chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient came in the pharmacy the next day and reported swollen lip and swollen right eye that developed about four hours after his FLUZONE HIGH DOSE flu shot.
sore arms; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. Post vaccination with Shingrix the patient had sore arms for several days. The patient had to revisit the pharmacy several times before he could get his second shot. This is 1 of the 3 cases reported by the same reporter for the same suspect.
Shortness of breath, swollen ankles. 05/10 - Visited E.R, was diagnosed with a Pulmonary embolism.
Initial information received on 04-Jun-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 10 years old male patient who had a cut in error, vaccinated with a dose of DAPTACEL (Batch number, expiry date, dose, dose in series, route and site of administration was not reported) on an unknown date. Patient's medical history and concomitant medications were not reported. It was a case of actual medication error due to Inappropriate age at vaccine administration. No adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 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. List of documents held by sender: none.
Patient broke out in hives on chest and neck about 5 minutes after the vaccination. This triggered chest tightness/asthma which patient took Albuterol. She also took BENADRYL and symptoms resolved after 3 hours.
Severe chills, looked like I was having seizures, extreme body aches, fever up to 101.7. Symptoms started within 10 hours of shot. Lasted 24 hours. Extremely lethargic, weak.
needle bent upon injection and as a result the vaccine ran down the patient and he did not receive any of the dose, with no reported adverse event; Initial information received on 23-Nov-2022 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 1 years old male patient and it was reported that the needle bent upon injection and as a result the vaccine ran down the patient and he did not receive any of the dose, with no reported adverse event while receiving HIB (PRP/T) vaccine [ACT-HIB].  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 (Daptacel); and pneumococcal vaccine conj 7V (CRM197) (Prevnar).  On 21-Nov-2022, the patient received a 0.5 ml dose of suspect HIB (PRP/T) vaccine powder and solvent for solution for injection with lot number- UJ646AAA and expiry date: 05-Mar-2023 (strength: unknown) via intramuscular route in the right thigh for prophylactic vaccination.   On 21-Nov-2022, the needle bent upon injection and as a result the vaccine ran down the patient and he did not receive any of the dose, with no reported adverse event (Inadvertent exposure to vaccine) (latency: same day) following the administration of HIB (PRP/T) vaccine.  Lab tests were not reported.  Action taken: Not applicable.  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.
This spontaneous report was received from a Medical Assistant referring to a patient of unknown age and gender.  The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On 20-NOV-2017,the patient was vaccinated with PNEUMOVAX 23 intramuscular (dose, frequency, and anatomical location were unknown) with lot # N025656 and expiration date 19-APR-2019 for prophylaxis. After this dose was given to the patient, the medical assistant received a call from her distributor. The distributor said "the  PNEUMOVAX 23 was unstable," but did not provide any details about how the PNEUMOVAX 23 became unstable. No known adverse effects. Medical assistant did not state that product looks different or unusual.
pt recv vax & p/vax pt devel a rash;another pt was reported who devel chickenpox p/vax (WAES97010072);
My menstrual cycle is all messed up. I am usually extremely regular and My periods have been coming late; My periods have been coming late, coming VERY heavy; Unusual ovarian pain; I am getting PMS symptoms like enlarged and painful breasts; I am getting PMS symptoms like enlarged and painful breasts; Bloating; Constipation; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8736) via an unspecified route of administration on 06May2021 (at the age of 31-year-old), as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Concomitant medications included fluticasone propionate (FLONASE) from an unknown date for an unknown indication. On 08May2021, the patient experienced menstrual cycle all messed up. The patient usually was extremely regular and periods had been coming late and very heavy, felt unusual ovarian pain, she was getting PMS symptoms like enlarged and painful breasts, bloating and constipation. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event menstrual cycle late, very heavy periods, unusual ovarian pain, enlarged and painful breasts, bloating and constipation was unknown at the time of this report.
