chrisvoncsefalvay/vaers-outcomes huggingface dataset:
quite sick / lasted days / ended up in ER; headache / lasted days / ended up in ER; vomiting / lasted days / ended up in ER; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced sickness, headache and vomiting. On an unknown date, the outcome of the sickness, headache and vomiting were unknown.   It was unknown if the reporter considered the sickness, headache and vomiting to be related to Shingrix.   Additional details were reported as follows: The case was reported by patient itself. The age at vaccination was not reported. The age group was not reported but was captured as adult as per vaccine indication.  The patient received the Shingrix vaccine and did not have a serious allergic reaction. The patient reported that he/she became quite sick with headache and vomiting that lasted days and patient ended up in the emergency room. This case is linked with US2021063407, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021063407:Same country, Same product
After getting up the next morning, I went to the bathroom and fainted on the floor, knocking the shower door out of its railing, The edge of the door hit me across the chest, resulting in pain and bruising. I continued to feel "woozy" for a couple of hours. I tend to have low blood pressure, which may have contributed to the event.
unspecified patients were administered BCG vaccine intravesical; No adverse effects reported; This initial spontaneous report originating as received from a healthcare worker referring to unspecified patients of unknown ages and unknown genders. Information about patients' pertinent medical history, drug reactions/allergies and concomitant medication was not reported.  On unknown dates, the patients were vaccinated with bcg live (BCG VACCINE USP) 50mg (dose detail, lot # and expiration date were not reported) via intravesical route for prophylaxis (incorrect route of product administration). No adverse effects were reported. For bcg live (BCG VACCINE USP PUNCTURE DEVICE (DEVICE)), the lot number is not available and the serial number is not available.  This is one of two reports received from the same reporter(linked case # 1910USA02382). combinationproductreport: Yes; brandname: BCG VACCINE USP PUNCTURE DEVICE (DEVICE); commondevicename: BCG live; productcode: LDH; devicetype: SYSTEM, DELIVERY, ALLERGEN AND VACCINE (LDH); deviceage and unit: 0 ; malfunction: No; deviceusage: Unknown; evaluatedbymfr: No; reasonfornoneval: 81 Other; reasonfornonevalother: no information about availability; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; evaluationvalue - Patient / Device: N/A / 1670; Sender's Comments:  US-009507513-1910USA012382:
Patient received Moderna as the first dose and then inadvertently received Pfizer as the second dose.
approx 8 hrs p/vax pt had an apparent sz-eyes rolled back, choking, not responsive; pt had a fever then which persisted until 1115AM; pt was taken to hosp ER;
Itching and dermatographia various parts of body, moved throughout the day. Symptoms started Saturday 12/4 on chin, then anterior neck. Also experienced itching behind ears, back of neck, chest, back within the first 24 hours. Hydrocortisone cream and Benadryl provided some relief but symptoms continued. Thursday 12/9 I sent a message to my PCP to report the symptoms and see him Friday 12/10. Intervention noted in item 19. Today, 12/14, symptoms are still present but improving.
Thick, clear mucus that collects in throat Difficult to cough up Sounds bronchial
On the night of my J&J my vaccine , I felt very tired and sleepy but I could not sleep. The next morning I felt a burning sensation to my eyes as well to my right ear and that went away. I went to see my PCP that day as well because I was having a pressure sensation down my right calf and leg. On Wednesday I felt numbness sensation down my right arm and the right side of my body was weak. On Thursday, I called my PCP who advised me to go to the ER and to get monitored for thrombosis. I also began to have headaches and blurry vision. At the ER they performed an ultrasound and did lab work. The ultrasound exam did not show evidence of thrombosis or blood clots. The ER physicians told me to rest and elevate my legs. I also noticed that  my BP was 130/90 which I never had before. To this day I still have throbbing sensation to my right calf and leg.  I again went to the ER and thy monitored me. They told me to take Ibuprofen for pain and again did an ultrasound which did not show any blood clots. I then started to have a burning sensation to my skull and scalp and also my left arm. I have not fully recovered from my symptoms.
Rash, itchy on trunk which got worse. Papular vescular rash in various stages on trunk and face.
Patient was shopping in the store with her mother post vaccination. Pharmacist was called to the store floor after seeing the patient fall to the floor, hitting her head.  Pharmacist monitored patient and patient's blood pressure while awaiting EMS.
