chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Slight swelling in the night 12/31/2016, itching and rash noted 1/1/17. 1/1/17 and 1/2/17 itchy, rash increasing on neck. No voice. Tuesday 1/3-went to pulmonologist increasing symptoms, asthma attack needing dose of epinephrine and IV BENADRYL.
Initial report was received from a consumer, who was also the patient, on 16 August 2012. A female patient (age and date of birth not reported) had received a dose of FLUZONE, Sanofi Pasteur Inc, lot number UH455AC on 30 September 2011. A day and a half later, the patient had the same allergic reaction she experienced after a previous influenza vaccine with pandemic influenza except it was twice as bad. She thought she was going to die. At the time of the report, the patient could not eat certain foods due to a delicate stomach. The patient experienced an allergic reaction where she got sick to her stomach, lips, throat and hands swelled up and she got severe diarrhea from an Influenza vaccine with Pandemic Influenza vaccine in October of 2010. This reaction was captured in case number 2012-07678. The patient received influenza vaccines for years prior to this reaction with no problem and was not allergic to eggs. The patient's outcome was not recovered. Documents held by sender: None.
Nurses chart note:  "pt came with four other siblings for covid vaccine. when speaking with me, patient was visibly upset and nervous about vaccine. i asked her age but patient did not respond as she continued to express her fear of shots. Pt did tell me her birthday but i did not realize her age. After administering the vaccine,  staff then realized patient was only 11 years old.   She turns 12 in July 2021.
Slight redness right deltoid injection site complained of itching, no warmth, no redness, no respiratory difficulty.
Pneumonia, unspecified organism FEVER COUGH GENERALIZED BODY ACHES
Pt Felt awful x1 week. With Fever x4 d  Chills, Headache & Body Aches Tested Negative for covid.
Received Trumenba at Pfizer sponsored at mass vaccination clinic. At midnight he began to feel feverish, headache, myalgia.  Better in AM with ASA x 2.  At 1700 on 03/05/2015 presents at Health Center with erythema covering complete left deltoid, 3 X 5.5 inches along with intermittent full body flushing.
Light headed and dizziness occurred about 30 minutes after injection.  Given water, some food, and laid down for 45 minutes and symptoms went away.
Patient lost consciousness for about 1 minute, she was able to wake up with smell of alcohol swabs and water.  Patient stayed in the store for 30 minutes following incident to monitor.
I had a severe flare of joint pain and I also had chills I felt really cold. I went to the rheumatologist and he state he believes I got serum sickness from the vaccine.
First dose before covid (early 2020); This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on early 2020 before Covid).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 01-NOV-2022 Reporter's Comment: The patient reported that he/she received Shingrix vaccine in early 2020 before Covid and he/she missed to receive the 2nd dose. The patient wanted to know that he/she need to start over or just he/she receive his/her second dose. The reporter did not consent to follow up. Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
"GI FilmArray Panel" came back positive for Rota-virus; diarrhea; This spontaneous report was received from a registered nurse and refers to a 11-week-old male patient. The patient had no pertinent medical history or drug reactions and allergies. Concomitant therapies included nystatin and unspecified drug reported as "multivitamin". On 27-SEP-2019, the patient was vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally, lot # R029818, expiration date 09-JUL-2020 (exact dose was not reported) for prevention of Rota-virus. On 02-OCT-2019, the patient experienced diarrhoea. On 03-OCT-2019, the patient sought medical attention and was taken to the emergency room where the gastrointestinal (GI) FilmArray Panel was performed and it came back positive for rotavirus on 04-OCT-2019. On an unknown date, unspecified blood work test was performed with unknown result. The outcome of the events was reported as recovering. There was no causality assessment provided by the reporter.  This case is linked to US-009507513-1910USA008085 due to same reporter.; Sender's Comments:  US-009507513-1910USA008085:
The first outbreak was when I woke up early Sunday morning on April 11, 2021, and I had red splotches that feel heated all over my arms, chest, stomach, and back. My ears were very swollen, feverish, and hot. In the next episode was I had red splotches on my chest, arms, and legs. Then I woke up one morning with an awfully bad rash on the left side of my face beside my lip area. I have continued to have red heated splotches every since the second dose of the vaccination (the first dose was on March 17, 2021; the second dose was on April 7, 2021). The most recent breakout was this morning on my chest and back (Monday, November 1, 2021). I reported all incidents to my primary doctor and the emergency visits are in my medical records. The doctor told me to take Benadryl when I experience the red splotches. The red heated splotches just appear out of nowhere and most times are on my arms, legs. chest, stomach, face, or back. I can feel it coming on because I will start to feel heated in the area and when I look at the area I see the red splotches.
