chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Booster; significantly swollen lymph nodes and pain; significantly swollen lymph nodes and pain; chest pain; swelling in neck/face/chest on side of injection; swelling in neck/face/chest on side of injection; swelling in neck/face/chest on side of injection; fever (at least 4 days); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Comirnaty (DOSE: 1), for COVID-19 immunization; Comirnaty (DOSE: 2), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Booster"; LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious), outcome "unknown" and all described as "significantly swollen lymph nodes and pain"; CHEST PAIN (non-serious), outcome "unknown", described as "chest pain"; PYREXIA (non-serious), outcome "recovered", described as "fever (at least 4 days)"; SWELLING (non-serious), SWELLING FACE (non-serious), VACCINATION SITE SWELLING (non-serious), outcome "unknown" and all described as "swelling in neck/face/chest on side of injection".  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Fatigue, eczema like skin rash on upper chest and neck, mouth sores, swollen finger joints.  Onset began in May and is ongoing, intermittent facial rash at cheeks.
pt brought to hospital via EMS with fever and increasing weakness over last week; fell last week in facility; COVID test was positive; COVID Pneumonia; treated with decadron and remdesivir; DNR; comfort measures; pt died in the hospital
Mom reports she first noticed left leg and thigh area redness and swelling the size of a quarter on 4/25/2000, for 3 days, then this redness resolved. On 5/1/00, she noticed raised red rash measuring 5cm X 3cm on 5/2/00.
hyporesponsive episode-went limp p/shot;seen in clinic stable p/event but drowsy x 5hr;
I had the shot on weds afternoon. On Thursday I felt ill with flu-like symptoms, mainly body aches and headache. These symptoms were gone by Friday and I felt great. I woke up Saturday morning at 4:30am and needed to use the bathroom/, which is about 10 steps from my bed. As I entered the bathroom I completely blacked out, causing me to fall and break my ribs. This has never happened to me, and there was nothing else wrong with me (I spent 2 days in the hospital checking heart, brain, inner ear, etc). In addition to the 4:30am blackout, it also happened again several hours later at 11am, saturday morning. This time I again got so dizzy I couldn't stay on my feet, and while my husband was right there lowering me to the floor I was in a daze, a cold sweat, and absolutely no control over it.
Have hives that last about 30 min in area and then go away and appear on other areas of body. Hives itch and burn
Lt arm swollen & red from slightly above elbow to shoulder onset 23OCT91; temp 104 evening following immun; unable to reduce fever w/APAP or sponge baths; 25OCT91 spoke w/mom p/MD visit; MD states local rxn & remove Pertussis from immun;
thrombocytopenia; Heavy blood in the stool; This is a spontaneous report from a contactable consumer (patient). A 61-year-old female patient received second dose of BNT162B2 (Lot Number: EN6148), via an unspecified route of administration in arm left on 21Mar2021 as single dose for COVID-19 immunisation. Medical history was none. No known allergies. The pateint was not pregnant. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 on 28Feb2021 for COVID-19 immunisation. No other vaccine in four weeks. No ther medications in two weeks. The patient experienced Heavy blood in the stool, thrombocytopenia on 07Apr2021. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, disability or permanent damage. No treatment received. No covid prior vaccination. No covid tested post vaccination. No covid tested post vaccination. The outcome of events was not recovered.
Approximately 25 minutes after the vaccine, I start to experience intense diaphoresis and nausea that lead to several bouts of vomiting. I then vasovagaled and had 1 bout of non-bloody diarrhea. The symptoms self resolved in about 20 minutes following vomiting, having diarrhea, and lying on the floor. I?m a primary care physician, and this happened while I was at work, so I knew what was occurring and did not seek a higher level of care. I also have never vasovagaled following vaccines previously, although I used to with venipunctures as a child.
Approximately 10 days after shot, I experienced an intense itch on my scalp and the palm of my hands. Scratching resulted in new, raised hives with red, inflamed lines where I scratched. Made appointment with dermatologist after a week of increased hive symptoms with no improvement using over-the-counter antihistamines.
