chrisvoncsefalvay/vaers-outcomes huggingface dataset:
get vaccinated / got it after the vaccine/suspected vaccination failure; got it; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.  The patient's past medical history included shingles.   On an unknown date, the patient received Shingles vaccine. On an unknown date, less than a year 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 patient reported the case for herself/himself. The age at vaccination was not reported. The patient started getting shingles in late 20s and finally was able to get vaccinated last fall. The patient still got shingles after the vaccine but not as bad as before. The patient stated that nothing is 100 percent. This case was considered to be a suspected vaccination failure case, as the details regarding completion of primary vaccination schedule and time to onset and laboratory confirmation for shingles were unknown. The follow up would not be possible as no contact details were available.
Hours after intramuscular tetanus shot, bilat visual loss was measured on a visual field. It was present a week later and now 5 weeks later, but shows improvement with time.
Received Influenza vaccine at approx 0830AM. Remained under observation for 20 minutes then returned to work. At 9:50AM he returned to clinic site complained of difficulty taking a deep breath, felt like he was wheezing and that his throat was tight and had just vomited. B/P  /HR R-20. Epinephrine 0.1ml given SQ and Benadryl 50mg given IM at 9:52am. 10:10 reported relief in shortness of breath and throat tightness. EMS dispatched 9:52 immediately and arrived at 10:20A. He was assessed and declined transport to hospital. 10:30A- transported home. Instructed to seek immediate medical attention if symptoms returned.
Cranky, fever 104 shot up suddenly; lethargic 2-3 hrs p/shot sx started; would not sleep at noc; Fever lasted about 8-10hrs; sl. swelling on rt leg; did not want to be touched;
At 2 months of age, pt received Pediarix, HIB, Prevnar 6/23/04. Parents noted 4-5 hours of inconsolable crying that day and excessive sleeping the next day. On 8/26/04 (4mo), received DT, HIB, Prevnar (due to possible pertussis reaction ) and parents reported >5 hours inconsolable period with low grade fever and emesis x 1.
Fever highest 103F, head ache, body ache, chills, tired, unable to eat symptoms lasted 3 days
Initial unsolicited report received from a health care professional on 21-Jun-2017. This case involves a child male patient who was vaccinated with a dose of IPV (Batch number: R0100, R0347-2, T1146-2, X0367), DTAP (Batch number: U0173AA, U0278AB, U0515AA), HIB VACCINE (Batch number: 582953A, 601063A, 477-393) (manufacturer other) and DTAP (Batch number:627A2) (manufacturer other) (expiration date, dose in series, dose, route and site of administration were reported for all) on an unknown date of 2000 and other years. Patient's pre-existing physician diagnosed allergies, birth defects, medical conditions (specify) and Illness at the time of vaccination was unknown. Any other vaccinations within four weeks of vaccinations were not reported. On an unknown date of 2003, following the vaccination, the patient had developed multiple allergies and eczema. Laboratory investigations and corrective treatment were not reported. The outcome of all the events was reported as not reported. List of the documents held by sender: none.
Information has been received from a registered nurse concerning an unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored (Oka/Merck) PROQUAD (lot # K008185, expiry date: 05-DEC-2015, dose and route unknown). The temperature excursion for (Oka/Merck) PROQUAD was supported with in-house stability date. No adverse symptoms were reported. This is one of several reports received from the same source. Additional information has been requested.
shingles; rash to her right hip/outbreak on her left hip/big red, horrible bits that were itchy; rash to her right hip/outbreak on her left hip/big red, horrible bits that were itchy; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 87-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th September 2019, the patient received the 1st dose of Shingrix. On an unknown date, 1 month after receiving Shingrix, the patient experienced shingles, itchy rash and red rash. The patient was treated with valaciclovir hydrochloride (Valacyclovir). On an unknown date, the outcome of the shingles, itchy rash and red rash were unknown.   It was unknown if the reporter considered the shingles, itchy rash and red rash to be related to Shingrix.  Additional case details were reported as follows: This case was reported by patient herself. The age at vaccination was not reported, however the patient could be 86 or 87 years old. The patient received a dose of Shingrix in right arm. The patient developed a rash to her right hip.  She described it as big red, horrible bits that were itchy.  The patient stated that her dermatologist told she had shingles and prescribed Valacyclovir.  On 13th November 2019, the patient then stated that she developed another outbreak on her left hip and saw her general practitioner who told her she had shingles again and prescribed Valcyclovir.  The patient was concerned about receiving 2nd dose as she was worried she would get shingles again and have to take valcyclovir again.  It was discussed that as Shingrix was not a live vaccine, it was not able to cause disease.  The patient gave medical information for her doctor to follow up for more information.  The reporter did not consent to follow-up.
