chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a physician, via company representative, refers to a 67 year old female patient. The patient's concurrent conditions, medical history and concomitant medications were not known. Patient was vaccinated with PREVNAR 13, 'one year ago' (approximately 2015). On unknown date, in approximately 2016, the patient was vaccinated with PNEUMOVAX 23 (dosing details not provided), intramuscularly. On an unknown date (approximately 2016) the patient experienced local injection site reactions including injection site pain, swelling and fever. Patient sought medical attention. Unspecified treatment was provided for the events. The patient recovered from the events after 1 week of receiving vaccine. Causality assessment was not provided. No product quality complaint was involved. Additional information has been requested.
Headaches, subjective fever, back pain, chills, general malaise. Back pain, fevers, chills all resolved on day 3. Back pain resolved on day 1. Headaches continue.
pt noted to have 15-20 macular papular lesions a few w/vesicles that appear pruritic;felt to be chickenpox-despite varivax given 1/17/96;
screaming, high pitched cry for 4 hrs; rt leg became red & swollen from mid thigh to toes;
On 06/10/2015 at approximately 1655 HRS, a woman called who identified herself as the mother of patient.  The caller stated that her child was having a reaction to a vaccine she received on 06/08/2015. Looking at the ASIIS report, the patient had been given a second Hepatitis A vaccine only. The caller reported "red bumps," "seizures," and said the child "wanted to only lay down." I asked if this had happened after the previous Hepatitis A shot and the caller said, "Yes, and it was even worse." I instructed the caller to contact 911 and have the child evaluated immediately. The caller agreed to do so.
On 04/10/2021, we were trying for a baby, so when my period did not come when it was supposed to, I started taking a pregnancy test. I was not pregnant. My period came on the 29th of April instead of the 10th. It was heavier and very painful, I had to take ibuprofen and it lasted a lot longer. I let my family doctor know, and they said it was normal for the 1st 2 months before it got to normal. I called my gynecologists, and we just started the process of getting testing done to see what is causing it. And they will do an ultrasound next week. I don't want to sound like I don't believe the vaccine,  but it started to happen right afterwards and I wanted to report it. I just want to contribute my information.
Red urticaria / wheals on thigh. URI symptoms - nasal congestion no fever starting day 2 post shot incidental?
I felt wonderful before my third Covid vaccine.  No effects day of or day after however day three I killed over with tremendous chest pains throbbing in my heart and I had a hard time catching my breath. Every time I exert myself the pain and throbbing comes back  so after six days I am still on my back
Patient, noted injection site reaction that did not respond to compresses, as discussed at time of immunization, site was itchy, red, and swollen, but patient very concerned, because of look of site and discomfort. She was told on 08/03/2016 to again use compresses and see if symptoms resolved. Voluntarily called patient as follow-up on 08/04/16 to get status of site and she stated it looked and felt better. However, later on the afternoon of 08/05/16 Patient contacted us and told us that her arm was again red and itchy, again at the site of injection. We called Merck, the manufacturer, and were told that injections site reactions may last up to 9 days, we relayed this information to patient and told her to use an antihistamine, benadryl AND to use cold compresses to the site for 15 minutes as needed. Called and spoke with patient on Saturday and Sunday, August 7 and 8th, 2016 and patient stated it looks and feels better. Explained to patient we would be calling her daily to check in with her progress and re-iterate the possible durations (9 days) of this injection site reaction.
Patient received COVID19 Pfizer BioNTech vaccination approximately 2:20p. After vaccination administering provider requested patient wait for 15 minutes prior to leaving. Approximately 2:22p patient began to feel faint - lightheadness, clammy skin, sweating and pale skin. Patient fainted at 2:24p. Patient remained in her chair and did not slump nor fall out of the chair. Two pharmacists were with the patient to assist the patient to the floor if needed, however was not necessary. The patient regained responsiveness within a couple of minutes. When regaining consciousness the patient was alert and oriented. She was provided a water and cold coke. Upon questioning the patient revealed the only thing she had eaten for the day was a muffin at noon. The patient stated feeling weak and hot. The patient was offered a snack, however declined. After drinking some of the coke the patient began to feel better. Patient was not diabetic. At 2:37p the patient's blood pressure was 114/81 and had a pulse of 95. The patient remained in her chair with supervision while coordinating a ride from her husband. Per the patient request she was transported to the front of the store at 2:50p via wheelchair to wait for her ride. She was picked up by her husband at 3:00p and was able to get out of the wheel chair and into the vehicle under her own power. The patient was instructed to continue to rest, hydrate, and eat something upon arriving home The husband was informed of the situation and informed if her condition worsened to call emergency services for additional help.
On 10/13/2016 client reported raised, reddened, slightly warm to touch spot where varicella shot given 2 days prior. Also reported slight fever and emesis. Instructed client to email picture of site to Public Health Nurse, and to put heat on affected area. Picture showed reddened area at shot site and chain-like reddened areas distal to central redness. Instructed client to use Tylenol as needed.