Exhaustion, thirst, joint pain, vertigo, headache, chills, Everything was severe.
three days after vax tiny white crust appeared around right eye...inside corner of right eye then cracked open and bled...three days after that, left eyelid cracked open and bled...skin around both eyes is totally dried out and flaky, some vision problems (increased spotting and floaters)  existing  tinnitus made much worse  no let-up from these problems in the months since vax
Before administering vaccine, pt was nervous and taking deep breaths prior to administration. After administering vaccine, patient was experiencing chills. Pt remained seated for about 4 minutes after administering vaccine. Pt then stood and walked over to the waiting area after vaccine. As soon as pt sat down, pt began to seize. Lasting about 35-45 seconds, pt has no recollection of what happened. Eyes rolled back, no conciousness. Immediately called emergency number and EMS arrived shortly. Pt vitals were checked by EMS and highly advised to check into hopsital as it is pts first seiuzure.
Patient received booster of Moderna (025ml) on 10/25/21. According to the website specific lot number has an exp of of 10/24/21. LOT 026C21A. I reached out to manufacturer for guidance if patient should receive an additional booster dose -still waiting on contact from manufacturer.
No adverse event; Vaccine coordinator is reporting the administration of improperly stored vaccines to unknown patients after the temperature excursion on 20JAN2022.; This spontaneous report was received from a vaccine coordinator and refers to a patient of unknown age and gender.  The patient's pertinent medical history, drug reactions or allergies, and concomitant therapies were not reported.  On 20-JAN-2022, the patient was vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) dose 1, lot #U020244, expiration date: 28-JUN-2023, (strength, route of administration and anatomical location were not provided) that underwent a temperature excursion in -14 degree Celsius (C)  for 7 hours (Product storage error). No additional adverse event (AE) was reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2205USA004997:02167739 US-009507513-2205USA005084:02167789 US-009507513-2205USA005067:02167643 US-009507513-2205USA005130:02167643 US-009507513-2205USA004990:02167746 US-009507513-2205USA005126:02167756 US-009507513-2205USA005023:02167763 US-009507513-2205USA005071:02167774 US-009507513-2205USA005229:02167797
(L)-arm, first 2 month, very sore. As of 8/5/2011, soreness is less, but still exists. Pt feels he cannot lift his arm at shoulder all the way up to ear. Pain & reaction staying local to the pectoral muscle only.
Symptoms similar to meningitis; severe headache, stiff neck, aching. No evidence.
This is a spontaneous report from a contactable physician communicated to a Pfizer sales representative. A 3-year-old male patient received a dose of PREVNAR13, lot number #80083 in the left thigh on 10MAY2011. Past vaccine history included four doses of PREVNAR13. Relevant medical history included allergy to grass pollens, week pollens, tree pollens, egg white, corn, maize, peanut, sesame seed, wheat, walnut, milk and soy bean. There is no drug allergies or any other relevant drug history. The child vaccines were not up-to-date. The patient's parents also have unspecified allergies. Concomitant medications were not provided. On 10MAY2011, the patient experienced redness and swelling around the injection site. ON 11MAYh2011, the day after administration of the vaccination, the patient developed swelling on the left thigh and had difficulty walking. The patient recovered from the vaccination site swelling and erythema (11MAY2011). On 12MAY2011, the following day, the patient was evaluated by the reporting physician. Following the evaluation, the physician stated the patient was much improved. The outcome of the events of swelling on the left thigh and difficulty walking were reported as recovering. Follow-up (08JUN2011): New information reported from a contactable physician includes: patient demographics, relevant medical history, dose, details, clinical course and outcome.
