chrisvoncsefalvay/vaers-outcomes huggingface dataset:
vaccination failure; shingles; This case was reported by a physician via call center representative and described the occurrence of vaccination failure in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis and mepolizumab (Nucala) unknown for prophylaxis.   The patient's past medical history included herpes zoster (experienced zoster a few years ago). Previously administered products included Zostavax (received Zostavax, few years ago). Concurrent medical conditions included eosinophilic asthma.   On an unknown date, the patient received the 2nd dose of Shingrix, Shingrix at an unknown dose and Nucala at an unknown dose and frequency. On an unknown date, less than a year after receiving Shingrix and Shingrix and not applicable after starting Nucala, 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 Shingrix and Shingrix. It was unknown if the reporter considered the shingles to be related to Nucala.  Additional details were provided as follows: The age at vaccination was not reported. The patient was nephrologist, who received Nucala 4 to 5 weeks for eosinophilic asthma and his next dose was due on 22nd August 2019. The patient had active shingle and asked to postpone dose of Nucala. The patient was nervous about taking an immunosuppressive, while shingles were active. This case was considered as suspected vaccination failure, since the details regarding time to onset for event and laboratory confirmation for shingles were not provided.
While drawing MMR vaccine out of the vial to administer to a pt, the hub of needle disengaged from syringe causing the vax to splash into her right eye.  The nurse immediately experienced stinging for approximately 1 hour.  She flushed her eye with water and subsequently recovered from symptoms. No further information is available.
As per Dr's note on 3/8/06 8x8 cm red warm area on left upper outer arm, mild induration over central portion with fluctuance. Recommended cool compresses to arm at home, gave RX for Benadryl 12.5 mg/5ml, 7.5ml PO q 6 hrs. prn. Redness or swelling of arm.
feeling weak; have low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (feeling weak) and PYREXIA (have low grade fever) in a 92-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced ASTHENIA (feeling weak) and PYREXIA (have low grade fever). At the time of the report, ASTHENIA (feeling weak) and PYREXIA (have low grade fever) 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.
Patient received moderna vaccine at 12:45 pm and at 12:47 after he went to sit down in the observation chair he passed out. Patient fell to the ground on his stomach and I rushed over to turn him on his back. He tried getting up and looked like he had no strength and kept falling back and trying again. The other pharmacist raised his legs while I supported his neck and checked for pulse. Initially we thought it was a seizure but patient was saying he just could not raise his head up and kept going in and out of consciousness. We stayed with the patient for 30 minutes and he felt perfectly fine. Gave him an ice pack for his forehead, but the shoulder took the brunt of the impact.
Fever (max 100.0 on Tylenol/ibuprofen), Chills, Body aches, headache + neck pain (>24hr), nausea/vomiting (x3), diarrhea (x6+)
CHRONIC HYPOXEMIC RESPIRATORY FAILURE 2/22/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Pt had Moderna vaccine #1 on 4/7/21 and # 2 on 5/5/21 and developed a LLE DVT on 5/4/21
pt called in to report the adverse reaction to the vaccine. symptoms like fever headache, inflammation in hands, night sweats, joint pain, neck stiffness, rash on head and neck and stomach upset.
Fever; chills; myalgia; large left axillary lymphadenopathy; This is a spontaneous report from a contactable physician (patient).  A 32-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number EJ1686), intramuscular at left arm on 14Jan2021 12:00 at single dose for COVID-19 immunization at a hospital. There was no known allergies, no other medical history. There were no concomitant medications, the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any other medications within 2 weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Lot number EJ1685), intramuscular at left arm on 23Dec2020 12:00 for COVID-19 immunization at a hospital. The patient had no COVID prior to vaccination, and had not been tested for COVID since the vaccination. It was reported that on 16Jan2021 01:00, the patient experienced fever, chills, myalgia and large left axillary lymphadenopathy. No treatment was received for the events. The outcome of the events was reported as "recovered with lasting effects".
Child received immunizations on 11/27/02. That evening child complained of pain and itching in the right arm. The arm is swollen from the shoulder to the elbow, warm to touch and red.
(L) deltoid area 3 x 4" area bright redness, then faint redness around area 7 x 6" & going bilateral side of arm 15 x 7. No induration. Pt had (+) pain, burning (+) shortness of breath. Seen today.
Progressing over 24 - 48 hours -> pt reported itching followed by edema & erythema which prescribed diagnosed as cellulitis.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The pertinent medical history and concomitant medication was not reported. On 16-JUN-2015, the patient was vaccinated with unspecified number of improperly stored doses of M-M-R II (lot: K004949 and Expiry: 04-APR-2016) (route unspecified). No adverse effect was reported. This is one of the several reports received from the same reporter. Additional information has been requested.
