chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Few drops came out; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Few drops came out) 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 16-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced UNDERDOSE (Few drops came out). On 16-Mar-2021, UNDERDOSE (Few drops came out) had resolved. Not Provided      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 medications were not provided by the reporter.  Treatment medications were not provided by reporter.
This is a spontaneous report from a contactable physician assistant reported for herself who was reporting on behalf of another HCP. A 74-year-old female patient received PREVNAR 13, via an unspecified route of administration on 28Jul2015 at 0.5ml single for immunization and lisinopril via an unspecified route of administration on an unspecified date till Aug2015 for hypertension. Medical history included hypertension from 2014, glaucoma at 15 years, depression from 1996, blood cholesterol increased at about 20 years, hypothyroidism at about 35 years, all ongoing and blood viscosity increased from an unknown date and unknown if ongoing. Concomitant medication included BABY ASPIRIN 81 mg, 1x/day, atorvastatin 40 mg, 1x/day, VITAMIN D3 2000 IU, 1x/day, dorzolamide hydrochloride, COSOPT 1 drop right eye twice a day, brimonidine tartrate, SIMBRINZA 1 drop left eye three times a day, ZIOPTAN 1 drop each eye at bed time, sertraline 75 mg, 1x/day and levothyroxine 125 ug, 1x/day.  The patient previously took PNEUMOVAX. The patient then received a influenza vaccine on 30Sep2015. The patient experienced pneumonia on Oct2015, primary infection site was the left lower lobe, cough on Aug2015, coughed until she vomited on an unspecified date, spiked a high fever of 103 degrees Fahrenheit on Oct2015, the physician heard the rales in her lung on an unspecified date, she had sinus and vocal cords infections on an unspecified date, she was left with gravelly voice on an unspecified date. The patient was hospitalized for pneumonia, approximately from 20Oct2015 until 23Oct2015.  The outcome of the events pneumonia and cough was recovered, the outcome of the other adverse event was unknown. Relevant Tests in Oct 2015: Chest X-ray: Negative, Blood work: Normal, Sputum culture Pneumococcus Pneumonia and Chest CAT scan of the lung in Dec 2015:  Negative. The patient took Ibuprofen 400mg tablet by mouth one dose only for the fever, then she went to the emergency room. Received IV antibiotics while hospitalized. Sender's Comments: Based on the information provided in the case, a lack of efficacy with PREVNAR 13 in this patient cannot be excluded. Further information like serotyping results is needed for a full medical assessment.
Blotchy Hives on Face Only. Chin, cheeks, and forehead, no treatment at this time.
Myalgia extreme pain in left arm Narrative: pain in left arm. shot was given very high almost at the shoulder. ice recomended.
Three days after my second vaccine, I had blood in my stool.  Has not happened since.   24 days after my second dose, I developed supraclavicular swelling (puffiness) on my right side.  Also discomfort in my neck.  I still have it.
Within 24 hours of receiving 1st dose of Moderna patient experienced spasms in lower portion of stomach. Visible on the outside. Conditions still exists in present day.
pt recvd vax & exp tenderness @ the site of inj followed by sore throat 3 days later, fever to 102 & cough 5 days p/inj; pt was treated w/Augmentin for bronchitis;
VOMITING; NAUSEA PERSISTED ON AND OFF BUT CURRENTLY PRESENT AND WORSE; HEADACHE PERSISTED ON AND OFF BUT CURRENTLY PRESENT AND WORSE; CHILLS; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 05-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 05-MAR-2021, the subject experienced vomiting. On 05-MAR-2021, the subject experienced nausea persisted on and off but currently present and worse. On 05-MAR-2021, the subject experienced headache persisted on and off but currently present and worse. On 05-MAR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vomiting, and chills on 06-MAR-2021, and had not recovered from nausea persisted on and off but currently present and worse, and headache persisted on and off but currently present and worse. This report was non-serious.
Patient took first dose, after 3.5 hours felt ill and vomited the capsule intact, second dose was taken and experienced nausea, diarrhea and malaise.
Fever blister outbreak that continued for 21 days despite regular use of Valcylovir prescription
This spontaneous report as received from a Physician Assistant refers to a female patient of unknown age. On an unknown date, the patient was vaccinated with GARDASIL injection, intramuscular (dose and lot number were not provided). No concomitant medications were reported. On an unknown date, "shortly after" being administered GARDASIL, "broke out in widespread tiny warts". Triamcinolone treatment was given for the adverse event. No laboratory diagnostics studies were performed. The outcome of "broke out in widespread tiny warts" was unknown. Additional information has been requested.