Pain at injection site/pain in her arm; This spontaneous case, initially received from a pharmacist on 16-Oct-2018, concerns a 49-year-old, adult female patient.  The patient had no relevant medical history and had not received any concomitant medications.  On 02-Oct-2018, the patient was administered Afluria Quadrivalent [influenza vaccine, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: YF39908, expiry date: 30-Jun-2019] for influenza prophylaxis.  On the same day, immediately after vaccination, the patient experienced pain at the injection site for 2 weeks. It was reported that, the patient felt fine when she was vaccinated but from the moment she was vaccinated, she experienced pain in her arm. The patient was treated with ibuprofen.  On an unspecified date in 2018, the patient was feeling better (recovering).  The reporter assessed this case as non-serious.  Follow up received from the pharmacist on 02-Nov-2018: The treatment drug (ibuprofen) was added in the product tab. The outcome of the event injection site pain was changed from not recovered to recovering. The narrative was amended accordingly.  Non-significant case amendment (16-Oct-2018): The duration (2 weeks) of the event was removed in the event tab. No changes were done in the narrative.; Reporter's Comments: A 49-year-old, female patient experienced pain at the injection site, immediately after vaccination with Afluria Quadrivalent. The company assessed the causality of the event as related due to the site-specific reaction and plausible temporal relationship between event and suspect vaccine.
This spontaneous report as received from 2 healthcare workers refers to unspecified amount of patients of unknown age and gender. On unspecified date between 10-MAY-2014 and 23-JUN-2014, the patients were vaccinated with 0.5ml, intramuscularly VAQTA injection (lot # J005010, expiration date 23-OCT-2015) that underwent a temperature excursion, 0.5 ml, intramuscularly. No adverse effect reported. This is one of several reports from the same source. Additional information has been requested.
10 minutes after patient received the vaccine she walking around the store with her mother became lightheaded and fell to the floor. Patient was transferred to a wheelchair by a store employee and was brought to TLC for further evaluation. No injuries or bruised noted, patient's mother declined EMS services, patient was able to walk out without difficulties
Patients lymph nodes were swollen on the left side, same as injection site. Location was on the neck. Contrast dye indicated nodules.
she had chronic diarrhea for a week which started in less than 24 hours after receiving the vaccine and just got better this last weekend; This is a spontaneous report from a contactable Nurse. This (Age-, Unit-unknown) female Nurse (Patient) reported that:  Primary source of information: Reporter Qualification: Other Health Reporter Correspondence Contact: False  Patient characteristics:  Sex:   Reaction/Event: MedDRA version for reaction/event term LLT: N/A Reaction/event in MedDRA terminology (LLT): Medical Information Potential AE   Drug Information: Characterization of drug role: (Suspect) Proprietary medicinal product name: Pfizer-Biontech Covid-19 Vaccine    Identification of the country where the drug was obtained:  Country of authorization/application:   Active Substance Information: Active Drug substance names: Pfizer-Biontech Covid-19 Vaccine     Narrative case summary and further information:  Case narrative: Originating AE Request: REQ # Attachments: 1 Patient Age:  Reporter Subtype: Nurse PQC Present: No AE Present: Yes  PQC Details: Request Name: REQ # Product: PFIZER-BIONTECH COVID-19 VACCINE Question: Caller is confirming if there is latex in the stopper of the vial. They were informed by the pharmacist administering the vaccine that there was no latex in the stopper of the vial. She mentioned that she worked with the (Hospital name) in (location withheld) in which they would pop the top off the vial if the patient is allergic to latex. She would also like to know what material the stopper is made from.  Request Name: REQ # Product: PFIZER-BIONTECH COVID-19 VACCINE Question: Nice to know that Pfizer is no longer using latex in their vaccines.  Request Name: REQ # Product: PFIZER-BIONTECH COVID-19 VACCINE Question: You were very helpful. Thank you for confirming and making me understand my concern.  Request Name: REQ # Product: PFIZER-BIONTECH COVID-19 VACCINE Question: Caller mentioned that she and her husband both received the 1st dose of the vaccine on 26Feb2021 and experienced side effects. Her husband, (name withheld), aged , experienced a low grade fever with temperatures going up to 99 degree F (his usual temperature is 98 degree F) that lasted for about 24 hours. The next day he went to the ER because of chest pain, but they attribute it to his long heart history. The caller mentioned that she had chronic diarrhea for a week which started in less than 24 hours after receiving the vaccine and just got better this last weekend. She is not sure if this is related to the vaccine.  Caller refused transfer to safety as she was busy. E-transferring to department, Possible AE DUplicate. Caller mentioned that she would be happy to provide more information upon follow up.  Request Name: REQ # Product: PFIZER-BIONTECH COVID-19 VACCINE Question: The general public needs to know anything that would trigger a possible severe reaction with the vaccine. Specifically the allergens in your vaccines.  No follow-up attempts are possible. Information about Lot/Batch number cannot be obtained.
hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (hives). At the time of the report, URTICARIA (hives) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment details not provided.  concomitant details not provided.
Patient presented to the ER - feeling weird - throat hurt and felt swollen.  Facial edema.  Patient given Benadryl 50mg IV, Duoneb, Epi x2, Pepcid 20mg IV, Solumedrol 125mg IV.  Labs were drawn in ER and she was kept in overnight as an observation patient.
Immediately, during the vaccine injection , it felt as though the needle hit a wall and caused me to yell out loud in pain. I received multiple injections, but I have never had such a painful shot. The nurse played it off stating that it hurt ?because it was a big needle.?
the patient experienced "red, swollen, painful injection site"; the patient experienced "red, swollen, painful injection site"; the patient experienced "red, swollen, painful injection site"; This spontaneous report was received from two nurses via company representative, referring to a 75-year-old female patient.  The patient's concurrent conditions and medical history were not reported. Concomitant medications included many unspecified medications and diphtheria toxoid (+) pertussis acellular vaccine (unspecified) (+) tetanus toxoid injection.  On 28-MAY-2019, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) (lot# R017900, expiration date 26-MAR-2020) 0.5 mL, one shot intramuscularly in the deltoid of the left arm due to center for disease control (CDC) recommendation based on age.  On an unknown day in May 2019, after receiving Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23), the patient's injection site became red, swollen and painful (injection site erythema, injection site swelling, injection site pain). The patient reported the events on 30-MAY-2019. The patient called the clinic and received an unspecified treatment for the event. At the time of the report, the patient was recovering from the events.  The causal relationship between Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) and the events was not reported.
Dizzy, hot, nauseated, intestinal upset, pt reported fever of 99.7 degrees.
Mother of pt. noticed on 5/14/17 a large redness area where vaccine was TDaP was administrated. She also noticed a small one where Varicella was given. Mother states daughter complains of itchiness on the area. Today provider ordered BENADRYL 125 mg oral tab/chewable. No other reaction from MMR.
pt recv vax 25APR96 & 22JAN97 pt exp rash;the reporter indicated the pt sibling also exp rash w/vax WAES 97020391;
Rash along upper arm around the area of the vaccine administered. No problems, just large area of raised redness.
Approximately one hour after the injection, patient reported difficulty swallowing, throat swelling/tingling, tongue thickness
This case was considered medically important (OMIC). Information regarding influenza virus vaccine was received from a health care professional regarding a 67 year old female patient who experienced an injection site reaction characterized by severe swelling of her arm and redness. At 67 years of age, the patient received a dose on an unspecified date in 2002. Relevant medical history was not provided. Indication for influenza virus vaccine was immunization. Product was administered on an unspecified date in 2002. Dose regimen was 1 dose. Concomitant medications were not reported. After receiving a flu vaccine on an unspecified date in 2002, the patient experienced severe swelling of her arm all the way down to her elbow (injection site swelling), and redness (injection site erythema) that lasted for several months. No additional information was available at the date of this report.
" I woke up with red blotches on my arm around the injection site. It was very itchy and hot. Throughout the day it became more red and itchy. This morning I woke up and my upper arm is very red and hot.   The redness and swelling spread through my entire upper arm the next day, much more then 2-5cm. It was hot, itchy, swollen and painful to the touch. I had a virtual urgent care visit yesterday due to the worsening condition. I was diagnosed with right arm cellulitis and prescribed antibiotics for 7 days.