Started 1 day after injection redness, tenderness and warmth to injection site. By next day fever, chills, worsening redness and warmth. Spreading to elbow. 1g Rocephin, Keflex 500 mg QID x 10 day
Patient reports that she started to develop persistent chest pain 2 days after her 1st dose of Covid Pfizer vaccine. Patient reported to the triage nurse "Ever since I got the covid shot, 5 months ago now, I've been having chest pain constantly. The palpitations occured for the first time last night multiple times intermittently. I feel sob too"
Received the vaccine on Jan 4 2021. Sore left arm for two days and nothing more. Woke up on Jan 13 2021 with itching, redness and swelling at the site of the injection. The irritation continues. It is not worse but not better either. Have also had headache for two days for which Tylenol has helped. No fever.
Patient fainted after being given the immunization. She has a history of fainting, However, she did not disclose this information because she hasn't fainted recently from an immunization and took the first Shingrix successfully.
Information has been received from a nurse concerning a twin patient who on 11-JUN-2009, was exposed through the mother who was vaccinated with the first dose of GARDASIL. On 20-JAN-2010, at approximately 36 weeks of gestation, the twin's mother delivered them by a planned C-section. It was noted that it was a repeat C-section for the mother. The nurse did not known the birth weights of the twin. The nurse also reported that there was nothing mentioned about any problems with either baby. The mother's experience has been captured in WAES 0906USA04966. The brother's experience has been captured in WAES 0906USA04966B2. No further information is available.
Baby cried excessively and inconsolably for approximately 2 hours 45 minutes. Patient given Tylenol in office. Baby sleeps after period of crying but wakes up crying excessively. At 3:20 PM baby stopped crying after sleep of 30 minutes.
She was able to speak a lot of clearer words after both covid shot; This is a spontaneous report from a contactable consumer (patient's son). A 90-Year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: unknown) via unspecified route on an unknown date at single dose for COVID-19 immunization. The patient's relevant medical history included Broca's Aphasia. Concomitant medication was not reported. It was reported that the 90-year-old patient who has Broca's Aphasia received her 2 shots. The patient was able to speak a lot of clearer words after both COVID shots. It was reported that this was extremely interesting, and they thought they would share the info. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Red, raised, itchy, hot circle the size of a tennis ball below injection; Red, raised, itchy, hot circle the size of a tennis ball below injection; Red, raised, itchy, hot circle the size of a tennis ball below injection; Throat glands are swollen; Throat is sore; Swallowing is uncomfortable; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 06Apr2021 at 13:45 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history included sulfa allergy and the patient had no other relevant medical history. Concomitant medications included guaifenesin, dextromethorphan hydrobromide (MUCINEX DM) tablet, taken from an unknown date for an unspecified indication. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 15Mar2021 at 12:45 (at the age of 54-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 09Apr2021, three days after the second vaccination, the patient experienced red, raised, itchy, hot circle the size of a tennis ball below injection. On the same day, the patient also experienced throat glands swollen, throat was sore and swallowing was uncomfortable. Therapeutic measures were not taken as a result of the events. The events did not result in a visit to the doctors or other healthcare professional office/clinic visit and emergency room/department or urgent care. The clinical outcome of the events red, raised, itchy, hot circle the size of a tennis ball below injection, throat glands swollen, throat was sore and swallowing was uncomfortable were not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
The next morning I woke up and my upper arm at and around the inject site was swollen, hard to the touch, splotchy red, and also warm to the touch. I had no other symptoms. This lasted for 3 days. It is now Tuesday May 19th and it?s slightly swollen but that is all.
Administer expired vaccine to patients/Dose administered after 30-day Use By Date or after manufacturer date of expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patients/Dose administered after 30-day Use By Date or after manufacturer date of expiry) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patients/Dose administered after 30-day Use By Date or after manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to patients/Dose administered after 30-day Use By Date or after manufacturer date of expiry) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  It was reported that 168 doses were administered with Lot number 048C21A. The vial did not undergo any temperature excursions. Date the vial initially stored in the refrigerator was unknown.  Treatment medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up received, reporter details updated.