Fainted immediately.  Caught by MA and aroused immediately. Was pale and nervous for several minutes. Was monitored with feet up in recumbent position until felt better. Was observed in clinic for 15 minutes until walked out comfortably.
pt recvd vax in approx 1959 & 29APR93 lab eval revealed neg antibody to measles & rubella & a pos antibody to mumps; 29JUN93 pt was vaxed w/MMR & 6 wks later lab eval revealed pos antibody to an immune level for measles & rubella;
The patient was sitting in the observation area 2 minutes after receiving the vaccine, and stated "I think I am getting dizzy". The patient then fainted while sitting and LOC. No injury occurred on site. Patient placed on flat surface and legs elevated. and performed sternum rub by the nurse, the patient gained consciousness after 10 seconds. VS initiated, WNL. Observation extended to 1 hour and 15 minutes. Symptoms fully resolved before leaving the site with the sister.
MASSIVE RELAPSE MULTIPLE SCLEROSIS; This spontaneous report received from a patient via social media via a company representative concerned a patient of unspecified age, sex, race and ethnic origin. The patient's height, and weight were not reported. The patient's past medical history included: surgery, and alopecia, and concurrent conditions included: leiomyosarcoma, svc syndrome, and multiple sclerosis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) 1 in total, dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case.  Concomitant medications included ocrelizumab for multiple sclerosis relapse, botulinum toxin type a, and docetaxel.  On an unspecified date, it was reported that, "IOcrevus. In my 23 years of MS I AM thrilled 2 have Ocrevus as my treatment of choice I had a massive relapse after the first and only vaccine Actually took pics walking in College  I HAD 2 B 'd I was bedridden for months Still require a. Text 2: Scroll thru my media went thru Leiomyosarcoma SVCsyndrome surgery 2 correct both 6months of ChemoDays Taxotere has left me with Alopecia All of that didn't put me in2 amoments after the jnj vaccine i was unable 2 stand then spasticity severely contracted my muscles. Text 3: Docs said it seemed as if I had a spinal cord injury from T-2 down I had multiple botox injections 2 my legs ,which were (prev pic shows) permanently bent in2 my chest It was THE MOST INCREDIBLY PAINFUL PHYSICAL experience of my life. spasticity has declined Not enough tho". On an unspecified date, the patient experienced massive relapse multiple sclerosis (bedridden, unable to stand, muscle spasticity, and most incredibly painful physical experience). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of massive relapse multiple sclerosis was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20220909503-covid-19 vaccine ad26.cov2.s-Massive relapse multiple sclerosis. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY. Therefore, this event(s) is considered not related.
Headache, fever which resolved in 24 hours and with ASA. Still has loss of appetite, nausea and fatigue. Severe pain-vice-like which moved from (L) arm to chest, spine and down (L) side and lasted 2-3 days and moved to (R) leg. Weakness in legs, difficulty walking. Some spasms (L) arm was "lumpy" swollen and red area 5-6" long. Legs remain weak but improving. Pain also occurred in previous surgical area of neck, spine and shoulder.
Itchiness with a burning sensation throughout body - from scalp to legs started within 30 to 45 minutes after the observation period ended.  Itching has persisted since the day of I got first dose of Pfizer vaccine.  I have taken Benedryl and Zyrtec to help control itching but still persistent through today - April 16th.
really high blood sugar, some mornings over 300 mg; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unknown date in Feb2021 (a week ago) as a single dose for COVID-19 vaccination. Medical history included ongoing diabetic from an unknown date. Concomitant medications were not reported (reported she takes 'sugar medicine' for diabetes). In Feb2021, since receiving the vaccine, the patient experienced sugar levels have been high, the first 3 or 4 days they were really high, some mornings they were over 300mg. The patient underwent lab tests which included sugar levels which showed over 300mg on an unknown date. The patient was treated for the blood sugar high with taking half of her sugar medicine. The clinical outcome of the event blood sugar increased was recovering reported as the levels were lowering a little.     The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.
Hot; Cold; Muscle aches; Fatigue; Chills; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Hot), NASOPHARYNGITIS (Cold), MYALGIA (Muscle aches), FATIGUE (Fatigue) and CHILLS (Chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Oct-2021, the patient experienced FEELING HOT (Hot), NASOPHARYNGITIS (Cold), MYALGIA (Muscle aches), FATIGUE (Fatigue) and CHILLS (Chills). At the time of the report, FEELING HOT (Hot), NASOPHARYNGITIS (Cold), MYALGIA (Muscle aches), FATIGUE (Fatigue) and CHILLS (Chills) outcome was unknown.            Concomitant medication was not provided.  Treatment information was not provided.
pt recv 1st dose of vax; w/in 2 hr of vax pt devel fever of 100 degrees F. Over next couple of wk she devel aches, pains, flu-like sx, vomiting & was found to have gastritis. pt recv 2nd dose & gastritis worsened;16dec96 vomit
Very sharp stabby pains all over my body. Like tiny knives repeatedly stabbing me quickly. Ibuprofen helps some. Also nauseous. Slight fever.
