chrisvoncsefalvay/vaers-outcomes huggingface dataset:
15  days after the vaccine I started with a slight ringing in my ears which has become more intense over the last three days. It has become a loud pitch ringing.  I looked up on line and have seen other people reporting the same issues. I hope this goes away because it's starting to affect the way I feel. My health has been excellent until this point!
This spontaneous report as received from a nurse refers to an unspecified number patients of unknown age and gender. On an unknown date in 2014 (reported as since 08-AUG-2014), the patients were vaccinated with VARIVAX which was improperly stored, (strength, dose, lot numbers and route were not reported). No adverse effects were reported. Follow up information has been received from the registered nurse who stated that it will take some times to get the VARIVAX information (patient identifiers, lot numbers, expiration dates and dates of vaccine administration) together and that she may send the information at a later time. Follow up information has been received from the registered nurse concerning a patient (age range reported as 6-12, units not reported) of unknown gender. On 25-SEP-2014, the patient was vaccinated with a dose of VARIVAX which was improperly stored (lot number K005180, expiration date 10-APR-2016; dose number, dose and route were not reported). The reporter stated that this was the information that they could find and provide and anything further would be much too difficult and time consuming due to their record keeping and tracking system. This is one of several reports received from the same reporter. Additional information is not expected because follow up has been obtained.
Expired dose administered; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose administered) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 068H21A, 004C21A, 013L20A and 011J20A) for COVID-19 vaccination.     Concurrent medical conditions included Seafood allergy (crab), COPD, Chronic kidney disease (Chronic Kidney disease stages (3b-4)), Hypertension, Hyperlipidemia, Diabetes, Anemia, Diverticulitis, Neuropathy and Cardiomegaly. Concomitant products included FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE, VILANTEROL TRIFENATATE (TRELEGY), TRIAMCINOLONE, VALACICLOVIR HYDROCHLORIDE (VALTREX), EZETIMIBE (ZETIA), LISINOPRIL DIHYDRATE (PRINIVIL), PREDNISONE, METOPROLOL TARTRATE (LOPRESSOR) and DICLOFENAC SODIUM (ANODYNE [DICLOFENAC SODIUM]) for an unknown indication.   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient received second booster dose on 07-APR-2022. Treatment details was not reported by the reporter.   This case was linked to MOD-2022-536072 (Patient Link).
sx APPROXIMATELY 20-30MINS AFTER: Facility nurse reported feeling light headed, heart rate was 44 bpm, feeling cloudy, fatigued
Puffed pocket on her arm; Red arm is extemely puffy; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Puffed pocket on her arm) and ERYTHEMA (Red arm is extemely puffy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On an unknown date, the patient experienced PERIPHERAL SWELLING (Puffed pocket on her arm) and ERYTHEMA (Red arm is extemely puffy). At the time of the report, PERIPHERAL SWELLING (Puffed pocket on her arm) and ERYTHEMA (Red arm is extemely puffy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
This spontaneous report was received from a healthcare worker (also reported as nurse) refers to a patient of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On 13-JAN-2015, the patient was vaccinated with a dose of PEDVAXHIB, (strength, dose, route and anatomical location were not reported), (lot # J016186, expiration date: 24-OCT-2016), which was incorrect stored since 02-DEC-2014. No adverse effects were reported and no product quality complaint (PQC) was filled. This is one of several reports received from the same reporter. Additional information has been requested.
Breakthrough infection of COVID-19; Breakthrough infection of COVID-19; This is a spontaneous report from a contactable physician. An 86-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Numbers were not reported), via unspecified routes of administration, on an unspecified date, as dose 1, single, and then on 10Mar2021, as dose 2, single, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient has received both doses of the Pfizer BioNTech COVID-19 vaccine with the second dose received 10Mar2021. However, last month (Jul2021), the patient had a breakthrough infection of COVID-19, but recovered well, physician states due to the vaccine. The physician wanted to know if getting COVID-19 again served as a booster dose and if getting the breakthrough COVID-19 infection did further increase the patient's immunity. The physician was aware that a booster dose is only currently available for patients with solid organ transplant or a similar level of immunocompromise. The patient recovered from the events in 2021.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal relationship between the events suspected COVID-19, Drug ineffective and suspect drug BNT162B2 cannot be excluded.
