chrisvoncsefalvay/vaers-outcomes huggingface dataset:
she has developed hives all over her body. Her legs and hands are swallon. The hives are slowly spreading to her face. Temperature since 08/08/08 has been between 103.2`F and 102.2`F from 7:30 pm to now 08/10/09 12AM. She has been given cold showers to bring fever down and given 1.875 ml Motrin alternated every 6 hrs to Tylonol infant drop of 1.6 ml. Fever and mild seizure still available. Very shallow breathing. Child is excessively fearful and jumpy to any movements or sounds.  8/11/09 Medical records received DOS 8/5/09 to 8/10/09. Assessment: Viral exanthem unspecified, gingivostomatitis.  Fever for 3 days, not eating well, fussy, taking fluids in small amounts. Blisters in mouth, erythematous maculopapular rash on forearms/feet and abdomen, clear nasal discharge, no wet diaper. Mucous membranes dry. Referred to ER for possible IV fluids. Pt did not go to ER.
About 3 inches below the injections site, pt presented with redness and slight swelling of the skin on his arm. It started the day after he received the vaccine. He didn't experience any pain, fever, or body aches. He was told if it gets any worse or doesn't improve to contact his dr. He was also told to place ice on the site.
Patient and Parent presented to Immunization clinic with order from provider for vaccines. Vaccines were administered and patient and parent were given VIS form. Patient was directed to wait in the lobby for atleast 15 minutes. About 5 minutes after patient entered lobby, he had a vasovagal reaction. Patient was caught by bystander. EMS was called and the closest provider and nurse team was brought to the scene. Vitals were performed and oxygen was given until EMS arrived and took patient to ER.
Strong episodes of brain fog resembling a marijuana high a couple of days apart; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 15Apr2021 at 16:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history of the patient was reported as none. Concomitant medications included PROPECIA from an unknown date for unknown indication and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03May2021 at 04:00, the patient experienced strong episodes of brain fog resembling a marijuana high a couple of days apart. No therapeutic measures were taken as a result of the event. The clinical outcome of the event strong episodes of brain fog resembling a marijuana was recovering at the time of this report.    No follow-up attempts are needed. No further information is expected.
vaccine was administered before the recommended booster schedule; Initial information received on 10-Apr-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves unknown age and gender of patient who received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [Pentacel].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE lot number not reported via unknown route in unknown administration site.  It was actual medication error due to inappropriate schedule of product administration. On an unknown date, the consumer began experiencing vaccine was administered before the recommended booster schedule.  Final diagnosis was vaccine was administered before the recommended booster schedule.  It was not reported whether the patient experienced any adverse event or not.  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 and Module VI of the 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.  List of documents held by sender: none.
This spontaneous report was received from a registered nurse referring to unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical histories and concomitant therapies were not provided. On unknown dates since October 2016, the patients were vaccinated with a dose of PNEUMOVAX 23 (dosage, route of administration, lot # and expiry date were not provided) which were improperly-monitored. No adverse experience was reported. The temperatures, when recorded, were always within the recommended storage range. There was a period, when the temperature would not be recorded for 3 or 4 days and there were occasions when the temperature would be recorded only once a day. There was no previous temperature excursion reported. Digital data logger was not involved. No product quality complaint was involved. Follow up information has been received from an unspecified reporter referring to a 63 year old female patient on 11-APR-2017. The first dose of PNEUMOVAX 23 was vaccinated in October 2016. On 06-FEB-2017, the patient was vaccinated with the second dose of PNEUMOVAX 23 (Inappropriate schedule of vaccine administered) (dose and expiration date unknown, lot# M036678, left deltoid) intramuscularly for prophylaxis. There was potential compromise of PNEUMOVAX 23 due to multiple in monitoring refrigerator temperature. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA012462: US-009507513-1704USA012461: US-009507513-1704USA012459: US-009507513-1704USA012460.
