chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a Registered Nurse concerning a 20 year old female with tourette's disorder who on 12-MAR-2007 was vaccinated IM 0.5 ml first dose with Gardasil (yeast) (lot # 654741/0013U). Concomitant therapy included clonidine HC1 (CATAPRES), sertraline HC1 (ZOLOFT) and ethinyl estradiol/norethindrone acetate (MICROGESTIN). On 12-MAR-2007 the patient experienced nausea, vomiting and diarrhea 2 hours after receiving Gardasil (yeast). The physician prescribed ondansetron hydrochloride (ZOFRAN) and loperamide hydrochloride (IMODIUM). The nurse is requesting a lot check. The patient sought unspecified medical attention. No lab diagnostics were performed. Additional information has been requested. This is in follow-up to report (s) previously submitted on 4/13/2007. Initial and follow up information has been received from a registered nurse concerning a 20 year old female with Tourette's disorder and no known drug allergies, who on 12-MAR-2007 was vaccinated IM 0.5ml, with the first dose of GARDASIL (lot# 654741/0013U). Concomitant therapy included CATAPRES, ZOLOFT and MICROGESTIN. There was no illness at the time of vaccination. On 12-MAR-2007 the patient experienced nausea, vomiting and diarrhea 2 hours after receiving GARDASIL. The physician prescribed ZOFRAN and IMODIUM. The nurse is requesting a lot check. The patient sought unspecified medical attention. No Lab diagnostics were performed. Follow up information fromthe nurse confirmed that the patient had recovered from the nausea, vomiting and diarrhea. The records of testing prior to release of the lot in question, have been rechecked and found to be satisfactory. The lot complies with the standard of the health regulatory agency, and was released. No further information is expected.
Fatigue, injection site pain, use of prescription pain reliever or prevents daily activity  Dizziness, lightheadedness  Myalgia, diarrhea, vomiting  Non-prescription medication use
Pt recvd 2nd dose of Hep B vax & on 18MAR91 24 hrs following 2nd vax pt had onset of urticarial lesions which were pruritic; devel arthralgia, fever; pt given meds; pt also exp dizziness, lightheadedness, anxiety, sleeplessness & nervous
Received flu shot at 12:11 pm. Went home and at approximately 2:30pm on 9/19/11 developed swelling and severe pain at injection site w/ feeling of SOB. Aches & pains throughout the hour then felt better.
Second dose of the Moderna vaccine was light pink color; Color of the vaccine is pink; A spontaneous report was received from a consumer, concerning a patient of unknown age and gender, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), which resulted in events, second dose of the Moderna vaccine was light pink color/poor quality product administered and color of the vaccine is pink/product colour issue.  The patient's medical history was not provided. No concomitant medications were reported.  On an unknown date, prior to the onset of events, the patient received their first dose of mRNA-1273 (Lot number: unknown), for prophylaxis of COVID-19 infection.  The patient stated that the vaccine was supposed to be white to off-white in color. The patient received the second dose of the Moderna vaccine on an unknown date and the color of the vaccine was light pink. The patient was concerned if the vaccine was stored improperly. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of the events, second dose of the Moderna vaccine was light pink color and color of the vaccine is pink, were reported as resolved on an unknown date.; Reporter's Comments: This report refers to a case of poor quality product administered, and product color issue for mRNA-1273 with no associated AEs.
This is a spontaneous report received from a contactable reporter (Consumer). The reporter is the patient. A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; varenicline tartrate (CHANTIX), for smoking cessation therapy. The patient's relevant medical history included: "smoker" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: RHINITIS (non-serious), outcome "unknown". The action taken for varenicline tartrate was unknown. Additional information: "The problem that I am having is with rhinitis and it's recurring and may have something to do with your not using fluorine. So, one product is, for person name is (PRIVACY) and (PRIVACY) is the one who has taken the Chantix. (further details unknown) I am smoker. I don't smoke THC. I smoke cigarettes. I smoke methamphetamine but I am having problems with rhinitis and I believe that it's because of the use of Chantix that is facilitated with your Pfizer Vaccine for COVID (clarified as COVID-19 Vaccine). Comparing that to the monkey pox treatment. I use tamarind with the fluorine. It's a kind of like Chantix however it doesn't, you don't have the fluorine, you are not using fluorine. I believe that your product is not safe and could be spreading some disease and there are non smokers that are presently, other use THC and CBD. I don't use THC and CBD. However, you know some of these people that are allowed to do that and others they are allowed to smoke cigarettes and one person got Chantix and that was enough to have a problems with the CF Virus." No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from an immunization coordinator refers to a 28 year old male patient. On 14-MAY-2013 and on 20-JUL-2013 the patient was vaccinated with first and second doses of GARDASIL respectively (dose and lot numbers not reported). The patient was 28 years old at the time of vaccination. No adverse effects were reported. Additional information is not expected.