Patient had the listed side effect of diarrhea after her second Rotateq vax that did not clear up after two weeks.  At which time we went back to the pediatrician with a diagnosis of new protein allergies.  Now in addition to dairy and soy protein she became allergic to wheat and egg as well as hydrosylate formula.  Continued breast feeding with the elimination of dairy, soy, wheat and egg from my diet (mother)supplementing occasionaly with elemental formula resolved the problem.  However, prior to the 2nd dose of Rotateq she was symptom free with only dairy and soy elimination and could tolerate hydrosylate formula.  Her ped GI doctor confirmed that it may be possible that the irritation of her gut mucosa from the vaccine could have triggered her new allergies.  I have heard similar stories from other mom's with babies with protein allergies.  I feel that the relationship between Rotateq and the increase in IgG protein allergies in the population must be investigated.  While this caution could be found on the Merck webpage "Also tell your doctor if your baby has received a blood transfusion or blood products recently or if he or she was born with gastrointestinal problems, had a blockage, or had abdominal surgery." I have not yet run into a pediatrician that connects the gastrointestinal warning with allergic colitis. I am a PhD research scientist and am fully supportive of vaccines.  I also understand the molecular mechanisms of the disease and feel that a specific warning to pediatricians and parents about possible complications with babies with protein allergies should be included in the insert.  While most children outgrow these allergies by age 2 (no permanent damage) it is often hard for mothers to continue breastfeeding on these strict elimination diets and elemental formula is extremely expensive.  We chose not to have the 3rd booster.
This spontaneous report was received from a back office lead and refers to a 73 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 29-DEC-2015, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB lot # L038499, expiration date: 26-JUN-2017, 1 ml, intramuscularly, in deltoid (dose number was not provided). There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
16 y/o was given a Janssen COVID19  vaccine shot, the product was only studied/approved for 18+ y/o
This spontaneous report has been received from a 60 years female consumer who was vaccinated SC with the first dose of ZOSTAVAX on 23-JUL-2012. No other co-suspects were reported. No concomitant medications were reported. On 28-JUL-2012 the patient stated she began to have pain and rash at the injection site. She was advised by her physician that she had shingles. The patient sought unspecified medical attention and VALTREX was given for the treatment. At the time of report, the patient's status was unknown. Additional information has been requested.
Within 15-minutes following vaccination, the patient reported lightheadedness. Medical staff managed patient's care on-site and they reported improvement before patient left the clinic.
Initial report received on 16 April 2010 from an investigator participating in the above-mentioned local trial under the reference number H-406-004. A 26 year-old female subject received ACAM2000, (lot number not reported) and tetanus vaccine (manufacturer and lot number not reported) on 05 April 2010. Five days after vaccination the subject developed severe chest pressure. The subject was subsequently hospitalized on Day 9 for a cardiology evaluation. The subject had no relevant medical history. An electrocardiogram performed on the day of admission was reported as normal. Per the investigator, the subject's symptoms, proximity to vaccination and hospital discharge regimen could be consistent with vaccine-induced myopericarditis. The final diagnosis is pending. The subject was discharged from the hospital on Day 10. Per the investigator, the event was assessed as possibly related.
intense joint pain and fatigue lasted 3 days, golf ball-sized swelling in left armpit lymph node (same side as the shot) that lasted two weeks, minor fluid swelling is still present 6 months later, even after multiple lymphatic drainage massages.
The day afterwards, I had about half the day, chills and fatigue. Two days after, I noticed and felt a lump. I also had a rash on my leg.
Patient received AFLURIA vaccination on 10/8/13. Came to pharmacy on 10/14/13 complaining arm still sore and lost some range of motion. Plans on seeing physician w/i the week.
Initial information received on 02-Oct-2018 regarding an unsolicited valid non-serious case received from a nurse. This case is linked to cases 2018SA277148, 2018SA278726 and 2018SA278737 (same reporter). This case involves 17 years female patient who received vaccine IPOL (Lot: P1A171M, expiry date: 20-Apr-2024) via unknown route in the left deltoid on 28-Sep-2018, which was stored incorrectly. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was an actual medication error due to incorrect product storage. It was reported that IPOL was exposed to temperature elevation for 3 days to 46.6 Fahrenheit and 48 Fahrenheit. It was that these IPOL will be discarded and all consumers will be re-vaccinated with new IPOL. It was reported that no reactions were 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. Documents held by sender: none.
