chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swelling and redness at the injection site, and swelling of the lymph nodes on the left side near her collar bone.
acthib was administered with an expired diluent with no reported adverse event; Initial information received on 20-Mar-2023 regarding an unsolicited valid non-serious case received from nurse.  This case involves a 1 years old male patient who was administered HIB (PRP/T) VACCINE [ACT-HIB] with an expired diluent with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) and PNEUMOCOCCAL VACCINE CONJ (PNEUMOCOCCAL CONJUGATE VACCINE) both for Prophylactic vaccination.  On 14-Mar-2023, the patient received a dose of 0.5 ml dose 3 of suspect ACT-HIB (Powder and solvent for solution for injection) (Lot: HIB: UJ646AA, DILUENT: U7251AA, Expiry date: HIB: 01APR2023, DILUENT: 05MAR2023) (strength: standard; frequency: once) via intramuscular route in the right thigh for immunization.  On 14-Mar-2023 the patient was administered ACT-HIB with an expired diluent with no reported adverse event (expired product administered) (latency: same day).  It was reported that Caller with question on whether dose needs repeating.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.   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 the guidelines. 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.
Itchy all over, sick to her stomach, dizzy. Had Tylenol/codeine.
I have a rash that is red an inflamed with bumps an some swelling and itches horribly; an inflamed with bumps an some swelling; itches horribly; inflammed; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (I have a rash that is red an inflamed with bumps an some swelling and itches horribly), SWELLING (an inflamed with bumps an some swelling), PRURITUS (itches horribly) and INFLAMMATION (inflammed) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 16-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-May-2021, the patient experienced RASH ERYTHEMATOUS (I have a rash that is red an inflamed with bumps an some swelling and itches horribly). On an unknown date, the patient experienced SWELLING (an inflamed with bumps an some swelling), PRURITUS (itches horribly) and INFLAMMATION (inflammed). At the time of the report, RASH ERYTHEMATOUS (I have a rash that is red an inflamed with bumps an some swelling and itches horribly) outcome was unknown.            No concomitant medication was provided.  No Treatment medication was provided.
12/12/2022, in the evening, I began to experience sore throat and sinus congestion. I took a COVID-19 test the next morning. I took off work for two weeks. Symptoms worsened, I had a lot of fatigue, could not get warm. I never ran a fever. I still have a cough.
Blistery rash first appeared on 4/6/21 near right eye.  Blistery, itcy  rash on right part of face near eye worsened, swelling of right side of face & eye & slight blistery itchy rash on right forearm and wrist began on 4/16/21, numbness in face and lips, additional rash on forearm and wrist, as well as a few sharp pains that run up and down right leg into right foot began on 4/18/21, .  Went to ER on 4/18/21 at about 10 a.m. was told this was shingles and given Valacyclovir medication to treat it.  Numbness starting to lessen, but swelling still persists as of 4/19/21.
itchy red rash on my chest and arms; very red, hot face; very red, hot face; This is a spontaneous case received from a contactable consumer (patient herself). A 34-year-old female patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EN6205) via an unspecified route of administration in left arm on 11Mar2021 17:40 (age at vaccination 34-year-old) as DOSE 1, SINGLE for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The patient's medical history included thrombocytopenia and 3 months postpartum/breastfeeding. Concomitant medications included aminobenzoic acid, biotin, calcium pantothenate, choline bitartrate, cyanocobalamin, folic acid, inositol, nicotinamide, pyridoxine hydrochloride, riboflavin, thiamine mononitrate (B COMPLEX [AMINOBENZOIC ACID, BIOTIN, CALCIUM PANTOTHENATE, CHOLINE BITARTRATE, CYANOCOBALAMIN, FOLIC ACID, INOSITOL, NICOTINAMIDE, PYRIDOXINE HYDROCHLORIDE, RIBOFLAVIN, THIAMINE MONONITRATE]), SELENIUM, VITAMIN C [ASCORBIC ACID], VITAMIN D NOS, ZINC, GoatsRue, Shatavari. The patient had known allergies with sulfa drugs, apple/pear and diary. Other vaccine administered in four weeks was reported as none. COVID prior vaccination and COVID tested post vaccination was reported as none. On 12Mar2021 09:10, the patient stated that she received the vaccine at 5:45 PM on Thursday, at Friday morning at 9:10 AM had a very red, hot face. Ten minutes later she had an itchy red rash on her chest and arms. No fever, she could breath find and it went away after an hour or so. No treatment was taken for the events. Outcome of the events was recovered on an unknown date in 2021.  No follow-up attempts are possible. No further information was expected.
