chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a medical assistant concerning a 64 year old male patient who on 08OCT2003 was vaccinated IM in the deltoid with a 0.5 ml dose of pneumococcal 23v polysaccharide vaccine. The pt was also taking other medications. Approximately five hours post vaccination, the pt developed swelling, redness and pain at the injection site. The pt was treated with abx and Benadryl. laboratory tests were not performed. A product quality complaint was not involved. Follow up information was received form the physician concerning a retired 63 year old white male pt with hypertension, polycystic kidney and a drug allergy to alloparinol who on 06OCT2003 at 11:30 was vaccinated in the right deltoid with a first dose of pneumococcal 23v polysaccharide vaccine. An adverse event onset time of 9:22 on 07OCT2003 was noted. The pt called and stated his arm was sore and hurting where the vaccine was given. The pt had an oral temperature of 99.8 it he am. The pt was not able to sleep the previous night. Per the physician, the pt was to take Tylenol and Benadryl 25mg three times a day and use a cold compact The pt was instructed to come in if it got worse. On 10OCT2003, the pt recovered. The medical assistant also mentioned two other patient who had similar experiences post vaccination with pneumococcal 23v polysaccharide vaccine. Two of the three pt also felt tired. It was noted that the lot number was the same for all three patients. The records of testing prior to release of this lot have been checked by AQ and found to be satisfactory. The lot complies with the standards of the Center for Biologics Evaluation and research and was released. Additional information is not expected.
devel lt arm cellulitis starting @ proximal arm @ site of DTP/HIB <24hr p/vax;spread distally to wrist & proximally down lt trunk;arm very edematous, warm & erythematous;afeb;non pruritic;required hosp x 3d;Annual follow-up dated 9/27/00 provided no additional data.
pt recv vax 27MAY97 & exp rash which began in groin & soon covered whole body;seen by MD on 31MAY who prescribed zirtec;pt fingers became dry, cracked, & sore;6 days post vax fingers began peeling, progressing to the hands;
The patient fainted shortly after receiving the vaccine. She didn't seem to fully lose consciousness, once she was lowered to the floor by her significant other, she was awake. She stayed seated and received water and some candy and after 10-15 minutes of feeling fine, she got up and left the building.
Redness and pain at injection site -> given KEFLEX and BENADRYL. Dx -> cellulitis, no allergic rxn. Previous flu vaccine without issue.
Extreme dizziness and nausea the following morning. Was better by that evening and 100% better the next day. However, on March 1st I was dizzy in the morning and it took 45 minutes to pass. March 2 I was even dizzier in the morning and March 3rd was even worse with dizziness, I had to lie back down after getting ready for work.  Each day thereafter, the dizziness was less, but I am still experiencing an uncomfortable level of dizziness.  It is especially noticeable when I put my head back to drink water, or shampoo/rinse my hair or while trying to do usual morning exercises or scrolling on computer.  I feel like since the extreme dizzy episode on 2/20 that my equilibrium is affected, hopefully not permanently.  I have no other symptoms.  If this does not improve, I will go to my doctor.
Acute onset of SOB, chest pain over sternum, rapid heartbeat, nausea Wed. eve 4/8/03. Was weak but left better after going outside in cool air, worked on Thurs. 4/4 but still felt weak and had discomfort in chest.
Extreme fatigue & weakness; excruciating headache; body-wide muscle pain. Duration approximately 36 hours. Note: I have history of hypersensitivity to numerous drugs, but not "allergic" to any. Note: Having had 3 episodes of Shingles (1979, 2004, 2013), I enthusiastically awaited approval of this vaccine, and, despite a day-and-a-half of discomfort, will definitely have the 2nd inoculation! The expected immunity (as opposed to ineffective ZOSTAVAX) is definitely worth temporary pain!!
about 5 minutes after the patient received her vaccination she felt light headed and dizzy and vomited. her face appeared to be swollen by the rph so emergency medical was called. patient  did not complain of difficulty of breathing or sob  and explained face is naturally puffy. rph did not administer epi pen but monitored patient directly until emergency medical arrived. after their arrival the patients blood pressure was low (reading unknown) and the patient was transported to hospital.
