chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Injection site warmth; Injection site induration; Injection site blisters; Injection Site swelling; Injection site pruritus; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (Injection site warmth), INJECTION SITE INDURATION (Injection site induration), INJECTION SITE VESICLES (Injection site blisters), INJECTION SITE SWELLING (Injection Site swelling) and INJECTION SITE PRURITUS (Injection site pruritus) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced INJECTION SITE WARMTH (Injection site warmth), INJECTION SITE INDURATION (Injection site induration), INJECTION SITE VESICLES (Injection site blisters), INJECTION SITE SWELLING (Injection Site swelling) and INJECTION SITE PRURITUS (Injection site pruritus). On 02-Feb-2021, INJECTION SITE WARMTH (Injection site warmth), INJECTION SITE INDURATION (Injection site induration), INJECTION SITE VESICLES (Injection site blisters), INJECTION SITE SWELLING (Injection Site swelling) and INJECTION SITE PRURITUS (Injection site pruritus) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment details were provided.
Left side of my face red and an ulcerated scab at the injection site, left upper arm. Today my whole face looks like I am a bit sunburned (both cheeks, across my nose). The left TMJ joint is a bit inflamed (just slightly) and my left cheek gums and sinus is uncomfortable (behind my cheekbone). Both cheeks are hot, left cheek a little inflamed.
Patient given ADACEL instead of DAPTACEL at age 4 yrs 10 mths. No adverse reaction. All other vaccines given in another state.
RAISED, WHELP, ITCHY  RASH ON BILATERAL ARMS, BACK, NECK, FACE, SHORTNESS OF BREATH, SORE THROAT, SWELLING OF THROAT,  FATIGUE, HYPOTENSION, LOW-GRADE FEVER- STARTED ABOUT 4 HOURS AFTER 2ND COVID VACCINE.
Strep infection; Rash all over the body; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of STREPTOCOCCAL INFECTION (Strep infection) and RASH (Rash all over the body) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced STREPTOCOCCAL INFECTION (Strep infection) and RASH (Rash all over the body). The patient was treated with TRIAMCINOLONE (topical) at a dose of 1 dosage form and METHYLPREDNISOLONE (MEDROL [METHYLPREDNISOLONE]) at a dose of 1 dosage form. At the time of the report, STREPTOCOCCAL INFECTION (Strep infection) outcome was unknown and RASH (Rash all over the body) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. Treatment medications included Antibiotics.
Patient received 2 dose of rabies vaccine as initial series prior to travel to endemic area.  She began to get full body pruritis shortly after leaving clinic.  3 hours after receiving vaccine, she felt abdominal cramping, nausea and vomited x 1.  Her abdominal cramping steadily decreased over next 24 hours.
This initial spontaneous report was received from a 72 year old female patient concerning herself.  Medical history included shingles in 2010. Concurrent conditions included diabetes. She stated she was taking no concomitant medications. The patient reported that she got shingles in 2010, and then later on, on 16-JUN-2010, she went to a drug store where she picked up ZOSTAVAX, then took it to her physician to have it administered.  The patient stated she became blind in her left eye and was losing sight in her right eye after administration of ZOSTAVAX. About three to six months after she was administered ZOSTAVAX, she got up one morning and could not see out of her left eye. She saw an eye doctor and was given a "shot" in her left eye once per month and was placed on four different eye drops to try and save the eye. She went blind in her left eye. Then, an unspecified time later, she began to experience loss of sight in her right eye. She also got a "shot" in her right eye once per month but was now at once per three months. She still took unspecified eye drops. The patient did not think they would be able to save the sight in her right eye. The patient called because she received a letter from an unspecified lawyer inviting her to join a lawsuit related to ZOSTAVAX. She was not sure if she wanted to join the lawsuit. The events were not resolved at the time of the report. Causality assessment was not specified. Upon internal review, blindness in left and right eye was considered medically significant. Additional information has been requested.
NO ADVERSE REACTION.   BOOSTER GIVEN ONE MONTH EARLY  2ND DOSE 7/22/21 BOOSTER GIVEN 12/7/21.     NO ADVERSE REACTION
heart beat was ranging from 53-155; This is a spontaneous report from a contactable consumer (patient).   This 83-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) from Lot# EL1283  on 19Jan2021 at SINGLE DOSE for immunisation .Medical history :none.There were no concomitant medications.  The patient experienced heart beat was ranging from 53-155 on 26Jan2021 15:30 and by midnight She was better. She said she was perfect now her readings were basically normal. she has never had that problems as long as she has lived. She did not know if it was related to vaccine. She was worried about getting the second dose. Lab data included heart rate (26Jan2021): 53-155  on 26Jan2021. Outcome of the event was recovered.
over left cheek bone feel sore, left side of neck sore as well; massaging to see if it goes away; no dizziness, no vision changes, no HA, no change in speech
Information has been received from a health professional concerning a 31 year old female with no pertinent medical history and no drug reactions/allergies who on 27 Apr 2006 was vaccinated SC with a 0.5 mL dose of Varivax (Lot# 652557/1024R). On 09 May 2006 the patient experienced swelling at the injection site and generalized itching of her body. No pox were noted. The outcome was reported as not recovered. There were no lab diagnostic studies performed. Unspecified medical attention was sought. There was no product quality complaint.  No further information was available at that time. Additional information has been requested.
