chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt developed fever up to 101.3 evening of vaccination to (L) arm. General malaise, chills. Pt had significant cellulitis of upper requiring IM & PO antibiotics. ROCEPHIN IM & AUGMENTIN 875mg bid x 10 days & Prednisone 40mg x 5 days. Required 2 office visits. Had complete recovery. See attached OV notes. The patient is a 24-year-old female who presents to the office today with onset of fever last evening of 101.3 axillary which was persisted through the night and today. She has generalized malaise and chills, feeling like she got "hit by a bus". Her upper right arm is gradually getting more tender and sore. She looked at it at the time of the office visit and noticed that it was red. She did receive PNEUMOVAX immunization in this office yesterday in that arm. She is mildly nauseous. No vomiting, diarrhea, runny nose, cough, cold, or sore throat symptoms. The patient is a 24-year-old female who is here today for followup on a fairly significant brisk cellulitis from a PNEUMOVAX immunization that was received on 01/25/2011. She voices that overall, she is feeling 75% better. Has not had fever since being in the office yesterday. Really began to feel better approximately 9:00 last evening. She has had no further body aches, chills, nausea, or general malaise. She voiced that her arm is still slightly sore and tender but is also improving. She is utilizing the BENADRYL as we had discussed and also has started on the AUGMENTIN and prednisone. Denies other symptoms.
Felt really tired then suddenly felt like fainting with rapid heart beat. Felt better after about 20min. Then went to sleep. Woke up around 12:30 AM in a sweat. This morn. (11/20/2009) feel really tired.
Nausea; fever; chills; muscle aches; injection site soreness. Self-treated with ibuprofen for 24 hours.
itchy rash 6" long on upper arm ,  3" below injection site, hard welt size of orange at top of rash
patient said her second injection was painful. Then,  that night her arm is swollen all the way down to her armpit and her breast and she ran fever. She contacted the pharmacy 2 days after her shot and she said she is still running a fever and her swellings are still present. She went to see a doctor today and awaiting her test results
No additional AE reported; temperature excursion; This spontaneous report was received from a certified medical assistant and refers to 11-year-old male patient. There was no information about the patient's concurrent conditions or medical history provided. Concomitant medications included meningococcal vaccine (MENINGOCOCCAL VACCINE) (lot # U7191AA, expiration date 18-JAN-2023, intramuscular, left deltoid) and diphtheria vaccine toxoid (+) pertussis vaccine acellular (+) tetanus vaccine toxoid (TDAP) (lot # U6900AA, expiration date 18-NOV-2022, intramuscular, right deltoid).  On 24-MAR-2022, the patient was vaccinated with the first dose (previous dose reported as 0) of improperly stored HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) lot # T036812, expiration date 28-APR-2023 (also reported as 23-APR-2023), intramuscular, left deltoid (dose and route of administration were not reported) for prophylaxis, which were involved in a temperature excursion of 0.39 degrees Celsius for 80 hours and 11.2 degrees Celsius for 80 hours (product storage error). This temperature excursion was found out on 31-MAR-2022. The medication error occurred in the process of storage in clinical practice. The operator of vaccine/vaccine-device was healthcare professional who was trained. The vaccine/vaccine-device was used according to the instruction leaflet. The patient wanted to repeat dose on 24-SEP-2022. There was no additional adverse event or product quality complaint reported. No information about previous excursions reported.  This is one of cases from same reporter. ; Sender's Comments:  US-009507513-2204USA005218: US-009507513-2207USA000783: US-009507513-2207USA000784: US-009507513-2207USA000785:
Angioedema 4 days post 2nd covid-19 vaccine. treated in ED with IV prednisone, Benadryl, zantac. fair resolution with discharge same day.
Patient presented for covid Pfizer vaccination. Patient presents very anxious. Vaccination administered, and patient was observed for 15 minutes for reaction.  Patient started to become lightheaded at around 10 mins after vaccine. Patient lied down with head elevated. Patients vitals stable at 135/90, pulse 75, pulse ox 99, and temp 96.9. Patient remained lying flat with head elevated for an additional 30 mins. With no relief. Gave patient juice and crackers and recheck vitals, which remained stable. No other symptoms reported by patient. No SOB, chest tightness, itchiness, sore throat, tingling or numbness, or headache. Patient continued to feel lightheaded/seeing spots and remained feeling anxious. Patient was evaluated by PCP and was advised to be seen in ER for possible reaction due to length of symptoms. Patient refused ambulance and was driven by significant other to ER.
