chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a nurse concerning a 68 year old patient of unknown gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On 22-FEB-2019, the patient was vaccinated with an expired dose of ZOSTAVAX lot # N032103 with expiration date of 11-FEB-2019 for prophylaxis (dose, route of administration and anatomical location were not reported). No  adverse effects were reported.
Severe Urticaria all over significant portions of patient's body. Severe itching associated with it.
Swelling and bruising in a semi-circle 3 inches in diameter.  Pt claims there is a little warmth from the site but no pain or discomfort.
shortly p/vax baby started screaming;would not stop inconsolable crying for 3hr;
Arm was sore from vaccine; This is a spontaneous report from a contactable consumer or other non hcp. A 76-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 04Feb2021 as single dose for COVID-19 immunization. Patient was 76 years old at the time of vaccination. Patient medical his-tory and concomitant medications were not reported. On 05Feb2021 the patient experienced arm was sore from vaccine. Outcome of the event was unknown.
Vasovagal, Dizzying, Nauseas, Vomit, Stiff body
Information has been received from a consumer concerning her neighbor's son who on an unspecified date was vaccinated with a dose of MMR II (Enders-Edmonston, Jeryl Lynn, Wistar RA 27/3).  On an unspecified date, post vaccination, the patient developed autism and eventually jumped in a lake and died.  A product quality complaint was not involved.  The adverse event autism was considered an Other Medically Important Event (OME).  Additional information has been requested.  4/4/08 Received via email from FDA & manufacturer: The reporter is a consumer who reported on a neighbor's child.  The reporter refused to provide information beyond what was on the VAERS form .  The reporter refused to provide the name and telephone number of the actual parents of the child.  This is unevaluable.
Both doses 2 years ago, developed shingles last month/Suspected vaccination failure; Developed shingles last month; 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 (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. In May 2022, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     Additional Information: GSK receipt date: 16-June-2022 Reporter's comment: This case was reported by a consumer via interactive digital media. The patient received the Shingrix vaccine (both doses) about 2 years ago and developed shingles last month. The patient asked if she/he need to repeat the vaccine series? Additional Supportive Information: This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles not provided.
Unable to speak with case due to hospitalization. Case was admitted to Hospital, on 03/15/2023, tested positive for COVID 19 on 03/28/2023. On 03/30/2023 was discharged from Hospital and admitted to Hospital, where case is currently.
R ARM PAIN WITH LOCAL SWELLING IN ABSENCE OF INFECTION  POSITIVE INDURATION
Vaccinated with 2nd dose on 4/13/2021. Pt admitted to the hospital on 6/2/2021 for non-COVID related issues. Pt tested positive by PCR on 6/3/2021.
Reported itchy tongue & scratchy throat, went to ER. Diagnosed with allergic response, given IV BENADRYL. Two days later admitted to hospital, inflamed pancreas and fluid around heart.
headache, sore throat, cough, dyspnea, body aches and nausea
Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date in 2015, the patient was vaccinated with a dose of ZOSTAVAX (exact dose, route of administration, anatomical localization, lot # and expiration date were not reported) for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On an unknown date in 2016, the patient was treated for a vesicular outbreak, which was diagnosed as herpes zoster or shingles (onset date unspecified). As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient had suffered significant medical expenses, and pain and suffering, and other damages. The outcome of vaccination failure and herpes zoster was unknown. The reporter considered vaccination failure and herpes zoster to be related to ZOSTAVAX.
I had a really severe sore throat and a lot of sinus pressure. I had a super low fever for only a day or two. I lost my sense of smell. I had really, really bad back pain. A little bit nauseous, cough and some shortness of breath. I had a lot of fatigue and still feel really fatigued. I initially tested negative for COVID - I had gotten an antibiotic thinking a strep throat and a sinus infection. But I wasn't getting better, so 3 or 4 days after that, I went to doctor my PCP - because of my cough - I couldn't sleep at night because of it. He retested me for COVID and I tested positive for COVID. He gave me a cough syrup to address the cough. He said I wasn't eligible for the infusion. I still have some symptoms but I'm definitely better. I still have a cough and shortness of breath. I am just starting to get sense of smell back and I feel very fatigued still.
Patient was given a vaccine that expired on 11/21/2022 on 11/22/2022 due to a vial being presumed non-expired. Error was spotted post-administration. Patient did not report any adverse reactions before leaving the clinic.
