chrisvoncsefalvay/vaers-outcomes huggingface dataset:
off label use; This literature marketed report has been received from the authors of a published literature article, titled as stated below and refers to a 23 year old male patient with hoarseness and poor voice projection without improvement from speech therapy or medical anti-reflux medication. The patient had squamous cell papilloma. The patient's historical drugs included bevacizumab and cidofovir.  On an unknown date, the patient was vaccinated with a dose quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) (lot #, expiration date, dose, rout and site of vaccination were not reported) for squamous cell papilloma (off-label use). COncomitant therapies included celecoxib.  A copy of the published article is attached as further documentation of the patient's experience
Second vaccination occurred only 14 days following first vaccination.  Outside of the 4 day grace period.
swollen neck; swollen face; swollen throat; Hard to swallow; swollen tongue; felt like she was on fire; rash behind her head on her neck; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swollen neck), SWELLING FACE (swollen face), PHARYNGEAL SWELLING (swollen throat), DYSPHAGIA (Hard to swallow) and SWOLLEN TONGUE (swollen tongue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 18-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SWELLING (swollen neck), SWELLING FACE (swollen face), PHARYNGEAL SWELLING (swollen throat), DYSPHAGIA (Hard to swallow), SWOLLEN TONGUE (swollen tongue), FEELING ABNORMAL (felt like she was on fire) and RASH (rash behind her head on her neck). At the time of the report, SWELLING (swollen neck), SWELLING FACE (swollen face), PHARYNGEAL SWELLING (swollen throat), DYSPHAGIA (Hard to swallow), SWOLLEN TONGUE (swollen tongue), FEELING ABNORMAL (felt like she was on fire) and RASH (rash behind her head on her neck) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The patient wanted to report her adverse event of yellow/ brown stool and dark urine.  No concomitant medication was reported. The treatment information was not given.  Action taken with m-RNA-1273 in response to the event was not applicable.   This case was linked to MOD-2021-114324 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Significant follow up appended; Sender's Comments:  MOD-2021-114324:reporter's case
This spontaneous report was received from a nurse refers to a 9 weeks old patient of unknown gender. The patient's relevant medical history, concurrent conditions, concomitant medications, drug reactions or allergies were not reported. On 02-OCT-2017, the patient was vaccinated with improperly stored  ROTATEQ (dosing details were not reported) (lot # N009948, expiry date: 12-OCT-2018) orally for prophylaxis (incorrect product storage). No adverse effects were reported. Temperature excursion was from 0 degree Celsius (C) to 1 degree C (0.8 degree C) for 52 minutes. The previous temperature excursion was reported as from 9 degree C to 25 degree C (10.9 degree C) for 3 hours 17 minutes. The call was because of a data logger. No product quality complaint involved. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1709USA007014: US-009507513-1709USA007011: US-009507513-1709USA007012:  US-009507513-1709USA007013: US-009507513-1709USA000054:
Received flu vaccination on Tues., 10/07/2008 at about 2:30 pm and Wed., 10/08/2008 at approximately 4 pm, developed whole body itch. No other symptoms. Went to family doctor - was examined and was given a BENADRYL shot. Within 20 minutes, itching had stopped has not returned. Sated is allergic to PNC, tetracycline, band aids with local reactive only. Has had flu vaccination last 40 years with no reaction.
Patient has primary essential hypertension. Patient undergoes an annual echocardiogram to monitor for ventricular hypertrophy. Prior to this years ECHO, all results have been normal. This year there was an  incidental finding of a small amount of fluid around her AV node. ECHO was performed on 5/21/21. She is to have a repeat ECHO on June 11 to monitor for changes. Patient did endorse stabbing like chest pain a couple of weeks ago, but dismissed it as heartburn. Her first Pfizer Covid shot was 3/18/21 and her second Pfizer Covid shot was 4/7/21. Same lot# for both vaccines.
pt recv vax;w/in 1/2 hr later, cried for about 4 hr; inconsolable & somewhat high pitch cry; p/ 4 hr apap given;slept at noc; doing well now;
Within five minutes was feeling dizzy, hot, vision started to tunnel. Suddenly broke into a sweat and then lost consciousness in a seated position.  Nurses came over, laid me on my side, took blood pressure and pulse, and loosened flannel shirt/jacket. After about 10 minutes started to regain mental clarity. After 30 minutes was driven home by husband.