Miscarriage: vaginal bleeding with clots and tissue within 1 week of a positive home pregnancy test, two days after vaccination.  Blood HCG take once vaginal bleeding commenced was <5.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Feb2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 63 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High cholesterol" (unspecified if ongoing), notes: High cholesterol managed with Atorvastatin, extra 15-20 pounds. Concomitant medication(s) included: ATORVASTATIN; TRAZODON, both received in 2 weeks around vaccination. Past drug history included: Percoset, reaction(s): "known allergies Percoset". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: positive test 6 days after completion of Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Chills/Fever 102.6  started hour 16 after vaccination with severe large bone aches which included femur, hips, pelvis, sacrum and scapula;   body aches, back ache, headache, general malaise and weakness. 2nd fever, no chills 38 hours after vaccine, with continued bone and body aches, back ache and headache, general malaise and weakness. mild dyspnea with continued back ache after 50 hours, still experiencing this at the time of report
Arm was sore, low grade fever, felt tired.  Parent unsure which arm was sore.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Headache-Medium, Systemic: Visual Changes/Disturbances-Medium, Systemic: Weakness-Medium, Additional Details: Patient was felling hot and had anxiety before getting the shot. He said he had breakfast at 7am and recieved the shot around 11:30 am.
Felt nausea; Headache after first dose; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Felt nausea) and HEADACHE (Headache after first dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was reported.     On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NAUSEA (Felt nausea) and HEADACHE (Headache after first dose). At the time of the report, NAUSEA (Felt nausea) and HEADACHE (Headache after first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant  information was  provided. No Treatment information was  provided.   This case was linked to MOD-2021-045353 (E2B Linked Report).; Sender's Comments:  MOD-2021-045353:Cross linked case
Got the vaccine about 3:30pm and about 9:30pm started feeling quite sick and not right. Went to lay in bed and was super cold despite the house being at 72 degrees and being under covers. Even after additional cover and electric blanket still cold. Terrible muscle aches all over body. Even after taking 3 Advil there was very little improvement in severity of aches/pain. Skin felt weird like it does when you have a fever or the flu. Very painful lymph nodes in neck behind jaw. Terrible headache that was not relieved with Advil or Tylenol. Lay in bed miserable and freezing for about 2 hours and then started feeling very nauseous and at about 11:30 threw up violently about 6 times. It has been almost a decade since I have thrown up for ANYTHING so that was alarming, as was the severity of the headache and body aches. Finally fell asleep and woke up the following morning feeling better but still had residual weakness and also had feeling in chest like you get with a chest infection. The chest feeling lasted two more days then resolved.
This spontaneous report was received from a physician via a company representative, referring to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On 26-FEB-2015, the patient was vaccinated with the improperly stored dose of PNEUMOVAX 23 "10 PK 0.5 ml SD-PFS-LLok wTip" lot number K009106 with expiration date of 25-FEB-2016 (dose number, route of administration and anatomical location were not provided), which was stored at -2.77 Celsius Degrees for 192 hours. The type of excursion was refrigerator. No adverse effects were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
dizziness; vertigo; mild headache; mild diarrhea; no appetite; This is a spontaneous report from a contactable consumer (patient). A 67-years-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number Unknown) via an unspecified route of administration, administered in left arm on 30Jan2021 at 09:00 (at the age of 67 years old) as a single dose, for COVID-19 immunization. The patient also received dose 2 of BNT162b2 (Lot number Unknown) via an unspecified route of administration, administered in left arm on 20Feb2021 at 09:00 (at the age of 67 years old) as a single dose. The patient was administered dose 2 of BNT162b2 at a Doctor's office/urgent care. Medical history included hernia from an unspecified date (Hernia surgery 22Feb2021). The patient did not have any known allergies to medications, food, or other products. The patient did not experience COVID-19 prior to vaccination. Concomitant medications received within 2 weeks of vaccination included levothyroxine and rosuvastatin. The patient did not receive any other vaccines within four weeks prior to vaccination. On 19Feb2021, six days after vaccination (as reported), the patient woke up with dizziness, vertigo, mild headache and mild diarrhea. These continued throughout the day with no appetite. The vertigo was better if the patient sat still. The patient woke up on day 2 to vertigo again but easing. The events did not result in hospitalization/prolongation of hospitalization. The patient had a negative COVID-19 test (nasal swab) on 19Feb2021. The patient did not receive treatment for the events. The clinical outcome of the events dizziness, mild headache, mild diarrhea and no appetite was not recovered. The clinical outcome of the event vertigo was recovering.   The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 mRNA VACCINE, were not provided and will be requested during follow up.