Sudden short episodes (less than 5 minutes) of excessive salivation followed by nausea. Hours later it morphed into  continual nausea and vomiting  not related to food intake or any illness - continued for 36 hours.
Myalgia, Rash, UrticariaPruritus, Fatigue, itching over entire body Narrative:
she subsequently has negative measles titers; she subsequently has negative measles titers; This spontaneous report was received from a physician, who was a female patient, currently 61-year-old, reporting on herself. She had no concomitant medication nor pertinent medical history but being allergic to sulfamethoxazole (+) trimethoprim (SEPTRA).  On an unspecified date in June 1970, when she was 12 years old, the patient was vaccinated with a dose of measles virus vaccine live (unspecified)(dose, route of administration, injection site, lot # and expiration date were not reported) for immunity.  On 06-APR-1991, she received another dose of measles virus vaccine live (unspecified) On 28-JUN-1996, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (albumin status unknown) (M-M-R II) (exact dose, route of administration, injection site, lot # and expiration date were not provided) for immunity and on 30-AUG-2018, with another dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) Subsequently after all vaccinations, her measles titers were negative (onset date unspecified). She sought medical attention by consulting an unspecified healthcare professional, however no treatment was given. The patient had multiple unspecified measles immunoglobulin (IGG) tests performed (dates and results were not reported).  On 26-SEP-2018, she had her last negative IGG titer. At the reporting time, she was not recovered from negative measles titers.  The causality assessment was not provided by the reporter.
No adverse event reported by patient. Patient 63 years old, but received Fluad influenza vaccine
Adverse side effects I'm having after being administered the 4th Moderna Booster Shot for Covid Protection, it was issued to me at the same place (Pharmacy by a Female Intern ) on Friday March 25, 2022 sometime late morning to afternoon. I took the 3rd one, except this 4th one came with some unexpected side effects: 2nd day woke up with a bad pounding headache that I could barely open my eyes; my blood pressure machine couldn't take a reading because it wouldn't go that high and stopped at 235/180; HR: 135; P: 120  later in the evening retook my blood pressure and it read: 173/108  Pulse: 84  I took my Valsartan right away I was feeling very drained, sluggish, unable to think, altered my mood as well; I was very sensitive to light, couldn't smell, or taste anything. Other side effects the same day included fever, chills, sweats, lots of muscle spasms, my gait was floppy spaghetti-like, therefore; I used a walker for part of the day and afternoon. The 3rd day which is today the 28th of March I woke up with my head bopping and my head wouldn't stop shaking, I don't have fever anymore but I still have sweats and chills, my walking is stable at times. I didn't know if I needed to have a cat scan due to the bopping head effect, or what could be done? Sincerely, The Patient.
mom & child @ clinic 5OCT94 w/not from FMD stating pertussis allergy 11OCT94; tc to mom stated pt started w/high pitched crying approx 3 1/2 hrs p/vax; pt had fever but doesn't recall how high it was-required visit to FMD 4AUG93;
When logging vaccines in the system, I came across this patient who we administered a booster shot for - she had already received 3 moderna doses prior to the booster dose we administered on 12/21/21. Spoke to Moderna about any reactions that may occur due to a fourth dose. Reporting incident to Director of our company.
DEVELOPED MRSA PNEUMONIA AND EMPYEMA, REQUIRED DECORTICATION.  APPEARS TO HAVE FULLY RECOVERED AT THIS TIME. I DO NOT BELIEVE VAX CAUSED ILLNESS, BUT MOTHER DOES AND WOULD LIKE EVENT REPORTED.  (PATIENT'S PCP)
Neuropathy beginning on right side of abdomen and back and slowly encompassing entire right leg and foot, as well as left foot and leg up to the shin. Additional symptoms include: nerve pain in abdomen and back, severe constipation, dizziness, poor balance, headache, blurred vision, brain fog, low flow urination, fatigue, brittle nails
Immediately following vaccination, pt complained of feeling hot and dizzy. She appeared anxious prior to and following shot. She complained of slight itch on her arm and developed flushing on her face and neck. Pulse rate 76-86. Resps 16-20. Red blotches began to resolve after 30 minutes.
Passed out, fall on her head, have to bring physician to check for concussion. Evaluated for and other signs and symptoms for seizure. Observed in the room for 10-20 minutes, finally recovered given lot of fluid.
