chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse effects reported; Patient recieved an improperly stored dose of PEDVAX; This spontaneous report was received from a medical assistant regarding a 18 months male patient. The patient's concurrent conditions, pertinent medical history, drug reactions, allergies, and concomitant therapies were not reported.   On 03-OCT-2019, the patient received an improperly stored dose (product storage error) of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) lot number R036177, expiration date 08-OCT-2021 for prophylaxis (strength, dose, and route of administration was not provided). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 46.5 degrees Fahrenheit (°F) for 5 minutes. Data logger was involved. There were no previous excursions reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1910USA006415: US-009507513-1910USA006414: US-009507513-1910USA006562: US-009507513-1910USA006576: US-009507513-1910USA006584:
Muscle soreness at injection site. Feels like a knot in the muscle - can ?probe? area with my finger and find find specific location within the muscle.  Not joint pain.  Soreness became noticeable and bothersome about 6 months after the second dose. Unable to raise my arm above shoulder without significant pain.
Pt recvd vax 15APR93 & the same day pt lt arm became inflammed & warm to touch; also devel erythema & pain for eight days;
After receiving the third vaccine, pt. passed out on exam table for approx. 30 seconds. He became pale and complained of being "cold" when he woke. Dr. monitored pt's blood pressure and pulse. He left the clinic approx. 25 minutes later.
About 15 minutes after injection felt lightheaded and "funny". Tried to walk to treatment room for closer observation and staggered and went down on her knees and laid down. No loss of consciousness. Was fully responsive throughout - even reached up to push her hair out of her face.
~5 minutes after administration of vaccine, patient returned to vaccinator to report firm area around vaccine site. RN noticed patient began to waiver and witnessed patient syncope (no trauma/fall) - patient helped to ground. full LOC and decorticate posturing and tonic clonic activity <5 seconds; immediate return to consciousness; RN provided pillow/legs raised; patient talking and laughing with nurse shortly after return to consciousness. monitored for an additional 30 minutes, water and cookie provided. patient stable to leave home with family member. No medications or other treatment provided to patient. all vitals WNL.
Hospitalized 3/17-21 for Pancreatitis 3 week after vaccine Doctor thinks cause was a side effect of Lisinopril, but I thought it should be reported
pt complaining of chest hurting like dull soreness. monitored an additional 15 minutes. pt better and wanted to leave. agreed to call 911 or go to er if symptom persists.
Marked right upper arm redness, warmth, swelling, itching.  Two episodes of "cold sweats" which woke her from sleep.  Oddly enough the arm symptoms were distal to the injection site.  The site itself appeared normal.
10 days since administration. Just got a big red bump on my arm. Itches if I touch it. Doesn?t hurt. I have a picture. I would report this through vsafe but for some reason I stopped getting the texts after 7 days.
syncope; diaphoresis; varying HR; blurred vision; This is a spontaneous report from a contactable physician (patient).  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 05Jan2021 as single dose for COVID -19 immunization.  The patient's medical history and concomitant medications were not reported.  The patient experienced syncope, diaphoresis, varying HR (heart rate) and blurred vision in Jan2021.  The patient underwent lab tests and procedures which included heart rate: varying in Jan2021. Details were as follows:   Patient received the vaccine in the morning.  He reported diaphoresis, syncope, varying HR, and blurred vision within 10 minutes of receiving the vaccine.  He was taken to the emergency room and therapeutic measures were taken as a result of the events; he was given fluids. The patient generally tolerated vaccines and has recovered from the episode. The events, syncope, diaphoresis, varying HR (heart rate) and blurred vision recovered in Jan2021.  The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up .; Sender's Comments: Based on the information available, a possible contributory role of the suspect products cannot be excluded for the reported event due to temporal association.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators as appropriate.
Patient presented with generalized vaccinia patches (approx 4x4cm) with 2-4mm vesicles with surrounding erythema on L.arm/chest wall/back.
When I woke up this morning, when I turned my head right or left I had a problem; didn't feel great the next day; arm very sore that day; dizziness; diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), DIARRHOEA (diarrhea), MALAISE (didn't feel great the next day), VACCINATION SITE PAIN (arm very sore that day) and MUSCULOSKELETAL DISCOMFORT (When I woke up this morning, when I turned my head right or left I had a problem) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 03M20A and 032L20A) for COVID-19 vaccination.     Concurrent medical conditions included Hearing aid user.   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) (Intramuscular) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced DIZZINESS (dizziness), DIARRHOEA (diarrhea) and VACCINATION SITE PAIN (arm very sore that day). On 19-Feb-2021, the patient experienced MALAISE (didn't feel great the next day). On 13-Apr-2021, the patient experienced MUSCULOSKELETAL DISCOMFORT (When I woke up this morning, when I turned my head right or left I had a problem). At the time of the report, DIZZINESS (dizziness), DIARRHOEA (diarrhea), MALAISE (didn't feel great the next day), VACCINATION SITE PAIN (arm very sore that day) and MUSCULOSKELETAL DISCOMFORT (When I woke up this morning, when I turned my head right or left I had a problem) had not resolved.            No relevant concomitant medications were reported. Treatment information was not provided. Patient stated that side effects they had were not because of the vaccine but due to their sinus problem.   Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: TCR attached included the causal relationship the adverse event and drug. Patient denied further follow up.
Severely red hot swollen knees, intermittent nausea -- no other injury to account for this symptom
headache; This is a spontaneous report from a contactable consumer (patient's husband) via a Pfizer-Sponsored Program. A female patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot number: UNKNOWN) via an unspecified route of administration on 21Jan2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date the patient experienced headache. The reporter and the patient both had their Pfizer COVID-19 vaccines on 21Jan2021, and the second dose would be given on 11Feb2021. The reporter stated that the patient had a very bad headache now and wanted to know if she could take Excedrin Migraine because this is what she had been using in the past when she had a headache. The clinical outcome of the event headache was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Bump on his left shoulder under his collarbone; It has not gone away; This is a spontaneous report from a contactable consumer (parent). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) dose 2 via an unspecified route of administration on an unspecified date as single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient historical vaccine included first dose of BNT162B2 ((PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date as single for COVID-19 immunisation. The patient experienced as, bump on his left shoulder under his collarbone; it has not gone away on an unspecified date. Reported as, "I am just concerned about my son, he had the second shot on Friday and he has a bump on his left shoulder under his collarbone that just appeared basically like yesterday evening and today, it has not gone away". Outcome of the event not recovered. Follow-up attempts are needed. Further information is expected.
Tachycardia and palpitations lasting from a few minutes to a day. Associated with dyspnea and sensation of chest swelling.
Patient developed several lesions on torso and face.  Follow-up information received 3/23/07 - This vaccine wa not given in our office. I do not have that information. Patient started in our office @ 3 yrs old and that info was not provided.
The patient received vaccination in both thighs (parent does not know which shots were in which legs). The next morning the sites were red and inflamed. Over the course of the day and night the sites become larger, hard and hot to the touch. The second day (6/9/2019) the mother brought the child in to the Urgent Care to be evaluated for the reaction. The child was not excessively fussy or irritable. Slightly less energetic and playful but still herself. The thighs both had noticeable large swollen red marks on them with hard indurations in the center of them above and below the skin.
It was reported in a published article that a 19 month old patient (gender not reported) with no history of atopy, was vaccinated on an unknown date with a dose of MMR (lot # not reported) and a dose of Hib conjugate vaccine (lot # not reported). Secondary therapy included a dose of diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid and a dose of poliovirus vaccine inactivated (unspecified). Five to ten minutes post vaccination, the patient developed anaphylaxis with urticaria, pruritis, swollen lips and slight stridor. The patient was treated with epinephrine and IM diphenhydramine. The patient's outcome was not reported. Upon internal review, anaphylaxis, urticaria, pruritis, swollen lips and slight stridor were determined to be other important medical events (OMIC). Additional information is not expected.
The pt developed fever, and urticaria one day following administration of Hep A #2. Treated with Benadryl and Zyrtec.
Bilateral pain in shoulders that radiates into bilateral  upper arms and elbows and down into wrist with associated weakness in upper extremities. Unable to adduct arms without severe pain in shoulders. Unable to perform daily activities without assistance at times due to the pain that debilitates the writer. for appx 5-10 minutes until spasms resolve. Writer is unable to open jars which is a new symptom since receiving the vaccine along the pain in the upper extremities. I feel that I am currently at appx 40% of my usual strength which is causing myself a great difficulty with ADLS and performing my work duties as a clinical nurse. The above symptoms are new since the vaccine and seem to be increasing in frequency regularly. The pain is symmetrical in nature and is on the medial aspect in bilateral elbow joints.
Arm has huge red welt that is extremely painful and itchy. Arm hurts extremely bad.  Headache and pressure in sinuses.
Positive erythema at site with induration and warmth 50mmx40mm diameter. No lymphodenopath. Pt treated with Keflex.
I had chills, body aches; headaches; I felt feverish but I don' t know if I had a fever. Body aches were really intense - I didn't sleep the whole night. I had swelling a little on my arm - at injection site. My arm was sore. In general, my body was really sore and I couldn't get up from bed for 24 hours. I still had a bit of a headache and chills after the 24 hours so I stayed home from work 48 hours. I have been seen by a doctor -after the second vaccine, I had a flare up with my rash on my face (had been experiencing a rash on face prior to vaccine but this was a flare). My face flare up was that I broke out in a rash after finishing doxycycline. Didn't put me on another antibiotic because they wanted to wait and see with the rash - and the tests. Flare up - I couldn't eat; painful to wear a mask to work; couldn't sleep on my face.  I was put on doxycycline again - on March 10th or 11th again because I couldn't handle the pain anymore. And it is getting refilled for another round.  I have had to take a leave a absence from work the last two weeks.
1/17/2021 - Fever (unknown temp) at 2AM 1/18/2021 - Fever, chills, emesis x2, syncope (unwitnessed) 1/18/2021 - Seen at ED - Pt c/o feeling sick for past 2 days after receiving 2nd dose Pfizer vaccine.  C/o fever & chills shortly after vaccine.  Vomited x2. Treatment in ED: ondansetron HCl/PF 4mg  IV x1 dose; Sodium Chloride 0.9% (NS) bolus 1,000 mL IV
Pt developed 5 painful, fever blisters on skin between nose and lips approximately 24 hrs after Zostavax injection. She reports history of herpes simplex eruptions with illness, fever or exposure to extreme temperatures. Vesicles are beginning to dry and heal. Client requested Vaers report merely to inform of possible vaccine adverse event as instructed by VIS provided at time of injection.
l got the shot and still got shingles/Suspected Vaccination Failure; still got shingles.; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt date: 28-Feb-2023 Reporter's Comment: This case was reported by a consumer via interactive digital media. The patient received the Shingles shot and still got shingles.  The patient stated that doctor said that could happen, what good was the shot. Additional Supportive Information: This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Immunocompromised patient received booster dose instead of full dose for 3rd dose; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL UNDERDOSE (Immunocompromised patient received booster dose instead of full dose for 3rd dose) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (Immunocompromised patient received booster dose instead of full dose for 3rd dose). At the time of the report, ACCIDENTAL UNDERDOSE (Immunocompromised patient received booster dose instead of full dose for 3rd dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. The reported wanted to know that if an immunocompromised patient received a two-dose primary series followed by a booster 5 months later, but should have received a third primary dose, should a a fourth dose (full dose) be given and at what timing post booster.
Information has been received from a patient's parents concerning an adolescent female who on an unspecified date was vaccinated with a dose of GARDASIL vaccine (yeast) (route and administration site not reported). Subsequently the patient experienced arthralgia. The patient sought unspecified medical attention. No further information is available.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 21-JUL-2014 the patient was vaccinated intramuscularly with an expired 0.5 ml dose of PNEUMOVAX 23 (lot # not reported, expiration date 11-JUL-2014). No adverse effects reported. No further information provided. Additional information has been requested.
SWELLING REDNESS, TENDER.  RED GOES DOWN ARM TO ELBOW. 2 days after shot, went to dr, said to put ice on arm and take Advil for pain if not better in 10 days go see your dr and you can not get another shot.
Sharp pain from shoulder to elbow when arm is moved in a certain position. Patient has used ibuprofen, heat, and cold to try to help.
