chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This literature marketed report was received on 02-MAR-2014 from a physician regarding a retrospective analysis of the utility of preimmunization and postimmunization titers to 23 serotypes of streptococcus pneumoniae. Aim: To identify a subset of 23-PPV serotypes with high diagnostic utilities for the diagnosis of Specific antibody deficiency (SAD). Rationale: SAD was diagnosed by lack of response to 23-PPV. It was unknown if each of the 23-PPV serotypes had similar diagnostic utilities for SAD. Method: The physician reported that they retrospective identified 126 patients aged between 2 to 18 years that had two sets of 23-PPV titers, which were drawn on an unspecified date 4-12 weeks apart. These patients did not have another identifiable cause of immunodeficiency. The adequate immunization response post vaccination of 23 PPV was defined as greater or equal to 4 fold rises in response for greater than 70 percent of serotypes (50 percent for 2-5years age group) and postimmunization titers or less than or equal to 1.3 microgram per milliliter. The calculations for sensitivity, specificity and area under the curve (AUC) were done for each serotype. This report refers to a group of 25 patients from the 126 patients identified retrospectively. On an unknown dates, the patients were vaccinated with 23-PPV (manufacturer unknown) (dose, route and frequency were unknown). No concomitant medications were reported. The author reported that 25 patients had inadequate responses and were diagnosed with SAD. The physician reported that the remaining 101 patients had an adequate response to 23-PPV. Post immunization titer to serotype 6B provided the best diagnostic utility, with an AUC of 0.91 (sensitivity 48%, specificity 98%). The following serotypes had AUC >=0.8 with corresponding sensitivity/specificity, 9N (AUC=0.87, 58%/93%), 9V (AUC=0.87, 48%/91%), 18C (AUC=0.85, 56%/92%), 4 (AUC=0.84, 56%/94%), 7F (AUC=0.81, 54%/85%), 17F (AUC=0.80, 54%/87%), 19F (AUC=0.80, 28%/99%), and 5 (AUC=0.80, 71%/76%). CONCLUSIONS: The authors identified a subset of pneumococcal serotypes that provide high diagnostic utility for the diagnosis of SAD, A further prospective study was required to investigate whether the diagnosis of SAD could be established based on a limited panel of pneumococcal serotypes. Additional information has been requested.
Immediately after the injection until about 2am I felt the following symptoms - pain/swelling at injection site - severe nausea - weak/tiredness - headache - dizzy - even though I was tired, I could not sleep when it was time for bed.  Now it is almost 24 hours alter and I still have the following symptons - headache - pain/swelling at injection site
Itching; Injection site hot to touch; Swelling in right arm; Redness from shoulder to elbow in right arm; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching), INJECTION SITE WARMTH (Injection site hot to touch), SWELLING (Swelling in right arm) and ERYTHEMA (Redness from shoulder to elbow in right arm) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced PRURITUS (Itching), INJECTION SITE WARMTH (Injection site hot to touch), SWELLING (Swelling in right arm) and ERYTHEMA (Redness from shoulder to elbow in right arm). On 27-Feb-2021, PRURITUS (Itching), INJECTION SITE WARMTH (Injection site hot to touch), SWELLING (Swelling in right arm) and ERYTHEMA (Redness from shoulder to elbow in right arm) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information was not provided.  Patient took Benadryl and the adverse events resolved in 5 days afterwards.   Reporter did not allow further contact
Pt had seizure symptoms. In the ER, they ruled out a seizure by CAT scan. However, the pt was exhibiting seizure symptoms with partial loss of consciousness (awake but not fully responsive).
