chrisvoncsefalvay/vaers-outcomes huggingface dataset:
bad flu symptoms; felt light headed; had pain in her upper back; Nausea; severe headache; fever of 102.5; ached all over; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the parent.  A 11-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Jan2022 08:45 (Lot number: FK5618) at the age of 11 years as dose 1 (tris), single for covid-19 immunization. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious) with onset 29Jan2022 17:00, outcome "not recovered", described as "felt light headed"; BACK PAIN (non-serious) with onset 29Jan2022 17:00, outcome "not recovered", described as "had pain in her upper back"; NAUSEA (non-serious) with onset 29Jan2022 17:00, outcome "not recovered", described as "Nausea"; HEADACHE (non-serious) with onset 29Jan2022 17:00, outcome "not recovered", described as "severe headache"; PYREXIA (non-serious) with onset 29Jan2022 17:00, outcome "not recovered", described as "fever of 102.5"; PAIN (non-serious) with onset 29Jan2022 17:00, outcome "not recovered", described as "ached all over"; INFLUENZA (non-serious) with onset 30Jan2022, outcome "not recovered", described as "bad flu symptoms". The events "felt lightheaded", "had pain in her upper back", "nausea", "severe headache", "fever of 102.5", "ached all over" and "bad flu symptoms" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dizziness, back pain, nausea, headache, pyrexia, pain.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. The patient was not diagnosed with covid prior vaccination and not been tested post vaccination. The patient had no known allergies.  No follow-up attempts are possible. No further information is expected.
No prior side effects with three prior shots and boosters.  Within 90 minutes of the 4 injection, Patient had a sudden explosion of Tinnitus in his left ear only.  The tinnitus is severe and constant and made sleeping almost impossible.  He was able to sleep on his right side, but when he slept on the left side, the sound was unbearable.  Patient has continued to experience extremely loud and constant ringing for the past 24 hours.
pt had lymph node swelling in armpit upper breast 12 hours post vaccine, rash development 24hrs post in same location of lymp node swelling and under arm
Rapid heart rate, face drooping (Bell?s palsy).  Given MRI, stroke test, and monitored form5 hours.  Prescribed steroids for Bell?s palsy.  Referred to cardiologist for tachycardia.
Turned into MRSA infection; Severe allergic reaction; Little bit of a rash that started going all over body; This is a spontaneous report from a contactable consumer reporting for herself. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot# and expiration date were not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that, on unknown date, she had a severe allergic reaction to the vaccine. She has been out of work. It has been a 2-month struggle. Also stated that, it started out like a little bit of a rash that started going all over her body. From that point, it turned into Methicillin-resistant Staphylococcus aureus (MRSA) infection. She has needed so many medications. Her pharmacist let her know that she can get reimbursement for medical bills and lost wages, she wanted to know how to go about getting it. Caller stated there was a study that she was connected to now regarding how the vaccine affecting some people's skin. The outcome of the events was unknown.  Information on Lot/Batch number has been requested.
Pt returned to clinic on 9/26/21 for second dose of Pfizer COVID 19 vaccine and handed NP a vaccine card with a Janssen COVID vaccine admin on it. When questioned, pt states "I am going to be honest with you. I received a dose of Jannsen COVID 19 vaccine on 3/14/21, and a doctor told me that it was not keeping people from being intubated and to get the Pfizer also, so I signed up to received the Pfizer vaccine." informed patient that she could not received the second dose of Pfizer today and that it is not recommended to mix the vaccines or receive more than 1 vaccine series/ additional doses after being vaccinated with Janssen.
An expired Kinrix vaccine dose was recieved on february 4th 2021/expired on 2nd February 2021; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received DTPa-IPV (Kinrix) (batch number unknown, expiry date 2nd February 2021) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 4th February 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The patient had received Kinrix vaccine dose on 4th February 2021 which had already expired on 2nd February 2021. The reporter did not have information about the patient. The reporter consented to follow-up. This case has been linked to US2021094184, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021094184:Same reporter.