In addition to the expected response such as fever, chilling, fatigue , for 24 hours, I had cardiac arrhythmias (PACs) lasting 1-2 hours on  February 24, 25 and 26, 2021.  No atrial fib but very frequent PACs which was highly unusual for me.  No atrial fib since July, 2020.  Also I think the expected response was for around 24 hours.  I was in the bed for 36 hours and felt fatigued from February 21, 2021 through February 26, 2021.
Information has been received on 31-JUL-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 27-MAR-2014, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a pharmacy as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. In 2016, the patient was treated at a medical center for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Red and swollen arm hot to the touch. Given RX for Keflex and Benadryl
Severe elevation of tinnitus starting on 4th day and lasting for 8 days/Disabling event. Back to work now, but still experiencing symptoms.
pt admitted to hospital for hypoxia; dx with COVID pneumonia; Vapotherm and BiPAP; in spite of aggressive measures, pt continued to be hypoxic; DNR/DNI; comfort care was instituted and pt died in the hospital
Palpitations for 10 minutes.  Forgot to take HTN meds and is feeling anxious.  Denies any HA, dizziness, CP, or SOB,  States she'll go home and take meds.  BP 202/110.  Doctor consulted and deemed her fit to be released.
shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. After receiving one Shingles vaccine, the patient got shingles.
Fever, extreme weakness, fainting, nausea, muscle pain, injection site pain, chills, swollen lymph nodes, headache, arm pain, cannot stand for more than 30 seconds. All symptoms have lasted many hours after onset (>6 hours)
Pfizer COVID-19 Vaccine EUA: Vaccine Administration Error - Extra Dose Patient received Pfizer Vaccines on 3/14/2021, 4/5/2021, 12/30/2021, and 1/20/2022. The fourth dose was administered in error to non-immunocompromised patient.
severe leg pain behind my knee; excruciating headaches; had random muscle twitching and sensations all over body in random places; had random muscle twitching and sensations all over body in random places; This is a spontaneous report from a contactable other Health Care Professional (patient). A 45-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported, patient was 45-year-old and not pregnant at the time of vaccination), via an unspecified route of administration, administered in Arm Left on 28Jul2021 at 12:00 PM as DOSE 1, SINGLE for covid-19 immunisation. Medical history reported as none. Concomitant medication(s) included levothyroxine sodium (SYNTHROID) taken for an unspecified indication received within 2 weeks of vaccination, start and stop date were not reported. The patient previously took morphine and experienced allergy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19; since the vaccination, the patient was not tested for COVID-19. On 30Jul2021 at 12:00 PM, the patient experienced severe leg pain behind my knee, excruciating headaches, had random muscle twitching and sensations all over body in random places. Reported that the shot followed by 3 days experienced events. AE resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events with Steroids. No seriousness criteria were reported. The outcomes of event were not recovered.   The lot number for the vaccine [BNT162B2] was not provided and will be requested during follow up.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Approximately 2 hours after receiving his injection the child became combative, irritable, sensitive to touch, hyperactive, banged head on wall, also experienced headache, Temperature 100, diarrhea 4 times. The side effects lasted from 12/8/00 - 12/10/00. The mother stated the child started behaving normally about 7 PM on 12/10/00. He had no problems with his sleep.
He had tingling and numbness in his face, right side that would then transiently be all over his body. He had a fever of 104 a couple hours after receiving vaccine.
some itchiness starting on THU night 12/16, picking up in the course of Friday 12/17 with rash and pustule all over the body with swollen feet and swollen fingers/ hands. Went to ER on SAT morning 12/18 at 4am. Reason for visit was noted as: Acute urticaria; allergic reaction and leg pain, swelling; Rash nausea.  We were able o leave the hospital around 11 am . Take home medication: Diphenhydramine, Prednisone, Ranitidine (Zantac). Swelling was gone after about 3 days - Rash and pustels come and go still today but seem to get better slowly
On 5/3/05, patient was given DTaP 0.5cc IM in the left arm and IPV 0.5cc SQ in the left arm. Prevnar 0.5cc IM given in right arm, and MMR 0.5cc SC given in right arm. Mother brought him in on 5/5/05 with complaints of redness on left and right deltoid. I noticed 6" of redness on left deltoid, firmness, and warm to touch and purplish discoloration at injection site (DTaP given at this site) on right deltoid noted a quarter size reddened area which was warm to touch. No firmness (Prevnar given at this site). Shots given at 9:00 AM. I recommended mother to take child to physician. Diagnosis of cellulitis. Put patient on Cephalexin for 10 days. Allergy testing done and Zyrtec PRN.