Information has been received from a physician concerning a 72 year old female with increased lipids who on 13-NOV-2007, in the AM was vaccinated subcutaneously with a first dose of Zostavax (Oka/Merck). There was no illness at the time of vaccination. It was reported that on 14 NOV 2007 the patient's right deltoid was red, warm, painful, bumpy, and hard. Subsequently, the patient recovered on an undisclosed date. There were no lab diagnostic studies performed. There was no product quality complaint. Additional information is not expected.
On 12/7/16 patient given the solution portion of PENTACEL immunization. Did not mix solution with the powdered vial to give DTaP IPV and Hib mix.
tired; pain on left arm from shoulder to elbow area; no energy; Slept 13-14 hrs; felt weak; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tired), PAIN IN EXTREMITY (pain on left arm from shoulder to elbow area), FATIGUE (no energy) and SOMNOLENCE (Slept 13-14 hrs) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 22-Mar-2021, the patient experienced FATIGUE (tired), PAIN IN EXTREMITY (pain on left arm from shoulder to elbow area), FATIGUE (no energy) and SOMNOLENCE (Slept 13-14 hrs). At the time of the report, FATIGUE (tired), PAIN IN EXTREMITY (pain on left arm from shoulder to elbow area), FATIGUE (no energy) and SOMNOLENCE (Slept 13-14 hrs) outcome was unknown. Not Provided          This case was linked to US-MODERNATX, INC.-MOD-2021-081715 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-081715:cross link Dose 2
Vaccine use by 12/12/2021, given today 12/13/2021
swelling & redness 5inches long x 2inches wide;thumb-sized knot in middle, painful to the touch;
The medical history reportedly included rheumatoid arthritis since 1972 affecting all of the vaccinee's joints. His range of motion was particularly limited in his ankles and elbows and his wrists were fused. Additionally, the medical history reportedly included osteoporosis and hypertension. Reportedly the vaccinee has developed a rash when taking sulfa drugs. Reportedly, the vaccinee had no history of gout, psoriasis, Crohn's disease or Lyme disease. There were no family history of lupus. It was reported that his concurrent medications included etanercept (Enbrel), celecoxib (Celebrex), alendronate (Fosamax), amlodipine (Norvasc), and hydrochlorothiazide. In April 01 and May 01, the vaccinee reportedly received his first and second injections of LYMErix respectively w/out adverse event. The vaccinee stated that on 4/15/02, he received his 3rd injection of LYMErix. Reportedly, "w/in one week" of his third LYMErix injection, the vaccinee experienced a rash on his waist, groin, buttocks, and upper legs. The vaccinee stated that the rash started as pimples and became welts. Reportedly, he was seen by a dermatologist who did a scraping for a culture and determined that the rash was not fungal. The MD reportedly told the PT that some of the rash appeared to be "hot tub type rash" but that some appeared similar to Lyme disease rash. Reportedly, minocycline 100 mg twice daily was prescribed to treat the rash. As of 4/29/02, the event was reportedly ongoing.
Pt states that he had a reaction to the second shingles shot. Pt symptoms included fever, diarrhea, tired, no appetite, and chills. Pt states he wants that included in his records.
Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Hypertension-Severe, Systemic: Unable to Sleep-Medium, Additional Details: pt complained of having chest pain,it has been for 10 days since the last dose.also he stated that he unable to sleep at night after the shot.
Large erythematous circular macule surrounding administration site. Warm and tender to touch. Area extends 3 inch. in diameter with regular borders.
I am not sure if this is truly an adverse event, but I would like: 1. to add to the data about Jynneos, esp. the intradermal route; 2. advice about whether or not to receive the 2nd dose at day 28-35, 3. to suggest that you add Jynneos to V-Safe so you can get a larger, unbiased sample of vaccine effects.  I received Jynneos 0.1 mL in my L arm, but no bleb was seen.  Therefore, I received a 2nd 0.1 mL dose 15 min later in my R arm, and a bleb was seen.  The next day, approx 18 hours later, I had significant erythema, warmth, and induration at BOTH injection sites.  48 hours after ID administration the erythema border  had retreated, but the induration and warmth increased, and the erythematous area was visibly swollen.  Max extent of induration was 30-40 mL at each site. At 72 hours the erythema is still 20 mL and swollen.  I have very slight arthralgias and HA but no LAN.  I received Sanofi-Pasteur Fluzone-ID when it was available, and I had erythema and warmth at the innoculation site, but no induration.  I am not sure if my vigorous response to Jynneos is typical.  I did receive smallpox vaccine as a child (56 years ago?).  Does my vigorous response mean that I boosted existing immunity?  Given that I inadvertently received two dose and given the vigorous response, should I receive the 2nd dose at 28-35 days?
