chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Site: Bruising at Injection Site-Medium, Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)
Pt. exhibited 3 episodes of altered consciousness of approx 15-20 secs each in rapid succession over 12-15 mins. Rigid musculature et LUE decorticate posture noted with each episode along with 5 secs apnea, B/P measured 78/56, HR 62, then B/P 92/65, HR 77, O2 97% RA after 15 mins.
Within 24 hrs, injection sites become red, hot and a rash appeared. Arm became painful to left - within the 2nd 24 hrs this pt's inner bicep began to turn blotchy red and now is full blown red, hot to touch and numb. Pt went to ER for treatment. Dx Cellulitis. Pt was + allergic rxn. Cephalexin 500 g QID x 7d and BENADRYL 25 g Q6H prn.
Information has been received from a health professional concerning a 13 year old female who on 05-NOV-2007 was vaccinated with a dose of zoster vaccine live (Oka/Merck). Other concomitant therapy included Menactra. On 05-NOV-2007, the patient experienced receiving zoster vaccine live (Oka/Merck) instead of varicella virus vaccine live. No adverse effect was reported. The caller reports it was just human error and there was no product confusion. Unspecified medical attention was sought. No product quality complaint. Follow-up information received from the Nurse indicating that the child was vaccinated with zoster vaccine live (Oka/Merck) (lot# 658603/1081U) via IM in the right deltoid and Menactra (lot# U23928A-Sanofi) via IM in the left deltoid on 05-Nov-2007. On 05-Nov-2007, the child experienced tenderness and pain in the right arm at the injection site. Two days after the injection, she experienced body aches, fever, a "cold" and sinus infection for 2 weeks after the injection. The child recovered approximately 2 weeks after the injection. No further information is expected.
severe arm pain limiting range of motion, diffuse joint pain, chills, flushing, severe headache. last for 12 hours until 800 mg ibuprofen taken.
pt recvd vax & devel fever of 101 ; pt was aching all over even bottom of feet; 19sep94 went to MD, dx made by an exclusive process not to have td in future;
I am 100% disabled from a flu shot in 2015; Initial information received on 11-Dec-2022 regarding an unsolicited valid serious case received from  a consumer via social media.  This case involves a patient of unknown age and unknown gender who reported i am 100% disabled from a flu shot in 2015 after receiving influenza vaccine.  It is unknown if the patient had any medical history, concomitant disease or risk factor. The patient's past medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient had received an unknown dose of suspect influenza vaccine produced by unknown manufacturer (strength, route, formulation, batch number and expiry date: unknown) in unknown administration site for flu.   On an unknown date, the patient had a serious event of i am 100% disabled from a flu shot in 2015 (disability) (latency: unknown) following the administration of influenza vaccine. This event was assessed as medically significant and was leading to disability.  It is unknown if there were lab data/results available.  Action taken: Not applicable.  It was not reported if the patient received a corrective treatment for the event.   At time of reporting, the outcome was Unknown for the event.; Sender's Comments: Sanofi company comment dated 14-Dec-2022:  This case involves a patient of unknown age and unknown gender who reported i am 100% disabled from a flu shot in 2015 after receiving influenza vaccine. The time to onset was compatible with the role of vaccine. The clinical course of the event was not provided.  Furthermore, information regarding condition at the time of vaccination, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Per patient's sister, Patient was administered the Janssen/Johnson &  Johnson COVID-19 vaccination on 3/23/21, then on 4/3/21 he was hospitalized for a brain bleed and has been hospitalized in the ICU ever since.
sleepy; headache; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (sleepy) and HEADACHE (headache) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included OXYCODONE HYDROCHLORIDE, PARACETAMOL (ACETAMINOPHEN W/OXYCODONE), VENLAFAXINE, LAMOTRIGINE, LEVOTHYROXINE and FERROUS SULFATE for an unknown indication.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (sleepy) and HEADACHE (headache). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, SOMNOLENCE (sleepy) and HEADACHE (headache) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Apr-2021, Urine analysis: positive large traces of Tramadol.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.    Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Non significant follow up received on 07-JUN-2021, no new information
Uncontrollable shaking, fever up to 101.6, some nausea and muscle pain in place of shot. Started around 11:00pm and took Tylenol to lower temperature. This worked over night, lowering temperature back to normal, 98.6.