w/in 12hr of inj sx nausea, vomit, weakness, dizziness, irritability;sx cont no further vomiting;saw MD for pregnancy test negative;hx naprosyn d/c 1 1/2wk ago;dx fibromyalgia;
Flu vaccine given @ 0922 AM.  Onset of chills (shaking) followed by fever to 102 degrees.  C/O nausea, diarrhea and muscle aches.  Also c/o fingers on left hand were numb feeling.  Took OTC antacid for stomach upset.  Symptoms resolved by 0800 on 9-16-09.
Patient came to get Pfizer  Pediatric 5-11 bivalent booster, but got Pfizer pediatric 5-11 Mono-valent vaccine
Developed right testicular pain within 12 hours, associated with mild chills and malaise.  Symptoms lasted for 48 hours.  The testicular pain is improving but not fully resolved.  Treatment started today with levofloxacin empirically.
Myalgia, Arthralgia, Fever, INDURATION, ELEVATED LUMP TO LEFT DELTOID Narrative:  Other Relevant History:
Redness and itching at injection site, itchy rash patches on right arm and right side of torso.
This case was reported by a physician via sales rep and described the occurrence of erythema of extremities in a adult female patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced erythema of extremities. On an unknown date, the outcome of the erythema of extremities was recovered/resolved. It was unknown if the reporter considered the erythema of extremities to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported, but the patient was in her 50s. The patient arm was red for an entire week after receiving SHINGRIX. The reporter did not agree to be contacted for follow up.
Night sweats, fever, chills, body aches, headache and sinus pressure from 1AM-6AM. Body aches and headache  have continued into the day, and I am currently experiencing them.
Tingling in leg , feet and arms  , muscle twitching in legs  , brain fog , headaches
she gave a patient a dose of MMR II that was expired; This spontaneous report, as received from a nurse refers to a 64-year-old male patient. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided.  On 30-OCT-2020, the patient was vaccinated with an expired dose of: measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (albumin status: recombinant human albumin rHA), lot # R028003, expiration date: 01-OCT-2020, 0.5 milliliter (route of administration was not reported) for prophylaxis. No additional adverse event (AE) details were available.
Information has been received from a physician concerning an approximately 36 month old female patient with no pertinent medical history who was vaccinated with a first dose of VARIVAX (Merck).  The physician reported that the patient experienced 2 breakthrough cases of chickenpox after being vaccinated 2 different times.  The first breakthrough occurred when the patient was about 3 years of age after the patient received the first dose of the vaccine on an unspecified date.  Sometime in 2004, the patient received her second dose and experienced the second breakthrough case, about 8 months later.  Unspecified medical attention was sought.  At the time of the report the patient had recovered.  Additional information has been requested.
Patient was given monovalent vaccine instead of bivalent vaccine. Patient states they have a sore arm.
Aux lymph nodes under left armpit are very swollen; Sore at injection site; Slept all day; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (Slept all day), LYMPHADENOPATHY (Aux lymph nodes under left armpit are very swollen) and VACCINATION SITE PAIN (Sore at injection site) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 052C21A, 025L20A and 011J20A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised (Immunocompromised with lupus but in remission) and Insomnia. Concomitant products included ESZOPICLONE (LUNESTA) for Insomnia, HYDROXYCHLOROQUINE SULFATE (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]) and GABAPENTIN for an unknown indication.   On 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Aug-2021, the patient experienced HYPERSOMNIA (Slept all day) and VACCINATION SITE PAIN (Sore at injection site). On 23-Aug-2021, the patient experienced LYMPHADENOPATHY (Aux lymph nodes under left armpit are very swollen). On 23-Aug-2021, HYPERSOMNIA (Slept all day) had resolved. At the time of the report, LYMPHADENOPATHY (Aux lymph nodes under left armpit are very swollen) and VACCINATION SITE PAIN (Sore at injection site) outcome was unknown.            Concomitant medication including Multivitamin/calcium was reported.  No treatment information was provided.   This case was linked to MOD-2021-294485, MOD-2021-294519 (Patient Link).
pt started getting nauseated and tired.  She woke up with tightness in her chest.  She thought she was having a heart attack.  She is having  pain that starts in her chest and goes to her left shoulder and then down her left arm.  Her left ring finger and pinky finger are numb.  Pt states these sharp pains will come and go.  She has been taking Aleve for her pain.  Says once the medicine wears off the pain comes back.  She has been having these sharp pains for over two weeks. Pt will contact her PCP today for medical advice.
