chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Itchy Skin; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itchy Skin) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Itchy Skin) (seriousness criterion medically significant). At the time of the report, PRURITUS (Itchy Skin) had not resolved.            No concomitant medications were reported.  It was reported that after reviewing the second dose, patient have been to the emergency room for 3 times and consulted a dermatologist for itchy skin. They prescribed a topical medicine but the condition was not improved. That problem was affected every aspect of patients life. Its been almost a year.  Company comment- This is a spontaneous case concerning a patient of unknown gender and age with no medical history reported, who experienced the serious (medically significant), unexpected event of pruritus after a second dose of mRNA-1273 vaccine was administered. It was reported that patient have been to the emergency room 3 times and consulted a dermatologist for itchy skin. They prescribed a topical medicine, but the condition has not improved. That problem affected every aspect of patient´s life for almost a year. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 02-May-2022: Follow up document received contains case type was updated and seriousness updated.; Sender's Comments: This is a spontaneous case concerning a patient of unknown gender and age with no medical history reported, who experienced the serious (medically significant), unexpected event of pruritus after a second dose of mRNA-1273 vaccine was administered. It was reported that patient have been to the emergency room 3 times and consulted a dermatologist for itchy skin. They prescribed a topical medicine, but the condition has not improved. That problem affected every aspect of patient´s life for almost a year. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
3 days after shingles vac - feet fell asleep - now legs, arms, abd & back peripheral neuropathy - severe fatigue.
Swelling (about 2 inches in diameter) and itching at the injection site for about 10 days.
The next morning after the second Gardasil shot she felt extremely weak, faint feeling, dizzy, lightheaded, pain in back of neck, headache, complained of tingling in arms and legs, pale lips and face. Complained of joint pain (knees, elbows, and lower back pain. Felt this way entire day with some slight improvement as day went on. The next day 8/30/13 (today) felt the same way as the day before. Extremely tired, fatigued, lower back pain, tingling and weakness in arms and legs, still complaining of joint pain (elbows, knees and ankles) also headache. Took her to see Dr., he would not agree that the Gardasil was the cause. However, All this happened after her 2nd shot.  She is still at this moment very weak. She has missed 2 days of school due to this. Wanted to report this because I feel strongly that the Gardasil shot is the cause behind these symptoms.
Patient was hotter to the touch than normal the evening of the vaccination. The next day, 4/19/11 she was limp and listless. Then started throwing up around 6PM and fever of 101 F. Continued fever and throwing up on 04/20/11 also. Threw up again morning of 4/21/11 although fever is down (but still hotter than usual).
Pfizer-BioNTech COVID-19 Vaccine EUA. Adverse events: chills, joint and muscle pain, nausea and vomiting. Events decreasing after one day.
Information has been received from a physician via a company representative referring to three patients of unknown gender and around a year to a year and a half years old. Between 16-FEB-2015 and 27-FEB-2015, these patients were vaccinated with VARIVAX (Merck) (dose, route and lot# were not reported) in the arm. These patients returned to the doctor's office within 7-10 days post vaccination (in approximately 2015) and they experienced injection site reaction including: swelling of the arm, large red bumps, fever and warmth to the touch. The outcome of these events was reported as recovering/resolving. The relationship between these events and VARIVAX (Merck) was not reported. Additional information has been requested.
