chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt devel rash on 4JUN91 started in hairline , neck spread to trunk by 5JUN91; Low grade fever; Mom took to MD who dx viral exanthem on 6JUN91;
patient was administrated with an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 12-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number x2xj7, expiry date 8th August 2021) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 11th August 2021, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On 11th August 2021, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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 details were provided as follows: The nurse reported that the patient received Boostrix which was expired on 8th August 2021, which led to expired vaccine used. No adverse event was reported. The reporter consented to follow up via email.
Patient described a rash beneath the breasts that started the afternoon of receiving the vaccine and excruciating joint pain.  The patient said the pain was so bad that she was bed-ridden the next day.
Pt came to our clinic, has swelling of both eyes and mom states pt has difficulty breathing, brought to treatment room, epinephrine and Benadryl given, monitored and sent home when stable, F/U appt booked for 7/15/15.
I am a very healthy person, 2 months after I got the flu shot I got Herpes Zoster {shingles} on my face involving my eye. I believe that the flu shot was the catalyst that activated the zoster.I noticed that many older persons were being treated at the same time for the same thing while at my eye doctor's office. I don't know if the fact that most had also probably had the flu shot because of there age is coincidental or if the flu shot is involved.There are many people on the web that say that they got zoster after receiving the flu shot. I think that you should check it out.
Patient was admitted because of cough congestion and sore throat for 5 days.  He went to urgent care on November 26.  After discharge he had a COVID-19 test resulted positive.  In emergency department he was having a generalized body ache and very mild symptoms of a cough and shortness of breath.  Emergency room physician expressed that he could of possibly go home but his creatinine is slightly elevated he is dehydrated need some IV hydration so patient is admitted for close monitoring. He required high levels of oxygen but did not require mechanical ventilation and was progressing well on medical floor. 12/28 rapid response called for sudden mental status change. Code stroke activated, CT/CTA head negative for intracranial pathology. Pt was intubated for airway protection and transferred to the ICU.    12/29/2021.  Remains intubated VC/AC 14/450/8/60%. EEG performed, results pending.  SAT performed and patient following commands.  Ammonia check 107.  12/30/2021. EEG yesterday read severe diffuse nonspecific slowing of the background rhythm, indicative generalized subcortical and cortical neuronal dysfunction likely seen in significant encephalopathic state including cerebral hypoxia. Agitation off sedation, Precedex added. Trial lasix. Creat 1.2. Ammonia 82. Trail SAT/SBT today  12/31/2021.  Remains intubated VC/AC 14/450/8/45%, breathing above vent.  Trial on CPAP.  Fluctuating mentation, reported response early this morning but unresponsive even to noxious stimuli during rounds.  Oliguric renal failure. Creat 1.6.  Nephrology consulted.  Ammonia 101, lactulose increased.  1/1/2022. Pt successfully extubated. Requiring HFNC 60L/60%. Ammonia 110. Small bowel movement overnight, rifaximin added. AST/ALT 518/370, total bili 6.0 and Alk Phos 369. U/S Abdomen ordered. Creat 2.0. U/O remains inadequate 1/2/2022. Remains extubated but more encephalopathic. No bowel movements with soap sud enemas. Pt was started on heparin infusion for portal vein thrombosis and GI consulted. This morning INR 5.8 and heparin infusion discontinued. Ammonia 146. Hepatic panel worsening. Creat 2.6. Pt removed NG overnight.     Pt was made a DNR and they would like to proceed with CMO-AND tomorrow when all significant family members can be present.    1/3/2022: Family arrived at bedside and again expressed wishes to transition to comfort care measures in the setting of his critical illness with multi-organ failure. Comfort care measures initiated and he passed @1450.
Immediately (within 10-30 Min) started with puffy eye Lids. Next day with increased puffiness and eyes hurt. Benadryl helped alleviate symptoms Improved 60%. today (2 days post vaccination).