The morning after getting the Moderna booster at 3:10 pm, I began to get very dizzy and somewhat nauseous though I never vomited.  The next thing I knew, I was on the floor and my husband was calling my name.  I don?t remember falling.  It took 10 minutes to feel steady enough to get up.  Was somewhat weak the rest of the day and sore from from the fall.
Pt states she broke out in hives and her throat felt scratchy. Pt states went to hospital and given steroids, epinephrine, and Benadryl.
Patient developed an itchy rash on her arms and stomach the day after receiving this vaccine. She took Benadryl for two days, and it was gone. She had no other symptoms.
Localized erythemic patch approximately 10 x 12 cm with well defined borders. Tender to palpation at left upper extremity mid-bicep. Site is also hot to the touch.  Tx: Keflex #40 Sig: Take 1Tab PO QID x 10 days. Finish all medication
05/13/2022 I had my vaccination. 05/20/2022 I went to see the dermatologist. I believe I had the rash beforehand but I cannot remember the dates. The rash seemed a weak area on my cheek. When it flares up, it is also on the back of my neck and head. I thought it was because I was trying to sleep on my back. The rash, I got little bumps. It spread to the rest of my head and eyelids. My right eye is still swollen. The dermatologist they were not sure what to recommend. They told me to try Acyclovir for 7 days and apply twice a day. Then they also gave me a Cortisone prescription. That seemed to improve the symptoms. I now only use when it flares up and it seems to get a little better.
I awoke the next morning after my 2nd dose with the following side effects:  Extremely light headed to the point it was hard for me to walk without feeling like I would pass out, body aches, severe headache, nauseous but never vomited, extremely tired as if I were given a sleep aid, and weak.  I called my primary care physician to see if there was anything I could take to help, they advised me to take Ibuprofen and Tylenol. I started to feel better a few hours after taking Ibuprofen.  The next day I just had a headache and am feeling tired.  I would say the most extreme symptoms lasted about 10 hours and started to slowly feel better after that.
Joint hurt; Nervous system felt as if it was on fire; headache; fever; Body ached all over; This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox. Concurrent medical conditions included lyme disease.   On 20th April 2020 09:30, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In April 2020, 17 hrs after receiving Shingrix and an unknown time after starting Acetaminophen, the patient experienced general body pain. On 21st April 2020, the patient experienced joint pain, burning sensation, headache and fever. The patient was treated with ibuprofen (Ibuprofen Unknown Manufacturer) and paracetamol (Acetaminophen). On an unknown date, the outcome of the general body pain, joint pain, burning sensation, headache and fever were not recovered/not resolved.   The reporter considered the general body pain, headache and fever to be related to Shingrix. It was unknown if the reporter considered the joint pain and burning sensation to be related to Shingrix.  Additional details were provided as follows: The patient stated she had the first dose of Shingrix on left arm on Monday of this week around 9:30am.   The patient woke up at 2:30 on Tuesday morning and her body ached all over.   On 21st April 2020, 1 day after vaccination, the patient's joints started to hurt and her nervous system felt as if it was on fire and the feeling was similar to that when she had chicken pox, also had a headache and fever.   The patient had been alternating ibuprofen and acetaminophen which had resulted in her symptoms improving but they were still present.   The patient only takes the ibuprofen every six hours.   The patient was diagnosed last week with Lyme disease and started on some medication so was unsure if this affected her reaction to the vaccine but her physician who diagnosed the Lyme disease advised her to proceed with the Shingrix vaccination. The reporter consented to follow up.
-BILATERAL PERIORBITAL SWELLING AND ITCHY/ WATERY EYES X 24 HRS -CHEST TIGHTNESS BUT NO RESPIRATORY DIFFICULTY X 2HRS TREATED WITH BENADRYL 25MG X 1  RESOLVED AFTER 24 HRS
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant therapies provided. On 28-DEC-2016, the patient was vaccinated with improperly stored dose of M-M-R II (lot# L049314 with expiration date 03-DEC-2017; site, dose and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccine was exposed to temperature of -14.4 Celsius degrees for 54 minutes before administration to the patient. No previous temperature excursion was reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected, all information has already been obtained.; Sender's Comments: US-009507513-1611USA011831: US-009507513-1611USA004113:
pt recvd vax & 6 wks p/dose 3 exp elevated SGOT & SGPT
Almost 24 hours post vaccine, 103 fever, brought down with medicine but recurrent for over 24 hours.  1.5 days after vaccine, vomiting started.
