chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vaccine was administered SQ.  Upon follow up with patient, she stated her arm swelled and was hot and her body hurts. The next morning (4/17)the swelling went down, but she had a whelp 1 1/2 inches x 3 inches.  Her arm feels really heavy and hurts. She says her back and neck are hot and she feels nausea.
4 weeks after the first dose, the patient was vaccinated with the second dose of Gardasil 9; No adverse effect; This spontaneous report was received from a medical assistant and refers to a 16 year old patient of unspecified gender.  The patient's concurrent conditions, medical history or concomitant therapies were not reported.  On an unspecified date, the patient was vaccinated with the first dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) as prophylaxis (dose, frequency, anatomical location, route of administration, lot number and expiration date were not provided).  On an unspecified date, 4 weeks after the first dose, the patient was vaccinated with the second dose of HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9)  (dose, frequency, anatomical location, route of administration, lot number and expiration date were not provided).(Inappropriate schedule of product administration) No adverse effect was reported.
Day after administration patient had red rash the size of an inch but as day progressed it became more prominent and swelling and pain became more severe. The deltoid muscle was sore and painful. By Saturday night the area of redness was the size of a baseball. She went to minute clinic and was prescribed KEFLEX by nurse practitioner. Her primary care doctor, was called by the patient on 12/31/18 and she told doctor that there was still knot in the middle of her arm and bruising in the surface but no soreness but still pain to touch/pressure.
developed numbness and tingling  3 or 4 on a scale of ten radiating down left arm to fingertips. Gradually improved during observation period.
This report was received from Pfizer and was assigned manufacturer report number 2016409613 for PREVNAR 13. This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (lot #, dose and route unknown). On an unknown date, the patient experienced allergic reaction to PNEUMOVAX 23. The outcome of the event was unknown. Additional information has been requested.
Suspected vaccination failure; shingles on the side of her head; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 19th April 2019, the patient received the 1st dose of Shingrix. On 13th August 2019, the patient received the 2nd dose of Shingrix. On 7th May 2020, 384 days after receiving Shingrix and 268 days after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovering/resolving.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: After receiving 2nd dose of Shingrix, the patient was started experiencing the symptoms of shingles on the side of her head on 07th May 2020. The reporter was consented to follow up. This case was considered as suspected vaccination failure, since the details regarding laboratory confirmation for shingles were not provided.
Bilateral hand rash. Symptom onset on day 3 (June 25, 2021) with progressive worsening. Itching and soreness.  Treated with Clobetas 0.05% cream - 2x daily beginning on July 2, 2021 through July 8, 2021.
Evening of 1-17-21 felt like I was having horrible vaginal infection symptoms. Saw a primary care physician on 1-18-21 and was found to have a raging yeast infection, bacterial vaginitis and urinary tract infection. I haven't had any of these in 15+ years. I was started on antibiotics. Next morning (1-19-21) felt extreme lower abdominal fullness and pressure and extreme nausea. I got in with my OBGYN at 9am same day and he discovered I had an ovarian cyst. He sent me down for an ultrasound and the results showed I had a ruptured ovarian cyst on my left side and an ovarian cyst on my right side. I have never had an ovarian cyst in my life. The next day (1-20-21) the right cyst ruptured. Having all three infections and two ovarian cysts (when I've never had one before) lead my OBGYN and I to feel it warranted filing a VARES report
Large red lump. Swollen, hot to touch. Rash. Increasing in size. Nurse called it covid arm. Take antihistamines and ice pack
Patient's wife called on Monday, 11/25/19 to inform me of patient reaction following vaccine given the afternoon of 11/23/19.  She states that patient experienced numbness and difficulty moving his fingers, arm, and some sensation in his legs.   He also developed a fever after receiving the vaccine.  She states that they went to the hospital, though he was not admitted.  She said the physician discussed the possibility of Guillain-Barre syndrome.  When I asked how he was doing today, she stated that he seemed to be doing better and had gone to work today.  She said they'll call me back if he has any additional problems.  I told her I would report what she had described as a potential reaction to the vaccine.
SLEPT LIKE SHIT; LACK OF APPETITE; CHILLS; BAD JOINT PAIN; FEVER; NAUSEA; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on JUL-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On JUL-2021, the subject experienced slept like shit. On JUL-2021, the subject experienced lack of appetite. On JUL-2021, the subject experienced chills. On JUL-2021, the subject experienced bad joint pain. On JUL-2021, the subject experienced fever. On JUL-2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nausea, lack of appetite, and bad joint pain, and the outcome of slept like shit, fever and chills was not reported. This report was non-serious.