Moderna COVID-19 Vaccine EUA Sore at the injection sight Sinus drainage (Possibly unrelated to vaccine)
extreme fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Jan2021 18:00 (Lot number: EL8982) at the age of 56 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: PROZAC (ongoing); LISINOPRIL (ongoing); LEVOTHYROXINE (ongoing); WELLBUTRIN (ongoing); OMEP [OMEPRAZOLE] (ongoing). The following information was reported: FATIGUE (non-serious) with onset 23Jan2021, outcome "recovered" (2021), described as "extreme fatigue". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of fatigue.  Additional Information: The AE did not require admission to hospital. The patient was fine now  No follow-up attempts are possible. No further information is expected.   .
Erythema, tenderness, and warm to touch at injection site, fever, chills, joint pain.
With both shots, during my 15 minute wait afterwards, my eyes burned and watered.  After the 2nd shot, the next morning my temperature was 103.1.  Over the next few days I had brain fog.  On May 7, 6 days after 2nd shot, I had projectile vomiting and diarrhea which happened 3 times during the evening and night.  Today - nearly 2 weeks after receiving the shot, I have intestinal noise and irritation (feels inflamed).   I started with pain behind my left eye yesterday and took advil (12 days after 2nd shot)
Induration of injection site. Physician instructed pt to apply ice to area and talk Motrin for pain.
Pt presented with approx 5 cm area of redness, sl warmth but minimal swelling. Mildly tender.  No streaking. Rx'd Tylenol or Motrin for discomfort.
I had a mild stroke.  I was typing on my laptop and all of a sudden my fingers were not working. They weren't pressing the keys. I thought maybe all the gardening I did that day my be contributing, plus I stayed up later after taking my insomnia medicine; so I went to sleep. Next morning, I could not hold my coffee cup and knew something was wrong. Plus I my left side arm & hand could not be used. It just flopped on the table; and left side of face & ear was numb and left leg was walking wonky. I went to the emergency room at the closest hospital.
I had difficulty sleeping, coughing, sneezing, a runny nose, achy joints. I also had a slight fever. I was prescribed PAXLOVID the day I tested positive.
Guillain Barre syndrome, autoimmune desease; log muscle problem; leg problem; This case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a 66-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included COVID-19 VACCINE for prophylaxis.   The patient's past medical history included guillain barre syndrome (had a case of GBS (guillian barre syndrome) in his/her 20's) and numbness of lower extremities (Could not feel his/her legs from waist down and recovered in about 2 months).   On an unknown date, the patient received Shingles vaccine and COVID-19 VACCINE. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced Guillain Barre syndrome (serious criteria medically significant), muscle disorder and musculoskeletal disorder. On an unknown date, the outcome of the Guillain Barre syndrome, muscle disorder and musculoskeletal disorder were not recovered/not resolved.   It was unknown if the reporter considered the Guillain Barre syndrome, muscle disorder and musculoskeletal disorder to be related to Shingles vaccine.     Additional Information: Receipt Date: 11-JAN-2023 Reporter's Comment: This case was reported by a patient via (social media) interactive digital media. The reporter was in late 60s. The reporter did not want shingles so he/she took the shingles vaccine when it first came out.  The reporter did not know the risk of Guillian Barre syndrome.  The reporter fast forward to now at the age of 66 year and took the shingles vaccine and latter Covid vacine.  The GBS (Guillian Barre syndrome) was an autoimmune disease and his/her roared back with GBS (Guillian Barre syndrome) again suffering leg and long muscle problems and not going away this time.  Only recent did they mentioned a risen in GBS (guillian barre syndrome) in their commercials if he/she had known he/she would not had taken it and not be going through this hell again as an older man.  The reporter stated that, it was rare but could happen to just a few in 100,000 and he/she was one.  The reporter stated that, just waiting for the class action lawsuit and shingles would be better than this. It was unknown if the reporter considered the guillain barre syndrome, muscle disorder and musculoskeletal disorder to be related to Covid-19 vaccine. Additional Supportive Information: The follow up would not possible as no contact details were available.
Information has been received on 08-OCT-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. In 2014, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a county health facility for routine adult health maintenance and for the long-term 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 or about 26-SEP-2016, the patient was treated at a clinic for the onset of a severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the 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 has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Fatigue without fever, chills, numbness, papular eruptions without pruritus over anterior chest and abdomen. Not c/w generalized vaccinia.
Mon. 8-26-13 vaccine given. Tues. 8-27-13 - small red area. Wed. 8-28-13 - larger red area patient went to her doctor and was given antibiotic and Benadryl.
Patient hospitalized for displaced intertrochanteric fracture of right femur. Initial encounter for closed fracture within 6 weeks of receiving the COVID-19 vaccination.
