chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Guillain-Barre; This is a spontaneous report received from a contactable reporter(s) (Physician).  A patient (no qualifiers provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown) for immunisation; BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GUILLAIN-BARRE SYNDROME (medically significant), outcome "unknown", described as "Guillain-Barre". Additional information: Caller (Physician) has a patient who received Prevnar 20 and also had covid-19 vaccine 5 days ago or maybe 10 days ago as he mentioned. Unfortunately the patient came down with Guillain-Barre so he was curious about the information about the rates of Guillain-Barre with covid.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein), BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information currently provided, Guillain-Barre syndrome more likely represents a intercurrent medical condition; Antecedent viral or bacterial infections are the commonly associated triggers.  Probing for recent medical conditions prior to the onset of GBS such as diarrhea and upper respiratory infection together with detailed lab investigations including pathogens detection are needed to identify an alternative etiology.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate
pain down her right side from her hip down after getting the booster dose; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (pain down her right side from her hip down after getting the booster dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   No Medical History information was reported.    In December 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (pain down her right side from her hip down after getting the booster dose). At the time of the report, ARTHRALGIA (pain down her right side from her hip down after getting the booster dose) outcome was unknown.            No concomitant medications was reported. No treatment information was reported. Patient was reporting adverse event for her mother. Patient took 2nd dose on 23 feb 2021 which was of other manufacturer.
On 10/20, began with right lower back soreness to more severe right lower back pain.  Saw doctor on 10/21, CT kidney stone protocl 10/22, no kidney stone on the right.  Extreme pain continued and on Sunday, 10/24 rash on right buttock around to right thigh.  Saw doctor again 10/25 and diagnosed with shingles in the L1 dermatome.
Client administered Fluarix in error. Client had registered for Tdap/Boostrix vaccine.
Patient had hives.  Patient went to get treatment at Hospital and received prednisone, naproxen and benadryl.  I told him that he shouldn't take naproxen with prednisone and to switch to tylenol- patient still having symptoms as of 12/24/22.  No breathing problem.   Told him to follow up, if still has rash.
2 mos later, grandmother states that after 10/13/99, 4 mo visit and immunizations that infant was unconsolable for 40 hrs. Probable Pertussis reaction.
11:30 AM Sore arm, red painful eyes, nausea, joint pain - took Tylenol, called nurse. 2:00 PM shaking (like extreme chills), weakness, hard to breathe, cough, dizzy - used inhaler. 10/27/2010 hives on injection arm - called doctor's office, recommended not getting the shot again.
Patient felt ok for a few minutes and then suddenly she turned white as a ghost and started screaming about her head hurting and nearly passed out.  I grabbed onto her as she was screaming and she projectile vomited all over herself and the floor.  She vomited one more time and said she was going to pass out so I quickly laid her down on a lunch table bench and lifted her feet above her heart.  She stayed very pale for 30 minutes and seemed extremely confused.  She said things that didn't make sense at all when she would speak.  I finally was able to get her home where I continued to monitor her as she laid in the living room unable to hold anything down.  She had severe child's and needed to be wrapped in blankets to keep warm.
24 hrs after vaccination, pt's neck (both front & back) start to swell and it last about 48 hrs after recovered there is no residual effect.
hives developed 60 hrs after getting vaccine.  took Benadryl but hives remained.  Sought tx at Care. Decadron IM and scripts for Vistaril and Pepcid
Severe ear ringing; sour taste in mouth every day since (nonstop); This is a spontaneous report from a contactable health care professional. A 48-years-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: UNKNOWN), via an unspecified route of administration in the right arm on 19Mar2021 at 10:45 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. The patient did not take any concomitant medication. The patient was allergic to BENADRYL. Prior to vaccination, the patient was 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 4 weeks prior to the vaccination. On 19Mar2021 at 11:00, the patient experienced severe ear ringing and a sour taste in the mouth every day since (nonstop). The patient received antianxiety, antihistamines, chiropractor and yoga as a treatment for the reported events. The adverse events resulted in a visit to the doctor or other healthcare professional office/clinic visit. The clinical outcomes of the events severe ear ringing and a sour taste in the mouth were not recovered at the time of the report.   No follow-up attempts are needed; information about the lot number cannot be obtained.
