chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Office visit 1/26: The employee is having right-sided back pain radiating down to her knee since 1/19/2021. She relates this pain to a vaccine for Covid which she received on 1/12/2021.  She has a history of right-sided shoulder tendinitis after flu vaccine and so she refuses to get the vaccine in her deltoid muscle and usually gets vaccines in her right gluteal area.  She had the vaccine for Covid on 1/12/2021 in the right hip area a little bit higher than where she normally gets it.  She developed some redness to the injection site which subsided but soon afterwards began having right-sided sacral pain and then right-sided knee pain. The pain is described as a ache and burning.  She does not have numbness and tingling down her leg.  And she does not have any limitation in terms of flexion or extension of her back but she finds that she cannot lie on her back at night because it hurts.  She also has trouble getting out of a chair because of right knee pain. She was seen by the orthopedist,  he has ordered an EMG which came out negative, and ordered to take Naprosyn twice a day. Dx: Lumbosacral radiculopathy at L3. F/U on 1/28: At this time she still having some dull right-sided back pain and pain to her knee but it is tolerable. She has been able to rest over the course of this week as she has not gone to work. She feels at this time that she can manage her pain and is able to start working this weekend on 1/30/2021. We expect that the pain will gradually subside as the effect of the injection subsides as well.
Moderna COVID-19 Vaccine EUA.  About 8 days after receiving the vaccine, developed a red, raised area over the injection side.  Itchy and slightly painful.  Treated with ice and antihistamines
had Fever; Chills; felt sore for a couple of days.; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (had Fever), CHILLS (Chills) and MYALGIA (felt sore for a couple of days.) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023C21A and 041B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-May-2021, the patient experienced PYREXIA (had Fever), CHILLS (Chills) and MYALGIA (felt sore for a couple of days.). On 16-May-2021, PYREXIA (had Fever), CHILLS (Chills) and MYALGIA (felt sore for a couple of days.) had resolved.            Concomitant drugs were not reported. Treatment medications were not provided.   This case was linked to MOD-2022-504251, MOD-2022-504267 (Patient Link).
Patient was having trouble breathing. He felt very weak. Complained of pain in his lower back that kept shooting down his right leg. 911 was called. They just took blood pressure and talked with patient. He refused treatment and drove himself home.
"excessive sweating, watery eyes, dizziness and nausea; symptoms worse 3rd day post vaccination"
Had impressive lethargy then droop on R side of face for about 24h after shots last time.
Exact time of symptom onset unknown.  Clinic was notified by family at 10am on 4/21 that patient had expired at home.  Family member reported that patient was tired and achy and was found deceased on the floor in his room.  Patient had a history of Covid-19 in January, 2021.
Pt received vaccine to R arm and within 3mins collapsed and hit back of hit head. Pt had seizure like activity for 1-2mins. Afterwards, pt was weak and confused. Pt taken to ER where he was given IVF and medication for nausea. Pt had neg head CT and CXR. Pt was  discharged about 4hours later.
Mom reports about 14 hours after shots, pt was seizing in his bed. 911 was called /ambulance son to hosp and pt taken to medical center (then transferred to another medical center). He is still on antiseizure meds.  3/26/09 Case closed w/medical records accompanying report for 2/6-2/8/09. FINAL DX: partial seizures & viral illness Records reveal patient experienced apparent seizure activity of left side lasting approx 20 min followed by vomiting & sleepiness.  Had nasal congestion, fever, eye irritation & cough for few days prior.  Temp 102 in ER.  LP done in ER. Tx w/IV antibiotic.  Developed maculopapular rash on trunk w/viral appearance & URI s/s w/ loose stool.  Neuro consult done.  Tx w/antiseizure meds, improved w/no further seizure activity & d/c to home on continued meds w/neuro f/u. Follow-up: Per mom, pt did start to have seizures lates that year, but Dr. stated we cannot ever be sure whether or not the seizures were related, but probably not due to the.
Information has been received from a Registered Nurse concerning a female patient (demographics not reported) who on 10-JAN-2007 was vaccinated intramuscularly with the first dose of Gardasil vaccine (yeast) (lot # not provided). Concomitant therapy included BOOSTRIX and hepatitis A virus vaccine (manufacturer unknown). On 10-JAN-2007 immediately post vaccination the patient "passed out and went into a seizure." The patient sought unspecified medical attention. At the time of this report it was not reported if the patient had recovered from her experience. Upon internal review the seizure was considered to be an other medical event. Additional information has been requested.