runny nose, tiredness and a scratchy throat; runny nose, tiredness and a scratchy throat; runny nose, tiredness and a scratchy throat; hot redness; soreness on her arm; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (runny nose, tiredness and a scratchy throat), THROAT IRRITATION (runny nose, tiredness and a scratchy throat), FATIGUE (runny nose, tiredness and a scratchy throat), VACCINATION SITE ERYTHEMA (hot redness) and VACCINATION SITE PAIN (soreness on her arm) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced VACCINATION SITE PAIN (soreness on her arm). On 25-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (hot redness). On 09-Apr-2021, the patient experienced RHINORRHOEA (runny nose, tiredness and a scratchy throat), THROAT IRRITATION (runny nose, tiredness and a scratchy throat) and FATIGUE (runny nose, tiredness and a scratchy throat). On 20-Mar-2021, VACCINATION SITE PAIN (soreness on her arm) had resolved. At the time of the report, RHINORRHOEA (runny nose, tiredness and a scratchy throat), THROAT IRRITATION (runny nose, tiredness and a scratchy throat), FATIGUE (runny nose, tiredness and a scratchy throat) and VACCINATION SITE ERYTHEMA (hot redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were provided. No treatment information was provided.
Contracted COVID 19 cough, sore throat, congestion and fatigue for 3 days
Developed severe pain in left arm, left shoulder, and neck (lower left) leading to ER visit and various doctor visit. Ended up with extreme weakness to left arm which is still present. Caused Parsonage/Turner Syndrome (Brachial Neuritis).
I was in a different state, and I started with a tooth ache and decided to come home. When I was traveling home, I didn't feel good. I was in pain and felt nauseous. My throat was itchy and my mom's immunocompromised, so I tested for COVID-19 when I got home, and it was positive. I've been in bed every day since then. My lymph nodes in my neck swelled up. I had a fever. They gave me amoxicillin for my tooth and Paxlovid for my COVID-19 infection. I've been taking pain medications around the clock because my lymph nodes have been aching badly. I haven't had an appetite and had diarrhea every day. I also had anxiety because of the pressure on my neck and chest. I also had a cough starting this past Sunday. I had a stuffy nose from Tuesday up until yesterday. I took some Benadryl last night to help me sleep and today's the first day I woke up feeling decent.
When the patient had her SHINGRIX #2 done, she didn't tell us she'd just had her 2nd covid vaccine (Pfizer) on 5/1.  The pharmacy she had it done at had not yet uploaded the data to WIR, so it didn't download to our EMR.  She has had no ill effects, but because the vaccines were given only 4 days apart and they should have been given 14+ days apart, I felt we should report it to you for further study on the matter.
Rash developed behind left knee, then in left groin, then behind right knee, in right knee in eight hours time. Intense itching. Later that evening for about 1 1/2 hr had leg pain. Took hot bath and 1 1/2 tsp of Bendaryl liquid. Felt much better. All leg pain resolved and has not returned.  Rash today is much less however itching is remaining.
stage 1 lung cancer; This is a spontaneous report from Pfizer sponsored program.  A contactable consumer (patient herself) reported that a 59-year-old female patient received her first dose of  bnt162b2 (BNT162B2 also reported as PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not reported), via an unspecified route of administration on 12Feb2021 at single dose for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. She informed that 3 days after the shot, she had CT with contrast for stage 1 lung cancer. She was scheduled to receive the Pfizer-BioNTech COVID-19 Vaccine Dose 2 on 12Feb2021. The outcome of event was unknown.  Information about batch/lot number has been requested.
ARM TINGLING; ACHY; BRUISE; SITE GOT RED & BLOTCHY; TIRED; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 17-MAR-2021 on an unspecified anatomical site for prophylactic vaccination. Batch number was not reported.  Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On MAR-2021, the subject experienced arm tingling. On MAR-2021, the subject experienced achy. On MAR-2021, the subject experienced bruise. On MAR-2021, the subject experienced site got red & blotchy. On MAR-2021, the subject experienced tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bruise, and the outcome of site got red & blotchy, arm tingling, tired and achy was not reported. This report was non-serious.
Immediate local skin reaction -erythema. No anaphylaxis. She had subjective fevers, burning, itching of L arm. Some edema.
