chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Customer requested "high dose" flu vaccine from tech, entered 10:06pm. Tech confirmed with pt about any reactions to vaccines. Customer confirmed "never had any reaction to any vaccine and I double checked at time of shot, also stated only PCN true allergy, others listed really weren't and pt confirmed "never reacted to flu shot, had many times before. Discussed VIS, after vaccine, pt was told to hand around for 15 minutes after shot to make sure everything ok. Customer sat in chair talking on phone in Pharmacy waiting area. Shot was given approximately 10:30pm, at about 10:45 pm pt complained of "just not feeling well" felt like she had more "mucus" and cold hands, she thought she maybe was having a reaction to the flu shot, monitored pt, she was coherent and responsive, no other issues reported at that time. Customer also stated she usually takes care of her allergic reactions herself and she was going to take cimetidine, BENADRYL and her QVAR (2 puffs) (these are what she told EMT...I only saw her with inhaler in hand, never witnessed her use/take meds). Customer thought she may be hungry, she was given water and ate "2 snicker snack size" (made sure no allergies to these) and she also at a "lunchable" while Police Officer here. Pt limits calorie intake to 1000 calories per day. At approx. 10:58, pt requested 911 called, officer already on site at our location outside, he notified EMT who was on their way already. Fire dept showed up as well prior to EMT. Pt did discuss with Officer about 1000 calorie intake, thought maybe she was hungry. Pt also stated maybe she should take her "prednisone", we both advised against before EMT arrival and recommended pt shouldn't eat any more food. EMT's arrived, took over care. We (tech and Pharmacist) told ok to leave. Informed EMT's of FLUZONE-HD shot given and never reacted, possible meds pt took/used. Also noted food eaten and limited caloric intake of 1000 calories/day and PCN allergy. Pt confirmed PCN allergy, when they asked about any allergies. Pt walked out to ambulance next to EMT's responsive and alert at about 11:22pm. Followed up with ER report, pt was seen and observed by Dr., released at 2AM as OK. Pt was given DECADRON and eating when Dr. went into see her. Dr. reports said, pt may have had some reaction, but some anxiety as well.
Allergic reaction to the Seqirus vaccine; Itchiness, rash and hives on mostly my arms and a bit on my legs; Itchiness, rash and hives on mostly my arms and a bit on my legs; Itchiness, rash and hives on mostly my arms and a bit on my legs; This spontaneous case was received on 26-Sep-2022 from other non-healthcare professional (consumer) via Agency (reference number: SEQW22-03512) and concerned 76-year-old, male patient.   The patient's medical history and concomitant medications were not reported. The patient's historical vaccines included unspecified flu vaccine shots received for over 20 years with no ill effect, as reported.  On 07-Sep-2022, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml, route of administration: intramuscular (IM) and anatomical location: not reported) for influenza prophylaxis. The batch number was not reported.   On the same date, after receiving Fluad Quadrivalent, the patient had a fairly severe allergic reaction with itchiness, rash and hives mostly on his arms and a bit on his legs.   On unspecified date in Spe-2022, the patient visited physician's office and physician confirmed patient's belief that it was allergic reaction to the Seqirus vaccine and advised him to take a different vaccine next year. The patient got steroid cream from his doctor which seemed to help.   At the time of initial reporting, the patient was recovering from the events. As reported, it largely faded after three weeks, but there was still some itching at wrist and back of elbows.   The reporter assessed the events of 'allergy to vaccine', 'extremities itchy sensation of', 'rash on legs & arms' and 'hives' to be related to Fluad Quadrivalent. As reported, the patient believed it was an allergic reaction to the Seqirus vaccine.   The case was assessed as non-serious.  Company comment: The events of allergy to vaccine, extremities itchy sensation of, rash on legs & arms and hives are assessed as possibly related to Fluad Quadrivalent due to plausible temporal relationship.; Reporter's Comments: As reported, the patient believed it was an allergic reaction to the Seqirus vaccine.; Sender's Comments: The events of allergy to vaccine, extremities itchy sensation of, rash on legs & arms and hives are assessed as possibly related to Fluad Quadrivalent due to plausible temporal relationship.
Immediately after shots - became Faint with pulse 50; Next Am had syncopal episode -> ER -> hosp Adm. with significant bradycardia -> cardiac work-up; now on Atenolol.  2/1/08 Reviewed ER medical records of 11/15/07 which reveal patient experienced feeling lightheaded, warmth & nauseated.  Felt faint, lost consciousness & collapsed for approx 1 min witnessed by parent.  Recovered at the scene.  In ER placed on O2.  Had additional episodes of syncope w/HR 30's while laying on gurney in ER.  Noted to have eye twitching, pallor & eyes rolling back in head, flaccid.  Awoke immediately but was very tired.  Transferred to higher level of care. FINAL ER Dx: syncope of unknown cause. 2/8/08 Reviewed hospital medical records which reveal patient admitted to PICU 11/15-11/16/2007.  Cardio consult done.  Syncopal episodes felt to be neurocardiogenic w/significant cardioinhibitory component, resulting in secondary bardycardia/asystole & syncope.  Tx w/meds & hydration & d/c to home w/cardio f/u. FINAL DX: syncope, probably neurally-mediated syncope; periods of marked bradycardia.
