chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 29Jan2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 23Aug2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 68 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 10Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 2022, outcome "unknown", COVID-19 (medically significant) with onset 2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Rebound COVID symptoms with positive antigen test. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: It was reported that, patient took Paxlovid from 09Jul2022 to 13Jul2022 for treatment of COVID-19. Adverse event reported as rebound COVID symptoms with positive antigen test on 24Jul2022, where reported AE was not recovered and no treatment was received. Patient had no known allergies.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provide and plausible temporal association, the causality between BNT162B2 and events cannot be completely excluded.
Breakthrough case admission after 3 vaccines #1 Moderna 2/17/21 Lot # 015M20A #2 Moderna 3/17/21 Lot# 002B21A #3 Moderna 11/5/21 Lot# 033F21A
Vaccine administered to R/thigh on 11/4/99. Returned to office 11/6/99, fussy,temp 99.2, decreased appetite w/redness, swelling and warm area at site of injection. Dx: Abcess; Rx: Keflex 62.5 mg po x 5 days.
"Pfizer-Bio-Tech COVID-19 Vaccine EUA" : Individual received the Pfizer Covid-19 vaccine. She began to feel dizzy and flushed at 1:00 pm. Her vitals were 82/46, 22, 68, 98% RA at1:00 pm. We applied ice to back of neck. B/P 72/42,20, 76 P, 98 % RA. 1:20 pm. Individual report that he had not drink any fluids and only had a few bites to eat. Patient swallowing intact. She was given bottle of water. 1:46 pm vitals were 82/54, 100% SATS, 81, 14. Individual stated she felt better and was not longer dizzy. 1:55 pm vitals 79/54. 14, 78, 98% RA. Individual went home with family with no noted distress.
Dull headache, photosensitivity, brain fog and ringing in the ears.  All symptoms have improved except the ringing in the ears and brain fog in the morning.
Approximately 7-8 days, post vax, child developed a bleb-like rash which worsened for 1-2 days, then began to fade, and was gone in a matter of 3-4 days. Child also ran a low-grade (less than 101F) fever and developed diarrhea for which she saw a physician and was treated with Pedialyte.
Red hot swollen itchy rash at on both legs.  Right leg worse than left. Got worse on Wednesday then on Thursday  right leg was better but the left leg got worse.  Afebrile.  Patient is doing a little bit better today, Mom applied cold compress and gave Benadryl.
Patient stated that she had a sore arm & difficulty moving the arm, restlessness, chills, sore joints starting the evening she received the vaccine.  The next day she said she felt very tired and slept for about 6 hours during the day.   When she called here, about 24 hours after the vaccine was administered, she stated that she was feeling mostly better.
Fever of over 102.3 for more that 24 hours Chills, body aches, pain, body swelling, injection site swelling (still over 48 hrs later), sweats. Very ill. On 3/31/2021 still have fever of 99.3
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 75-year-old male patient received BNT162b2 (BNT162B2), on 12Jan2021 as dose 1, single (Lot number: EL3246), on 02Feb2021 as dose 2, single (Lot number: EL9263), on 13Oct2021 as dose 3 (booster), single (Lot number: FF2589) and on 06Apr2022 as dose 4 (booster), single (Lot number: FJ4991) at the age of 75 years for covid-19 immunisation. The patient's relevant medical history included: "A-Fib A symptomatic" (ongoing), notes: A-Fib A symptomatic; "pacemaker" (ongoing), notes: pacemaker, Continuing: true. Concomitant medication(s) included: XARELTO, stop date: Jun2022; WELLBUTRIN, stop date: Jun2022; TAMSULOSIN, stop date: Jun2022; EPLERENONE, stop date: Jun2022. The following information was reported: VACCINATION FAILURE (medically significant) with onset 27Jun2022, outcome "unknown", COVID-19 (medically significant) with onset 27Jun2022, outcome "not recovered" and all described as "COVID 19 Treatment". The event "covid 19 treatment" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Jun2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Course: Tested Positive for Covid 19 on 27Jun2022 after 4 Doses of the Pfizer Covid 19 Vaccine. He had the Pfizer Series of shots including the Second Booster, later clarified as the Pfizer Covid 19 Vaccines. 2 to 3 days ago he must have been in contact with someone with Covid and he tested himself and he had the Covid virus in his nostrils, so he went to his doctor, and they looked at him and prescribed him Paxlovid, the 2-pill version. He noticed it made him very very sleepy, he was just sleeping away the day. He also reported it was almost giving him a bit of a brain fog, he doesn't know how to describe it, but other than that he feels okay. He just wants to lay down and sleep and when he gets up, he was in a brain fog. He could think and he knows where he was, but he doesn't feel right. Caller asking, was that something he should expect and when he was finished with the medication, should it resolve. On Monday, he had a lot of body aches when he woke up so Monday afternoon, he took a Covid test, and it was positive. He made an appointment on Tuesday to see his doctor. He had to stop a few medications before taking the Pfizer antiviral, so he started the medication on Wednesday morning. He stopped taking these medications because of the Antiviral Paxlovid.