Pt had swelling and redness in area of immunization shot. Pt had gone to walk in clinic to have treatment normal side effect of shot. Pt took diphenhydramine and swelling and redness cleared up.
pt states back of thighs achy;MD reports reflexes 0 from knees & below pt sent to hosp;spinal tap done numbness to lower back & arms;recv breathing tx for cough & stuffy nose, couldn't take deep breath;exp flu sx, achy, h/a,lethargic;
weakness in arms and feet  numbness and tingling in hands and feet  unable to make a fist with the right hand (RHD)  fell in bathroom ; dizziness  all symptoms took place within 24 hours of vaccine being received
became ill p/inject nausea, vomiting, h/a, flu-like sx & severe weight loss (60 lbs) since 1SEP92;
Patient felt lightheaded and needed to lay down. Patient laid down and stated he had a little ringing in his ears. After a few minutes the patient announced he felt better, sat up, then stood up.
extreme vertigo; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (extreme vertigo) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included DORZOLAMIDE HYDROCHLORIDE, TIMOLOL MALEATE (DORZOLAMIDE/TIMOLOL ACTAVIS) and BIMATOPROST (LUMIGAN) for an unknown indication.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced VERTIGO (extreme vertigo). At the time of the report, VERTIGO (extreme vertigo) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Tinittus experienced shorty after 1st injection. Ringing in the ears for a little over 4 months.
cloudy precipitant in Vaqta vaccine syringe reported to merck 6-17-19 and awaiting results
10 min after #2 dose of  Pfizer covid 19 vaccine client c/o "hives" and "itchiness" to bilateral, posterior thighs. Clients bilat thighs noted w/ redness and hives. Denies shortness of breath, throat tightness or any other respiratory problems. Vaccine injection site to left arm WNL. Client medicated w/ Benadryl 25mg po at 1810. Monitored x 40 minutes; VSS. Instructed to take an additional Benadryl 25 mg at home if s/s return and call Dr or go to ER. In addition, instructed to notify PCP of incident. Discharged to home w/partner in stable condition; redness/hives resolved. VSS.
Swelling left eyelid; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: En6204) in the arm right on 09Apr2021 at 15:45 as a single dose for COVID-19 immunisation. The patient also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Er8729) in the arm left on an unknown date, as a single dose for COVID-19 immunisation. Medical history was reported as none. Concomitant medications were not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Apr2021, after first COVID-19 vaccine the patient experienced left eyelid swelled up for four days. After the second vaccine, on an unknown date his left eye swelled up again and went on day four at the time of report and it was not got any better. Therapeutic measures were not taken as a result of this event. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event swelling left eyelid was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
About 48 hours I started experiencing adverse event, both of my knee's were hurting so bad I couldn't even walk because they hurt so bad. I was unable to go to work. Both knee's were hurting at the same time. I waited about a week then I went to the doctor and he told me that I had a bad adverse event from the vaccine. They told me to take Ibuprofen but I couldn't take it because of my high blood pressure. I took my regular pain meds. It took about six months to get better.
Systemic: Fainting / Unresponsive-Severe, Systemic: patient had a seizure about 5 mins following adminstration-Severe, Systemic: Seizure-Severe, Additional Details: ems was called and patient was evaluated and pt was cleared with normal vitals and alert from ems parent refused to go to er i tried calling to follow up with patient and now answer on best contact number
Couple of weeks after shot, about eight 1/2 cm itchy red spots on a few inner finger and toe joints, mostly on the right side of the body. Took some antihistamines to stop itching, and it went away after about 5 days.
I ordered a monovalent covid vaccine for the pt.  My MA gave a bivalent covid vaccine to the patient.
On 03/01/2002, the pt presents generalized itching, hives, erythema, and urticaria. She had a rabies vaccine that day. On 20:00 the pt states itching is decreased and redness is subsiding.
REDNESS, SWELLING AND HARD RAISED WHEEL (55 X 40 mm), SOARNESS. REACTION STILL PRESENT AT THIS TIME 3 DAYS AFTER RECIEVING VACCINE.
Administration Error: Patient was given .2ml of Pfizer (purple cap vial that is used for 12 years of age and older) by one of our nurses in our facility.
Patient experienced fever > 102 degrees F and chills. Also what his wife described as "seizure-like movements" lasting approximately 4 hours beginning approximately 2 hours post vaccine. Patient was taken to ED and was hospitalized for 2 days with diagnosis of sepsis/community acquired pneumonia.