Dark area where the blisters healed; Had blisters /blisters also kept getting "really big"; More swelling; Had a rash; Arm started swelling /arm kept getting "really big"; This spontaneous case was reported by a pharmacist and describes the occurrence of PERIPHERAL SWELLING (Arm started swelling /arm kept getting "really big"), BLISTER (Had blisters /blisters also kept getting "really big"), SWELLING (More swelling), SKIN DISCOLOURATION (Dark area where the blisters healed) and RASH (Had a rash) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006M20A and 013L20A) for COVID-19 vaccination.     The patient's past medical history included Lymphadenectomy (removed several lymph nodes in left side of the neck (the same side of the injection)). Concurrent medical conditions included Lymphocytic lymphoma (Small lymphocytic lymphoma (In Jan2021, not too long before the vaccine).) in January 2021, Hypertension and High cholesterol. Concomitant products included HYDROCHLOROTHIAZIDE, AMLODIPINE, ATORVASTATIN, ACETYLSALICYLIC ACID (ASPIRIN 81), ZOLPIDEM and GABAPENTIN for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Feb-2021, the patient experienced PERIPHERAL SWELLING (Arm started swelling /arm kept getting "really big") and RASH (Had a rash). On 21-Feb-2021, the patient experienced BLISTER (Had blisters /blisters also kept getting "really big") and SWELLING (More swelling). On an unknown date, the patient experienced SKIN DISCOLOURATION (Dark area where the blisters healed). The patient was treated with DEXAMETHASONE (DEXPAK JR) for Adverse event, at a dose of 1 dosage form and TRIAMCINOLONE ACETONIDE (TRIAMCINOLONE [TRIAMCINOLONE ACETONIDE]) for Adverse event, at a dose of 1 dosage form. At the time of the report, PERIPHERAL SWELLING (Arm started swelling /arm kept getting "really big"), BLISTER (Had blisters /blisters also kept getting "really big"), SWELLING (More swelling) and RASH (Had a rash) had resolved and SKIN DISCOLOURATION (Dark area where the blisters healed) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient reported that she removed several lymph nodes in left side of the neck from the same side of the injection.  Patient reported that events eventually went away but now she had a dark area where the blisters healed.
Vaccine was administered on 2-27-2023 with BUD (Beyond Use Date) in vial 2-28-23, however, we later realized that the original box of the vial had an expiration date of 2-25-23. Moderna was called to be notify and evaluate the case. They sent their response via email indicating - "the vaccine administered on February 27, 2023 from lot number AR6965B maintained the activity necessary to protect against the SARS-CoV-2 (covid-19) virus at time of administration". We tried to contact the patient but the phone number we have is not working. So far no adverse effects have been reported.
Patients entire arm swelled-double the size of her normal arm from shoulder to elbow. When breathes in deep-back hurts. Arm is red and warm.
Vaccine was not diluted as instructed by the manufacture.  An undiluted dose of 0.2mL was administered to the pt.
First 24hrs high fever, head and body aches, chills. After approx 2 days I developed a hard, inflamed lump in the skin of my injection arm. The inflamed area matched the site of a skin tag removed 18 months ago.
Patient was given a booster dose for his first vaccine in the series, both vials have grey top and the booster vial was inaccurately in a box that was labeled as monovalent
Information has been received from a male patient with a history of chickenpox when he was 6 years old who on 04-APR-2011 was vaccinated with a dose of ZOSTAVAX (Merck) (therapy route not provided, lot # 669263/1361Z, expired date 15-JAN-2012) from his physician during a physical exam. "Within 5 days", on approximately 09-APR-2011 the patient developed lower back pain on the right side and by Thursday, 14-APR-2011 he developed a rash on his right foot, ankle and leg indicative of shingles. It was ultimately diagnosed as shingles. Atypically, it occurred in a motor function ganglion off the lumbar spine area. Patient believed that the vaccine might have awakened the virus thereby triggering the outbreak of shingles. At the time of reporting, the patient's outcome was unknown. The consumer questioned if perhaps there was an issue with the lot #. A standard lot check investigation has been finalized. All in-process quality checks for the lot number in question (669263/1361Z) were satisfactory. The lot met the requirements of the Center for Biologics Evaluation and Research and was released. Follow-up information was received via medical records concerning a 60 year old male who on 04-APR-2011 was vaccinated with ZOSTAVAX (Merck). Concurrent medical conditions included asthma, hyperlipidemia, hypertension and gastroesophageal reflux disease. Past medical history included tonsillectomy, bone spur removal, ankle surgery, sinus surgery, thumb surgery and testicular torsion. On 14-APR-2011, the patient presented to his physician with a rash that was located primarily on the right lateral leg and right foot and was described as blistery, painful, red, warm and following a dermatome distribution. Associated symptoms included flu-like symptoms and pain in back, leg and buttocks, but not a fever. The physician noted that possible contributing factors might include recent illness, recent upper respiratory infection or he just got the ZOSTAVAX (Merck). Assessment was shingles. The patient was prescribed VALTREX. At the time of the report, the patient had recovered from shingles. Follow-up information was received from the responsible physician. On 04-APR-2011, at 3:00 pm, the 60 year old male received his first vaccination of ZOSTAVAX (Merck) in the left arm. He had no illnesses at the time of vaccination. On 14-APR-2011 (also reported as "within 5 days"), the patient had right low back pain and right leg pain with "a typical shingles rash". Patient was treated with VALTREX, prednisone and PERCOCET. He had severe pain for weeks, requiring multiple follow-up visits. The patient had not recovered as he still had some pain-post herpetic neuralgia at the time of the report. The physician reported that the shingles and post herpetic neuralgia resulted in persistent or significant disability/incapacity. All available medical records will be provided upon request. Additional information is not expected.
pt devel antigen & reporter did not know how many doses of vax pt had recvd; mom's hx is sketchy & incomplete;
Palpitations, anxiety, BP 160/82, Pulse 80, no chest pain, trouble breathing noted, patient asked to remove mask. Patient transferred to gurney, Gave her sips pf water. Vitals checked after 15 minutes Bp 142/82, Pulse 68. Patient states she feels better. Patient observed for another 30 mins. Patient left with daughter and stated she will take her blood pressure medication when she reaches home. Advised to consult with PCP regarding adverse reaction and to clarify before taking second dose of Pfizer. Suggested to go to ER is symptoms persist again. Not any palpitations or any adverse reactions while left  for home.
1st Dose Oct 9 at 10 AM, arm itched right after getting it By pm Had - headache, body ache + chills - But wasn't Real Bad - and a sore arm for next 2 days. had some fatigue with the above But was able to function. On 1-07-2020 had 2nd dose - arm started to itch Right after the shot about 5 pm after - By 8 pm my arm was very sore as the night went on I started to get a headache and my Arm was so sore I could hardly move it without it hurting. Wednesday - I also had Body Aches and chills - the next morning after a rough night of all the things listed - I then felt Nauseous, with a headache, chills, Fatigue, sore arm, body Aches, fever I also had a bout of diarrhea - I was so sick I could not move and just suffered and layed on the couch Because I didn't have strength to go up stairs to my Bed Because I had come down in the AM thinking if I ate something I would feel Better But that was not the answer - I only got worse and could not make it Back upstairs at one point I almost passed out! and stayed on the couch form 8 AM until 8 pm in and out of sleep and with all of the symptoms listed - Headache, fever, sore Arm, nauseous, (not able or wanted to eat or drink anything all day + Night, Body Aches, chills my husband wanted to take me to the Dr. or ER But I didn't feel strong enough to get up and go - Everything hurt + I was SO weak!! Thursday - the next day (Thursday) I still had the same symptoms but not as pronounced - after a very Bad night Because I hurt so Bad I was able to sit up and By 2:00 pm able to drink a portion of Vitamin Water. Still very weak + arm sore, aches all over + feeling feverish as the day went on I felt stronger. A strange thing happened on Thursday night my left side of my face + my eye socket hurt + the  nerves in my face only on that side hurt It hurt when I touched it. Friday - I felt much Better able to each still low energy and finally looked at my arm I had a red look like a huge hive where the injection was given it was at least 4 inches wide and long I should have look at it sooner But that was minor compared to all the other symptoms I had - But I guess that is why my arm hurt so badly - If you need to call me feel free Willing to talk to anyone - hope you can read this
Local redness and swelling 13 x 10 cm on the L thigh. Noted approximately 30 minutes after Imms. Given BENADRYL and warm compresses. Resolved after 6 days.
Arm pain and swelling, worst around 10 pm on same day of vaccine.  Feels a little better the following morning, but still pain around shoulder and injection site.
