chrisvoncsefalvay/vaers-outcomes huggingface dataset:
bilateral stiffness in all knuckles; swelling in the ring and pinky fingers on both hands and just under the fingers on the palm sides are puffy; there is no pain, only slight discomfort when he "push it in"; He feels more resistance to close his hand; swelling around knuckles; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-2021592715 (Pfizer).  A 71 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 18May2021 15:30 (Lot number: EW0178) at the age of 71 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PERIPHERAL SWELLING (non-serious) with onset May2021, outcome "not recovered", described as "swelling around knuckles"; MUSCULOSKELETAL STIFFNESS (non-serious), outcome "unknown", described as "bilateral stiffness in all knuckles"; PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "swelling in the ring and pinky fingers on both hands and just under the fingers on the palm sides are puffy"; MUSCULOSKELETAL DISCOMFORT (non-serious), outcome "unknown", described as "there is no pain, only slight discomfort when he "push it in""; MUSCULAR WEAKNESS (non-serious), outcome "unknown", described as "He feels more resistance to close his hand". Therapeutic measures were not taken as a result of peripheral swelling, musculoskeletal stiffness, peripheral swelling, musculoskeletal discomfort, muscular weakness.  Additional information: Patient had no known allergies not even Penicillins. He states he noticed something different 3-4 days before when starting a leaf blower. He had difficulty getting it started. On an unknown date, he noticed bilateral stiffness in all knuckles, swelling in the ring and pinky fingers on both hands and just under the fingers on the palm sides are puffy. He states there was no pain, only slight discomfort when he "push it in". He feels more resistance to close his hand. It got a little bit worse last night. He felt it started late since he had read that most side effects occur within a day or two and go away. He wants to know would it go down eventually and is this normal. There was no emergency room or physician office visit. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. No other vaccine was administered on same date of the Pfizer suspect.  Follow-up attempts are completed. No further information is expected.
Swelling and warm, red rash on right leg at site of injection and diarrhea, loss of appetite from 1900 18DEC09 to present.  Told to give Benadryl.
Mom noticed redness around injection site the next day (10/01/2003) area of redness increasing.  Child complained of pain at site 5x6cm area of redness and swelling, warm to touch.
This spontaneous report was received from a Certified Medical Assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On 08-JAN-2017, the patient was vaccinated with an improperly stored dose of PROQUAD, lot number M006102, expiration date 01-AUG-2017, (dose, route and anatomical location were not reported), for prophylaxis. The temperature was greater than -10 Celsius degrees but less than 8 Celsius degrees for a time frame of 40 hours. The vaccines did not experience any previous temperature excursion and digital data logger was not involved. The outcome was reported as "Supported". No product quality complain was involved. No other suspect or concomitant therapies were reported. This is one of two reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA005705.
tingling sensation around the face, lips and throat--sensation of swelling of cheek--no swelling of tongue, no CP or SOB IM 50mg Benadryl given and observed in medical tent for 60 minutes. Vitals stable, improved symptoms during the observation time.
Experiencing sick, chemical smells bleach and all that; chemical smells bleach; This is a spontaneous report from a contactable consumer. This consumer reported for 25-year-old female patient (reporter's daughter) that:  A 25-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: Unknown), via an unspecified route of administration, in left arm on 13Aug2021 as a dose 1, single for COVID-19 immunization. The patient medical history and concomitant medication was not reported. On an unspecified date of Aug2021 the patient experienced sick, chemical smells bleach and all that. The reporter stated that the patient started experiencing sick a couple of days after reporters other daughter got the shot. Experiencing sick, chemical smells bleach and all that, patient told to reporter about that Thursday. Reporter thought it was something going on with patient sinuses. Reporter queried if that virus was introduced in patient body could get them sick. Reporter called the emergency room, and they could not tell reporter. Reporter queried if emergency room are sure, it cannot be shed. The response reporter had that Individuals who have received a COVID-19 vaccine cannot shed or release any of the vaccine components. In addition, none of the vaccines authorized for use contain a live virus so it was not possible to shed it. Reporter stated that for almost 2 years, they have been ok. When they go out, they wear masks, use hand sanitizers and sprays, and had never gotten sick. Reporter stated that she called the hospital the other day when her daughter got her shot and everyone else in the house got sick. Reporter was trying to figure out, even though they are not giving them the Corona virus, it was the same type of molecule or a fake virus. Reporter was clarified that her daughter, who took the COVID vaccine had not experienced anything. Reporters whole thing she read was that if it was COVID in the house, even if she got in the house, would they still experience the same type of symptoms. The outcome of the reported events was not recovered.  Information about lot/batch number cannot be obtained. No further information expected.
