours after receiving vaccine, spouse found pt slouched and unresponsive. After arousing him, he was disoriented, nausea, dizzy,chilly, rapidly breathing x 30 minutes.
2nd dose of oral Typhoid on 07/17/, 3 days later nausea, weak, tiredness, woke up with stomach pain (like food poisoning), lead to diarrhea for days, no vomiting, no fever.  Now gets stomach pain after eating.  Also took oral contraceptive 3 days after oral Typhoid.  Symptoms decreased with time.
Within 2-3 mintues of the fourth injection given. All 4 injection sites red, raised rash. No resp. Symptoms, no itching, rash on thighs traveled up to hip area and right thigh rash traveled up to right side of back area.  After redness noted mother relates child may have had rash with previous immunizations. (mother not sure). Rash on arms resolved and fading on legs.
I got fairly sick after the first dose with cold symptoms. They lasted about a week. The most severe symptom was a sore throat that persisted the entire time. The second dose I didn't get any cold like symptoms, but my left arm was so sore, it sent pain along my back, neck and leg on the left side. The left underarm lymph node is severely swollen and hurts like hell. It's a little better the 3rd day after the 2nd shot, but it's still visibly swollen to look at and very tender to the touch.
apporx 4 hrs p/vax exp sudden onset of runny nose, eye irritation, nasal/sinus congestion draining into nasopharynx causing coughing/wheezing, h/a, injected ocnjunctive; sx resolved w/in 24 hrs; pt did take DPH 2 hrs p/onset sx;
A physician reported that children experienced pain during the administration of Prevnar. The physician stated that more pain is experienced during Prevnar administration compared to other vaccines. No further information was available at the date of this report. The reporter was unable to specify the number of pts who experienced this event. Additional reports will be generated when identifying information is provided.
NDC # 58160-842-43 BOOSTRIX) 0.5ml IM was given in left deltoid on 7/12/17. This prefilled syringe tip cap may contain latex; plunger contains no latex. On 7/14, patient complained of scratchy throat. Diagnosed with viral pharyngitis not thought to be related to Tdap immunization.  Given viscous lidocaine prescription swish and spit and Epipen. Patient was seen on 7/27/17 for pruritic, erthyematous hard spot described as "pimple" by the patient at the injection site of the left deltoid. MD assessed and recommended cold compresses and acetaminophen as needed. Lot # 34574; GSK product NDC 58160-842-43 with exp 5/20/19.
This spontaneous case reported by a consumer, describes the occurrence of vaccination site warmth (feels a couple of degrees warmer' than the surrounding skin), vaccination site swelling (raised, firm area where she received the booster) and vaccination site pain (area is tender to the touch) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# unknown) for COVID-19  immunization. No medical history reported. On Nov 2021, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Nov 11, 2021, patient experienced vaccination site warmth (feels a couple of degrees warmer' than the surrounding skin), vaccination site swelling (raised, firm area where she received the booster) and vaccination site pain (area is tender to the touch). At the time of the report, vaccination site warmth (feels a couple of degrees warmer' than the surrounding skin), vaccination site swelling (raised, firm area where she received the booster) and vaccination site pain (area is tender to the touch) outcome: unknown. Reportedly, patient went to bed and waking up the next morning, she observed a raised, firm area where she received the booster. The area was tender to the touch and, from her description, it felt a couple of degrees warmer than the surrounding skin. No concomitant medication or treatment information reported.
Full body urticaria beginning on stomach and rapidly progressing to large area across stomach and back. Hives subsided and have resurfaced for several days across arms legs face torso . Over the counter antihistamine Allegra in combination with Benadryl at night and steroid pack initiated.
7d s/p vaccinia innoculation-no complaint, local redness and pain days 8-9 with axillary pain. Systemic symptoms of fever, malaise, myalgia and pruritis beginning day 10 s/p vaccine. Day 12 woke with pustules on scalp, face, back, chest/stomach, and arms. Diagnosed as generalized vaccinia and treated with antihistamines and NSAIDS.
2 hours following vaccination - pt had difficulty breathing for 15 mins. For remainder of day, pt had red eyes, runny nose, "felt like steam/heat were coming out of her," felt like she had a fever but she didn't take her temperature. Joint pain and pain throughout body. Tx: took 2 TYLENOLS every time her bone hurt. Client instructed to call 911 next time she has difficulty breathing.
Coughing up blood, after second vaccine; Feverish, after second vaccine; Lymph nodes swollen, with bruising under arm, after second vaccine; Under arm bruised, after second vaccine; This is a spontaneous report from a contactable nurse (patient's grandmother). A 24-year-old female patient received bnt162b2 (Pfizer Covid shot), dose 2 (at the age of 24 years) via an unspecified route of administration, administered in left deltoid on 09May2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunization. Medical history included ongoing polycystic ovaries from a couple of years ago and allergic to peanut butter from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient received the first shot of bnt162b2 one month ago (Apr2021) for COVID-19 immunization. The patient experienced coughing up blood, feverish, lymph nodes swollen, with bruising under arm/under arm bruised all on 11May2021 after second vaccine. Outcome of events was unknown. The events did not require a visit to Emergency Room or Physician Office; no treatment was given. Events coughing up blood, feverish, lymph nodes swollen were reported as serious medically significant, event under arm bruised was non-serious.  Information on Lot/Batch number was requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a close temporal relationship. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate.