Dizziness, hypotension,    HR 64 Sp02: 99% BP:100/69,C/o dizziness, reported hx of vasovagal episodes w/ blood draws. A/O x4.   Marathon runner VS: HR 56, BP 80/52, Sp02: 100%   After laying down, patient reported significant improvement in symptoms. Tolerating PO well
Shortness of Breath, fever-ish, muscle aches throughout body. Took ibuprofen, but didn't seem to help.  Ice packs on forehead and neck.  Sleep
05/29/08 - 8 pm - notice different size pupils, headache.  5/30/08 - 1 pm - dizziness, 30 second loss of vision, headache, uneven pupils.  6/4 uneven pupils, headache.  8/26/08 Reviewed ER medical records of 6/05/2008. FINAL DX: probable migraine HA Records reveal patient experienced HA, transient visual disturbance & intermittent unequal pupils.  Referred to neuro & neuro-opthalmologist & those reports are included.  Neuro exam was WNL.  Neuro-Ophtho exam of 6/19/08 revealed significant orthostatic blood pressure changes with normal neuro/eye exam.  Recommended additional cardiology w/u to include transesophageal echocardiogram, tilt table test & catecholamine blood test.  6/6/08 Reviewed PCP medical records. FINAL DX: vasovagal syncope Records reveal patient experienced good health on day of vax.  Only complaint re BCP which caused nausea.  Seen in ER on 5/30 w/episode of bilateral loss of vision that day.  Had seen chiropractor & also exercised earlier that day.  While stretching her neck during exercise, felt lightheaded & weak then lost vision in both eyes & felt faint.  Symptoms resolved spontaneously in approx 20 seconds.  Seen by PCP & sent to ER.  Neuro consult done.  Continued to feel lightheaded while in ER otherwise asymptomatic.  Placed in cervical collar.  F/U visit to PCP on 6/2 for continued vision difficulties & dizziness.  Optho eye examination WNL.   Eye exam on 6/2 revealed PERL.  Concured w/ER diagnosis   6/13/08 Reviewed ER medical records of 5/30/2008. FINAL DX: near syncope Records reveal patient had seen chiropractor 5/30 for neck manipulation then went to gym for work out.  While stretching neck laterally, had lightheadedness & felt weak then gradually lost vision in both eyes & became very light headed & felt like she was going to pass out.  In ER, placed in cervical collar & felt better.  7/11/08 Reviewed opthamologist & neurologist medical records of 6/2-6/19/2008. FINAL DX: transient vision loss Records reveal patient experienced sudden onset dizziness & loss of vision followed by HA, unequal pupils & fatigue.  Exam WNL.  Referred to neurology & seen 6/19/2008 w/HA x 3 wks, blurred vision, dizziness & fatigue.  Neuro exam revealed significant orthostasis.  Suggested referred to cardiologist & additional lab work by PCP.
The next morning following the injection I was starting to feel flu-like symptoms, along with muscle aches that continued throughout the day and became worse/ I also felt very warm as if I had a fever even though my temp. never went above 99.0; the worst symptom was a rash/inflammation on my upper back that extended to my neck and ears, and I even had  swelling in the neck area, this inflammation was so intense throughout the day that it made me feel like I had a much  higher temp., when this finally subsided, I developed chills/shakes that lasted only for a short time
pt recvd pedvaxHIB vax on 8DEC90 & approx 1hr following vax devel mild local rxn @ inject site w/a little swelling; On approx 15DEC90 devel flat papule @ inject site; lesion grew to measure approx 8 cm in diameter; 17JAN92 dx w/granuloma a;
Patient had severe aching after wk of vaccination starting (4/20/21) and currently still has (5/3/21) with difficulty getting out of bed
Immediately I could taste the vaccine and my arm is sore, I couldn't sleep, I woke up at 2am with severe pain and vomiting. I did more dry heaving than throwing up. The next day I had a fever of 99.9, and I couldn't eat then diarrhea started and lasted a couple weeks along with headaches. I just don't feel good and haven't but don't know if it's vaccine related.