Raised rash & elevated temp 24 hrs p/inject; rash continuing & then fading x 12 days; general muscle malaise x 48 hrs;
On 10-28-17 the morning after receiving the flu vaccine, the patient swollen red arm. Family gave appropriate dosing of Benadryl with no change noted. On Monday 10-30-2017, patient complained of shortness of breath and her injection site increased with swelling, redness, and warmth. She was taken to the ER where she received steroids and Benadryl intravenous. She was started on Zyrtec oral and monitor, discharged home. The redness had almost disappeared by evening with no complaints of shortness of breath. 10-31-2017, she complained again of shortness of breath and the redness was returning to the arm along with developing a harsh cough. The ER Provider was called and was prescribed oral prednisone and continue with Zyrtec x 7days. 11-05-2017 was last dose of prednisone, 11-06-2017 last dose of Zyrtec. 11-07-2017 Arm is back to normal and no shortness of breath or cough noted.
Redness, heat, induration starting at injection site and spreading over entire thigh over 2-3 days.
Arm sore; Accidental underdose; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number XJ57B, expiry date 18th October 2021) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced pain in arm and accidental underdose. On an unknown date, the outcome of the pain in arm and accidental underdose were unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported, but it could be 58 or 59 years. The healthcare professional reported that needle leaked while Shingrix was being administered to the patient, which led to accidental underdose.  The healthcare professional would like to know how to proceed.  The patient was also concerned because her arm was not sore as it was for the first dose. The reporter gave permission to follow up.
SHORTNESS OF BREATH; SWOLLEN MOUTH; BUMPS  IN DIFFERENT PARTS OF THE BODY; CONSTANT HEADACHE; NAUSEA; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 10-APR-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On 2021, the subject experienced shortness of breath. On 2021, the subject experienced swollen mouth. On 2021, the subject experienced bumps in different parts of the body. On 2021, the subject experienced constant headache. On 2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the constant headache, nausea, shortness of breath, swollen mouth and bumps in different parts of the body was not reported. This report was non-serious. This case is a duplicate of 20210505746.
Initial report received on 25 April 2013 from the Investigator participating in a post-marketing study under the reference number M5A16. A case of pertussis disease in a 23-month-old female subject (initials not collected) was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDSS) electronic database. The subject had received three doses of PENTACEL: dose one, lot number C3896AA, received on 01 August 2011; dose two, C3954AB, received on 23 September 2011; and dose three, lot number C4192AA received on 02 August 2012 (routes and sites of administration not reported). The subject developed cold-like symptoms on 01 March 2013, approximately six months after the last dose. On 15 March 2013, the subject developed a cough and paroxysmal cough on 16 March 2013 with a whoop. The subject also experienced posttussive vomiting, sleep disturbance and apnea. Laboratory testing included positive PCR on 20 March 2013. Chest x-ray findings were negative. Corrective treatments consisted of Azithromycin starting on 20 March 2013 for five days. The subject was not hospitalized. At time of final contact on 10 April 2013, the subject's cough had resolved. The duration of the cough was reported at that time as 14 days. The subject's outcome was not reported. Investigator causality assessment is not required as per protocol. This is one case out of a cumulative total of 196 cases solicited from the Electronic Disease Surveillance System (EDSS) during the surveillance period from 01 January 2010 to 25 April 2013. These 196 cases represent children who received three or more doses of sanofi pasteur vaccine; cases of pertussis disease in children who received DTaP combination vaccines from other manufacturers are not reported as per study protocol. Documents held by sender: None.
Received DTaP vac in right deltoid 12/16/2003. Mother states child has had no significant fever On PM of 12/17/2003 mother noticed increased swelling and redness at injection site. Arm was red and swollen from shoulder to elbow. Mom took him to ER, CBC was WNL. Treated with Tylenol with children's Motrin. On 12/18/2003 swelling was less- now from right detoid to just above elbow.
Patient came into our office on 09-14-10 in regards to concerns mom had about her (L) leg. She crawled with her left leg straight and it was painful when touched. X-Ray was done and a mass was identified in pt's (L) leg. Mass was later identified as myositis ossificans and is believed to be caused by the vaccine.