patient was given an expired vaccine/ no AE; Initial information regarding an unsolicited valid non-serious case was received on 17-Aug-2021 from a Physician via Global Medical Information (GMI) (Reference number- 00728357) and transmitted to Sanofi on 16-Aug-2021.  This case involves an 11-year-old male patient who was administered with an expired DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] vaccine with no adverse event (Expired product administered).  The patient's medical history, past medical treatments, concomitant medications, vaccinations and family history were not provided.  On an unknown date, the patient received a 0.5ml (total) (once) dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [lot number: U6401AA and expiry date: 26-Jul-2021] via intramuscular route in the left deltoid (also reported as left arm) for prophylactic vaccination.  It was reported that, "she gave an expired ADACEL vaccine. She states that the vaccine was expired and she gave it to the patient intramuscularly in the left arm, she asked how soon the patient could be revaccinated". Emergency Room/Dr. visit and date 17Aug2021. First time product used: No. Still using product : Yes. Was Device Used : No.  It was case of an actual medication error due to expired vaccine used (latency was on the same day).  At the time of reporting, 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 by the regulatory authority. 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 start to have fatigue. On Sunday, it felt like I had COVID-19 again. I had painful body ache, joint pain around my back, stomach, and shoulders. I have fever of 101. I had some changes in my heart rate. I had brain fog and difficulty focusing. Then, I started have low heart rate. I been having these symptoms for about 6 days now.
get a flu shot, got the flu / suspected vaccination failure; flu; sick; This case was reported by a consumer (facebook) via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced vaccination failure (serious criteria GSK medically significant), influenza and sickness. On an unknown date, the outcome of the vaccination failure, influenza and sickness were unknown.   It was unknown if the reporter considered the vaccination failure, influenza and sickness to be related to Influenza vaccine Quadrivalent unspecified season.  Additional case details were reported as follows: The reporter was patient itself. The age at vaccination was not reported. The patient did not get flu shots or pneumonia shots either, because every time patient used to get a flu shot  and get super sick with the flu, so the patient afraid to get the vaccine for shingles. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required. THis case has been linked with US2021AMR205452 and US2021AMR205442, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR205452:tag at post / same reporter US-GLAXOSMITHKLINE-US2021AMR205442:tag at post / same reporter
My joints became loose/lax and felt like they were loose and popping and one of fingers popped sideways at one point. I was noticing my fingers were all starting to feel unusual. And all my joints were starting to feel loose. So, I went to the chiropractor because of inflammation and pain, and loose joints. When she checked my hip, she said it felt inflamed. And with my fingers she said she noticed there was a connective tissue issue taking place. Felt like a connective tissue disorder but have not looked deeper into that. But definitely inflammation in the hip joint and trying to pop out.
Vaccine administration error related to temperature excursion from recommended storage temperature, not known to to this writer to be associated with an adverse event. The clinic has relayed to this writer that prior to the vaccine's thawing and administration to the vaccine recipient, the administered vaccine was stored in frozen temperatures for longer than recommended by the manufacturer. (This VAERS writer assigned to form completion was not the administrator of this vaccine.)
CLIENT WAS ONLY 17 YEARS OF AGE AT TIME OF VACCINATION. NO ADVERSE EFFECTS REPORTED.
This spontaneous report was received from a nurse and refers to a currently 16-year-old patient of unknown gender. The patient's concurrent conditions, medical history and concomitant therapies were not provided. On an unknown date, the patient was vaccinated with improperly stored GARDASIL 9 (lot # R002344), expiration date: 16-NOV-2020 (dose and route of administration were not provided) for prophylaxis. Temperature and time frame were reported as: below 0 degrees Celsius (-0.6 degrees Celsius) for 7 hours and 38 minutes and 9 degrees Celsius to 25 degrees Celsius (13.3 degrees Celsius) for 1 hour and 14 minutes. Previous temperature excursion was reported as: 9 degrees Celsius to 25 degrees Celsius (11.7 degrees Celsius) for 3 hour and 53 minutes and 9 degrees Celsius to 25 degrees Celsius (23 degrees Celsius) for 11 hours and 21 minutes. Digital data logger was involved. No adverse effects were reported. Sender's Comments: US-009507513-1811USA001303; US-009507513-1811USA007948; US-009507513-1811USA007949; US-009507513-1811USA007950; US-009507513-1811USA007951; US-009507513-1811USA007946; US-009507513-1811USA007945; US-009507513-1811USA007947.