After leaving from health clinic mother and daughter went to grocery store. When leaving mother noticed like a heat rash on child. It continued to cover body. She took child to health clinic where she was seen by the PA and Dr. They prescribed Benadryl and 1/8th tsp every 6 hrs.
Left arm described as swollen and red at injection site. Pneumovax was administered to pt day 06/06/02.
This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (patient was administered vaccine which had undergone several temperature excursions), PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified/vaccines have undergone several temperature excursions) and NO ADVERSE EVENT (No adverse event) in a 48-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     Patient didn't had any known allergies.       For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (patient was administered vaccine which had undergone several temperature excursions) and PRODUCT TEMPERATURE EXCURSION ISSUE (Refridgeration excursions identified/vaccines have undergone several temperature excursions).    No concomitant drug information was provided.  Patient had received previous 3 doses of vaccine, intramuscular with anatomical site as deltoid. Dose 4 anatomical site was also reported as deltoid. It was unknown if the patient had ever tested positive or been diagnosed with COVID-19.  It was reported that the vaccines had undergone several temperature excursions in August 2022.  Refrigeration excursions were identified, state vaccine was housed in the units. There were excursions noted. Manufactures were notified and the state department was made aware of the situation.  No adverse reactions were reported for any of the patients at the time of the report.  No treatment drug information was provided.
Patient said one week after vaccine her injection site started swelling and red. she reported to pharmacy 2 weeks post vaccine and the redness was stretched across deltoid (approx. 5 inches) and warm to touch.
Information has been received from a medical assistant concerning a 23 year old female with not reported drug reactions/allergies and medical history, who on 10-MAR-2009 was vaccinated IM with 0.5 ml first dose of GARDASIL (lot number: 0074Y). There was no concomitant medication. The medical assistant reported that the patient developed hives on her shoulder and back, after receiving her first and only dose of the GARDASIL vaccine. The patient was recovered "3 days after vaccination" (13-MAR-2009). The patient did not seek medical attention. Additional information has been requested.
CAREGIVER RECEIVED FIRST VACCINE DOSE AND SOON AFTER BEGAN TO FEEL DIZZY AND HER EYES BEGAN TO TWITCH, FOLLOWED BY UNCONTROLLED SHAKING, WITH HIGH FEVER FOLLOWED BY SEVERE SHORTNESS OF BREATH AND GASPING, WITH TIGHTNESS AROUND THE CHEST.  TRANSPORTED TO EMERGENCY DEPARTMENT. HAD MULTIPLE EPISODES OF ITEMS LISTED ABOVE WHILE IN ED, INCLUDING HEAVINESS IN HER LEGS AND TINGLING IN ARMS.  SHE WAS DISCHARGED FROM ED AT 10:30PM BUT WAS READMITTED ON 12/24 TO ED FOLLOWING SIMILAR ISSUES.  TO DATE SHE HAS HAD 5 RAPID RESPONSES IN HOSPITAL DUE TO REPEAT OF SIGNS/SYMPTOMS. CT AND PULMONOLOGY CONSULT SCHEDULED FOR 12/28/2020.
This spontaneous report as received from a registered nurse refers to a 15 week old female baby. On 10-DEC-2013 the patient was vaccinated with oral ROTATEQ dose 1, 2 ml. The baby was inadvertently administered her first dose of with oral ROTATEQ at 15 weeks of age. No adverse effect was reported. Additional information has been requested.
Chills, fever, joint aches, body aches. Onset: 12 hrs after injection duration 72 hrs.
Initial information received on 11-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 08 months old patient for whom received the second dose of FLUZONE QUADRIVALENT at 2 weeks and 2 days from the first dose was reported, while he/she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. No other vaccines were given. On 10-Oct-2018, the patient received a dose 2 of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UT6259LA expiry date 30-Jun-2019 via intramuscular route in the left thigh. On 24-Sep-2018 he/she also received a dose 1 of the same vaccine lot UT6259LA expiry date 30-Jun-2019 via intramuscular route in the left thigh. The patient developed a non-serious received the second dose of FLUZONE QUADRIVALENT at 2 weeks and 2 days from the first dose. Unknown latency following the administration of INFLUENZA QUADRIVAL A-B VACCINE. Lab data not reported. The case is actual medication error due to inappropriate schedule of vaccine administered. Final diagnosis was received the second dose of FLUZONE QUADRIVALENT at 2 weeks and 2 days from the first dose. No AE symptoms have been reported. Outcome of the event was not applicable. 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 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. Documents held by sender: none.
mom observed large elev red area rt arm;child also c/o itching 10AM 9/16/99 called hlth dept & was seen 1130AM;6cm cluster of macular rash, no elevation felt;warm to touch;T96.7 playing; denies any discomfort other than sl itching;T104 x 2d
Chills, fever of 101.9, aches, stiffness - around 6:30 pm.  Around 1 am next am0 headache, sweating, nightmares, few hives on hands.  Symptoms improved 1-14-09, resolved 1-15-09.