Sensation of cold feet / cold feet; This case was reported by a physician via call center representative and described the occurrence of cold feet in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 4th March 2020, the patient received the 1st dose of Shingrix. On 4th March 2020, less than a day after receiving Shingrix, the patient experienced cold feet. On an unknown date, the outcome of the cold feet was recovered/resolved.   It was unknown if the reporter considered the cold feet to be related to Shingrix.  Additional case details were reported as follows: The patient reported case for himself, who was dentist. The age at vaccination was not reported. The patient did not have prior health conditions. He stated that after he received 1st dose, he had the sensation of cold feet for one month. The cold feet was resolved in warmer weather. The reporter did not consent to follow up. For tolerance of 2nd dose refer case US2020211125.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020211125:same patient, same reporter, 2nd dose
Client called 3/25/21 and reports experiencing swelling to her left arm and face starting approximately an hour after receiving the vaccine. She states she also felt difficulty with breathing as if she could not take a full breath. Client states that this lasted through the night, but is moderately improved today 3/25/212 at 1145. Client states that she felt improvement in airway with a hot steam shower. Client states she is now feeling headache and body aches.  Client was instructed to immediately seek medical attention via physicians office or emergency room if she is having difficulty breathing. Client stated it is okay to follow up with her.
Though on 4/7/2022 I received my 4th dose of Pfizer, I tested positive for COVID on 5/14/2022.
Numb on whole left side for 6 months so far, very numb on small finger and small toe,  numbness goes up my are and leg and very numb on side of face. Sharp pains on left side of head.
body hurts; dizzy; stomach ache; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 20 year-old female patient received bnt162b2 (COMIRNATY), administration date 25Jan2022 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete, MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: PAIN (non-serious), outcome "unknown", described as "body hurts"; DIZZINESS (non-serious), outcome "unknown", described as "dizzy"; ABDOMINAL PAIN UPPER (non-serious), outcome "unknown", described as "stomach ache".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
AT APPROXIMATELY 5:10 PM PATIENT FELT DIZZINESS AND LIGHT HEADED.  WE HAD THE PATIENT LAY DOWN AND BLOOD PRESSURE WAS TAKEN.  AT 5:29 PM THE PATIENT'S DIZZINESS HAD RESOLVED AND ANOTHER BLOOD PRESSURE WAS TAKEN
Hugh erythema, swelling 13 x 17cm  on left mid-proximal thigh. Child can walk.
Found unresponsive 5/4/13 - EMS witnessed generalized tonic-clonic seizure x1 minute. ECG showed Afib in field, intubated brought to (7AM) medical center where she was r/o for stroke. S/P imaging, thought to have seizure in setting of possible TIA in setting of Afib. Day 3 she became extremely encephalitic (non verbal, not following commands). Coma continued in ICU until 5/8/13 where she improved then developed bilateral pulmonary embolism (PE) and LE DVT calf. D/C home 5/15/13.
IT IS NOT AN ADVERSE EFFECT, THE PATIENT WAS ADMINISTERED A THIRD DOSE AND IS ONLY 12 YEARS OLD. THE PATIENT IS IN WELL HEALTH AND I DID NOT PRESENT ANY EFFECT. I AM REPORTING AN ERROR MADE BY THE PERSONNEL THAT MANAGED IT.
Pt. states that after receiving the Booster dose of Janssen 12/12/2021 ( Previous Moderna 1st and 2nd) , started experiencing symptoms of fatigue, numbness in the Left arm, vision blurred, chills, body aches, fever, sweating, headache, loss of appetite, nausea, high blood pressure, light headedness, heart rate low, and lump developed under the arm (Left) with swelling. Urgent Care visit 12/15/2021, Covid Test = (Waiting for Results), Flu Test = Negative. Confirmed Lymphnoid swelling under Left arm.
Patient reported that upon receiving the vaccine he went home and experienced flu-like symptoms for the next 4 days.
I had my vaccination around 2PM. Around 2AM, I woke up with chills, severe body ache and my temperature went up to 105.
Headache (2 days) Feeling cold (2 days), chills/shakes (1 - 1-1/2 days), tiredness (3 days), torso rash (3 days), covid arm (4 days)
This non-serious initial spontaneous case, was received from a pharmacist on 25-Oct-2017, concerning a 25-year-old adult female patient. On 02-Oct-2017, the patient administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch number: XF30607, expiry date: 30-Jun-2018). Around 04-Oct-2017, 2 days after receiving the shot, the patient complained of sore arm. On an unspecified date, the patient also developed bursitis. It was reported that the arm in which she took the shot get better but it went to the other arm. At the time of this report, the patient had not yet recovered from the event bursitis and outcome of the event pain in arm was not reported. The reporter assessed the events as non-serious.