really sick; on her back with a 102 temp; joint pain; muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (really sick), PYREXIA (on her back with a 102 temp), ARTHRALGIA (joint pain) and MYALGIA (muscle pain) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048b21a and 025b21a) for COVID-19 vaccination.     The patient's past medical history included Crohn's.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Apr-2021, the patient experienced ILLNESS (really sick), PYREXIA (on her back with a 102 temp), ARTHRALGIA (joint pain) and MYALGIA (muscle pain). The patient was treated with IBUPROFEN for Pain, at an unspecified dose and frequency and KETOROLAC TROMETHAMINE (TORADOL) for Fever, at an unspecified dose and frequency. In May 2021, ILLNESS (really sick), PYREXIA (on her back with a 102 temp), ARTHRALGIA (joint pain) and MYALGIA (muscle pain) outcome was unknown.
Dose of Havrix was given 3 weeks before the correct schedule; This case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 19-month-old male patient who received HAV (Havrix) (batch number YR532, expiry date 9th September 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Havrix (1st dose received on 28th December 2020).   On 7th June 2021, the patient received the 2nd dose of Havrix and Havrix Pre-Filled Syringe Device. On 7th June 2021, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details provided were as follows: The patient received booster dose of Havrix  3 weeks before, which led to shortening of vaccination schedule. The reporter consent to follow up via email.
large blood clot in the right lung/smaller blood clot in the left lung; blood clot in the calf of the left leg; Baker's cyst behind the left knee; "I still didn't feel right or good"; "problems with my kidneys"; dull pain; "really bad chest pains"; "knee got swollen up"; This spontaneous case was reported by a patient and describes the occurrence of PULMONARY EMBOLISM (large blood clot in the right lung/smaller blood clot in the left lung) and THROMBOSIS (blood clot in the calf of the left leg) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was reported.  Concomitant products included LOSARTAN, NEBIVOLOL HYDROCHLORIDE (BYSTOLIC), OMEPRAZOLE, EZETIMIBE, CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), VITAMIN D [VITAMIN D NOS], CALCIUM, MULTIVITAMINS [VITAMINS NOS] and APIXABAN (ELIQUIS) for an unknown indication.    On 28-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced JOINT SWELLING ("knee got swollen up"). On 26-Apr-2021, the patient experienced PULMONARY EMBOLISM (large blood clot in the right lung/smaller blood clot in the left lung) (seriousness criteria hospitalization and medically significant) and CHEST PAIN ("really bad chest pains"). On an unknown date, the patient experienced THROMBOSIS (blood clot in the calf of the left leg) (seriousness criterion medically significant), SYNOVIAL CYST (Baker's cyst behind the left knee), MALAISE ("I still didn't feel right or good"), RENAL PAIN ("problems with my kidneys") and PAIN (dull pain). At the time of the report, PULMONARY EMBOLISM (large blood clot in the right lung/smaller blood clot in the left lung), THROMBOSIS (blood clot in the calf of the left leg), JOINT SWELLING ("knee got swollen up"), SYNOVIAL CYST (Baker's cyst behind the left knee), MALAISE ("I still didn't feel right or good"), CHEST PAIN ("really bad chest pains"), RENAL PAIN ("problems with my kidneys") and PAIN (dull pain) outcome was unknown.        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.   Company comment: Very limited information regarding this events has been provided at this time. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Very limited information regarding this events has been provided at this time. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Swelling and redness to the injection site. Instructed parent to apply a cold pack to area for 20 minutes at a time and if it doesnt go away becomes worse or is painful to call her medical home.