Received Expired Dose; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Dose). On 17-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Received Expired Dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided. Treatment medication were not reported.   This case was linked to MOD-2021-418891 (Patient Link).
The patient experienced dizziness, shivers, and syncope following vaccination with VAQTA, GARDASIL9, and TRUMEBA.; The patient experienced dizziness, shivers, and syncope following vaccination with VAQTA, GARDASIL9, and TRUMEBA.; The patient experienced dizziness, shivers, and syncope following vaccination with VAQTA, GARDASIL9, and TRUMEBA.; This spontaneous report was received from a nurse referring to a 13-year-old female patient. The patient's medical history, concurrent conditions, concomitant medications, and drug reactions or allergies were unknown by the reporter. The patient's historical vaccines included meningococcal b rfhbp vaccine (e. coli) (TRUMENBA).  On 04-JAN-2020, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) 25/0.5 (units not reported), hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and meningococcal b rfhbp vaccine (e. coli) (TRUMENBA) (dosage schedule, route, anatomical location, lot number, and expiration date of the three vaccines were unknown by the reporter) for vaccination prophylaxis..  On the same day during an office visit following vaccination, the patient experienced syncope, shivers (chills) and dizziness. After 2 minutes, the patient recovered consciousness. The patient also mentioned that she had not had breakfast before going to the doctor's office. No treatment was provided for the adverse events. It was reported that the patient sought medical attention since she was in the physician's office at the time. The outcome of syncope, chills, and dizziness was reported as recovered.   The causality assessment between the adverse events and the suspect therapy was not provided.  Upon internal review, the event syncope was considered to be medically significant.
Within the 15 minute waiting period post injection, I felt like I was starting to have an asthma attack and had tons and tons of postnasal drainage.  I was hoarse with a sore throat.  My husband got the doctor's attention and he came to check on me.  My vitals were checked and my pulse ox was 96 and my first blood pressure reading was about 170/101 (very abnormal for me).  I was taken to a room and examined and was monitored regularly.  I had scattered rhonchi bi-laterally.  Since I did not worsen, and had a nebulizer and inhaler at home, I was given a dose of Benadryl and allowed to leave.  Prior to leaving, my pulse ox was 98 (after taking Benadryl).   I am still very sick and am to follow up with an allergist.  I am still very congested and am wheezing but using breathing treatments, taking benadryl, and mucinex, and will follow up with an allergist.
Discharge Provider: FNP Primary Care Provider at Discharge: FNP  Admission Date: 3/1/2023 Discharge Date: 03/02/2023  PRESENTING PROBLEM: COVID-19 virus infection   HOSPITAL COURSE: Patient is a 92 year old male with history of chronic atrial fibrillation on oral anticoagulation with warfarin who presented to the ED with complaints of sore throat for one day. In the ED they ambulated him but his oxygen saturations remained 90% but he appeared to have significant work of breathing. Labs revealed that he was positive for COVID 19. Chest xray was done which was nonconcerning. Due to his shortness of breath with walking the ED provider requested the hospiaist service to consult. Patient endorses a long standing history of shortness of breath with activity and per recent office visit it also makes note of this. Patient denies any worsening of his shortness of breath from baseline. He was monitored overnight and his oxygen saturations remained normal on room air, and he was not in any distress. His blood pressure was elevated and recommended that this be followed up outpatient. We did continue his coumadin and this will need to be followed up as on day of discharge his INR was slightly subtherapeutic.   Patient is being discharged in stable condition and was agreeable with discharge plans.
I received the 1st pfizer vaccine on 9/2/21.  A day later I felt tired and weak, nothing too serious.  I got the 2nd dose on October 3rd and a day layer I felt like my whole body was in a cast, I could barely move.  My left arm was so painful & under my armpit was very swollen.  Back pains and body aches all over & feverish with hot & cold sweats on and off for 12 hours. I took 3 tylenol and seemed to feel better afterwards. Major pelvic area pain bad cramping without me even being on my period.  Finished my period and huge blood clots came out (that I never experienced before).  Mild blurred vision in my eyesight.
I felt really terrible. I was just really fatigue. I tested positive for COVID-19 and on the same day I talked to my doctor. He prescribed me Paxlovid.
The same day of the vaccine: For about 6 to 8 hours describes he had feverish feeling with chills to the point of hard shaking (he did not take his temp) and he felt he was hyperventilating or at least breathing faster. Also had feeling of facial swelling. No SOB. No syncope. No rashes. He has been fine since.
Following the shot came the typical aches & pains, but they didn't go away. Instead they got worse & worse until my body was wracked in pain. It was obviously the shot. I have not had a pain free day since & rheumatologist diagnosed me with fibromyalgia.
