chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt has a history of congenital stroke/hemiplegia and epilepsy. His seizures had been controlled on meds. Shortly after receiving PCV 13 -> had several episodes of incontinence and altered mental status -> likely seizures controlled with benzodiazepine.
excruciating abdominal cramps; diarrhea; This is a spontaneous report from a contactable consumer (patient). A 61-year-old non-pregnant female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 03Feb2021 09:00 (at the age of 61-years-old) (Batch/Lot Number: EN9581) as dose 1, single for Covid-19 immunisation. Medical history included chronic obstructive pulmonary disease and rheumatoid arthritis. Concomitant medications included adalimumab (HUMIRA). The patient previously took sulfasalazine and experienced known allergies: Sulfasalazine. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not have COVID prior and post vaccination. The patient had excruciating abdominal pain and diarrhea starting 16 hours after injection and lasting 4 hours which was comparable to labor pain on 04Feb2021 01:00. The patient did not receive treatment for the events. The outcome of events abdominal pain and diarrhea was recovered on 04Feb2021.  Follow-up attempts are completed. No further information is expected.
Headache, Arthralgia, shivering, insomnia,  Narrative: SHORTLEY AFTER 2ND COVID VACCINE GIVEN PT REPORTED headache, arthralgia, shivering, insomnia RELIEVED WITH TYLENOL AND IBUPROFEN
Information has been received from a doctor of pharmacy concerning a female patient in her 50's, who in October 2010, was vaccinated with a 0.65 ml dose of ZOSTAVAX (Merck) (Lot # not reported). Concomitant therapy included COUMADIN. The pharmacist reported that the patient received a shot of the ZOSTAVAX (Merck) and then was rushed to the hospital with a hematoma. After being admitted to the hospital the patient passed away, in October 2010, "a week after her shot". The pharmacist was not sure if it was due to the ZOSTAVAX (Merck) or not, and she was also not sure of the length of time between the patient getting the ZOSTAVAX (Merck) and being to the hospital. The pharmacist considered that the hematoma and that the patient "passed away" to be life threatening. Additional information has been requested.
Initial information received on 21-Aug-2018 regarding an unsolicited valid non-serious case received from other health professional. This case involves a 13 months old patient (gender unknown) who received vaccine PENTACEL which was not reconstituted properly. The patients past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication not reported. On 16-Aug-2018, the patient received a 0.5 ml single dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot C5262AA via intramuscular route in the right thigh. It was a case of actual medication error due to Inappropriate reconstitution technique. It was reported that PENTACEL a Nurse took out Dtap, took powder and mixed it with powder and sterile water made by Merck. It was unknown whether patient experienced any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. 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.
felt sick; tired; wheezing in her chest; feels weak; has to catch her breath; a little bit of a cough; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (felt sick), FATIGUE (tired), WHEEZING (wheezing in her chest), ASTHENIA (feels weak) and DYSPNOEA (has to catch her breath) 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 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, the patient experienced ILLNESS (felt sick), FATIGUE (tired), WHEEZING (wheezing in her chest), ASTHENIA (feels weak), DYSPNOEA (has to catch her breath) and COUGH (a little bit of a cough). At the time of the report, ILLNESS (felt sick), FATIGUE (tired), ASTHENIA (feels weak), DYSPNOEA (has to catch her breath) and COUGH (a little bit of a cough) outcome was unknown and WHEEZING (wheezing in her chest) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.
This case was reported by a consumer and described the occurrence of thrush in an adult male subject who was vaccinated with Engerix-B for prophylaxis. The reporter is the subject. A physician or other health care professional has not been verified this report. Medical history included "exposure to someone who had hepatitis C". There were no concurrent medications. In "the spring of 2005" the subject received 3rd dose of Engerix-B. At an unspecified time following th e3rd dose of Engerix-B, on an unspecified date in June 2005, the subject experienced thrush. The subject stated that , on an unspecified date in October 2005, his, "teeth were coming loose in his gums with one breaking off" when he "pulled it out with a string". The subject reported that, on an unspecified date in November 2005, on or before 18 November 2005, he "has a lack of energy and sleeps a lot". The subject was seen at a physician's office and was treated with fluconazole for the thrush. At the time of initial reporting, 18 November 2005, the events were ongoing.
dead two weeks later, is that good enough for your "adverse event"? Are you using the data to be sure it's killing like you want? What do you want from me here?