It has been 6 days - I am still nauseus; lite headed; throat feels tight; lack of energy. I'm this way off and on thru out the day.  I have been using Mucinex to relieve the mucus in my throat and Benadrl to relieve other side effects.  I have not been ill nor have I experienced any pain.  I have an allergy to bee stings but have never been on medication for it.
Adacel was given today with an expiration date of 22-Aug-2020/no AE; Initial information regarding this unsolicited valid non-serious case via Medical Information (reference number: 00322479) was received from consumer and transmitted to Sanofi on 19-Oct-2020.  This case involved an unknown age female patient who received a dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot number: U6043BA, expiry date: 22-Aug-2020), via unknown route in unknown administration site for prophylactic vaccination(Expired product administered).  Relevant medical history, past medical treatments, vaccinations details, Concomitant medication and family history were not provided.  No adverse event was reported at the time of reporting.  It was a case of actual medical error as expired product administered.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in 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.
Broke out in a rash over my entire upper body Friday night. By Sunday, the rash had spread to the rest of my body and remained there (small red spots) for 3-4 days.
Fever for 5 days, coughing and wheezing. Mom alternated TYLENOL and MOTRIN for 5 days. Labs drawn CRP, CBC, sedimentation rate and mono.
A couple of hours after the vaccination my left arm, the site of the vaccination, became very painful and had limited range of motion.  For two days I could not lift my arm above my waist.  Finally on Monday 7/29 my arm returned to normal.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding medical history, concurrent conditions, and concomitant medications. On or about 27-JUL-2012, the patient received ZOSTAVAX for its intended purpose: the prevention of shingles.  As a direct result of the vaccine, the patient suffered from a shingles outbreak, in addition to chronic pain, rash, and lesions to various parts of his body.  The patient did not have a shingles outbreak until 08-JUN-2017. As a direct result of ZOSTAVAX, the patient suffered mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries.  Further, he suffered serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The outcome of the event was unknown at the time of reporting. Causality assessment was related. The lawyer considered shingles outbreak/chronic pain, rash and lesions to various parts of his body to be disabling. Additional information has been requested.
pt recvd vax 25MAY93 @ 4PM woke mom up 5AM 26MAY94 w/redness @ inject site & whelps; mom took to ER; Md there notes vax react; fever about 100-101;
Woke up the day after injection with fatigue, headache, dizziness, armpit pain, tenderness at injection site.  At 2pm, aches and chills began.  By 1700, temp was 103.  Continued to have fever, body aches, chills for 48 hours with highest temp being 104.  3 days after injection a knot and redness developed at the injection site.
The patient reported no problems immediately following her H1N1 spray. On 12/27/09, she reported an onset fever, sore throat, malaise, cough, palpitation all at once. She also suffered from increased frequency of micturition, difficulty in walking as well as talking. She also complained of itchy skin, generalized muscle pain, and atrophy. On 1/14/10, she was diagnosed with Graves disease. She has been put on medication. On 1/19/10 the patient reported that her symptoms are improving but the skin itching worsened. She has no history of chronic medical conditions or vaccine-related adverse events.  follow-up infrmation received - RE: Missing information letter dated 1/28/2010.  Unfortunately, this information is not available to us. When a report of symptoms suggesting a possible adverse event of interest is received, our team attempts to contact the reporting individual - provided that permission to contact has been granted. We have contacted this patient and he or she has agreed to share his or her contact information with VAERS. E-mail address and phone number provided.
pt recv vax 20NOV96 & pt learned was pregnant;A pregnancy test was positive on 19DEC96 (LMP 15NOV96);in DEC96 the pregnancy was terminated;
Fast heartbeat at rest (over 115/min), neck tightness,  lightheaded, dizzy, nauseous, sweating  Lasted around 20 minutes
I am post menopausal and approximately 5 weeks after having my second covid vaccination, I had vaginal bleeding that lasted about a week.  I had had no spotting or breakthrough bleeding since my last peroid in September 2019.  I had no other unusal side effects.   I experienced the expected fatigue, sore arm and axillary lymph node swelling (12 days post vaccination).
