chrisvoncsefalvay/vaers-outcomes huggingface dataset:
both were sick, It was brutal; flu like symptoms; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 2nd June 2022, the patient received the 1st dose of Shingles vaccine. On 4th June 2022, 2 days after receiving Shingles vaccine, the patient experienced sickness and influenza-like symptoms. On an unknown date, the outcome of the sickness and influenza-like symptoms were unknown.   It was unknown if the reporter considered the sickness and influenza-like symptoms to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 05-JUN-2022 Reporter's Comments: The patient self-reported this case via interactive digital media. The patient received 1st dose of the 2 series shot on Thursday. The patient was sick with flu like symptoms on yesterday (day before reporting). The patient said hopefully the second shot was not bad. This was 1 of 2 linked cases, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR089784:same reporter
No adverse events - child received extra dose of DTaP, IPV< MMR and Varicella discovered previous doses per CVIIS.
Patient presents in clinic c/o right arm red, hot, itching, swollen, and very painful to touch. She had her 1st Shingrix vaccine 9/29/23. Saturday low grade fever at 99.3F, chills, shivering. Sunday the arm rash started. She has taken Zyzal, Motrin, and iced arm on and off since Sunday w/o relief. Also tried Cerave OTC to arm to help with itching, cream is not new to daily regimen. Denied changes in laundry detergents or creams. .
This spontaneous report was received from a healthcare professional referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 17-May-2016, the patient was vaccinated with a dose of PEDVAXHIB lot number reported as M001813 and expiration date 14-OCT-2018 (route of administration, dose, dosage number and anatomical location were unknown) instead of an intended dose of ENGERIX-B. Concomitant or co-suspect therapies were not provided. No adverse effect reported. Additional information has been requested.
mastitis; breastfeeding; breastfeeding; This is a spontaneous report from a non-contactable consumer (patient). The consumer reported information for both mother and baby. This is the mother case. Only this case is serious. A 30-year-old non pregnant female received patient first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: FC3181), via an unspecified route of administration, administered in Arm Left on 10Sep2021 12:45 at the age of 30-year-old as dose 1, single and second dose received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: FF2588), via an unspecified route of administration, administered in Arm Left on 01Oct2021 12:30 at the age of 30-year-old as dose 2, single for covid-19 immunisation from pharmacy or drug store. The patient medical history was none and concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with covid prior to vaccination and patient was not tested for COVID-19 post vaccination. The patient had a baby so patient have been breastfeeding. On 15Sep2021, 5 days after the first dose, patient got mastitis and patient took dicloxacillin (antibiotic) after the first occurrence of mastitis. Then 4 days after the second dose, patient started developing mastitis again on 05Oct2021. The event resulted in doctor or other healthcare professional office/clinic visit. The outcome of event mastitis first episode was recovered, while second episode was unknown.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101329831 baby case
After 1st dose, she had cellulitis in injected arm couple days after injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE CELLULITIS (After 1st dose, she had cellulitis in injected arm couple days after injection) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No medical history reported.  Concomitant products included HYDROXYCHLOROQUINE for an unknown indication.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. In February 2021, the patient experienced VACCINATION SITE CELLULITIS (After 1st dose, she had cellulitis in injected arm couple days after injection). The patient was treated with NAPROXEN SODIUM (ALEVE) for Adverse event, at an unspecified dose and frequency; IBUPROFEN for Adverse event, at an unspecified dose and frequency and MELOXICAM for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE CELLULITIS (After 1st dose, she had cellulitis in injected arm couple days after injection) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medication include allergy medication and supplements. Treatment medication include X-ray, MRI, followed up  with rheumatoid arthritis specialist.   This case was linked to MOD-2021-351175 (Patient Link).
Very mild red circular skin irritation around the site of injection lasting for 3 days. A little itchy, but barely noticeable.
Woke around 5:30 am the morning after the 2nd shot with chills and body aches.  Had severe fatigue, joint and muscle aches all day.  Took ibuprofen every 5 to 6 hours.  The 2nd day after the shot, no chills, but continued fatigue and body aches although better than the day before (continued taking ibuprofen).  The 3rd day, swollen and tender lymph nodes under my left arm and over my left clavicle.  Lymph nodes continue to be swollen and tender 5 days after shot.  Energy level has returned to normal and body aches are gone.