fever of 100.3, chills, nausea, heart rate of 110 while sleeping/lying in bed, lightheadedness, body aches
This spontaneous report as received from a pharmacist refers to a 60 year old female patient. On an unknown date the patient was vaccinated with ZOSTAVAX (0.65 ml/one, subcutaneous). The pharmacist reported that, following administration with ZOSTAVAX, the patient developed "a mark on her arm that had not gone away with time". This mark on the patient's arm had now been present for over one month. The patient visited the pharmacy on an unspecified date, and spoke to the pharmacist, but the patient did not seek additional medical attention. No treatment and lab diagnostics studies performed. Additional information has been requested.
Redness, swelling within 24 hours. Single blister formation at injection site. As of 10/14/13 25 x 24 cm area of redness/warmth/induration lt arm 2 cm blister.
First dose: swelling of glands under armpits (past after a week) Second dose: swelling and redness of my right eye
Date the vial was initially stored in the refrigerator was 31Jan2022 and Administered on 09Mar2022; Moderna Covid-19 vaccine that was beyond 30 day use by date was given to patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine that was beyond 30 day use by date was given to patient) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator was 31Jan2022 and Administered on 09Mar2022) in a 62-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 042J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 09-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine that was beyond 30 day use by date was given to patient). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator was 31Jan2022 and Administered on 09Mar2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine that was beyond 30 day use by date was given to patient) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator was 31Jan2022 and Administered on 09Mar2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Reporter stated that the vial was initially stored in the refrigerator on 31-Jan-2022 and the vial did not undergo any temperature excursions.  No treatment medications were reported.
Received dose at approx. 9:45 am , returned to work and end her shift 3:30 pm went home tired, went to bed until 6pm woke up and had a tem of 101 F temporal , took Aleve went back to sleep and woke up around 12 am feeling fatigue and dizzy took water and went back to sleep, woke up at 5am the following day and notice rashes on trunk area, looking red and burning , also felt swelling and sore on injected site area feels warm and applied cold compress no relief. Took Aleve  and Benadryl itching was relieved and burnins sensation minimize but painful to touch. The next few was very uncomfortable with pain on injected site with no temporary relief on OTC meds. She then seek help from Covid clinic nurse for further evaluation. Upon assessment, L deltoid area appears reddened with swelling and warm to touch  with moderate pain
Received call from wife. Approx. 3AM pt. aspirated and 911 was called. Pt. expired in transport. Due to close proximity of vaccine administration we are reporting the event.
Patient in for travel appointment, given appropriate immunization for area traveling into. Tdap given after 15 minutes. Patient noted "itchy" around injection site, progressed with swelling to area and redness from 25 cent size to covering all of deltoid area. Benadryl 50 mg IM given and ice pack to area.
9/28/2006-client called Health Department to report Right arm pain and inability to use arm for approximately 8 hours. Pain on scale of 8-9. Arm between shoulder and elbow feels bruised but no visable swelling or bruising noted. Advised calling medical doctor. 10/3/06 states better. Pain 1-2 of 10. On 10/1/06 with Naprosyn but 10/2/06 pain again 3-4. Advised calling medical doctor for anti-inflammatory and evaluation.
About 7-8 days days after 1st dose, noticed a large area near injection site that looked like a bruise, the next day the area had expanded and turned red (the bruise & discomfort from the initial injection had resolved several days prior to this appearing). It was firm/mildly swollen and warm to the touch, and appeared to expand further throughout the day. When first measured it was approximately 2.75 inches across at it's widest point and a border was drawn to track changes. Two days later it was ~3.75 inches across at its widest part and we drew another border to track. It has continued to expand past the borders. Swelling also noticeably increased in my upper arm and axilla (also has intermittent itching). Treatment has consisted of benedryl at night and occasional ice packs. Ice decreases redness temporarily, but then returns and the area has continued to expand.
Case number PHEH2016US026263, is an initial spontaneous report received from a pharmacist on 10 Oct 2016. This report refers to a 52 years old male patient. Medical history and concomitant medications were not reported. The patient was vaccinated with a single dose of FLUVIRIN (batch number: 162301) at a dose of 0.5 ml intramuscularly on 09 Oct 2016. The pharmacist stated that, 2 patients received FLUVIRIN multi dose vial (MDP) that had experienced a temperature excursion up to 16 C for up to 12 to 20 hours, on 09 Oct 2016. No adverse event was reported following this administration error. The pharmacist assessed the case as non serious.