Immedietly after receiving the vaccine, I had a fever, fainted , and then vomited in the pharamcy. I was unconcious and unable to drive myself home from the appointment. The days following, I was unable to eat, and had flu like symtpoms.
Patient complains of arm swelling that begin when she got home from the pharmacy to the point she wasn't able to use her arm, flushing, tremors and malaise/lethargy (malaise lasted 2 days). She also complains of nocturnal diuresis - specifically, the night after she got this vaccine, she had to get up in the night to urinate every hour.
A vial of a previously diluted and mostly empty vaccine was diluted with saline instead of a new vial and accidentally assumed to be the correctly concentrated vaccine.  Thus, the patient was given an extremely diluted vaccine that was mostly saline instead of the correct concentration of the vaccine.  The error was discovered approximately one hour after vaccination and an offer to revaccinate with the booster dose 3 will be given.
On 12-16-08 patient woke up with a 103.5 degree fever (a couple of times the fever ranged from 103.7-104.4 on the high end) that lasted for three days.  I gave her Motrin every 6 hours during those three days.  She did not want to eat much, but she did drink a lot of fluids.  On the fourth day the fever was completely gone.
Joint aches and neuralgia. Took Ibuprofen every 6hpurs for 24 hours, starting at 9am the morning after vaccination. Symptoms vanished 36 hours after on set.
I had a blood vessel in my right eye rupture. The white of my eye is blood red. I did not have any event which would have potentially caused this. I do not know if it is related, however I thought it was worth mentioning.
This case was reported by a healthcare professional and described the occurrence of arm pain in an adult female subject who was vaccinated with FLULAVAL (GlaxoSmithKline). In 2008, approximately one week prior to reporting, the subject received unspecified dose of FLULAVAL (unknown). At an unspecified time after vaccination with FLULAVAL, the subject experienced arm pain, arm redness and arm swelling. This was also considered to be a product complaint as the reporter stated that 5 additional subjects reported similar events following administration of the same lot of FLULAVAL. At the time of reporting the outcome of the events was unspecified. Linked cases include: A0752107A, A0752229A, A0752230A, A0752232A, A0752233A and A0754297A. A quality statement received on 24 October 2008 indicated that no deviation that could be linked to the complaint had been highlighted. GlaxoSmithKline Biologicals therefore confirmed that this batch is suitable for vaccination purposes.
Approximately 12h after injection developed fever/chills/rigors/nausea that lasted for about 1 hour
IM influenza, vaccine was mistaken for "Flu Mist" and administered to the nasal passage as a liquid.  Once mistake was determined it was given IM.
diarrhea which persisted for more than four days with liquid or very loose stools; Five or more bowel movements/day with considerable gas; This is a spontaneous report from a contactable consumer reported that a 78-year-old female patient (consumer) received first dose BNT162B2 (COVID 19, brand: Pfizer, Solution for injection, lot number: EN5318) via an unspecified route of administration on 28Jan2021 at 15:30 on Left arm for covid-19 immunization. Patient medical history included Type II diabetes, heart problems, bypass surgery in Sep2019. Concomitant medications were not reported. It was reported that, three days after receiving the injection, on 31Jan2021 she developed diarrhea which persisted for more than four days with liquid or very loose stools. Five or more bowel movements/day with considerable gas. No fever, aches. No urge for bowel movement when there was nothing to evacuate. Age at vaccination was 78 Years. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No treatment was received for the adverse event. No seriousness criteria was reported. Outcome of events was recovering.
Pfizer on 2/1/21 and 2/22. Positive on 11/16
On 10/27/00, began crying and screaming Friday through Sunday. Began vomiting on Sunday. Temperature was 101F (R) through Sunday. Called MD on 10/28/00 and he recommended lemon and honey. Give Tylenol every 4 hours. Both arms are red still; little swelling. No redness or swelling of legs. She is calm and feeling better today.