I started getting symptoms of scratchy throat and congestion. I got a positive COVID-19 at home test as well as my 4 year old daughter. Then I felt very tired. Going up and down stairs were exhausting and hard to breath. I did monitor my oxygen. My symptoms lasted for about a week. I felt lethargic from there on until this day. I feel more tired and drained than usual. I am also getting more headaches than before and dizziness. My first dose was Johnson and Johnson.
arm tender; not being able to sleep well; This spontaneous case was reported by a consumer and describes the occurrence of TENDERNESS (arm tender) and INSOMNIA (not being able to sleep well) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, the patient experienced TENDERNESS (arm tender) and INSOMNIA (not being able to sleep well). On 27-Jan-2021, TENDERNESS (arm tender) and INSOMNIA (not being able to sleep well) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.   Treatment information was not provided.     This case was linked to MOD-2021-309642 (Patient Link).
Patients second dose not administered due to potential allergic reaction. Patient reported having hives 24 hours after first dose vaccination. No respiratory symptoms reported. Reports symptoms resolved after 2-3 after they first occurred.
swelling rt arm immed p/vax;nurse gave DPH p/3hr;tremendous pressure redness & swelling down to elbow-around back to shoulder blade;saw MD 6NOV prescribed ATB & Vicodin x 10 days;still has some pain;most of redness & swelling gone;
Fatigue, 99.3 temp, sore throat, chest and sinus congestion, left earplugged, dizziness, sores in nostrils,  headache
Hives all over the body; Swelling; Joint pain; Fever; severe allergic reaction to the booster; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives all over the body), SWELLING (Swelling), ARTHRALGIA (Joint pain), PYREXIA (Fever) and ALLERGY TO VACCINE (severe allergic reaction to the booster) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030H21B, 004C21A and 031B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Jan-2021, the patient experienced ALLERGY TO VACCINE (severe allergic reaction to the booster). On 04-Jan-2022, the patient experienced URTICARIA (Hives all over the body), SWELLING (Swelling), ARTHRALGIA (Joint pain) and PYREXIA (Fever). At the time of the report, URTICARIA (Hives all over the body), SWELLING (Swelling), ARTHRALGIA (Joint pain), PYREXIA (Fever) and ALLERGY TO VACCINE (severe allergic reaction to the booster) had not resolved.            No concomitant drug details were reported.  Treatment medication include antihistamines.  Patient stated that nothing changed in her lifestyle but getting the booster dose. She has seen five doctors including an allergist and an immunologist and they confirmed it is an allergic reaction to the vaccine. Patient stated it is really horrible. Symptoms were still ongoing at the time of reporting. Patient stated she was not obese and she was totally healthy.With the first two shots she had no problems.
This spontaneous report as received from a Licensed Practical Nurse refers to an unspecified number of patients of unknown age and gender. Information regarding the patients' medical history, concurrent condition and concomitant medication was not reported. On unknown dates in 2016 (reported as since 01-JAN-2016), the patients were vaccinated with improperly stored doses of VAQTA (dose and route of administration were not reported, lot# L031196 with expiration date of 05-FEB-2017 and lot# L030442 with expiration date of 19-DEC-2016). No adverse effects had been reported. The VAQTA vaccines underwent a temperature excursion of -3 Celsius degrees for 19 hours. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
patient received J & J vaccine at 1050 am  patient was talking with nurse and suddenly stiffened his body with clenching fists curled upward to chest.  He had bright red skin color, and could not speak.  this lasted 10 seconds at most.  Afterward the patient was sitting in chair had turned very pale and did not realize what had happened.  one of the other nurses asked him if he knew where he was, he stated "In the Hospital", the nurse repeated that he was not in hospital, that he was at the health department getting a Covid shot.  He stated "oh yeah.. I forgot,"  patient stated he was going to be sick,  patient grabbed garbage can that was sitting next to him Patient was hooked up to oximetry, reading was 99% on RA, attempted Blood pressure 3 times but was unable to attain a reading, patient was holding garbage can tightly.  patient had emesis 3x's that was clear in color, cold packs were placed on the nape of the neck and under armpit, patient was sweating and white in color.  patient stated he had blurred vision, and noted that he was unconscious for approx. 25-30 seconds.  911 was called at 10:57.  Nursing supervisor was notified at 10:58. Patient stated that he had nothing to eat today, and his mother stated that he had been anxious about getting the vaccine and that she made her son get it.  Epinephrine was available but not given.  no issues with breathing.  EMS came in did a quick evaluation and transported patient to the hospital.  Mother was with patient during the entire incident.