On 11-5-09 pt c/o fever. Got up in AM before school and legs "collapsed". Went to school. Came home had a fever at 4:15pm 100 degrees headache. Did eat well. 4:40pm c/o eyes blurry tingling of lips. Instructed to go to ER. Went to ER.
The below statements were per patient. Received vaccine around 8am and within 2 hours after vaccination had dry cough and slight sore throat.   As day continued eyes became bloodshot and felt very swollen.  Denied hives or rash, however said face and neck were reddened.  Throat became swollen and became hard to swallow. Went to ER around 1:15pm and was given a bag of fluids, IV steriods, and an antihistamine.  Was discharged around 3:30p and was given a 10 day dose of steriods and benadryl prn.
Presented to ED with dizziness and nausea and vomiting and SOB. Na level of 111 (1/27); Cl 82; CO2 17 All other BMP labs WNL.  Urine Osmolality 436; urine sodium 89. Admitted to hospital for treatment. Nephrologist states that she has not prior history of hyponatremia (12/1/20 Na was 139)
Mild to moderate abdominal discomfort starting 2 days after the vaccination that lasted for about 5 days and then mostly resolved for about a week. After the week of very mild discomfort, the discomfort started worsening again. On 10/29/21 I was diagnosed with appendicitis and on 10/30/21 I had an appendectomy.
This is a spontaneous report from a contactable consumer. A 86-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0164 and Expiration Date not reported) via an unspecified route of administration, administered in Arm Left on May 2021 as 1ST DOSE, SINGLE DOSE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient had no family medical history relevant to Adverse event. The patient had no history of all previous immunization with the vaccine considered as suspect. The patient did not receive any other vaccinations within four weeks prior to the first administration date of the suspect vaccine. The patient reported that, he took one shot. The patient took the first shot about 2 weeks ago. The patient reported that in the last day or so he noticed a little lymph node swelling in the left chest area and stated that, it was not bad, it was not something that the patient cannot live with. The patient stated that the swelling came up about 3 days ago and it was just tender when he pressed on it. The patient was due to get his second shot next week. The patient was wondering if he should take it as scheduled or wait a few days for shot. The patient mentioned later should he take it in the right arm this time instead of the left arm. The patient denied medications, medical conditions, labs, testing, or treatments relevant to event. The patient did not visit emergency room and physician office. The outcome of little lymph node swelling in left chest area was not resolved and the outcome of event asking about postponing second dose of the vaccine was unknown. Information on Lot/Batch number was available. Additional information has been requested.
He has a cold with a cough and a sore throat.; He has a cold with a cough and a sore throat.; He has a cold with a cough and a sore throat.; not feeling well; This is a spontaneous report from a contactable consumer reported. A 39-year-old male patient received PFIZER-BIONTECH COVID-19 VACCINE (Formulation: Solution for injection, Batch/Lot Number was unknown, Expiration Date: Unknown), dose 1 Single, via an unspecified route of administration on 25Apr2021 for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported.On an unknown date patient stated as of two days ago, he started presenting cold symptoms consisting of a cough and sore throat. The patient reported that for his throat hurting and a cold  started a couple of days ago but today he was feeling much better although he still has the throat condition. The patient stated that he was possibly missing the second dose of the COVID vaccine on Sunday, 16May2021, since he was not feeling well as of two days ago. The outcome of all the events was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
77 patients received Moderna bivalent booster doses that had undergone a temperature excursion; product storage error; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion), PRODUCT STORAGE ERROR (product storage error) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion), PRODUCT STORAGE ERROR (product storage error) and NO ADVERSE EVENT (no adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion), PRODUCT STORAGE ERROR (product storage error) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion) and PRODUCT STORAGE ERROR (product storage error).    No concomitant medications were reported. It was reported that the doses were administered before it was known if the vaccine was ok to use after the excursion. No treatment medications were reported.  This case contains information for the 68th of 77 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-696122 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696122:Master case
This spontaneous report was received from a registered nurse, referring to unspecified patients. Patients' medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored GARDASIL 9 lot # L019297 with expiry date 18-AUG-2017, lot# L044475 with expiry date 12-MAY-2017, lot # K026247 with expiry date 29-JAN-2017, lot # L027282 with expiry date 21-SEP-2017 and lot # L036245 with expiry date 09-FEB-2018, (strength, dose, anatomical location and route were not reported). No adverse events were reported and no product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Difficulty breathing as a result of swelling back of nose, diarreha, nausea,