Approx 8 hours post innoculation, I had chills, fever and body aches. Conditions subsided after taking Tylenol.  However, I did have to take Tylenol 16 hours later as conditions returned.    By 24 hours, I was better.
pt had a tonic clonic sz which lasted 1hr 15min & treated w/meds;pt also had a temp of 104 prior to transport;sz started 4AM 1 day p/vax;
Information has been received from a registered nurse concerning a male patient who's child was vaccinated with a dose of varicella virus vaccine live on 4/28/04. The RN reported that on 5/4/04, the patient developed chicken pox. Unspecified medical attention was sought. The RN noted that the patient and his child had not had a follow up titer. At the time of this report, the outcome was unknown. Additional information has been requested.
Pt received Janssen vaccine on 03/11/2021. Pt presented to the ED with complaints of HTN and generalized weakness. Pt was found to be COVID positive.
A report has been received from a Health Professional concerning an 8 year old, subject of unknown gender, who had been receiving nasal FLUMIST Quadrivalent. FLUMIST Quadrivalent started on 29-OCT-2014. Patient received FLUMIST Quadrivalent on 29-OCT-2014 ad later tested positive for Flu A which started on 17-NOV-2014. The outcome of the event of patient received FLUMIST Quadrivalent and later tested positive for Flu A was unknown. The report was considered to be non-serious.
L THIGH REDNESS, SLIGHT SWELLING, AND  ITCHING declined to go to ED
redness on injection site; swelling on injection site; pain at injection site; feels hot again after 6 days; This case was reported by a consumer via interactive digital media and described the occurrence of injection site erythema in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31st August 2020, the patient received Shingrix. In September 2020, less than a week after receiving Shingrix, the patient experienced injection site warmth. On an unknown date, the patient experienced injection site erythema, injection site swelling and injection site pain. In September 2020, the outcome of the injection site pain was recovered/resolved. On an unknown date, the outcome of the injection site erythema, injection site swelling and injection site warmth were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site swelling, injection site pain and injection site warmth to be related to Shingrix.  Additional details were provided as follows: The patient had reported the events for himself/herself. The age at vaccination was not reported. The age group was not reported but was captured as an adult as per vaccine indication.  The patient received vaccine 7 days ago from the reporting date and experienced redness, swelling and pain on injection site, which was wane away on the 4th day, but it was red, swollen and felt hot again after 6 days.  The reporter asked what should he/she do. The follow-up was not required.
nausea; soreness in her arm after receiving the 1st dose of the vaccine for 4 days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (soreness in her arm after receiving the 1st dose of the vaccine for 4 days) and NAUSEA (nausea) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included DENOSUMAB (PROLIA) for an unknown indication.   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In February 2021, the patient experienced PAIN IN EXTREMITY (soreness in her arm after receiving the 1st dose of the vaccine for 4 days). In March 2021, the patient experienced NAUSEA (nausea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. In February 2021, PAIN IN EXTREMITY (soreness in her arm after receiving the 1st dose of the vaccine for 4 days) had resolved. At the time of the report, NAUSEA (nausea) had not resolved.
Intense nerve pain in entire arm where shot was administered.  Peripheral neuropathy.  Nerve pain and local swelling  in wrist observed.  I had trouble opening and closing hand/fingers.  Iced area.  Pain lasted through the next 12-18 hours.  Symptoms less next day.  These symptoms were not in the advised side effects, but found evidence of others who experienced peripheral neuropathy in online blogs of patients who took Shingrix.
Information was received on 22-FEB-2019 from a lawyer regarding a case in litigation regarding a male patient, history not provided. The patient was prescribed ZOSTAVAX by a healthcare provider for the long term prevention of shingles and zoster related conditions. In 2015, at age 69, the patient was administered ZOSTAVAX by a pharmacist at a pharmacy. On an unspecified date, the patient was treated by a physician for the following injuries resulting from ZOSTAVAX: shingles.  Outcome was not provided. Additional information has been requested.
This spontaneous report as received from a physician via a company representative refers to a patient of unknown age and gender.      The patient's medical history or concomitant medications were not reported. On an unknown date in 2013 (reported as 4 years ago), the patient was vaccinated with a dose of ZOSTAVAX, subcutaneously (dose and lot number not reported). On an unknown date, the patient developed chickenpox. The outcome of of the event was unknown.       The relationship between vaccination with ZOSTAVAX and the event was not provided. Additional information is not expected as the reporter did not wish to be contacted.