PT RECEIVED HER FIRST DOSE OF COVID VACCINE (MODERNA) ON 4-1-21.  SHE DEVELOPED REDNESS AT THE INJECTION SITE.  IT HAS CONTINUED TO GET WORSE.  SHE VISITED A DOCTOR WHO INFORMED HER IT WAS AN INFECTION AND PRESCRIBED AN ANTIBIOTIC FOR HER.  THE DOCTOR WANTED HER TO RETURN TO THE PHARMACY TO SHOW US THE RASH/REDNESS.  SHE RETURNED TO THE PHARMACY ON 4-12-21
day p/vax pt devel fever 102f for approx 2 days. pt extremely fussy & had eyes rolled back. no treatment necessary
Pregnant and fully vaccinated; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant and fully vaccinated) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and CHLOROQUINE PHOSPHATE (CHLOROCIN [CHLOROQUINE PHOSPHATE]) for an unknown indication.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on 22-Jan-2021 and the estimated date of delivery was 29-Oct-2021. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant and fully vaccinated). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  At the time of the report, EXPOSURE DURING PREGNANCY (Pregnant and fully vaccinated) outcome was unknown.            The patient mentioned her Date of last menstrual period: 22-Jan-2021.  No  treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Non-significant Follow Up - (Source Doc added, contact info updated)
Information has been received from a register nurse concerning a 19 years old female patient, who was vaccinated with the complete doses of GARDASIL. The nurse reported that on an unspecified date a PAP smear test was performed, the patient tested positive for HPV. One of the strains she tested positive was strain 16 (along with many other strains of HPV). No further information is available.
Pt came in asking for second booster and received booster dose. However, patient is not eligible for second booster at this time.
Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Body Aches Generalized-Severe, Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Exhaustion / Lethargy-Severe, Systemic: Headache-Medium, Systemic: Joint Pain-Severe, Systemic: Tachycardia-Severe
Patient got 3rd dose of Moderna. She has redness and swelling of the arm at injection site and was concerned. She is going to follow-up with her doctor.
I have restless leg syndrome and Fall of 2021 I noticed I was having mild joint pain every once in awhile in my arms and legs and just a bit achy. It just felt like I had walked a mile or worked out.  After my second booster in May of 2022 I noticed my joint pain was more severe in my arms, hips, knees ankles and feet. The pain would come and go more often and would bother me most when I am at rest and then move again. My doctor recommended that I see a neurologist. My appointment is scheduled for August 31, 2022.
"COVID arm", large red splotch/rash at injection site, defined borders, no itching, lesion is painful to the touch,   swollen lymph nodes in armpit of the same arm as injection
Became painful and tender about 07:30PM last night.  Mother gave Motrin for pain and applied cool rag.
flue like symptoms, bedridden for two weeks at home, visit to emergency room led to admission in hospital, diagnosis kidney failure. three weeks in the hospital now with several Predinizone and infustion treaments underway. STILL IN HOSPITAL!!
initially soreness @ site, no fever noted; 2 1/2 hr p/vax devel severe migraine h/a, seeing lights/auras;Ibuprofen took h/a away;
experienced a sensation in the back of her throat, not a burning, but like a heated sensation; it was a weird sensation; her arm is hurting; tired; headache; burning/warm sensation in the back of her throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 57 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Mar2021 15:00 (Lot number: EN6205) at the age of 57 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: HEADACHE (non-serious) with onset 09Mar2021, outcome "recovered" (09Mar2021), described as "headache"; THROAT IRRITATION (non-serious) with onset 09Mar2021, outcome "recovered" (09Mar2021), described as "burning/warm sensation in the back of her throat"; PAIN IN EXTREMITY (non-serious) with onset 10Mar2021, outcome "unknown", described as "her arm is hurting"; FATIGUE (non-serious) with onset 10Mar2021, outcome "unknown", described as "tired"; FEELING HOT (non-serious), outcome "unknown", described as "experienced a sensation in the back of her throat, not a burning, but like a heated sensation"; FEELING ABNORMAL (non-serious) with onset 10Mar2021, outcome "recovered" (10Mar2021), described as "it was a weird sensation".  Additional information: Caller stated that she received the first dose of the pfizer covid 19 vaccine yesterday and within five seconds she got an instant headache and then a few seconds after that felt a burning/warm sensation in the back of her throat. Caller stated that it was completely gone in one-half hour. Caller stated that her arm was hurting and tired today. Caller wanted to know if this has been reported and was it safe to get the second shot. Caller states that she also experienced a sensation in the back of her throat, not a burning, but like a heated sensation, like people get if they go for a CAT scan or Magnetic resonance imaging (MRI), with the dye, but it happened within seconds of getting the vaccination. Caller was passionate about getting the vaccine because she takes care of her 92-Years-old mother who had Dementia and Parkinson's and the caller smokes, so she just had to get the vaccine. Caller states that it was a weird sensation and only lasted about 10 minutes and then it dissipated, but she did feel it for another two hours, but then it went away completely. Caller states that she was either 119 or 120 pounds.  No follow-up attempts are possible. No further information is expected.
Employee states that she had pain from front of left shoulder and radiating to elbow. Pain medication doesn't work, Referred to provider for ongoing care.