SUSPECTED IMMUNOLOGICAL VACCINE FAILURE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (Dose number in series was 1) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, administered on 10-DEC-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  The patient had an antibody test in NOV-2021, which was negative. After vaccination on 24-DEC-2021, the patient again had an antibody test which negative as well, hence suspected immunological vaccine failure. The patient asked that, did he had protection from the vaccine, or did the antibody test not recognize the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected immunological vaccine failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint.; Sender's Comments: V0:20211259113-COVID-19 VACCINE AD26.COV2.S-Suspected immunological vaccine failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS
Urticaria, welt at site. Rhinorrhea, lacrimation, laryngospasm.
expired on 03Apr2021 was given with no reported adverse event; Initial information was received on 09-Apr-2021 regarding an unsolicited valid non-serious case from a other health professional. (Inquiry number: 00555611).  It was reported that DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (lot number: C5611BA) (Suspension For Injection) was expired on 03-Apr-2021 and it was administered to a two-year-old male patient on 09-Apr-2021 for prophylactic vaccination (expired product administered).  It was a case of actual medication error due to expired vaccine used.  Concomitant medications included HEPATITIS A VACCINE, HEPATITIS B VACCINE and FLUZONE [FLUCONAZOLE].  At the time of report, no adverse event 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. 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.
Started with the morning after the vaccine I experienced dizziness and double vision. I had gone out to an event and came home early and was able to fall asleep for a few hours. I had body aches and very strong pain from neck down to my arms, the pain was so bad that at one point I got out of bed and fainted. I did take Tylenol but it was not helping with the pain. After that I experienced body aches, chills, strong fatigue and weakness in my limbs. Because some of the issues are similar to what I have with my health condition I decided to go to ER and the doctor determined that most of my symptoms neck stiffness, chills, body aches and dizziness to the vaccine. Today the pain has started to be better.
After the 15 minutes in observation, the patient called by phone to inform she was experiencing body itching and throat.
pt recv vax 2FEB98 & 3FEB98 & 4FEB98 lt arm had redness & mild swelling from elbow to shoulder;no rash 5FEB98;930AM 9FEB98 mom noticed rash beginning on ankles;big circular rash to knees;erythema multiforme;
Within about 1-2 hrs developed neck stiffness, watery eyes, sinus pressure after flu shot. Symptoms lasted about 24 hrs. No treatment was required.
STIFFNESS IN HANDS, FEET AND LEG; CHILLS; HEADACHE; This spontaneous report received from a patient concerned a female of unspecified age. 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: 1802068, and batch number: 1802068 expiry: 25-MAY-2021) dose was not reported, administered on 10-MAR-2021 to left arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced headache. On 18-MAR-2021, the subject experienced stiffness in hands, feet and leg. On 18-MAR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stiffness in hands, feet and leg, chills, and headache on 19-MAR-2021. This report was non-serious.
Initial report received from a non-healthcare professional on 10-Oct-2013. This case is part of 1 cluster cases and is linked to case number 2013SA103904 (same reporter, events after FLUZONE QIV, lot number: U4772AA). A patient whose gender, age, medical history and concomitant medications were not reported, received a dose of FLUZONE QIV (Lot number: U4772AA, expiration date: 30-Jun-2014) intramuscular route (site of vaccination was not reported) on 08-Oct-2013. On 09-Oct-2013, patient had 10 patients complain of pain at the injection site lasting several days and more painful than what they recall from previous years influenza vaccine. List of documents held by sender: none.
pt recvd vax; c/o "heart pounding" & "feeling faint: immed p/ vax;c/o sl nausea & red rash appeared on upper chest & neck;sxs persisted for 45mins;BP 142/90; HO inc 120; no SOB;
pt saw MD on Saturday 18APR98;dx w/cellulitis & lt inguinal, lymphadenitis;
Fever, cough, congestion, runny nose decreased appetite. Patient examined on 12/17/15, on presentation. Tx: diphenhydramine.