Bronchitis; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6202; Expiration date was not reported) on the right arm, on 03Mar2021 (19:10) as a single dose, with route of administration unspecified, for COVID-19 immunization. Medical history included pacemaker, high blood pressure, and was diabetic; all were ongoing. Concomitant medication included metformin. In Mar2021, after the first dose of vaccination, the patient had bronchitis. The patient's bronchitis got real bad, and he fought it for three to four weeks. The physician had given him some pills to be taken one every day, and a stronger steroid that had knocked the bronchitis out of the patient. The event, bronchitis, was assessed as serious (medically significant). The event had resulted into a physician office visit. The patient had a chest x-ray on an unspecified date in 2021 (results were not provided). The outcome of the event was recovered on 20Apr2021. The patient was scheduled to receive the second dose of vaccination on 24Mar2021 or 26Mar2021 ("or something like that"). The physician advised the patient to get the second dose until he was better from the bronchitis.  No follow-up attempts are needed. No further information is expected.
This spontaneous report was received from a licensed nurse referring to multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of M-M-R II (unknown albumin status) for prophylaxis (dose, route, frequency, lot/batch # and expiration date were not reported). No adverse effects were reported. It was stated that the vaccines underwent a temperature excursion of 32 to 35 degrees Fahrenheit for 8 days (192 hours, worst case), and a temperature excursion of 47 to 77 degrees Fahrenheit for 1 hour, however it was reported that no previous temperature excursion was performed. The call was because of a "data logger". This is one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1707USA013214: US-009507513-1707USA013301: US-009507513-1707USA013302.
A non-serious spontaneous report of rhinitis with symptoms of running nose with a bit of blood has been received from a nurse/health professional concerning a 36-month-old male, subsequent to FLUMIST. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age. Neither medical history nor concomitant medication was reported for this patient. On an unknown date, the patient received FLUMIST. The patient experienced running nose with a bit of blood, diagnosed as rhinitis. The outcome of the event rhinitis was unknown.
Mom reported child had 104 fever during night, gave APAP every 4 hrs; Seen by MD-stated fever related to DTP;
No adverse reaction as of 3/25/10 (ZOSTAVAX given instead of Varicella).
The day after my vaccination, my arm was swollen with a large mass running about 2" long down from the injection site and about 1/2" wide (like the size of my thumb).  It was red and hot to the touch.  I had this for about 2 weeks.  I started getting what I would describe as bone pain the day after the vaccination as well.  I was getting bolts of pain in my jaw when talking that would take my breath away.  That only lasted for the one day and only happened a handful of times.  I also started getting somewhat severe, achy pain in my shoulder joint and sharp bolts of pain from my shoulder to my collar bone and down to my wrist.  This has not stopped.  It happens a few times a day or a few times a week and is more of an achy pain and not as sharp of a pain as before.  It is worse when doing manual labor such as working in my yard.  I type all day at work and think that aggravates it as well.  My injection site is still a little sensitive to the touch, but not that bad.  It is more the bone pain that catches me off guard at time.
Fever over 100; extreme soreness in whole body, horrible headache, swollen lymph node in left armpit, difficulty moving left arm
Headaches, Pruritus general malaise, generalized pain, rash, sexual impotence, no treatment received, memory loss and cramps.
Patient developed a 6 x 6 cm area of redness and warmth to the touch. The patient became fussy but not inconsolable.
Initial report received on 08/May/2006 from an investigator participating in the above mentioned trial.  An 18-year-old female subject developed dehydration one day after she had received an injection of Menactra, lot number not reported, and Hepatitis A vaccine, manufacturer not reported, lot number not reported.  Routes and sites of administration were not reported.  One day post-immunization, the subject was examined by a  physician and was complaining of a sore throat, difficulty swallowing, not drinking fluids, and back and abdominal pain.  She had bilateral swollen and tender lymph nodes in the neck and a temperature of 100.1 degrees Fahrenheit.  A strep culture was obtained, and the subject was sent to the emergency room for treatment of dehydration.  During re-exam in the emergency room, she additionally complained of crusty eyes and a severe headache.  Her temperature, at the time, was 101.1 degrees Fahrenheit.  Oropharynx was red and slightly swollen.  WBC was 16.1 with 93% neutrophils and 3% lymphocytes.  Urinalysis was negative.  She was treated with two liters of normal saline after which time she felt much better, and her headache had resolved.  Impression was a febrile illness, suspect viral etiology with pharyngitis being a strong component of the illness.  The following day, none screen was negative, and WBC was 16.8 with 89% neutrophils and 6% lymphocytes.  Treating for strep A was negative by DNA probe.  Recovery status was not provided.  The investigator did not consider this event to be a serious adverse event.  However, the event was considered to be related to vaccination.