Normal sore arms; Might have had a funny feeling; This spontaneous case was received on 04-Nov-2022 from a consumer via Communications (reference number: SEQW22-05431) and concerned a female patient of an unreported age.   The patient's medical history and concomitant medications were not reported. The patient's historical vaccines included unspecified flu vaccines received in the last 40 years, after which the patient experienced sore arm, reported as 'normal sore arms'.  On an unspecified date, the patient was vaccinated with the Fluad Quadrivalent (influenza vaccine inact sag 4v; dose reported as 0.5, route of administration and anatomical location: not reported), against influenza caused by influenza virus subtypes A and B contained in the vaccine.  On an unspecified date, an unknown amount of time after receiving the Fluad Quadrivalent vaccine, the patient experienced sore arms and said she 'might have had funny feeling'.  The outcome of the event was not reported.  The reporter did not provide a causality assessment. The patient described her experience with the vaccine- and with flu vaccines in general for the last 40 years- as positive apart from the 'normal sore arms'.  This case was assessed as non-serious.  Company comment: The events of pain in arm and feeling strange are considered as possible related to Fluad Quadrivalent due to temporal relationship.; Reporter's Comments: The patient described her experience with the vaccine- and with flu vaccines in general for the last 40 years- as positive apart from the 'normal sore arms'.; Sender's Comments: The events of pain in arm and feeling strange are considered as possible related to Fluad Quadrivalent due to temporal relationship.
Information has been received from a health professional concerning a female with no known medical history or allergies who in approx June 2004 was vaccinated with two doses of varicella virus vaccine live. Six months post vaccination, in approx Dec 2004, three titers were drawn, and all three titers were negative for seroconversion. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Urticarial rash-itchy blotchy raised lesions noted same night as he received Dtap #3 and Hep A#1 (within several hours of immunization, (12 hrs); stated by parent report on left thigh where received Dtap, spread to trunk and buttocks. Started 11/10/15l seen office on 11/19, diagnosed with hives; no anaphylaxis. Treated with BENADRYL, low grade fever day 1 and 2 only.
On the day after receiving vaccine, patient developed symptoms similar to those she had years ago when she had an allergic reaction to PNC. Her symptoms included bilateral lower leg pain and weakness. By the time she visited her doctor two days later, she was wheelchair bound and remained in this weakened state for about 1 week. Her legs are still a bit weak, but she exercises them daily and has no permanent problems.
Dizzy, nausea, vomiting, fever, sweats, diarrhea, body aches, severe headache, loss of appetite, weakness. Began 16 hrs after injection. Nausea, vomiting, diarrhea lasted 2 hrs. Weakness lasted 3 days. Weakness, headache, night sweats still occurring.
Headache, flu-like symptoms.  ONGOING TO PRESENT INCLUDES EXTREME FATIGUE, MALAISE, FREQUENT DAYTIME EXHAUSTION AND PERIODS OF SLEEP.-
When patient and mother consented to vaccine instead of putting her correct DOB they put  08/21/04 and also put age 16 and it was discovered when this RN went to administer vaccine in the web immunization that patient was really only 15.
Swollen of breast, redness around areolas and pain on both breasts. Also nipples were very sensitive. I starting having vaginal bleeding. I am on menopause (without my period for the last 4 years). Feeling very tired in the middle of the day and I have no strength to do anything.
swollen painful  glands under arm at vaccination site, painful groin gland, runny nose, cough mucous, headache, light headed , weakness, abdominal pain chest pain , rt arm pain.