rash, fever, decreased appetite, lethargic, and cough and vomiting/the patient was diagnosed with dehydration and viral illness; the patient was diagnosed with dehydration; The patient was also suspected of having Kawasaki disease but was not confirmed with a diagnosis; Information has been received from a registered nurse referring to a 13 months old male patient. The patient's had no pertinent medical history and concomitant medication. The patient was allergic to egg white, milk, almonds and soy.   On 07-FEB-2020, the patient received both 1 dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant Human albumin (rHA)) (M-M-R II) (strength, dose and frequency were unknown; subcutaneous, lot # S015092 and expiration date 15-MAY-2021) and 1 dose of varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose and frequency were unknown; subcutaneous, lot # S021323 and expiration date 09-JUL-2021) for prophylaxis.    The patient developed rash on 11-FEB-2020 and fever on 12-FEB-2020. On 12-FEB-2020, the rash spread onto entire body and on 13-FEB-2020 rash started to fade. On 13-FEB-2020, the patient also experienced decreased appetite, was lethargic and developed cough. On 14-FEB-2020, the patient went to an emergency room and was admitted into hospital. In the hospital, the patient was diagnosed with dehydration and viral illness. Respiratory panel result was negative. On 17-FEB-2020, the patient was discharged. The patient was also referred to cardiologist after discharged from hospital. The cardiologist tested the patient with an electrocardiogram and echocardiogram but results were all normal. The patient was also suspected of having Kawasaki disease but was not confirmed with a diagnosis. The outcome of all the events was recovering. The causality between measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), varicella virus vaccine live (oka/merck) (VARIVAX) and the events were not provided.  The event of viral illness was considered as significant disability or incapacity by the nurse since patient was lethargic and vomiting. Upon internal review, Kawasaki disease was considered as medical significant.
Few seconds after receiving GARDASIL vaccine patient fainted (pale looking with circum oral cyanosis) & jerking movement lasted about 10-15 seconds.
Bad rash all over my face; This is a spontaneous report from a contactable other HCP (Patient herself). A 56-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: unknown, expiry date: unknown) via unspecified route of administration in left arm on 22Jan2021 (age at vaccination: 56-years) as dose 2, single for covid-19 immunisation. Historical vaccine included first dose via unspecified route of administration in left arm on 12Feb2021 (age at vaccination: 56-years), as dose 1, single for covid-19 immunisation. Patient was not pregnant at the time of vaccination. Patients medical history included atrial fibrillation from an unspecified date and unknown if ongoing. Concomitant medications were not reported. Patient did not take any other vaccine in four weeks or any other medications in two weeks. On 23Jan2021, patient experienced "Bad rash all over my face". Ae resulted in Doctor or other healthcare professional office/clinic visit. Treatment was given with antibiotics due to the adverse event. It was unknown whether patient had not been diagnosed with COVID-19 prior to vaccination and she had not been tested since the vaccination. The outcome of event was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot been obtained.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warmth at the injection site), VACCINATION SITE PRURITUS (itchiness at the injection site) and VACCINATION SITE ERYTHEMA (redness at the injection site) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (warmth at the injection site), VACCINATION SITE PRURITUS (itchiness at the injection site) and VACCINATION SITE ERYTHEMA (redness at the injection site). At the time of the report, VACCINATION SITE WARMTH (warmth at the injection site), VACCINATION SITE PRURITUS (itchiness at the injection site) and VACCINATION SITE ERYTHEMA (redness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.   No treatment information for the events was reported.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Follow up received on 15 Jul 2021 contains non significant information
Within two hours of receiving the immunization, my right arm became very painful. I could not lift my arm. The pain was severe. I began to feel sick and feverish, but my temp was not elevated. The right side of my chest, neck and face was swollen but I did not have any problem breathing. The next day, the pain in my arm continued and after several doses of Tylenol the pain lessened and finally subsided the next day. The swell lasted about 5-7 days. However, during this period the skin on my face became very red and inflamed. I could not use any skin care products without severe burning. I called the Dr. for help but her office refused to see me, stating that the dr. was on spring break and I could just go to urgent care. They did not ask for any details of my reaction. I went to urgent care and was put on a 7 day series of prednisone. The symptoms improved, but the day after my last dose of prednisone, I became gradually sicker and sicker. It started with a harsh dry cough. Over the next few days, it became productive for thick yellow mucus. Sometimes when I awakened in the morning, I would throw up from coughing and gagging on this mucus. I never experienced anything like this. I took OTC cough suppressants and mucus medications, which did not help. The most acute sx lasted for about 2 weeks, but to this day I still have thick mucus and the occasional emesis in the am.