burning and itching all over; burning and itching all over; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on Mar2021 (Batch/Lot number was not reported) as 1st dose, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. In Mar2021, the patient experienced burning and itching all over 4 hours after receiving the vaccine. The patient informed that her doctor recommended using over the counter medicine, which she reported that did not help. The patient was prescribed Methyprednisone. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
This spontaneous report as received from a nurse practitioner via company representative refers to a 16 year old male patient. On 05-MAR-2013 the patient was vaccinated with his first dose of GARDASIL (lot number not provided). The patient was admitted to the hospital on 14-MAR-2013(no hospital details were provided, length of stay undetermined), and was diagnosed with pancreatitis. Lab diagnostics studies about CT and Cats Scan were performed without result provided. The outcome of pancreatitis was unknown. The relatedness for pancreatitis was unknown for GARDASIL. Additional information has been requested.
Information has been received from a nurse concerning a 14 year old female who was vaccinated with the first dose of GARDASIL. Subsequently the patient experienced seizure right after received the vaccine. Dosing schedule will be discontinued due to the patient's reaction. The had patient recovered. Upon internal review, seizure was determined to be an other important medical event. The test was performed (results not provided). Additional information has been requested.
Stomach pains.  no pains during the day of the injection but I woke  up at  2 AM with extreme stomach cramps. for  3 days. Fourth day I had no cramps but   I experienced  dizziness and could not keep my balance
I had pain all over my body and I was still sick within a month. I am assuming that I had COVID in December of 2019 because I had the same symptoms I had after having the vaccine. I had body aches, headaches and was unbalanced. I went to see my doctor after speaking to a nurse at my job. I went to the doctor 3 or 4 months after having vaccine and he indicated that I had post covid symptoms. In my opinion, the vaccine gave me covid, I took a treatment for about 2 months and was given celecoxib and gabapentin. I am still having shortness of breath. I am now on another medication bacloaen.
@ 6PM 29AUG96 5hr post vax t100.0 R given APAP @ 6PM & 10PM & 6AM;t105.2 R @ 6AM;
Covid vx Pfizer Swollen lymph nodes under arm on the same side as injection site. Fatigue, nausea, chills, body aches, fever
Swollen throat glands + sore throat, beginning January 1, 2021 through January  7, 2021. Stiff and sore right shoulder and neck (muscular and joint pain), mid-January through present. Multiple Canker Sores on lower lip, January 22 through present.
Right hand/arm started itching, right palm turned red and puffy..  Took 2 bendaryl , told nurse and timer said I had 19 mins left of my 30 min wait.
little tight around my neck and throat, like a tightness; Tightening in my neck and around my mouth area; As soon as I got the shot I felt a little strange; My arms hurting a little; I did not eat anything; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/lot number: EL9263), via an unspecified route of administration on 25Jan2021 (at the age of 77-years-old) as a single dose for covid-19 immunisation. Medical history included ongoing low thyroid and mostly it's food allergies. Concomitant medication included levothyroxine sodium (SYNTHROID) 125 ug, daily for low thyroid. The consumer stated, I took the vaccine on Monday (25Jan2021), three days ago and as soon as I got the shot I felt a little strange and I came prepared because I do have some reactions sometimes. Mostly it's food allergies but I guess was being prepared, so I took Benadryl with me and I took it out of the packet. When probed for the treatment, consumer stated, "I just took Benadryl as soon as I got the shot I felt a little strange and I was prepared and I took my Benadryl with me and we stayed there I guess about 45 minutes until I felt better it would have been 12:15 and I was fine." The consumer stated, "I have been trying for two days, that was in my arms hurting a little on an unspecified date in Jan2021 and then today (28Jan2021) around noon I was feeling a reaction again. I had the tightening in my neck and around my mouth area that's where I usually get the reactions from, but for two days I have been fine and I did not eat anything on an unspecified date in Jan2021 out of the way to give me a reaction to it. Now I took 2 Benadryl and it subsided but it's still tight around my neck and a little tight around my neck and throat, like a tightness. What am I supposed to do? After I took this shot on Monday today is Thursday and I am having the same reactions that I had when I took (incomplete sentence) (pending clarification). The outcome of the events as soon as I got the shot I felt a little strange was recovered on 25Jan2021, little tight around my neck and throat, like a tightness and tightening in my neck and around my mouth area was not recovered and other events was unknown.