Hives, tongue swelling, fever, chills, aches, metal taste in mouth  Tongue swelling and metal taste happened immediately after shot. Staff requested I waited additional 15 minutes on site. When I got to my car, maybe 5 minutes , I had hives on my neck. By the time I got home, about 30 minutes, I had hives on my stomach as well.  That night I had fever and chills which went into next day.
onset of conjunctivitis in the left eye . I was unable to get into a walkin center on Sunday. My niece,filled the order for me . The symptoms quickly resolved with eye drops.  After my second shot , I has tinnitis in my left ear for several days a few weeks after the shot. It resolved spontaneously
Blisters up and down left and right arms and top of shoulders; This is a spontaneous report from a contactable consumer, the patient. A 63-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 in the left arm on 30Apr2021 at 10:45 (at the age of 63-year-old), as a single dose for COVID-19 immunisation. Medical history included diabetic type 2 and the patient had known allergies to medications, food, or other products. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10May2021, the patient experienced blisters up and down left and right arms and top of shoulders. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken for the events. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event of blisters up and down left and right arms and top of shoulders was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
The next day, I had a huge lump the size of an egg in my arm that I received the vaccine. The next morning after that, I couldn't move or lift my arms and legs; I was walked a bit crippled and shuffle my walk in order to move. For the first two months, I could barely move up and down the stairs. I started getting a bad pain in my left hip joint and it began swelling. I went to my doctor, and they determined I had reactive arthritis and bursitis. I was taking ibuprofen and naproxen to reduce inflammation to regain slight mobility. I attended physical therapy 3 times a week for two months to help with my mobility as well.
8/6 had immunized, pt healthy at the time. 8/8/01 mom phoned and 1 hour post vaccination the pt had fever of 101.1 with Tylenol and 102  in spite of Tylenol. Pt fussy. 8/11 was taken to ER because of crying, afebrile. On 8/15 rash on him.
This spontaneous report as received from a Licensed Practical Nurse refers about 30 patients. The reporter stated that since 2007, on unspecified dates, about 30 patients had received ZOSTAVAX subcutaneously, where the final ZOSTAVAX was only about 0.5 ml in each case. No lot# was reported. No known adverse effects. PQC filed for ZOSTAVAX having a smaller volume than expected. Additional information has been requested.
07mar90 pt vax hepta B.  28mar90 pt devel pain in shoulder and left arm between shoulder and elbow.  pt recovered.
First symptom was a headache followed by burning rash on right side of chest, shoulder, and neck. I continue to have neck pain and burning of the rash. I went to the doctors on 10/25/2021 and My doctor confirmed shingles. I was prescribed Valtrex and Prednisone for 7 days, as of 10/27/2021 more rash spots are appearing in same area and neck stiffness is getting worse.
Swelling and redness in arms and lymph nodes; swelling and redness in arms and lymph nodes; subconjural fluid filled cysts; Swelling and redness in arms and lymph nodes; Fever 102.3; Pain in arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (Pain in arm), PERIPHERAL SWELLING (Swelling and redness in arms and lymph nodes), ERYTHEMA (swelling and redness in arms and lymph nodes), BONE CYST (subconjural fluid filled cysts) and VACCINATION SITE LYMPHADENOPATHY (Swelling and redness in arms and lymph nodes) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Breast cancer.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Feb-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm). On 09-Apr-2021, the patient experienced PERIPHERAL SWELLING (Swelling and redness in arms and lymph nodes), ERYTHEMA (swelling and redness in arms and lymph nodes), BONE CYST (subconjural fluid filled cysts), VACCINATION SITE LYMPHADENOPATHY (Swelling and redness in arms and lymph nodes) and PYREXIA (Fever 102.3). At the time of the report, PAIN IN EXTREMITY (Pain in arm), PERIPHERAL SWELLING (Swelling and redness in arms and lymph nodes), ERYTHEMA (swelling and redness in arms and lymph nodes), BONE CYST (subconjural fluid filled cysts), VACCINATION SITE LYMPHADENOPATHY (Swelling and redness in arms and lymph nodes) and PYREXIA (Fever 102.3) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: subconjural fluid filled cysts (abnormal) MRI which showed subconjural fluid filled cysts.         Action taken with mRNA-1273 in response to the events was not Applicable.  No concomitant medications were provided. Treatment included patient had been taking Tylenol at first, then Percocet and flexural prescribed by primary care physician. She had also been treated with steroid tablets and injections.  Based on the current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
On day 10 following vaccination I started waking in the night covered in hives (so far, for 5 night but the symptom is weakening). I have been taking an antihistimine which alleviates the hives and when I wake in the morning, everything seems fine.