Varicella - Information has been received from a registered nurse concerning a 1 year old female patient who on 01 Nov 1999 was vaccinated with varicella virus vaccine live.  On 04 May 2000, the patient presented with 4 days of vesicular rash with in creased spots over most of her body.  She was diagnosed with varicella.  She did not have any prodromal symptoms and at this time was not experiencing fever, but she did have moderate to severe rash, extending from head to toe.
Patient stated that starting Friday (7/30/21), approximately 24 hours after receiving the vaccine, she experienced swelling in her legs. She ended up have swelling in her face and joints as well. She experienced migraine and blurry vision since Friday as well. She stated the blurry vision and leg swelling has persisted until today 8/2/21. She does not report a headache or migraine today. Instructed patient to go to ER for follow-up since primary care provider was not available.
Pt was vaccinated (1st Moderna dose) at 13:50. She waiting for period (15mins) w/o symptoms but returned to POD 5mins later with reason decrease anxiety. VS as shown. Pt stated issue was anxiety and she would go home with family and monitor condition. c/o nausea and anxiety. Vital:14:12-153/87 P 112 resp 20; 14:19 153/86 P 111 resp 20. Disposition: Pt to monitor at home.
ADMINISTRATION ERROR : Pt. received 1st dose of Moderna 10/08/2021 UNDERAGE ADMINISTRATION
No adverse reaction.  Expiration format different and expired vaccine given to patient.  When error discovered (9/14/2022) Agency notified and advised corrective action to take. Parent notified on 9/15/2022 and will bring patient back to office to get recommended repeat vaccine. Documentation in patients' chart and staff educated on format of expiration dates
This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated 2 doses of RECOMBIVAX HB in one day. The date, lot# and route was not provided. The outcome of patient was unknown. Additional information has been requested.
This spontaneous report as received from a healthcare worker via company representative refers to an unspecified number of unspecified patients. There were no concomitant medications, concurrent conditions and medical history reported. On an unknown date, an unspecified number of unspecified patients who were each administered either one of two doses of GARDASIL (dose, route of administration, lot# and expiration date not reported), then each were administered either one of two doses of GARDASIL 9 (dose, route of administration, lot# and expiration date not reported) to complete their HPV vaccination series. No adverse effect reported. Additional information is not expected.
This case was reported by a consumer via sales rep and described the occurrence of injection site pain in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain and general malaise. On an unknown date, the outcome of the injection site pain and general malaise were unknown. It was unknown if the reporter considered the injection site pain and general malaise to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient did not reporter agree to follow up. The patient experienced moderate pain at injection site, general malaise for 2 days.
believed it was injected incorrectly because she didn't have pain in her deltoid but she did have all the pain inside her shoulder, like in the bursa; received the first dose 17DEC2020 / received the second dose 4JAN2021; anterior medial shoulder joint/shoulder pain/pain in shoulder after second dose of COVID 19 vaccine; can't actively use shoulder / can't move her arm; weakness in her hand; bone pain; This is a spontaneous report from a contactable healthcare professional (HCP) reporting for herself.  A 40-year-old female patient received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EJ1685, expiry date not provided) via an unspecified route of administration in the left arm on 17Dec2020 13:30, and the second dose (lot number EK9231, expiry date not provided)via an unspecified route of administration in the left arm on 04Jan2021 13:30, for COVID-19 immunization. There was no relevant medical history. The patient's concomitant medications were not reported. The patient experienced anterior medial shoulder joint/shoulder pain/pain in shoulder after second dose of the vaccine on 04Jan2021, and couldn't actively use shoulder. She believed it was injected incorrectly because she didn't have pain in her deltoid but she did have all the pain inside her shoulder, like in the bursa, and she couldn't move her arm and felt weakness in her hand. She noticed the pain and all other symptoms immediately when they were injecting it. She told the nurse who said she was tensing up. The events were considered medically significant by the patient. She also reported experiencing bone pain, unable to put in sutures at work.  She was taking 600mg Ibuprofen and 1000mg paracetamol (TYLENOL) every 6-8 hours. The events were not resolved. The pain had gotten worse. The other symptoms were persisting.; Sender's Comments: Based on the compatible temporal association, the vaccination with BNT162B2 might play a contributory role in triggering the onset of the events. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Patient presented to the ED on 2/9/22 with chest pain associated with SOB, fatigue and weakness.  .  Supposedly patient's chest pain started on Saturday, she states that when she gets up to walk she feels the chest pain as well as shortness of breath, it comes and goes with activity, she characterizes the pain as sharp in nature, she states she holds her chest and after a few seconds the pain goes away, she does have associated shortness of breath, fatigue and weakness with the pain as well as dizziness.  Patient denies taking anything for the pain, she denies any known alleviating factors.  Denies any recent nausea and vomiting with the pain and denies ever having this type of pain before.  No indication for sterio
On August 10, 2023 Medical Assistant administered Pedvax Hib to a 4 year old patient instead of administering Proquad.  No signs or symptoms were reported.  The parents were contacted and advised to bring patient in for the correct vaccine.