Patient is here for dizziness and left arm pain-tingling, that started after a hep B shot given in same day. Patient alert and oriented times 3.  Appears pale to face.
Headaches Persistent Low-Grade Fever (daily for over 4+ weeks) Fatigue Nausea
Pt recv vax on 10/23/98; on same day pt exp congestion, sneezing, cough & dizzy; 10/26/98 pt exp headache & lethargy; dx=R/O viral
Woke up at 3:00 AM with extreme itchiness to bilateral inner thighs .  Discovered many hives on inner thighs. As the day progressed, I began to have hives and severe itchiness throughout the rest if my body.  I have been having difficulty sleeping due to the rash and extreme itchiness. I bought over the counter zyrtec and pepsid and do experience mild relief but continue to randomly get rashes and hives on random parts of my body, including my face.
On 2/19/21 patient received Moderna covid vaccine to LA lot #038K20A.  On 3/19/21 patient received Pfizer covid vaccine to LD lot # EL9269, instead of 2nd Moderna vaccine in series. Error identified after patient left clinic. No adverse effects to patient reported.
Within 24 hours  - pt c/o HA - vertigo, amused response to louder sounds - symptoms persisted for 3 weeks - F/U with neurologist - Dx post vaccination syndrome - continues follow up.
At 3:40 when pt. rec'd her immunization There was immediate swelling at the injection site.  Site was reddish/blue, not hot to the touch.  Pt. states no pain, no itch, no bleeding.  Pt states she "feels a little shakey".  Pt was kept sitting upright in the immunization chair and is returning emails on her phone.  She was given a breakfast bar and water, as she stated she had a "small salad at 11:15 this morning". No epi required.  Pt was offered po benadryl but refused.  pt advised tylenol and ice applied to injection site when she gets home, and to notify her PCP if sx worsen.  Pt verbalized understanding and went home at 4:30pm.
Narrative:  2-16-2021 admitted with sepsis, pyelonephritis and "HAGMA with lactic acidosis". WBC 2.8K, AST 332, ALT 196, T bili 1.8, gap 1.8, Lactic acidosis" but no value seen on note. CT abd shows bilateral perinephric stranding and fluid. and mild adynamic ileus. admitted to ICU. vitals: 39.2C, HR 107, resps 19, BP 114/58, sat 96%. "awake but somnolent. cooperative, ill appearing....". not requiring vasopressors, continuing with IV fluids and trending lactate. COVID test pending. Discharged 2/23- 3 days in ICU and 5 days on the floor Diagnosis: PATIENT WITH SEVERE SEPSIS SECONDARY TO ACUTE PYELONEPHRITIS. WAS ADMITTED TO HOSPITAL HE HAD SEPSIS SECONDARY TO  PYELONEPHRITIS ,HAGMA WITH LACTIC ACIDOSIS , HE HAD PROFOUND INTRAVASCULAR VOLUME DEPLETION,ELEVATED LIVER ENZYMES PAROXYSMAL ATRIAL FIBRILLATION , THROMBOCYTOPENIA CHRONIC HYPERTENSION, DM TYPE 2 .PATIENT WITH LIFE ORGAN SYSTEM THREATENING CONDITION WHICH PATIENT WAS AT HIGH RISK OF DECOMPENSATION .EMPHYSEMATPUS CYSTITIS MILD ADYNAMIC ILEUS. Unable to review chart notes from patient's stay at hospital. Nothing scanned in to chart.