chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pharmacy provided adult Flu Shot. My left ear suddenly has changed its frequency response. Testing with a telephone dial tone. The left ear delivers a higher tone than the right ear. Sensitivity is higher to sound. The stereo effect is shifted left. Received Adult Flu Shot. Not certain of correct data entry of Item 17.
3 inch red, hot and swollen sore on the back of my arm that was very itchy.  Also a severe headache.
cellulitis below injection site. 2nd dose received 4/28. First indication of problem came 5/1 with fever and chills as well as a large red splotch on arm. 5/3, the splotch had grown larger, was extremely painful and hot, still running low-grade fever. Diagnosed by primary care dr. as cellulitis and course of antibiotics started. 5/6 noticeable improvement in appearance and pain level of cellulitis location. Intensity of discoloration and pain significantly less.
really bad tummy ache; shaking; chest pain; body is not my body; severe chills; Abdominal Pain; unbearable pain; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (really bad tummy ache), TREMOR (shaking), CHEST PAIN (chest pain), FEELING ABNORMAL (body is not my body), ABDOMINAL PAIN (Abdominal Pain) and CHILLS (severe chills) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033821A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 28-May-2021 at 10:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-May-2021 at 5:30 PM, the patient experienced ABDOMINAL PAIN (Abdominal Pain) (seriousness criterion hospitalization). On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (really bad tummy ache) (seriousness criterion hospitalization), TREMOR (shaking) (seriousness criterion hospitalization), CHEST PAIN (chest pain) (seriousness criterion hospitalization), FEELING ABNORMAL (body is not my body) (seriousness criterion hospitalization), CHILLS (severe chills) (seriousness criterion hospitalization) and MYALGIA (unbearable pain). The patient was hospitalized on 25-May-2021 due to CHILLS and FEELING ABNORMAL, and then on 29-May-2021 due to ABDOMINAL PAIN. On 29-May-2021, ABDOMINAL PAIN (Abdominal Pain) had resolved. At the time of the report, ABDOMINAL PAIN UPPER (really bad tummy ache), TREMOR (shaking), CHEST PAIN (chest pain), FEELING ABNORMAL (body is not my body), CHILLS (severe chills) and MYALGIA (unbearable pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No treatment medications provided.  Company Comment: 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.   Most recent FOLLOW-UP information incorporated above includes: On 12-Jun-2021: Follow up received on 12 Jun 2021, added patient demographics (height, weight) and event (abdominal pain).; Sender'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.
sore arm; Caller reported a vaccine recipient thought the first dose of the covid 19 vaccine was too high up on the arm so the vaccine administrator gave a second dose within 15 minutes.; Caller reported a vaccine recipient thought the first dose of the covid 19 vaccine was too high up on the arm so the vaccine administrator gave a second dose within 15 minutes.; This is a spontaneous report from a contactable Pharmacist. A female patient in her 20s received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose on 27Jan2021,14:30 (lot number: unknown) and second dose on 27Jan2021, 14:40- 14:45 both via an unspecified route of administration in the arm at 0.3mL single dose for COVID-19 immunization in the clinic. The patient's medical history and concomitant products were unknown. The reporter, was a pharmacist, was a Depo leader with the pharmacy COVID-19 vaccine clinic. They had a clinic in one of the facilities. One of the patient who could have been a Nurse, or at least had medical background was the patient. The pharmacist at a pharmacy gave the patient 0.3mL of the Pfizer COVID vaccine. The patient claimed the Pharmacist gave it too high up, near her shoulder. The patient then went to a different Pharmacist because she felt like she didn't get her dose and got a second dose of 0.3mL within 15 minutes. The reporter doesn't know which arms they were given in. The reporter stated the patient had experienced sore arm. The pharmacist assessed the events as non-serious. The outcome of the event as unknown.  Information on the lot/batch number has been requested.  Follow-up (02Feb2021): New information reported from a contactable Pharmacist includes: new event (sore arm).   Information on the lot/batch number has been requested.
pt recv vax in lt arm 16hr a/onset of sx was the only unique prior event;sudden build up of muffled sound in rt ear, shifted to ringing then only deafness & growing imbalance;dx viral infect or swelling of inner ear;
Vesicular rash with erythematous base erupted one day after receiving sunburn on face & arms at day 16 post smallpox vaccination. Rash mainly on both elbows & forearms with vesicles coalescing. Erythematous papules on forearms, hands, and few on legs.
