chrisvoncsefalvay/vaers-outcomes huggingface dataset:
We received the following information for a Novartis Vaccines and Diagnostics employee on 06 NOV 2009: A male patient was vaccinated with H1N1 (batch number or manufacturer unknown) on 30 OCT 2009. The patient has ever had diarrhea since then. He was scheduled to have a stool sample examined by his health care provider on 07 NOV 2009. This case was previously reported as MA2009-3773. Follow up information via e-mail from consumer received on 20 Jan 2010: The patient developed mettalic taste in the mouth. He felt better after few days; so, he never had in a stool sample examination. No other new information was reported. Follow up report received via e-mail from consumer on 22 Feb 2010: The patient reported that he was feeling very well, since he received the H1N1 vaccine. The patient had diarrhea and was about to submit stool sample to the health care provider, but the symptoms went away after a few days (exact date not specified).
I took 2 vaccine (simultaneously) Basic arm tightness and malaise, tolerable for 2 to 3 days.... Headache for one week affecting nerve damaged by Shringle on L side of top of head.  It bacame Hypnic Headache by 4th and 5th days, and now became Circul Rhy Sleep Disorder (CRSD) waking up at 2pm every night. I am a person that have no headache usually. Concern will be if I should take any COVID vaccine in the future causing more headache problems???
Care facility nurse asked EMS staff to give patient a Covid vaccine. EMT gave vaccine and then it was discovered in our covid vaccine reporting system that patient had already had 2 Moderna covid 19 vaccines .
On an unknown dates an unspecified number of unspecified patients received VARIVAX or PROQUAD that wasimproperly stored; No additional adverse events reported; This spontaneous report was received from a medical assistant and  refers to an unknown number of patients of unknown age and gender. Concomitant therapies, medical history and historical drugs were not provided.  On an unknown date, the patients were vaccinated with an improperly stored  dose of  varicella virus vaccine live (oka/merck)(VARIVAX) lot # S006019 (expiration date 27-FEB-2021) and lot  S021928 (expiration date 15-JUL-2021) for prophylaxis.  Other suspect therapies included measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) lot S013715 (expiration date 01-NOV-2020); lot T009930 expiration date (16-SEP-2021) for prophylaxis. Strength, dose, frequency, and route of administration were not reported for any of the vaccines involved.   On 06-AUG-2020, the improperly stored suspect vaccines experienced all a temperature of  -10.1 degrees Celsius (°C)  for 15 minutes and -7.21°C for 5 minutes.  On 10-AUG-2020: -10.87°C for 45 minutes.  On 14-AUG-2020: -13.97°C for 15 minutes.  On 19-AUG-2020: -14.25°C  for 45 minutes.  The call was made due to a digital data logger. No adverse events were reported.
This spontaneous case, initially received from Pharmacist on 11-Dec-2017, concerning a 40-year-old adult female patient. The patient had no medical history and he had not received any concomitant medications. On 11-Dec-2017, the patient was administered with FLUCELVAX QIV (trade name, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 195225A and expiry date: 30-Apr-2018). It was reported that, patient received the partial dose as some of vaccine leaked onto arm from the plunger area (explicitly coded as incomplete dose administered and product leakage). There were no any signs of damage on the syringe and needle and they were tightly attached. The PTC number (product technical complaint) was reported as 1026564. It was reported that, the patient did not experience any adverse event. The reporter assessed the event as non-serious. Follow-up received from on 13-Dec-2017: Added PTC number (product technical complaint: 1026564). Follow up report received on 09-Jan-2018: It was reported that, the patient did not experience any adverse event. The narrative was amended accordingly.
Cellulitis; Sepsis; Rash / Severe Rash at the Collarbone; This case was reported by a nurse via call center representative and described the occurrence of cellulitis in a 63-year-old female patient who received Herpes zoster (Shingrix) (batch number, expiry date unknown) for prophylaxis.   Concurrent medical conditions included systemic lupus erythematosus.   On 26th July 2020, the patient received the 1st dose of Shingrix. In July 2020, less than a week after receiving Shingrix, the patient experienced cellulitis (serious criteria hospitalization and GSK medically significant) and sepsis (serious criteria hospitalization and GSK medically significant). On 26th July 2020, the patient experienced rash. The patient was treated with antibiotics nos. On an unknown date, the outcome of the cellulitis, sepsis and rash were unknown.   It was unknown if the reporter considered the cellulitis, sepsis and rash to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The reporter was patient's daughter. The patient was immunocompromised with lupus. The patient immediately developed rash. The rash improved over the days but this Monday it get worse again, more severe along the collarbone area.  On day of reporting, the patient was diagnosed with cellulitis and sepsis and she was hospitalized. The patient was administered with antibiotics by intravenous route. The reporter did not have the lot number and expiration date of the vaccine. The reporter consented to follow up.