SLEEVE SURGERY; HIP PAIN; LEG PAIN THAT TRAVELS FROM  KNEE TO THIGH TO HIP; This spontaneous report received from a patient concerned a 55 year old female. The patient's height, and weight were not reported. The patient's past medical history included: open heart surgery, and concurrent conditions included: baker cyst, and hypertrophic cardiomyopathy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: 25-MAY-2021) dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination. Concomitant medications included duloxetine hydrochloride.  On 04-APR-2021, the patient experienced leg pain that travels from knee to thigh to hip. On MAY-2021, the patient experienced hip pain. On an unspecified date, the patient experienced sleeve surgery. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from leg pain that travels from knee to thigh to hip, and hip pain, and the outcome of sleeve surgery was not reported. This report was non-serious.
Presented w/ complaints of worsening SOB; tested positive for COVID-19  in the ER; chest x-ray showed pneumonia.   Placed on broad-spectrum IV antibiotics along with steroids and symptomatic treatment.  Patient's symptoms improved but required higher than baseline home oxygen off 5 L to maintain adequate oxygen saturations.   Patient and his sons decided to proceed to pursue hospice care at home.  Pt dc'd home with hospice.
About 10 hours after vaccine, chills & nausea started. As the night progressed and into the next day symptoms appeared in the following order :  -soreness at vaccination site on arm -nausea -chills -headache -fever -sore throat & acid reflux  -congestion -extreme fatigue
12 YO MALE BECAME LIMP AND FAINTED AFTER VACCINE. PER MOM PATIENT HAS NOT HAD BREAKFAST OR LUNCH, NO SEIZURE ACTIVITY REPORTED. 12 YO W VASOVAGAL SYNCOPE. PT OBSERVED FOR 20 MINS, ER WARNINGS GIVEN.
I did not experience any of the typical side effects. However, I went into labor, three weeks early, exactly twelve hours after receiving the vaccine. This was my first child.
Arm is itchy, itchy, itchy.   Red, scaly patch about two inches.   No pain or discomfort
About 14 hours after my 2nd dose I experienced headache, fever, chills, body aches for about 12 hours; What is concerning is that my Vsafe app asked if I received the 2nd dose and then never checked back for side effects.  This is when most people are experiencing side effects and the monitoring parameters that are set forth by the CDC are failing
This case was reported by a nurse via sales rep and described the occurrence of pain in a patient who received BEXSERO. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, unknown after receiving BEXSERO, the patient experienced pain. On an unknown date, the outcome of the pain was unknown. It was unknown if the reporter considered the pain to be related to BEXSERO. Additional details were reported as follows: The age at vaccination was not reported. This case might have been reported by the sales representative previously however, no duplicate case was found. This case was linked to case US2017GSK135090, reported by the same reporter.
First dose / 03Jul2020 / has not received a 2nd dose yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 3rd July 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of vaccination the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consented to follow up.
Chills, fever, dizziness last 4 days. Called pt back 3/25/14 and again 4/19/14.
Headache Narrative: I have a sore throat with headache late yesterday I felt with no energy and extremely tired. I have been taking Tylenol extra strength.
Dizziness, CoughWheeze, NauseaVomiting, HYPERtension, generalized itching, absent of rash or generalization monitored in emergency department, discharged without concern
Fever started 10/11/09 rash - on trunk, neck, itches.
Cliet received the 1st dose Pfizer COVID vaccine (lot# FF8841) in the L  deltoid at 0943. At approximately 0948 the client reported toEMT that she was feeling dizzy.  EMT notified  Lead RN.  RN transferred the client to a zero gravity chair and offered the client water. Client denied SOB, numbness, tingling, headache, and nausea. Client was A&O x4, warm and pink to touch, and no diaphoresis or respiratory distress was observed. At 1000  EMT took client vitals with HR 104, O2 saturation 96, RR 14, and BP unavailable due to BP cuff broken. , RN advised the client to remain in observation for 30 minutes.  RN notified Vaccine Operations Lead that the adult BP cuff was broken and requested a new one to be delivered to the mobile site. Client reported that she ate an egg muffin at 0810 for breakfast. Client reported that she has hx of diabetes, hypertenstion, and high cholesterol. Client reported that she did not take insulin this morning. No juice was available on-site to offer to client, RN notified Vaccine Operations Lead RN and requested juice for the site. Client reported taking medications Metformin, Glipizide, Lasix, and Lipitor. At 1006 client reported to  RN that her "light headedness went away". Client drank water and remained in observation with her friend. Client reported to RN that her "light headedness went away". Client drank water and remained in observation with her friend. Client reported to RN that her friend will be driving her home. At 1025, RN assisted client to standing and client denied dizziness. At 1025 client left the site with her friend and RN observed a balanced, even and symmetrical gait.
Severe headache, body aches, fever of 102.6, sore throat,  nausea, discomfort in chest-center right.