SAT AM hands & feet rash, red arm & fever 99 1hr; red swollen allergic rxn Sunday 10-2PM both feet & both hands called MD Monday AM little rash a few pills; hands & feet swell-bruising on ankles; black marks;
Very tired; Rash on her torso (stomach, chest and back)/rash came just on abdominal area. It was a flat rash. When she pressed it, it was white.; Chills; Fever; Swollen lymph nodes under the arm she got the injection in/ swollen gland under my left armpit size of a baseball; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash on her torso (stomach, chest and back)/rash came just on abdominal area. It was a flat rash. When she pressed it, it was white.), FATIGUE (Very tired), LYMPHADENOPATHY (Swollen lymph nodes under the arm she got the injection in/ swollen gland under my left armpit size of a baseball), CHILLS (Chills) and PYREXIA (Fever) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 071F21A, 032B21A and 044A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced LYMPHADENOPATHY (Swollen lymph nodes under the arm she got the injection in/ swollen gland under my left armpit size of a baseball). On 28-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CHILLS (Chills) and PYREXIA (Fever). On 30-Oct-2021, the patient experienced RASH (Rash on her torso (stomach, chest and back)/rash came just on abdominal area. It was a flat rash. When she pressed it, it was white.). On an unknown date, the patient experienced FATIGUE (Very tired). On 29-Oct-2021, CHILLS (Chills) and PYREXIA (Fever) had resolved. On 31-Oct-2021, RASH (Rash on her torso (stomach, chest and back)/rash came just on abdominal area. It was a flat rash. When she pressed it, it was white.) had resolved. At the time of the report, FATIGUE (Very tired) and LYMPHADENOPATHY (Swollen lymph nodes under the arm she got the injection in/ swollen gland under my left armpit size of a baseball) outcome was unknown.            Concomitant product use was not provided by the reporter.  Treatment information was not reported.   This case was linked to MOD-2021-373326 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Nov-2021: Significant follow-up received include additional information of reporter, patient and events (Start and stop dates and outcome) and new events added. On 04-Nov-2021: Non Significant follow-up.
Left arm below shot numbing, down towards wrist, waking me from sleep, took blood pressure at 12:06 am, was elevated, took Lisinopril (2.5 mg), went down, numbness continued until 1:30 am, went to ER, thinking it might be a stroke, but they did all kinds of tests and just decided it was the shot.  My arm had ached after getting the shot and was quite sore, but no swelling or redness.
Positive Covid case investigation with the PA DOH. Spoke with case's daughter. States her mother recieved vaccine at clinic on 01/27/21. Had no complaints of illness or exposure to a positive case prior to vaccine. Daughter states she's independent and stays alone at night. Felt fine the day and the day after of the vaccine. Per daughter, case's last known well time was Friday 1/29/21 at 730pm. Daughter states they found her Saturday morning with stroke like symptoms and was admitted to Hospital step down unit. She was also informed by the doctor that her heart was irregular with atrial fibrillation.
Hot flashes, irritability, cold hands and feet, hypersensitive to noise, severe acne, yellow eyes, hair loss, depression, red feet.
DEHYDRATED; THROWING UP; INCREASED RESTING HEART RATE TO 110 TO 120 BEATS PER MINUTE/ INCREASED HEART RATE; HYPERTHYROIDISM; GRAVE'S DISEASE; LIGHT-HEADEDNESS; SHORTNESS OF BREATH; This spontaneous report received from a consumer concerned a 22 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: celiac disease, alcohol user, and non-smoker. The patient did not have any drug abuse or illicit drug use. The patient had a family history of thyroid related issue. The patient experienced drug allergy (vomiting) when treated with cefixime. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, expiry: 19-SEP-2021) dose was not reported, dose number in series was 1, administered 1 in total to left arm on 01-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, 2-3 weeks after vaccination, experienced lightheadedness, shortness of breath and started losing weight (by mid-June he lost 20 pounds out of a 155 pounds and he was gaunt) and he had a resting heart rate of 110-120 beats per minute. The patient also visited a nurse practitioner. On MAY-2021, patient saw an endocrinologist and was diagnosed with hyperthyroidism and Grave's disease and was put on methimazole and a B-blocker. On 16-DEC-2021, the patient was hospitalized because he had eaten gluten and was throwing up, got dehydrated and had an increased heart rate. The hospital would not discharge him until they spoke with the endocrinologist, which they ultimately spoke and that resulted in changing of dose of both methimazole and the B-blocker. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the light-headedness, shortness of breath, increased resting heart rate to 110 to 120 beats per minute/ increased heart rate, hyperthyroidism, grave's disease, throwing up and dehydrated was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition).; Sender's Comments: V0: 20211251042-covid-19 vaccine ad26.cov2.s- hyperthyroidism, grave's disease, increased resting heart rate to 110 to 120 beats per minute/ increased heart rate. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20211251042- Covid-19 vaccine ad26.cov2.S-Throwing up, dehydrated. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: MEDICAL HISTORY.