Right arm swollen, red, with rash, swelling moving down to arm to elbow area, symptoms started Friday (next day after vaccination).
very red & swollen upper arm where DTAP given;warm compresses & advil for discomfort;
Day after shot my arm felt like I had been hit with a baseball bat for about 8 days.  Completely normal and expected, however it has been 2 weeks since 2nd dose and my right rotator cuff is killing me.   The pain also is traveling up my collar bone and into my neck.   It feels extremely sore and almost like something is torn.  I do not have any activities in my life that would cause this and it has been feeling like this after the shot.  Other then feeling kind of worn down and tired after the 2nd dose this is my only issue.  Kind of seems like the medicine has settled in my joint, it is that sore.
Bad colds; This is a spontaneous report from a contactable consumer or other non hcp via a Pfizer sponsored program. A male patient of an unspecified age received bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced bad colds and scheduled for the second dose of the Pfizer COVID-19 vaccine on 23Jun2021, his doctor said to wait a week before getting the vaccine. The outcome the event was unknown.  Information on the lot/batch number has been requested.
Information has been received from a RN concerning many males, who were vaccinated with varicella virus vaccine live. Subsequently, the patients later had varicella. All of the children received the vaccine after one year of age and later. Unspecified medical attention was sought. Additional information has been requested.
PATIENT CALLED ABOUT 1 HOUR AND 15 MINUTES AFTER RECEIVING TWINRIX AND SAID HE THINKS THE ROOF OF HIS TONGUE IS SWOLLEN. ADVISED HIM TO TAKE 50MG BENADRYL AND HAVE SOMEONE DRIVE HIM TO THE ER. PATIENT CAME IN THE NEXT DAY TO SAY THAT HE FEELS BETTER AND DOES NOT NEED THE PREDNISONE THAT AN ER DR CALLED IN LAST NIGHT. HE STATED THAT HE RECEIVED BENADRYL, PREDINSONE AND PEPCID AT THE ER AND WAS KEPT FOR A COUPLE OF HOURS AND GOT DISCHARGED.
Peristalsis at the injection site; Signs of mono; This case was reported by a nurse via call center representative and described the occurrence of injection site muscle reaction in a 16-year-old female patient who received Men B NVS (Bexsero) (batch number ABXB34AA, expiry date 31st July 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 3rd August 2021, the patient received the 1st dose of Bexsero (intramuscular) .5 ml and Bexsero Pre-Filled Syringe Device. In September 2021, 4 weeks after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced injection site muscle reaction and mononucleosis. On an unknown date, the outcome of the injection site muscle reaction and mononucleosis were recovered/resolved.   It was unknown if the reporter considered the injection site muscle reaction and mononucleosis to be related to Bexsero and Bexsero Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 15-AUG-2022 Reporter's Comment: The reporter was a nurse. The reporter reported that the patient received Bexsero vaccine. The reporter stated that four weeks after received Bexsero vaccine patient experienced peristalsis verified with reporter at the injection site and signs of mono. The patient was not seen by the HCP for the reported side effects, reporter had nothing else to report. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up.
12 hrs after injection (next morning 04/01/2021) I had: Arm pain at injection site, tiredness, muscle pain everywhere, sore throat, nausea, fever of 101, swelling of sinuses, coughing. Took 500mg of Tylenol at 5:30pm that night and 11:00pm (04/01/2021) it relieved the fever. On 04/02/2021 woke up and still had muscle pain at injection site and everywhere, swelling of sinuses, coughing. Took 500mg of Tylenol at 10:30am to help with muscle pain.
Redness, swelling, heat, and pain to injection site. Treated with steroid and antibiotic for potential cellulitis. CBC checked (wnl).
Site: Redness at Injection Site-Severe, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Headache-Mild
4 years old patient received a dose of one vial Menveo by mistake; 4 years old patient received a dose of one vial Menveo by mistake; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 4-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA91A, expiry date 08-FEB-2025) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: 4 years old patient received a dose of one vial Menveo by mistake) and inappropriate dose of vaccine administered (Verbatim: 4 years old patient received a dose of one vial Menveo by mistake). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 22-JUN-2023 and 23-JUN-2023 The medical information specialist attempted callback this morning around 10 AM (delayed callback due to different time zone of caller).  The reporter was not in the office and anonymous front office staff informed. The medical information specialist that other medical assistants were busy with other patients.  Front office staff member stated that she did not know any details, so Medical Information Specialist was unable to clarify vaccine brand or any additional details. The reporter reported that the incorrect administration of a vaccines (no data apart from this one) and reported that the patient received a dose of one vial Menveo by mistake (it was approved until the patient was 10 years of age), which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.