Woke up next morning after dose with severe headache, mild muscle aches, chills, fatigue, injection site pain.  Symptoms worsened throughout the day to include fever of 101 degrees, worsened muscle and body aches, chills, fatigue, severe injection site pain, nausea, feeling very unwell.  Headache and muscle/body aches lasted another day after this, so total of 2 days after dose I didn't feel well, but by day 3 I was fine again.
No adverse events, therefore no treatment was needed in the last 36 hours. Patient is doing well.
6 days p/recv vax, areas of inj became red;seen 4 days later w/1 1/2cm induration on 6 1/2cm area of warm papular erythema @ inj site rt thigh;
pt guardian reported rash 17 days p/vax;pt examined & urticaria noted on trunk w/isolated lesion noted rt upper arm & rt thigh;negative temp;c/o SOB eval instructed to use DPH OTC;
swelling at injection site Narrative:  72 yo malw with unknown PMH reported having headache and swelling at injection site for 5 days after his first covid19 vaccine dose on 1/27/2021. This ADR was reported on 2/17/2021, when patient came back for the second dose of covid19 vaccine.
Patient nauseated and vomited x 1 approx 8 min after vaccines. Felt better within 20 mins.
5min p/inject became limp, a little unresponsive but no/LOC. Lower lip & feet very pale/mottled & knees straight. Cried immediately then went passive & w/in 2-3min responded w/smiles & flexion in extremities.
Felt fatigue to start, slight fever peaking at 102 on Saturday night. Sore throat, some cough, but not much. Felt weak with body aches and difficulty breathing. Urgent care ran a PCR COVID-19 test, positive. Prescribed PAXLOVID. Symptoms cleared up within 2 days. Coughing fits with difficulty breathing still linger.
One day post vax, the pt developed a fine maculo-papular rash over face and thighs, and mild fever.
No adverse event - This was an administration error and I am reporting through VAERS per the instruction within the Moderna COVID Vaccine EUA Fact Sheet for Healthcare Providers. The patient received this vaccine (Moderna 100 mcg/0.5 mL) as the second dose in their series in error. They should have received the Pfizer COVID vaccine. The vaccinator had inadvertently taken a vaccine that was prepared for another patient from a different vaccinator's work-station and did not realize the error until after they had administered the dose. The patient thus received a Pfizer 1st dose, with a Moderna 2nd dose. The patient was observed following the injection as they would have been otherwise, and no additional action was taken or subsequent doses scheduled based on the CDC recommendations RE: Interchangeability
Neurological symptoms such as disorganized thinking; trouble finding words; Bedridden for three days; This spontaneous case was reported by a patient family member or friend and describes the occurrence of BEDRIDDEN (Bedridden for three days), THINKING ABNORMAL (Neurological symptoms such as disorganized thinking) and APHASIA (trouble finding words) in a 56-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7163B) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for an unknown indication.    No Medical History information was reported.   On 29-Sep-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) (unknown route) 1 dosage form. On 04-Oct-2022, the patient experienced THINKING ABNORMAL (Neurological symptoms such as disorganized thinking) and APHASIA (trouble finding words). On an unknown date, the patient experienced BEDRIDDEN (Bedridden for three days). At the time of the report, BEDRIDDEN (Bedridden for three days) had resolved and THINKING ABNORMAL (Neurological symptoms such as disorganized thinking) and APHASIA (trouble finding words) outcome was unknown.            No concomitant medications were reported. The patient was in mid-50s.  The patient's previous Moderna vaccinations included dose 1 received on 02-Apr-2021 (lot number: 021B21A), dose 2 received on 30-Apr-2021 (lot number: 005C21A), dose 3 (first booster) received on 10-Dec-2021 (lot number: 069F21A) and dose 4 (second booster) received on 05-May-2021 (lot number: 0571421A). The patient usually only experienced the normal headache/fever reactions 48 hours after receiving previous doses.  It was reported that, the patient had several symptoms after bivalent booster dose. The patient was bedridden for 3 days after receiving the booster. On day 5 after receiving the booster, the patient felt fine starting off the day but started work with neurological symptoms such as disorganized thinking and trouble finding words. The patient found the neurological reaction weird and concerning.   No treatment details were reported.   This case was linked to MOD-2022-656156 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Oct-2022: Live follow-up information included patient's details (initials, date of birth and age), vaccine information (vaccination date, batch lot number, dose number) updated, event onset date as per vaccination date updated and previous vaccination and reaction details updated in narrative supplement.
