chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received 5 doses of the Johnson and Johnson vaccine.  Patient was observed post shot for extra 30 minutes.  No symptoms at time of discharge. Patient was checked on via phone call during the evening on 3/9/2021.  Wife stated that he had no adverse symptoms and that he had a good appetite.  Patient and wife were reminded that if patient feels bad to call 911.  Patient was checked again on 3/10/2021.   Pt reports minor headache, shoulder and neck pain.  Physician was made aware and Tylenol was prescribed for discomfort.
Temperature was 101.2F/100.5 degrees Fahrenheit; Felt fatigue; Congestion; Headache; felt warm; This is a spontaneous report from a contactable nurse (patient). A 23-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), second dose via an unspecified route of administration on 06Jan2021 at a single dose for COVID-19 immunization (direct patient care). The patient previously took first dose of bnt162b2 via an unspecified route of administration on 16Dec2020 at a single dose in the right deltoid for COVID-19 immunization and she had no side effects to. There were no medical history or concomitant medications. On 07Jan2021, the patient experienced temperature was 101.2 degrees Fahrenheit, felt fatigue, congestion and headache. She woke up this morning an felt warm, which was why she took her temperature. She also took paracetamol (TYLENOL) last night prior to bed but clarifies that she had no side effects last night from the COVID Vaccine. They all started this morning. Treatment included after she checked her temperature, she took 1000 mg of paracetamol. She rechecked her temperature 1.5 hours later and it was 100.5 degrees Fahrenheit. The paracetamol also helped her headache improve. The outcome of event temperature was 101.2F and headache and felt warm was recovering, outcome of events not recovered.   Relatedness of product to reactions temperature of 101.2 degrees Fahrenheit, fatigue, Congestion, Headache was assessed related by Primary Source Reporter. Events temperature of 101.2 degrees Fahrenheit and congestion were assessed related to COVID vaccine.   Information on the lot/batch number has been requested.
brain is slowed down; easily tired; fever/ temperature went up to 102/ body temperature has increased; cold; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (cold), BRADYPHRENIA (brain is slowed down), PYREXIA (fever/ temperature went up to 102/ body temperature has increased) and FATIGUE (easily tired) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041B21A and 046A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced NASOPHARYNGITIS (cold). On 17-Apr-2021, the patient experienced PYREXIA (fever/ temperature went up to 102/ body temperature has increased). On an unknown date, the patient experienced BRADYPHRENIA (brain is slowed down) and FATIGUE (easily tired). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. On 17-Apr-2021, PYREXIA (fever/ temperature went up to 102/ body temperature has increased) had resolved. On 18-Apr-2021, NASOPHARYNGITIS (cold) had resolved. At the time of the report, BRADYPHRENIA (brain is slowed down) and FATIGUE (easily tired) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Apr-2021, Body temperature: 102 (High) His temperature lowered by 18Apr2021,His body temperature was 99 degrees from time to time. When he gets up in the morning, it's 98.5. In the afternoon, it can go up to 99.2. In the evening after 10 PM, it drops down to 98.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   After the first dose, he was perfectly fine,he felt nothing, After the second dose, the reaction was pretty bad. He stated it got better after 2 days. Initially he got fever on 16Apr2021 and cold. This has been going on for 2 months. He still feels like he is easily tired.Prior togetting vaccinated, his body temperature was 97.5-98 degrees during the day. He states his body temperature has increased after getting the vaccine, and his brain is slowed down.   No  Concomitant medications were provided
Pt was very nervous about the injection. It was determined that she had anxiety related to the injection. She passed out and was unresponsive at times, cold sweats, limp. There were no signs of swelling  or throat closing. and airways were clear. All vitals were normal following the event, 911 was called and arrived within 5-10 minutes and check vitals again then administered oxygen and she became more responsive. Blood sugar was also checked with a hand-held device and finger stick blood sample. It was determined that she should go top the hospital for additional care and tests.
Upon injecting vaccine IM into the left deltoid, the needle separated from the syringe.  The person administering the vaccine thought that a minimal amount of vaccine was injected prior to separation of the needle from the syringe.
Pt vaccinated with DTP developed temp 104, cried excess more than 4 hrs.
Patient was intended to receive haemophilus vaccination but Menveo administered instead. Patient is in need of both vaccines so no harm done.