This spontaneous report as received from a registered nurse refers to a currently 14 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 17-NOV-2014, the patient was vaccinated with a dose of GARDASIL (dose, route of administration, lot # and expiration date were not reported). Then, on 28-JUL-2016, they received a dose of GARDASIL 9 (dose, route of administration, lot # and expiration date were not reported). There was no adverse effect reported. Additional information has been requested.
Has fever, chills, shaking, nausea, vomiting, and diarrhea.
Pt reported redness after injection 10/20/16. On 10/25/16 pt reports start of severe itching and redness spreading down arm. Redness observed with raised darkened border around it's edge from around injection site of left deltoid extending down towards elbow and inside of left upper arm on 10/27/16 when pt returned to health department.  Denies swelling or pain.  Heat at site of redness felt.  Denies fever or chills.  Reports c/o malaise for first 2 days after injection with flu vaccine given in right deltoid.  Denies any c/o with right deltoid site.  Pt. saw primary care provider on 10/27/16 with report of steroid shot given and instructions for benadryl use.  Phone call 10/28/16 with report of improvement after provider treatment.
This occurred on Friday, 12/10/21 starting at 2:00am: he lost strength in the lower body and this worsened as the day went on until he lost strength in both legs and his upper body became weak. He lost his ability to focus on things as well. EMT arrived to the home and recommended he go to the hospital for a check-up, he was hospitalized for 2 days. After about 2 days, patient regained normal functioning.
Here, client received Janssen vaccine at 11:32 and while in the recovery area, @ 11:37 began to c/o  palpitations, feeling clammy, dizzy and feeling faint. VSS @ 11:37: 110/78, HR 109-88, O2Sat 99%, skin wnl, very anxious, requesting to lie down, was lowered to the floor, placed in supine initially then feet elevated on chair, breathing easily but expressed feeling anxious.  VSS @ 11:39: 102/61, HR 73, Sats 99%.  Symptoms ongoing, 11:40, monitoring continued by recovery team, 911 called, Engine 340 arrived @ 11:47.  EMS Assessment: EKG, Blood Glucose 92, VSS@ 11:59: 150/83, HR 76, continued to monitor. Following EMS assessment, refused EMS transport stating feels better, able to stand w/out incident, assisted to chair, monitored for add'l 15 minutes.  Son was contacted and request to assist client w/ride home, drove to site independently, not safe to drive back alone.  12:13 Sone arrived, stand by assist to vehicle by recovery nurse, stable for dc to home.
Sweating, chills, feeling hot and feeling cold, headache, right arm is incredibly ginger
NO SYMSTOMS ON THE DAY EACH SHOT WAS RECEIVED. WAITED THE 15 MINUTES AND WAS ABLE TO GO HOME.  LATER IN THE EVENING ONLY EXPERIENCE PAIN ON SITE OF INJECTION, TIREDNESS AND SLEEPY, SLIGHTLY FATIGUE. ON SECOND SHOT ONLY FELT VERY TIRED, DRAINED AND ONLY WANTED TO SLEEP ALL DAY.  AFTER ABOUT A MONTH OR TWO IS WHEN I STARTED FEELING THE ANXIETY AND PANIC ATTACKS, HAVE VISITED WITH MY DOCTOR AND IS TREATING ME FOR THE ANXIETY AND PANIC ATTACKS WHICH HAVE GOTTEN SLIGHTLY WORSE TO SOMEDAYS SEVERE ANXIETY AND PANIC ATTACKS.
Administration Error: o         Pfizer Covid-19 Orange Top vials (Pediatric age 5-11) were diluted and administered following the Pfizer COVID-19 Purple Top vial  (Adolescent age 12 and older) preparation and administration instructions. o         1.8 ml was used to dilute the 1.3 ML vial instead of 1.3 ml. o         This would change the concentration to 130 mcg/3.1 ml = 41.9 mcg/ml. o         The dose given out of this vial was 0.3 ml. o         The children (age 5-11) received 0.3ml x 41.9 mcg/ml = 12.6 mcg.  Pfizer Case #: int00506363