Information has been received through the pregnancy registry and a nurse concerning a 17 year old female who on 09-AUG-2007 and 11-OCT-2007 was vaccinated with a first and second dose of GARDASIL, respectively. Subsequently, she became pregnant. Her last menstrual period (LMP) was reported as July 2007. She received late prenatal care. On 30-MAR-2008, the patient was hospitalized "for delivery" and delivered a healthy baby. Her pregnancy was reported as normal. At the time of this report, the patient had recovered. No product quality complaint was involved. In follow up medical record it was reported that patient developed an infection two days after delivery. The outcome was not reported. Pediatric medical records were received and reviewed. The following experience with the baby were identified. On 08-APR-2008 the baby was brought to the clinic and thick white patch was present on her tongue. She was prescribed nystatin 4 cc on a swab. The mother was instructed to boil blttle nipples. She was instructed to call the clinic if it dose not clear within two weeks. On 11-APR-2008 the baby came to the clinic again. The mother thought she was fussy with bowel movement and felt that she had constipation. Mother reported that the baby was very irritable and screamed with bowel movement. She was advised to use 1-2 teaspoons of dark Karo syrup in every other bottle to see if it helps with the irritability and difficulty stooling. On 01-MAY-2008 baby had a visit to the clinic. On this visit mother reported that baby had watery left eye. It was reported that the baby recovered from constipation (date not reported). Her diaper area was reddened with multiple papules. No excess tearing from the eye noted in this visit. On 01-JUN-2008 the baby reported to have diaper candidiasis. She was called in clotrimazole cream to apply three times per day for ten days to the diaper area. It was discussed with mom other methods of improving diaper rash. Mom was concerned about a bump on baby's right hand. She wanted it to be checked. The physician reported it as a bony prominence on baby's hand. She was instructed by the physician to contact the clinic if any redness, increase in size or signs and symptoms of infection should occur. At the time of this report the outcome was unknown. The baby also had events after she was vaccinated with ROTATEQ, Hib conj vaccine (tet toxoid) (manufacturer unknown), PREVENAR, PEDIARIX which is reported in (WAES # 0811USA02266). Additional information is not expected. All medical records will be provided upon request.
R edness at injection area, swelling and redness around upper arm from injection area to elbow, advised patient to seek medical attention and prescription antibiotics if necessary.
Pt was vaccinated at an outside homeless outreach vaccination event. Pt reported body itching with rash 2 days after receiving second Covid (Moderna) vaccine.
Four hours after vaccine, pt could not move arm (L) or grasp with hand (L). Had lower back pn that moved up neck. Also developed symptoms of a cold. Saw PCP who prescribed Ibuprofen. Symptoms resolved two weeks later.
LOOSE 10 LBS/DROPPED BELOW 100LBS; DIFFICULTY GAINING BACK THE WEIGHT; FATIGUE; HEART PALPITATIONS; INTESTINAL PROBLEMS; CONSTIPATION; LACK OF CONTROL OF BOWELS; LEG SWELLING; STRONG IRREGULAR HEART BEAT; This spontaneous report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: soy allergy, and other pre-existing medical conditions included: The patient had unspecified dietary related allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 2072A12 expiry: UNKNOWN) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 12-APR-2021, the patient experienced heart palpitations. On 12-APR-2021, the patient experienced intestinal problems. On 12-APR-2021, the patient experienced constipation. On 12-APR-2021, the patient experienced lack of control of bowels. On 12-APR-2021, the patient experienced leg swelling. On 12-APR-2021, the patient experienced strong irregular heart beat. On 12-APR-2021, the patient experienced fatigue. On an unspecified date, the patient experienced loose 10 lbs/dropped below 100lbs, and difficulty gaining back the weight. Laboratory data (dates unspecified) included: Laboratory test (NR: not provided) No blood clots. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from heart palpitations, intestinal problems, constipation, lack of control of bowels, leg swelling, strong irregular heart beat, and fatigue, and the outcome of loose 10 lbs/dropped below 100lbs and difficulty gaining back the weight was not reported. This report was non-serious.
