chrisvoncsefalvay/vaers-outcomes huggingface dataset:
She has a history of Bipolar II, dx about 2 years ago. She has been in counseling for the past 5 years. She just changed from effexor to lexapro about 1 month ago. She has been on abilify 10mg for the past ~6months.  On 4/8/21 she went to bed around 11pm and awoke on 4/9 around 8:30am.   She had her JJ covid vaccine on 4/9/21. She had 2 handfuls of goldfish crackers on the way to her vaccine appointment around 11am. She had ~6-8oz of water when she awoke. She arrived at the Clinic on campus. She sat down for ~5 minutes and then the staff came to get her. She had the shot administered in left deltoid. When she first felt the pain her vision started to go black and she felt like she was going to pass out. She denies feeling hot or dizzy prior to event. Her vision went completely black, then when she "came to" she was bent over in her chair with arms drawn up to body and fists clenched. Immediately her body relaxed and she felt very confused. She was told she just had a seizure - bend forward and had whole body shaking for ~30 seconds.   She felt extremely nauseated and had some dry heaving. Someone helped her to the floor and put up her legs. She was told she looked very pale. She felt much better within 5 minutes. Vitals were checked and were stable. She was given granola bar to eat and drank ~12oz of water. No one sided weakness, no incontinence, no tongue bite. She stayed there for ~45 minutes for monitoring. Someone walked her to her car, asked her if she was ok, and then she drove herself home.   Of note, the room she was in was warm and they were going to open doors to get some air. She was not ill or tired at the time.   After the event she drove for 5 minutes to her home. Once in her room she felt extremely tired and then slept until 7pm (~6-7 hours). She then called Mom. Mom reports that patient sounded different on the phone. Speech was slow and she seemed "off." Mom drove to her and was at her room by around 7:40pm. At that time, patient looked very pale to Mom. Mom took her home, gave her chicken soup. She did not have an appetite. She just wanted to go to sleep. Mom tried to have her stay up until around 10pm. She had ~8oz of water and then went to bed. She slept through the night. She awoke the next morning and reports that her brain felt like it hurt to work. She had chills, body pain, shakiness during the day on 4/10/21. This was easily managed by tylenol q4.   Of note, she did have covid19 in 8/2020. She was ill for ~1 week with lack of smell/taste, febrile, shakiness, headache.  She had an odd event on 4/19/21 while giving a presentation at school. She had sudden onset of left pinky numbness/tingling with radiated up the side of her forearm. This lasted ~1-2 minutes. However, her left arm hurt for a few hours afterward. She denies any fatigue after event.  She has a Mirena IUD. She smokes nicotine via vape numerous times per day. She smoke weed up to 3X/day but not every day. She drinks beer a few days per week.
symptom of redness and swelling at injection site of a vaccine; symptom of redness and swelling at injection site of a vaccine; This case was reported by a other health professional via sales rep and described the occurrence of injection site erythema in a 17-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis, HPV 16-18 (HPV vaccine) for prophylaxis and MENINGOCOCCAL A, C, Y, W135 CONJUGATE VACCINE (DIPHTHERIA) (MENACTRA VACCINE (MENINGOCOCCAL GROUPS A,C,Y,W135 POLYSACCARIDE DIPTHERIA TOXOID) for prophylaxis.   On an unknown date, the patient received the 1st dose of Bexsero, Bexsero Pre-Filled Syringe Device, HPV vaccine and MENACTRA VACCINE (MENINGOCOCCAL GROUPS A,C,Y,W135 POLYSACCARIDE DIPTHERIA TOXOID. On an unknown date, unknown after receiving Bexsero, Bexsero Pre-Filled Syringe Device and HPV vaccine, the patient experienced injection site erythema and injection site swelling. On an unknown date, the outcome of the injection site erythema and injection site swelling were unknown.   It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to Bexsero, Bexsero Pre-Filled Syringe Device and HPV vaccine.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced symptoms of redness and swelling at injection site of a vaccine, but was not sure which of 3 injections it was. The patient was given HPV, MCV4 Menactra booster and BEXSERO on same day in 2 different arms. Two injections in one arm and one in the other were administered, but they weren't sure which site or vaccine had the redness and swelling. It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to Menactra vaccine. The reporter consented to follow up.
3 x 5 in circular rash with warmth - denies pain - itching.