Flublok Quadrivalent was administered to two 11 year old female, no AE; Initial information received on 28-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked with 2019SA301738 (same reporter)  This case involves a 11 years old female patient who received a 0.5 ml dose of vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] lot: QFAA1963, expiry date: 30-Jun-2020 via intramuscular route in the right deltoid, on 24-Oct-2019.  The patient's past medical history, medical treatments, vaccinations and family history were not provided.  It was an actual medication error due to Inappropriate age at vaccine administration.  At the time of reporting the patient had no adverse 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 Directive 2001/83/EC and Module VI of the Good Pharmacovigilance 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.
had high heart rate after getting covid shot. 158/93, 117. Remained sitting and was fine after.
Diffuse rash predominently papular on legs and urticatial on thorax, mildly pruritic, approximately 7 days after immunization, treated with ceterizine and 40mg depo triamcinolone acetate,
Rash, red, raised pinpoint blotchy n/v, diarrhea, temp, rash became worse.  still present on 7/17/2014
Intermittent fever; Headaches; Aches in bones; Flu-like symptoms; Balance issues; Injured my knee; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Intermittent fever), HEADACHE (Headaches), BONE PAIN (Aches in bones), INFLUENZA LIKE ILLNESS (Flu-like symptoms) and BALANCE DISORDER (Balance issues) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No adverse event reported.).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) unknown. On an unknown date, the patient experienced PYREXIA (Intermittent fever), HEADACHE (Headaches), BONE PAIN (Aches in bones), INFLUENZA LIKE ILLNESS (Flu-like symptoms), BALANCE DISORDER (Balance issues) and JOINT INJURY (Injured my knee). At the time of the report, PYREXIA (Intermittent fever), HEADACHE (Headaches), BONE PAIN (Aches in bones), INFLUENZA LIKE ILLNESS (Flu-like symptoms), BALANCE DISORDER (Balance issues) and JOINT INJURY (Injured my knee) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications reported. No treatment information provided.
experiencing severe pain in lower abdomen, in the pelvis area; Shaking; Nausea; This spontaneous case was reported by a nurse and describes the occurrence of ABDOMINAL PAIN LOWER (experiencing severe pain in lower abdomen, in the pelvis area), TREMOR (Shaking) and NAUSEA (Nausea) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 03AK20A) for COVID-19 vaccination.     The patient's past medical history included Lower limb fracture (Patient broke her leg years ago.).   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced ABDOMINAL PAIN LOWER (experiencing severe pain in lower abdomen, in the pelvis area), TREMOR (Shaking) and NAUSEA (Nausea). At the time of the report, ABDOMINAL PAIN LOWER (experiencing severe pain in lower abdomen, in the pelvis area), TREMOR (Shaking) and NAUSEA (Nausea) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the event was not applicable.  No concomitant medications provided. No treatment information provided.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jun-2021: Event outcome updated to recovered.
Information has been received form a physician concerning an 18 year old female who was vaccinated with the 1st and 2nd doses of MMR II on 26-APR-1993 and 13-MAY-1997, respectively. On 25-NOV-200, the patient developed parotitis on the left side. On 29-NOV-2009 the patient experienced mumps on left side with fever. The outcome was unknown. Follow up information was received which reported that on 28-DEC-2009, the 18 year old patient (also reported as 16 year old) developed mumps on the left side without fever (previously reported as parotitis diagnosed on 25-NOV-2009 and mumps onset 29-NOV-2009). The patient was exposed to others with mumps. On 30-DEC-2009, the patient was diagnosed with left parotitis. At the time of this report, the outcome was unknown. Follow up information was received which reported that on 30-DEC-2009, laboratory tests revealed mumps immunuglobulin M antibody <1:10, mumps immunoglobulin g antibody 6.92 and amylase 282. At the time of this report, the outcome was unknown. This is one of several reports received from the same source. No further information is available.