Patient received covid vaccine and during observation reported palpitations and nausea. Patient stated that her normal heart rate was 75 BPM and normal BP 90/ 60. During the episode BP ranged from 110 /80 to 150/ 85 with heart rate of 88 to 80 BPM. Patient reported being anxious. No signs or symptoms of anaphylactic reaction. Patient was discharged to self after 30 minutes.
This is a spontaneous report from a contactable physician via a Pfizer sales representative. A 65-year-old female patient of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration, on an unspecified date, at single dose. Relevant medical history was not reported. Concomitant medications included ALLEGRA, HCTZ and ZOLOFT. The patient experienced redness swelling and heat at site lasting a week on an unspecified date. The outcome of the events was recovered on an unspecified date. No follow-up attempts possible. No further information expected.
erythema, ecchymosis, pain & edema @ inject site are reported in a pt receiving flu vax sx occurred 12 hrs p/vax & resolved w/in 48 hrs;
Severe and erratic heartbeats, heavy slow breathing accompanied with severe fatigue, severe headaches, and severe chills with no energy to move around for a week. After these symptoms eased, no appetite (went from eating five times a day and gym workouts 5 days a week to maybe eating twice a day and unable to walk up 20 stairs without shortness of breathe and heavy erratic heartbeats) still accompanied with little energy, erratic heartbeats, shortness of breath, and lingering headaches well into week three.  Admitted myself to the ER on due to lingering affects and a new symptom of swelling/throbbing on the left side of my head; previous mentioned symptoms still there but milder than before.  Diagnosis at ER was high blood pressure 150 over 92; never had blood pressure problems prior 1st COVID vaccine dose. Follow-up visit with primary care provider, checked my vitals and high blood pressure remained; primary care provider diagnosed high blood pressure, prescribed Amlodipine 5MG tablets.
Patient possibly inadvertently received 1cc of   Modena COVID vaccine instead of 0.5cc. Patient was notified. State was notified
no adverse effects reported; patient was vaccinated with improperly stored MMR II; This spontaneous report has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not provided.  On 26-NOV-2018, the patient was vaccinated with improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (albumin status rHA) one dose, lot # R000554 with expiration date 08-JAN-2020 (frequency, route and anatomical location were not provided) which was reconstituted with sterile diluent (dose, frequency, route, lot number and expiration date were not provided) for prophylaxis. No adverse effects reported.  The temperature and time frame were unknown by reporter. There was previously temperature excursions and digital data logger was involved.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA011469: US-009507513-1907USA010301: US-009507513-1907USA010302: US-009507513-1907USA010303: US-009507513-1907USA010304: US-009507513-1907USA010305: US-009507513-1907USA010306: US-009507513-1907USA010307: US-009507513-1907USA010308: US-009507513-1907USA010309: US-009507513-1907USA010310: US-009507513-1907USA010311: US-009507513-1907USA010312: US-009507513-1907USA010313: US-009507513-1907USA010314: US-009507513-1907USA010315: US-009507513-1907USA010316: US-009507513-1907USA010317: US-009507513-1907USA010318: US-009507513-1907USA010319: US-009507513-1907USA010320: US-009507513-1907USA010322: US-009507513-1907USA010323: US-009507513-1907USA010324: US-009507513-1907USA010325: US-009507513-1907USA010326: US-009507513-1907USA010327: US-009507513-1907USA010328: US-009507513-1907USA010329: US-009507513-1907USA010330: US-009507513-1907USA010331: US-009507513-1907USA010332: US-009507513-1907USA010333: US-009507513-1907USA010334: US-009507513-1907USA010335: US-009507513-1907USA010336: US-009507513-1907USA010337: US-009507513-1907USA010338: US-009507513-1907USA010339: US-009507513-1907USA010340: US-009507513-1907USA010341: US-009507513-1907USA010342: US-009507513-1907USA010343: US-009507513-1907USA010344: US-009507513-1907USA010345: US-009507513-1907USA010346: US-009507513-1907USA010347: US-009507513-1907USA010348: US-009507513-1907USA010349: US-009507513-1907USA010350: US-009507513-1907USA010351: US-009507513-1907USA010352: US-009507513-1907USA010353: US-009507513-1907USA010354: US-009507513-1907USA010355: US-009507513-1907USA010356: US-009507513-1907USA010357: US-009507513-1907USA010358: US-009507513-1907USA010359: US-009507513-1907USA010360: US-009507513-1907USA010361: US-009507513-1907USA010362: US-009507513-1907USA010363: US-009507513-1907USA010364: US-009507513-1907USA010365: US-009507513-1907USA010366: US-009507513-1907USA010367: US-009507513-1907USA010368: US-009507513-1907USA010369: US-009507513-1907USA010370: US-009507513-1907USA010371: US-009507513-1907USA010372: US-009507513-1907USA010373:
4th day after vaccination, area below injection site still sore and swollen, area feels warm to touch. Skin over swollen area is pink and a little itchy.