I gave the MCV MENACTRA vaccine first in the right deltoid and then the HPV GARDASIL 9 in the right deltoid. Patient stated she was ok I then put syringes and needles in the sharps container and then took my gloves off and threw them away, I asked patient if she felt ok she stated yes then I stated that we were going to keep her for a few minutes to monitor her this is when she began to pass out and began leaning to her left side. Patient was still on the exam table I grabbed her so that she would not fall off and laid her down. I began trying to get her to respond when she began to start mild convulsions, I opened door with one hand still on  my patient and asked the employee to assist me because she was right outside the door. Patient was still having mild convulsions and had a loss of urine. I went to grab PAC-C and a pulse oximetry to do vitals. Blood pressure was taken by employee and it was stable at 120/80 and oxygen stats were stable in the 98%. By this time patient had already stopped with convulsions and was talking to PA-C who was next to her trying to calm her down, patient was very shaken up and scared. Patient recovered well and was taken home by her mother. Patient will follow up in one week with PA-C.
This spontaneous report as received from a nurse (also reported as a medical assistant), refers to an unspecified number of patients of unknown age and gender. No information on patients' concomitant medications, pertinent medical history, drug reactions or allergies was reported. On unknown dates, the patients were orally administered improperly stored doses of ROTATEQ, lot # L039640, expiration date: 24-AUG-2017 (dose not reported). The administered doses experienced a temperature excursion of 33.4 degrees Fahrenheit for 7 hours. The temperature excursion was detected by a data logger. There were no previous temperature excursions. No adverse effects were reported. This is one of two reports from the same reporter.  Additional information has been requested.
Patient was administered the Johnson and Johnson Janssen COVID-19 vaccine.  Shortly after, a few seconds, the patient stated he felt flushed and head started to fall back. Staff member cradled his head and called another staff member over.  Staff member called 9-1-1.  Patient went unconscious and his eyes rolled back for approximately 30 seconds.  When aware, we (staff members) transferred patient from the chair to the floor where staff member supported his back and fanned him due to his profuse sweating.  Staff member continued talking to him when he became unconscious again, this time gasping for air and turning pale.  We kept saying his name until he came to again and was somewhat aware of his surroundings.  He fainted one last time.  After this time, he sat up on his own and seemed to be very coherent.  The EMS arrived shortly after and took over.  They said they would take him out to check him out but he seemed to be doing better.  An EMS personnel let us know the patient did tell him that he has fainted from vaccines before.  However, he did not disclose this to us on the PQCF form or when asked verbally.
Day 1 of vaccine 1/4/21-no symptoms.  Day 2-1/5/21-Left arm and all left side down arm, leg to foot sore and painful and having headache.  Day 3-1/6/21-Now having all over body aches, painful and still having headache. Day 4-1/6/21-Vaccine site is now very tender and sore, and upper body mildly sore. Day 5-1/7/21 No symptoms.
Numbness/tingling sensation in left arm; Reduction of motor skills in left arm; Occasional mild pain; Numbness/tingling sensation in leftarm; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the arm left on 05Apr2021 at 14:30 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history.  The patient did not receive any concomitant medications. The patient had no known allergies. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6205) via an unspecified route of administration in the arm left on 15Mar2021 at 14:45 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Apr2021 at 17:00 the patient experienced numbness/tingling sensation in left arm, occasional mild pain and reduction of motor skills in left arm. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events numbness/tingling sensation in left arm, occasional mild pain and reduction of motor skills in left arm was not resolved at the time of this report.    No follow-up attempts are needed. No further information is expected.