Consulted 3 local doctors , all of who ran tests and concluded their field of expertise could not help me (GP, ORTHOPEDIC, PAIN MANAGEMENT.  I WAS ON A WALKER FOR 3 MONTHS with acute and debilitating pain in all limbs.  Finally made it to Dr., rheumatologist at facility and diagnosis was PMR, and began prednisone on September 2, 2022, 5 months after reaction to 4th COVID shot (2nd booster).  I am down to 3 mg prednisone today, and if inflammation markers are holding good on next blood draw next week, will go down to 1 mg.  During this time, I have had a hip replacement, and am awaiting cardiology appointment for blood pressure issues (headaches started 12/28/22.  I BELIEVE THE PMR WAS A DIRECT RESULT OF THAT LAST COVID SHOT and while some of the doctors I consulted opted to say NO OPINION, several said they indeed have seen many patients who developed complications after the 4th shot.  I have lost the last 10 months of my life SO FAR  to illnesses resulting from the COVID shot, the instant development of PMR, and subsequent issues.
Pt reported feeling like his throat was tight and sob. pt assessed. airway patent. o2 sat 97%. ni distress noted. pt medicated with 50 mg benadryl IM. Provider made aware. provider assessed pt with no further orders. Pt observed for 30 minutes. reported relief of symptoms. ambulated out of clinic with steady gait.
Hives all over body, skin warm like a sunburn, swollen joints, pain in hands along with swelling of my fingers and discoloration
I was exposed probably 05/13/2022 by my massage therapist.  He called and told me on 05/15/2022 he tested positive for COVID-19, so I tested on that same date as I had friends coming to visit and I wanted to be sure I was not positive. However, I was.  I called my doctor's office on that same day and she called me back and prescribed Paxlovid.  My symptoms were a really bad headache, I was exhausted, a really bad sore throat, cough, and some loss of my taste and smell. I really only took Tylenol.  I was sick for a week and a half and felt better for about a half of a day and every symptom I had came back worse for the next 10 days, the cough was really bad with the relapse. I needed to call the doctor to obtain a cough medicine so I could rest.  It took no less than 6 weeks for me to feel better.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 59 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Hashimoto's" (unspecified if ongoing). Concomitant medication(s) included: ARMOUR THYROID, start date: 07May2022.  The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown", COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical information: Other medication in 2 weeks was Yes Armour Thyroid. Not sure of any known allergies.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
a knot in her shoulder area on top of the cephalic vein under her collar bone surgically removed / It was a lymph node /had other lymph nodes in her arm near her elbow that were enlarged but not removed; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (a knot in her shoulder area on top of the cephalic vein under her collar bone surgically removed / It was a lymph node /had other lymph nodes in her arm near her elbow that were enlarged but not removed) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 029L20A) for COVID-19 vaccination.     The patient's past medical history included Systemic lupus erythematosus.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In July 2021, the patient experienced LYMPHADENOPATHY (a knot in her shoulder area on top of the cephalic vein under her collar bone surgically removed / It was a lymph node /had other lymph nodes in her arm near her elbow that were enlarged but not removed). At the time of the report, LYMPHADENOPATHY (a knot in her shoulder area on top of the cephalic vein under her collar bone surgically removed / It was a lymph node /had other lymph nodes in her arm near her elbow that were enlarged but not removed) had resolved.      No concomitant medications were provided.  No treatment medications were provided.   This case was linked to MOD-2021-368139 (Patient Link).
Headache, Myalgia, Fever, chills Narrative:  Headache all day the following day, a lot of arm soreness, fever 99F with Ibuprofen on board, temp went as high as 101.5F, head was "pounding", body aches, chills, felt like she had "the flu". Today still has a headache and has felt hot and cold all day. Symptoms are subsiding but almost had to go to Urgent Care yesterday because her headache was so bad.
After I got the vaccine, I was also exposed to COVID 19 and had a confirmed COVID test Oct 1, 2021.  My symptoms were a runny nose with no cough or fever.  My husband had a cough and had a confirmed COVID 19 infection which is why I was tested for COVID.  On Oct 9, I could not sleep due to tinnitus in both ears.  I went to my physician and had wax removed from my ears.  This did not stop the hissing sound in my ears.  I have also had bouts of insomnia either due to the vaccine/COVID exposure or the tinnitus .  My ears also plug and will unplug sometimes when I yawn.  These problems are ongoing so I am also seeking care thru a chiropractor and an audiologist.
Complaint of cough, chills, headache, runny nose/congestion, myalgia and nausea/vomiting.
Pain at site of injection, fatigue, headache, muscle aches, chills, fever, injection site swelling, and nausea.  Symptoms faded after 24 hours.  Tylenol was taken for 102.4 fever.
