chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a medical assistant referring to a 15 year old patient. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 07-JUN-2017, the patient was vaccinated with an improperly stored dose of GARDASIL 9 with lot # N002720 and expiration date 12-MAY-2019 (dose and route of administration were not reported) for prophylaxis. There was no adverse effect or product quality complaint reported. No excursion details had been determined at the time of the report. There was a data logger involved. This is one of several reports received from the same reporter. Follow up information was received on 18-SEP-2017 from the medical assistant, concerning GARDASIL 9 with lot # N002720. On 11-MAY-2017 at 12:24, the time in the range 32°Fahrenheit (°F) to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 1. On the same day at 21:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 8. On 12-MAY-2017 at 03:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 5. On 13-MAY-2017 at 05:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 26. On 14-MAY-2017, the time in the range 32°F to 35°F (0°C to 1°C) was 2 hours from 16:24 to 18:24, number of cycles 21. On the same day at 20:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 1. On 15-MAY-2017, the time in the range 32°F to 35°F (0°C to 1°C) was 3 hours from 01:24 to 04:24, number of cycles 4. On the same day at 12:24, the time in the range 32°F to 35°F (0°C to 1°C) was 1 hour at 34.9°F, number of cycles 7. It has been determined that case # 1710USA009218 was created with the wrong Aware date as 02-OCT-2017 which is previous of the correct Aware date 18-SEP-2017. Therefore, case # 1710USA009218 is being deleted from our files and the case is consolidated into case # 1711USA003957 with the correct Aware Date 18-SEP-2017. Sender's Comments: US-009507513-1708USA011654.
Pins and needles (tingling) sensation on both hands and both legs from the knee down.
Pt reported severe arm pain immediately following injection. pain did not go away and has gotten worse. ibuprofen has not helped. pt is unable to lift anything, can write minimally. pt is looking into medical care with pcp.
pregnant; 1st dose 19 Jan 2021, received 2nd dose on 12 Feb 2021; A spontaneous report was received from a 33-year old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) 24 days apart and is pregnant.   The patient's medical history included two previous pregnancies. No relevant concomitant medications were reported.  The patient received her first of two planned doses of mRNA-1273 (Batch number: 026L20A) on 19 Jan 2021.  On 12 Feb 2021, the patient received her second of two planned doses of mRNA-1273 (Batch number: 013M20) intramuscularly for prophylaxis of COVID-19 infection.  On 12 Feb 2021, when the patient received her second dose of the Moderna vaccine, the patient was 5 weeks pregnant. The patient's last menstrual period was 10 Jan 2021. The estimated date of conception was not provided. The estimated due date is 17 Oct 2021. The patient received the first and second dose 24 days apart. No treatment information was provided.   The patient received both scheduled doses of mRNA-1273; therefore, action taken with the drug in response to the event is not applicable.  The outcome of the events, pregnancy and inappropriate schedule of vaccine administration, were considered resolved on 12 Feb 2021.; Reporter's Comments: This is a case of product exposure during pregnancy and inappropriate schedule of vaccine administration (Lot # 026L20A and 013M20) with no associated AEs for this 33-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Vomited once, Dysphagia comes and goes. Explained to seek medical attention if dysphagia continues. Caller voiced understanding.
Client verbalize feeling heaviness to right arm.  Pt. denies any other symptom. Pt seen by EMD and vital signs are:  149/71, HR 70, O2 98. Pt. cleared to go home by EMT.
I developed hives to my left jaw; woke up with a sore throat yesterday and this morning; throat feeling tight; I feel like I am getting sick; This is a spontaneous report from a contactable consumer (Patient).   A 21-year-old-female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: unknown), via an unspecified route of administration on an unspecified date, at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient stated that, she developed hives to her left jaw, woke up with a sore throat yesterday (a day before this report) and this morning (on the day of this report) and throat feeling tight, and she felt like she was getting sick. The patient asked these symptoms that are common and reported. Patient was asked about the second dose that she should get the second dose of the vaccine since she developed hives and response was should not. At the time of this report the event outcome was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
The day after I started to have fairly serious muscle pain in my shoulder.  It now nearly four days later and it is reoccurring multiple times each day, with red inflammation visible near the injection site.  I'm treating with ibuprofen.