her back is still aching; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program.  A 72 year-old female patient received bnt162b2 (BNT162B2), administration date 12Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Back Pain" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: BACK PAIN (non-serious) with onset 2021, outcome "unknown", described as "her back is still aching".  Additional information: Husband called in behalf of his wife who took the 1st dose of the PFIZER-BIONTECH COVID-19 VACCINE today 12Apr21 - She had back pain prior to getting the 1st dose - After getting vaccinated her back was still aching and wanted to know if she could take pain medication.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
same day: arm pain next day: arm pain, total body pain, exhaustion, headache, extreme CHILLS, high resting heart rate (90+ BPM), low O2 (below 90), overall shakiness
administered a dose after temperature excursion; This case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 16-year-old male patient who received Men B NVS (Bexsero) (batch number ABXB59AA, expiry date 30th September 2022) 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.   On 18th July 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 22-Jul-2022 Reporter's comment: Nurse practitioner reported that they administered a dose of Bexsero after a below temperature excursion, the vaccine reached 31.7 Fahrenheit. The reporter consented to follow-up. Additional supportive information: The vaccine was administered after a below temperature excursion, which led to incorrect storage of drug. The case was linked with case US2022110059, reported by same reporter.; Sender's Comments:  US-GSK-US2022110059:Same reporter
administered only the adjuvant; administered only the adjuvant; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number LF799, expiry date 31st January 2023) for prophylaxis.   On 1st November 2021, the patient received the 1st dose of Shingrix. On 1st November 2021, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided are as follows: The reporter was practice manager. The reporter reported that the patient was administered only adjuvant component of the Shingrix vaccine in right deltoid inadvertently, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow-up.
Gave rotavirus vaccine  2-3 days later there was a rash without fever and loose greenish stool. The stool then improved over 3 days but then got slight mucous and some blood. Was referred to ER to see Dr who is Pediatric GI specialist. Abdominal sonogram and X-ray neg. Baby alert and gaining weight. Discharged from ER. Dr. did not think it was intussuception. His opinion is that it could have been unrelated virus, it could be the vaccine, and maybe an outside chance that it is a protein sensit. (I do not think it is protein sens--mom is 95% breast feeding)Baby as of 3 days ago still had tiny amt of blood and mucous--they followed up with GI and he is not worried.
10 days after the vaccine the injection sight and surrounding tissue is hard, red, hot, itchy, and swollen.
10/7/22: HIGH FEVER, FOLLOWED BY LOSS OF MUSCLE CONTROL, FEARFUL OF STROKE, CALLED PARAMEDICS HE RECEIVED AN EKG, AND RULED OUT STROKE.    10/10/22 FELT 100% BACK TO NORMAL
Covid exposure; Runny nose, after booster shot; Caller started sneezing, after booster shot; Felt out of sorts, after booster shot; felt tired; Booster; off label use; This is a spontaneous report from a contactable consumer or other non hcp. A 74-years-old female patient received bnt162b2 (BNT162B2), dose 3 via an unspecified route of administration on 09Sep2021 (Batch/Lot number was not reported) as DOSE 3, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: not reported) via unspecified route of administration unspecified date as DOSE 1, SINGLE for covid-19 immunisation. Patient previously received second dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: not reported) via unspecified route of administration on unspecified date as DOSE 2, SINGLE for covid-19 immunisation. The patient experienced covid exposure on an unspecified date, runny nose, after booster shot on an unspecified date, caller started sneezing, after booster shot on an unspecified date, felt out of sorts, after booster shot on an unspecified date, felt tired on an unspecified date, booster on 09Sep2021, off label use on 09Sep2021. Caller stated that she was exposed from her friend, and she just wanted to relay her experience to support the booster dose. The outcome of the events exposure to sars-cov-2, rhinorrhoea, sneezing, malaise, fatigue was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow-up.
a lot of body Pain Swelling Tiredness dizziness Headache Muscle pain Fever Nausea and vomiting
pt c/o chest pain following vaccination of 2nd dose Pfizer vaccine.  5min following complaints pts symptoms subsided. Vital signs were stable. BB 110/68
Started to feel a little dizzy but ignored it. Got dinner started. Sat down and looked at my phone for a minute, then it came all at once. I had vertigo so bad that I could not walk. I had to keep my eyes closed or room would spin. Mouth dry, nauseous, throat itchy.
Information has been received from an office manager concerning an 8-year-old male student with allergies to ragweed, trees, dust mites, grassweed, cats and allergic rhinitis who on 05-Mar-1998 was vaccinated subcutaneously at another medical facility with a 0.5 ml dose of dose of varicella virus vaccine live.  There was no illness at the time of the vaccination.  On 29-Sep-2005 at 11:00 the patient presented to the physician's office with chickenpox characterized by 30-40 "bumps on chest, face, back"; a low grade fever; and nasal congestion.  The symptoms developed approximately 14 days after exposure to a child with chickenpox.  No treatment was given.  The reporter reported the patient's status as recovered as of 02-Oct-2005.  No product quality complaint was involved.  Additional information has been requested.
