chrisvoncsefalvay/vaers-outcomes huggingface dataset:
As I sat down for the 15 minute review period both hands and arms turned beet red. I am a woman and my normal skin undertone is yellow.  My hands and feet started tingling as well. When I got home the right side of my face started tingling. My family was slightly upset because I did not mention it while I was at the site. I called one of my collogues she advised me to get Benadryl I bought liquid Benadryl and to drink 1 glass of water every hour for 10 hours.  My left lower lip was swollen the next day and it looked as if I had been hit in the face. The tingling has lasted  for a while and has been going on for a few months. I called my PA's office they couldn't help me they advised me to go to urgent care and I went to urgent care in April then I went to  urgent care facility. I told them the issues about my thighs swelling and they did bloodwork . All of my blood work was inconclusive. When I was at urgent care I was advised that my white blood count was high but they couldn't explain why. I then went to another urgent care. I was concerned about blood clots after sitting for 3-4 hours i went home though they advised me to go to the ER at Hospital Center a while back. I finally went in to the ER on yesterday 6/16/2021 because the pain was shooting through my back and legs and it was very painful to walk and hard to stand. They completed bloodwork. They did not find any blood clots. I was referred to a spine specialist by the hospital and I was advised to go to an allergist by my doctor because of possible inflammation and my hair is falling out.
Patient was given the above mentioned vaccinations. After appox  5 min  in the observations area pin sized red raised dots were noted on just the forehead area.  Nurse administered 2 chewable Benadryl . At appox 5 - 10 min later hives were gone.  No s/s of respiratory distress  noted at this time.
Fatigue; Body aches; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 41 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 04Jan2022 09:37 (Lot number: FJ1620) at the age of 41 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE: 1), administration date: 29Apr2021, for COVID-19 Immunization; Bnt162b2 (DOSE: 2), administration date: 20May2021, for Covid-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 05Jan2022, outcome "unknown", described as "fatigue"; PAIN (non-serious) with onset 05Jan2022, outcome "unknown", described as "body aches". Therapeutic measures were not taken as a result of fatigue, pain.  Additional Information: The patient provided information to regarding the reported adverse events with the use of the product to the physician when she presented to the office for her daughter's routine visit. Possible normal expected side effect is from expired vaccine. The Pfizer product had a causal effect to the adverse event. The patient was not willing to be contacted again by Pfizer on the reported adverse event. The patient had no prior Vaccinations within 4 weeks. The vaccines reconstituted and stored in syringe on 31Dec2021. The nurse did not read label on syringe that showed the date and administered the dose on 04Jan2022. She said she did not recall a label on it and thought it was just drawn up. The nurse did not see expiry date and has been reminded to never administer a vaccine without a label. The patient's mother both experienced fever, fatigue and body aches that they did not experience with previous doses both recovered without a need to seen medical attention.   Follow-up attempts are completed. No further information is expected.
Patient reported to medical center on 8/4/2021 after complaints of shortness of breath for 3 days and increased cough for 2 days. Patient is fully vaccinated against COVID-19 and had a negative COVID-19 test as of 8/2/2021. The morning of 8/4/2021, the patient was extremely short of breath which was not improved with albuterol, and presented to the ER for treatment. The patient had an oxygen saturation of 84% on room air upon arrival.
Hives on his elbows, ankle, leg, groin, buttocks, foot.
Outreach vaccination clinic at the jail.  Client signed up for COVID vaccines, and verified that he had not been vaccinated against COVID.   Due to offsite clinic, unable to verify history so we took patient at his word.  Janssen vaccine given.  Once arriving back to clinic to put vaccines in, noticed client has received a Janssen vaccine on 05/07/2021.
more shortness of breath walking on site visit out of doors 4-1-03 than expected at "take" evaluation 4-2-03 c/o feeling "tachycardic, PVS-ish".  Stated pulse 80-90 when checked.  no chest pain.  no heaviness in chest.  (Pt is emergency medicine physician)
Family went through some unpleasant times; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Family went through some unpleasant times) in a patient of an unknown age and gender 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Family went through some unpleasant times). At the time of the report, VACCINATION COMPLICATION (Family went through some unpleasant times) outcome was unknown.            Concomitant medication were not reported.  Treatment medication information were not provided.   Reporter did not allow further contact
Hot spots-rashes-hives-redness of skin when touched - cracked fingertips - extreme itching. There occur at different times, and not all at once. Was told to use BENADRYL. I need to know how long this will last. And what to do about 2nd shot. Who to contact. This is important, as it affects my life.
The patient was very happy that he got 1st dose of Pfizer Covid vaccine.  He did not report any adverse reaction.
24 hours later, swelling and redness and soreness at injection site. Starting to go down 4 days later.
Inappropriate schedule of vaccine administered; No adverse event; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and NO ADVERSE EVENT (No adverse event) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 057M21A, 004F21A, 030M20A and 041L20A) for COVID-19 prophylaxis.     Concurrent medical conditions included Allergy.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  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-2022-623140 (Patient Link).
