chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Missed Dose; Covid-19; No smell; Sneezing; No Taste; Chills; Arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid-19), PRODUCT DOSE OMISSION ISSUE (Missed Dose), PAIN IN EXTREMITY (Arm was sore), ANOSMIA (No smell) and SNEEZING (Sneezing) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced PAIN IN EXTREMITY (Arm was sore). On 30-Mar-2021, the patient experienced COVID-19 (Covid-19), ANOSMIA (No smell), SNEEZING (Sneezing), AGEUSIA (No Taste) and CHILLS (Chills). On 31-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed Dose). On 31-Mar-2021, PRODUCT DOSE OMISSION ISSUE (Missed Dose) had resolved. At the time of the report, COVID-19 (Covid-19), PAIN IN EXTREMITY (Arm was sore), ANOSMIA (No smell), SNEEZING (Sneezing), AGEUSIA (No Taste) and CHILLS (Chills) had not resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Mar-2021, COVID-19: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication were reported No treatment medication were reported.
rash (blotchy) on left dorsal foot and lower let as well as right foot and lower leg within 5 days post vaccination with yellow fever vac no urticaria, vesicles, edema.
Pfizer COVID-19 vaccine was administered to a 15 year old. No adverse reactions reported.
The vaccine did not prevent shingles as intended; severe vesicular outbreak, which was diagnosed as herpes zoster, or shingles; Information was received from a lawyer regarding a case in litigation concerning a female patient (pt) of unknown age. The pt's medical history, concurrent conditions, or concomitant medication were not provided. In an unspecified date in 2015, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, frequency, route of administration, anatomical location, lot number and expiration date were not provided) at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended (Vaccination failure), and the pt subsequently contracted a persistent strain condition of herpes zoster or shingles. Later that year, the pt was treated for a severe vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX) vaccine, and/or despite receiving the vaccine for long-term prevention of shingles, the pt suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the pt suffered and would continue to suffer significant medical expenses, pain and suffering, and other damages. The outcome of the events was not reported. The events were reported to be related to zoster vaccine live (ZOSTAVAX).
My husband died of a sudden massive heart attack.  He was one of two teachers who died after the moderna vaccine, second dose.  A third teacher had a stroke.
Information has been received from a health professional concerning a 20 year old female who on 22-JAN-2008 was vaccinated with first dose of GARDASIL. Per the reporter, on 24-JAN-2008 the patient called the office and complained she had a headache, nausea, vomiting and did not feel good. The office recommended that the patient treat the symptoms with over the counter medication and to call back on Monday. Per the reporter, the patient has not called back and calls to the patient's house have gone unanswered. The patient's present status is unknown and no other information is available. Additional information has been requested. Follow-up received 04/16/2008. Information from B Form 15-FEB-2008. The patient's adverse events were reported as a cough, vomiting, slight sore throat and an increased temperature. The patient's status is still unknown.
12/28 In the morning felt feverish and chills, shortness of breath. Went to PCP and after a physical advised to alternate between Tylenol and other pain relief/fever reducers. Fever got worse but only to 99.8 and kept fluctuating. Did not start feeling better until 12/31. On Sunday 01/01 only felt short of breath while walking. No more feverish chills. As of 01/3/2022 no fever, chill or headache, but still short of breath.
HPV vaccine adm at last MCV4 & BOOSTRIX given on (L) arm, first, HPV given on (R) arm. C/O pain after given mom was told to wait, said she would order shot records for siblings up front.
08/14/13 Right arm swollen from shoulder to elbow, very red, diameter of a softball, hard to touch, itches, no fever, breathing normal. No pain. Mom treated with BENADRYL and iced arm. Call into doctor.
vaccine was exposed to 31 degrees Fahrenheit for a couple of days/ no AE; Initial information was received on 18-Nov-2021 regarding an unsolicited valid non-serious case from a Pharmacist (under reference- 00864195) and transmitted to Sanofi on 18-Nov-2021.  This case is linked to cases 2021SA389706, 2021SA392839 and 2021SA392836 (CLUSTER).  This case involves a 76-year-old female patient who received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] that was exposed to 31 degrees Fahrenheit for a couple of days with no adverse event (product storage error).  The patient's medical history, past medical treatments, concomitant medications, vaccinations, and family history were not provided.   On 12-Nov-2021, the patient received 0.7 mL (total) dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [lot UJ764AC and expiry date 30-Jun-2022] via intramuscular route in left arm for prophylactic vaccination.  It was reported "Caller stated that co-worker called in to report the excursion on Monday. Caller wanted to know what would happen if patient took product after being exposed to temperatures 31Fahrenheit degrees. What to the product when exposed to low temperatures?"  It was case of an actual medication error due to product storage error temperature too low (latency was on same day).  At the time of report, 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 the 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.