metallic taste in my mouth; numbness in certain areas of my face, particularly around my lips/facial numbness; numbness in certain areas of my face, particularly around my lips; local anesthetic; noticed some sporadic tingling in my legs on the day of the vaccine; This is a spontaneous report from a contactable consumer or other non-healthcare profes-sional. A 32-years-old female patient received first dose of BNT162B2 (solution for injec-tion) via an unspecified route of administration on 01Feb2021 13:00 at single dose for for COVID-19 immunization. The patient medical history was not reported. Concomitant medica-tion included minerals nos, vitamins nos (PRENATAL VITAMINS), docosahexaenoic acid, eicosapentaenoic acid (OMEGA-3), probiotics (PROBIOTICS), colecalciferol (VITAMIN D). The patient previously took erythromycin and experienced hypersensitivity. The patient experienced immediately after receiving the vaccine metallic taste in my mouth and numbness in certain areas of my face, particularly around my lips. The numbness isn't complete (I can still feel when I touch my face), but it feels like being partially recovered from a local anes-thetic. I also noticed some sporadic tingling in my legs on the day of the vaccine. The facial numbness issue persists on 01Feb2021 13:00. The event considered non serious. The outcome of the event was not recovered.  Information on the lot/batch number has been requested.
Chills, aches, diarrhea, sore throat, sore arm/shoulder
190 patients (9 different lot numbers) received a vaccine past the beyond used by date; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    190 patients (9 different lot numbers) received a vaccine past the beyond used by date. This case belongs to 185 of 190 Cases. Concomitant medications were not reported.  No treatment information was provided by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:Master case
Nervous system disorder NOS; Severe uncontrollable body movements, my tongue was also affected; Allegedly having an adverse reaction with seizures; A spontaneous report was received from a consumer who was a 42-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced attack on nervous system, severe uncontrollable body movements, and allegedly having an adverse reaction with seizures.  The patient's medical history, as provided by the reporter, included hysterectomy.  No concomitant medications were provided.  On 04 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot Number: 011L20A) for prophylaxis of COVID-19 infection.   On 07 Jan 2021, the patient's tongue began to spasm.  On 08 Jan 2021, the patient's whole body had been convulsing all day.  The patient reported that it was attacking her nervous system on an undisclosed date.  She visited four hospitals in two days; all blood work was normal. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, attack on nervous system, severe uncontrollable body movements, and allegedly having an adverse reaction with seizures, was considered not recovered/not resolved.; Reporter's Comments: This case concerns a 42-year-old, female patient with medical history of hysterectomy, who experienced serious, unexpected event of seizures and non-serious, unexpected event of dyskinesia and nervous system disorder NOS. The events occurred 4 days after the first dose of mRNA-1273 (Lot Number: 011L20A) administration. Very limited information regarding this event has been provided at this time.  Based on temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Vaccine was not reconstituted. PT only received the diluent portion of vaccine.  Pt advised of error and will be recalled to administer complete dose.
Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Tachycardia-Medium, Systemic: Visual Changes/Disturbances-Mild, Systemic: Weakness-Mild, Additional Details: Oral benadryl liquid given (50mg) and 2 doses of Epi-pen given.  Ambulance arrived and transported patient to emergency room.
No additional AEs; an expired PEDVAX HIB dose was administered to one patient on today; This spontaneous report was received from a medical assistant referring to a patient of unknown age or gender.   No information regarding the patient's pertinent medical history, concurrent conditions, concomitant medication, or drug reactions/allergies was provided.  On 30-AUG-2021, the patient was vaccinated with an expired dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) (lot number UJ351AAB is an invalid lot number for Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB), and it does not match any Company product as confirmed by Lot Validation team) as 1 time dose for prophylaxis (administered dose, vaccination scheme, route of administration and anatomical location of vaccination were not reported; expiration date was reported as 09-AUG-2021) (expired product administered).  The reporter confirmed that Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) did not experience any temperature excursions. No additional adverse events (AEs) were reported.
Arm soreness, Emesis,  Nausea, Urge to vomit for 24 hours,  Insomnia, Lethargy,  Body aches, Diarrhea
client complained of feeling lightheaded  after receiving 1st Moderna Covid Vaccine. Client informed EMTs of dizziness. Vitals at 1310: blood pressure 100/70, pulse 61, oxygen 96%. Client stated history of fainting with needles, had not ate this morning. Current medications: antidepressant and adderall. RN joined team. Client able to transfer himself to anti gravity chair. Water given. 1320 vitals: blood pressure 110/70, pulse 61, oxygen 97%. 1325 per client dizziness resolved. 1330 vitals: blood pressure 120/70, pulse 61, oxygen 97%. Client given ER precautions. Mother present, driving client home. Per client symptoms resolved. Client left facility with steady gait at 1335.