TOOK SECOND DOSE A DAY LATE; This spontaneous case report (PVX2019-1762) was received from a pharmacist on 08-Jul-2019. It describes a female consumer who "took second dose a day late" (PT: Inappropriate schedule of product administration), while being on oral Vivotif (one dose every other day) (lot number: 3003279) for typhoid fever prophylaxis.  Case report: The consumer took the first dose of Vivotif on 03-Jul-2019. Then, she took the second dose on 06-Jul-2019 instead of 05-Jul-2019.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took second dose a day late" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took second dose a day late" was considered as not applicable.
After receiving her vaccine client complained of pressure in her chest.  Vital signs obtained by EMS. BP 162/106, HR 82, O2 Sat 99%. Client states she feels better.  Client discharged home by EMS.
patient reported to public health nurse that he started to have "a reaction to my booster vaccine" that he received yesterday (vaccine administered on 12/13/22 around 4:30 p.m.); onset of symptoms was today, 12/14/22, at 10:25 AM; side effects reported to public health nurse from patient included sudden onset of muscle aches, flu like symptoms, chills, feeling very thirsty, tiredness, and a sore arm at site of injection.. At 12:10 PM patient reports that all side effects have subsided, with the exception of the sore arm.
Initial swelling 3" by 6" (per patient) within hrs after receiving vaccine. When seen in office localized Rx 2" by 2 1/2" - red, warm.
This spontaneous report as received from a physician refers to an unspecified number of patients of unknown age and gender. No medical history and concurrent conditions were reported from the patients. On unspecified dates between 14-OCT-2015 and 16-OCT-2015, the unspecified number of patients were vaccinated with improperly stored doses of GARDASIL lot # K007264, expiration date 02-MAR-2017 and lot # K008621, expiration date 04-MAR-2017 (dose, frequency and route were not reported). No concomitant medications were reported. No adverse effects were reported. No product quality complaint was involved. This is one of several reports from the same source. Additional information has been requested.
COVID-19 after BNT162B2 Immunization; COVID-19 after BNT162B2 Immunization; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 28-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 23Aug2021 as dose 1, single (Lot number: FC3182) and on 15Sep2021 as dose 2, single (Lot number: FC3180) at the age of 28 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 12Jun2022, outcome "recovered" (2022) and all described as "COVID-19 after BNT162B2 Immunization". Therapeutic measures were not taken as a result of vaccination failure, covid-19.  Clinical course: It was reported that the patient had no other vaccine in four weeks and had other medication in two weeks. The patient had no Covid prior vaccination and was not covid tested post vaccination. The patient had no known allergies.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Based on the known safety profile of the vaccine  BNT162b2, a causal relation between the reported event Covid-19, Vaccination failure and the administration of the vaccine cannot be excluded.
hot, red skin at site of injection, lump beneath skin at injection site, itching at injection site
Fever, body aches, clogged ducts and decreased milk production for three weeks after and continuing.
Subsequently, pt developed a large swollen gland under his arm and an extensive rash approximately 2 inches round.