4 y/o female received MMR, IPV in right deltoid. About 5 hours later she developed significant abdominal pain and achiness of her arms and legs. 36 hours later she developed pleuritis, redness, swelling that worsens and grew after 3 days.
she felt a little more local soreness than she did with the regular seasonal influenza shot; This is a spontaneous report from a non-contactable consumer (patient's husband). A female patient in her mid 30s received her first BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration on 20Dec2020 at a single dose for COVID-19 immunization. The patient's medical history was not reported. The patient's concomitant medications were not reported. The patient noted that she felt a little more local soreness than she did with the regular seasonal influenza shot on an unknown date in Dec2020. The outcome of the event was unknown.  No follow-up attempts are possible, information about lot/batch cannot be obtained. No further information is expected.
Client requested Pfizer -- after dose given, nurse realized he had received a Moderna for the Prime Dose.
Information has been received from a physician concerning an approximately 36 month old female patient who on 13-SEP-2007 received the first dose of ROTATEQ (Lot # 657659/0969U) and on unspecified dates received the second and third (2 mL, Oral) doses of ROTATEQ (Lot # 657511/0553U and 657672/0903U respectively). The patient started experiencing vomiting and diarrhea 5 days prior to visiting the physician's office (on 30-APR-2010). On 05-MAY-2010 the patient was brought to the office and on that day experienced 12 vomiting episodes and the physician sent the patient to ER. The patient was admitted and kept for 2 days and she was given IV hydration. On an unspecified date, a specimen test was positive for Rotavirus. The patient followed up with the physician on 11-MAY-2010 and was recovering well. Additional information has been requested.
Information has been received from a physician who is the father of a male who at "15 months of age" was vaccinated subcutaneously with a dose of varicell virus vaccine live 0.5 ml. In approximatel July 2003, "within the last month or two", the patient "broke out with chicken pox". It was noted that this "was more than a mild case" and that the child had "at least 50 lesions on the head alone, but no scarring." Unspecified medical attention was sought. There was no product quality complaint involved. The reporter also mentioned other patients (WAES #0308USA02392) and one sibling (WAES #0308USA02391) who experienced a similar reaction with varicella virus vaccine live. Additional information has been requested.
Information has been received from a medical assistant concerning a her 7 year old daughter with history of asthma and no drug reactions/allergies, who on 26-OCT-2001 was vaccinated with a dose of VARIVAX (Merck). There was no concomitant medication. On 20-MAR-2008 the patient experienced about 20-30 itchy, red pustule dermatomes on her head and a couple of pustule spots under her left ear. Unspecified medical attention was sought by an unspecified dermatologist who did a culture and confirmed the patient had shingles. No further information was available. The outcome was reported as recovering. There was no product quality complaint. Additional information has been requested. Follow-up has been received from a medical assistant concerning her 7 year old daughter female with a history of asthma and no drug reactions/allergies, who on 01-FEB-2002 was vaccinated with MMR II. It was previously reported that the patient was vaccinated with a dose of VARIVAX on 26-OCT-2001. On 13-MAR-2008 the patient had sudden onset of herpes zoster on the left side of her head. The patient treated with ACYCLOVIR 200mg/5cc and the patient "cleared up within one week". On 24-MAR-2008 the laboratory test confirmed Herpes Zoster. On 20-MAR-2008 the patient recovered from herpes zoster. No further information is available.
C/O blurred vision, cough, blood shot & swollen eyes, tight throat, low grade nausea approximately 4 hours after receiving flu shot.  Seen in ER, giving IV fluids, CT scan, blood work.  Felt "back to normal" within 24 hours after the shot.
Pt recvd vax NOV91 & on 24FEB92 pt devel pneumococcal pneumonia w/pleural effusion & sepsis; also hypotensive; pt hospitalized; BC revealed type 11 pneumoccosis; lab eval revealed elevated liver transaminases;
PATIENT FAINTED ROUGHLY 5-1O MINUTES AFTER RECEIVING VACCINE. WAS SEATED ON CHAIR AT THE TIME, SLUMPED OVER BUT DID NOT HIT HIS HEAD. PT DIAPHORETIC AND A+OX4. PT REPORTED NO KNOWLEDGE OF EVENT UNTIL MET WITH NURSE.