Stayed in bed for 5 days after booster; Diarrhea after booster; Fever after booster; Very fatigue after booster/ Drained; Nausea after booster; This spontaneous case was reported by a consumer and describes the occurrence of BEDRIDDEN (Stayed in bed for 5 days after booster), DIARRHOEA (Diarrhea after booster), PYREXIA (Fever after booster), FATIGUE (Very fatigue after booster/ Drained) and NAUSEA (Nausea after booster) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, the patient experienced BEDRIDDEN (Stayed in bed for 5 days after booster), DIARRHOEA (Diarrhea after booster), PYREXIA (Fever after booster), FATIGUE (Very fatigue after booster/ Drained) and NAUSEA (Nausea after booster). On 31-Oct-2021, BEDRIDDEN (Stayed in bed for 5 days after booster) had resolved. On 02-Nov-2021, PYREXIA (Fever after booster) and NAUSEA (Nausea after booster) had resolved. At the time of the report, DIARRHOEA (Diarrhea after booster) and FATIGUE (Very fatigue after booster/ Drained) had not resolved.            No concomitant medications were reported. Treatment medications were not provided by the reporter. Patient was healthy.  On 26-Oct-2021, seven months after second dose, patient received booster shot of Moderna COVID-19 vaccine. After the booster shot, patient had fatigue, nausea, diarrhea, and fever. Patient stayed in bed for 5 days.  Weeks later, patient was still feeling very fatigue, drained and still had a little diarrhea.   This case was linked to MOD-2021-390829 (Patient Link).
This is a spontaneous report from a contactable consumer (patient's sister) or other HCP. This is 1st of 2 reports.A 60-years-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot number and expiry date was not reported) via an unspecified route of administration at Arm Right on 10Mar2021 at 11:00 (at the age of 60-years-old) as Dose 1, single for COVID-19 immunization. The patient's medical history included atrial fibrillation, cardiac disorder from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. No other products were used.On an unspecified date the patient experienced congestive heart failure and shortness of breath on an unknown date in Mar2021. The patient underwent lab tests and procedures which included blood test: good on, chest x-ray: good on, electrocardiogram: good on. Outcome of the event was cardiac failure congestive was unknown, shortness of breath was not recovered on unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Cellulitis at injection site. Redness, swelling, pain and itching. Met with Md, placed on antibiotics
pt recv vax 9APR96 & exp a racing pulse, palpitations, dizziness & lightheadedness;the palpitations subsequently resolved however cont to exp dizziness upon standing;
Administration Error.  Vaccine was administered past BUD date.  Vaccine received on 02/01/2022 and BUD was 04/12/2022.  Patient did not experience any adverse event from the administration of the vaccine past the BUD.
No additional AE; two doses were administered after a temperature excursion that occurred on 4/29/2022.; This spontaneous report was received from a Licensed Practical Nurse, referring to a 4-year-old male patient. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 02-MAY-2022, the patient was vaccinated with improperly stored of varicella virus vaccine live (oka/merck) (VARIVAX)  for prophylaxis (lot # U022320, U026207, U028164, U015689 and U025791 has been verified to be a valid lot number varicella virus vaccine live (oka/merck), expiration date reported and establish as 15-JUL-2023, 24-AUG-2023, 09-SEP-2023, 18-MAY-2023 and 19-AUG-2023 respectively) (0.5 ml, strength, route of administration and anatomical location were not provided) (specific lot# was unspecified) (Product storage error). The temperature of storage and time frame of the excursion were 0.8 degree Celsius for 4 hours and 19 minutes respectively. There was no previous temperature excursion. No adverse event reported.   Another patient was capture in Case# 2205USA004796. This is one of some reports from same reporter.; Sender's Comments:  US-009507513-2205USA000806: US-009507513-2205USA004796:
Several hours after the vaccines, pt. began displaying an odd head tilt to the left. She kept dropping her head to the left, as if she couldn't hold it up. It immediately stuck me as unusual. She also shook, from head to toe, for at least 10 seconds. A few hours after that, she began screaming. It was a high pitched scream that lasted for hours. She was inconsolable.  She spiked a fever, which I was able to bring down with Infant Tylenol. The crying continued throughout the entire evening. The head tilt continues to be an issue.