This is a prospective pregnancy case. This 36-year-old female subject was enrolled in a study. On 15th October 2014, the subject received Flu Seasonal QIV Dresden (intramuscular) .5 ml. The subject's last menstrual period was on 18th April 2014 and estimated date of delivery was 23rd January 2015. The subject received Flu Seasonal QIV Dresden at week 26 of the pregnancy and during the second trimester of pregnancy. On an unknown date, an unknown time after receiving Flu Seasonal QIV Dresden the subject developed exposure during pregnancy (Non-serious). The outcome of exposure during pregnancy was unknown. The pregnancy was ongoing. It was unknown if the investigator considered the exposure during pregnancy to be related to Flu Seasonal QIV Dresden. Additional details: The dosage given was 0.5cc. She stated she is 26 weeks gestation. Reporter called to register in pregnancy registry.
Client states he developed bumps that itch the day after vaccination given. Showed his mother on Monday 9/12/05. She brought him in on 9/13/05 bumps noted where vaccine administered and band aid applied. No soreness, lump, redness or pain at site.
pt recvd vax 22JUL93 pt returned 27JUL93 w/complaint of swollen, red lt deltoid area; cellulitis vs adverse event;
I HAVE SEVER ASTHMA AND BRONCHITIS AND GET PNEUMONIA 2 OR 3 TIMES A YEAR. I HAVE TROUBLE TAKING A DEEP BREATH AND CONSTANTLY TAKING MY INHALERS DAILY TO BREATH, I ALSO TAKE STEROIDS. I TOOK THE VACCINE AFTER GETTING OFF WORK ON 12/31/2020. THE NEXT DAY ON 1/1/2021 AND WOKE UP BEING ABLE TO TAKE A DEEP BREATH WITH NO PROBLEMS AND NO CHEST PAINS OR COUGHING. IT IS 1/2/2021 AND I HAVEN'T TOOK NONE OF MY INHALERS OR STEROIDS SINCE I TOOK THE VACCINE. IT IS AN AMAZING FEELING TO BREATH WITHOUT PAIN OR TAKING ANYTHING.
This spontaneous report was received from a pharmacist referring to a "baby" female patient of unknown age. Patient's medical history and concurrent condition were not provided. On 29-NOV-2015, the patient was vaccinated with RECOMBIVAX HB (lot # L018500) Expiration 13-APR-2017 (route, dose number and anatomical location were not provided) which was incorrectly stored. Concomitant medications were not reported. No adverse events were reported. This is one of five reports from the same source. Additional information has been requested.
pt came to pharmacy on 9/9/19 around noon time reported that his arm is still sore, had constant vomiting post vaccination and had to call 911- he had his shot on 9/5/2019 and he had to take 3 advils po for pain. as per pt, his side effects were more moderate such as arm soreness ( still painful). he said, he went to hospital and did all reports, check up, MRI- but everything was normal, and they did not find anything wrong as per pt. he has ENT visit coming up next to find out more.  educated pt on common side effects such as soreness, HA, redness, injection site pain. but pt was saying his side effects were not mild and he had to call 911 because constant vomit & not feeling well post vaccine
There was pain at time of injection on August 27,2019. At 3am the morning after getting vaccinated, patient had chills.  That afternoon he noticed his upper arm was red and swollen.  August 28 the patient called the pharmacy, describing his symptoms. He was told it was possible side effects from the vaccine. On August 29 patient went to urgent care clinic. Doctor said it may be an entry point infection and prescribed doxycycline. Follow up on August 31, patient said the redness and swelling were going down.
Pt developed blurry vision in (R) eye, loss of vision in (R) eye temporarily. Pt also c/o dizziness 3 min after vaccine.
Nausea; Very low-grade pain in ankles , wrists, knuckles; slight headache; tiredness; itching in lower arms & legs; This is a spontaneous report received from a contactable consumer (patient) herself. A 74-years-old non-pregnant female patient received first dose bnt162b2 (BNT162B2, Solution for injection, lot Number: EL3246) via an unspecified route of administration, on left arm on 25Jan2021 17:00 at single dose for covid-19 immunisation. Medical history included asthma, dermatitis, osteoporosis, psoriasis, bradycardia, allergies to molds, grasses, tress, glowers primarily and other allergens. Concomitant medications included theophylline, salbutamol (ALBUTEROL), fluticasone propionate (FLOVENT) and lisinopril. Since the vaccination, the patient had not tested positive for COVID-19. Patient has not had symptoms associated with COVID-19. On 26Jan2021 02:30, the patient experienced nausea, very low-grade pain in ankles, wrists, knuckles, slight headache, tiredness and itching in lower arms and legs (the latter still ongoing 40+ hours later). The outcome of the events were recovering.
A pharmacy technician reported that a pt received an injection of TD Toxoids Adsorbed, Purogenated and subsequently developed generalized hives. The pt also developed an injection site reaction which the reporter did not describe. No further information was available at the date of this report. This is 1 of 2 pts from this facility who had an adverse experience following receipt of this vaccine, lot 471638.