Patient's 1st done of MMR, and 2nd dose of Varicella were given to early and were both considered  invalid. Patient was given a MMRV. Patient tolerated vaccine well. No signs or reaction.
This is a spontaneous report from a contactable consumer who reported for himself and his caregiver (nonHCP). A 92 year-old male patient received PREVNAR 13, via an unspecified route of administration to right upper arm on 23Nov2015 at single dose. The patient medical history was not reported. The patient previously took pneumococcal 13 vaccine 2 years before. Concomitant medication included Baby Aspirin at 81 mg one in the morning till Dec2015. On unspecified date in 2015 the patient experienced rheumatoid arthritis, it was like he was paralyzed, couldn't walk, fever, spasms; redness and swelling of right knee / redness and swelling of right hand / redness to right knee, right hand, and right knuckles, loss of appetite; both legs were stiff, couldn't move them, drowsiness, muscle pain mostly on the right side, weakness, was in bed for 2 weeks all with outcome of unknown; and pain started in upper right hand, then down to knuckles, them to right knee, right foot, and also in his left neg, cannot grasp things with outcome of not recovered. All side effects started about 7 days post injection. Events were described as follows. Fever started about 7 days after the injection. Went up and down. Did not check it constantly. When checked, result ranged from 98-99. The highest result for the times they checked it was 99. Pain, cannot grasp things started about 7 days after the injection. Started in upper right hand, then down to knuckles, then to right knee, right foot, and also in his left leg. It was like he was paralyzed, he couldn't walk because the pain was so bad. He was in bed for 2 weeks. This got better after about four weeks, but over the past two days, has constant pain in ankles all the way to fingertips. He cannot grasp things. After the pain started, these areas got red and swollen. Over past two days, he has had a little bit of swelling to his right knuckles and wrist but they are not red. Has to keep opening and closing his hand to keep it comfortable. The patient could not open or close his hand, and was really red. For about three weeks, patient consumed just tea and water, had no appetite. Gradually began eating again. The patient underwent lab tests and procedures which included blood test with unknown results on unknown date. Therapeutic measures were taken as a result the events and included ibuprofen 200mg three times daily, started about 6-7 days post injection and taken for two weeks. Then, the third week, dose was decreased to two daily. After four weeks, patient was doing better. He saw a physician, who did not know what was wrong with him, so referred him to a rheumatologist. The rheumatologist, said he may have rheumatoid arthritis and gave him Methylprednisone 4mg, which the patient did not take. Went to hospital doctor and was told it was okay to take the prednisone
Patient reported feeling near syncope and sat down in his vehicle at 09:17. Patient had previously had Janssen COVID-19 vaccination on his right deltoid via intramuscular injection at 09:11.  Patient was found awake, alert and oriented to person, time, place and event however was sluggish in response. Patient was observed pale, skin was dry to touch. Vital signs were obtained and patient was monitored every 5 minutes during incident. Patient reported progressively feeling better during interaction however patient stated that initially he experienced dizziness, a ?white-out, like a flash bang? to his vision, and feeling of near syncope. Patient stated not having any food intake that morning and to have previously used marijuana over night. Patient was offered EMS services on his behalf but patient stated he felt better after 15 minutes of monitoring and was well enough to drive home on his own. Patient was educated to stay hydrated and to have meals to compensate for his incident and informed to call 911 if his condition worsen or continued.
Pt recv vax & devel rash on face & trunk & fever of 103f for 48 hr.3 other pt exp similar rxn (WAES98040053,98040054,98040055.
This spontaneous report was received from a pharmacist concerning to a patient of unknown age and demographics. The patient's concurrent conditions, medical history, drug reactions/allergies, and concomitant therapies were not provided. On 27-MAR-2017, the patient was vaccinated with an expired dose of VARIVAX with lot # L007225, and expiration date 27-MAR-2017, for prophylaxis (the strength, dose, route, and frequency were not provided). The vaccine was reconstituted with a Merck diluent. No adverse effects were reported. Additional information is not expected because there was no consent to contact physician.
Injection given 12/26/2020. On 1/2/2021 around 1:40 pm injection site erupted into a painful, red, itchy hot rash. Seen in Urgent Care on 1/3/2021 where doctor diagnosed probable cellulitis and advised time off of work. Given antibiotics and steroid cream to treat.  Seen for follow up with same doctor but in occupational health on 1/6/2021. Doctor extended course of antibiotics and did not release me for work. At time of this writing,  I am still being treated and my next appointment with occupational health is 1/14/2021.