This is not an adverse event from the vaccination. This is a case of being tested positive while on a cruise and being treated/quarantined on the cruise ship. Symptoms initially involved a sore throat, headache, and congestion. Quarantine continued in a hotel before flying home. Quarantine continued at home as my wife also tested positive and was quarantined after we returned home. Note: We were not together during my on-ship or hotel quarantine. As advised by the ship doctor, I quarantined for a total 10-day period.
Initial report received from a health care professional on 14 November 2011. This reporter also reported another adverse event, which was captured in case number 2011-09213 and 2011-11123. An unidentified patient received an injection (route not reported) of FLUZONE, sanofi pasteur Inc. lot number UH453AD, on an unknown date in 2011. The patient's medical history and concomitant medications were not reported. On an unknown date in 2011, the patient developed vaccination site cellulitis. The outcome was not reported. Documents held by sender: None.
Muscle twitching at injection site for Covid vaccine (left arm); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 20Oct2023 at 10:30 as dose 1, single (Batch/Lot number: unknown) at the age of 47 years, in left arm for covid-19 immunisation; influenza vaccine inact sag 3v (FLUCELVAX), on 20Oct2023 as dose 1, single (Lot number: 70461032303), in right arm for influenza immunisation. The patient's relevant medical history included: "covid" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 5 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: VACCINATION SITE REACTION (non-serious) with onset 21Oct2023 at 10:30, outcome "not recovered", described as "Muscle twitching at injection site for Covid vaccine (left arm)". Therapeutic measures were not taken as a result of vaccination site reaction.  Additional information: The patient had no known allergies. Patient did not tested COVID post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
9;:05am nausea, headache.  9:27am Patient reported that she was feeling much better.  EMS informed patient if still experiencing symptoms to call 911 or contact primary care physician.  Patient verbalized understanding.  (Patient is alert x3.)  B/P 150/84, HR 78, O2Sat 98%, BS 88.
Pt c/o radiating nerve pain from left deltoid to (L) shoulder blade area.
COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) (oral) on 29-Mar-2022 for COVID-19 treatment, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive.         Race of the patient was reported as.  Concomitant medications details were not reported.  The reporter was the patient who was reporting for herself. The patient took a rapid test, that had any kind of lines, basically result was not clear. Patient  was confused on whether she was positive or not. Patient does not had any symptoms however clarified patient only had a minor sore throat Patient's test showed very faint. Patient assumed she and her husband got Covid from a wedding they attended together. They done the Rapid BINAX test after attending the wedding and patient was immediately positive however hers was faint. The patient concerned being on border of being positive and if the PCR test would be more definitive for her. The patient received all of the doses which were Moderna. reporter does not had their vaccination cards handy to provide lot, or expiration date.   The doctor prescribed medication Paxlovid.  This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna mailbox were missed to be booked-in.   This case was linked to MOD-2022-619120 (Patient Link).