Patient vaccinated at 2:37pm. At 2:46pm, patient reported throat tightness, tongue tingling, and extremities tingling. Administered liquid Benadryl 25mg at 2:46pm. Continued to observe patient for 30 minutes. Vital signs remained WNL throughout observation period. Patient reported overall improvement 15 minutes after Benadryl administered.  Symptoms diminished by end of observation period.
Expired dose; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose). On 23-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.
Patient noticed soreness in arm 3 days post injection (3/24) and small bump and pink skin around injection site. Called pharmacy and reported on 3/25 AM.
he indicated recent medical tests reading excessive levels of "CRT" inflammation; He has been suffering a decline in cardiac function since Feb2021 of this year - so far explained as new blockages; decline in cardiac function since Feb2021 of this year so far explained as new blockages; This is a spontaneous report from a contactable consumer. A 79-year-old male patient (reporter's father) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on Jan2021 at the age of 79-year-old as single dose for covid-19 immunisation. Medical history included cardiac disorder from 2011, he had been a cardiac patient more than 10 years. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient received unspecified concomitant medications within 2 weeks of vaccination. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. In discussion with the patient on 15Jun2021, he indicated recent medical tests reading excessive levels of CRP (reported as "CRT") inflammation which he and doctors are trying to resolve by changing some meds. The reporting consumer recalled that the Cominraty vaccine did have some warnings about inflammation and so need to report this for review. Patient had been suffering a decline in cardiac function since Feb2021 of this year so far explained as new blockages. He had been a cardiac patient more than 10 years and experienced a shift in his condition and function during the 1st quarter of 2021. The adverse event result in doctor or other healthcare professional office/clinic visit. The adverse event result in emergency room/department or urgent care and hospitalization. Since the vaccination, it was unknown if the patient had been tested for COVID-19. Outcome of the events was unknown.   Information about lot/batch number was requested.
About three weeks after receiving the vaccine, I began experiencing SEVERT headaches, nausea, and sometimes vomiting after eating a meal. After consulting the information on the side effects of the vaccine from the CDC website, I called doctor's office on 01/24/2021 @ 9:08 am to report my side effects and ask for any information to help with them. The young woman who answered my call stated that she was the doctor's assistant. I then proceeded to advise her of my extreme discomfort that included headaches, extreme nausea and sometimes vomiting. I could hear the Assistant asking my questions to the doctor, as well as the doctor's response that my symptoms were NOT vaccine side effects. I ended the call, very disappointed because I knew that I had NOT had ANY of these side effects PRIOR to taking the MODERNA vaccine. These symptoms have since become MORE heightened and frequent, post the 2nd round of the vaccine, and have yet to subside. I am extremely concerned about this because my quality of life has been greatly affected.
This spontaneous report was received from a healthcare worker and refers to a 15 month old patient of unknown gender. On 07-APR-2015, the patient was vaccinated with adult dose of VAQTA (lot # J014587, expiry date: 15-JAN-2016, dose: 1.0 ml, intramuscularly). No adverse effect was reported. Additional information has been requested.
Had arm pain for three days; This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored program COVAX US support. A 38-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EW0175, expiry date: 31Aug2021) via unspecified route of administration, administered in right side upper arm on 20May2021 (08:05 AM may be, he clearly didn't remember) as single dose for COVID-19 immunization. There were no medical history and concomitant medications. The patient had no family medical history. Patient did not receive prior vaccination (4 weeks prior). In May2021, after the first dose patient had arm pain for about three days. Patient did not received treatment. The outcome of event was resolved in May2021.  Information on lot/batch number was available. Additional information has been requested.
After administration of both vaccines patient felt dizzy and lightheaded. Patient looked a little pale and had to remain in her seat until she felt better. She remained consciousness the entire time.
Pain at the site of injection; shoulder pain; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site pain and shoulder pain. On an unknown date, the outcome of the injection site pain and shoulder pain were unknown.   It was unknown if the reporter considered the injection site pain and shoulder pain to be related to Shingrix.  Additional details were provided as follows: The patient's demographic details were not provided. The age at vaccination was not reported. The patient received dose of Shingrix and experienced injection site pain and shoulder pain. No further details were provided.
induration, pruritis and erythema patch 9 by 5 cm left deltoid area, fever of 100.1  these symptoms started 3 days after the vaccine
All symptoms started 2 hours after 1st dose of Moderna  Shortness of Breath Difficulty swallowing (Benadryl 25mg Oral One Time Dose)  Throat tightness Palpitations
Site at arm turned slightly  red and swollen by evening time; within 24 hours the swollen area became red hot, itchy and her whole body was achy and felt feverish. The sit was hot to touch and she was feeling bad with pain for about 3 days. The site stayed inflamed until Sunday 4-7-19 then the redness started going away. She stated that she is better and her arm is slightly raised and hurting little.
Patient started feeling nauseous and sweating, she was shaking and very anxious.  Her glucose read 190 and her vitals: BP 120/88, HR 96.  Surgery a month ago on her pancreas.
