chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Case number PHEH2014US025123, is an initial spontaneous report from a nurse received on 09 Dec 2014. This report refers to an 84-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 145701) intramuscularly at a dose of 0.5 ml on 27 Oct 2014. The nurse reported that FLUVIRIN administered had 12 separate temperature excursions lasting for 30 minutes over a period of 34 days. The temperature excursion began on 16 Oct 2014 and the temperature was between 46 to 49 degree F during the excursion. No adverse event was reported following this maladministration.
Patient experienced new onset Shortness of breath and palpitations on the day of vaccinations. She noted experiencing body aches and pain . She also notes getting heart palpitations that come and go. She reports new Shortness of breath with climbing stairs. She reports overall feeling exhausted and having a dry cough.
Information has been received from a physician concerning a 10 year old patient who at 15 months of age, in approximately 1998, was vaccinated with varicella virus vaccine live (Oka/Merck). Two months post vaccination, in approximately 1998, the patient developed chickenpox.
Right arm became swollen & very painful, bruised Temp 100.1. No redness noted Pt reported symptom 3/15/07 given RX for Medrol dose pack.
Tingling sensation moving up the arm/shoulder, itching rash on upper arm/shoulder/neck, improved with one dose 25mg diphenhydramine
Spontaneous CSF leak starting 4 days after second vaccine. Horrible positional headache every day for 5.5 months following the second vaccine. Treated with a lumbar blood patch.
Developed shingles on right axilla and down the arm; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ep7534) via an unspecified route of administration in the left arm on 16Mar2021 at 23:00 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. The patient did not receive any medications within two weeks of COVID-19 vaccination. On 24Mar2021 at 08:00 the patient experienced shingles on right axilla and down the arm. Therapeutic measures were taken as a result of shingles and included treatment with VALTREX given 3 times a day for 1 week. The adverse event resulted in doctor or other healthcare professional office or clinic visit. The clinical outcome of the event shingles on right axilla and down the arm was recovered on unspecified date in 2021.   No follow-up attempts are needed. No further information is expected.
A nurse reported that an 18 month old female received an injection of Acel-Imune on 4/21/00. The next day, she developed an injection site reaction characterized by a 5" area of redness, edema and warmth. The child also developed a fever of 99.8F. She was treated with topical and oral Benadryl. As of 4/24/00, the injection site reaction was "smaller", but the swelling and warmth persisted. This is 1 of 3 pts from this facility who developed an injection site reaction following receipt of 2 different lots of Acel-Imune.
Initial report was received from a health care professional on 20 October 2011. A female patient (date of birth and age were not reported) received an intramuscular injection of FLUZONE (site of administration not reported), lot number UH477AC on 29 September 2011. On 30 September 2011, the patient who is also a student went to the health center due to difficulty breathing after vaccination. The patient received corrective treatment with albuterol Inhaler, 2 puffs and the patient was fine. Medical history and concomitant medication were reported as unknown. The patient outcome was recovered/resolved. Documents held by sender: none.
Hives appreared 3 ours post vaccination starting in her neck and torso. Client took benadryl  for  2 days until hives fully recovered.
On 01/12/2011 she developed a high fever (102.7) that lasted most of the day. She was also unable to put any weight on the leg that the vaccine was administered in. By early evening (around 1800) she developed a flat, irregular red rash at the top of her right thigh (the vaccine was administered in the side of the right thigh). The red spot was exceptionally painful. Nothing could touch it - clothing, a person, etc. She was unable to walk for two full days. She had the painful red spot for three days. It began to diminish on the fourth day and was fully resolved after five days. The spot was about 2 inches long and about an inch or so across.
Patient began vomiting and diarrhea at 7PM on 9/21/13 and continued for several hours until 1AM on 9/22/13. Patient has recovered since.
At around 6:20 PM, on duty administered the Covid-19 Bivalent vaccine to the patient. This is the very first Covid-19 vaccine the patient has ever received. After administered the vaccine, asked for patient to sit on one of the chairs at the pharmacy waiting area for 15 minutes. At around 6:30 pm his brother came to the consultation window and said he was not feeling well. Then checked up on the patient who appeared very pale. Asked about his symptoms to which patient said he felt like his extremities were tingling and numb, it was difficult for him to breathe, everything was bright around him so he closed his eyes. Immediately called the ambulance. Patient asked for a bottle of water.  While waiting for EMS, patient said he was feeling slowly better. When EMS came, they took down his vitals. The lead paramedic recommended for him to go to the hospital but the patient declined. The parademic then called a nurse and informed her of patient's decision. Nurse then asked to speak to patient on the phone who asked several follow up questions. Prior to leaving, EMS asked for a signature to waive liability. Patient felt a lot better after the interaction with the pharmacist and paramedics. Informed patient to call the pharmacy if he has any further questions.