This spontaneous report received from a healthcare worker refers to a unknown number of patients of unknown age and gender. Since 23-MAY-2014 the suspect vaccines were improperly stored and on unknown date (in approximately May 2014) the patients were vaccinated with VARIVAX Lot #, dosage, anatomical localization and route of administration were not reported. Vaccines has been administered up to 8 patients. No adverse effects reported. This is one of the several reports of the same source. Additional information has been requested.
Information has been received from a registered nurse concerning a 12 month old male with no medical history and no known allergies who on 5/14/02 was vaccinated with a first dose of MMR II (639513/1118L). Concomitant therapy included the fourth dose of HibTiter (481573). There was no illness at the time of vaccination. On 6/3/02 the pt developed a macular rash on abdomen and a temperature of 102 deg F (x 1 day). The pt sought unspecified medical attention. There were no relevant diagnostic tests or laboratory data performed. It was noted that the pt did not have any adverse events following prior vaccinations. Additional info has been requested.
Systemic: Numbness (specify: facial area, extremities)-Mild, Additional Details: Patient stated she was having numbness (pins and needles sensation) through arm and fingers during the 15 minute observation period. No other symptoms or presentation of allergy. No shortness of breath or anaphylactic like reaction.
pt recv vax & about 2:30 next day pt noted white circle around the inj site that morning;pt had swelling of hands neck & arms;advised to get DPH & use q 4hr;describes chills & ?fever;
Total of 4 seizures 48 hours after vaccine administration. No fever. Was hospitalized. Normal CT, EEG. Discharged with Diazepam Rx.
shingles after she was vaccinated/ suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient got the shingles well after she was vaccinated with Shingles.  The follow-up would not possible as no contact details were available. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting.
This literature marketed report as received from the authors of a public article. Introduction: Jacobsen's syndrome (JS) was a rare disorder (prevalence: 1: 100,000) associated with partial deletion of the long arm of chromosome 11. Clinical features included learning disorders, hearing, ocular, hepatic and renal dysfunction, and growth hormone deficiency. Low CD4+ T-Cells and humoral defects had been reported in three cases in the literature. The reporters presented three patients (pts) with a spectrum of immunodeficiency. Three patients with JS aged 3 to 9 years (median age: 6 years) presented for immune assessment. All had a history of recurrent infections: sinopulmonary infection (n=3) and cutaneous warts (n=2). All patients had chromosomal analysis consistent with JS. Two patients had hearing deficits, all three had skeletal abnormalities, one had short stature, and one had anatomical lung disease on Computerized Tomography (CT). Leukopenia was identified in a single patient but no other cytopenias were identified. B cell assessment documented low age-matched serum immunoglobulin levels (IgA, IgG, IgM) in two of three patients who concomitantly had absent or very low class switched memory B cell (CD19+27+IgM-IgD-) populations. Two had robust responses to polysaccharide and protein vaccination. One patient had a suboptimal response to PNEUMOVAX (< 60% serotype specific antibody production). T cell assessment was abnormal for a single patient with low CD3+ and CD3+4+ cell percentage and absolute cell numbers but normal in vitro proliferation to phytohemagglutinin A, Candida and tetanus. IgG supplementation was provided to the child with leukopenia, poor pneumococcal vaccine response and absent switched memory B cells and antibiotic prophylaxis for the patient with low IgG levels and low memory B cell studies. Both had improvement of their sinopulmonary infections. Conclusion: Two of three patients with JS and recurrent infections had immune abnormalities characterized by B cell dysfunction. The affected patients responded well to immune interventions including IgG supplementation and prophylactic antibiotics. This rare disorder was reported to impact 200 individuals and these 2 cases increased the number of reported JS patients with B cell dysfunction to 4%. The reporters recommended that patients with JS had complete immune evaluation of B and T cell function. As in other B cell disorders, IgG supplementation or antibiotic prophylaxis might improve quality of life for affected individuals. This case refers to the child of unknown gender who on an unknown date was vaccinated with a dose of PNEUMOVAX 23 (reported as "PNEUMOVAX", dose, route and lot # not reported). The patient had a suboptimal response to PNEUMOVAX 23 (< 60% serotype specific antibody production) (Vaccination failure). IgG supplementation was provided to the child. The patient had improvement of sinopulmonary infections. The outcome of "suboptimal response to the vaccine" was unknown. Additional information has been requested.
Swelling going on 11 days, fever at site 3 days, sore going on 11 days   iced, tylenol
LARGE BLISTER AND BRUISING AT THE INJECTIONS SITE. ENTIRE UPPER LEFT ARM SWOLLEN
5 hours after receiving 1st Rabies dose, complained of nausea, vomit, diarrhea.  Next day complained of fatigue then felt fine the following day.  Denies fever or respiratory symptoms, denies hives.