Pulsatile tinnitus in right ear. When ear is covered it becomes a simple ringing. Otherwise it is a whooshing noise and always coincides with my pulse.
This case was reported by a consumer via call center representative and described the occurrence of fever in a 53-year-old female patient who received SHINGRIX for prophylaxis. On 17th January 2019 09:00, the patient received the 1st dose of SHINGRIX (intrameningeal) .5 ml. On 17th January 2019, several hours after receiving SHINGRIX, the patient experienced fever, injection site pain, shivering, headache, tiredness, injection site nodule and muscle pain. On 18th January 2019, the patient experienced sleepiness and inability to work. On an unknown date, the outcome of the fever, shivering, headache, tiredness and inability to work were recovered/resolved and the outcome of the injection site pain, sleepiness, injection site nodule and muscle pain were not recovered/not resolved. The reporter considered the fever, injection site pain, shivering, headache, tiredness, sleepiness, injection site nodule, muscle pain and inability to work to be related to SHINGRIX. Additional details were provided as follows: On Thursday at 9:00 am, the patient received vaccine and immediately experienced injected site soreness. The patient was tired that evening and went to bed early, in the night the patient developed shivering, headache, fever and muscle pain. On Friday the patient was unable to work and slept most of the day. The patient reported that shivering was worse and these lasted for about 3 days except for the muscle pain and the nodule that form around the site. The muscle pain didn't resolve until that week but the nodule was smaller but was still there. The patient consented to follow-up.
12 hr after injection: headache myalgia, arthralgia, fever, abdominal pain, severe nausea started and lasted for 12 more hours. Conservative management at home with oral fluid hydration, acetaminophen and ibuprofen helped improved symptoms. Headache is still present on 1/10 at 0200 am, over 24 hr after injection.
Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Additional Details: Patient stated "I think I'm gonna pass out" 1 minute after Janssen COVID19 vaccine injection. Pt sitting down, fainted with head drop x 10 seconds. Raised up head and opened eyes after 10 seconds, was fully responsive. Noticed to be diaphoretic and flushed face that lasted for about 5 minutes. Vital signs remained normal throughout. After 5 minutes, diaphoresis and face flushing resolved completely. After 20 mins of observation, pt was able to drive home safely.
Came in 09/05/2001 spot on leg, cellulitis left leg. Rx Keflex 250 mg BID for 10 days. Vaccines given 08/20/2001, Varivax to left leg. Came in 11/15/2001 left leg with abscess, incision and drainage and culture sent. No growth in culture as of 11/19/2001.
Local reaction at injection site that has spread down to the elbow, very hot, patient is almost 90 and does not have a lot of muscle mass, told patient to put a cold compress on arm and take Zyrtec and if it got worse to go to doctor.
101 fever for 5 days straight. Still get a fever every afternoon/evening but about 99. Extreme fatigue for first 10 days. As soon as eat breakfast have to go back to bed for 1-3 hours. Same with lunch, eat, go back to bed about 3 hours and same with dinner. Then go to bed for evening. Extreme brain fog and forgetfulness. Can't think of words or make sentences. Can't remember anything. Feels like a very heavy feeling in head like head weighs a lot and very cloudy. Pain from shot in arm moved up to neck, ear and jaw the day after shot. Arm quit hurting but couldn't lift it. Pain stayed in neck, ear and jaw for a week and now is a stiff feeling. I think the lymph nodes are swollen. Effects eating, hard to keep food down. Nausea and stomach pain. I have appetite but have to eat while nauseous and pain. Still severely fatigued every day and have to sleep most of each day or at least sit and rest. So exhausted. Also night of shot started getting hot and cold chills. Still have them over 2 weeks after shot. Bad tinnitus started night of shot and still have it over 2 weeks after shot. Very loud and nothing makes it go away. Bad headache started morning after shot. I have had a headache pretty much everyday, all day since the shot over 2 weeks ago. I feel sick like I have flu.
TONGUE TIMGLY, FEELING FLUSHED, SHILLED, TIRED Narrative:  VITAL SIGNS: @1255 BP 127/87 HR 83 O2 98 @1315 141/79 HR 66 PO2 100% @ 1335 BP 145/83 HR 74 O2 100%
My face began to tingle (specifically the left cheek) and my lips began to swell (similar to "liver lip" when I take hydrochlorothiazide).  This began 20 minutes after the injection. I contacted a nurse (?) who was said to wait and she would return to check on me. After 10 minutes no one came back and things did not get worse so I left. The lip swelling remained for a couple of hours. It looked like I had botox (bad botox) on my lips.