After administering first covid dose, pt. began developing hives across chest and collar bone area. Patient declined shortness of breath, itching, GI upset, difficulty swallowing. Epi-Pen and 9-1-1 offered, patient declined. At this time, pt. stated about 15 years ago developed an idiopathic allergic reaction to an unknown allergen requiring epinephrine administration. The patient stated she does not carry an EpiPen nor does she have one at home. Patient declined 9-1-1 and EpiPen and stated she wanted to remain in observation area for a few more minutes. Patient remained in car in observation area for approximately 20 minutes longer and then choose to return home. At time of departure, patient did not have shortness of breath, GI upset, difficulty swallowing, itching and exited from drive thru site on her own.
Fever, 104 degrees, extreme pain in extremities. Administered: Ibuprofen, TYLENOL, PHENERGAN, DEMORAL, sent home with PERCOCET.
Chills started on 3/16 and ended the evening of 3/17 Pain and swelling at injection site started on 3/16 and diminished after the evening of 3/17 itchiness started on 3/16 and is still present but has subsided lymphadenopathy started on 3/15 and is currently still present
Joint pain, hives, burning sensation in skin, headache, fatigue, muscle pain, difficulty walking, night sweats, swelling all of which is still on going
Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Severe
Redness with some pain. Redness started small Tuesday morning and increased in size by Tuesday afternoon. Warm to the touch, some soreness and itchiness
2 days after receiving vaccine, developed redness and swelling of lips. Symptoms have persisted, however, slowly been improving.
7 days post-vaccination, patient states that the injection site  had redness, itching and swelling.  Patient notified her primary care provider and was informed that this is a common side effect.
High-pitch whine in both ears. Started on day 5, and has been there every day since.
Per pts guardian, began 10/10/2005 to have increased fever, complain of headache, vomiting. Seen in clinic 10/11/2005 with altered behavior, stumbling, restless, tremor, pacing, non verbal, VS; BP 112/68, T 99, P 118, R 24, To ER via ambulance for evaluation.
Redness in the left eye that is blood shot;  Hot flashes and Flushing of the face Sever brain fog, and had a hard time focusing
Shoulder pain and limited range of motion then lead to extreme shoulder pain that felt like a torn rotator cuff. Went to PCP and was told it was a vaccine reaction, given steroids and prescribed Physical therapy.
On 12/25/20 I developed blisters at the injection site. It was painful and itched. Rash spread down my arm over the next week to my wrist. The rash is still present. My doctor is treating me for possible shingles and started me on an antibiotic for infection. I developed severe body aches and fever on 12/30 that lasted another 4 days.
Within one week of 1st Anthrax shot, pt developed fairly intense pain and discomfort in upper back. This has lasted until now. Within two weeks of 3rd shot, pt developed joint pain in both elbows with occasional numbness in my right hand.  Follow up 05/17/2000: "Patient partially recovered from adverse event.  Pain and discomfort remain in joints (shouders and elbows) occasional numbness in right hand."
PT HAD A TDAP SHOT ON FRIDAY(04-03-09) AND SAT. HE HAD BODY PAIN & CHILLS.LEFT ARM WARM AND TENDER TO THE TOUCH. TODAY PT PRESENTED WITH A WARM ARM/NO PAIN JUST RED.
Received TDaP 6/7/2016. Discomfort began that day. 6/16/16 called nurse recommended IBU or/and go to walk in clinic. Decided to try meds. Did not improve under treatment. Dec arm range of motion not recovered.
About a week after my first shot on 2/18/21 I noticed a ringing in my ears. I checked for side effects and did not see it listed. I thought it was just a coincidence. I saw my oncologist and she said that it may be a sign of hearing loss. So I scheduled an upcoming hearing test and ENT visit. Then today I had my second shot and within an hour the ringing in my ears increased significantly. I did further research and found that their are others who have experienced the onset of tinnitus or worsening tinnitus after receiving the vaccine.
After showering on 4/14/21 I immediately developed a full body rash with very itchy hives and severe swelling (body and facial).  I immediately took 2 benadryl (50mg total) this took about an hour to kick in and helped somewhat with the itching.  The swelling persisted.  I visited my PCP on Thursday (4/15) and he prescribed zyrtec 2x daily and 2 benadryl at bedtime.  He also prescribed a prednisolone pack in case it worsened  but I did not take because I didn't want to negate the effects of the vaccine.   I was also seeing improvement so I didn't feel I needed the steroid.    I followed the 2 zyretc /benadryl for 2 full days and then reduced dosage to 1 zyrtec/1 benadryl at bedtime starting 4/18 and continue to do so.   As of today 4/20 my body rash is greatly reduced as is the facial swelling.  I have very minimal of both as of today.