24hr post vax pt began exp swelling of ankle, wrist, & lips;mild itchy red raised rash on lower back, forearms & stomach;when pt awoke in AM approx 36hr post vax lips & ankle were very big swollen;also hot flashes;DPH given;
Person administering the shot gave me wrong dose; This spontaneous case was reported by an other health care professional and describes the occurrence of INCORRECT DOSE ADMINISTERED (Person administering the shot gave me wrong dose) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INCORRECT DOSE ADMINISTERED (Person administering the shot gave me wrong dose). At the time of the report, INCORRECT DOSE ADMINISTERED (Person administering the shot gave me wrong dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Treatment details were not reported by the reporter.   Reporter did not allow further contact
None immediate. No negative reaction to first dose (3/17/21).  Swelling: 6 hours following second dose (4/14/21), noticed swelling on lower lip. Swelling continued overnight and through morning of 4/15. Took Benadryl around noon 4/15 and swelling receded by evening.  Rib/back/chest pain: Around 11:30pm on date of injection, had strong acute pain around lower rib cage. No difficulty taking breaths but pain was intense for about 30 minutes.  Hives: Woke up morning of 4/16 with hives on lower back. By 11am, hives continued to spread to hips, neck, under arms, chest, belly. Sought treatment at urgent care at 12pm and received steroid injection. Took 1 Zyrtec around 1 pm on doctor?s orders. Also applied some triamcinolone acetonide cream on some spots, not on doctor?s orders (he?d leftover from old prescription). Hives continued to get worse until about 3:30pm, have since steadily subsided.
received vaccine reconstituted with non GSK diluent; received vaccine reconstituted with non GSK diluent; This case was reported by a nurse via sales rep and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA751A, expiry date unknown) for prophylaxis.   In September 2022, the patient received Menveo. In September 2022, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 23-SEP-2022 Reporter's Comment: The reporter reported that, the patient received Menveo vaccine reconstituted with a non-GlaxoSmithKline diluent.  After this conversation, a medical Information agent contacted the nurse by phone and confirmed the situation.  The reporter stated that, they have noticed that, patient that could possibly have gotten a partial dose of Menveo along the past week.  The patient that received Menveo powder reconstituted with saline diluent. The reporter consented to follow up by email. Additional Supportive Information: The reporter reported that, the patient received Menveo vaccine reconstituted with a non-GlaxoSmithKline diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. This was 1 of 4 cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2022AMR137840:Same reporter US-GSK-US2022137202:Same reporter US-GSK-US2022AMR137842:Same reporter
Patient states her flu shot was given improperly. The pharmacist injected into her upper shoulder and starting the day after, it became difficult to lift and move.
Information has been received through the Merck pregnancy registry, for GARDASIL, concerning a 14 year old female patient with attention deficit disorder and no drug allergies reported, who on 07-APR-2008 was vaccinated with the first dose of GARDASIL (Lot # 659964/1978U). Concomitant therapy included a dose of HAVRIX, a dose of MENACTRA and RITALIN. Subsequently, it was reported that the patient was pregnant at the time she received the GARDASIL. At the time of this report, the patient is presently fourteen weeks pregnant. The patient did not have any adverse experiences as a result of the vaccine. The patient sought unspecified medial attention. A pregnancy test was performed. At the time of this report the patient's outcome was unknown. No product quality complaint was involved. Follow up information indicated that the patient delivered a 6.8 pound normal baby boy on 03-NOV-2008 at 39 weeks. There were no complications, abnormalities or congenital anomalies. The patient also used vitamins and calcium during pregnancy. Pediatric medical records were received. On 12-NOV-2008 the 9 day old baby went in for a pediatric visit. The newborn screen results were normal. The birth history included the baby being induced due to possible leakage. The Apgar score was 8/9.5. The physician commented the baby was alert and looking about. The assessment was the baby was back to the birth weight. The plan was feeding and G&D was discussed. Weight check was in 3 weeks. On 26-NOV-2008 at the age of 3 weeks the baby came in for a well child visit for weight check and growth. There was occasional spitting. The baby was having bowel movements daily; does grunt/cry with stooling. Diluted juice was used if needed. There were no hard stools now but did have. The baby was waking up 2 to 3 times a night. Impression was a 3 week infant with excellent growth. Discussed stools - normal versus constipation. Discussed fever and illness again. Call if any concerns. On 17-DEC-2008 at the age of 6 weeks. There was no spitting. Bowel Movement was good, an occasional use of apple juice. Tends to be fussy with gassy; gas drops were used. The assessment was  a 6 week infant with good growth. The plan was a follow-up in 2 months. The outcome of grunting, crying and flatulence was not reported. On 12-DEC-2007 the baby had the following immunizations DTAP (unspecified), HIB (unspecified carrier), POLIO (unspecified),  PREVENAR, Hep B (unspecified) and ROTATEQ. Pediatric medical records were received and reviewed and the following experience was identified: grunting, crying, feces hard, infantile spitting and flatulence. Additional information not expected.