This spontaneous report has been received from a nurse, concerning a 83 year old female patient. The patient's concurrent condition included hypertension, thyroid disorder and high cholesterol. There was no drug allergies or reactions reported. Concomitant therapies included aspirin(manufacturer unknown), calcium (+) vitamin d , atorvastatin calcium(LIPITOR), Lisinopril and levothyroxine sodium(SYNTHROID). On 19-DEC-2017, the patient was inadvertently vaccinated with an expired dose of PNEUMOVAX 23 intramuscularly, lot number L048680 and expiration date 10-JUN-2017 (dose and frequency were not reported) for prevention of pneumonia.  On 19-DEC-2017 (reported as shortly after receiving the vaccine), the patient experienced pain, redness and swelling at the injection site. The patient sought medical attention and did not receive any treatment for the adverse events. The outcome of pain, redness and swelling at the injection site was reported as not recovered. The causal relationship between pain, redness and swelling at the injection site and the therapy with PNEUMOVAX 23 was not assessed.
Dizziness, Headache, Sedation, Arthralgia, NauseaVomiting, chills and fatigue. Pain and soreness at the injection site. Narrative:
17 yr old incorrectly given Moderna--- no side or ill effects for this booster dose.  primary series was Pfizer
100+ days of chronic nausea, diarrhea, extreme debilitating stomach cramping, and excessive salivating episodes (as if patient is going to vomit, but no vomit comes). Note that patient had similar ~20 days of chronic nausea after first Pfizer COVID vaccine shot (not yet reported in VAERS). Note that patient's genetic father had similar 80+ days of chronic diarrhea after second Pfizer COVID vaccine shot (reported in VAERS). Treatment was only maintaining extremely limited "bland food" diet, probiotics, and ginger during episodes.
Numbness to right side of cheek/lip Rash to bilateral hands/arms/abdomen/legs/back/chest Arm injection pain.  Mottling to skin all over Warmth radiating up my arm to my face where it?s numb Body aches
1 month p/vax pt exp cardiomyopathy, heart block, & syncope; a pacemaker was inserted; outcome: resolved; further details have been requested;
MOC informed nurse that on 28APR92 2 hrs p/pt recvd vax pt awoke crying then turned blue; pt was brought to ER for eval;
This case was reported by a nurse via call center representative and describe the occurrence of injection site redness in a 16-year-old male patient who received FLUARIX QUADRIVALENT (batch number 9J4B7, expiry date 30th June 2017). In November 2016, the patient received FLUARIX QUADRIVALENT. In November 2016, less than a week after receiving FLUARIX QUADRIVALENT, the patient experienced injection site redness, injection site swelling and injection site pain. On an unknown date, the outcome of injection site redness, injection site swelling and injection site pain were unknown. It was unknown if the reporter considered the injection site redness, injection site swelling and injection site pain to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The patient received a dose of FLUARIX QUADRIVALENT and experienced an injection site reaction, described as redness, swelling, and pain. The reporter has given the permission to contact again. This case has been linked with case US2016GSK162604 for the same patient for event experienced after receiving BEXSERO vaccine. This is one of the 5 cases reported by the same reporter.
Mother states rectal temp of patient at home is 103F. The patient's temp at the dr's office is 100.8F. The patient's mother states the patient was "acting funny" after getting immunizations. The patient was sent to the hospital for lab work. Over the counter meds were used to reduce the fever.
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Details: patient received 2nd vaccination, did not sit and wait around 15 minutes as directed and fainted in the store.  patient was very nervous before getting shot and stated later that he was sick last week and had not eaten anything all day (shot administered at 1230p). pt felt dizzy and lightheaded before fainting.  paramedics were called and pt vitals were checked and all normal. pt went home with dad to be monitored closely for rest of day.