Information has been received from a certified medical assistant concerning a 5 year old male with no past medical history who on 3/1/01 was vaccinated with varicella virus vaccine live. There was no concomitant medication. On 4/13/04 the patient broke out in head to toe lesions and was diagnosed as having chicken pox by physician. The patient was advised to soak in colloidal oatmeal and apply calamine lotion. No other treatment was prescribed. The patient was recovering with sequelae. No lab diagnostic tests performed. No product quality complaint involved. Additional information has been requested.
This spontaneous report as received from a Medical Assistant refers to an unspecified number of patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical histories provided. The Medical Assistant reported that from 11-MAY-2017 to 09-JUN-2017, the patients were vaccinated with improperly stored doses of ROTATEQ(strength, dose, frequency, lot number and expiration date were not provided) lot # M041765 with expiration date of 05-MAY-2018 and lot # M045545 with expiration date of 10-JUN-2018, orally for prophylaxis. No adverse reactions. No further information to report. Administered doses of vaccines experienced the temperature excursion of 32 degrees Fahrenheit to 35 degrees Fahrenheit for 1 hour 15 minutes. Data logger was involved. There were no previous excursions reported. Additional information has been requested.
This spontaneous report was received from a registered nurse and refers to a 3 different adolescent patients of unknown gender. No information regarding the patients' pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On an unknown dates, the patients were vaccinated with GARDASIL 9 for prophylaxis (doses, route of administration, lot# and expiration date were not reported). On an unknown date in approximately 2017, also reported as "after receiving a shot of GARDASIL 9" and "in the last 6 to 9 months", the patients had bumps in their arms that persisted and did not stick out. The nurse also reported, that the patients had the bumps in their arms in a close proximity of time. It was unknown, if the patients received the treatment for reported event. On an unknown date, one of the patients was seen by a dermatologist (details were not provided). The outcome the event was unknown. The relatedness between the events and GARDASIL 9 was not provided.
DURING ADMINISTRATION, THE VACCINE EXPELLED FROM SYRINGE OUT OF LUER-LOCK HUB. SEQIRUS WAS CONTACTED AND LOT NUMBER AND INCIDENT WAS REPORTED. I WAS INSTRUCTED BY SEQIRUS THAT PROTOCOL ALLOWED ME TO ADMINISTER A NEW FULL DOSE TO PATIENT IF LESS THAN HALF OF THE ACTUAL DOSE WAS ORIGINALLY RECEIVED; I WAS ALSO INFORMED THAT QUARANTINE OF THAT PARTICULAR BOX OF SYRINGES WAS UNNECESSARY.