pt devel nausea, myalgia, h/a, chills on 28OCT93 & 29OCT(3 in the evening had 3 episodes of vomiting; 30OCT93 had a bad h/a 31OCT93 all sx had resolved;
1 of 4 pts immunized w/in a 2 wk period from the same lot who exp an inject site react the size of a silver dollar; react consisted of erythema, swelling, & hot to touch; treated w/APAP; pt recovered;
Joint pain (all joints) pain 7 out of 10, chills, muscle ache. Lasting 24 hours. Second day mostly muscle ache 4 out of 10 pain. Third day only pain at injection site when touched.
Patient had bruise at injection site and a case of cellulitis below the skin near the bicep.
Moderna vaccine pulled from freezer on 12/16/2021. BUD date of 01/15/2022. On 1/26/2022, staff brought it to attention that it was still in the fridge and expired; On 1/26/2022, staff brought it to attention that it was still in the fridge and expired. 5 doses had been given at that point; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (On 1/26/2022, staff brought it to attention that it was still in the fridge and expired. 5 doses had been given at that point) and PRODUCT STORAGE ERROR (Moderna vaccine pulled from freezer on 12/16/2021. BUD date of 01/15/2022. On 1/26/2022, staff brought it to attention that it was still in the fridge and expired) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Jan-2022 at 9:58 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 21-Jan-2022 at 9:58 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (On 1/26/2022, staff brought it to attention that it was still in the fridge and expired. 5 doses had been given at that point). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Moderna vaccine pulled from freezer on 12/16/2021. BUD date of 01/15/2022. On 1/26/2022, staff brought it to attention that it was still in the fridge and expired). At the time of the report, EXPIRED PRODUCT ADMINISTERED (On 1/26/2022, staff brought it to attention that it was still in the fridge and expired. 5 doses had been given at that point) and PRODUCT STORAGE ERROR (Moderna vaccine pulled from freezer on 12/16/2021. BUD date of 01/15/2022. On 1/26/2022, staff brought it to attention that it was still in the fridge and expired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that the Moderna vaccine was pulled from the freezer on 16-Dec-2021. BUD date was 15-Jan-2022 which was printed in red and taped to the top of the boxes. On 26-Jan-2022, the staff brought it to attention that it was still in the fridge and was expired. It was also reported that 5 doses had been given at that point. On 27-Jan-2022, remaining county sites were checked. All other clinics had been found to have same error of not noticing the BUD date. It was reported that the patient mother/guardian were notified of the error and were also notified that a repeat vaccination was not required. Patient denied any adverse effects. No concomitant medications were reported.  No treatment medications were reported.
GENERALIZED ITCHING AND HIVES WITHIN 10 MINUTES OF ADMINISTERING VACCINE.  SWELLING AT INJECTION SITE.
Patient came to pharmacy to get Janssen booster and Flucelvax vaccine. After receiving both vaccine, a provider recommended patient to sit down for 15 min. Patient looked normal and she had no sign of reaction. Patient started feeling dizziness in about 1 min, she sat down and her eyes had blurry vision. BP was 64/44 and we tried to keep her stay awake while calling 911. She could answer questions while provider asked her. She felt better when paramedic arrived.
Hives and bumps over both cheeks, face, and neck, all up and down her left and right arms, more severe on left arm which is where the TDaP was given.