Information has been received from a health professional concerning a 4-year-old white female with no pre-existing allergies, birth defects, or medical conditions who on 14-MAR-2007 at 1:43PM was vaccinated in the left thigh with a second dose of MMR (Lot # 654896/1180F). There was no illness at the time of vaccination. Concomitant therapy that day at 1:43PM included a dose of HAVRIX (Lot # 636320/1281F) administered in the right thigh, TRIPEDIA (Lot # C2570BA) administered in the left thigh, and a fourth dose of IPOL (Lot # Z0324) administered in the left thigh. On 16-MAR-2007 the patient's immunization site was red, swollen, and warm to the touch. No tenderness was present. At the time of the report, the site was 4 inches width by 3 and 1/2 inches in length. The patient was given OMNICEF (250/5) tsp PO qd and 10 days. There were no relevant diagnostic tests or laboratory date. There were no adverse events following prior vaccinations. Additional information has been requested.
DIZZINESS (WHEN WALKING); FEVER; SORE ARM; SEVERE HEADACHES; This spontaneous report received from a parent concerned an 18 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, and batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 07-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-JUN-2021, the subject experienced sore arm. On 07-JUN-2021, the subject experienced severe headaches. On 08-JUN-2021, the subject experienced dizziness (when walking). On 08-JUN-2021, the subject experienced fever. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine was not applicable. The patient was recovering from sore arm, and had not recovered from severe headaches, dizziness (when walking), and fever. This report was non-serious.
My right shoulder had intense deep muscle and surface soreness around the injection site  that kept me awake the first night of receiving the first vaccination.  The site was slightly swollen and warm to the touch with a few red dots that did not itch.   I did use 500mg of Tylonal to help alleviate the pain.  Within 35 hours of the first injection, my arm was not as tender or sore to the touch and did not keep me awake at night.  Although still sore, 48 hours later, there is no more swelling and the redness and red spots are gone.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old male patient received BNT162b2 (BNT162B2), in Apr2022 as dose 4 (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) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "bronchial pneumonia in past" (unspecified if ongoing), notes: other medical history: bronchial pneumonia in past. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2022, outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: First round of Paxlovid was great. symptoms diminished by day 2, felt good for several days. But symptoms returned by @ day 9 or 10, positive test returned by day 12, symptoms continued and evolved (throat, nose, head, chest); (11Jul2022) Positive, notes: First round of Paxlovid was great. symptoms diminished by day 2, felt good for several days. But symptoms returned by @ day 9 or 10, positive test returned by day 12, symptoms continued and evolved (throat, nose, head, chest). Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional Information: Patient received Anti-viral treatment for COVID 19 and product brand was Paxlovid. The treatment start date was 25Jun2022 and stop date was 30Jun2022. Treatment given for COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
fever 102 - 103, chills, muscle & joint pain approx 6 hrs.  Fatigue next 48 hrs with body aches'
SORE ARM AT THE SITE OF INJECTION; VERY EXHAUSTED; ARM STIFFNESS; UNCOMFORTABLE; This spontaneous report received from a patient concerned a 72 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy, and food allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018, and expiry: 25/MAY/2021) dose was not reported, administered on 20-MAR-2021 for prophylactic vaccination on left arm. No concomitant medications were reported. On MAR-2021, the subject experienced arm stiffness. On MAR-2021, the subject experienced uncomfortable. On 20-MAR-2021, the subject experienced sore arm at the site of injection. On 20-MAR-2021, the subject experienced very exhausted. Laboratory data (dates unspecified) included: ELISA (NR: not provided) Negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from very exhausted on 27-MAR-2021, was recovering from sore arm at the site of injection, and the outcome of arm stiffness and uncomfortable was not reported. This report was non-serious.
On 07/20/06 the pt arrived in our office with quadriceps, muscle bruise, atrophy medially, reflexes normal, strength normal, tone normal. Per dad it has been there for a few months, he thinks it happened after her last set of immunizations. Referring pt to an ortho for evaluation.