First, site of injection in my left arm started to twitch, muscle spasm. Then my heart started to have palpitations then it started to feel like it was on fire with pain intensifying through my body to my back. My tongue felt like it had pins and needles in it like when you eat pineapple. A few days later my fingers and toes went numb for a day then exactly two weeks later on 9/01/21 the injection site in my left arm became inflamed and blew up and was hot to the touch resembling an allergic reaction to a bee sting. To this day I still feel pain in my heart with radiating pain to my back. I went to the doctor the very next day and the nurse practitioner preformed an EKG which showed nothing. I was scheduled to get the second shot this past Wednesday but the pharmacist refused stating I needed clearance from a doctor to get the vaccine after the experience I had. The nurse practitioner felt it was just heart burn and prescribed me Nexium which I took for over a month now and has done nothing.
Patient was inadvertently administered with Fluzone Quadrivalent instead of Fluzone HD, no AE; Initial information received on 11-Nov-2019 regarding an unsolicited valid non-serious case received from a Other Health Professional.  This case is linked to cases 2019SA316262, 2019SA316289, 2019SA316290, 2019SA316263, 2019SA316286 and 2019SA316288.  This case involves a 74 years old female patient who received a 0.5 ml dose of vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot: UJ305AA, expiry date: 30-Jun-2020), via intramuscular route in the Right Deltoid, on 07-Nov-2019 instead of Fluzone HD (INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE).  Relevant medical history and concomitant medication were unknown.  It was an actual medication error due to the wrong vaccine administered. It was reported that the Fluzone Quadrivalent was inadvertently administered to the patients instead of Fluzone HD.  At the time of reporting, the patient had no adverse event.  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 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
Immediate taste sensation and then swelling of tongue w/o any change in breathing, some sense of tongue soreness and hyperemia remains
11 days after the vaccine I broke out in hives all over my body. It's now been almost 2 months and the hives have not gone away. I've been unable to sleep they are so itchy. I went to an allergist and have tried antihistamines, and steroids and neither have been successful in getting rid of the hives. They are welts all over my body and they are impacting my quality of life.
Fever of 103*F, chills and fatigue: called occupational health line, was told not to come to work, rest, fluids and alternate Tylenol and ibuprofen q4h to break fever. Fever broke 24 hours after onset.
1- hives/rash back of my neck, ears, head, crotch area and tailbone up the middle of my back  2 days after the 2nd shot/started to fade after 3 days/ dr prescribed Claritin and steroidal cream to use lightly on the hives twice/day 2- horribly bad breath that started  the next day after the 2nd shot- metallic, awful taste that won't go away even after brushing, flossing and rinsing with mouthwash constantly- still with me- going on  day 5
Patient has had a bruise the size of a half-dollar since injection on the 1/3/2022
Irregular menstruation  (no menstruation for 2 months- this is the first time I skipped 2 months (non-pregnant) in my life, and only one time I skipped one month.)
pt recvd vax;immed p/ dose 1,exp neck,back,& arm pain; 2 hrs later,tingling arm & dyspnea; sxs resolved in 1 wk;
8/28/2021 - run down and fatigued feeling most of the day. Also noted lightheadedness. 8/30/2021 - evaluation appointment with physician to determine "next steps" for rash and run down feeling noted previously. An EKG was ordered and I was found to be in A-Fib. Was sent to ER and ultimately admitted into ICU on 8/30/2021 and was not released until 9/2/2021. Heart rate was initially in the 140's. ICU time was spent finding a combination of medications to lower HR, but I still have an abnormal rhythm.
Ears clogged, Right Ear is still clogged and now I have tinnitis
choking; scratchy throat; the muscles in her throat started seizing up completely within minutes; couldn't swallow whatsoever/no muscle control with swallowing; she couldn't control her spit; fingertips started turning blue; anaphylactic shock; This is a spontaneous report from a contactable consumer from a Pfizer sponsored program. A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EN6208), via an unspecified route of administration, administered in right arm (reported: right upper arm) on 19Mar2021 12:30 (at the age of 48 years old) as dose 1, single for COVID-19 immunization. Medical history included triple negative breast cancer from 2017 to an unknown date, CREST (an autoimmune disorder that affects the scleroderma), and asthma from an unknown date. Concomitant medications include unspecified blood pressure and asthma medications. The patient received her 1st dose of COVID vaccine on 19Mar2021 and on the same day had anaphylactic shock. She reported she got the shot and within 10 minutes she had a really scratchy throat and she reported it to the nurse. The muscles in her throat started seizing up completely within minutes. She stated she did not have trouble breathing but she couldn't swallow whatsoever, she couldn't control her spit, when she tried to swallow, she was choking as she had no muscle control with swallowing. She also relayed her fingertips started turning blue. She was given an epi pen for the events. She was transported in the emergency room (ER) for 8 hours but was not admitted. The outcome of the events was unknown.