Patient stated that she started getting oral abscesses on her gums about 4 months after receiving Moderna vaccine.
Daughter complained of extreme pain in leg a couple hours after the shot. I checked the site of injection and felt that her entire thigh was swollen, rock hard and extremely hot. I was worried and called the doctor when they opened the next morning. They said to give her an epsom salt bath with lavendar essential oil, and if it didn't improve by morning, to schedule a chiropractor visit for a mudding treatment to draw out the irritation. I did as instructed, but there was no improvement, and my daughter was limping from the pain. This was her third DTaP shot. I don't remember the others giving such a bad reaction. The chiropractor adjusted her and sent us home with bontonite clay and spagyric greens. We gave the greens in her juice for the next few days and applied the bentonite clay topically to the site. There was a 75% improvement by morning the next day, and it continued to improve with the clay treatment and greens. She was probably 100% better 6 days after shot.
This spontaneous case was reported by another health care professional and describes the occurrence of WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR5186C) for COVID-19 prophylaxis.     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 WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Pediatric dose was given to adults mistakenly), PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna COVID-19 vaccine administered to patients post temperature excursion), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered) and NO ADVERSE EVENT (No adverse event) outcome was unknown.           Concomitant product use was not provided by the reporter.   This case contains information for the 17 of 104 patients described by the reporter.
Afternoon of second vaccine- malaise and sore arm. 1/15- body aches, malaise, sore arm, swelling of arm and tingling in hand that lasted 3 weeks. Red injection site with hard 3 inch diameter at the injection site. 1/15- chills and sweating, but no increased temperature  1/16-18- malaise, body aches, swollen lymph nodes in right axilla.
My arm is sore; my arm was sore, it is still sore; I wasn't feeling right, my breath was not right/shortness of breath; Chills; I wasn't feeling right, my breath was not right; temperature was 101; This is a spontaneous report from a contactable Consumer (patient). A 59-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6208) via an unspecified route of administration in left arm on 11Mar2021 as single dose for covid-19 immunization. The medical history included acid reflux. The concomitant medication included Pantoprazole taken for acid reflux (40 mg, Once every other day for acid reflux) and Patient had been taking it from past 3 years. In Mar2021, the patient experienced that his arm was sore and it was still sore, patient wasn't feeling right, his breath was not right, shortness of breath, don't feel good, went to the bathroom a lot and chills. Patient further explained his arm was just a little sore other stuff went away. It was also reported, that was all until last Monday, after Monday I still have sore arm, my arm is still sore but I don't have shortness of breath anymore. patient is supposed to go back on the 2nd of Apr for his shot. Patient reported that he took some Tylenol and NyQuil for the chills and all. The patient underwent lab test of blood test and diabetes check-up and temperature was 101, SWAB test and it was positive 22Feb2021. The outcome of the event arm was sore was not recovered, wasn't feeling right, breath was not right, chills was recovered.   No follow-up attempt are needed. No further information expected.
Pt states she has been experiencing arm pain for a few months and is unable to lift her arms. She believes it may be due to the vaccination she received. She states her pain began a few days after receiving the vaccine and has not resolved. Informed to consult with her provider to make sure there are no other underlying causes for her arm pain.
Information has been received from a registered nurse concerning a 26 year old female who on 25-SEP-2008 was vaccinated with a first dose of GARDISIL vaccine. After the first dose of GARDASIL vaccine she felt pain in the muscles around her chest but they resolved in three days. Concomitant therapy included vitamins (unspecified) and OMEGA-3. On 18-dec-2008 the patient received a second dose of GARDASIL vaccine and later that day called the nurses and stated that she experienced slight nausea, pain in her left arm and pain in the muscles around the chest not her heart. The nurse also reported that she advised the patient after she told her the experience with the second dose to seek further medical attention, but the patient said she would not since it happened with the first dose and it resolved. The nurse at this time is unsure if the patient had recovered. The patient sought medical attention through a call to the nurse. Additional information has been requested.
Moderate Fever: starting ~5 hrs after Dose 2 injection and lasting 72hrs with gradual decline  Chills & Cold Sweats: starting ~5 hrs after Dose 2 injection and lasting 48hrs, on and off Site Pain: starting ~12 hrs after Dose 2 injection and lasting 24hrs  Moderate Headache / Mild Migraine: starting ~12 hrs after Dose 2 injection and lasting 72hrs  TINNITUS: accompanied headache/migraine aforementioned
45 minutes after getting the vaccine, my left ear was ringing with Tinnitus. I have had Tinnitus in that ear for 25 years, but have not even noticed it for the last 10 years. And it was never the high-pitched sound I am hearing now. Some days are less annoying, but other days it's hard to cope with. I do have some hearing loss to high-frequencies in that ear. But, again I have never had the problem with the ringing in the past, like I am having now. I pray it goes away at some point. If you have any news on this might help me, please let me know.