I received the booster 10/1/2021 minor headache and aches 10/2/2021 but woke up 10/3/2021 massive lymphadenopathy under left arm size of baseball ready to explode and golf ball size in left supraclavicular so painful to touch could not move. used heat and advil to manage . Very red hot to touch as well as injection site hard swollen and hot. better little 10/4/2021 but still very tender and swollen. also filed incidence with work and seeing PCP tomorrow. I am an oncology nurse 35 years and never saw LN this large even with lymphoma.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. Concomitant medication and pertinent medical history were not provided. In 2002, the patient was vaccinated with the first dose of VARIVAX (Merck) (injection, 0.5ml, lot# was unknown) subcutaneously. In March 2013, the patient was vaccinated with the second dose of VARIVAX (Merck). In May 2014, the patient was inadvertently vaccinated with the third dose of VARIVAX (Merck). No symptoms reported. Additional information has been requested.
Hives, throat close, head red and itchy. Subsequent reaction 04/26/2016, 2:00 AM.
He got his 2nd vaccine, he had one day of falling asleep every hour for a 24 hour period.  He went to see his cardiologist and had an event monitor around 2/19/21, and wore that for a month which did not show the A-fib but that he was back into bradycardia.  He has had subsequent EKG's by his cardiologist and an Electrocardiophysiologist which was done on 9/22/21 and it was fine.  He continues to be on the Eliquis and was told to continue it.
ears are plugged; cough; stuffy head; diarrhea; tired/very fatigued; body aches; Chest heaviness/heavy chest; bad head cold/heavy duty cold; stuffy nose; headache; Swollen glands; Sore throat; Chills; Nausea; Runny nose; This is a spontaneous report from a 'contactable consumer and a physician. A 59-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0140, expiry date not reported), via an unspecified route of administration in the left arm on 11Jan2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously took first dose of bnt162b2 (lot number: EJT685, expiry date not reported) intramuscular in the left arm on 19Dec2020 at single dose for COVID-19 immunisation. On 11Jan2021, the patient felt tired/very fatigued, had body aches, chest heaviness/heavy chest, bad head cold/heavy duty cold, stuffy nose, headache, swollen glands, sore throat, chills, nausea, runny nose, ears are plugged, and diarrhea. On 12Jan2020, the patient experienced cough and stuffy head. Therapeutic measures were taken as a result of bad head cold. Clinical outcome of the events was unknown.
This spontaneous report as received from a nurse refers to a 27 year old female patient. The patient was seen in the office. On 28-JAN-2014 for a "post-partum" visit. At that time the patient received a dose of M-M-R II (lot # H016132, 31-AUG-2014) injection, 0.5 ml/once, subcutaneous. No concomitant medication was reported. The patient had a "pregnancy test" conducted. The pregnancy test showed "positive" and the nurse stated "we had already given the M-M-R II and then we learned she was pregnant". No treatment was given to the patient. The last menstrual period (LMP) and expected delivery of date (EDD) were unknown. Additional information has been requested.
Injection site is still red.  On Saturday, I had hives on my face and my throat was itching.  I took 2 doses of Benedryl between 12:30 and 1:30 pm.  By 4 pm. my face and airways felt fine.
Child had fever for 3 days and emesis rash Decreased PO intake child was sent to Hospital report was sent to Dr office stating child had mild dehydration in the setting of varicella chicken pox mouth lesions.
7/14 began with congestion, runny nose. Tested with an at home COVID 19 test, positive. 7/15 developed a cough and a fever that peaked at 99.5. Tested with rapid COVID 19 test, positive. Doctor called in a prescription for PAXLOVID. Didn't take the medicine. Prescription for TUSSIN cough medicine used. 7/16 felt weak, congested, productive cough, sore throat. 7/16 symptoms improved more through present.
Loss of hearing in left ear to high pitch noises, saw a ENT specialist in June and hearing test confirmed hearing loss, mri confirmed I have a 17mm benign vestibular schwnomma tumor on my nerve to the brain, also causing  dizziness and vertigo and balance issues and falls. I have loss of taste and smell. Everything tastes like salt to me. Always have a runny nose and sneezing and tired. Lot #s for injections EN6198 EN6204
About ten hours after vaccine I started feeling lightheaded, chills, fever, body aches and weakness. All through the the night I had flu like symptoms - chills, fever, aches. 24 hours after vaccine I am still feeling weak, fever, body aches.