was suppose to get my second shot in march; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (was suppose to get my second shot in march) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Jul-2021, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (was suppose to get my second shot in march). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (was suppose to get my second shot in march) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were reported. No other adverse events were reported No treatment information was reported.   Reporter did not allow further contact
left leg went to sleep and when I stood up I fell on my left foot; Maybe I have just sprained my ankle and there was extreme swelling has moved up to my calf area and feels like there is water in the leg and it's throbbing; left leg went to sleep and when I stood up I fell on my left foot; Maybe I have just sprained my ankle and there was extreme swelling has moved up to my calf area and feels like there is water in the leg and it's throbbing; left leg went to sleep and when I stood up I fell on my left foot; Maybe I have just sprained my ankle and there was extreme swelling has moved up to my calf area and feels like there is water in the leg and it's throbbing; left leg went to sleep and when I stood up I fell on my left foot; Maybe I have just sprained my ankle and there was extreme swelling has moved up to my calf area and feels like there is water in the leg and it's throbbing; left leg went to sleep and when I stood up I fell on my left foot; Maybe I have just sprained my ankle and there was extreme swelling has moved up to my calf area and feels like there is water in the leg and it's throbbing; left leg went to sleep and when I stood up I fell on my left foot; Maybe I have just sprained my ankle and there was extreme swelling has moved up to my calf area and feels like there is water in the leg and it's throbbing; little bit of soreness on my left arm where the injection went; This is a spontaneous report from a contactable consumer (Patient). A 79-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 09Feb2021 (Batch/Lot Number: EL9269) as SINGLE DOSE for covid-19 immunization. Medical history included blood cholesterol, glucose tolerance impaired, pre-diabetic with HbA1C 6.1. Patient was allergic to Penicillin (swell), Metformin (swell), Sulfa (breathing trouble) and Allegra (headache). Concomitant medication(s) included rosuvastatin, calcium, vitamin D3, vitamin B complex. On 09Feb2021 (Monday, same day of vaccination, patient experienced little bit of soreness on my left arm where the injection went, on 10Feb2021 (Wednesday) left leg went to sleep and when stood up i fell on my left foot; maybe i have just sprained my ankle and there was extreme, swelling has moved up to my calf area and feels like there is water in the leg and it's throbbing (Throbbing pain). The patient was treated with Ibuprofen 200 mg (Intent: Advil) and Aspirin but it was not doing anything to the patient. Patient states that she was usually very healthy and dont have problem with blood pressure. She was prediabetic and just taking care with diet and exercise. Patient was worried if this affect heart in anyway. There was a heart disease on her mother's side of the family, everybody on her side of the family died of a heart attack and patient younger brother has a stent put in and seen other people who have heart problems, and they have the swollen legs and feet and just wondering if that's the same thing that's happening to her. The second dose of vaccine was scheduled for 03Mar2021. The outcome of the events was unknown.
Injection site reaction after several hours : pain, tenderness and swelling of the lymph nodes in the same arm of the injection, swelling, (hardness) and redness
Child was here for second Pfizer shot. Was given the second Peds Pfizer in left deltoid. After shot was given, RN realized it was given too early. The first vaccine was given 12/18/21, and the second dose was given on 12/31/21. Mom was made aware that vaccine was given too early. Child had no ill side effects and stayed the 15 minutes observation time. RN's supervisor and child's PCP were also made aware.
Only received first dose of shingrix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 80-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in November 2018).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Only received first dose of shingrix). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 21-JUN-2023 The reporter asked for information regarding a patient who had not received the second dose of Shingrix yet. The reporter asked if they could administer the second dose or if the patient had to restart the vaccination. The reporter did not provide information about first Shingrix dose (lot number, expiry date). The reporter consented to follow up. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Muscle weakness, ¨it is like tired ¨ in the same arm of the injection; Soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (Muscle weakness, ¨it is like tired ¨ in the same arm of the injection) and INJECTION SITE PAIN (Soreness at the injection site) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included VITAMIN B12 [VITAMIN B12 NOS] for an unknown indication.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, the patient experienced MUSCULAR WEAKNESS (Muscle weakness, ¨it is like tired ¨ in the same arm of the injection) and INJECTION SITE PAIN (Soreness at the injection site). At the time of the report, MUSCULAR WEAKNESS (Muscle weakness, ¨it is like tired ¨ in the same arm of the injection) and INJECTION SITE PAIN (Soreness at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient received their first dose of Moderna vaccine on 26-Mar-2021 and since 27-Mar-2021 the patient experienced soreness at the injection site and also reported of experiencing muscle weakness, like tired, in the same arm of the injection.   Reportedly, the patient tried to call their doctor, but their doctor was busy.  Concomitant medication used by the patient also included anti depressive medication.  No treatment information was provided.