NO ADVERSE EVENT.  MINOR WAS GIVEN (5-11) FORMULATION INSTEAD OF FORMULATION FOR 12 AND OVER.  GIVEN PROPER DOSAGE FOR ORANGE CAP.  NOTIFIED PARENT OF MED ERROR.  ADVISED NO REPEAT DOSE NECESSARY.  MOTHER STATED UNDERSTANDING.
no adverse event; patient male was supposed to receive 2nd dose of SHINGRIX but was administered VARIVAX vaccine; This spontaneous report was received from a certified medical assistant (CMA) and referred to a 55-year-old male. Information about historical condition and concomitant medication was not reported.  The patient was supposed to receive the second dose of varicella zoster vaccine RGE (CHO) (SHINGRIX) (anatomical location, strength, dose, route, lot number, and expiration date were not reported) for prophylaxis but was administered varicella virus vaccine live (Oka/Merck) (VARIVAX) (dose: 0.5 ml; anatomical location, strength, route, lot number, and expiration date were not reported) for prophylaxis instead on 12-OCT-2022 (Wrong product administered). There was no adverse event.
Fever; KNEES AND JOINT HURT; NOSE WITH STOPPED UP; Sore throat; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), ARTHRALGIA (KNEES AND JOINT HURT), NASAL CONGESTION (NOSE WITH STOPPED UP) and OROPHARYNGEAL PAIN (Sore throat) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis, Ankylosing spondylitis and Ulcerative colitis.    Concurrent medical conditions included Ulcerative colitis, Ankylosing spondylitis and Rheumatoid arthritis.   On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) unknown. On an unknown date, the patient experienced PYREXIA (Fever), ARTHRALGIA (KNEES AND JOINT HURT), NASAL CONGESTION (NOSE WITH STOPPED UP) and OROPHARYNGEAL PAIN (Sore throat). At the time of the report, PYREXIA (Fever), NASAL CONGESTION (NOSE WITH STOPPED UP) and OROPHARYNGEAL PAIN (Sore throat) had resolved and ARTHRALGIA (KNEES AND JOINT HURT) outcome was unknown.            No information on concomitant medication were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event(s) of SORE THROAT, FEVER, AND NOSE WITH STOPPED UP WITH AFTER TAKING COVID VACCINE unknown onset, SORE THROAT, FEVER, AND NOSE WITH STOPPED UP WITH AFTER TAKING COVID VACCINE unknown onset, SORE THROAT, FEVER, AND NOSE WITH STOPPED UP WITH AFTER TAKING COVID VACCINE unknown onset and KNEES AND JOINT HURT with HUMIRA(ADALIMUMAB) was no reasonable possibility. No treatment details were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Patient reports a lump on her cheek, below her left ear that is the size of a golf ball~egg and tender to the touch.  There is no redness.  She assumes it's a swollen lymph node but isn't sure.
Patient is complaining of ringing in her ears since vaccine and tightness in her throat (not anaphylaxis type tightness)
Soon after receiving the vaccine, patient communicated to caregiver that she was having difficulty breathing.  This continued to occur, I administered an epipen. I called for paramedics to come.  Her pulse ox was low when I checked but improved to normal when paramedics arrived.   Caregiver stated she may have been having a panic attack.  Paramedics decided to take her to hospital for observation due to difficulty breathing.  I called caregiver  the following day- patient was discharged previous night and doing ok.
pt recv vax 22JAN99 to lt deltoid area;went to ER 23JAN99 w/ c/o inc swelling, erythema, dizziness, fever, chills, temp, leg cramps, warm tender to area of shot;reports now has cellulitis;
This case was reported by a consumer via call center representative and described the occurrence of atrial fibrillation in a male patient who received SHINGRIX for prophylaxis. On 11th May 2018, the patient received the 1st dose of SHINGRIX. In May 2018, less than a day after receiving SHINGRIX, the patient experienced atrial fibrillation (serious criteria GSK medically significant). On an unknown date, the outcome of the atrial fibrillation was unknown. It was unknown if the reporter considered the atrial fibrillation to be related to SHINGRIX. Additional details were provided as follows: The patient's wife reported this case. The age at vaccination was not reported. The patient received initial SHINGRIX dose and less than 24 hours later his heart rate was 250 beats per minute. The reporter asked if there was any information indicating that the vaccine could have triggered this episode of atrial fibrillation.