hives at injection site; itchy at injection site; rash at injection site; red at injection site; chills; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE URTICARIA (hives at injection site), INJECTION SITE PRURITUS (itchy at injection site), INJECTION SITE RASH (rash at injection site), INJECTION SITE ERYTHEMA (red at injection site) and CHILLS (chills) in a female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced INJECTION SITE URTICARIA (hives at injection site), INJECTION SITE PRURITUS (itchy at injection site), INJECTION SITE RASH (rash at injection site), INJECTION SITE ERYTHEMA (red at injection site) and CHILLS (chills). At the time of the report, INJECTION SITE URTICARIA (hives at injection site), INJECTION SITE PRURITUS (itchy at injection site), INJECTION SITE RASH (rash at injection site), INJECTION SITE ERYTHEMA (red at injection site) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.     As per client, MI error in DOB capture No concomitant medication were given. No treatment information were provided by the reporter.   This case was linked to MOD-2021-227044 (Patient Link).
Purpuric-like discoloration to her distal right fourth digit. There was also some mild involvement into the second interphalangeal joint. Patient denied pain, shortness of breath, chest pain. There was no decreased range of motion of her finger. She had no rashes that she knew of anywhere else on her body.  Patient was monitored for an additional 30 minutes. When provider returned to the room she had c/o new blotchiness of her arms bilaterally on the ventral aspects. Patient was still asymptomatic, no pain in her finger or anywhere else, no shortness of breath, no throat tightening. Patient then sent to our ER department.
104.7 fever, shortness of breath, delirious, fatigue, body aches, sweats and chills. Fever, body ache, delirious, sweats and chills lasted several days. Shortness of breath, body ache, fatigue was more than 2 weeks and I had to miss work and go out on FMLA
Noticed spotting today (5/17) . Not sure if it will be a full fledged period.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 28-JUL-2014, the patient was vaccinated with a 0.5 ml expired dose of M-M-R II (lot # reported as J008882, expiration date 27-JUL-2014) subcutaneously. No adverse effects were reported. Additional information has been requested.
Information has been received from a nurse practitioner concerning a 28 year old patient with penicillin allergy and no pertinent medical history reported who on 10-JUL-2009 was vaccinated intramuscularly into the right deltoid with first 0.5mL dose of GARDASIL (lot number 661953/1130X). Concomitant therapy included YASMIN. "Four days after injection", on 14-JUL-2009, the patient experienced developed a rash. The fine raised rash started out on her legs or arms and then covered her entire body. No lab tests were performed. The patient sought unspecified medical attention. Follow up information was received from the nurse practitioner. She reported that the patient had decided to not receive any more doses. She reported that the patient has a lot of allergies (to foods, medications). The patient's rash started four days after the first dose of GARDASIL and the rash resolved but it took about a week to resolve. No further information is available.
Localized reaction to tetanus vaccine resulted in moderate to severe arm pain, numbness and weakness.  Area around injection is warm to the touch, swollen and red.  Low grade fever (100 deg F).  Mobility of the arm is hindered, and patient screams when it is touched. Numbness, pain and weakness lasted for the first 24 hours after vaccination.  Pain got worse over the next couple of days.  On the 25th, patient noticed swelling, redness, and fever.   Only treatment given was over the counter motrin to ameliorate pain, swelling, and fever.  Fatigue was also present.
Dizziness, headache, and soreness at the injection site. Three hours after the injection the dizziness started again which caused her to fall and injure herself, scraped up her knees, hands, and injured her shoulder; Fall; Headache; Soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness, headache, and soreness at the injection site. Three hours after the injection the dizziness started again which caused her to fall and injure herself, scraped up her knees, hands, and injured her shoulder), FALL (Fall), HEADACHE (Headache) and VACCINATION SITE PAIN (Soreness at the injection site) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Q11J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Dec-2020, the patient experienced DIZZINESS (Dizziness, headache, and soreness at the injection site. Three hours after the injection the dizziness started again which caused her to fall and injure herself, scraped up her knees, hands, and injured her shoulder), FALL (Fall), HEADACHE (Headache) and VACCINATION SITE PAIN (Soreness at the injection site). On 22-Dec-2020, FALL (Fall) had resolved with sequelae. At the time of the report, DIZZINESS (Dizziness, headache, and soreness at the injection site. Three hours after the injection the dizziness started again which caused her to fall and injure herself, scraped up her knees, hands, and injured her shoulder), HEADACHE (Headache) and VACCINATION SITE PAIN (Soreness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not reported.  Treatment medication was not reported.    Most recent FOLLOW-UP information incorporated above includes: On 01-Mar-2021: No new information received. A request to provide patient identifiers was received.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. The event: fall is unlikely related. This case concerns a 64-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot Q11J20A), and who experienced dizziness, headache, injection site pain, and fall.  The events of dizziness, headache and injection site pain were considered possibly related to the vaccine due to the temporal relationship, while the event of fall was considered unlikely related to the vaccine and more likely explained by the dizziness.
Narrative:  82yo male pt had several falls at his community Adult Living Facility and was taken to hospital on 10/19 for a fall. Pt then presented to ER again on 10/29/21 at hospital for a fall. Pt then died at non-agency hospital on 11/2/2021. Pt's problem list: A fib BPH Bladder neck obstruction Compressing fracture L3 HTN GERD Alzheimers Hypothyroidism Pt had received covid vaccines on 3/9/2021 & 4/7/2021. This death is likely not related to the vaccinations due to comorbidities, age, and length of time from vaccine administration.
Pneumo vaccine given am. Pt noticed swelling, pain, arm red, warm to touch, difficulty moving arm afternoon. Applies ice pack, took pain med, Increase arm movement. Came to clinic on 8/1/06. Dr examined arm. To continue with ice pack, increase arm movement.
Approximately 5 minutes after receiving the COVID19 vaccine patient reported feeling 'weird'. Denied any specific symptoms. Denied feeling light headed, dizzy, short of breath, difficulty breathing, sensation of foreign body in throat, itching. Also denied sensation of tongue, lip or throat swelling. Patient was taken by wheelchair to a treatment room and placed on a gurney. Pt preferred to sit up. Initial BP of 174/111, HR of 105. Shortly after patient reported starting to feel better. States she did not eat that morning. Repeat BP 163/95 HR 97. Patient continued to report symptom resolution. BP repeat again 163/94 HR 96. Denied history of hypertension. Advised patient on following up on BP. Patient discharged after monitoring for approximately 30 minutes. Follow up precautions discussed.
Pt had febrile seizures with temps to 103F 7 days after MMR vaccination. Pt presented to outside ER. Patient received tylenol in ER, and discharged with amoxicillin for bilateral otitis media.
paresthesias of bilateral feet and lower legs, bilat forearms, R hand and inability to fully extend R index finger; started the morning after the vaccine; states she also feels weak; advised observation. 5/29/09 Medical records received DOS 5/27/09. PRIMARY DIAGNOSIS: Vaccines Allergic Reaction Post Vaccination - Woke up next morning with tingling in right hand, bilateral legs from knees down, and bilateral forearms. Arms and legs weak, difficult to walk. Finger nails are tender. Pain in index finger - cannot straighten. Substernal chest soreness.
Initial report received from a healthcare professional on 12 JUNE 2013. A 23-year-old female patient had received an intramuscular dose 1 of MENACTRA (lot number: U4594AB, site of vaccination was not reported) and an intramuscular dose 1 of ADACEL (lot number: U4612AA, site of vaccination was not reported), both on 12 JUNE 2013. It was reported that the patient was pregnant at the time of vaccination. The last menstrual period date was 27 MAY 2013. The patient's estimated date of delivery was 03 MARCH 2014. The patient had no risk factors (e.g. alcohol, tobacco, or recreational drugs). Concomitant medications and medical history were not reported. The patient had not received any treatment for infertility. At the time of this report, the patient had not experienced any adverse events. Documents held by sender: none. Follow up information received from a healthcare professional on 12 JULY 2013. The patients address details were updated. The patient had no illness at the time of vaccination and had no previous pregnancy. The patient had received 0.5 ml dose of each ADACEL and MENACTRA vaccines. Initial laboratory tests were normal, further prenatal testing to be done at patient's chosen OB/GYN. The patient had no complications in pregnancy.
Approximately 10-12 areas of blanching circular erythema, the largest of which is less than a 2 cm in size, on the chest, posterior arms,axilla, and torso. slight dorsal hand swelling but no erythema.
Swelling ,large lump, red rash, skin peeling on arm and other limbs. Very tired.
Fright, dizziness, lightheadedness. Laid flat on floor w/elevated legs until symptoms resolved (approximately 15-20 mins).