Fever/104 degrees F/102 degrees F/99.9 degrees F; Chills; Headache; Joint pain; Arm at the injection site was a little sore; Sweating; Received third dose on 17/Aug/2021; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweating), EXTRA DOSE ADMINISTERED (Received third dose on 17/Aug/2021), PYREXIA (Fever/104 degrees F/102 degrees F/99.9 degrees F), CHILLS (Chills) and HEADACHE (Headache) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A, 007M20A and 054C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Quadruple vessel bypass graft. Concurrent medical conditions included Diabetes.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Aug-2021, the patient experienced EXTRA DOSE ADMINISTERED (Received third dose on 17/Aug/2021). On 18-Aug-2021, the patient experienced HYPERHIDROSIS (Sweating), PYREXIA (Fever/104 degrees F/102 degrees F/99.9 degrees F), CHILLS (Chills), HEADACHE (Headache), ARTHRALGIA (Joint pain) and VACCINATION SITE PAIN (Arm at the injection site was a little sore). On 17-Aug-2021, EXTRA DOSE ADMINISTERED (Received third dose on 17/Aug/2021) had resolved. On 18-Aug-2021, HYPERHIDROSIS (Sweating), CHILLS (Chills) and ARTHRALGIA (Joint pain) had resolved. At the time of the report, PYREXIA (Fever/104 degrees F/102 degrees F/99.9 degrees F), HEADACHE (Headache) and VACCINATION SITE PAIN (Arm at the injection site was a little sore) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Aug-2021, Body temperature: 104 (High) 104 degrees Fahrenheit., 102 (High) 102 degrees Fahrenheit. and 99.9 (High) 99.9 degrees Fahrenheit..         No concomitant medication was reported.  The treatment information was not reported.
Day of: full arm soreness, swelling, soreness, and hardness at injection site; Day 2: soreness, muscle swelling, and hardness at injection site, some itchiness; Day 3 to present: very itchy, sensitive to touch; Day 9: large red area around injection site, itchy, sensitive to touch.
Was ill 1MAY-4MAY w/fever, screaming, taken to ER on 4MAY91 had CBC drawn MD dx allergic rxn to Pertussis; Pt had t102-105, wouldn't eat, edema of tongue, & head became limp; fever fr 1MAY91-5MAY91; Dx viral infect or Pertussis rxn;
Intense itching /burning at the injection site, then redness, swelling and rash which is warm to the touch.  Also felt  achy  overall.
Diaphoretic  Narrative:  Patient was assessed with vitals, gave him gingerale, crackers, Glucose was 112, patient then became very pale in color and dizzy, transferred to bed and put in Trendelenburg, vitals returned to baseline and patient recovered without further incident.
Pt called on 9/3/19 at 7:15pm, reporting adverse reaction to flu shot (administered at 5:30pm on 9/1/19). She first noticed symptoms at around 3:00am on 9/2/19 when she got up to nurse her infant. Injection site was red and swollen (welt-like per pt), area around eyes was itchy. Also reports of itching on forehead, neck and elbows. As of now, itching and redness has started to subside. No new medications or foods recently, per pt. Pt has received flu shot in previous years without any issues/allergic reactions.