since date of dog bite/tetanus vax, increasing problems w/tightness of muscles of scalp, neck, jaw, eyes;some memory problems, eye weakness;
TROUBLE SLEEPING; TROUBLE GETTING UP; HEAVY HEAD; NAUSEA; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 2021 for prophylactic vaccination. The batch number was not reported. We are unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 2021, the subject experienced trouble sleeping. On 2021, the subject experienced trouble getting up. On 2021, the subject experienced heavy head. On 2021, the subject experienced nausea. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the trouble sleeping, trouble getting up, nausea and heavy head was not reported. This report was non-serious.
Administration at 1533, muscle spasm onset at 11 minute mark after administration of vaccine. Patient BP 140/82, HR 65, O2 room air at 99%. Patient was observed for 30 minutes, family came to pick her up. She was escorted out of the facility in a wheelchair for safety. Follow - up at 1730, pt still had muscle spasm but without pain or worsening symptoms or those symptoms related to anaphylaxis. Will follow up Monday with patient.
The client reports approximately 12 hours after his first dose he lost his taste and partially his smell. It has still not returned.
Clinician prepared vial with 1.3ml Normal Saline diluent rather than 1.8ml Normal Saline for her 1st dose on 12/23/21 and 2nd dose on 1/13/22  No Clinical concerns were reported
Patient states that while he was sitting at his home when attempted to stand up did not feel his legs which did not leave him stand. This lasted for approximately for five minutes and caused him concerned. He said that he did not feel any tingle either. This was a one-time episode and has not been repeated.
Headache feels it mostly on one eye; A spontaneous report was received from a consumer (patient), concerning herself, a 72 years-old female patient, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273), and experienced headache feels it mostly on one eye (headache).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 02 Mar 2021, prior to the onset of the event, the patient received their second of two planned doses of mRNA-1273 (lot/batch: 023M20A), intramuscular for prophylaxis of COVID-19 infection.  On 03 Mar 2021, the patient experienced headache and feels it mostly on one eye. No treatment information was provided.  Action taken with second dose of mRNA-1273 in response to the event was not applicable.  The outcome of event, headache feels it mostly on one eye was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Excruciating radiating pain in right arm, muscle pain, loss of range of motion, pain while lifting arm or reaching, burning, stabbing pain.
meningitis; This case was reported by a consumer via interactive digital media and described the occurrence of meningitis in a male patient who received Men B NVS (Bexsero) for prophylaxis.   The patient's past medical history included food allergy and sensorimotor disorder.   On an unknown date, the patient received Bexsero at an unknown dose. On an unknown date, 3 days after receiving Bexsero, the patient experienced meningitis (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the meningitis was unknown.   It was unknown if the reporter considered the meningitis to be related to Bexsero.  Additional case details were provided as follows: The age at vaccination was not reported. The patient had terrible food allergies prior and sensory issues and therefore reporter was feeling that it was not right to give it to him but the physician forced for this vaccination. 3 days after getting the meningitis shot, the patient got meningitis.  The patient was admitted in the intensive care unit for 10 days. The reporter tried to obtain the batch number of the shot but even after three requests, the physician did not report it.  The reporter was wondering about the accuracy of the reported shot related events.
Pt states that she had a swollen arm, just below immunization spot. It was painful and reddened for 7 days. It became itchy for the last 3 of the 7 days.
Woke up at 4 am  with extreme teeth-chattering shivering.  Hard to sleep with muscular aches, primarily shoulders, arms and back.  At 10 am after very disrupted sleep due to above symptoms, had a fever of 100 with persistent headache primarily affecting the top and back of the head and also the neck.  Extrem soreness of upper torso and extremities continuing.
mom gives hx of fever up to 104;crying, fussiness occurring w/in 5hr of vax also concerned that pt appears jumpy & nervous;