My 16 year old daughter had a "medical reaction" to the first Pfizer vaccine. The shot itself was fine. As we pulled away from the tent, in an alarmed voice, my daughter exclaimed that she could feel the shot traveling down her left arm into her hand. She said her arm felt really weird and her hand felt buzzy. By the time we rounded the corner to get to our mandatory 15 minute wait period, the reaction began. She lost eyesight and hearing - foggy hearing and began to sweat profusely. Her pupils were completely dilated. She became very weak and her hands were cold and clammy to the touch. The sweat was beading on her face and arms. Her hands became rigid and she cried that she can't move her fingers. When the ambulance arrived, they put her on oxygen - as she was blue at the extremities.  Her eyesight faded in and out several times throughout the reaction as did the foggy to almost gone hearing. We went to the hospital via ambulance. They tested her with an EKG. We were there for 4 hours. Her eyesight returned and her hearing became less foggy as time went on. When we left the hospital, my daughter was still very shaky. Her symptoms of shakiness lasted another 2-3 days and emotionally took another week to calm down. The trauma of the event is still with her. She was diagnosed with "medical reaction" from hospital.
This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in a 80-year-old male patient who received SHINGRIX (batch number 3Z53C, expiry date unknown) for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of influenza like illness (1st dose, refer case US2018GSK208641). On 6th November 2018, the patient received the 2nd dose of SHINGRIX. In November 2018, less than a week after receiving SHINGRIX, the patient experienced influenza-like symptoms. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the influenza-like symptoms was unknown. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The reporter reported, the patient developed flu like symptoms after both doses of SHINGRIX. Consent to follow up was provided.
Large pruritic erythematous reaction around injection site. She has never had any reaction for the last 42 years to flu vaccine she said.
NSTEMI, bypass. ED visit to hospital admission. This visit was within 6 weeks of receiving the COVID vaccine.
Severe apneic episodes with sleep. I have no history of sleep apnea, BMI of 24, exercise regularly, no known snoring. The night after my first dose at around 23:00 while falling asleep I shortly after having been asleep would wake up gasping for air.  Attempting to fall back asleep I felt the need to consciously make myself breathe, and when I would fall asleep no more than 5-10 after I would wake up gasping for air. This continued on until around close to 03:00 on 1/7/21. When I finally fell asleep around 03:00 woke up gasping for air around 04:45 and never fell back asleep. The next two nights, 1/7/21 and 1/8/21 I would have trouble falling asleep because these same apneic episodes were happening until around 03:00. The night of 1/9/21 I had no issues sleeping, and have had no apnea since those three nights.  These apneic episodes were followed by extreme anxiety from being unable to sleep fully (I worried moreso about not falling asleep than the apnea). Heart rate when counted ranged for 70s-80s and my normal HR while sleeping is around low 50s.
Patient said her arm was sore at sight of injection and it hurt to move it. It got better each day, and is no longer difficult to move but sore to touch.
Starting 8am after the vaccine I was completely exhausted, body aches, and lymph nodes in neck and under arm were very swollen.  That lasted about 12 hours. The lymph node under my arm in the same arm I got the vaccine in is still veery enlarged and sore 40 hours after the vaccine.
RespDepression, CoughWheeze, Diarrhea, Syncope & Tachycardia  Narrative:  EMPLOYEE WAS EVALUATED IN ER THE SAME DAY OF THE SECOND DOSE OF COVID VACCINE ADMINISTRATION. SHE WAS DISCHARGE FROM ER AFTER 2 HOUR OF OBSERVATION AND TREATMENT GIVEN. AT MOMENT OF DISCHARGE EMPLOYEE REFER FEEL BETTER. EMPLOYEE REFER THAT SHE DEVELOP SOB AGAIN 24 HOUR AFTER THE ADMINISTRATION AND SHE WAS EVALUATED AND HOSPITALIZED FOR TREATMENT. SHE STILL ON OBSERVATION AT MOMENT OF THIS NOTE.
Sore arm; Fever of 100.8; Headache; Chills; Fatigue; This is a spontaneous report from a contactable other healthcare professional, the patient. A 20-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the arm left on 07Apr2021 at 08:45 (at the age of 20-year-old) as a single dose for COVID-19 immunisation. Medical history included covid-19 (Prior to the vaccination, the patient was diagnosed with COVID-19). Concomitant medication included birth control (MANUFACTURER UNKNOWN) started on unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the arm left on 16Mar2021 at 10:15 (at the age of 20-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. Since the vaccination, the patient had not been tested for COVID-19. On 07Apr2021 at 20:30 the patient experienced sore arm, fever, chills, headache, fatigue. On 07Apr2021 body temperature was checked and the result was 100.8. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event sore arm, fever, chills, headache, fatigue was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
On 3/5/2021 Moderna COVID19 Vaccine Vial was punctured at 10:45A, vaccine was given at 5:20P.  Vaccine expired at 4:45P (6 hours after punctured).  Reported to Moderna same evening, received response 3/18/2021.  Representative gave instruction that repeat dose was not needed as viability of vaccine was demonstrated 12 hours after puncture time, however as there was no preservative there was increased likelihood of infection.  Patient was informed, patient denied signs of infection.  Patient was instructed to monitor for signs of infection at vaccine site.
Narrative:  Patient received 2 doses of Pfizer mRNA vaccine in a timely manner in February and March of 2021 but was hospitalized with COVID-19 with a positive test 7/22/21 and developed respiratory failure, then improved and was discharged.
Intradermal injection to left forearm given but did not wheal. Repeat injection given subcutaneous to left back of arm successfully.
Breakthrough COVID19 infection; Breakthrough COVID19 infection; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A child female patient received bnt162b2 (BNT162B2) (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: COVID-19 (medically significant) with onset Dec2021, outcome "recovered", DRUG INEFFECTIVE (medically significant) with onset Dec2021, outcome "unknown" and all described as "Breakthrough COVID19 infection". It was unknown if therapeutic measures were taken as a result of covid-19, drug ineffective. Clinical course: It was unknown that the patient received any other vaccines within 4 weeks prior to the COVID vaccine, unknown whether prior to vaccination, the patient was diagnosed with COVID-19 or unknown since the vaccination, the patient had been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
No AE; HCP calling to reported administering adult dosage of VAQTA to a 16-year-old patient. Permission to contact HCP was granted. No additional information. No AE/PQC reported.; This spontaneous report was received from a nurse and refers to a 16-years-old patient of unknown gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 02-AUG-2023, the patient was vaccinated with adult dosage of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, unk, lot #W028824, expiration date: 07-JAN-2024, administered for prophylaxis (strength, and route of administration were not provided) (Product administered to patient of inappropriate age). No additional adverse event was reported.
ABDOMINAL PAIN IS ON THE LOWER RIGHT SIDE AND IS ALSO RADIATING TO THE HIP AND AROUND THE BACK AND IS CONSISTENTLY THERE AND SOMETIMES GETS WORSE WITH  MOVEMENT; GROIN PAIN WAS ONGOING BUT COMES AND GOES; This spontaneous report received from a patient concerned a 53 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: cigarette smoker, and diabetes, and other pre-existing medical conditions included: The patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: 21-SEP-2021) dose was not reported, administered on 19-AUG-2021 for prophylactic vaccination. Concomitant medications included glipizide for diabetes, metformin for diabetes, acetylsalicylic acid for drug used for unknown indication, apixaban for drug used for unknown indication, lisinopril for drug used for unknown indication, and simvastatin for drug used for unknown indication. On AUG-2021, treatment medications included: ibuprofen. On 19-AUG-2021, the patient experienced groin pain was ongoing but comes and goes. On 20-AUG-2021, the patient experienced abdominal pain is on the lower right side and is also radiating to the hip and around the back and is consistently there and sometimes gets worse with movement. On 22-AUG-2021, Laboratory data included: Blood test (NR: not provided) Not reported. On 23-AUG-2021, Laboratory data included: HbA1C (NR: not provided) high, and WBC count (NR: not provided) normal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from abdominal pain is on the lower right side and is also radiating to the hip and around the back and is consistently there and sometimes gets worse with movement, and groin pain was ongoing but comes and goes. This report was non-serious.
Pharmacy technician administered the vaccine. The needle was not all the way in. Technician was informed. As the needle was being removed, notice some of vaccine coming out of the arm. Post vaccine, redness, swelling, itching, and a large hematoma. Concerned that it was not correctly done and if fully vaccinated.
Severe headache, persistent intermittent cough everyday. Some days only in the AM. Other days only in the PM. Currently headache is more PM and nagging intensity with cough mostly evening.
Discomfort upper right arm during night after receiving vaccine - bruise and feels hard per patient.
Information has been received from a physician concerning her 8-year-old daughter who on 17-MAR-1999 was vaccinated subcutaneously in the left arm with a 0.5 ml dose of Varivax (Lot # 629249/1845H). Concomitant medication on that day was MMR (Lot # "121408/03"). On 02-JAN-2007 (previously reported as 03-JAN-2007), the patient experienced a breakthrough of approximately 50 lesions of varicella rash. It was noted that this was a "mild case" of varicella disease. The outcome was reported as recovered. Unspecified medical attention was sought. No additional information to report. There was no product quality complaint involved. No additional information is expected.
Had Tdap in office Thurs 10/15/09 developed hives 10/17/09. Rx with Benadryl after calling doctor on call.