Chest tightness; Breathing problems; This is a spontaneous report from a contactable consumer (patient).   A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: Not Reported, Expiry Date: Not Reported), via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: Not Reported, Expiry Date: Not Reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. With first shot, was fine. Had flu like symptoms for a couple days. Was fine. With second dose within minutes had chest tightness and breathing problems. Was administered a steroid injection and was on prednisone for about a month. Her doctor asked if she had hives, which reporter said no, just had the breathing issues. After she had the steroid injection, she was kept for a couple hours. She felt better. The place that administered the steroid injection said she had a reaction. Her doctor is saying she did not have a reaction because she did not have hives and she is perfectly safe to take the booster. The reporter was not sure. She does not have a problem getting the booster and having to take another steroid injection. But it does not make sense to her. Seeking clarification on whether to take the booster shot. Also asking if that was a side effects she should be concerned about for the next round. Since doing the Prednisone, does that affect the efficacy of the vaccine? Wanted to know if it was safe for her to get the booster shot. Does not wanted to involve her doctor with that. Wanted to know if that sounded like a valid reaction and if there should be concern. Stated she had a reaction on an experimental drug. It was so crazy with all the information and went on and on. By the end of it, they could not really give her any information. It was just for their record keeping. The reporter provided no further details on this. After second dose of COVID-19 Vaccine, experienced chest tightness and breathing problems. Was given a steroid injection and on Prednisone for about a month. Asking if the Prednisone affects the efficacy of the vaccine. Outcome of the events was unknown.    The lot number for BNT162b2 was not provided and will be requested during follow up.
(red spot) warm to the touch; red spot little bigger than quarter maybe dollar size; injection site has had a bruise the size of a dime; (bruise) hurting; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (injection site has had a bruise the size of a dime), VACCINATION SITE WARMTH ((red spot) warm to the touch), VACCINATION SITE PAIN ((bruise) hurting) and VACCINATION SITE ERYTHEMA (red spot little bigger than quarter maybe dollar size) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced VACCINATION SITE BRUISING (injection site has had a bruise the size of a dime) and VACCINATION SITE PAIN ((bruise) hurting). On 14-Apr-2021, the patient experienced VACCINATION SITE WARMTH ((red spot) warm to the touch) and VACCINATION SITE ERYTHEMA (red spot little bigger than quarter maybe dollar size). At the time of the report, VACCINATION SITE BRUISING (injection site has had a bruise the size of a dime), VACCINATION SITE WARMTH ((red spot) warm to the touch), VACCINATION SITE PAIN ((bruise) hurting) and VACCINATION SITE ERYTHEMA (red spot little bigger than quarter maybe dollar size) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient denies any itching. No concomitant information was reported. No treatment information was reported.
pt recv vax 7OCT98 & on 8OCT98 pt exp a sore throat, h/a, ear pain, malaise, laryngitis, congestion & a low grade fever;9OCT98 pt exp lethargy;
Patient has a history of adverse reactions to vaccines. He fainted briefly post-vaccination but revived quickly. EMS gave him water and a cold compress.  6/1/21: 11:50am - TC to number listed - recording that said this is the . No other contact number listed. will defer call. -  RN
Patient said that he developed a rash around armpit and biceps. Also a rash on feet and ankle and up and down legs on both right and left side
At 8:00pm on day of injection started with rash on neck. During night started with fever ranging from 100.6-102 which went on till 7pm following day, Friday the 12th. Woke up Friday morning with face swollen with rash that kept spreading. Was unable to move from bed. Saturday went to urgent care once. I could get out of bed. Elevated heart beat at 100.
Patient administered Janssen Covid vaccine at 0943AM on 5/1/21 by pharmacist on duty. Patient had no prior reactions to vaccines but did admit being needle adverse prior to administering vaccine. After administration patient sat in waiting area within direct view of pharmacist. No sooner than 2 minutes post administration patient spoke up to pharmacist assisting customer at consultation window about feeling nauseous, and vision fading. Patient comfortable being assisted in taking two steps to immunization room to lie flat on ground after removing outer jacket. Patient was visibly sweating profusely and described hands feeling cool, dizzy, and lacking peripheral vision slightly. Pharmacist remained in immunization room talking to patient for 10 minutes, patient never fully lost consciousness and within 10 minutes recovered from all visual disturbances. Patient moved to seated position within immunization room and accepted offer for juice box.   Patient remained seated in immunization room for additional 10 minutes under supervision from pharmacist through window. Patient comfortable moving to waiting area again for additional 10 minutes, afterwards he described feeling still slightly nauseated but no other symptoms. He called his ride from the waiting area and told pharmacist he was recovered and comfortable leaving. Pharmacist agreed to call patient later in the day to check in again. Pharmacist left message at 5pm 5/1/21. Appropriate parties notified and VAERS completed.
No immediate adverse reaction after 2nd Moderna shot - delayed 2 months later - chronic itching with and without rashes. Super sensitive skin reacts to clothing tags/seams and loose hair. Skin-colored goosebumps appear and disappear multiple times throughout the day for no reason. Itching every day for about 6 months now, itching all over body in specific parts: stomach, chest, neck, genital area, near armpits, upper right thigh near butt, anus, scalp, legs and arms. Different parts of body itch at different times or days. Infrequent but super unusual red rashes on neck and chest and legs that last for 5-15 minutes. Sometimes skin shows red small bumps that itch.
When my monthly period arrived (slightly earlier than usual), my cramps were incredibly painful and my period was unusually heavy. This has happened for a cycle or two after every COVID vaccine I have received. The cramps are so bad that I stay in bed and cry, heat compresses don't help, pain relievers don't help. They last for 2 full days.
Vomiting - within 24 hrs of dose. Diarrhea - within 36 hrs of dose. Low grade temp. Information has been received from a consumer concerning her child, a 4 month old female with no medical history or allergies, who on 17-MAR-2008 (no adverse effects reported) and 28-MAY-2008 at 14:00 was vaccinated PO with the first and second dose respectively of ROTATEQ (second dose lot: 660291/1829U). Concomitant therapy included amoxicillin. It was reported that on 28-MAY-2008 14 hours after receiving ROTATEQ the patient began vomiting which lasted for 14 hours. On approximately 29-MAY-2008 (20 hours after receiving ROTATEQ the patient had diarrhea which lasted four days. It was reported that the patient sought medical attention (unspecified) and an ultrasound was done (date and results not provided). The consumer reported that the patient recovered and returned to normal as of 03-JUN-2008. A product quality complaint was no involved. Follow-up information was received from a registered nurse who reported that the patient was also vaccinated on 26-MAY-2008 at 2:00 pm with the second IM (left thigh) dose of DTAP (Sanofi Pasteur) (lot # C2900AB1. The patient was seen in the office on 29-MAY-2008 and had vomited five times since 04:00 am, the patient was afebrile. No diarrhea, questionable tenderness in lower abdomen, questionable viral gastroenteritis and questionable vaccine reaction. An abdominal ultrasound was done on 29-MAY-2006, the results were reported no evidence of intussusception or enlarged tissue mass, normal visceral organ and liquid like stool in ascending colon. On 30-MAY-2008 the patient had no vomiting and had 3 loose stools per patients mother. The patient was reported as recovered at the time of this report. Additional information has been requested.
acute onset ataxia about 3hr p/vax & was evaluated in ER;tests NL;resolved w/in 24hr;evaluation 22MAR99 WNL no deficit;
sustained high fever; swelling and itching at injection site; swelling and itching at injection site; loss of appetite; nausea; chills; fatigue; joint pain; wheezing and congestion; wheezing and congestion; headache; dizziness; shaking; This is a spontaneous report from a contactable other HCP (patient herself). A 45-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation, solution for injection, lot number: EN6208, expiry date: unknown) via unspecified route of administration, in left arm on 12Mar2021 13:45 (age at vaccination: 45-years) as dose 1, single for covid-19 immunisation. Patient was not pregnant at the time of vaccination. Patients medical history included covid 19 in Jun2020, asthma from an unspecified date and unknown if ongoing. Concomitant medications were not reported. Patient had been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. She did not take any other vaccines in four weeks, or medications in two weeks. On 13Mar2021 04:00, patient experienced sustained high fever, swelling and itching at injection site, loss of appetite, nausea, chills, fatigue, joint pain, wheezing and congestion, headache, dizziness, shaking. Treatment received due to the adverse events was not known. The outcome of the events was not recovered.   No follow-up attempts are possible. No further information is expected.
the Boostrix was inadvertently administered to a pregnant patient; Boostrix, exposed to unknown temperature over weekend; This non-serious prospective pregnancy case was reported by a nurse via call center representative and described the occurrence of vaccine exposure during pregnancy in a 40-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 2B723, expiry date 17-OCT-2025) for prophylaxis.   On 06-SEP-2023, the patient received Boostrix (left deltoid). On an unknown date, an unknown time after receiving Boostrix, the patient experienced vaccine exposure during pregnancy (Verbatim: the Boostrix was inadvertently administered to a pregnant patient) and incorrect storage of drug (Verbatim: Boostrix, exposed to unknown temperature over weekend).  The outcome of the vaccine exposure during pregnancy and incorrect storage of drug were unknown.   Pregnancy exposure: Gestation time at first exposure (Boostrix): 27 Weeks Pregnancy Exposure (Boostrix): To mother in second trimester Last Menstrual Period Date: 25-FEB-2023 Estimated Delivery/Due date: 18-NOV-2023 Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK receipt date: 12-Sept-2023 License practical nurse called to check stability of vaccine. From 1st September 2023 to 2nd September 2023, Boostrix was exposed to unknown temperature over weekend due to power outage. No prior. Did not consent to follow-up. Boostrix was inadvertently administered to a pregnant patient after temperature excursion, which led to vaccine exposure during pregnancy and incorrect storage of drug.
Both left and right hands turned denim blue starting at the meat of the hand under the thumb and spread up into the thumb and middle finger.  Often discovered while driving with my hands at 10 and 2 o'clock.  Second symptom was an on again off again dizziness that would come on me for 2 to 3 hours at a time along with tiredness.  Both of these symptoms subsided around or about April 21st. I have visited with my primary doctor and a cardiologist.  No treatment prescribed.
This spontaneous report was received from a healthcare worker refers to a 13 month old female patient. No medical history was reported. On 21-MAY-2013, the patient was vaccinated with VARIVAX lot # G007461, expiry: 02-AUG-2013 (reported as 20-AUG-2013) subcutaneously. Concomitant therapies included cetirizine hydrochloride. On 28-MAY-2013, the patient experienced rash on left arm, left chest and left flank. No treatment was given. Patient sought medical attention (seen in the physician's office). The physician documented that the rash was not a classical appearance of Varicella and had discussed appearance of rash, with department of health and was advised to report to the manufacturer of the VARIVAX. The outcome of rash on left arm, left chest and left flank was unknown. Additional information has been requested.
On March  10th I noticed my right arm was itchy.  Also, my knees were throbbing.  On the evening of March 11th my right arm had a warm, red patch of 3 x 4 inches at the injection site.  Each day the patch grew and today (3/16/21)  is over 6 x 8 inches. The knees stopped throbbing yesterday 3/15/21.
numbness and facial swelling on right side lower lip and chin. Uticaria on chest and itching all over body.  took Benadryl PO and some relief.
zoster related vision loss; zoster related vision loss; Information has been received from a lawyer, regarding a case in litigation, and refers to a patient (pt) of unknown age and gender. No information about the pt's medical history, concurrent conditions and concomitant therapies was provided. On an unknown date in 2017, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not provided) by a healthcare provider for the long-term prevention of shingles and/or zoster-related conditions. On an unknown date, subsequent to the pt's zoster vaccine live (ZOSTAVAX) inoculation, the pt was treated by a healthcare provider at an eye center for zoster related vision loss. As a direct and proximate result of the pt's use of zoster vaccine live (ZOSTAVAX), the pt had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future. The outcome of the events was considered to be not recovered. The reporter considered the events of zoster related vision loss to be related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event of vision loss was determined to be medically significant.
05/22//2022 I tested positive, but no symptoms. Then around 5:00 or 6:00 that evening, I began having aches, runny nose, sneezing, a little bit of fever. The next morning, I ached, but was breathing okay. I called my doctor because my wife had COVID and was prescribed Paxlovid. I took the first dose on 5/23/2022. By the next morning, all the aches were gone. I still have the metallic taste. I still feel weak and sleep a lot. I am feeling better.
Severe bloating, constipation, cramping, distended belly soon after receiving the 1st COVID vaccine.  I had an emergency appendectomy on 29 May 2021.  I had acute appendicitis with localized peritonitis, without perforation or gangrene.   Admitting and attending physician, MD.
Severe headache, vomiting, chills and involuntary movement of legs.  Extreme fatigue for two days afterwards and rash on checks.  Looked like I had been slapped and they hurt.
Reconstituted vaccine with provided 0.7mL diluent and total volume of vaccine was 0.72mL 0.5mL was administered per manufacturer website and package dosing  Vaccine insert states to give the total amount despite a 0.5mL dose Unsure if this constitutes a valid administration due to conflicting information with vaccine insert and instructions Was asked to make a report based on conflicting and unclear administration details
Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe