chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a physician assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions or allergies and medical history provided. In January 2016, the patient was vaccinated with the first dose of RECOMBIVAX HB injection (route of administration, lot # and expiration date were not reported), in June 2016 with the second dose of RECOMBIVAX HB injection (route of administration, lot # and expiration date were not reported) and in August 2016 with the third dose of RECOMBIVAX HB injection (route of administration, lot # and expiration date were not reported). The physician assistant stated the patient had "titers drawn" on an unspecified date in 2016 (after the 3rd dose of RECOMBIVAX HB) and the patient was not showing immunity for Hepatitis B. No product quality complaint was involved. The outcome of the event was not reported. The relatedness between the event and RECOMBIVAX HB was not reported. Additional information has been requested.
The ring finger and pinky of my left hand, along with part of my palm up to the wrist, became numb on March 25, 2021. The condition persisted and only began to lessen in September of 2021. Dr. believed it was caused by a pinched nerve, though I had no pain; x-ray revealed nothing relevant. Began occupational therapy for the condition which continued to improve though it never disappeared. On 12/9/21 I received the Pfizer booster shot, again in my left arm, and 3 days later the numbness returned in full-force and continues to this day.
Right Shoulder Injury, consisting of soreness, cramping, and limited range of motion associated with pain
About 8 minute seizure and fever occurred about 32 hours after MCV4 given.
When I received the injection on my left arm, I felt a current run from my left arm to the middle of my back/shoulder blade. It came and went since that day but in the last week it's everyday all day long and the feeling leaves a numb sensation.  No pain, only weird sensation, numbness when it occurs and then goes away.
flushing of face within 10 minutes, light rash arms, and trunk; flushing of face within 10 minutes, light rash arms, and trunk; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received the first dose of bnt162b2 (BNT162B2, lot number and expiry date were not reported), via an unspecified route of administration, on 23Jan2021 01:00 PM at a single dose on the right arm for COVID-19 immunization. The patient did not receive any other vaccine within four weeks prior to receiving bnt162b2. The patient was not diagnosed with covid prior to vaccination. The patient was not pregnant. Medical history included allergies to tree nuts, bees, penicillin, and sulfa. Concomitant medications were included hormones, fluticasone propionate, salmeterol xinafoate (ADVAIR), and esomeprazole sodium (NEXIUM). The patient experienced flushing of face within 10 minutes (as reported), light rash arms, and trunk on 23Jan2021 01:15 PM (as reported). The patient was not tested for covid post-vaccination. The patient received Benadryl as a corrective treatment. Outcome of the events was recovered on an unspecified date in Jan2021.   Information on the lot/batch number has been requested.
After the vaccine I only had a sore arm, months later I went to my normal appointment to get my allergy shots. She was told she cant get her allergy shots because she wasn't breathing well, she was breathing below her breathing rate. they told her to see her primary care, because she needs to get her lungs taken a look at. She got a lung X-ray, they found a spot on her lungs that could  be ammonia and she needs a CT scan. They also, found a little on the inside of her lungs. they also found a cists on her kidney but thankfully wasn't cancer.
The patient appeared to have fainted in his chair. When I went back over to the patient, I reached out to hold his shoulders and asked him if he was ok. He mumbled or made sounds that I couldn't understand and his head and upper body shook for about 2 seconds then he stopped and slowly raised his head and started to speak. He became responsive. His face and body got very sweaty. His face and lips were pale but he was responsive and looking at me. We were able to talk back and forth so I asked him if he felt comfortable enough for me to step in the stockroom and grab a water for him (less than 10 feet away). After getting him a water, I sat with him longer then offered him some crackers and got them for him. We sat in front of the pharmacy for an hour since I administered his vaccine. During that time we discussed his health history.
Developed hives/welts on her torso, chest, arms and legs. The hives hitch. Taking Benadryl and topical antihistamine lotion.
asthma; strep test came back positive.; This is a spontaneous report from a contactable consumer (patient). This female patient of unspecified age (age: 62 unit: unspecified) received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 12Jan2021 at single dose for covid-19 immunisation. Medical history and concomitant medications were unknown. The patient received the first vaccine on the 12Jan, in between that time, she went to the doctor to check on her asthma, her strep test came back positive. She was on an antibiotic. The patient asked if she was able to get the second dose. On 02Feb2021, the patient was due to go back to get the vaccine. Her doctor who also provided the vaccine said that it was okay for her to get the second vaccine. Outcome of the events was unknown.   Information on the lot/batch number has been requested.
This case was reported by a physician via sales rep and described the occurrence of injection site rash in a 6-year-old female patient who received HAVRIX 1440 (batch number X22P4, expiry date 16th October 2017). Concurrent medical conditions included drug allergy. On 29th June 2015, the patient received the 1st dose of HAVRIX 1440. On 29th June 2015, several hours after receiving HAVRIX 1440, the patient experienced injection site rash, overdose and inappropriate age at vaccine administration. On an unknown date, the outcome of the injection site rash was recovered/resolved and the outcome of the overdose and inappropriate age at vaccine administration were unknown. The reporter considered the injection site rash to be probably related to HAVRIX 1440. Additional details were provided as follows: This case was not reported previously. The patient had allergy to benzalkonium chloride. Two different dates of birth were reported. On 29th June 2015, the 6 year old patient received the 1st dose of HAVRIX 1440, leading to an overdose and an inappropriate age at vaccine administration. The patient experienced rash from the initial point of the injection on the upper left arm from the deltoid muscle approximately to the elbow, the night after receiving HAVRIX. Rash resolved on its own in a couple of days. The physician seek guidance for administering the second dose. The patient had denied permission to contact their physician.
Systemic: Visual Changes/Disturbances-Medium, Additional Details: Pt. called Specialist after vision became impaired and was instructed to take benadryl. Shortly after vision returned with some blurriness. provider did not speak directly with pt. Message was relayed by Pharmacy Manager around 5pm on 10/26/2022. Will follow up with pt to check status on 10/27/2022.
Rash began 9APR92 back & chest, & extremities raised & red; 10APR smaller still raised; mom called MD; 13APR92 MD felt was viral origin unrelated to vax; pt well & acting nl today;
Our patient received her shot and stayed in the pharmacy area for 15 minutes and was released. Fifteen minutes late she returned to the pharmacy says she was dizzy and nauseated. We had her sit in the pharmacy for about 20 minutes at whichn time she said she felt better and was ready to go. We had one of our pharmacists walk her but she became dizzy and nauseated again and had to sit down. At this time she said she was hot and very light headed and her vision was starting to get blurry. A minute or so lefter that she sat up in her chair and stopped breathing and started to fall off. One of our pharmacists caugt her and at point she went into convulsions and started gagging and could not breath. 911 was called at this time and an Epi pen was administered. The convulsions stopped 30 seconds afer the Epi and her breathing eazed. The EmT's arrived with in 10 minutes and took her to local emergency room. Our pharmacist called the emergency room about a hour later and they said that She wwas doing well.
Having troubles walking; Having troubles inhaling/Having troubles exhaling; The pain in the muscles around her stomach makes it difficulty breath; Nausea; Myalgia; Really bad back pain; Vomiting; Bad weakness; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (Having troubles walking), DYSPNOEA (Having troubles inhaling/Having troubles exhaling), MYALGIA (The pain in the muscles around her stomach makes it difficulty breath), NAUSEA (Nausea) and MYALGIA (Myalgia) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 19-Feb-2021, the patient experienced NAUSEA (Nausea), MYALGIA (Myalgia), BACK PAIN (Really bad back pain), VOMITING (Vomiting) and ASTHENIA (Bad weakness). On 01-Mar-2021, the patient experienced GAIT DISTURBANCE (Having troubles walking), DYSPNOEA (Having troubles inhaling/Having troubles exhaling) and MYALGIA (The pain in the muscles around her stomach makes it difficulty breath). At the time of the report, GAIT DISTURBANCE (Having troubles walking), DYSPNOEA (Having troubles inhaling/Having troubles exhaling), MYALGIA (The pain in the muscles around her stomach makes it difficulty breath), NAUSEA (Nausea), MYALGIA (Myalgia), BACK PAIN (Really bad back pain), VOMITING (Vomiting) and ASTHENIA (Bad weakness) outcome was unknown.            Treatment included Advil and Tylenol. no concomitant medications reported.
Pt fully vaccinated with the COVID-19 Pfizer vaccine, on 3/27/2021 and 4/17/2021 respectively.  Pt presented to the hospital ED on 10/19/2021 with both symptoms of COVID and a hypertensive emergency.    Hospital Course: Acute hypoxic respiratory failure  -Transient, short-lived.  Possibly secondary to Covid, but other etiology more likely - perhaps hypertensive emergency. -Supplemental oxygen only needed for a few hours overnight after admission.  Weaned off oxygen. -as needed albuterol   COVID  -Symptom onset uncertain -Positive Covid test result 10/19/21  -Risk factors for severe disease BMI >34 -Vaccinated for covid -Dexamethasone 6mg started 10/19/21 -since he is already weaned off oxygen within just a few hours of admission, stopped dexamethasone.   -Remdesivir not indicated -Tocilizumab/Baricitinib not indicated -Isolation: droplet/contact/N95 or PAPR/eye protection -DVT prophylaxis Lovenox -Lab trends: Mildly elevated CRP, but down trending D-dimer normal x2 days Normal white blood cell count Procalcitonin mildly elevated, but down trending -Imaging: Chest x-ray 10/19/2021 bronchial wall thickening in the perihilar regions, heart enlargement Things to follow-up as an outpatient: - covid vaccine booster candidate?
Swelling in upper arm, then was worse on the next day. Swelling down Rt arm. Pt was given Doxycycline Monohydrate.
Some dizziness on 10/12 only followed by somewhat itchy hives on the arm where shot was given. Hives appeared on 10/13.
Headaches to the right side of the head. Has taken tylenol and cold medicine to manage symptoms
Narrative: Pt reported swelling around they eyes 4-5 hrs after receiving first dose of Pfizer COVID-19 vaccine. Pt stated that she took some antihistamines (Chlorpheniramine) and it helped. Swelling subsided the next morning. Has a history of swelling around the eyes after taking NSAIDS.
Pt received MMR and Prevnar on 7/18/02. On 7/19/02, developed fever of 103F, followed by an erythematous papular rash. Rash and fever persisted to when I saw the pt on 7/23/02. Language barrier. More info no known.
This case was reported by a nurse via sales rep and described the occurrence of rash in a patient who received BEXSERO (batch number 116901A, expiry date unknown) for prophylaxis. On an unknown date, the patient received BEXSERO. On an unknown date, less than a year after receiving BEXSERO, the patient experienced rash. On an unknown date, the outcome of the rash was unknown. It was unknown if the reporter considered the rash to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced rash on neck, arm, and chest of the side of BEXSERO injection. This event was occurred in past 6 weeks from the date of reporting. This is 1 of the 3 linked cases reported by the same reporter.
Muscle leg pain, bilateral, from hips down. Continuous pain. Difficulty walking and lifting legs. Gait is a shuffle instead of a walk. Sometimes she will go to walk and her leg won't move. The more activity the worse symptoms. At night cannot get comfortable no matter the position.
Headache, hives, back ache, muscle aches, spine pain, nausea, weakness.
arm pain, concern is the injection site; a swollen injection site a size of a quarter with heat 13 hours later; she has swelling at the injection site and heat underneath it; BNT162B2 first dose was administered on 16Dec2020, second dose was administered on 04Jan2021; joint pain; This is a spontaneous report from a contactable healthcare professional (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), first dose on 16Dec2020 between 12:30 and 1:30 via an unspecified route of administration at single dose, then the second dose on 04Jan2021 via an unspecified route of administration at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient got the first vaccine on the 16Dec2020 between 12:30 and 1:30 and had symptoms 12 to 13 hours post injection. She had joint pain which is normal. Two or three weeks later she had the second vaccine. It was given yesterday (04Jan2021) around the same time as the first one was given. About 13 hours later she had arm pain. She didn't feel anything until 2AM when she started feeling achiness. Her concern is the injection site. She doesn't know if it will get infected. The patient added that she had experienced arm pain, a swollen injection site a "size of a quarter" with heat 13 hours later. She also stated that she did not experience this with the first shot and is asking if this normal for the 2nd shot. She knows it is listed as part of the side effects, but she has swelling at the injection site and heat underneath it. The patient asked, "Is that normal to sustain for about 12 hours? It started around 2am". She took three Tylenol and that seemed to help. The outcome of events was unknown.  Information on the lot/ batch number has been requested.
6x5 cm area of pruritic angioedema surrounding site of Tdap.