Treatment of COVID-19/Covid symptoms on day 11. Persistent low-grade symptoms headache sore throat and cough; Treatment of COVID-19/Covid symptoms on day 11. Persistent low-grade symptoms headache sore throat and cough; This is a spontaneous report received from a non-contactable consumer. The reporter is the patient.  A 71-year-old female patient received BNT162b2 (BNT162B2), on 16Apr2022 as dose 4 (booster), single (Lot number: FK9895), in right arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 23Jan2021 as dose 1, single (Lot number: 037K20A), in right arm, on 27Feb2021 as dose 2, single (Lot number: 026A21A), in right arm and on 15Nov2021 as dose 3 (booster), single (Lot number: 065F21A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: statins" (unspecified if ongoing). Concomitant medication(s) included: LEXAPRO; AMLODIPINE. Past drug history included: Lusinopril, reaction(s): "known allergies: Lusinopril". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19/Covid symptoms on day 11. Persistent low-grade symptoms headache sore throat and cough". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Return of Covid symptoms on day 11. Therapeutic measures were taken such as Paxlovid as a result of drug ineffective and covid-19. Additional information: The patient had return of Covid symptoms on day 11. Persistent low-grade symptoms headache sore throat and cough that have lasted one week (unspecified date).  No follow-up attempts are possible. No further information is expected.
On 12/12/2022, I felt cold and had a bit of a cough and fatigue. Tuesday night, I woke up at 2 AM with chills and took my temperature which was 101. Took an at home COVID-19 test on 12/14/2022 and it was positive. I still have a little bit of a cough and very congested. My fever hung around until 12/15/2022 but it seems to be gone for today. I am still feeling very tired with general body aches.
INITIALLY: Patient described having Flu- like symptoms of fatigue, body aches, also nausea within hours of receiving the vaccine.  She had to stay in bed for 2 days because of it and her arm was "extremely" sore, and the symptoms were on and off for the subsequent 2 weeks. THEN:  Patient gets admitted to the hospital on 5/15/21 (two weeks from the shot) for a HEART ATTACK.  She presented with  atypical symptoms, describing a "pulling sensation" in the back of her head and extreme weakness where she couldn't stand.  Patient was then hospitalized twice due to the heart attack, and will require open heart surgery which she is scheduled for later this month.  Patient is on several new medications now.
Vaccine unintentionally administered to a 17 year old. She had no adverse event from the vaccine
45 Y male with h/o IDDM, severe obesity (BMI 40.35), OSA, CT Chest findings suggestive of RAD, recent hospitalizations for hypoxic respiratory failure (8/22-8/26, 9/14-9/17 s/p prednisone taper) on home O2 2L, who presented with +COVID 9/29 with worsening shortness of breath and transferred to the ICU for rapidly escalating oxygen requirements.   Hx of recent admissions for acute on chronic hypoxic respiratory failure (8/2-8/26, 9/14-9/17) on 2L home O2, possible small airway disease. OSA with CPAP but not compliant at home, likely contributory factor of OHS and OSA. Hx of CAP 8/22 s/p cftx/azithro. Recent CTA 8/22 w/ possible small airway disease. Recently seen as an outpatient (9/21). CTA performed on last admission (08/22) with questionable subtle groundglass opacities in the upper lobes left greater than right which may be infectious or inflammatory, air trapping in upper lobes on expiratory views, diff dx bronchiolitis obliterans or other small airways disease. Outpt infectious workup overall negative. Thought to be possibly environmental, as patient works at a car company on the manufacturing line and is exposed to a lot of smoke & welding fumes. S/p recent prednisone taper  (9/14-9/25). Symptom onset on 9/28, SARS-CoV2 PCR positive on 9/29. spO2 95% on 40L 80% at time of presentation and required HFNC 40L 100% FiO2 to maintain SpO2 >95%. CXR 10/3 with diffuse multifocal consolidation and opacity suspicious for pneumonia.  Received remdesivir 200 mg Ivx1 and dexamethasone 6mg IV x2 in ED. CTA negative for PE but with GGO/ diffuse consolidations. ABG on 10/4 7.45/37/55. Continues to have borderline sats. Repeat ABG on 10/5 improved at 7.43/38/91. CXR unchanged. Currently with cough, SOB that may be exacerbated by anxiety and worsening COVID vs superimposed infection, although ABG improved and inflammatory markers down-trending. Procalcitonin elevated at 0.27, not elevated prior. D-dimer also elevated, suspect superimposed infection +/- PE as patient's oxygen needs have remained despite inflammatory markers down-trending. Pt left AMA 10/9.  Reason for Hospital Admission (Admitting Diagnosis):  Covid Pna  Pt was seen again in ED on 10/14 High Risk patient with Severe symptoms.  Sx are Stable but not improving  - Addressed patient's questions about COVID-19
Case previously recorded as MA2009-0432. Initial case report received from a physician via MedCom on 05 NOV 2009. A 34 year-old female patient was vaccinated during pregnancy with 0.5 mL of S-OIV FLUVIRIN (batch no. 100738) i.m on 03 NOV 2009. No adverse events were reported. MedCom reference no.: NA09-007596.