"Covid Arm" symptoms began developing approximately 42 hours after injection.   Redness area is growing (approximately 2") and arm is getting sore.  No itchiness.
C strain infection; sore throat, lethargy & fever; 11th case in county; 45,000-48,000 does administered;
Flu-like symptoms for one week, followed by persistent muscle and joint pain in right arm, spreading to left arm days later.  In the past two months, the pain has increased in the right arm, spreading down to the elbow, then to the hand.  Painkillers help some, but pain is so bad that it wakes me up at night (if I can sleep at all).
Rash on neck and shoulders. Rash spread over entire body in 24 hrs, turned to raised red bumps, coughing, runny nose, restless.
Pfizer-BioNTECH COVID-19 Vaccine EUA   I had a mild headache 20-30 minutes after vaccine was administered on 12/18/20 that went away 4-5 hours later. I did not take any medication to help with headache.  I woke up the next day with extreme fatigue, muscle aches and hot flashes/chills from Saturday-Tuesday morning. I had radiating pain down my arm to my fingers that lasted about a day on 12/19/20.
Pt recvd vax & devel 2" x 1" area of redness & induration, swelling & pain;
6/2 scratchy throat, congestion. 6/3 same symptoms, but added nausea, fatigue, chills, and fever 103. 6/4 tested at the urgent care, positive test. Prescribed PAXLOVID, FLONASE, and ZYRTEC, symptoms continued. 6/5 strong taste in mouth after taking PAXLOVID and pain in left side with strong nausea, but otherwise same symptoms. Same through 6/8.
GOT COVID; This spontaneous report received from a consumer via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: gall bladder issue. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, dose number in series 1, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient got covid while in the hospital for a gall bladder issue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of got covid was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000209597.; Sender's Comments: V0: 20211265966-COVID-19 VACCINE AD26.COV2.S- Got COVID. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
sore, red knot that is tender touch at the site of injection; sore, red knot that is tender touch at the site of injection; Rash along arm; sore, red knot that is tender touch at the site of injection; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PAIN (sore, red knot that is tender touch at the site of injection), VACCINATION SITE SWELLING (sore, red knot that is tender touch at the site of injection), VACCINATION SITE RASH (Rash along arm) and VACCINATION SITE ERYTHEMA (sore, red knot that is tender touch at the site of injection) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On 12-Jan-2021, the patient experienced VACCINATION SITE PAIN (sore, red knot that is tender touch at the site of injection), VACCINATION SITE SWELLING (sore, red knot that is tender touch at the site of injection), VACCINATION SITE RASH (Rash along arm) and VACCINATION SITE ERYTHEMA (sore, red knot that is tender touch at the site of injection). At the time of the report, VACCINATION SITE PAIN (sore, red knot that is tender touch at the site of injection), VACCINATION SITE SWELLING (sore, red knot that is tender touch at the site of injection), VACCINATION SITE RASH (Rash along arm) and VACCINATION SITE ERYTHEMA (sore, red knot that is tender touch at the site of injection) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Te concomitant medications were not provided. The treatment information was not reported.  Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jan-2021: No specific follow-up information recorded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.
Redness, swelling, and pain at injection site beginning 10/24/2015 AM, and completely resolved by 10/28/2015 PM. Headache, aching joints, and fatigue began 10/24/2015 PM, also completely resolved by 10/28/2015 PM.
Swelling redness and itching below injection and skin  hot to touch. Headache and body aches
Information has been received from a pharmacist, via a company representative, concerning an unspecified number of patients (unknown ages and genders). Pertinent medical history of patients and their respective concurrent conditions were not provided. On an unknown date the patients were vaccinated with ZOSTAVAX lots # M013377 and L044529, with expiry dates 25-MAY-2016 and 09-FEB-2016 respectively (concentrations, dosages and therapy routes were not reported). Concomitant therapies were not provided. The pharmacist stated that on an unspecified date in 2016, reported as "over the last month", administering several doses of ZOSTAVAX, the patients had experienced unusually large injection site reaction. The outcomes of injection site reaction were unknown. No product quality complaint (PQC) was involved. Additional information has been requested.