This spontaneous report as received from a medical assistant refers to a 13 year old patient of unknown gender. The patient's drug allergies and pertinent medical history was not reported. On 01-JUL-2014 the patient was vaccinated with second dose of GARDASIL (dose, frequency and route of administration were not reported) (lot # K005083, expiry date: 04-NOV-2016) which was stored improperly. No adverse effects were noted. No product quality complaint was reported for GARDASIL. This case is linked to 1407USA010956, 1407USA012902, 1407USA012903, 1407USA012904, 1407USA012905, 1407USA012906, 1407USA012907, 1407USA012908, 1407USA012909, 1407USA012910, 1407USA012911, 1407USA012912, 1407USA012913, 1407USA012914, 1407USA012915, 1407USA012916, 1407USA012917, 1407USA012918, 1407USA012919, 1407USA012920, 1407USA012921, 1407USA012922, 1407USA012923, 1407USA012924, 1407USA012925, 1407USA012926, 1407USA012927, 1407USA012928, 1407USA012929, 1407USA012930, 1407USA012931, 1407USA012932, 1407USA012933, 1407USA012934, 1407USA012935, 1407USA012936, 1407USA012937, 1407USA012938, 1407USA012939, 1407USA012941, 1407USA012942, 1407USA012943, 1407USA012944, 1407USA012945, 1407USA012946, 1407USA012947, 1407USA012948, 1407USA012949, 1407USA012950, 1407USA012951, 1407USA012952, 1407USA012953, 1407USA012954, 1407USA012955, 1407USA012956, 1407USA012957, 1407USA012958, 1407USA012959, 1407USA012960, 1407USA012961, 1407USA012962, 1407USA012963, 1407USA012964, 1407USA012965, 1407USA012966, 1407USA012967, 1407USA012968, 1407USA012969, 1407USA012970, 1407USA012971, 1407USA012972, 1407USA012973, 1407USA012974, 1407USA012975, 1407USA012976, 1407USA012977, 1407USA012978, 1407USA012979, 1407USA012980, 1407USA012981, 1407USA012982, 1407USA012983, 1407USA012984, 1407USA012985, 1407USA012986, 1407USA012987, 1407USA012988, 1407USA012989, 1407USA012990, 1407USA012991, 1407USA012992, 1407USA012993, 1407USA012994, 1407USA012995, 1407USA012996, 1407USA012997, 1407USA012998, 1407USA012999, 1407USA013000, 1407USA013013 and 1407USA013014 (same reporter link). Additional information has been requested.
Patient's parents reported noticing frequent eye blinking while watching tv the day after receiving her COVID19 vaccine and continuing intermittently. She has no eye irritation/ pain, does not seem to be aware she is doing this. no prior eye injury. She did not exhibit this behavior prior to her COVID19 vaccine. Patient was not evaluated for this concern- her dad reported it to me during her younger brother's well visit on 7/5/22.
Sl. atypical Gianotti-Crosti; skin reacting on arms/legs/face (min) and feet/minimal on trunk. Clinically confirmed as probably by dermatologist as of yet (will follow). Pt see one month later Giantti Crosti type rash resolved.
Headache and body aches began about 10.5 hours after dose and came on quick. Chills began about 12 hours after vaccination. Woke up the next morning ~23 hours later drenched in sweat
Patient experienced fatigue, malaise and rash within 24 hours of second COVID vaccine. Then reported feeling short of breath with exertion while at wrestling practice on 5th day following COVID vaccine.
Felt as if drunk, off balance, had to hold furniture to walk, lasted into 2nd day. No fever or soreness.
Patient has a history of metastatic uterine leiomyosarcoma treated with chemotherapy (most recently thalidomide), radiation, hepatic chemoembolization and recent back surgery. One day after receiving a flu vaccine, patient developed fevers to 103 degrees F, nausea/vomiting, fatigue and pain and weakness in the proximal legs. Renal function also deteriorated and hemoglobin dropped (see lab results below) requiring a three day hospital admission for blood transfusion and treatment of dehydration and leg pain. Medical Record received on 1/12/2005 states mouth ulcers, wheezes, diarrhea, and cough.
Information has been received from a medical assistant concerning a 30 years old female patient. The patient had none concomitant medication or medical history. The patient was Reactions/Allergies to lobster and asparagus. On 21-JUL-2014, the patient received the first dose of dose of the GARDASIL (lot # J002641 with expiration date 10-DEC-2015; strength and dose were not reported) intramuscularly in the left deltoid for prophylaxis. On 23-SEP-2014, the patient received a second dose of GARDASIL (lot # K009482 with expiration date in March 2017; strength and dose were not reported) intramuscularly in the left deltoid for prophylaxis. On 19-SEP-2015, the patient received the third dose of GARDASIL (lot # J002641 with expiration date 10-DEC-2015; strength and dose were not reported) intramuscularly in the left deltoid for prophylaxis. On 12-OCT-2018, the patient was seen in the office for a wellness exam and a human papilloma virus test was conducted. On 01-NOV-2018, the results from the a Papanicolaou (PAP) test came back with positive for human papilloma virus (HPV) 16, Messenger Ribonucleic Acid (MRNA) E 6 and 7. No treatment was given for the events and the outcome of the event was not recovered. Causality assessment was not provided.