This is a spontaneous report from a contactable nurse reported through a Pfizer sales representative. The nurse reported for herself. A 58-year-old female patient received PREVNAR 13, via an unspecified route of administration at 0.5 ml, single on Jul2015 for reduce incidence of pneumococcal infection. The patient medical history and concomitant medications were not reported. On Jul2015, the patient experienced pain at injection site and limitation of arm movement lasted 48-60 hours. She did not take any analgesic or have any further treatment. Final outcome of the events was recovered.
Patient had recent hospitalization (05/12/22-05/25/22) with fever, hypotension concerning for sepsis.  Imaging at that time showed progression of lymphoma nd ureteral compression.  On the morning of 5/31/22 patients husband noted worsening lethargy, and brought the patient to ED.  In the ED patient's HR 118, BP 78/42.  Patient was given 3 L of IV fluid and admitted for encephalopathy and shock requiring pressors.  Patient was found to be Covid positive and maintained saturations on home 2-3L O2.  After arriving patient developed worsening encephalopathy and was no longer able to follow commands.  Per discussion with husband, decision was made to transition to comfort care.  Pressors stopped on the evening of 05/31/2022.  Patient passed away on 06/02/2022.
This spontaneous report was received from a licensed practical nurse and refers to an unspecified number of patients of unknown age and gender. No information about the patients' pertinent medical history, concomitant medications and drug reactions or allergies was reported. On an unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX injection, lot # M017290, expiry date 07-APR-2018 (dose, route of administration and anatomical location were not specified). The administered doses of VARIVAX underwent temperature excursion under 13.3 Fahrenheit degrees for 7.5 hours in the freezer and 62.6 Fahrenheit degrees for 10 hours in the refrigerator. No prior excursions were reported. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Still have a red rash around the injection site about the 3" in diameter. Injection site and area around it are hot to the touch.
So right after the second vaccine, I had problems, my kidneys were hurting and I had difficulty breathing. I had scheduled to get bloodwork done and after that work it showed that my kidneys were not functioning like they were supposed to. I told my DR that I felt like I had mono. My DR said tests results show that the results are similar to mono. I also lost like 8 pounds and had basically no strength. I was so tired and had to continue working, wearing two face masks and a shield because I work at a school. I was also dizzy and fatigued and would just sit down on the floor because I was getting so dizzy. I am also sleeping a lot. When school ended I was able to really just sleep a lot. Usually I would wake up on my own before 5AM but now I sleep in several hours past then. After medical tests the DR put me on two allergy medications and an antibiotic. The antibiotic was Azithromycin 500MG for five days 1x daily. The medications I am still having problems with my lungs/breathing and the tiredness. I also had a cough which seems to be getting better but I am still not recovered. I did not take the inhaler from the DR because I didn't want to take the antibiotic at the same time due to a worry about thrush.
On 10/20/15, I visited my family physician, who prescribed some medications for my sinus and respiratory distress. On 11/6/15, I visited my Cardiologist, who confirmed I did not have a heart issue. On 11/7/15, I again went to Hospital, because I swallowed a large pill that got caught in my throat and went into my lung. I was now having difficulty swallowing and beginning to lose weight. Fortunately, I was able to cough up the pill. On 11/10 and 11/15, I went to my Pulmonologist for an X-rays of my Lungs and then a reading of the X-rays. The Pulmonologist said my lungs were not the cause of the breathing difficulty. He also suggested that I continue the sinus medications and visit an ENT doctor. The first available appointment for my ENT was December 12, 2015. During the time between this appointment and the ENT appointment, my ability to swallow decreased dramatically. I had to cut food smaller and smaller and eventually, I could only eat cereals like Cream of Wheat. On 12/11/2015, I went to an ENT doctor, and after an extensive office visit, he recommended that I see a neurologist as soon as possible. On 12/12/2015, I was in severe respiratory distress and my daughter took me to Hospital for evaluation and testing because of my persistent sinus issue and respiratory distress. Some of the evaluation tests completed at Hospital included an MRl, CT scan, and an Endoscopy, various blood tests plus others. I was told by various doctors at Hospital that perhaps I had a sinus infection, or a severe allergic reaction to one of my long term blood pressure medications or a DVT among other possibilities. I was admitted to hospital and moved from the ER to an observation room to continue my medical evaluation. However, my condition continued to deteriorate and on December 16, I was transferred to an ICU room at Hospital and placed on a ventilator with a suspected diagnosis of Myasthenia Gravis. On 12/18/2015, I was transferred to another hospital to a Neurological ICU for further examination. During my time there I underwent several tests to rule out different diagnostics. On 12/28/2015, because of continued respiratory distress and difficulty swallowing I received a Tracheostomy, a PEG tube and IVIG infusions (over several days) while in the ICU. On 1/4/2016, the results of a blood test taken at another Hospital confirmed the originally suspected diagnosis of Myasthenia Gravis. On 1/6/2016, I was transferred by ambulance to rehab because I needed oxygen, suctioning for my Trach, training on how to use my feeding tube, and rehabilitation to help me relearn how to walk and talk again. On 1/28/2016, I was released from Rehab to continue my rehabilitation at home using the service of Rehab's home health care services. These services were specifically for physical, speech and occupational therapy as well as the services of a visiting nurse. These services lasted approximately 6 to 8 week depending on my progress on each service. Speech therapy took the longest.