Swelling at the injection site (3in), hot to the touch. Painful to the touch. Slightly pain when arm is in motion.
Pt vaccinated with DTP approx 18-20 hrs after shots child experienced a short 1-2 min generalized tonic clonic seizure - no specific treatment necessary. Afebrile. Alert, normal exam.
Red, inflamed, very itchy rash in center of chest on the same night of the vaccine.  Picture provided to primary doctor's office during Telehealth visit.  Rash lasted 3-4 days..  On fourth day, similar, but smaller, rash appeared further up chest near left shoulder blade.  It only lasted a hour or so.
Fever began a few hours after vaccination. Reached 103 F by midnight. Excessive menstrual bleeding and excessive bleeding from minor scrape on lip.  Note: for three days after first vaccination, we noticed excessive bleeding from minor abrasions on the roof of mouth. We also noticed bruising as a consequence of minor bumps to arms, legs, and torso.  After both vaccinations, in other words, we noted that her blood did not clot as normal.
NEUROPATHY; SHINGLES OUTBREAK/SHINGLES RASH; This spontaneous report received from a patient concerned a 77 year old Male. The patient's height, and weight were not reported. The patient's past medical history included shingles outbreak- last time was 12 years ago and concurrent conditions included non alcohol user, and non smoker and other pre-existing medical conditions included the patient was allergic to unspecified antibiotic. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: A240421 expiry: UNKNOWN) dose was not reported,1 total, administered on left arm on 03-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date in MAY-2021, the patient experienced shingles outbreak/shingles rash and he began to experience severe pain around mid stomach on left side under breast area 3-4 inches long and 1 inch wide around the middle side and back. The patient reported he put off seeing his doctor for about a week after pain symptoms began. The patient reported going to the doctor one week after symptoms began for the pain he was experienced  and doctor discovered the shingles rash. On an unspecified date in JUN-2021, treatment medications included: gabapentin, and tramadol. On 03-JUN-2021, treatment medications included: valaciclovir. The patient said the pain began at least a week and a half before he began the valacyclovir. On an unspecified date, he still has lingering pain (neuropathy) since he waited to see the doctor for assessment after symptoms began. Additional treatment medications (dates unspecified) included: acetylsalicylic acid, aspirin and oxycodone hydrochloride/paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered with sequelae from shingles outbreak/shingles rash, and had not recovered from neuropathy. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210801276-Covid-19 vaccine ad26.cov2.s -Neuropathy. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY
Information has been received from a nurse concerning a 17 year old female who on 21-JUN-2007 was vaccinated intramuscularly with the first dose of Gardasil. Concomitant therapy included sertraline HCl (ZOLOFT). After the vaccine was administered, the patient said that she felt nauseous and wanted to lay down. The reporter stated that the patient had not been sweating and was given crackers and soda. After about twenty minutes, the patient said that she felt better and was sent home. The patient sought unspecified medical attention. Additional information has been requested.
Chills; Fever; Sweats; Severe headache; This is a spontaneous report from a non-contactable consumer, the patient. A 28-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ew0196) via an unspecified route of administration in the left arm on 21Jun2021 at 11:00 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications taken within two weeks of vaccination were not reported. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ew0191) via an unspecified route of administration in the left arm on 01Jun2021 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. 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 vaccination. On an unknown date in Jun2021, the patient experienced chills, fever, sweats, severe headache. The clinical outcome of the events chills, fever, sweats, severe headache was not resolved at the time of report.   No follow-up attempts are possible. No further information is expected.