After Dose 1 of the vaccine, my shoulder stayed sore where I had the vaccine. About 2 weeks after I had it I went to see my doctor and he told me that he that they had given me the shot in the Bursar. He prescribed Prednisone and my arm got better. I also had an awful pain underneath my left breast. He also thought there was some inflammation on the left side of the lung. I had the 2nd dose even though my arm was still sore from the first vaccine. So I had the 2nd vaccine and my shoulder never quit hurting. I went to see an orthopedic doctor. At this point my right hip was swollen and both of my knees below the knee cap were swollen. It was extremely painful and I went to the hospital to see the ER doctor who prescribed a large dose of Naproxen EC to take for the inflammation and referred me to a rheumatologist. It took me until January to see the rheumatologist. He prescribed Plaquenil. I was unable to take the Plaquenil due to palpitations and I had pressure on my eyes. I had shortness of breath also. I have a follow up appointment on the 22nd of this month.
Felt tickle in the back of throat and throat clearing which turned into a productive cough and felt like was "drowning".  Atrovent nebulizer given and an Albuterol inhaler--3 puffs.  Axid and Zyrtec were given orally.  Began 'flushing', but lasted only 45 minutes and throat clearing continued to be productive.  6-14 hours after injection nasal congestion started along with headache, feeling achy, and a sore throat.  All symptoms resolved 24 hours after injection and patient felt fine.
ON 10.12.2022 PATIENT STARTING HAVING RIGHT FLANK PAIN AND THEN NAUSEA AND VOMITTING. HE PRESENTED TO THE ER ON 10.13.2022 VERY EARLY.
No Adverse effects, Issue was too many doses given due to incorrect documentation within immunization tabs. Resident is stable with no complications at this time.
This spontaneous report as received from a physician via company representatives and from a support services director, refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 08-JUL-2014, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 lot number K003074 with expiration date of 13-MAR-2015 (route of administration and anatomical location were unknown), which was stored at the lowest recorded temperature of 33 degrees F (0.555555556 Celsius degrees) for the sum of 1000 hours and at the lowest recorded temperature of 34 degrees F (1.111111111 Celsius degrees) for 192 hours. The storage criteria and the storage type were reported as "Refrigerator(R)". The vaccine status was reported as "in excursion". No adverse effect was reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Pt reports fatigue and inability to get up, accompanied by severe "traveling" pain, primarily in legs and feet. Required meloxicam to treat, which she is still on as of August 18, 2018. States that MD drew labs and confirmed significantly increased inflammatory mediators and has told pt not to complete SHINGRIX series.
Information has been received from a registered nurse concerning a 13 year old Caucasian male who on 07/29/98 was vaccinated in the right tricep with a first dose of Varivax. On 12/19/01, the patient broke out in a chicken pox rash. It is reported that his temperature was 100 and the rash was all over his torso, in his mouth and down his throat. Subsequently, the patient recovered . Unspecified medical attention was sought. FOLLOW UP information from a nurse indicated that the patient's fever started on 12/18/01. On  12/19/01, there were a couple of vesicles by the evening. By 12/20/01, they covered his arms,legs, torso, in his mouth and in his hair. He was given valacyclovir hydrochloride (Valtrex) 500 mg prescription on 12/21/01 and he cleared up by 12/25/01. The patient was considered recovered.
Day 8. Erythema and induration 10.5 cm, 1/2 inch pustule leaking clear fluid.  Two short streaks of lymphangitis medially.  Inmpression: robust response, rule out bacterial infection, culture pending.