Around 2:30-3pm I began feeling tired. I went to lay down and rest and started to get chills and a bad headache along with hot and cold episodes.   I started to sweat but had no fever at the time. This continued all night. I had no appetite after receiving my vaccine. Around 6:30 I started to get a fever of 100.3 and continued chills with headaches. I took Tylenol when needed. My whole body was sore throughout the day and got worse are the night progressed. My fever was in and out but around 9pm I had the highest temp of 101.4. I didn't get good sleep due to feeling unwell all night. I belive I stared feeling more myself sometime around 9:34am. But was still feeling a bit warm. But felt way better as the day progressed. My left arm where I received my shot is still very sore. And I still don't have an appetite.
Nerve damage in right  hand and foot, muscle weakness, vasculitis, drop foot, double vision, weight loss, high blood pressure, loss of feeling in right pinky
This spontaneous report was received from a Pharmacist concerning a patient of unknown age and gender. No pertinent medical history, drug reactions/ allergies or concurrent conditions were reported. On 15-AUG-2018, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 lot # R002084; expiration date: 02-OCT-2019 or lot # N024717; expiration date: 06-APR-2019 (dose and route of administration were not reported) for prophylaxis, which had a temperature excursion of 47°F to 77°F (56F) for 15 days on unspecified dates. There were no previous temperature excursions and no digital data logger involved in recording the temperature excursion. No adverse effects were reported. This is one of several reports from the same source. Sender's Comments: US-009507513-1808USA012996: US-009507513-1809USA006251: US-009507513-1809USA006252: US-009507513-1809USA006253: US-009507513-1809USA006254: US-009507513-1809USA006255: US-009507513-1809USA006256: US-009507513-1809USA006257: US-009507513-1809USA006258: US-009507513-1809USA006259: US-009507513-1809USA006260: US-009507513-1809USA006262: US-009507513-1809USA006263.
Case previously recorded as MA2009-4409. Initial case report received from a consumer on 07 NOV 2009. A 12-year-old female patient was vaccinated with seasonal influenza on 12 OCT 09 and experienced local aching near the point of administration for a week. On 07 NOV 2009, the patient received S-OIV FLUVIRIN (batch no. unknown) and experienced local aching in the muscle tissue near the point of administration for about a week.
it was rpt fr person concerning a pt who in apr98 was vax & subsequently broke out in a rash w/about 30 lesions all over arms & legs.
Pt. given the wrong booster dose of Pfizer vaccine.  Should have gotten 0.3ml, received 0.25ml instead.  Pt. already informed by me and will be offered a re-booster Pfizer vaccine as soon as possible.
no adverse event to report---administration error only. Patient needed to be 18 yrs old to receive vaccine.
Full body itch began about forty minutes after vaccination, spread from head to toe (including eyeballs, lips, and tongue), subsided two later after anti-histamines
Swelling below injection site, received Rx for hydroxyzine HCL 10mg/ml dose 25mg TID. Patient reacts to lots of meds due to pancreatitis.
itching over her chest, both upper arms, stomach, and back; a slight rash on both upper arms , chest, back, and stomach; This spontaneous report was received from a female patient of unknown age, referring to herself. The patient's concurrent conditions included asthma, seasonal allergies and allergy to cats. Her concomitant therapies included unknown medication for high blood pressure and unknown medication for acid reflux. On an unknown date in September 2019 (reported as: at the end of September 2019 or in the beginning of October 2019), the patient was vaccinated with zoster vaccine live (ZOSTAVAX) subcutaneously (exact dose, lot # and expiry date were not reported) for prophylaxis (reported as: prevention of shingles). Other suspect therapies included sterile diluent (STERILE DILUENT) (exact dose, lot # and expiry date were not reported). On an unspecified date in October 2019 (also reported as: around 2 or 3 weeks later), the patient experienced itching over her chest, both upper arms, stomach, and back. She was also experiencing a slight rash on both upper arms, chest, back, and stomach. She stated that she took fexofenadine hydrochloride (ALLEGRA) for these symptoms and the rash and the itching came and went. The patient did not seek medical attention. The outcome of itching and rash was reported as not recovered/not resolved. The causality assessment was not provided by the reporter.