This spontaneous report as received from a registered Nurse refers to a 71 year old male patient with diabetes mellitus. The patient's medical history was not provided. Concomitant therapies included metformin. On 30-AUG-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 0.5 ml, with lot # N011491 and expiration date of 04-NOV-2018, intramuscularly in the left arm for prevention against pneumonia. On an unspecified date in 2017, a complete blood count (CBC) and basic metabolic panel (BMP) were performed and the results showed neutrophils high, monocyte absolute was high and white blood cell count was 16.2 (units not provided). On approximately 01-SEP-2017, 48 hours later of vaccination, the patient developed swelling of the left arm and both legs, unspecified fever and unspecified joint pain. The nurse stated that the patient was seen in the office on the following dates: 05-SEP-2017 and 07-SEP-2017. On 07-SEP-2017, the nurse also stated that the patient was seen in an unspecified emergency room for the events but the patient was not admitted. The patient was seen in the office also on 08-SEP-2017 and 18-SEP-2017. The nurse stated that the patient was treated with unspecified antibiotics and unspecified steroids on unspecified dates for the events. At the time of reporting, the patient was not recovered from the events. The causality between PNEUMOVAX 23 and the events was not provided.
20MAY91 felt hot, temp not measured, lt arm @ site hard lump, soreness, warmth; 4JUN91 rash, itching, inflammation on hands & feet x 10 day; 4JUL91 severe stiffness of neck, aching all joints; MD gave meds;
tested for Covid on Jan 3 2022; tested for Covid on Jan 3 2022; cough; congestion; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 5 year-old patient received bnt162b2 (BNT162B2), administration date 20Dec2021 (Batch/Lot number: unknown) at the age of 5 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 03Jan2022, outcome "unknown" and all described as "tested for Covid on Jan 3 2022"; COUGH (non-serious) with onset 2021, outcome "unknown", described as "cough"; NASAL CONGESTION (non-serious) with onset 2021, outcome "unknown", described as "congestion". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (03Jan2022) positive. Clinical course: Patient was tested for Covid on 03Jan2022. The rapid at home test came back positive. Patient has cough and congestion, Event took place after use of product.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Patient presented to our hospital with fever of 102 F, elevated white blood count at 30.7, tachycardic at 123 beats/min and respiratory rate of 33 breaths/min. Patient presented with right-sided weakness in both the right arm and right leg. Infectious Disease consult determine patient has received pneumovax 23 within the past 5 years and this reaction could likely be due to an acute allergic reaction. Patient was given cool compresses, as needed acetaminophen for pain and started on piperacillin/tazobactam for empiric antibiotic treatment while cultures were finalizing. Piperacillin/Tazobactam was discontinued on 7/22/2019 due to rule out of infectious processes, symptoms resolved by 7/23/2019 with no further treatment and patient was discharged on 7/24/2019 in stable condition to home.
ITCHING; hard; feeling of warmth; redness; pain; A spontaneous report was received from a other health professional concerning a  36-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events Pruritus, Somnolence, Feeling hot, Erythema and pain.   The patient's medical history was not provided. No relevant concomitant medications were reported.    On 22-JAN-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch:029L20A) intramuscularly in the Anatomical location unspecified for prophylaxis of COVID-19 infection.  On 01-FEB-2021, The patient experienced the itching, hard, warm, red and painful.  Laboratory details were not provided.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   On 01-FEB-2021 the outcome of the events itching, hard, warm, red and painful is unknown.  The reporter assessed the events itching, hard, warm, red and painful related to the study drug is unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.. Further information has been requested.
Swelling, redness, dizziness, nausea. Main reaction at PNEUMOVAX site.
Patient returned with chills, nausea/vomiting, bodyaches. No fever on vaccination day but guardian reports patient had low grade fever of unknown temp for 48 hours past vaccination. Patient return to school on 10/10/19. Symptoms resolved.
msucle aches; fever; Headache; chills; fatigue; This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced muscle pain, fever, headache, chills and fatigue. On an unknown date, the outcome of the muscle pain, fever, headache, chills and fatigue were unknown.   It was unknown if the reporter considered the muscle pain, fever, headache, chills and fatigue to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient received Shingrix and experiencing common side effects muscle aches, fever, headache, chills and fatigue.      Lab Comments: Lab test performed on unknown date