On 02/26/2023, I started getting a sore throat no other symptoms on the back upper portion of the roof of my mouth, I felt a sore throat the back of my mouth was very sore. It did not hurt to swallow. On the morning of 2/28/2023 I had a nurse a virtual visit.  I went in the doctor's office, after speaking with the nurse, she told me to have a COVID-19 quick test, Flu Quick Test, both tests were negative. I was positive for rhinovirus. 03/01/2023, I did not have a sore throat, I did have an unproductive cough. The doctor suggested to use saline nose drops, Mucinex DM, and I drank a lot of liquids.
terrible, terrible dizziness;  has started little by little/dizzy in the head when getting up and feeling very weak; Weakness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2, solution for injection) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "terrible, terrible dizziness;  has started little by little/dizzy in the head when getting up and feeling very weak"; ASTHENIA (non-serious), outcome "unknown", described as "Weakness". Additional information: States she got the Pfizer Covid-19 injection about 2 weeks ago and is due for the second one next week, but she has been having these terrible, terrible dizziness and some weakness. Having dizziness in her head and didn't feel anything after she had had it, she was fine. Now this has started little by little and she doesn't understand why. When she is getting up she is so dizzy in the head and feeling very weak and just so dizzy. Wanted to know if it's possible to have side effects later on or do they only happen right after getting the vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
lt arm @ inject site- itched for 4 hrs-swelled up-got red & hot;
it has been over 60 days and i still have extreme pain at the vaccine site, my arm movement is very restricted
pt recv vax 17OCT96 & devel pain @ site, swelling & extensive ecchymosis of rt upper arm;
Patient had shortness of breath and complained of tightening felt in the throat chest area after her initial 15 minutes of observation post vaccination.  She was coherent and verbalizing the entire time.  She was observed while 911 was called.  She stated she was feeling better and her symptoms were resolving as she sat for 10 minutes.  She was taken to a different facility ER for assessment (Kaiser).  When we spoke to her later at night, she was home and said she did not receive any treatment while at the ER.
By 22 hours after my booster shot, I ran a fever of 105 and required an urgent care visit for ice packs and cold saline IV.  I tested negative for covid, flu, and RSV, so the doctor?s assessment is that it was a strong vaccination reaction.
I woke up about 10-11 days post receiving my booster shot to have hives covering a large part of my body focused primarily around my underwear line. I took some Benadryl and hoped it would reduce and go away. It proceeded to spread over the next few days and get worse including swelling happening in my feet, ankles, wrists, hands and face (chin and lips). After seeing my doctor and mixing multiple antihistamines at her direction I ended up in the ER due to the facial swelling. I received IV antihistamines and a shot of epinephrin at that point. I was sent home with a prescription for  prednisone at 20mg for 4 days and had to continue taking the antihistamines (specifically Zyrtec and Tagamet). I had a resurgence of hives on Sunday, things improved on Monday and Tuesday but Wednesday when I had completed the  prednisone I woke up with more hives and had some facial swelling later in the day. Thursday my doctor prescribed 10 days of 10mg prednisone along with the antihistamines and she added a singular prescription to take at night as needed. With those drugs I was able to not get any more hives or swelling. I am now down to just taking a Zyrtec in the morning and sometimes adding in a Tagamet or Singular if I feel it's needed. I have had no more hives but sometimes when I scratch my skin for an itch the redness and marks do seem to linger a bit longer than normal. I do have a history of random hives however it has been more than 20 years since my last occurrence. At that time and again now we were unable to pin point the exact reason for the hives and swelling.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program (159558).  A 75 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Flu, reaction(s): "cold sweats", "diarrhea", "sick", "vomiting". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Saturday 14th was walking, develop pain in left calf up thigh, low grade fever, painful to walk.  Used ice, baby aspirin and Aleve.  Went to doctor's on Monday.  Doctor sent patient to get ultrasound.  After ultrasound went to ER.  DVT diagnosed using Lovenix and Coumadin for treatment.  08/14/2008 MR received from PCP. Pt presented to office 6/16/2008 with c/o popliteal tenderness. Sent for US which revealed DVT above the left popliteal vein.  Refered for anti-coagulation therapy. 9/25/08 ER record received for DOS 6/16/08 with DX: Lower extremity pain.  DVT.  Presented with pain and swelling of RLE. D/C home on Coumadin and then Lovenox. Seen 6/25 with c/o knee/leg pain on the R 2' to L leg issues. Rx-percocet.