At injection site - hotness; Skin hardness at injection site; Extreme pain at injection site; Redness at injection site that has spread; This is a spontaneous case, initially received from other health professional via agency (case ID: SEQ19-04875) on 16-Oct-2019, concerning a female patient of an unknown age.   The patient's medical history and concomitant medications were not reported.   On an unknown date, the patient was administered Afluria Quadrivalent [influenza vaccine, dose: 0.5 ml, batch number: P100112490, expiration date: 11-Jun-2020, route of administration and anatomical location: not reported] for an influenza prophylaxis.  On an unknown date, after vaccination, the patient experienced hotness, extreme pain, skin hardness at injection site and redness at injection site that had spread.   On 24-Sep-2019, the reporter stated that the patient was doing well.  The outcome of all the events was recovered, on an unspecified date.  The reporter did not provide seriousness and causality assessment.  The case is linked to 201905307, 201905317, 201905318, 201905319, 201950320, 201905321, 201905322, 201905323 and 201905325 due to same reporter.  Follow up received from other health professional via agency (SEQ19-05499) on 24-Oct-2019: The reporter stated that all vaccine recipients were doing well. The outcome of all events updated to 'Recovered/resolved'. Narrative amended accordingly.  Company comment: The patient experienced vaccination site warmth, vaccination site induration, vaccination site pain and vaccination site erythema after vaccination with the suspect product Afluria Quadrivalent. Chronology is plausible. No medical history, diagnostic findings and concomitant medications were reported. Considering all the above mentioned, causal role of the suspect product cannot be totally excluded and is assessed as possibly related.; Sender's Comments: The patient experienced vaccination site warmth, vaccination site induration, vaccination site pain and vaccination site erythema after vaccination with the suspect product Afluria Quadrivalent. Chronology is plausible. No medical history, diagnostic findings and concomitant medications were reported. Considering all the above mentioned, causal role of the suspect product cannot be totally excluded and is assessed as possibly related.
Remains in hospital on date of report.  Pt is here today due to a callback for positive blood cultures.She was seen yesterday for increasing confusion.Blood cultures were sent and there was positive growth.Instructed to return to the ED.No new complaints this evening.Covid (+) on 09/20/21.Patient was vaccinated for corona coronavirus 19 with Moderna vaccine back in March and developed coughing congestion fever on September 19th or 20th was positive for COVID-19 on the 20th.  She presented the ER yesterday due to lethargy and confusion but she was not hypoxic and she was given the monoclonal antibody treatment and 255 mils of normal saline and discharged home stable vital signs.  She had blood  cultures done at the time which turned positive for Gram-positive cocci in clusters which led to ER call back and return tonight.  Which she presented ER she is having no respiratory distress but she developed acute respiratory failure with hypoxia and hypercapnia .  She was placed on BiPAP and given IV Lasix and admitted to the ICU with critical care consultation.  She received IV vancomycin due to her positive blood cultures as noted above  In discussion with daughter and husband, patient has flash pulmonary edema twice.     Up to chair, down to 40L.  Pleasant, says she feels better.  No fever or chills or shortness of breath.  No cough.
Modest swelling left arm dependent from site of vaccine left arm dependent from site of vaccine. Today (4 days out) 6x6 cm with moderate redness, tenderness.
On 6/11/99, 7/12/99 and 12/9/99, the pt received her 1st, 2nd and 3rd doses of Engerix-B, respectively. A titer drawn on 4/22/01, indicated that the pt had not seroconverted. The pt received her 4th dose Engerix-B and again failed to seroconvert. As of 7/17/01, the outcome of the event was unknown.
Tested positive for Covid-19 on 7/3/2022. Mild symptoms-cough, nasal congestion, fatigue, low-grade fever, lasting approximately 3 days. Tested negative on 7/28/22
3 days after receiving vaccine started to experience severe vertigo, imbalance, blurred vision, rocking and swaying sensation, headaches, eye strain, extreme fatigue, mood swings, migraine, lightheadedness, fainting.
Inj done Thurs (? or Wed) 10-04 (10-03) arm achy that pm - Fri 10/05/12 arm sore - lump app size of half dollar - present in area of injection & very warm.
I adminstered the vaccine SQ instead of IM.  No symptoms as of date and time administered
Dull pain in right side of stomach; Burning pain in stomach; Lower back pain; Top of legs pain; Hip pain; Knees felt like could burst open with pain; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Dull pain in right side of stomach), ABDOMINAL DISCOMFORT (Burning pain in stomach), BACK PAIN (Lower back pain), PAIN IN EXTREMITY (Top of legs pain) and ARTHRALGIA (Hip pain) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Fibromyalgia and Arthritis.    On 25-Feb-2021 at 3:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced ABDOMINAL PAIN UPPER (Dull pain in right side of stomach), ABDOMINAL DISCOMFORT (Burning pain in stomach), BACK PAIN (Lower back pain), PAIN IN EXTREMITY (Top of legs pain), ARTHRALGIA (Hip pain) and ARTHRALGIA (Knees felt like could burst open with pain). At the time of the report, ABDOMINAL PAIN UPPER (Dull pain in right side of stomach), ABDOMINAL DISCOMFORT (Burning pain in stomach), BACK PAIN (Lower back pain), PAIN IN EXTREMITY (Top of legs pain), ARTHRALGIA (Hip pain) and ARTHRALGIA (Knees felt like could burst open with pain) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.  On 01-Mar-2021, patient's pain got a little better, she was able to sit up and eat.
Severe fever and chills, flu like symptoms approx. 8 hours after injection lasting approx. 24 hrs.