Pfizer Vaccination ... affect took place aproximately 2 weeks after my final shot.   Racid smell and taste ongoing for two weeks now.
The patient was in along with older sister and parents for his 2nd pediatric dose.  After approximately 3-5 minutes of receiving  his dose the patient fainted/experienced brief seizure-like activity lasting less than 2 minutes. After contacting emergency, patient's breathing was monitored and patient responded to basic questions (name, DOB,etc).  Upon arrival, monitored patient's respiration, bp, pulse, temperature, as well as tested blood glucose which was all reported as normal.  The parents refused transportation to hospital and were advised to follow up with PCP, urgent care, or ER. Spoke to patient's father at 7:45pm and was told patient is doing fine.
5/9/08 6 m WCE and vaccine. 5/10/08 urgent care w/ 100-102 bl cx and CBC - nl. 5/11/08 urgent care 104 -> ROCEPHIN IM. 5/12/08 urine 20-40 WBC cx neg -> KEFLEX due to ROCEPHIN IM.
1, Left arm sore 4 plus hours following the injection  sore to touch for 48 hours.   2. Dizziness / double vision - 48 hours after receiving the injection  - lasting 24hours.
Systemic: Visual Changes/Disturbances-Mild, Additional Details: Patient fainted at observation area
Arm pain; Chills; This is a spontaneous report from a non-contactable healthcare professional, the patient. A 54-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EW169) via an unspecified route of administration in the left arm on 17Apr2021 at 11:00 (at the age of 54-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies  to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medication was not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: Lofer8733) via an unspecified route of administration in the left arm on 27Mar2021 at 14:30 (at the age of 54-year-old), as a single dose for COVID-19 immunisation. On 18Apr2021, the patient experienced arm pain and chills for 1 day. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events arm pain and chills were resolved on 19Apr2021.  No follow-up attempts are possible. No further information is expected.
After getting the third shot my husband had to help me out of bed, my joints where hurting and were flared up, I couldn't even squeeze my hand. I was unable to walk without help because my ankles were swollen. I felt hot and fever like.
Information has been received from a 68-year-old female with a history of influenza immunization 'a few weeks ago" and "feeling a little achiness" following vaccination, who on 10-Nov-2006 was vaccinated with a dose of varicella-zoster virus vaccine live. There was no concomitant medication. On 12-Nov-2006 the patient experienced " a big red spot that was itchy, hot and hard after vaccination. The patient did not describe it as a rash but as a single hard area. No medical attention was sought, no laboratory or diagnostic tests were performed. At the time of this report, the patient had not recovered. No product quality complaints were involved. Additional information is not expected.
This spontaneous report as received from a physician via a field representative refers to a 77 year old female patient with none pertinent medical history. On an unspecified date in 2009, the patient was vaccinated with a dose of ZOSTAVAX, single shot, subcutaneous for prevention of shingles (lot# and expiry not reported). On an unknown date, this patient developed a "light case of shingles" (also reported as "post vaccination shingles") that according to the representative "came and went". For this patient there was no need for hospitalization and treated in a "normal fashion by the physician". The outcome of the event was now recovered on an unspecified date. The patient sought medical attention. Therapy with ZOSTATAX was also reported as continued. This is one of several reports from the same source. Additional information has been requested.
I experienced cold, numb and stiffness in my feet and arms. My doctor sent me to the hospital to be tested and they diagnosed me with Raynaud's disease. The test that was run measure the blood flow in the legs and feet. I was told to try to keep my feet warm. I still suffer from the symptoms (haven't improved or worsened).
Swelling in my hands. I had a stroke. When I got the booster, it seems it has aggravated things that are going from me having a stroke after doses 1 and 2. This 3rd Dose I can't distinguish if it is the third dose of my stroke. My hands are swelling more on left side where I had my stroke. It is worse than the swelling on my right hand as well. The pain is a constant ache. It is a pain on my neck on my left side similar to the pain in my hand. I had a reaction after the 1st Dose of the vaccine. I was just told to sit longer. My fingers started to swell and red. It lasted a few minutes; it went down enough that they checked my blood pressure and let me go home. Between my 2nd dose I think back in March of 2021. I had a stroke after my 2nd dose in June. I don't if it caused it, I had no major issues before I taken the vaccine. I didn't get put on the diabetes medication after my stroke.