Woke Up on Thursday and arm was swollen about half dollar sign amount at the  injection site.. Tissue underneath the skin was harder Area was raised about a quarter of an inch  Red and itchy  Vomited  Estimated date if delivery - 07/31/2021
Fatigue, Fever.  Erythema at injection site, Injection site pain, Swelling at injection site. Requires emergency room visit or hospitalization. Dizziness, headache, shortness of breath, myalgia. Diarrhea, nausea. Requires ER visit or hospitalization. ED visit. Needs further determination of action for next dose. Patient states she had her first dose of the Pfizer vaccine yesterday afternoon around 12:30 PM.  She states initially she felt okay and about an hour after getting home she started feeling nauseous and dizzy with standing and walking around.  She states later in the evening she started feeling increasingly short of breath with minimal activities and at times feeling like it is hard to get a deep breath then.  She denies any feelings of throat swelling or tongue swelling.  She was always able to handle her secretions.  She has been feeling nauseous but denies any vomiting.  She had 3 episodes of watery diarrhea yesterday and decreased appetite.  She does not believe she ever had COVID-19 and denies any recent ill contacts or known exposure.  She denies any complaints of chest pain but does admit to feelings of palpitations at times yesterday.  She has a pulse oximeter that she was able to check her heart rate at home and states that her pulse ox was always okay and heart rate was around 80s at home.  She does currently admit to mild nausea and aching in her right arm.  She denies dizziness while lying in bed but states she feels like it would be harder for her to get up and walk around. She has had previous allergic reactions to antibiotics but denies any history of throat swelling or anaphylaxis.  States her right arm looked red and has a burning sensation around the injection site but never noticed any rash or hives otherwise.  She took Tylenol and Motrin over-the-counter yesterday with some temporary improvement in the arm pain and headache that she was experiencing yesterday but has not yet taken any Tylenol or Motrin today.  She denies current headache.
refrigeration excursions identified; No Adverse Event; Vaccine have undergone several temperature excursions and was administered to the patient; This spontaneous case was reported by a nurse and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine have undergone several temperature excursions and was administered to the patient), PRODUCT TEMPERATURE EXCURSION ISSUE (refrigeration excursions identified) and NO ADVERSE EVENT (No Adverse Event) in a 59-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-Sep-2022 at 10:44 AM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 26-Sep-2022 at 10:44 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine have undergone several temperature excursions and was administered to the patient). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (refrigeration excursions identified) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine have undergone several temperature excursions and was administered to the patient), PRODUCT TEMPERATURE EXCURSION ISSUE (refrigeration excursions identified) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Vaccine have undergone several temperature excursions and was administered to the patient) and PRODUCT TEMPERATURE EXCURSION ISSUE (refrigeration excursions identified).    No concomitant medications were reported.  Patient had received previous 3 doses of vaccine, intramuscular with anatomical site as deltoid. Dose 4 anatomical site was also reported as deltoid.  On 07-Sep-2022, the vials were initially moved from freezer to refrigerator.  The nurse reported that, Moderna Monovalent and Bivalent vaccines stored in the refrigerator that underwent several temperature excursions going back in Aug-2022. It was reported that, refrigeration excursions were identified, and state vaccines were housed in these units. The manufactures were notified, and the state department made aware of the situation. The storage condition of vial at the time of excursion was in refrigerator. The vials were not visually inspected.  No adverse reactions reported for the patient.  No treatment medications were reported.
Next day after shot, felt like I had the flu. Body aches, sleepy and headaches. Felt fine the day after. May 25th, felt very lightheaded,dizzy and slight headaches. As of May 30th, still not feeling 100%.  Still feel slightly dizzy and lightheaded. Will be going to the doctor if it persists after today.
8/11/21 Received 1st dose of Moderna Covid shot 8/12/21 Woke up at 4am for work and heart was racing, left arm hurting. Heart rate continued 140 beats at rest for over an hour. Went to ER. Diagnosed with tachycardia and lactate 2.2.  I was seen by two emergency doctors (shift change) and both agreed it was possible symptom of the shot. Was given 2 bags of fluid. After receiving fluid my glands starting aching and had headache. Mid day at home had 101.1 fever. slept on and off rest of day. Drank fluids and switched between Tylenol and ibuprophen as instructed by ED doctors 8/13/21 Woke up at 2am with 102.6 fever, 120 heart rate, headache and aches. Again took tylenol, drank fluids. 8/14/21 Glands in neck are swollen, 99.5 low grade fever, headache, fatigue and just not feeling great. Tylenol and ibuprophen with drinking fluids.