Information has been received from a physician concerning a 49 year old female with no known drug allergies who on 01/23/2001 was vaccinated with hep b vaccine recombinant and who on 02/19/2001 was vaccinated with hep b vaccine recombinant. The pt was started on Bizxin on 03/03/001. On 03/17/2001, the pt had experienced acute abdominal pain and had developed a chemical hep with elevated liver function tests. On 03/11/2001, the pt was seen by her physician for complaints of acute abdominal pain which had started on 03/17/2001. At that time, blood laboratory tests were performed which revealed a serum alanine aminotransferase of 1250, a serum alkaline phosphate of 371, a serum aspartate aminotransferase of 978, and a total serum bilirubinof 1.9 on 04/26/2001, blood laboratory tests were performed which revealed that her hepatic function tests had returned to normal limits. The reporting physician felt that the pt event may have been achemical hepatitis. On an unspecified date, therapy with Biaxin had been discontinued. Additional info has been requested.
Metallic taste and metallic cold feeling on tongue, intermittent. It was all the time the first two days, then it started to come and go, and has subsided over time to only be once or twice a day for roughly 15 minutes at a time.
Day 1-3 =pain; Day 1 - 5 = fatigue, chills, body aches, fatigue, fatigue, body aches, fatigue, fatigue.  Narrative:
Case number PHEH2016US016988, is an initial spontaneous report received from a nurse on 17 Oct 2016. This report refers to a female patient of unknown age. Medical history and concomitant medications were not reported. The patient  was vaccinated with an expired FLUVIRIN (batch number: 158105) at a dose of 0.5 ml intramuscularly on 17 Oct 2016. The nurse reported that, expired vaccine of Jun 2016 was given to a patient. No adverse event was reported following this administration error. The case was lot to follow up at initial.
Erythematous rash around injection site-- 5x5 cm-- and scarring from band aid at the ends- plans to start taking for the Benadryl tonight for the itching
Information has been received from a consumer concerning her 82 year old husband with high blood pressure, and a history of brain neoplasm and no known allergies who on 19-FEB-2008 was vaccinated with 0.65ml Zostavax. Concomitant therapy included "high blood pressure medication". On 21-FEB-2008, two days after receiving Zostavax the patient experienced a high fever of 103 degrees and began having convulsions. The patient was hospitalized for 4 days and became incoherent. The patient had unspecified blood work done and an MRI results are not reported. At the time of the report the patient was recovering in rehab. Additional information is not expected.
subconjunctival hemorrhage left eye; started about 54 hours after injection   (coincidence?)
Threw up; A little sore at the injection site; Terrible headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Terrible headache), VOMITING (Threw up) and VACCINATION SITE PAIN (A little sore at the injection site) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced HEADACHE (Terrible headache). On 11-Jan-2021, the patient experienced VOMITING (Threw up) and VACCINATION SITE PAIN (A little sore at the injection site). At the time of the report, HEADACHE (Terrible headache) was resolving and VOMITING (Threw up) and VACCINATION SITE PAIN (A little sore at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant and treatment information not provided Company comment:Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Swollen lymph nodes, fever, chills, overall weakness, swollen arm at injection site.
I came in there to have my right ankle sprain checked. They don't have x-ray so I'm going to Ortho till the next day and I said can I just have a flu shot. RN practitioner injected me with a tuberculin shot intramuscular on the left arm .5 mL instead of flu shot. CDC and poison control were called. They said no harm but that's supposedly intradermal. She has an intern with us in the room doing the computer work. She then proceeded with injecting flu shot on R arm. She gave me a post visit summary with a handwritten note at the bottom that stated she gave me an overdosed tuberculin shot. The next day Monday, 9/17/18, I went to Dr., my primary MD and Dr., my Ortho. I also called Advocate patient portal and spoke with RN but they don't know anything and referred me back to talk to pharmacy. I asked for another written report from clinic in pharmacy of my medical records Tuesday. I can't drive because of my R post tib tendon rupture per Ortho on Monday so I asked my husband to pick it up and there was no record of her giving the tuberculin injection to me. The mere fact that the wrong medication, wrong dose, and not documenting properly, as well as not following up is unacceptable. I am so enraged and at the same time very worried that I'm going to be positive for TB in the future. I'm a physical therapist and every year at work, we have a physical exam which includes TB testing which I am negative. I am so mad that she is incompetent.
Fever, lethargic, pain  Started day of. Hard to console unless nursing. Once asleep sleeps long stretches
Patient started to feel faint. Started to turn pale white.  Patient stated "I think I am having a reaction." Patient then blacked out and was unaware of his surroundings for a just a minute before coming to.