Information has been received from a licensed practical nurse concerning a 12 month old male with a history of tubes in the ears and no drug reactions or allergies who on 30-APR-2010 was vaccinated subcutaneously with a first dose of VARIVAX (Merck) (lot# 665990/1437Y) into the upper lateral thigh. Concomitant therapy included VAQTA (manufacturer unknown) and PREVNAR. On 11-MAY-2010 the patient was seen in the office with adverse reaction. The child had firm erythematous area on upper left lateral thigh with 3.5 centimeter by 3 centimeter, induration palpable 5 centimeter by 4.5 centimeter. There was no fluctuations, no tenderness, palpable warm to touch, or no drainage from site. No laboratory diagnostics studies were performed. The child was treated with KEFLEX. At the time of the report, the patient's status was unknown. Additional information has been requested.
chickenpox-devel chickenpox in JUL97;MD is 100% positive that child devel chickenpox;
This spontaneous report as received from a Licensed Practical Nurse refers to an unspecified number of patients of unknown age and gender. Information regarding the patients' medical history, concurrent condition and concomitant medication was not reported. On unknown dates in 2016 (reported as since 01-JAN-2016), the patients were vaccinated with improperly stored doses of GARDASIL 9 (dose and route of administration were not reported, lot# L038917, expiration date 20-FEB-2018). No adverse effects had been reported. The GARDASIL 9 vaccines underwent the temperature excursion of -3 Celsius degrees for 19 hours. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
12APR91 began severe diarrhea x 2wks, fussy, cranky, irritable- usually happy & cheerful; afeb; Mom phoned MD, tx'd by phone x 1wk, no improvement status; Has intestinal flu;
At 4 am I awoke feeling poorly and had an alert from my watch that my heart rate was 140; I went to work (I am an ICU nurse) and felt fine until 08:30 when I felt heart palpitations, dizziness, light headedness, chest pain and pressure and I felt like I was going to pass out. I checked my pulse and it was 140. I asked my coworkers to put me on the monitor so they put me on pulse ox and checked my blood pressure. On pulse ox my oxygen saturation was 98%, my heart rate was 125 to 130 with some dropped beats that were non-perfusing. I was hypertensive at 160/90. This episode lasted about 10 minutes. After my heart rate normalized so did my blood pressure but I still felt lightheaded and dizzy and nauseated. After leaving work, I went to my doctors office. As I was being assessed by the nurse at 2:40 PM I felt another episode coming on. My heart rate was 150, I felt lightheaded and dizzy, nauseated, I felt like I was going to pass out, and I had chest pain and chest pressure. I had to lay back flat with my feet elevated so that I would not pass out. I was normotensive when the nurse checked my blood pressure. By the time the nurse got me on a 12 lead EKG, my heart rate has slowed down to 90 to 115, and appeared to be a sinus arrhythmia with increases in rate by 20 beats with any movement. For about 30 to 40 minutes I was unable to sit up because I still felt discomfort in my chest and I felt like I would pass out if I sat up. After I was able to move my heart was in a normal sinus rhythm and I was transferred to urgent care for further monitoring. In urgent care I had some blood sample sent including a CBC, BMP, D dimer, and troponin. The D dimer was normal and the troponin was negative. The BMP was normal, and the CBC was normal with the exception of A slight bump of my white blood cell count to 10.5, and a slightly elevated neutrophil count. I also received a chest x-ray which was normal. After I was discharged, I had another event at home with a heart rate of 100-115. This episode lasted about 30 minutes and I had to lie on my back with my feet elevated for the duration.
Pfizer COVID-19 Vaccine EUA 1-12-21 Pfizer Covid 19 vaccine given left deltoid Seen at Employee Health on 1-21-21 Pfizer initial dose given on 1-12-21 56-60 hrs later, bilateral cervical adenopathy incl. submandibular. Then 6 hrs later, awoke with constitutional symptoms of myalgias, felt feverish/chilled, headache, night sweats, fatigue, thinks had some arthralgias when symptoms were peaking late on 1-15-21 or early 1-16-21; currently sx improving but persistent. Arm was sore at vaccine site, but no localized itching type reaction noted. Additional symptoms are pharyngitis/expectorate yellow phlegm. No h/o Covid 19.  Has enrolled in the V-safe CDC monitoring program Rapid strep/rapid mono/Covid 19 PCR/Flu PCR negative. Throat culture negative for strep. Diagnosis: Adverse reaction to vaccine, moderate 1-26-21: symptoms are resolving. There is no contraindication to booster vaccination. Patient needs to decide if risks of adverse reaction to booster outweighs benefits of vaccination to determine if he will proceed with booster.
Information has been received from a company representative concerning a female who was vaccinated with GARDASIL (LOT# not reported).  After getting the GARDASIL, the patient had unknown AE and would be on TV that night.  The outcome of the patient's adverse events was not reported.  It was reported whether the patient sought medical attention.  Attempts are being made to verify the existence of an identifiable patient and reporter.  Additional information has been requested.