2 patients received Flublock quadrivalent instead of the Fluzone Quadrivalent because the boxes and the syringes are so similar between these two vaccines, no adverse event; 2 patients received Flublock quadrivalent instead of the Fluzone Quadrivalent because the boxes and the syringes are so similar between these two vaccines, no adverse event; 2 patients received Flublock quadrivalent instead of the Fluzone Quadrivalent because the boxes and the syringes are so similar between these two vaccines, no adverse event; Initial information received on 05-Nov-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves two patients of unknown demography who received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] instead of the INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] because the boxes and the syringes are so similar between these two vaccines (wrong product administered, product administered to patient of inappropriate age and product packaging confusion).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] dosage unknown (lot not reported) lot number not reported via unknown route in unknown administration site instead of INFLUENZA QUADRIVAL A-B VACCINE.  It was a case of actual medication error due to wrong product administered, Product administered to patient of inappropriate age and Product packaging confusion. At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.
fever 102, body aches, cough, headache, sore throat, chills, shortness of breath starting 1/22/22
immediately after injection patient had normal swelling, redness and soreness for approximately 1 week (consistent with response to first shot). At the 3-4 day after injection point the patient developed pain, tingling and "numbness" in the left arm (vaccinated arm) - symptoms were described to pain management md and chiropractor. Consistant with onset of shingles case. No rash developed but burning pain and tingling remain. Patient already on gabapentin
Typical mild side effects for the first 24-36 hours, including soreness at injection site and mild flu-like symptoms. Starting in the evening of the next day, the soreness got worse and the area around the injection site turned red. By the next morning, the area was red and swollen and felt hot. My left armpit was also swollen. I'm now on the third day after receiving the shot, and my arm is still red, sore, and hot, and my armpit is still swollen. It is a little bit better than yesterday or I would have tried to get in to see a doctor.
Information has been requested from a registered nurse concerning a female patient between the ages of 11 to 13 who within the last 3 months was vaccinated intramuscularly with a 0.5mL dose of HPV. Subsequently the patient experienced dizziness to the point of losing consciousness. The event lasted for a matter of seconds. The patient was well enough to leave in a few minutes. Additional information has been requested.
Very, Very bitter taste in the mouth. Frequently happened during the day about 1 hour after meals and other times like, when I woke up or in-between meals.  Lasted about 30-60 mins
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "obesity" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "sleep apnea" (unspecified if ongoing), notes: using a cpap for sleep apnea. The patient's concomitant medications were not reported. Past drug history included: Macrodantin, reaction(s): "Known allergies: macrodantin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included Paxlovid from 28Aug2023 to 31Aug2023.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
This spontaneous report was received from a certified medical assistant referring to a patient of unknown age and gender. The concurrent conditions and medical history were not provided. On 02-FEB-2016, the patient was vaccinated with improperly stored dose of PEDVAXHIB lot #: L030867, expiration date on 09-JUN-2018) route, dose and anatomical location were not reported). Concomitant therapies were not provided. No adverse events were reported. No product quality issues was involved. This is one of several reports coming from the same source. Additional information has been requested;
other than a bit of a "fog"; cramps in the back of my thighs; strong pain in the front of my shoulder joints/pain in hip; weakness in my hips and pain; numbness and tingling in my hands/feet; numbness and tingling in my hands/feet; have no fever but I feel flush; sore arm/pain and weakness in my hips and pain and weakness in my muscles of my forearms and hands.; am sensitive to heat; pain in my muscles of my forearms and hand; weakness in my muscles of my forearm and hand; This is a spontaneous report from a contactable consumer or other non hcp (patient).  A 58-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number and expiration date were not reported), via an unspecified route of administration, administered in right arm on 24Mar2021 at 11:00 hours (Age at vaccination was 58 years) as dose 2, single for covid-19 immunization. The devise date was 28Apr2021. Medical history included atrial fibrillation, irritable bowel syndrome from an unknown date and unknown if ongoing. Patient did not have known allergies. The patient concomitant medications were not reported. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for covid since vaccination.The patient did not receive any other vaccine within four weeks and any other medications within two weeks. Previously patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number and expiration date were not reported), via an unspecified route of administration, administered in left arm, on 24Feb2021 at 11:00 hours (Age at vaccination was 58 years) as dose 1, single for COVID-19 immunization and experienced sore arm. On an unspecified date in 2021 after second dose patient experienced very little side effects initially, other than a bit of a fog for about 24 hours and a sore arm. In the days or weeks that followed, he continued to have thigh cramps and pain in his shoulder joints. Patient also have new symptoms that are getting worse over the past few weeks including pain and weakness in his hips and pain and weakness in his muscles of his forearms and hands. He also had mild numbness and tingling in his hands or feet and was sensitive to heat in ways that didn't bother him before. Patient had no fever but he feel flush. Patient was concerned that the vaccine may had triggered some type of autoimmune response attacking his joints and muscles. Patient plan to see his doctor in a few weeks.  Therapeutic measures were not taken. The outcome of events was not recovered.   No follow-up attempts are needed. No further information is expected.