Received Moderna vaccine on 04/30/21 and 05/27/21. COVID positive on 1/11/22.  Patient was sent to ED to receive regeneron infusion. Patient indicated that he had some slight shortness of breath. Denies having any chest pain, loss of taste or smell. Patient currently uses oxygen at home at 2L. Patient is full vaccinated.  In the ED, patient was afebrile, with a BP 120/54, HR 54, RR 24, saturating at 93% on 3L of oxygen. Labs demonstrated no leukocytosis on cbc,  cmp was within normal limits. The ABG pH(7.3), pCO2(28.3), pO2(144.6), HCO3(26.9). Patient had an elevated HS troponin at a level of 158.1 and no ischemic changes on EKG. The chest xray demonstrated atelectasis of the right lung. Patient has been admitted for further observation and treatment. He was admitted for COVID-19 and to r/o ACS. Pt was started on rocephin, doxycycline, and decadron. Blood cultures were collected and showed no growth for 2 days before discharge. Respiratory culture was also collected and showed normal flora on gram stain. Home medications were restarted. Pt was found to have pancytopenia with WBC 2, HgB 9.6, and Platelets 131. This was likely due to COVID. Pt also has a history of low platelet counts in the 120's. Before discharge, pancytopenia resolved. He had a 6 minute walk performed that revealed that pt does not require oxygen. Pt was sent home with decadron, azithromycin, cefpodixime, and losartan in addition to home medications. Discharged on 1/13/22
Not receiving 2nd dose on time; 16 year old receiving a dose of the Moderna COVID19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old receiving a dose of the Moderna COVID19 vaccine) and INTENTIONAL DOSE OMISSION (Not receiving 2nd dose on time) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027d21a) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Aug-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old receiving a dose of the Moderna COVID19 vaccine). On an unknown date, the patient experienced INTENTIONAL DOSE OMISSION (Not receiving 2nd dose on time). On 17-Aug-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old receiving a dose of the Moderna COVID19 vaccine) had resolved. At the time of the report, INTENTIONAL DOSE OMISSION (Not receiving 2nd dose on time) had resolved.            No concomitant medication was provided. No treatment medication was provided.; Sender's Comments: This case concerns a 16 year old female patient with no relevant medical history reported, who experienced the non serious unexpected events of product administered to patient of inappropriate age and intentional dose omission. The event occurred on an unknown date after the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge is unknown, since no information about second dose is provided and the event is resolved. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report
Pt reported pain and difficulty moving left arm x3 days. This appears to be standard as several people have reported it. What is not frequently reported is the patient having a multiple body area rash, including trunk and back. Pt called MD and was told to take BENADRYL for 2 days and not get the second shot.
Given vaccines on 12/17/10. Parents gave TYLENOL after vaccines. Normal routine afterwards. Put patient to bed, mom awakened later by noises, found patient seizing in crib. Lasted approx 1 min, postictal for 3 min. Transport by EMS to ER. No documented fever per parents or told to them by EMSA or ER. Tmax 99. Discharged home with dx of febrile seizure. No recurrences since then per parents.
Initial vaccine reaction: reports a history of vaccine reactions with bilateral red swollen eyelids, mild irritation of eyelids and these same symptoms occurred within several hours of receipt of the 1st dose of Pfizer mRNA Covid-19 vaccine and resolved within 24 hours. Did not take any OTC antihistamines. Also, reported onset of acute lower abdominal/pelvic pain within a short period of time after the vaccine with associated mild associated nausea without emesis, fever, chills, bodyaches, night sweats, chest pain, shortness of breath, breathing difficulty. States she was evaluated in a local ED that same day with no known cause for the lower pelvic pain, but was found to have hydronephrosis and was advised to over hydrate, and was discharged home in stable condition. States she followed up with Ob-GYN and baby in utero is doing well. States the lower abdominal/Pelvic pain resolved within 12 hours. Continues to hydrate. No current symptoms. Requests VAERS report be submitted for the pelvic pain and also for the history of red swollen eyes s/p vaccines. States she was cleared after ED visit and OB GYN to receive the 2nd dose of Pfizer vaccine. This patient is pregnant and was 22 weeks gestation on 10/25/2021 EDD 2/25/2022  Ed Visit 10/25/2021: "at 1920 patient presents ambulatory from home for evaluation of preterm cramping." "Patient reports lower mid abdominal cramping radiating to the right side with onset on/at 1050 when she had her COVID-19 vaccine today. Rates pain 4-5/10. Patient denies vaginal bleeding loss of fluid, headache, visual changes, epigastric pain and unusual edema. Patient reports normal fetal movements. Patient is a G2P0010 at 22w3d gestation," also had a mild headache while in the ED. Urine, large occult blood and 11 25 RBCs Ultrasound: bladder and kidney as well as a transvaginal cervical length had follow up Appointment with OB-GYN on 11/04/2021
I was at the office. It felt like I was getting strep throat. I went to the doctor; he tested me for strep throat and COVID-19. The test for strep came back negative, the COVID-19 test came back positive. I was prescribed Paxlovid, I took the 5-day course and was back to work as I no longer had a fever.