The pneumonia shot was admisnistered at the last part of office visit in Nov. 11, 2008, by the time I was at the parking lot, I felt pain/numbness on my left arm  by the location of the injection.  I went home and all night long I felt so much discomfort and pain, nausea, and upset stomach and diarrhea.  I urinated more often than normal, unable to sleep and my arm kept getting worse.  By morning, I am hardly moving my left arm, it is swollen, too.  Around 9am, the pain increased and I cannot work, so by noon I had to leave work as the pain increased and I was having a fever.  I went back to the clinic, was seen by the PA, fever was 100.7 and the injection site and around it was hard to the touch, red and very much swollen and she can see that I can't move my arm without having severe pain.  I was given antibiotics and steroid pack, was told to put either hot or cold compress.  The 2nd night, was worst, I cannot lay on any of my sides as the pain radiated to my right shoulder and through my back.  My fever was on and off, restless all through the night - on the morning of Nov. 13th, I was not any better, so I had to take off work again, the pain is as severe as the night before.
Moderna vaccine was given to patient from a vial that was opened the previous day and was past the 12 hour beyond use time. Patient has not reported sign/symptoms from vaccine.
Patient stated got shot on Monday 7/25/16, on Tuesday her arm was red, not, hurting, hand going numb at times. On Wednesday she started developing allergy symptoms stated runny nose, throat hurt and fatigued and arm itching.  Stated today, Thursday, 7/28/16 the day she called that her lips were burning and felt like having a reaction from this shot, arm still itching, felt like was getting a cold sore. Was instructed to inform physician.
pt recv vax 6JUN96 & 8JUN96 pt recv PPD test;20JUN96 pt exp numbness & paresthesia in lt arm;paresthesia started to occur in the rt arm but resolved quickly;JUL96 paresthesia persisted in lt arm but was resolving;
This case was reported by a other health professional via call center representative and described the occurrence of mesenteric lymphadenopathy in a 18-year-old female patient who received MENVEO (batch number M17038, expiry date 1st March 2019) for prophylaxis. Previously administered products included Meningococcal vaccine (the healthcare professional thought it was the MENACTRA). On 3rd July 2018, the patient received the 1st dose of MENVEO (intramuscular) .5 ml. On an unknown date, 12 hrs after receiving MENVEO, the patient experienced mesenteric lymphadenopathy (serious criteria other: As per reporter), flank pain (serious criteria other: As per reporter), vomiting (serious criteria other: As per reporter), headache (serious criteria other: As per reporter) and nausea (serious criteria other: As per reporter). The patient was treated with TORADOL, morphine and hydrocodone. On an unknown date, the outcome of the mesenteric lymphadenopathy was unknown and the outcome of the flank pain, vomiting, headache and nausea were recovering/resolving. The reporter considered the mesenteric lymphadenopathy, flank pain, vomiting, headache and nausea to be possibly related to MENVEO. Additional details were provided as follows: The patient woke up from severe right flank pain, nausea, vomiting, and headache. The patient went to the emergency room and underwent performed CT scan for possible kidney stones but it was negative. The patient had mesenteric lymphadenopathy but had a normal abdominal exam. The healthcare professional stated that the patient's appetite was off for 2 days prior to the vaccination. Lab Comments: the patient underwent for CT scan for possible kidney stones but it was negative.
To Health Dept for school vaccinations- given 5th dose of DTaP and 4th dose of IPV (Quadracel) Right deltoid and also given Hep A Right deltoid. Had Proquad Left deltoid.  Gave family instructions: "After Shots Information from the site. 07/31/2020 Child brought into the health dept with concerns for Right upper arm redness/swelling approx 2cm circular area- no redness to the left upper arm noted- child had good range of motion does not complain of pain when area touched. Foster parents report, he was fine yesterday and noticed the redness and swelling when he woke up today; they brought the child in to the health dept. advised to call child's pediatrician- they do voice understanding that the redness/swelling can be a normal reaction after the DTaP and Polio vaccine. Nurse called to speak with child's physician's nurse- message left on nurse line-
Dr.: Mother and Father returned with the patient about 20 minutes after the immunizations noting swelling and redness of the left thigh. This was the location of the Varicella and MMR immunization. The child was evaluated and did have an area of swelling and erythema measuring about 2 inch in diameter. Ice was placed and 1/4 cc of Benadryl at 12.5 mg/5cc was given. Ice was applied. Patient was monitored for another 25 minutes. The area of swelling decreased, vitals was stable, respirations were normal. Patient was discharged in good condition. Our office will call mother/father back later today to check the status. Benadryl advised tonight at the same dose as above. Ibuprofen dosed based on weight recommended for any fever pain. Parents understood, all questions were answered. Dr. also evaluated the patient.