Information has been received from a medical assistant concerning a female patient who on unknown date, was vaccinated with a dose of PNEUMOVAX 23 (dose, route and lot number not reported). It was reported that on unknown date, the patient who received a dose of PNEUMOVAX 23 developed a rash that was so bad she could not even bend her arm. It was reported that the patient sought unspecified medical attention. The patient outcome was unknown at the time of report. This is one of two reports from the same source. Additional information has been requested. Follow-up information was received from a physician refers to a 86 years old male (also reported by medical assistant as female) patient with no illness at time of vaccination, with type 2 diabetes mellitus, atrial flutter, sick sinus syndrome (SSS), CAD (coronary Artery Disease) and PD (Parkinson's disease). The patient was intramuscularly vaccinated at left deltoid with lot # (671401/1158AA) the first dose PNEUMOVAX 23 (dose unspecified) on 11-NOV-2011 (5:34 pm). Concomitant medications included SINEMET, DIGITEK, propafenone hydrochloride, warfarin, atenolol, metformin, lisinopril, NAMENDA and EXELON. On 12-NOV-2011 the patient experienced severe left shoulder pain, he was seen in office in 16-NOV-2011 (reported 16-NOV-2012), no rash (also reported by medical assistant as developed a rash), no swelling, Range of motion was severely limited by pain. No treatment information was reported. The patient had sought medical attention via doctor visit. No relevant diagnostic test and laboratory data was provided. The outcome of severe left shoulder pain was reported as recovered/resolved on 21-NOV-2011 (reported 21-NOV-2012). Additional information was not expected.
This spontaneous report as received from a pharmacist refers to a male patient of unknown age. The patient pertinent medical history and drug allergies were not reported. Approximately on 10-AUG-2016 (reported as at the time of this call), the patient was vaccinated with third dose of GARDASIL 9 series about one year after the second dose was administered. No adverse effects were reported. No product quality complaint (PQC) was reported. Additional information has been requested.
GBS-no strengh; numbness & tingling 9 fingers rt foot- 2 & 3rd toes, upper gum numb, weakness problem swallowing, nose numb, tongue, top lip numb, nerve ripples up neck to head;
Immediate welt that changed to a raised red rash on the date indicated.  Estimated delivery  date: 10/14/21
red rash began to form along w/sl resp increase pt sib w/same sx p/MMR given;the rxn began immed p/vax epi given;
Could barely feel a little soreness where the needle went in; Rash on area 10 days later; This is a spontaneous report from a contactable consumer (patient). A 79-years-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number, Expiration date and NDC number was not reported), via an unspecified route of administration on 18May2021 as dose 1, single (at the age of 79-years-old) for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient stated that she had no problem at all for 24 hours and on May2021, patient could touch her arm and had a little soreness/could barely feel a little soreness where the needle went in. On May2021, 10 days later, patient developed a rash on area and wanted to know if she was allergic to something in the vaccine, specifically mentioning preservative. Patient also asked that should she get her second dose. The outcome of all the events was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Headache; Swollen Lymph node in right armpit; General fatigue; Injection site pain; This is a spontaneous report from a non-contactable consumer, the patient. A 46-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the arm right on 27Apr2021 at 13:30 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included anemia. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included bupropion hydrochloride (WELLBUTRIN), lamotrigine (LAMICTAL), vortioxetine hydrobromide (TRINTELIX), verapamil hydrochloride (CALAN) and pantoprazole sodium sesquihydrate (PROTONIX); all since an unknown date for unspecified indications and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP6955) via an unspecified route of administration in the right arm on 06Apr2021 at 13:30 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 28Apr2021, the patient experienced headache, swollen lymph node in right armpit, general fatigue and injection site pain. Since the vaccination, the patient had not been tested for COVID-19. 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. No therapeutic measures were taken as a result of the reported events. The clinical outcome of the events headache, swollen lymph node in right armpit, general fatigue and injection site pain were unknown at the time of this report.  No follow-up attempts are possible. No further information is expected.
Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 41-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026B21A) for COVID-19 vaccination.     RX number: private.     On 05-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 05-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant products and treatment information were reported.
Administered 1st dose to patient under the age limit parameter for the Moderna Vaccination. Patient under the age of 18 (currently 16 years, 11 months).
Fever of 102, pulse rate of  120-130, headache, dizziness, blurred vision, nausea, entire body sore and achy.