From telephone contact received on 7/12/02, it was reported that a 27 year old female received dose of TD ADS in the left deltoid on 6/27/02. Patient's arm was sore for the next day. Patient reported that when she woke up on 6/29, she got up and went out for a walk and while walking she lost her balance. Patient experienced visual disturbances, hot flashes through her whole body (warm sensation). Her head felt like little needles were sticking her in her head, was also nauseated. Patient was seen by the doctor on 6/29/02 who said it was an allergic reaction to the TD. Tylenol #3 prescribed for pain in her arm. On 7/4/02, she had another episode where she almost fainted during the day. She was seen by the doctor on 7/5/02 and prescribed with hydrocodone. Soreness in the patient's arm continued for several weeks and is still slightly sore. Prednisone prescribed on 7/11/02 for pain and inflammation in arm. Patient stated she is starting to do better as time passes but then has periods of exacerbation with regard to pain in her arm, unable to move it without the assistance of her other hand. Patient isn't sure if this was reported or not. From additional information received on 11/4/02, the reporting physician provided the patient's birth date. The patient had an MRI of the left shoulder on 8/6/02, which was consisted with bursitis. Per the physician, the patient has had no follow up since this, so assumption is symptoms have resolved (she has been in twice since, for unrelated problems). The adverse event coding was updated (deleted injection site reaction and added codes for ataxia, bursitis and hypokinesia. This case is closed.
After 2-3 weeks in the morning around 8:00AM my left my arm was hurting, it was getting worse day by day. I tried all the things I could think of at home; I even took Tylenol, Aspirin and Aleve. My doctor said I was taking too much so I had to stop it. It was causing me more problems in my body. My doctor sent me to do physical therapy. She also gave me this medication to take 2 twice a day: Celecoxib.
This spontaneous report as received from an office manager refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 03-JAN-2018, the patient was vaccinated with improperly stored VARIVAX (lot # M034586; expiry date: 27-JUL-2018), which was reconstituted with properly stored sterile diluent (lot #N021583, expiry date: 08-NOV-2019). The vaccine was stored at a temperature of 15ºF to 46ºF for 132 Days. There was no previous temperature excursion. Digital data logger was involved. No adverse effects reported. This is one of the several reports received from the same reporter. Sender's Comments: US-009507513-1802USA012317: US-009507513-1802USA012320: US-009507513-1802USA012326.
Patient received Moderna COVID vaccine #2 dose at 21 days, not at 28 days.
Patient came to the pharmacy wanting to get the Pfizer COVID vaccine on 8/12/21 at 1:20pm. Patient had made an appointment with another location, but appeared at this location. We told the patient it was no problem, we could administer the vaccine at our location. FT Pharmacy Techinican confirmed with patient this was their FIRST dose (as written on vaccine consent form). Patient said "Yes." Technician asked patient if they had insurance. Patient responded "No." Technician proceeded to ask if left arm was okay, processed the vaccine, and made a vaccine record card. Pharmacist reviewed consent form prior to administering vaccine. Patient had selected "Pfizer Dose 1" and answered "No" to Question 14 ("Have you had the vaccine(s) you are receiving today before?") Following vaccine administration, Pharmacy Intern went to enter vaccine into the management system and discovered patient had already received 2 doses at a Health Center. No adverse events were reported by patient, but pharmacy wanted to report the error.
2/10  Got shot at 3:30 in left arm, arm was a little sore before bed 2/11  Very sore and achy arm 2/12  Very sore and achy arm, felt nauseous on my way home from work, started running a fever which got up to 101.6 in the evening 2/13  Fever gone, felt normal, arm no longer ached 2/14  Felt normal 2/15  Left armpit started to ache in the afternoon 2/16  Left armpit ached all day, especially when lifting my arm 2/17  Left armpit felt the same as yesterday 2/18  Left armpit felt the same as yesterday, noticed a couple red bumps on my right forearm near wrist (itched a little) 2/19  Armpit pain is improving greatly, but still noticeable, woke up to a rash of red bumps on both arms (8 spots on left forearm area, 16 spots on right forearm area)
Stomach cramps and vomiting.  Sudden onset and then fine the rest of the day.  He was able to eat later.  The next morning of the 8th, the same thing feeling fine when he first woke, then shortly after breakfast, nausea, stomach cramps and light vomiting.