Female patient 45 and / or reports that one day after vaccination reports experiencing redness of the puncture area, headache, pressure on the neck, shoulders and chest. feeling of hardening, limitation of movement in neck and arms, palpitations. Patient reports that the day after vaccination the redness in the puncture area worsens and feels warm to the touch.
9:50 pt c/o mild pressure in middle of forehead and nervousness. Elevated legs and provided water. Pt took her own Tylenol at 10am. Reassessed at 10:15 due to pt coughing and constantly clearing throat, sensation that something was in her throat.  NP administered 25 mg Benadryl PO at 10:20.  Pt  stated head issue resolved after Tylenol @ 10:45.  10:50 symptoms resolved states feels better, denied headache, and throat discomfort. She was able to drink water and eat candy (patient brought the candy). Discharged at 11:03.
Went to ER on 4-29-09 c/o fever nausea and diarrhea and pain left arm - Followed up @ doctors office 4-30-09 and 5-6-09
Idiopathic Ischemic Stroke affecting Globus Pallitus and Patenum
Fever of 100.8; chills; headache; This is a spontaneous report from a contactable consumer (patient sister). A 66-year-old female patient received BNT162B2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) second dose via unspecified route of administration, administered in left arm on 02Feb2021 13:30 and first dose via unspecified route of administration, administered in left arm on 12Jan2021 3:00 PM as single dose for COVID-19 immunization. The patient medical history included prior breast cancer. The patient concomitant medications were not reported. 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 vaccination, patient had not tested for COVID-19. Patient does not for underwent lab test and procedures which included COVID-19 test for post vaccination. On 10Feb2021 03:00 PM patient experienced Fever of 100.8, chills, headache. This report was for reporter's sister who received the second dose of the Pfizer COVID vaccine. The reporter reported it on the day she told me about it also reported that within 24 hours of learning of her reaction as required under our reporting policy. The outcome of the events was recovered.  Follow-up (19-Feb2021): This is a follow-up spontaneous report in response to mail trail sent regarding confirmation of reporter and awareness date. This report included the awareness date.  Information about lot and batch number was requested.
Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) in a 36-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     The patient's past medical history included Fertility testing. Family history included Diabetes (father) since an unknown date. Concurrent medical conditions included Pregnancy and Alcohol use (2 drinks/week). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for Pregnancy, PROBIOTICS NOS and ACETYLSALICYLIC ACID (BABY ASPIRIN) for an unknown indication.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 03-Aug-2020 and the estimated date of delivery was 11-May-2021. On 07-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-second week of the pregnancy.  On 07-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (Maternal exposure during pregnancy) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2020, Pregnancy test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient's mother has history of fertility treatment. Patient has history of Pre-term labor scare in 01 OCT 2018.  Treatment information for the event was not provided. Estimated date of conception on 15 Aug 2020  patient take Alcohol 2drinks/week; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 36-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
armpit pain; Lump; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received first single dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER2613) via an unspecified route of administration on the left arm on 17Mar2021 at 16:45 (at the age of 31-year-old) for COVID-19 immunisation. Medical history of patient was not reported. The patient's concomitant medication included prenatal vitamins (MANUFACTURER UNKNOWN). The patient had no known allergies reported. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medication within two weeks of vaccination. On 26MAR2021 at 07:45, the patient experienced armpit pain, and lump under left armpit. The event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures and treatment were not taken for the adverse event. The clinical outcome of the events armpit pain and lump was unknown.   No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a pharmacist refers to a 77 year old male patient. Pharmacist reported that on 14-JAN-2015, the patient was inadvertently given with GARDASIL (lot #, dose and route not reported). No adverse effect reported. There was no additional information to report. Additional information has been requested.
Child received duplicate dose of IPV. Given individual vaccine along with combination vaccine, which already contained IPV.