Inc temp 38.5 (rectally), irritability, tremulous, hypoglycemia (<46).  12/31/2007 MR received for DOS 12/7/2007.  Newborn infant with newborn exam WNL noted to have developed temperture elevation of 38.5'C and tremulousness of feet bilat.  Initially hypoglycemic but tremors did not resolve with improvement in BS.  Tonic-clonic tremors of L foot >R foot, progressed to R arm. Transfered to higher level of care on date of birth. 01/14/2008 MR received for DOS 12/07-10/2007 with D/C Dx: Fever.  Hypertonia. Newborn infant admitted from hospital of birth with fever and seizure like activity (hypertonia/hyperreflexia with ? of myoclonus). Txd with empiric abx x 48hrs.  Neuro status greatly improved
Started with muscle pain in neck for 2 weeks. Around 11/17 pimples in the neck hairline popped up. By 11/21 the skin broke out in the left side of neck, on the left and back side of the head in the hair. Pain in throat. Needles and pins  in left side of the head, shoulder and inside of left arm. Consulted a physician on 11/23 and the conclusion was Shingles. Aciclovir 800mg was prescribed for 7 days. By 12/1 the skin had healed, but the pain got worse and the pins and needles are still there. On 12/2 I visited the Dr again and prescribed Gabapentin. From various sides I heard that the could be a link with the COVID vaccination. The vaccination affects the immune system and may wake up the dormant Chickenpox virus.
9 1/2cm x 4cm (R) outer thigh with erythema, no induration, no treatment at time of visit.
This spontaneous report as received from a registered pharmacist refers to a patient of unknown age and gender. On approximately 16-DEC-2014 "6-7 days ago", the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot # not reported). The pharmacist reported that in December 2014, the patient experienced feeling under the weather. The patient received treatment with an unspecified dose of prednisone which the patient had not begun taking at the time of the report. The outcome of feeling under the weather was unknown. Additional information has been requested.
A few days after receiving the first Moderna Covid-19 vaccine, the low level of tinnitus I normally have ramped up to pretty high levels. It is now June 25, three months later, and the ringing in my ears is still intense. Before my second dose, I researched online if anyone else had experienced tinnitus, or increased tinnitus, and saw that many people had. I called my doctor's office to discuss and we agreed that it would not be wise to take the second injection until the tinnitus resolved back to the low level that I normally have. I still have not taken the second Moderna shot. The doctor's nurse practitioner said the level of protection from Covid would still be effective with only one Moderna shot (in the 80% range), which is comparable to the J & J vaccine which is one dose, so that is what I chose to do. It is still bothering me quite a bit, so I am reporting it since it has not gone away even after 3 months.
Headache, fatigue, dry eyes, heartburn/sour stomach, fever and chills.
A few minutes after pts vaccine, she complained of dizziness, severe lightheadedness and pressure in her head like someone was squeezing it. We watched her for a few minutes but symptoms didn't get any better. We called EMS.  They monitored her for awhile. Pt didn't want to go to the ER. She called someone to pick her up and said she would go home and lay down. If her symptoms didn't improve she would go to the ER later.
Patient less than 18 years of age received dose # 2 of vaccine after inadvertently receiving dose # 1 previous month. No adverse reactions reported.
Nurse documented that she gave a Hepatitis A adult dose when she should have administered a pediatric/adolescent dose.
Post vax, the patient experienced a fever of 103F and chills. The patient had no other symptoms.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 12Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 15Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Type 1 diabetes" (unspecified if ongoing); "hypothyroidism" (unspecified if ongoing). Patient had no known allergies. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown result, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.   Clinical course: Anti viral details for COVID 19 Treatment included PAXLOVID (brand), treatment start date was on 15Jul2022 and treatment stop date on 18Jul2022. Patient got very nauseated and vomited after 5th dose of PAXLOVID and the taste was extremely bitter, which made patient vomit more. Patient stated that, "I would estimate that I vomited at least a half gallon of fluid." Adverse event start date/time reported as 17Jul2022 at 10:00 PM.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Site: Redness at Injection Site-Medium, Systemic: Flushed / Sweating-Medium, Additional Details: Patient reports severe flushing that occurred within 6 hours of receiving the Covid vaccine. Injection site, chest, and face were "very red and very warm," but no rash, swelling, or trouble breathing. Determined with patient best course of action to not get second vaccination unless determined by primary care physician that benefits outweigh risks.