Information has been received from a licensed practical nurse concerning a patient who was vaccinated with PNEUMOVAX 23. The patient was given ZOSTAVAX and PNEUMOVAX 23 at the same time and there was an increased localized reaction with the PNEUMOVAX 23. It was unknown if the patient sought medical attention. At the time of the report the outcome of the patient was unknown. No further information is available.
0905: Patient feeling shaky & nauseous  0910: HR 89 SpO2 100%, Benadryl 5ml [12.5mg] given with apple juice & saltines 0925: HR 68 SpO2 100%  Pt states she feels much better; released home
Blister like bumps developed in the mouth within a hour or two of receiving the vaccine. There was no pain associated with the bumps. It is now 5/23/2021 and the bumps are still present in the mouth.
After 10 minutes the patient complained of lightheadedness and seeing spots.  The patient was negative for chest tightness, throat/lip swelling.  The patient drank two  full bottles of water; however, there was no improvement in symptoms after 20 minutes.  He then complained of chest tightness and the ambulance was called.  The ambulance arrived and took the patient to the hospital.  The whole event transpires within 45 minutes.
The symptoms began the morning after 10/15/14. Included: Severe flare to lipodystrophy with nerve pain and more atrophy. Legs below knees numb and nerve pain with balance problems. Severe pain in hands and wrists. Throat muscles hurt. Cervicogenic headache becomes deeper and more severe. Increased fatigue.
This spontaneous report was received from a medical assistant refers to a female patient of unknown age. The patient was vaccinated with the first, the second and the third dose of GARDASIL 0,5 ml, intramuscularly (IM) (lot number not reported) on 15-NOV-2010, 24-MAY-2011 and 25-JUL-2012, respectively. No other co-suspects were reported. No concomitant medications were reported. No adverse event reported. No treatment information was reported. At the time of report, the patient's outcome was unknown. Additional information will be provided if available. Additional information is not expected.
I had the second Covid (Pfizer) vaccine on February 22. The next day I had chills, fever, aches, nausea and was very weak. After about 30 hours I felt okay again.  However, a week and a half later, I noticed red bumps on the back of my neck. The next day, my neck and scalp had red, itchy blotches. Through the next five days, these spread down my body to my ankles until I was covered with the red, very itchy blotches. I did go to Urgent Care on the third day and I was given a 5-day prescription of Prednisone. It did not do much until the third day and then it relieved the itching somewhat for about 6 hours, but then it would start again. After the five days of Prednisone, I took Benedryl for three days until the itch and redness disappeared.  I checked the facility web site on types of rashes and my rash fits the description (and the photo) of a drug-related rash, but I have not changed or added any drugs for several years other than the Covid vaccine (I did some research online and found two other people who have had the same problems I have had after the second Covid vaccine. Both of them had the typical reaction of chills, fever, aches and dizziness for about a day after the second shot and then 1-2 weeks later, broke out in a rash. Both reported having the rash start at the neck or head and then spreading down the body throughout one to two weeks before disappearing. There were photos on the facility site of drug-related rashes and they were exactly like what I had.  Since the rash was almost certainly covid vaccine related, I am making this report, which my doctor recommended. I had no other changes in diet, medications, environment, etc. ? only the Pfizer vaccine was new to my body.