No adverse affects reported.; Medical assistant called reporting fuat patient was administered fuere first dose of MMR at 24 monfus on 2/12/2019 and fue second dose was administered on 6/12/2020.; This spontaneous report was received from a physician, referring to a 3 years old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant medications were not reported.  On 12-FEB-2019, at the age of 24 months, the patient was vaccinated with the first dose of measles, mumps, and rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II), on 12-JUN-2020 the patient was vaccinated with the second dose of measles, mumps, and rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (dose, vaccination scheme, anatomical site of vaccination, lot number and expiration date were not reported for any of the vaccines) as prophylaxis (inappropriate schedule of product administration). No additional adverse event were reported.
Headache, Sedation, Myalgia, Fever, chills, pain at injection site Narrative:
pt alleges devel GBS & suffered an aggravation of a pre-existing disease or condition;hosp for 3mo;month which was spent in ICU;22OCT96 has not recovered balance & strength;severe psychological problems which has drastically curtailed work
Suffered from a stroke on 4/3/21 from a blood clot in his brain stem. Prior to vaccine he was healthy and 100% independent, still drove, did grocery shopping, yard work, etc. Now he cannot move his left side and was placed on hospice as he has lost his will to eat, drink, or live.
After vaccine administered, pt fainted on exam table. She then quickly was layed on table. Was given cold compress on forehead. Given water & crackers. Pt stated she felt dizzy.
Starting on the day after the vaccine-my arm was sore, felt heavy, slept a lot  and I felt a little tired.  However about  2 weeks later, my  right arm  became swollen, red, hot and I felt a hard spot. I was using ice packs until I could see the doctor.  I went to see the doctor the following day  and by that time, I also had red spots on both ankles and the bottom of both legs  and both ankles were swollen and extreme pain in both ankles, more pain with the right ankle.  I was prescribed antibiotics Bactrim and Fluconazole for 10 days. The symptoms (swelling and hotness)  started to go away after several days.  I went to see an allergist who ordered blood work. I also saw a dermatologist but by that time most of my symptoms have resolved.  It took about 2 weeks for most symptom to resolve.  I currently still have swollen ankles, pain in my right ankles,  uncomfortable pricky itch like sensation in my right arm.
Throat swelling, chest pain, difficulty breathing, rapid heartbeat, high pitch ringing in ears, numbness in face, upper body, arms and hands about 6 hours after shot was given. 103.5 fever for 18+ hours, severe nausea, severe headache, lethargic, muscle aches, body aches, chills & shaking.
patient received vaccination at 9:43 am , at 9:45 am she passed out briefly.  We called 911, paramedics came and checked her out ,gave her the ok to leave
Pt received dose #1 of the Moderna vaccine and within minutes reported feeling tingling in both of her feet and hands. Pt was evaluated by EMS on site. Pt signed a refusal for transportation to the hospital. Pt notes she thinks it may be from anxiety. No other symptoms.
felt fatigued; Initial information was received on 19-May-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves female patient of unknown age who felt fatigued after receiving vaccine Diphtheria-2/Tetanus/5 AC Pertussis Vaccine [Adacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect Diphtheria-2/Tetanus/5 AC Pertussis Vaccine (formulation, strength, dose, route, batch/lot number, expiration date: unknown) in unknown administration site as prophylactic vaccination.  On an unknown date, the patient felt fatigued (fatigue) (unknown latency) following the administration of Diphtheria-2/Tetanus/5 AC Pertussis Vaccine.  Seriousness criteria: non-serious  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (fatigue).  At time of reporting, the outcome was Unknown for the event (fatigue).
Medication error:  Patient was administered Pfizer vaccine that was not diluted.  Confirmed with Pfizer that 0.3mL of undiluted vaccine contains 150mcg dose.  Patient was observed for several hours following immunization, and following in the days following.  The only adverse effect described was a headache in the 24 hours post-vaccine that resolved.  No other ADRs reported.  Internal investigation into error in preparation in progress.  This was reported to Pfizer, who could provide no comment on anticipated adverse effects or guidance on patient care plan (if dose counts as valid, if dose #2 should proceed).  Have submitted a consult question to CDC-Info / CISA for any guidance available for undiluted dose errors.  Awaiting response.
I had the shot at Pharmacy the afternoon of March 6.  Sat. morning soon after I got up I felt hot and sweaty.  I sat down for awhile, then got up to continue what I was doing in the kitchen.  I passed out and struck my head on the floor.  Neighbors took me to the emergency where I had a CAT scan and xray.  All were okay.  The dr. put stitches in the back of my head.  I was stiff and sore, took tyanol for 2-3 days and visited the PA at my family dr.'s office.
pt recvd vax pt had an urticarial reaction p/vax w/2nd dose of Hep B vax; No further details were provided;