Patient has a rash on 7/3/21 that started off as localized to right flank area then became diffuse
Allergy: Pneumococcal Vaccine; This is a spontaneous report from a contactable nurse. A female patient of an unspecified age received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced allergy: pneumococcal vaccine. Outcome of the event was unknown.  The following information on the batch number has been requested.
received an expired dose of Menactra with no reported adverse event; Initial information received from on 22-Feb-2022 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 17 years old female patient who received an expired dose of menactra with no reported adverse event, after being vaccinated with MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].    The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 21-Feb-2022, the patient received a dose of 0.5 ml of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (strength, formulation: unknown) with lot u6690a; expiry date: 31-Aug-2021 via intramuscular route in the left arm as immunization ((expired product administered, onset, latency: same day).   Action taken with MENINGOCOCCAL VACCINE (MENACTRA) was not applicable.  It was not reported if the patient received a corrective treatment for the event (received an expired dose of Menactra with no reported adverse event).  At time of reporting, the outcome was Unknown for the event received an expired dose of menactra with no reported 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 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.
I had a job at the time I received the vaccine from the Health Department.  I was not making a lot of money at my job, so I sot the assistance of the Health Department for a flu vaccine.  The phlebotomist was not experienced enough to administer vaccines and I received too much vaccine out of vile into the syringe.   On Friday, November 6, 2020, I received a flu vaccine from the Hospital that was pre-measured and today is Monday, November 9th 2020, and I'm not experiencing any adverse events.  Friday was the first time in 12 years that I felt comfortable enough to get the flu vaccine.  Pre-measured is the way to go!   I thought it is necessary to keep my immune system up in these times of Covid-19.
Shortness of breath sepsis AKI (acute kidney injury) (CMS/HCC) Atrial fibrillation with rapid ventricular response (CMS/HCC) Acute respiratory failure with hypoxia (CMS/HCC) Pneumonia of both lower lobes due to infectious organism
C/O nausea w/vomiting followed by diarrhea starting at approximately 12:30 PM. Later in the day around 8:00 PM stated that she had a seizure on public transportation system, transported by EMS to Hospital.
3pm developed sore throat and rhinorrhea. Concerned that I was positive, left work and scheduled symptomatic test next day. Noted on home pulse ox that my heart rate was in 140s (otherwise vital signs were normal and I was afebrile). Symptoms got better and after pushing fluids I was able to get my heart rate under 100 by end of the day. 12/20 woke up heart rate 140s now down to 105 at time of reporting.  Sore throat and rhinorrhea are getting better but tachycardia is concerning and I am worried I may have developed an arrhythmia as my Apple Watch consistently marks my rhythm as inconclusive
Patient said she went to ER 10/18/19 after she received the pneumovax-23 on 10/16/19. She said she couldn't lift her arm, it was very red, she had fever and the doctor had to administer IV antibiotics
Adult patient was given a pediatric 10 microgram dose; Adult patient was given a pediatric 10 microgram dose; This non-serious case was reported by a nurse via call center representative and described the occurrence of underdose in a 34-year-old female patient who received HBV (Engerix B pediatric) (batch number FB9RH, expiry date 21-JAN-2024) for prophylaxis.   On 18-APR-2023, the patient received the 1st dose of Engerix B pediatric 10 ug. On 18-APR-2023, an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: Adult patient was given a pediatric 10 microgram dose) and adult use of a child product (Verbatim: Adult patient was given a pediatric 10 microgram dose). The outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK Receipt Date: 18-APR-2023 The nurse reported that an adult patient was given a pediatric 10 microgram dose of Engerix.  The event occurred in the healthcare professional's location/clinic. The reporter consented to follow up via email. The adult patient received a pediatric dose of Engerix, which led to underdose and adult use of a child product.
Hard lump in arm, with a abscess that patient stated she drained fluid out herself. Mild cold like symptoms.
ON 12/1/05 P.M. PATIENTS ARM BELOW SITE OF INJECTION TURNED PURPLISH-RED AND WAS VERY HOT. MOTHER TOOK CHILD TO NP @ 3 P.M ON 12/2/05 AND WAS TOLD THAT CHILD HAD CELLULITIS. RX FOR ANTIBIOTICS, STEROIDS, AND BENADRYL. RED AREA MEASURES ABOUT 2 1/2 INCHES BY 1 1/2 INCHES.
Exanthema, Fever - Information has been received from a physician concerning a 5 year old female who four years ago, in approximately 1996, was vaccinated with one dose of varicella virus vaccine live (unknown site )  On 26 Apr 2000, the patient developed a varicella like rash with less than 20 lesions and a slight fever.  The patient sought unspecified medical attention. Follow up information from the physician indicated that this was not an adverse reaction because the patient had less than 50 lesions and it was uncomplicated.  No further information is expected.
Headache, Myalgia, fatigue, chills Narrative:  Myalgia, chills, headache, fatigue