Post vax, pt developed redness, swelling and tenderness at injection site. Seen in ER at 15:14 and received Benadryl and Solu-Medrol IV. Was told to take Benadryl 25-50 mg every 4-6 hours at home. On 12/21/00, seen by MD and face was flushed. Rx given for prednisone.
Client reports that the early morning following the vaccine she found herself on the floor - fell out of bed and does not know what precipitated the fall.  She thinks that she black out.  She reports feeling like she has been in the clouds for since her vaccine and is finally thinking more clearly.
Minor swelling, redness, and pain on left upper arm reported. On 9/23/05, 8:30 AM, DTaP administered on 9/21/05; site left deltoid, IM. Parents reported no fever after immunization on 9/21/05. Under the care of a doctor. Given a course of Prelone and Keflex per doctors orders.
Puked on the afternoon of Sunday May 28th with no fever or other signs of distress. He ate 'brat diet' foods (banana, bread, rice puffs, apple sauce) that night without any vomiting or discomfort. Patient first presented with a high fever (>103 degrees) and a refusal to walk or bear weight on his legs at home on the morning of May 29th. Took patient to primary care pediatrician for initial sick visit in the morning on Monday May 29th. After dosing him with acetaminophen and ibuprofen during the day and checking back in with the doctor, his continued high fever and refusal to walk prompted the primary care pediatrician to recommend Emergency Room visit. At the hospital, patient had blood work done to check white blood cell count, and other lab markers as well as a blood culture to test for infections, and an x-ray of his right side, and had urine extracted via catheter for cultures. During this time he appeared to respond more painfully to touch/manipulation of the right leg below the hip. All tests came back inconclusive, and attending ER doctor consulted with orthopedic doctors hospital, who thought he may be presenting with septic joint due to fever and how he was holding his leg while at rest. We transfered to hospital where the orthopedic doctor attempted a hip aspiration, but was unable to withdraw any fluid from the joint to perform an analysis on. Patient was admitted for observation Tuesday May 30th. While at Hospital he continued to have both a fever and pain in his lower appendages; it was still not entirely clear where exactly his pain was located and he still refused to walk or bear weight until about Thursday, June 1st, when he started to show signs of improving. May 31st the attending orthopedic doctor recommended an MRI of his foot to determine if patient had a bone infection or soft tissue inflamation; the MRI showed that it was soft tissue inflamation in his right foot (pain had moved from hip/knee area to foot, and also presented on left side, although less intensely than right). After the MRI, he was officially diagnosed with myositis from an unknown vector. Hospital discharged us on May 30th as patient's fever and overall pain seemed to be improving; he was willing to put pressure on his legs to stand with assistance, and roll around with assistance; neither of which he did prior in his hospitalization. Sometime in the weekend/week of June 3rd he recovered enough to walk, although it took him many days if not a week or more to walk without a 'drunken' stumble or hesitation/delay in getting up off the floor.
1st 03-03-2021, 2nd 03-26-2021  BOOSER 10-11-2021 After the booster shot, days later I ended up in the ER with chest pains, rapid heart rate irregular heart beat, super elevated High Blood Pressure, felt like I was having a heart attack, I thought I was going to die!. This was the first of 4 ER visits. Ended up on the 4th ER visit they found a blood clot in my right lower lung, PE. I'm have now been on blood thinners since November 4, 2021 and to continue for 6 months. I've suffered an injection injury and this has altered my life for the last months. I ended up in the ER 5 times during the worst part of this and a 1 night stay for observations.
Sharp pain at and surrounding the injection site began within hours of receiving the vaccine.    12 hours after receiving injection:  sharp, stabbing, searing pain along all the nerves that radiate from L4, L5, through both hips, down and around both legs.  Sharp, stabbing, searing pain in the upper back.   Intense knee pain - unable to  walk.  Temperature of 100.2 degrees.  Headache.  Brain Fog.  Nausea.  Extreme fatigue.  Loss of balance.  Loss of appetite.  These symptoms lasted about 36 hours.  After 36 hours muscle pain all over and fatigue.   At the injection site on my left arm, the pain gradually subsided and eased over a period of 96 hours.
I started having runny nose, fatigue, body aches, post nasal drip with no fever on 4-25-2022. I took a home Covid test on 4-27-2022 and it was positive. I called my PCP on 4-27 and they told me to wait until quarantine is up. I was not prescribed any medications. I went in to the doctors office on approx. 5-2-2022. They still did not order/prescribed anything and just suggested antihistamine but I did not take any. I am feeling better now, symptoms are resolved. I am reporting my breakthrough case of Covid.
Minor received third dose of Pfizer vaccine on 8/29/2022. Then received a fourth dose of Pfizer vaccine on 9/2/2022.
according to pt's mom pt devel maculopapular rash on face about 1/2 hrs p/vax; c/o itchiness;