Metallic taste in mouth about 20 minutes after receiving the vaccine Sore at injection spot in left arm and almost a numbness in left arm.  My left arm feels fuzzy. The rest of me is fine right now.
17 year old patient received a 1st dose of the Moderna vaccine (Lot#041J21A) on 12/17/2021 at the Community Center.
THE PATIENT GOT THE FIRST SHOT OF MODERNA VACCINE AND HE IS  17 YEARS OLD
Within 24 hours, lassitude, slightly feverish. Within 48 hours: red rash on left buttock, painful and itchy, persisted about 2 weeks, gradually subsided. Eventual swelling of lymph node (inguinal) in left leg. Persisted symptom; wave of numbness down left leg when I bend my head forward. Lymph node still (very) slightly swollen and tender 1 month after shot.
Pt given Hib vaccine in left leg developed 2 cm area of erythema and hives immediately. Watched in clinic without progression 14 min at home developed fever irritability, total body hives resolved after 48 2 doses BENADRYL.
pt recv vax & pt had temp of 100.8 & pt devel few lesions on upper back, forehead, legs & scalp;pt also c/o itching & stomachache;MD dx chickenpox;
Patient presented to the ED and was subsequently hospitalized for rectal bleeding, new onset atrial fibrillation and anemia within 6 weeks of receiving COVID vaccination.
3 days after given ZOSTAVAX, pt. c/o numbness & sharp pain in ears; twitching of eyes & burning sensation - was seen in ER. Dx: Bell's Palsy. Consult with neurologist there suggested possible (not conclusive) link to vaccine.
CT scan showed enlarged left acollarte lymph node, chest pressure and pain, neck pressure and pain, perpetual dizziness, feeling faint, inability to concentrate, headache, tingling and coldness in hands and feet, adrenaline surges, nervous system triggered without stimulation or stress, heart palpitations, sensation of drowning during sleep. These symptoms have been present on and off since 8/20/2021. I was advised to take ibuprofen and follow an anti inflammatory diet and take anti inflammatory supplements, which have not been helpful for symptom management.
So I puked both times offered each shot the next day after receiving it but the first time I was sick for a couple days just feeling lucky like puking nauseated the second one just the other day or yesterday I feel I puked and it lasted for about 5 hours and then today on the 29th I am really sore I'm on my whole body aches and I have not been to the doctor.
Bottom of both feet were very blue/purple, bottom of my feet became very red and eventually returned to the normal color; Numbness in my hands and feet; Became very cold; This is a spontaneous report received from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (Lot number: ER2613) via an unspecified route of administration in left arm on 23Mar2021 (at the age of 60 years) at 11:00 as a single dose for COVID-19 immunisation. The patient had no medical history. Concomitant medication included CRESTOR for an unknown indication. Prior to vaccination, patient was not diagnosed with COVID-19 and since the vaccination the patient had not tested for COVID-19. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The events had not resulted in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. On 23Mar2021 at 19:00, the patient became very cold whereas the temperature remained 97.3 (unspecified units) and bottom of the feet turned blue/purple. The patient took a warm bath after which the bottom of the feet became red and eventually turned normal. The hands and feet had numbness. No treatment was received for the adverse events. The clinical outcome for the events feeling cold, feet turned blue/purple and numbness of hands and feet were recovering.   No follow-up attempts are possible. No further information is expected.
Within 10 minutes of vaccination the patient stated she was feeling her heart race. We took her blood pressure at 5:03 her blood pressure was 136/106, at 5:07 it was 132-105 with a pulse of 110. 5:18 138/107 pulse 95. 5:39pm 146/97 pulse 93. 5:48 155/108 pulse 102. We let the patient move to a seat to a cooler quieter environment and then let her test her blood pressure. At 6:11 her blood pressure was 136/80. Since back in normal range we let her go. She said she felt better though still slightly shaky.
Severe lower back pain. Pain has not subsided since day after vaccination. Cannot walk normally and have to carefully sit down, lay down, get up. Taking ibuprofen throughout the day.
Significant pain and soreness in shoulder at/near injection site.  Feels like I have been punched in the arm/bone for weeks now.  Limited range of motion.