Red, swollen and painful at injection site. 3 inches. Advised Motrin-cool compress.
Received flu vaccine at approx. 10 am on 1/20/16. Developed generalized, severe rash, hives, and itching approx. 24 hrs later. Denied swelling or trouble breathing. Started BENADRYL 1/22/16 and improved.
received the Moderna Covid-19 vaccine 8 days ago (Friday 1/8/21) and yesterday (Friday 1/15/21) developed itching and hives at the site. No other symptoms and I otherwise feel well.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), the first episode of FATIGUE (Fatigue), PAIN IN EXTREMITY (Sore arm had returned around 20 days after), INJECTION SITE PAIN (aching at the site of injection) and the second episode of FATIGUE (Fatigue) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Drug allergy (Allergy to codein), Iodine contrast media allergy (Iodine contrast), Allergy to antibiotic (Allergy to cipro and levaquin), Drug allergy (Allergy to Tramadol), Drug allergy (Allergy to Compazine) and Drug allergy (Allergy to Lortab). Concomitant products included PANTOPRAZOLE, MULTIVITAMINS [VITAMINS NOS] and VITAMIN C [ASCORBIC ACID] for an unknown indication. On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-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 PAIN IN EXTREMITY (Sore arm), the first episode of FATIGUE (Fatigue), PAIN IN EXTREMITY (Sore arm had returned around 20 days after), INJECTION SITE PAIN (aching at the site of injection) and the second episode of FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm) and the last episode of FATIGUE (Fatigue) had resolved and PAIN IN EXTREMITY (Sore arm had returned around 20 days after) and INJECTION SITE PAIN (aching at the site of injection) had not resolved.
(1) Fever + rash -> (2) devel URI (3) well now  Fussiness with lacey; light pink, blanchy rash + mucus; extremities 5 days after 12 month WCL/ immunizations assoc with cough. Admit 6 days after with cough, wheeze, eye irritation, high fever up to 105, mild dehydration, rash macular lesions. Similar illness in father, twin sister and cousin infant with fever and cough. F/U he - 9/30-10/2 ADM AUGMENTIN Rx, much better back to nl.
Patient was showing symptoms of a systemic reaction to the vaccine. She reported feeling warm, was flush, and broke out in hives. She also c/o itching all over. Doctor was notified and gave orders for Methylprednisolone 80mg IM x 1 dose and 25mg tab of Benadryl. Patient's VS were taken. BP 159/89 HR 93 RR 20, SP02 on RA 96%. Patient did not exhibit any difficulty breathing, swallowing or SOB. Medications were given as ordered, without difficulty. Patient's was monitored 1:1 for worsening symptoms. Symptoms resolved after 45 minutes VS returned to normal limits, BP was checked again and was at 150/83, HR 82, SP02 on RA 97% RR 18. Patient had no other complaints, and no other symptoms. Patient was informed if symptoms return or worsen to be evaluated in the ED. Patient had no other problems and walked out on her own without difficulty. RN
Client into clinic on 5-3-2010 for immunizations. Administered 1st Hep B (L) Deltoid, Tdap (R) Deltoid and MCV4 (R) Deltoid. Client reports played tennis after IZ and (R) arm began to hurt. By evening redness, swelling, fever of 102 degrees that lasted 2 days. Redness and swelling totally gone by 8-9 days after immunizations. Took MOTRIN for pain. Ice and heat to area. Did not seek medical attention or contact Health Department.
I started feeling the tingle of herpes outbreak on the evening of 6/1/21 and had a severe vaginal outbreak by the morning of 6/2/21. I had never had a previous vaginal outbreak despite having herpes for approximately 15 years and I had not had an oral outbreak in about 2 years. The burning and pain and number of sores was quite severe by 6/2/21. My healthcare provider ordered Valacyclovir for me and I took 2gm BID for a week, then went down to 1gm BID after that. It has now been over 6 months since the original outbreak and I have been unable to reduce my dosage or discontinue suppressive therapy without immediate recurrence. I continue to need 1gm BID to keep it suppressed. In addition, on June 15th, I had a routine PAP and tested positive for HPV Genotype 16 for the first time ever. I believe both of these occurrences are possible evidence of viral reactivation by the vaccine.  In addition, my female cycle has been quite sporadic since my Moderna dose on June 1. I have been getting cycles every 2-4 weeks and migraines with each cycle lasting 2-4 days at a time. Prior to this, my cycle had been coming every 28 days like clockwork for over 6 years and migraines only 1 day per month for the past 2 years.
Dizziness, faint felling, fatigue, heart palpitations, resting heart rate 100+,chest pain
Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild