chrisvoncsefalvay/vaers-outcomes huggingface dataset:
23mins post vaccination, pt c/o tongue swelling, "tingles" to the left side of the face.  Smile is center, tongue movement is normal, no facial droop noted.  No respiratory distress.  Pt reported that she had the same symptoms with 1st and 2nd dose Moderna both prior doses were "more severe than today and lasted ~5hrs". Vitals: @12:15 BP 119/86, HR 77, RR 20, T 98.9, SpO2 99% -- > @12:30 111/64, 67, 20, 100% -- > @12:44 117/64, 66, 20 100% Pt stable, talking, able to take sips of water w/o difficulty.  No meds given.  Father and pt educated on s/sx to watch for and when to call 911 for medical emergency.  Pt wheeled to car and released to mother and father in stable condition @12:48.  Recommended pt f/u w/ PCP.
Sore Arm; Fever; Aches and Pains; This is a spontaneous report from a Pfizer sponsored program  COVID-19 Vaccine Testing-2021, a non-contactable physician reported for patient.   A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced sore arm, fever, aches, and pains. It was stated that, the event was caused by suspect product. The outcome of the events was recovered on an unspecified date.    No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Headache, Myalgia, HYPERtension, Angina, bilateral hand swelling Narrative: vaccinated in R) arm reports pain went down right arm into forearm and had bil hand swelling. Reported soon after chest pain and headache. BP elevated 190/122 P 64 did come down to 152/91 P 65. EMS called to transport for work up.
Patient received both vaccines on 10/13/23 then presented to walkin clinic on 10/20/23 and O2 levels were "low" but pt did not wish to go to hosptial at the time and returned home. On 10/22/23 pt returned to walkin clinic and O2 sat was low enough to warrant transport directly to hospital where she was admitted with heart failure and pneumonia.
Case number PHEH214US009913, is a spontaneous report from a nurse received on 13 May 2014, with follow up received from a nurse on 30 Jun 2014. This report refers to a 17-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. She was vaccinated with MENVEO(batch number: NOVM13017) at a dose of 0.5 ml intramuscularly into the left deltoid on 07 May 2014. On 08 May 2014, she experienced low grade fever, body aches, dizziness and a lump at the injection site. The quarter size redness at site of vaccination increased each day. Also she had warmth at site of vaccination. She was examined on 12 May 2014, as redness had increased to 4 into 4 cm area with a slight appearance of inflammation at site. The final outcome of the events was complete recovery. Causality was not reported. Follow up received from a nurse on 30 Jun 2014: Updated patient demographics, date; route; site of vaccination, batch number of vaccine, new events (body aches, dizziness, vaccination site erythema, vaccination site warmth and vaccination site inflammation), outcome of the events and other clinically relevant information in the narrative.
Beginning December 1 chronic spontaneous urticaria in various locations including lips, eyes, face, torso, extremities.  Locations come and go and change throughout the day.  Angioedema on lips.  Still ongoing.  No other changes to diet or environment.  Prednisone 40 mg for 5 days relieved symptoms temporarily but returned 1 week after completion of prescribed dosage.
Left Arm Hurts; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Left Arm Hurts) and HEADACHE (Headache) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     Concomitant products included PARACETAMOL (TYLENOL), ASPIRIN ALUMINUM, TURMERIC [CURCUMA LONGA RHIZOME] and COENZYME Q10 [UBIDECARENONE] for an unknown indication.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced VACCINATION SITE PAIN (Left Arm Hurts) and HEADACHE (Headache). At the time of the report, VACCINATION SITE PAIN (Left Arm Hurts) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment of the event included Paracetamol, 1 glass of wine and 2 beers.   Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested
Elevated temperature that continued to increase and reached 103.7 at 4AM.  Tylenol was given and the temperature returned to normal 02/04/2010 at 5 PM.
Patient was given 0.2ML of the 30mcg formula instead of 0.2ml of the 10mcg formula,
Pt. c/o tongue swelling. Numbness and tingling.  Vital signs:  2:10pm 135/105 82 17 O2 96% 2:25pm 125/100 75 16 O2 94%;   2:40pm 130/82 75 16. Given 20ml of Diphenhydramine by mouth @ 2:30pm.
10 days later had an asthma attack, diagnosed with asthma and now on asthma medications daily. Also have persistent chest tightness and SOB not related to asthma.
Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient's healthcare provider recommended, and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2007, a healthcare provider administered ZOSTAVAX, (lot# and route unknown) to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries. In March 2017, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. The patient used the ZOSTAVAX vaccine for the permanent prevention of shingles and zoster-related injuries. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive 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; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. Additional information has been requested.
Moderna for 1-2 and 1st booster (3rd shot Dec 31 2021) same side effects, Phizer Biv was 2nd booster (4th shot)   Both hands: loss of grip strength, unable to open cans/bottles or hold a cup without shaking.  Painful to make a fist, even worse if a tight fist.  Both forearms are extremely sore and tinder, moment of hands and wrists make pain worse.
Patient received Pfizer Bivalent instead of monovalent for dose 2 of primary series
Patient seen in the ER for GI symptoms Nausea, vomiting and diarrhea.  began right before second dose of oral typhoid.
On Sat 3/ 6 I woke of with bright red eye lids. My face burns when water touched it. Then my eyelid skin peeled over the next few days. I had a very pale eczema patch on my neck prior to the vaccine. On Saturday night my husband said my neck was the reddist he'd ever seen it in 17 years. I said it was burning, and then looked in the mirror and realized it was as red as my eyelids had been in the morning. Like a severe sunburn. I had been parched all day like I had a lump in my throat. I took benedryl for the next 24 hours. My breathing remained fine and it passed .
10 X 9 1/2 cm erythematous indurated area at site of vaccine.
Large rash 3-4 inch in diameter on left deltoid (+) erythema.  In center of rash is a 3-4 cm welt, warm to touch (+) thrombotic thrombocytopenic purpura.
Burning, itching and intolerance to sunlight. Cheek area with heaviness and tingling.
Headaches,  hot flushes, and vital changes She experienced headaches and hot flushes right after vaccination Her BP went up  to 164/72 (baseline BP 120/80), and HR up to 103 She stated she felt anxious while answering questions.  HR down to 80 , but BP stayed high (160/70) in about 15 minutes Provider at the observation room checked her, instructed to continue to check vitals for the next couple of days, and let her leave.   She was sent home.
I have had severe migraine events for over a week with little to no relief from tylenol, advil, sumatriptan, lidocaine patches, icing painful area. All of my regular ways to abort a migraine have failed for the last week and I have been in severe and unrelenting pain This has disrupted my ability to work. Also I have had photosensitivity.
Day of injection: Foggy head, injection site pain, chills, fever, muscle aches, sensitive to touch (lightly touching my skin felt like needles and washing my hair hurt my scalp).  Day 2: Felt hungover, nausea, splitting headache, fever, muscle aches, sensitive to touch, lethargic  Day 3: Sneezing (~60 + times), pain from lymph node in left armpit, dizziness, lump in throat, fever, lethargic   Day 4: Sneezing, swollen and red eyelids, dizzy, lethargic
pt recv vax & post vax exp h/a, muscle aches, nausea;pt recovered;
APPENDICITIS; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: unknown) dose was not reported, administered on 2021 for prophylactic vaccination. Batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date in 2021 (3 weeks after the vaccination), the patient developed appendicitis and ended up in the emergency room (ER) (hospitalization date unspecified) and underwent a surgery. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from appendicitis. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:-20210408818- Covid-19 vaccine ad26.cov2.s-appendicitis. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
HEAVIER MENSTRUAL FLOW WITH VISIBLE CLOTTED BLOOD; MENSTRUAL CRAMPING; FATIGUE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the subject experienced heavier menstrual flow with visible clotted blood. On APR-2021, the subject experienced menstrual cramping. On APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the menstrual cramping, heavier menstrual flow with visible clotted blood and fatigue was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Worried; (Ball) hurts; Has a little ball, and a little higher there is another ball in her neck in the left side/Inflammed nodes; Itchy in the injection zone; Little bumps in the injection zone; Pain in the injection zone; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (Worried), PAIN ((Ball) hurts), VACCINATION SITE MASS (Little bumps in the injection zone), LYMPHADENOPATHY (Has a little ball, and a little higher there is another ball in her neck in the left side/Inflammed nodes) and VACCINATION SITE PRURITUS (Itchy in the injection zone) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included VITAMIN B12 [VITAMIN B12 NOS], MULTIVITAMINS [VITAMINS NOS], COLECALCIFEROL (D3 VITAMIN) and BIOTIN for an unknown indication.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced VACCINATION SITE PAIN (Pain in the injection zone). On 22-Mar-2021, the patient experienced VACCINATION SITE MASS (Little bumps in the injection zone) and VACCINATION SITE PRURITUS (Itchy in the injection zone). On 23-Mar-2021, the patient experienced ANXIETY (Worried), PAIN ((Ball) hurts) and LYMPHADENOPATHY (Has a little ball, and a little higher there is another ball in her neck in the left side/Inflammed nodes). At the time of the report, ANXIETY (Worried), PAIN ((Ball) hurts), VACCINATION SITE MASS (Little bumps in the injection zone), LYMPHADENOPATHY (Has a little ball, and a little higher there is another ball in her neck in the left side/Inflammed nodes), VACCINATION SITE PRURITUS (Itchy in the injection zone) and VACCINATION SITE PAIN (Pain in the injection zone) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication details was reported.
After a week, my arm started to itch and in a few hours it swelled up. The site was red, itchy, hot and hard to the touch. My arm swelled a bit on the day of the shot but it was small and went away after 2 days. But a week later it showed up and the swelling was bigger.
Information not known to me.  Information learned as Dr. provided Complication from COVID Vaccination as Cause of Death on Death Certificate.  Decedent died at home and he went to the funeral home.  He did not come to Coroner.  However, cause of death reported to Coroner and how we learned.  I am reporting it but have no particular information specific to vaccination.
Discharge Provider: DO Primary Care Provider at Discharge: DO Admission Date: 5/22/2022 Discharge Date: 5/25/2022  HOSPITAL PROBLEMS 1. Covid-19 Infection 2. Diarrhea secondary to Covid-19 3. AKI 4. HTN 5. T2DM 6. IDA 7. COPD 8. GERD 9. HLD 10. RLS  HOSPITAL COURSE: Patient is a 72 y.o. female admitted to hospital due to diarrhea and dehydration secondary to Covid-19 infection.   Covid-19/Diarrhea: Patient admitted with several days of copious diarrhea and subsequent dehydration. She had also been feeling generally unwell, with congestion and rhinorrhea. Was found to be Covid positive on 5/22/2022. Did not have SOB, fever or cough. Was not candidate for steroids or Remdesivir. While thought diarrhea due to Covid infection did not want to overlook bacterial cause so enteric pathogens and C diff were tested which came back negative. Patient was started on IV fluids. Diarrhea began to resolve and patient was tolerating diet. Was able to discharge home.   AKI: On admission Cr 3.32, with baseline 1.0-1.3. Likely prerenal given GI losses and dehydration. Lisinopril and Maxide was held, and she was started on IV fluids, with subsequent improvement in Cr. IV fluids were discontinued when patient had adequate PO intake, and Cr continued to show improvement. Was deemed stable for discharge home with follow up with PCP. Lisinopril and Maxide held at discharge, with repeat BMP ordered for 5/27/2022.    IDA: Patients Hb 8.5 on admission. Vit B12 and folate WNL. Iron low at 26. Was started on Iron supplementation.               EGD 2019:  distal stricture with erosion, moderate HH.               Colon 2017:  5 mm, diminutive polyp - tubular adenoma
AUTISM SYMPTOMS OCCURRED RIGHT AFTER VACCINATION, WE DIDNT FIND OUT HE HAD AUTISM UNTIL 2011-2012.
Patient received Fluad intramuscularly. She left the vaccination room and began to walk up the aisle toward the front of the store. After walking about 30 seconds, she became short of breath. A minute or 2 later, she began to have nausea on and off. We applied an ice pack to her neck and called 911. Once they arrived, they provided her with oxygen and albuterol. Her oxygen levels improved (they were about 80 upon their arrival and up to 92 by the time she left) and she began to feel better after about 5 minutes. They brought her to the ER to be further worked up to see if the reaction was caused by the shot, anxiety, or her emphysema.
Patient found unconscious unwitnessed. Syncopal incident, code called, medics at patient?s side. EMS contacted; en route. Patient initially A&Ox3, event unknown. Patient stated neck and head pain. Hard c collar placed; EMS arrived. Patient received 2nd moderna vaccine today. Patient stated walking out and feeling BLE weakness, dizziness and patient cannot recall what happened after.
Information has been received from a physician concerning a 15 year old patient who on an unspecified date was vaccinated with a dose of ZOSTAVAX (Oka/Merck) instead of a dose of a dose of varicella virus live (Oka/Merck) (MSD). The incident was due to human error and not product confusion. It was unspecified if medical attention was sought. No further information was provided. There was no product quality complaint involved. Additional information has been requested.
fever, irritability, lethargy, anterior fontanelle bulging & tense spinal tap was neg;
patient came to pharmacy on 4/10 after receiving her moderna vaccination on 4/8 she reported redness swelling and soreness at injection site. She said the redness and swelling was noticeable a few hours following injection. Her arm appeared to have a circular red rash. she has taken tylenol to help with soreness. i advised pt to try ice and antihistamine and or a topical steroid to help with symptoms. pt is going to self monitor and treat symptomatically she did not report any other reactions/
pt recv vax & w/in 24hr of vax pt exp a fever of 101-103;tx APAP;pt was seen by MD & dx w/heavy sinus drainage & an ear infect;pt placed on ATB which was ineffective & currently 21OCT96 is on a second antibiotic;
Patient developed redness, swelling and pain over area of injection site. Also developed a very large area of cellulitis near the injection site. This required antibiotic treatment for 10 days.
Patient received VARIVAX 3/14/16 at 12 month physical. Rash erupted 3/16/16 involving the extremities and trunk. Progressed from 10-12 lesions to 200 + lesions before it started to resolve. Now resolving and getting better, but has taken some time.
This was the second booster shot. After I took the shot, in a few hours, my arm started getting sore. I woke up at 4 am with 101 fever. I have been very achy all over. I have been managing the fever and the aches with Advil. This is day 4, and my arm is still swollen and red, although it is finally getting better. I am still achy and feel tired.
Discharged. Per ICU Course: " Patient is a 59-year-old female with a history of chronic obstructive pulmonary disease, coronary artery disease who presented to the emergency department on 01/14 with approximately 2 weeks of chest pain and shortness of breath.  She was found to have increasing oxygen requirements, likely secondary to chronic obstructive pulmonary disease exacerbation with overlying COVID pneumonia.  During workup in the emergency department patient had abrupt decompensation during which she desaturated and required intubation and 1 round of CPR before obtaining ROSC.  At that point patient was placed on pressors for persistent hypotension post cardiac arrest and admitted to the medical intensive care unit intubated and sedated for further care of acute hypoxic respiratory failure.  Patient was treated for COVID pneumonia and chronic obstructive pulmonary disease exacerbation, pressors and sedation or slowly weaned.  Patient was able to be extubated on 01/16 and has been stable on 6 L nasal cannula since that time, she is on 2.5 L at baseline.  She was initially found to have elevated troponins in the 200s, however there were stable and thought to be likely secondary to cardiac arrest.  She had an abrupt elevation of her troponins on 1/16 with continued ST depressions in the lateral leads most notably V4 through V6, cardiology was consulted at this time for further evaluation.  Patient remained hemodynamically stable off pressors and sedation, continued to maintain oxygen saturation above 95% on 6 L nasal cannula, and was improving from symptomatic standpoint.  Cardiology has requested left heart catheterization some point during hospitalization although this is not urgent at this time.  She is no longer requiring intensive care unit level of care secondary to no need for further pressors or respiratory support."  Post ICU Care:   - she continued to do well post extubation. She was able to wean off of her oxygen and she was placed on oral steroid taper. Cardiology did left heart cath with successful PCI with DES to proximal right posterior lateral branch. She was started on brillinta and eliquis after cath. She was started on metoprolol and lisinopril at lower dose than at home.  Her oxygen saturation improved and she was at her baseline 2-3 liters of oxygen and 4 liters with exertion.   She was also given prescription for norco as she was having rib pain following chest compression.   Report from controlled medication registry has been reviewed.  This patient will be prescribed an opioid analgesic at discharge. I have discussed the risks of taking this type of medication. This includes the risk of substance use disorder, addiction, overdose, and mixing with other sedating medications. For female patients of child bearing age I reviewed the risks of taking these medications while pregnant. I also reviewed the safe disposal of opioids and the fact that it is a felony to distribute these medications without a prescription. A "Start Talking" form will be signed by the patient at discharge.
Information regarding Flumist (2003-2004 Formula)(influenza virus vaccine, live intranasal (2003-2004 formula) nasal solution (frozen)) was received from a consumer regarding a 5 year old male pt who experienced nasal congestion, feeling lethargic and cough.  At 5 years of age, the pt received a dose on 10/16/03.  Relevant medical history was not provided.  Indication for Flumist (2003-2004 Formula) was immunization.  Product was administered on 10/16/03.  Dose regimen was 1 dose (IN).  Pt was not taking concomitant therapy.  The pt experienced nasal congestion (nasal congestion), feeling lethargic (lethargy) and cough (cough) on 10/16/03.  The pt's mother stated that she did not know if the events were related to Flumist or to seasonal allergy or cold.  As of 10/29/03, the pt's symptoms persisted.  No additional information was available at the time of date report.