Fever, excessive chills(3 days), nausea, vomiting(1 day),
Pt developed first a blister on lip and then hives on chin, eyes swollen and tongue felt "tingly". Pt took 25 mg BENADRYL otc PO. Symptoms resolved. No reoccurrence of symptoms. No additional BENADRYL taken.
Parent reports 7pm Pt C/o throat discomfort, heat, itchy leg- swelling and induration at injection site started in AM soon after injection per mother 1x 2 inches then gradually became more red and swollen, warm next AM.
Vomiting; Initial information received on 01-Nov-2019 regarding an unsolicited valid non-serious case received from a consumer/non-healthcare.  This case is linked to case 2019SA307182 (same reporter).  This case involves a patient of an unknown demographics who experienced vomiting (vomiting), while he/she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via unknown route in unknown administration site.  On an unknown date, the patient developed a non-serious vomiting, Unknown latency following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  It was not reported if the patient received a corrective treatment.  The outcome of the event was not reported.  Information on the batch number was requested.
p/sleeping 4 hrs, pt was listless, unable to focus, eyes rolled back, appeared to have some type of sz activity alternated w/crying unconsolably;
Patient presented from the Cancer Clinic d/t multiple episodes of diarrhea, sore throat, and overall concern for possible sepsis.    Patient was admitted for confusion and hypoxemia and was found to be Covid positive and eventually intubated. Supplemental oxygen was given. Patient was started on Remdesivir and steroid.
This is an instance of COVID-19 breakthrough disease after which death occurred. The individual was vaccinated with the Pfizer product on 02/19/2021, 03/10/2021, and 11/30/2021. They tested positive for COVID-19 via antigen test on 07/16/2022. They were seen for a LTC Progress visit to a primary care clinic on 07/19/2022 and were placed on palliative care due to poor prognosis due to underlying medical condition. The individual died on 07/20/2022.
Arm started getting sore within 24 hrs. then ran temp up to 103 for the next 2 days. He developed a rash at the site of the injection. He was seen in the ER 5-4-07 and given Benadryl. It is almost gone, except for at the sorearm 1,5627
patient began to  experience Right hand  fingers and palm tingling sensation.  Vaccine Administered at 12:15PM Started experiencing symptoms at 12:27PM, symptoms lasted approximately ( 5) minutes .   Observed patient for 30 minutes and seen by doctor. Per patient symptoms were relieved and patient was release.
Erythema, induration, warmth, non tender, right deltoid area 7x6cm.
Pt denied on her consent form that she had previously received a COVID vaccine but when the clerk was entering her vaccination into system, she found that the pt had already been fully vaccinated with Pfizer on 1/26/2021 ad 2/16/2021.
Patient presented to the ED with chest pain.  Cardiology was consulted patient underwent left heart cath which demonstrated multivessel CAD including significant RCA disease.  Patient was referred to cardiothoracic surgery for CABG but was determined not to be a candidate due to left subclavian occlusion.  Patient then underwent staged PCI with drug-eluting stent to proximal to mid RCA. Hospital admission within 6 weeks of receiving the COVID vaccine.
Vaccine was expired on 05-MAY-2022, initially stored in refrigerated on 09-MAY-2022 at 8 AM and administered on 09-MAY-2022; Vaccine expired on 05-May-2022 administered to patient on 09-May-2022; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 05-May-2022 administered to patient on 09-May-2022) and PRODUCT STORAGE ERROR (Vaccine was expired on 05-MAY-2022, initially stored in refrigerated on 09-MAY-2022 at 8 AM and administered on 09-MAY-2022) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 084J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-May-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 05-May-2022 administered to patient on 09-May-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was expired on 05-MAY-2022, initially stored in refrigerated on 09-MAY-2022 at 8 AM and administered on 09-MAY-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine expired on 05-May-2022 administered to patient on 09-May-2022) and PRODUCT STORAGE ERROR (Vaccine was expired on 05-MAY-2022, initially stored in refrigerated on 09-MAY-2022 at 8 AM and administered on 09-MAY-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that the vial did not undergo any temperature excursions. Patient was not experiencing any symptoms. No treatment information was reported.