12 hours after redness and heat on hand and elbow on the left side; 12 hours after redness and heat on hand and elbow on the left side; This is a spontaneous report from a contactable consumer, the patient. A 36-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot unknown, first dose) solution for injection intramuscular in the left arm on 26Jan2021 at 07:30 (at the age of 36-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. There was no medical history. Concomitant medications included caffeine/paracetamol (EXCEDRIN), paracetamol (TYLENOL) and ergocalciferol (VIT D). Past drug history included known allergies: cefaclor (CECLOR) and sulfamethoxazole/trimethoprim (SEPTRA). The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 26Jan2021 at 19:30, 12 hours after vaccination, the patient experienced redness and heat on hand and elbow on the left side. Treatment included applied Burts Bees lotion on hand and elbow for the event redness and heat. The outcome of the event redness and heat was not recovered.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
presents today for a video visit with complains of taking her first dsoe of covid vaccine 8 days ago.  Has sinus congestion 5 days later. Has nasal obstruction and now some runny nose. No cough, no shortness of breath, no chest pain. No fever. No nausea or vomiting. Has had diarrhea. No headache.   She felt some body aches and chills but this has resolved.  Has history of asthma has been out of her maintenance inhaler Advair.  Is currently using the rescue inhaler albuterol. Reports home temperature is 97.8°.
Information has been received from a health professional concerning a 12 month old male who on 10-JAN-2007, 00-MAR-2007 and 09-MAY-2007 was vaccinated PO with his first, second and third doses of Rotateq (batch# not reported, lot# not reported). Six months after the third dose, middle November 2007, the patient experienced diarrhea with severe vomiting, severe dehydration, weight decreased (1 kg). The patient was admitted to the hospital for 4 days. The patient was treated with intravenous rehydration. A stool analysis was performed which revealed a rotavirus positive result. Subsequently, the patient recovered. Other business partner numbers include: E2007-09304. No further information is available. The case is closed.
Rash of increasing severity, treated beginning 04/05/21 by PCP with prednisone 20 mg 1x/daily. Referred to dermatology; diagnosed by PA on 04/13/21 as Seborrheic Keratosis and treated with IM steroid and begin triamcinolone acetonide. Rash worsened. On 04/20/21, seen by dermatologist and diagnosed as Urticaria. Prescribed loratadine 10 mg 6x daily/famotidine 10 mg 2x daily/hydroxyzine 25 mg 1x/daily. Seen again 04/27/21; confirmed continued Urticaria and continue loratadine/famotidine/hydroxyzine regimen. Condition persisted; on 05/24/21 dermatologist observed severe erythematous patches on trunk, arms and legs. Another IM steroid, continue loratadine/famotidine/hydroxyzine and referred to allergy clinic (cont)
Pt had an area of induration about the size of a quarter in left deltoid, range of motion in his left arm limited due to pain, pt informed to use warm compresses and ADVIL for pain, pain and range of motion should get better in about a week.
Medication error 0.3ml was administered when 0.5ml was Moderna's recommended dose. Per the CDC and Moderna no treatment is needed, advised to follow up with a 2nd dose of 0.5ml 28 days post the first injection.
patient had fever sore arm and swelling on 4/25/21 after 24 hours then 04/26/21 onwards rash on face redness and swollen lips  . developed  thrush in mouth. experienced some palpitation she went to ER on 4/30/21 as symptoms would not go away ... ER doctor gave her 10 day course with some cream, antiviral an mouth wash
Antigen test done at pharmacy. Case investigation interview has not been performed at the time of this note to provide further details.
patient having left shoulder pain 1 day after vaccine administration that still persists, losing range of motion to shoulder. Now 12 days out from vaccination and still having pain. There is no swelling, redness or lump noted to deltoid.
Chest pain, fatigue, muscle pain, H/A, burning eyes, difficulty swallowing (felt throat tightness), cough, facial flushing). Chest pain described as heartburn". Started 4 hrs after vaccine improved gradually. At office visit 24 hours after vaccine, but only fatigued - not other sx.
A couple hours later after she received the shot she was vomiting for a couple hours and broke out in hives. The next morning she was fine. She had a few hives but by 11AM or 12PM that day she was back to normal. We called the doctor that night and went to the doctor the next morning and they thought it was allergic reaction to the vaccine. The doctor recommended we take a allergy test before getting the second vaccination.
Pt reported back pain, HA, neck pain, 1 week after immunizations. At 10-11 days post vaccine pt began to experience blurry vision, (B) Amblyopia, and was unable to sit or stand > 5 min  D/T back pain. Pt was sent to hosp and is currently in Peds ICU with idiopathic intracranial hypertension. 10/3/08-records received for DOS 8/20-8/22/08-DX: Pseudotumor cerebri unknown etiology. Headache 30 minutes after vaccination and headaches preceding vaccination by several weeks or years. CSF removed only 4ml doubt that pressure was reduced by LP although symptomatic relief afterwards. After vaccination had paresthesia of arms and neck pain. Subsequently became pale and C/O double vision. Blurry vision. PE:sixth cranial nerve palsy, bilateral papilledema.