Initial case received from a consumer on 11 October 2012. A female patient, age not reported, with no known allergies, received a dose of FLUZONE with Lot # UH722AA (to be confirmed), expiry 30 June 2013, site and route of administration not reported on an unspecified date. Concomitant medications and lab results were not reported. The patient experienced an "anaphylactic reaction" right after vaccination. The patient developed swollen eyes, was unable to talk or unable to move her arm. The patient was treated with 25 mg of BENADRYL, reported as BENEDRYL, and was transported to the hospital. The reporter declined to provider further information for the patient, but reported that this was the first flu vaccination the patient had received. No further details were available at the time of this report. The patient outcome was not reported. Documents held by sender: None.
Patient developed a fever that night which rose as high as 103.5 at 12:30pm on 10/24/20.   The fever ranged between 100-103.5.  She also experienced muscle pain, nausea, and headache.  By Sunday (10/25/20), the temperature had decreased to 99.5 and she felt better, but was still experiencing bodyaches. Today Monday (10/26/20), she is still experiencing a headache, eye pain, and nausea.  She stated that she has also been experiencing a little bit of dizziness.
Muscle pain; Fatigue; Runny nose; Red eye; Swollen eye; Dryness in throat; watery eyes; A spontaneous report was received from a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced muscle pain, fatigue, runny nose, itchy, swollen, red eyes, watery eyes and dryness in throat.  The patient's medical history included Covid-19. No relevant concomitant medications were reported.   On 03 Jan 2021, the patient received their first of two planned doses of mRNA-1273 intramuscularly (lot number 011L20A) for prophylaxis of COVID-19 infection.    On 03 Jan 2021, the patient experienced muscle pain, fatigue, runny nose, itchy, swollen, red eyes, watery eyes and dryness in throat. No treatment was provided.   Action taken with mRNA-1273 vaccine was unknown.  The outcome of event, muscle pain, fatigue, runny nose, itchy, swollen, red eyes, watery eyes and dryness in throat were 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.
Almost 2 yrs p/initial 3 series vax pt found not immune; Given 3 doses vax 5OCT88, 3NOV88, 21APR89; Lot 1893P
Information has been received from a physician concerning a 63 yr old male physician, with unk medical history, who on 13Apr06 was vaccinated (route unk) with a dose of pneumococcal 23v polysaccharide vaccine (lot 651328/1046P). There was no concomitant medication. On 13Apr06 the pt developed cellulitis. The pt was treated with antibiotics (unspecified). No product quality complaint was involved. The reporting physician requested a lot check. Cellulitis was considered to be disabling and other important medical event (OMIC). The records of testing prior to release of this lot have been checked by QA and found to be satisfactory. The lot complies with the standards and was released. In addition, a review revealed that there were no open quarantines registered against this lot/fill. Additional information has been requested.
12/30/20 - developed new redness/warmth/itching and swelling at injection site 12/31/20 - symptoms continue and now having redness/warmth/swelling approximately 2 fingers below injection site
Immediately after getting the vaccine, I felt a rush. I felt a little lightheaded, but I was okay on my drive home I felt very lightheaded and dizzy. I almost fainted in the car. I felt like my vision was weird. I don't see double, but I feel that my vision doesn't line up like it used to. I think this is permanent. This happened within 20 minutes. I also got vertigo within 20 minutes as well. After that, it felt like I was on a boat. If I turned my head too fast things moved too quickly. I felt off balanced as if I was in a boat. I felt tired and sick as well. After the vaccine I also got severe headaches and head pressure. I also experienced tinnitus and my ears felt as if they were spasming inside. This has gotten better over a few months and went away. I do still get headaches more often. The vertigo waned over a few months and is now basically gone. The first night after the 1st dose, I also had a pounding heart palpitation which I usually get when I am really sick. For my second shot, within 24 hours, I had sore arm, nausea, fatigue etc which all went away in a few days.  I saw an NP for the vertigo who told me to take Ativan which helped significantly. I then found out that you need to stop taking the Ativan in order for your brain to cure the vertigo. So, I stopped taking the Ativan and within 3 days, it had improved and eventually went away. I am supposed to go for a full vestibular testing (4hrs) but I feel I am okay for now so I have put it off. Based on his full evaluation, he suggested I have vestibular neuritis.  He said that this happening so soon after the vaccine, it was possible the vaccine could've caused it. One morning in August, I had blurred vision in my right eye. I went to the ER but it had resolved by the time they evaluated me.