Patient vomited with the first Rotateq but no other problems.  She took half of the 2nd dose of Rotateq and then vomited forcefully twice.  She had no associated coughing or gagging.
This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old female patient who received KINRIX (batch number 3ZL2Y, expiry date 27th March 2016). In December 2014, the patient received KINRIX. On an unknown date, an unknown time after receiving KINRIX, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown. Additional information received: KINRIX administered to a 4 month old.
About 36 hours after receiving both shots high up  in my upper left arm, I had excruciating pain in my shoulder and could not lift my left arm in front of me.  The pain has gotten worse over the last 5 weeks.  Doctor prescribed PT that starts Sec 5th.
Mother states that pt. fell asleep minutes after the immunizations. woke up approximately 1 1/2 later 7 had 3 1/2-4 hours of unconsolable crying.
After getting flu shot, (L) arm at site of injection became swollen - no redness noted, no itching.
Have had Tourette's Syndrome all my life. It was showing up at 5%, all of the sudden at 100%+. right at the time of the COVID shot; Have had Tourette's Syndrome all my life. It was showing up at 5%, all of the sudden at 100%+. right at the time of the COVID shot; This is a spontaneous report from a contactable consumer (patient). A 61-years-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for Injection, Batch/Lot Number: ER8733) via an unspecified route of administration, administered in left arm on 30Apr2021 at 04:00 PM (vaccinated at the age of 61 years) as a single dose for covid-19 immunization. Medical history included heart issues and ongoing tourette's syndrome. No known allergies. Concomitant medications included clopidogrel bisulfate (PLAVIX), metoprolol, atorvastatin (LIPITOR), carbamazepine and lisinopril dihydrate (LISINO); all taken for an unspecified indication from an unknown date, the patient received within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient was not diagnosed with COVID-19, Since the vaccination, the patient had not been tested for COVID-19. On 01May2021 at 04:00 PM, the patient reported that he had Tourette's Syndrome all his life which shows 5%, all of the sudden at 100%+ right at the time of the COVID shot. Adverse event resulted in doctor or other healthcare professional office/clinic visit. No treatment was given for the event. The outcome of the event was not recovered.  Additional information on the lot/batch number has been requested.
Nosebleed; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  A 72-year-old female patient received BNT162b2 (BNT162B2), on 28Jan2022 as dose 3 (booster), single (Lot number: FJ5683) at the age of 72 years for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "Vascular Carotid Surgery", start date: Nov2021 (unspecified if ongoing). Concomitant medication(s) included: CLOPIDOGREL, start date: 2021; LISINOPRIL taken for hypertension, start date: 2021; LASIX [FUROSEMIDE], start date: 2021; LIPITOR, start date: 2021; ASPIRIN 81, start date: 2021. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot Number: EW0191), administration date: 07Jun2021, when the patient was 71-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2, SINGLE; Lot Number: EW0217), administration date: 01Jul2021, when the patient was 71-year-old, for COVID-19 immunization, reaction(s): "Nosebleed", "Vascular Carotid Surgery". The following information was reported: EPISTAXIS (non-serious), outcome "unknown", described as "Nosebleed". Therapeutic measures were taken as a result of epistaxis.  Additional information: The patient did not receive any other vaccine within 4 weeks prior to vaccinations. The patient received the first, second, and booster doses of the vaccine. After the second dose and the booster dose the patient had nosebleeds. The reporter wanted to know the information related to the vaccine and blood thinners. It was reported that nosebleed occurred after the patients second dose and booster dose of the vaccine. Stated that it was not severe. The patient would feel something in nose and then when she would blow it there would be blood. Adverse event treatment included Vitamin C, so the patient increased her Vitamin C at that time and the nosebleed went away after several days. It was reported that nosebleed was more after the second dose of the vaccine than the booster dose of the vaccine. When the reporter realized she will probably need a second booster and was thinking somewhat surprised that it happened with the patients booster dose. The patient was on several medications. Initially reported that the patients question was related to Lipitor, which she states she thinks it was a blood thinner. It was reported that blood thinner was Plavix, Clopidogrel; not Lipitor. Clopidogrel was in a pharmacy vial. The reported that Lipitor was an Aspirin, then stated no, maybe it was a Calcium. The reporter reported no further information related to her Lipitor.