Patient reported hives/rash and intense itching all over head and torso that started the next day after the second shot. Patient reported she did have some itchiness on her head after the first covid shot but not nearly as intense of a reaction as with the second shot. She had to visit her PCP and the emergency room several times to receive antihistamines and steroids to treat the reaction. No difficulty breathing or swelling of the tongue. Patient believes and some of her doctors believe that this is an allergic reaction to the covid shot. She will also be following up with an allergist. Still having mild rash and itch today.
Significant increase in peripheral neuropathy bilat feet, hands, peri oral. Had to use albuterol inhaler in the middle of the night.
PT felt dizzy and lightheaded after injection. transported to healthcare facility with father. vitals monitored. 1652 LYING - BP: 91/64, HR: 71, O2: 98 1659 LYING - BP: 93/68, HR: 80, O2: 97 1701 LYING - BP 101/71, 76, O2: 98 1706 STANDING - BP: 111/81, HR: 79, O2: 99
Rash at injection site a day after. Itchy. Swollen/bump. Warm to touch.  Still here a week later.
Was supposed to receive second dose on 23JUL2021, but the home health nurse never came to give him that vaccine; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Was supposed to receive second dose on 23JUL2021, but the home health nurse never came to give him that vaccine) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Was supposed to receive second dose on 23JUL2021, but the home health nurse never came to give him that vaccine). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Was supposed to receive second dose on 23JUL2021, but the home health nurse never came to give him that vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No treatment information was provided.
Severe joint pain in ankles, knees and hips started at 3:15am the evening after my shot accompanied by headache and muscle pain. This lasted for 3 days.  Left armpit was severely swollen and painful to touch. This lasted for approximately 5 days
Patient was given pediatric dose of vaccine rather than the adult dose. The pediatric dose was being stored where the adult dose normally was stored. The vaccine was drawn up by one nurse but given by another. The dose amount was verified, however the vial was not. Patient outcome was fine, rescheduled for full adult dose to be given.
Pt reported swelling, warmth, redness and hardness at injection site @ L upper arm.  Patient states she treated self with Benadryl.
Two weeks after this shot (which was second and final in series) a flare-up of genital herpes started which lasted for about a month. Lesions were large, multiple and came repeatedly, close together in time, which had not occurred for many years prior. After a month this stopped on its own.
After MMR and Kinrix given in left arm, experienced left arm swelling from shoulder to elbow.  Mom questions if "relates to bug bite."  Mom gave 2 doses of Benadryl and it resolved within 24 hours.
I felt like I was going to pass out . I got really dizzy . That night I had bad vertigo , headache , body aches and just felt like the flu . Everyday after that the vertigo , left sided headache , left eye blurred vision and fatigue was getting worse. On 8/6/21 I went to the ER because it was so bad . They wanted to admit me and I said let me see how it goes for the next day . I?m a single mom. On 8/9/21 I couldn?t walk a all bilateral gate was off . Then it was just on the left . Left side headache, face was numb on. The left side ,  left sided weakness ,my left eye was in and out of being blurred and I saw lights flash. My body felt like it was a hundred degrees inside like a crazy hot flash. They admitted me did a MRI and  heart ehco they were fine and a day and a half I regain the strength in my left side . I still get the left sided headache but not as bad and have the optical migraines. I called Pfizer and they said not to get the second vaccine. My antibodies are still over 400 just 3 days ago . I work for a hospital and they are making me get the second vaccine they are not taking too many exception. Please help me and tell me what I can do . I don?t want to have a stroke and cause damage. I have to do it by 10/1  The hospital said it?s per CDC
pt recvd vax; slowly progressive sensory neuropathy, loss of reflexes (especially lower extremities) parathesias, ataxia, Raynaud's disease;primary dx :sensory neuropathy of ideopathic origon"
Information has been received from a physician concerning a 10 year old male who was vaccinated with a dose of Varivax. "Last week", on approximately 23-MAY-2006, the patient developed over 100 lesions over his body. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
I received the flu shot on Wednesday, September 19, 2018. Pregnant and due was October 5th. I was sore the next day, thinking it was normal. A week passes and my pain was worse, with limited range of motion and the feeling as though I was being punched in the arm everyday. Another week passes, and my pain is even worse, with very limited range of motion, a clicking in my shoulder and sharp pain whenever I'd make certain moves. Sometimes, I can't lift my arm at all. I went to the doctor and she said it was a shoulder injury. Prescribed me prednisone and physical therapy.