Information has been received from a consumer and a physician concerning a 9 year old white female with CP, "hemi-hypertrophy syndrome", anxiety , GI feeds and chronic otitis media and a history of 28 wk premie who on 09/12/95 was vaccinated in the right arm with the first dose of varicella virus vaccine live. In 11/01, the pt developed chicken pox. subsequently, the pt recovered Unspecified medical attention was sought. No further information is available. the physician also reported that the pt's sibling, 2 females and 2 males, developed chicken pox after vaccination with varicella virus vaccine live. (see WAES0112USA01251, 0112USA01253, and0112USA01254 and 01100739). The consumer reported that 14 pts at her child's school developed chicken pox after vaccinations with varicella virus vaccine live.
This case involves patient (age not reported) who got sick (illness), while he/she received vaccine INFLUENZA VACCINE. The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via an unknown route at an unknown administration site for prophylactic vaccination. On an unknown date, the patient got sick (illness) (unknown latency) following the administration of INFLUENZA VACCINE. Laboratory details were not reported. It was not reported if the patient received a corrective treatment. The event outcome was unknown for illness. There will be no information available on the batch number for this case.
Joint pain/stiffness that started in left hand digits and left knee, moved to left ankle, then to right big toe joint.  The pain has been ongoing but transient (moving from joint to joint).
This spontaneous report was received from a nurse who referred to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient might have been vaccinated with improperly stored doses of VAQTA (lot # N005605, expiration date 08-APR-2018; lot# N016805, expiration date 04-SEP-2018; lot # N020503, expiration date 04-SEPT-2018; lot # N012324, expiration date 05-APR-2018; lot # N019924, expiration date 02-SEP-2018, lot # N014945, expiration date 31-AUG-2018; lot # N017094, expiration date 31-SEP-2018), RECOMBIVAX HB (lot # N002920, expiration date 30-SEP-2018; lot # M044032, expiration date 03-JUL-2019; lot # 20613, expiration date 05-MAY-2020), GARDASIL 9 (lot # N014470, expiration date 17-JUN-2019; lot # N017697, expiration date 21-JAN-2020), PNEUMOVAX 23 (lot # N014188, expiration date 22-JAN-2019; lot # N005096, expiration date 22-OCT-2018) or ROTATEQ lot # N004814, expiration date 21-OCT-2018; lot # N004946, expiration date 05-OCT-2018 or M043838, expiration date 18-JUN-2018 for prophylaxis. The nurse was unsure which lot # the patient received. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion from 32 degrees Fahrenheit to 35 degrees Fahrenheit for 20 hours and 45 minutes. Data logger was involved. There were no previous excursions reported.
Patient developed cellulitis which required treatment by a physician after immunization with PNEUMOVAX 23 and FLUZONE.
Within 20 minutes of vaccine admistration, pt felt lightheadedness, which turned into nausea. Nausea worsen within 1-1 1/2 hours. Pt had 5 episodes of emesis, and feeling shakes, fevers and chills. Pt had similar sxs to prior dose but less severe.
No additional AE reported; 15 year old patient was administered with a dose of PROQUAD; This spontaneous report was received from a nurse referring to a 15-year-old patient of unknown gender. The patient's pertinent medicalñ history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported.      On 20-AUG-2021, the 15-year-old patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (recombinant human albumin) 0.5 ml, lot # U009259 with expiration date 17-SEP-2022, for prophylaxis (strength, route of administration and anatomical location were not reported). No additional adverse event (AE) was reported.
Patient's parent put incorrect DOB on consent form, indicating the patient was 5 when she was really 4. Patient received the Pediatric Pfizer when she was not eligible. Parents were contacted and told she should not receive a 2nd dose.
Redness and welt at site of MMR immediately after injection. Resolved with in 20 minutes with no other symptoms.
Product storage error; No adverse event; 40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 02-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored) and PRODUCT STORAGE ERROR (Product storage error).    No concomitant medications were reported.  It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  It was reported that the vaccine dose would be either 1st or 2nd. Vaccines were stored in the fridge on 30-Jun-2021 and best used date was reported as 30-Jul-2021.  The patient did not report any side effects.  No treatment information was provided by the reporter   This case was linked to US-MODERNATX, INC.-MOD-2023-698994 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698994:Master case
Maculopapular rash spreading across left anterior shoulder, left upper trunk  and right anterior shoulder then behind ears. Mild pruritus, self-limited to rash without airway involvement
PATIENT PASSED AWAY UNEXPECTEDLY. UNKNOWN TIME OR CIRCUMSTANCES SURROUNDING THE DEATH.
Patient exhibited a high fever after shots. 12 days later (on the 25th), she had a fever of 103.6. This was taken down by administering infant's Tylenol for two days. As of today, 3/27/2011, her fever was 96.4, which her normal temperature is 98.2 Her rash spread from her face to all over her body within two days. The rash was noticed at the evening time of 03/25/2011-since it is Sunday, there is no place to take my daughter. I have taken pictures with my camera-on 03/28/2011, I will take my daughter to either the health dept. or to her pediatrician's office to confirm.