Headache Sore arm Sore armpit Chills Body aches Nausea Vomiting  Duration 5 hours.  Zofran and Advil/tylenol were taken.
Patient states within 30 minutes her cheek felt weird.  Then since then off and on, states cheek goes numb, and top of her head gets tingly and feels like wearing a hat and tinnitus.
5 hours after injection of PREVNAR it started with pain and then pt could not raise her arm and her arm was very painful. The next morning pt had body aches, no appetite and felt like she had the flu. Pt felt fine by the end of the 2nd day.
Running 100 degree fever, slow (foggy brain), very tired, coughing, and slight headache.
Pt received his first dose of the Moderna Covid-19 vaccine. Immediately following the injection the pt began convulsing. Convulsions lasted for less than 30 seconds. Upon completion of convulsions pt  was awake and alert. He stated he was thirsty. Before we could provide water to pt, the pt began vomiting. Pt was placed on his side and paramedics were called. Pt remained in a laying position until emt's arrived. Pt was examined and released. Pt was encouraged to follow up with his pcp.
Severe pain in shoulder area with difficulty to move and very stiff upon trying to move. Still present on 09/21/2015 at 10:00 AM and no treatment performed.
can still get shingles if you got the shot/Suspected Vaccination Failure; get shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in an unspecified number of patients who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: can still get shingles if you got the shot/Suspected Vaccination Failure) (serious criteria GSK medically significant) and shingles (Verbatim: get shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.   It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 25-MAR-2023 This case was reported by a consumer via interactive digital media. The reporter stated that you could still get shingles if you got the shingle shot and he/she knew people who had. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Redness left upper arm and around;Around arm 2 hour shots DTaP, IPV
pt exp h/a day of vax cont next day w/photophobia;inc pain on Sunday, w/leg becoming numb, was confused;Tuesday arm numb, back hurt;went to ER:Thursday confusion inc & vomiting, was dizzy, speech was garbled & passed out;dx meningitis;
got shingles after.having two shingles vacc./suspected vaccination failure; shingles/got shingles after having two shingles vacc.; Pain and pain; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date: 1-Mar-2023 Reporter's comment: The case was received from the patient via interactive digital media. The patient had pain and pain and got shingles after having two shingles vaccination. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
We were conducting a clinic for second shots. Patient and her husband came in and sat down and filled out their info. We added the lot to their card and did not notice the date of the first shot. They had their 1st shot on 04/02/2021 . Patient's husband said he heard to come back next week but was told 4 weeks and given the appointment card that he verified when called said 04/29/2021. I contacted Moderna and they said to not give another shot later and monitor. Patient's husband was doing fine when I called and I will check in daily on them.  I also contacted their physician and made them aware of the issue.
"After 12 month visit (10/13/08) the next morning and for about 6 weeks, we did not have our baby". Flat affect did not want anything to do with us. Was almost walking , went back to crawling again. Will not let self feed. Will not chew. Will not pick up food to mouth, still sucks food off spoon. Will walk around coffee table now, around and around forever.
pt exp pain during vax & approx 5hr post vax pain radiated to shoulder & neck & had limited ROM of shoulder & wrist;pain @ inj site then radiated down arm;pt exp some relief p/taking Ibuprofen;
This is a spontaneous report from a contactable nurse calling from physician's office who reported similar events for 15 patients. This is the 9th of 15 reports. A patient of an unspecified age, gender and race/ethnicity received PREVNAR 13 (lot number N4385, expiry date 31Oct2017) via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient received the vaccine after temperature excursion and experienced severe reaction on arm on an unspecified date, with unknown outcome.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017060849 Same reporter/drug/AE, different patient.
Severe headache, strong heart palpatations, racing heart, chest tightness, change in affect of personality.