Patient's mom states that the patient (20 yr old) is still having arm/shoulder pain from her 1st dose on 7/24/21. Reported on 9/14/21
Appeared fine all day and into bedtime routine.   Extreme restlessness during sleep.   Single barking cough 2x between perhaps 11:30p.m.-12:45 a.m. prior to hearing odd sound at roughly 1:15 AM and finding him on all fours struggling to get air, as if vocal cords were tight together.    Brought him outside into the cold immediately and called ambulance.   Patient could manage a couple of words in response to questions, but more often nodded or shook head to focus on breathing.   EMTs noted coarse sounds in lower lobes bilaterally - upper lobes too tight to hear anything.   Oxygen and nebulizer given en route.    O2 sats remained high enough that he was triaged and had to wait 1-2 hours to be seen.    Was given recepinephrine 0.5 mL nebulizer at 4:47 AM and dexamthasone (10 mg) at 4:41 AM.    Tight voice quality remained.   Was diagnosed with croup.   However, this child has never had a significant respiratory illness in the past, has never been a "lung" kid.   (He's a gastrointenstinal kid).    Staff at hospital did comment that 6 is "a little old for a first instance of croup..."     Discharged home at 6:30 AM.
Pt. called his daughter on Sunday April 18 and told her was not feeling well and said it was from the effects of the (one shot) COVID-19 vaccine. You would have to contact her directly for more information. He was found dead in his room  by the manager around 5 pm on April 22nd. Manager told me his body was cold to the touch so she thought he may have passed the previus day on April 21st.  Daughter todl me earlier today that a doctor is running some tests to try to determine the cause of death. You would need to contact her for the doctors name.  My own inpression is that the emphysema was not severe enough to have d=caused his death as he could walk up to half a mile.
AWOKE 1-2AM 27JAN91 W/CRYING 8AM BECAME CONSTANT SCREAMING DESCRIBED AS "STRANGE & HIGH PITCHED" MO STATES CHILD FELT WARM BUT DID NOT CHECK TEMP-SPONGED CHILD DOWN-LIMP & EYES ROLLED BACK IN HEAD-NO JERKING MVMT; TO ER-DX FLU; SEE WORM
The pt developed rash, generalized macular erythematous on the trunk and extremities.
Cannot feel heat with right leg, but extremely sensitive to cold. After 2nd Shot - Chest Pains. After 3rd Shot - Woke up at night paralyzed from mid chest down, all muscles contracting and the most unbelievable pain I have ever experienced. Lasted about 2 minutes. Eventual MRI revealed Lesions in Spinal Chord and Brain.
Information has been received regarding a case in litigation.  On 31-JAN-2007 the mother of a 25 year old female reported that on 25-JAN-2008 her daughter was vaccinated IM with 0.5 mL of the second dose of Gardasil (Lot #659657/1487U).  No concomitant medications were reported.  The patients mother reported that post vaccination on 26-JAN-2008, the patient experienced numbness and tingling in her extremities.  That same day the patient reported that on an unspecified date her physician had her get unspecified blood work for the event.  She reported that all of the blood tests were normal and that her physician was "ruling out paraesthesis".  The patient reported that she did not have any events after her first vaccination with Gardasil (Lot #, dates of vaccination and details were not provided).  On 01-FEB-2008 the patient's father reported "my daughter went to the ER (date not provided) and apparently had a low electrolyte level.  She is stable now, but her condition has not improved much.  My daughter has no other medical conditions".  Later that same day the patient's mother reported that her daughter was experiencing what "she believes is Guillain-Barre syndrome."  She reported that her daughter experienced numbness from her waist down, back tightening, tingling in her fingers and was extremely tired.  She stated "she feels like going to the dentist and coming off anesthesia."  At the time of this report the patient had not recovered from these events.  No further information is available. 9/25/08-records received-for DOS 1/30/08-presented to ED with C/O numbness. Two day history of lower extremity numbness now associated with bilateral hand numbness as well. PE:WNL. Assessment:parestheias.
This spontaneous report as received from a 61 year old female patient refers to herself with thyroid disorder and hypersensitivity. Medical history included cataract surgery, hysterectomy, carpel tunnel both hands and methylprednisolone allergy and break out on itch and scratch if medication not taken. In approximately April 2013, the patient was vaccinated with a dose of ZOSTAVAX (lot #, dose and route was not reported). Concomitant therapies included levothyroxine sodium (manufacturer unknown) and ATARAX. The patient had been experienced two outbreaks of herpes. She advised the first outbreak was about a month after the vaccine in May 2013 and the second was in June but not sure on exact date. She described it as having lesions, swelling, pimple like blisters. She stated that the pimples were now scabbing. The patient sought unspecified medical attention. The doctor prescribed acyclovir for future break outs. She advised that she started to get a pain on the upper right thigh area prior to the outbreak. The outcome of events was unknown. On 09-MAY-2013 before herpes eruption, the patient performed an unspecified lab diagnostics study. Additional information has been requested.
He got his vaccine, the injection site was tender but he knew that was due to the injection.  The following morning he had some swelling of his arms, both of his knees hurt, some swelling in his testicles and joint pains, and a queasy feeling.  Today when he woke up all of his joints hurt, the swelling on the shoulder had gotten significantly worse and the swelling in his testicles has gotten worse and had swelling in the left side of his jaw and ended up throwing up his breakfast due to stomach upset.   He has not taken anything for his symptoms and is going to give it a couple of hours to see if things calm down and felt that he needed to report his symptoms.
After the second vaccination in February, somewhat gradually, but by mid April, I realized that I now had tinnitus in my left ear. It is still happening 24/7. Basically is very annoying, not life threatening.
pt recv vax 4JUN97 & 5JUN97 pt devel cellulitis @ inj site;pt was treated w/Cephalexin from 6JUN97 to 16JUN97;pt recovered;
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 25-OCT-2013 the patient was vaccinated with an improperly stored dose of GARDASIL, which was exposed to 31F for 1 hour, (lot # J003727, Exp date: 07-NOV-2015), 0.5 ml, intramuscularly. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Headache, Myalgia, INJECTION SITE PAIN Narrative:  Other Relevant History:
No additional adverse events reported; The VAQTA expired on 10APR2021 and was administered 16APR2021; This spontaneous report was received from other reporter referring to a patient of unknown age and gender. The patient's pertinent concurrent conditions, medical history, concomitant medications and previous drug reactions or allergies were not reported.   On 16-APR-2021, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) as prophylaxis at a dose of 0.5 milliliter (concentration, number of administered dose, vaccination scheme frequency, route of administration and anatomical location were not reported; lot number S037574 and expiration date 10-APR-2021) (expired product administered). No adverse events were reported. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S037574; expirationdate: 10-APR-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
By 9 am the morning of the vaccination I was vommiting,  had muscle aches and dizziness.  During the next day 01/06/21 I experienced a fever, pronounced muscle pain, numbness and tingling in my extremities /face and diarrhea. It continued to get worse over the following 2 days and persisted.
Symptoms of extreme skin pain on extremities (Hands, Feet, Knees, Face) upon being exposed to cooler temperatures. Symptoms of extreme pain upon being brushed against or scratched causing feelings of being cut on skin. Symptoms started approximately 2 weeks after receiving COVID19 Vaccination- Johnson and Johnson.
7d post KINRIX and PROQUAD patient had generalized tonic-clonic seizure. No prior fever but fever noted afterwards. Seen in ER - dx febrile seizure. Also seen by PCP 2d after seizure and noted to have rash on trunk.
Tachycardia, fever, tachypnea, elevated troponin level, 0.12, and concern for friction rub.   RSV positive..  RSV could explain all symptoms  but not friction rub on exam and not elevated troponin level.
Patient with emesis within 10 min after receiving vaccine first dose. She has reported history of emesis 3-4 times a week typically within 5 minutes of taking her chronic daily medications. Today she took medications approximately 20 min prior to arriving for her vaccine. She reported emesis was typical for her. She denies other symptoms such as shortness of breath, chest discomfort or tightness, dizziness, lightheadedness. Fatigue is at baseline. She had copious non-bilious, non-bloody emesis which resolved spontaneously after approximately 5 minutes. She declined treatment with IV fluids or Zofran. She declined EMS transport to the hospital. She was evaluated by this provider and EMS and signed declination of treatment. She reported feeling at her baseline after approximately 10 minutes and was monitored for 30 minutes without further adverse event.
Nausea weakness multiple seizures that began at midnight the following morning and continued throughout 6/8 into 6/9. I missed 2 days worth of work. I had loss of energy no appetite
On 4/3/23 an internal vaccine audit identified this patient as being vaccinated on 12/9/22 with a Jynneos vaccine that was potentially exposed to room temperatures for greater than the allowable time. Patient is being contacted for revaccination
painful arm; redness in arm; stomach distress; diarrhea; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (painful arm), ERYTHEMA (redness in arm), ABDOMINAL DISCOMFORT (stomach distress), DIARRHOEA (diarrhea) and HEADACHE (headache) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced PAIN IN EXTREMITY (painful arm), ERYTHEMA (redness in arm), ABDOMINAL DISCOMFORT (stomach distress), DIARRHOEA (diarrhea) and HEADACHE (headache). On 23-Jan-2021, PAIN IN EXTREMITY (painful arm), ERYTHEMA (redness in arm), ABDOMINAL DISCOMFORT (stomach distress), DIARRHOEA (diarrhea) and HEADACHE (headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information provided.   This case was linked to MOD-2021-020863.
(L) deltoid node to (L) arm 4 x 5 area if erythema. Warm to touch discrete tender to touch not involved to forearm. (+) ROM to shoulder.