Positive COVID-19 test; This is a spontaneous report from contactable consumer (Patient). This is First of 2 reports. A male patient of an unspecified age received bnt162b2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1st via an unspecified route of administration on 27Jan2021 as single dose for covid-19 immunization. Medical history and concomitant medication were not reported. On 08Feb2021, patient was tested positive for covid-19. Patient wanted to know the process of getting the vaccine after testing positive for COVID-19. if they should repeat the dose or should they wait. The outcome for the event was unknown.  Information about lot/Batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021167914 same reporter, suspect, events, different patient
At 4:44 PM, the client received Hep B vaccine. She walked back to the waiting area, sat on a chair and fell forward to the left onto the mother's lap. Assisted to the floor by the mother. The patient was positioned on her back with her knees bent. Initial BP 108/70, P 72. At 5:02 PM BP 124/80, P 78. The patient did not loose consciousness. She was allowed to rest. She recovered and left the clinic approximately 25 minutes later.
Shortly after vaccine was given, patient became very dizzy, and stated she was not feeling well and it seems to be getting worse.  She reported having a light meal and no prior vaccine reactions.  She reported nausea and threw up.  She also stated she had some blurry vision.   Her legs were elevated, and was allowed to lay down.  She was given cold water and transferred to the Emergency Department, by which time she stated she was feeling better.
C/O swollen, red, hot R arm. To ambulatory clinic 2/20. Celafen 200mg po X 7 days prescribed.
had flu sx middle of December fever-aching (viral like); numbness, soreness tingling 1DEC93; lost motor control of both feet & rt hand 24DEC93  pain-anorexia; seen by MD; GBS:
pt recv vax & lt office w/o problems;mom stated that on the way home pt blacked/out & began shaking like petit mal sz x 15sec then became limp & woke up;could not remember what happen;was sleepy & went to be when got home;saw MD;
Pt reported feeling dizziness, nausea and feels like she is having a panic attack.  Pt also is diaphoretic, appears pale and low blood pressure.  BP 80/50 pulse 78, Resp. Rate 18,  pulse ox 100%
This case was reported by a pharmacist and described the occurrence of decreased therapeutic response in an unspecified number of subjects of unspecified ages and genders who were vaccinated with ENGERIX B (GlaxoSmithKline).  On unspecified dates, the subject (s) received the three dose ENGERIX B (unknown) series.  At an unspecified time after vaccination with ENGERIX B, the subject (s) experienced decreased therapeutic response.  A pharmacist reported that several employees completed the three dose ENGERIX B vaccination series "a few years ago".  Recent titer testing indicated that the subjects ha lower than normal titer levels.  The pharmacist was inquiring about the need for possible booster dosing for the subjects.  No further information was provided.  At the time of reporting, the outcome of the events was unspecified.
Developed Alopecia areata (spotty hair loss on scalp) about eight days after the vaccine.  It continues to worsen.
Started with a fever that slowly worsened to a high temperature. This resulted in chills, aches, pains, fatigue. nausea, congestion, sore throat,  headaches, and weakness. There was also swelling at the injection site and  swelling of my eyelids.
FAMILY CAME IN 2/19/21 TO HAVE NURSE LOOK AT L ARM. REDNESS APPROX 2 X2 INCHES THAT APPEARS TO BE QUITE A BIT DOWN AT LOWER DELTOID REGION  FROM THE APPEARED INJECTION SITE OF THE KINRIX. AREA WARM TO TOUCH. NO OTHER SYMPTOMS REPORTED. CALLED REGION DIRECTOR AND RELATES HAVE THEM USE COOL COMPRESSES AND NOTE/MARK IF THERE BECOMES ANY INCREASED REDNESS. DISCUSSED WITH FAMILY AND THEY ARE GOING TO GO BY PCP TO HAVE HIM LOOK TODAY