peri/myocarditis; peri/myocarditis; This is a spontaneous report from a non-contactable consumer (patient). An 18-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported), via an unspecified route of administration, administered in the left arm on 14Apr2021 at 11:30 AM at the age of 18-years-old as single dose for COVID-19 immunization at Public Health Clinic. The patient had no COVID prior vaccination. The patient had no other vaccine in four weeks. The patient's medical history included known allergies to nickel and dust mites. The patient's concomitant medications were not reported. The patient developed severe chest pain between the night of 16Apr2021 to 17Apr2021, and was admitted to the hospital on 17Apr2021, diagnosed with peri/myocarditis. The cardiology team was convinced it was an adverse reaction to the vaccine. He remains hospitalized (number of days of hospitalization was also reported as 2). The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, and hospitalization. The patient was tested for COVID post vaccination which was a nasal swab with negative result on 17Apr2021. Therapeutic measures were taken as a result of peri/myocarditis which included ibuprofen, aspirin, and colchicine. The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous report as received from a physician refers to a "8.5" month old (34 week old) patient. On 31-MAR-2014, the patient received a dose of (Oka/Merck) VARIVAX (0.5 ml, subcutaneously, lot # was not reported) and MMR II (dose, frequency, lot # and indication were not reported). No adverse effect reported. Additional information has been requested.
Patient stated on 4-24-2021 in person that she received her fist COVID-19 (Moderna) subcutaneously and that she noticed "liquid sloshing around her  her back arm for about week after the injection.  Patient received second Moderna dose on 4-19-2021 with no reported issues.
Pt. developed cellulitis after getting the vaccine. She was treated with IV antibiotic in hospital.
Information has been received from a county health nurse concerning a 9 year old female who on 11-JUN-1999 was vaccinated with varicella virus vaccine live (Oka/Merck). On 22-FEB-2007 the patient developed varicella, between 50 and 249 lesions. The nurse reported that an outbreak of varicella had taken place in the local school district in April 2007, and this student was identified during the county health investigation. An immunization clinic was conducted in the school where students received a second dose of varicella virus vaccine live (Oka/Merck). This is one of 28 reports received from the same source. No further information is available.
a 11 months old patient was accidentally administered the diluent portion of the pentacel without the ActHIB and they used Pedvaxhib ( for the missing ActHIB portion)/No AE; Initial information received on 31-Oct-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 11 months old patient who was accidentally administered the diluent portion of the DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] lot U6137AA, dose: 0.5 ml via intramuscular route in the left thigh on 31-Oct-2019 without the acthib and they used HIB VACCINE CONJ (OMPC) [PEDVAXHIB] ( for the missing acthib portion).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant vaccinations included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) and INFLUENZA VACCINE INACT SPLIT VIRION 3V (FLUARIX).  It was an actual medication error due to inappropriate reconstitution technique.  At the time of report no adverse event was reported.  Corrective action: patient was administered Pedvaxhib ( for the missing ActHIB portion).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.