not received the 2nd after 12 months; This non-serious case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: not received the 2nd after 12 months). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 26-JUL-2023 The health care professional (HCP) reported that, if patient received one dose of Shingrix and had not received the 2nd after 12 months, do they need to start the series over? Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient. A 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 09Apr2021 10:45 (Lot number: EW0153) at the age of 37 years as dose 1, single for Covid-19 immunisation. Patient received bnt162b2 Dose 2 (Lot number: EW0153) in arm left on administration date 30Apr2021. Relevant medical history included: "Known Allergies: Sulfa" (unspecified if ongoing) and other medical history was none. The patient's concomitant medications were not reported. The following information was reported: THROMBOSIS (medically significant) with onset 09Apr2021, outcome "not recovered", described as "Blood Clogs"; ANXIETY (non-serious) with onset 09Apr2021, outcome "not recovered", described as "Anxiety"; PANIC ATTACK (non-serious) with onset 09Apr2021, outcome "not recovered", described as "Panic Attacks"; FATIGUE (non-serious) with onset 09Apr2021, outcome "not recovered", described as "Tiredness"; PAIN (non-serious) with onset 09Apr2021, outcome "not recovered", described as "Body Pain". The events "blood clogs", "anxiety", "panic attacks", "tiredness" and "body pain" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (28Dec2021) negative, notes: Nasal Swab; (04Jan2022) positive, notes: Nasal Swab; (12Jan2022) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of thrombosis, anxiety, panic attack, fatigue, pain. Patient had not received any other vaccine in four weeks. Patient had not received any other medications in two weeks. Patient did not experienced Covid prior vaccination. Sender's Comments: As there is limited information in the case provided, the causal association between the Reported events and the suspect drug cannot be excluded. The case will be reassessed once new information is available. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Pt was given menquadfi first , then was given the hpv to the right arm.  I turn and placed my syringe on counter and looked back to pt when he said I dont feel good, I stood right in front of him , asked him to take some deep breaths, which he did then he fainted into my arms.  His arms were became rigid. Within 30 secs, he opened his eyes and said "what happened?"  I told him that he fainted and he asked for his grandmother. he still didn't feel well. His skin was pale and diaphortic, he drank some water,  I had him lye down  on exam table for 15 - 20 min.  he felt better after that . He did co,mplain  of a Headache. He was able to ambulate to the car with his grandmother.
Friday evening arm & neck pain. Saturday arm and neck pain,  got hot went turn heat down and fainted landed on tail bone. . Felt nauseated, flush and sweaty. Sunday to current neck pain and very foggy in the head, lightheadedness.
This spontaneous report as received from a physician and office manager refers to a 4 year old patient of unknown gender. Pertinent medical history, drug reactions or allergies were not reported. On 09-JUN-2015 the patient was vaccinated with an improperly stored dose of MMR II lot # K014833, expiration date 14-sEP-2016, for prophylaxis (dose, dose number, route and anatomical location were unspecified). No adverse effects reported. Concomitant therapies were not reported. This is one of several reports received from the same source. Additional information has been requested.
Information has been received from a  physician concerning a female patient who was vaccinated with the first two doses of GARDASIL. The patient fainted after receiving her first two doses of GARDASIL. The patient sought unknown medical attention. At the time of report the patient's status was unknown. Additional information has been requested.
shingles; Developed swollen lymph node in her right groin; Like blisters on the tip of the spine and across right buttock and were getting worse; This spontaneous case was reported by a consumer and describes the occurrence of BLISTER (Like blisters on the tip of the spine and across right buttock and were getting worse), HERPES ZOSTER (shingles) and LYMPHADENOPATHY (Developed swollen lymph node in her right groin) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-May-2021, the patient experienced BLISTER (Like blisters on the tip of the spine and across right buttock and were getting worse) and LYMPHADENOPATHY (Developed swollen lymph node in her right groin). On an unknown date, the patient experienced HERPES ZOSTER (shingles). At the time of the report, BLISTER (Like blisters on the tip of the spine and across right buttock and were getting worse), HERPES ZOSTER (shingles) and LYMPHADENOPATHY (Developed swollen lymph node in her right groin) outcome was unknown.        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.   No concomitant medication was reported . No treatment medication as reported .   This case was linked to MOD-2021-116684 (Patient Link).
fever (over 101), chills, muscle aches, swelling in left armpit, headaches lasted about 2 days. swelling in armpit and headaches lasted another day
The night I got my shot, my entire body was freezing and I couldn?t sleep at all because my entire body was in so much discomfort and pain, especially near my rib cage area in the front and back. The following day was the exact same, except my front rib cage didn?t hurt anymore (only the back). I was extremely fatigued and I couldn?t sit down because my body hurt so much. The worst symptoms were the sharp ear and neck pain (by the ears). It was a sharp, sporadic pain, but it still hurts a lot.  It?s now been 2 days since the shot and the neck and ear pain is now more frequent, though my fever and some of my muscle sores are now getting better. I also feel extremely nauseous, like I?m going to puke anytime soon.