(Post and possibly Long CoVid) 1/11 Woke up in the middle of the night and felt like my lungs were on fire, Seemed like I had flu-like symptoms and had vomiting issue as well. I had already had medicine from when I had CoVid and had exact same reaction on first J&J shot. Was advise to just take same medicine and have had some improvement but still having issues.
Diarrhea - 01/04/18 - 01/07/18, Fever - 01/04/18 - 01/05/18, Upset - 01/04/18 - 01/05/18, Not sleeping - 01/04/18 - 01/05/18, Fatigue/no energy - 01/06/18
gave a 3rd dose about 22 hours after the vial had been first punctured; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (gave a 3rd dose about 22 hours after the vial had been first punctured) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039D21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On 13-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (gave a 3rd dose about 22 hours after the vial had been first punctured). At the time of the report, EXPIRED PRODUCT ADMINISTERED (gave a 3rd dose about 22 hours after the vial had been first punctured) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication use was reported.
Sinus infection; A spontaneous report was received from a male patient of unspecified age concerning himself who received Modern's COVID-19 vaccine (mRNA-1273) and experienced sinus infection.  The patient's medical history provided was not provided. No relevant concomitant medications reported.  On 21 Jan 2021, 21 days prior to the onset of the events, the patient received the first dose of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route of administration in an unknown anatomical location for prophylaxis of COVID-19 infection.    On an unknown date in Feb 2021, the patient experienced sinus infection.  No treatment information provided.  Action taken with mRNA-1273 in response to the events was not reported.   At the time of the report, the outcome of event sinus infection was unknown.
Urticaria, bruising/ecchymosis, malaise, localized swelling at injection site.
expired dose of MENACTRA was administered with no adverse event; Initial information was received on 22-Feb-2022 regarding an unsolicited valid non-serious case received from a pharmacist via call center.  This case involves a 23years old female patient who was administered an expired dose of vaccine Meningococcal A-C-Y-W135 (D CONJ) vaccine [Menactra] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 21-Feb-2022, the patient received a 0.5 ml dose of suspect Meningococcal A-C-Y-W135 (D CONJ) vaccine (formulation: unknown) (batch number: U6827BA; expiration date: 18-Feb-2022) once (strength: unknown) via intramuscular route in an unknown administration site for immunization.  On 21-Feb-2022, the patient experienced no adverse event on administration of an expired dose of Meningococcal A-C-Y-W135 (D CONJ) vaccine (expired product administered) (latency: same day).  Action Taken: not applicable.  At time of reporting, the outcome was Unknown for the event (expired product administered).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Fever of 100.4 axillary 36 hours after flu vaccine with associated rash to chest, upper back, arms & legs - raised,m erythematous, blanching.
it knocked her out for 2 days; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 46 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 46 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st Dose, lot unknown), when the patient was 46 years old, for Covid-19 immunization; Bnt162b2 (2nd Dose lot unknown), when the patient was 46 years old, for Covid-19 Immunization. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "it knocked her out for 2 days"; IMMUNISATION (non-serious), outcome "unknown", described as "booster". Additional information: the reporter is patient's neighbor.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Covid19 Pfizer Gray Top was diluted with 1.8ml of diluent in error. Patient received diluted dose
A few minutes following her 2nd Moderna COVID-19 Vaccine EUA, the patient stated that she was having " brain dizziness, neck muscle tension , and fatigue ."  Vitals assessed immediately :  1:50 pm 136/83, HR 68, Resp 18, 02% 97; 1:55 pm 134/79, HR 71, Resp 18, 02% 97; 2:00pm 127/81, HR 71, resp 16, 02% 98; 2:05 120/76, HR 68, resp 16, 02% 97; 2:10 pm 120/75, HR 69, Resp 16, 02% 96. Patient reported that the symptoms only lasted 10 minutes. Patient instructed to remain until 2:15pm and was released with instructions to f/u with ER or PHP if symtpoms return.
Headache within 1 hour  chills  diarrhea  Lasted til 10 P M.  Felt fine next day
the next day, the patient had increased pain and observed a purple area that was indurated, the injection site had a tiny scab and was surrounded by an area of clearing approximately 4 mm in diameter
Patient received 2nd Moderna dose 4 days early, outside of the 28 days +/-4 day grace period