4 hours after flu vaccine, blurry vision, itchiness, red eyes. Progressed and worsened over 3 weeks. 1/3/12-had colonoscopy. 1/17/12-hospitalized for complete blindness. MRI showed optic neuritis. Treated with steroids with.
Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Shakiness-Medium, Systemic: Weakness-Severe
This is a spontaneous report from a contactable consumer. A 96-years-old female patient (grandmother) received the second dose of PREVNAR 13, via an unspecified route of administration at single dose for pneumococcal immunization, on 13Sep2018, 30 days after the administration of the first dose. The patient medical history and concomitant medications were not reported. The patient received the first dose of pneumococcal 13-val conj vac (dipht crm197 protein) on 14Aug2018, 30 days before the second. On unknown date in 2018 the patient experienced immune system compromised with outcome of unknown. The event was serious due to hospitalization. Consumer reported her grandmother was given 2 injections of PREVNAR 13, 30 days apart. She received the first one on 14Aug2018 because it was mandatory before going into a nursing home. Consumer told the facility that her grandmother had received a pneumonia shot. Her records did not show that she had received the first one and she was given the second one. Consumer stated her grandmothers immune system was compromised. Whether someone is 52, 92 or 10 this shouldn't have happened. Consumer adds that this was potent and her grandmother was hospitalized. Consumer confirms she previously reported this to the safety department. Information on the batch number has been requested.
Family from another area new to city, mom is a nurse reported client experienced nausea, fatigue, malaise several days after immunizations.
Sore shoulder and pain lifting arm after 2 hours. Headache and mental fogginess after 3 hours. Fatigue and low-grade fever after 6-7 hours. Slept around 16 hours with no appetite, muscle aches (particularly in shoulder, back and abdomen) and fever of 102F. Swollen and painful lymph node in armpit on side shot was administered, and persistent fever lasting at least 40 hours. Icepick headache and sharp abdominal cramps upon standing occurred consistently between 24 and 40 hours after shot was received.
Redness and knot size of a silver dollar warm. Had a similar reaction to her pneumonia (PNU) vaccine. Resolved by the next Tuesday.
Significant increase of tinnitus that I didn't realize was perhaps caused by the vaccine.  This past year the ringing in my ears has been "different" than it was & constant.  Tinnitus runs in my family & I've had it for a number of years, but it has certainly increased.  I don't know for sure if it's related to the vaccine, but I haven't done/had anything  to cause it to increase as it has.
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient through other manufacturer (Pfizer Inc.) concerned a 44 year old male. Initial information was processed along with the additional information received on 13-APR-2023. The patient's height, and weight were not reported. The patient's concurrent conditions included: asthma, and penicillin allergy. The patient previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin not reported, batch number: 205A21A expiry: UNKNOWN) dose was not reported, 1 total administered on 03-MAY-2021 to left arm for covid-19 prophylaxis. It was unknown whether patient had any adverse events following covid-19 vaccine ad26.cov2.s (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin not reported, batch number: 211A21A expiry: UNKNOWN) dose was not reported, 1 total administered on 23-OCT-2021 to left arm for covid-19 prophylaxis. Age at time of vaccination 42 years old. Concomitant medications included salbutamol for unknown indication.  On an unspecified date in 2023, the patient experienced covid-19 infection (Confirmed covid-19 Infection) (Dose number in series 2)  for which patient received non-company suspect drug Paxlovid, (nirmatrelvir/ritonavir) (pill, route of admin, and batch number were not reported) dose and frequency were not reported from 24-MAR-2023 to 29-MAR-2023 for covid-19 treatment. Patient felt better 2 days after taking paxlovid and was tested negative on 29-MAR-2023 (last day of pills). On 04-APR-2023 10:00, 6 days after last dose patient felt stuffy and cough and tested positive which led to confirmed clinical vaccination failure (Dose number in series 2). On 29-MAR-2023, Laboratory data included: COVID-19 virus test Negative. On 04-APR-2023, Laboratory data included: COVID-19 virus test Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with nirmatrelvir/ritonavir was not reported. The patient had not recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000278873.; Sender's Comments: V0: 20230425035- confirmed clinical vaccination failure . The event 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. Specifically: SPECIAL SITUATIONS. Therefore, this event is considered inconsistent with vaccine administration.
PER PATIENT SHE REPORTS SHE HAS BURSITIS ON RIGHT ARM AS ARESULT OF THE FLU SHOT. SHE SAW DR (HER PCP) ON 11/11/2019 AND ACCORDING TO PATIENT THAT WAS THE DR'S DIAGNOSIS.