Within a minute or two of receiving a TB skin test (Mantoux) and the seasonal flu vaccine, patient started to become pale, was shaking, felt heavy and lost consciousness for less than a minute.  She was put in recumbent position and let rest and recover for almost 30 minutes.  Her vitals were:  BP 163/86, P 68; 15 minutes later, her vitals were BP 116/71, P 80.  Within a few more minutes, she felt fine and was able to walk out of the clinic without assistance.
I was menstruating at the time of my first dose, 07/02/2021. I have not had a period since. I am not pregnant.
Patient reports week-long, not yet resolved, numbness in fingers, pain in elbow of injected arm.  Also ?hard to bend? and injected arm ?darker than other arm?
An hour after receiving my first dose of the Pfizer vaccine in my right arm; my entire right arm, right side of my neck, right side of my face, and whole right side of head went entirely numb and ting; An hour after receiving my first dose of the Pfizer vaccine in my right arm; my entire right arm, right side of my neck, right side of my face, and whole right side of head went entirely numb and ting; flu like symptoms; Fever; body aches; Pain and Swelling in injection sight( my shoulder, shoulder blade, and my right arm to my elbow was swollen); Pain and Swelling in injection sight( my shoulder, shoulder blade, and my right arm to my elbow was swollen); nausea; diarrhea; headache; my elbow was swollen; This is a spontaneous report from a contactable consumer (patient herself).   A 26-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number: Ew0191, Expiry date was not reported), via an unspecified route, administered in Arm Right on 09Jun2021 15:00 (Age at vaccination 26-years-old) as dose 1, single for covid-19 immunization. The facility type vaccine was clinic. The patient was not pregnant at time of vaccination. Medical history included osteogenesis imperfecta, had papillary carcinoma of the thyroid and had the right side removed, scoliosis from an unknown date and unknown if ongoing, known allergies: tegaderm, covid-19 from an unknown date and unknown if ongoing. There were no concomitant medications. On 19Jun2021 16:00, the patient experienced an hour after receiving my first dose of the Pfizer vaccine in my right arm; my entire right arm, right side of my neck, right side of my face, and whole right side of head went entirely numb and tingly. Within an hour of this symptoms, they went away without medical attention. I also had flu like symptoms, fever, body aches, pain and swelling in injection sight (my shoulder, shoulder blade, and my right arm to my elbow was swollen), nausea, diarrhea, headache. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not received any other medications within 2 weeks of vaccination. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not received treatment for the events. The clinical outcome of the events an hour after receiving my first dose of the Pfizer vaccine in my right arm; my entire right arm, right side of my neck, right side of my face, and whole right side of head went entirely numb and tingly was recovered on 09Jun2021 and rest of the events was recovered on an unspecified date.  Follow-up attempts are completed. No further information is expected
Inflamed lymph nodes (swollen and tender) at the base of neck on the side the vaccine was administered.
possible late 2nd dose, longer than 6 month interval; This case was reported by a other health professional via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 3-Aug-2022 Reporter's comment: The case was received from agency information request via sales representative. The reporter reported that possible late 2nd dose of Shingrix on a longer than 6 months interval . The sales representative did not include any adverse event. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The case was processed in worst approach, as there is limited information due which incomplete course of vaccination was coded as event and for the vaccination details follow-up clarification request was raised.
About five hours after vaccination received 3/8, chills and fever started, then severe headache, followed by projectile vomiting off and on all night. Heart was racing/pounding. Unable to keep anything down and became dehydrated. Contacted pharmacy in morning on 3/9 and started taking Pedialyte late morning. Also took liquid children's Tylenol every four hours. Also talked with doctor's office (GP); advised to go to Urgent Care if could not keep anything down for extended period. Stayed in bed and continued regimen until went to bed 3/9. Today, 3/10, symptoms substantially better although I am weak and have some stomach uneasiness. Urination back to normal.
Gave client TdaP, she is 78 years old. Should not have given TdaP. It is for age 65 or younger
Next day around 1pm experienced swelling in face and itchyness, hives in abdomen which was relieved by Benadryl.
Approximately 50 minutes after injection, having waited the 30 minutes for observation, while driving home my tongue started to feel wrong and the top started to tingle. Uncertain which direction this was going to go, I drove to the ER (which was near home, close to where I was at the time). I felt light-headed for a little bit just after getting a room and talking with the insurance & copay person. The doctor noticed I was flushed/red, which extended from my face down my chest and shoulders. The reaction didn't seem to progress further than that, thankfully. I was treated with Solumedrol, Famotidine, Benadryl.