chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The client attended a health clinic at a community center on 11/14/01 where she received a TD booster. She complained of swelling to the left arm, face and neck. She was seen be an RN at the office at 15:30. Her left arm had redness to the deltoid area of approx. 2" in diameter with moderate swelling. No swelling to face, neck or chest, as she had stated. Her arm was warm to touch. Advised her to apply warm and wet soaks.
This spontaneous report was received from a healthcare worker (medical assistant) and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history, concurrent conditions and concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of oral, ROTATEQ (lot # L004466 and expiration date 02-AUG-2016, lot # L008996 and expiration date 01-DEC-2016; exact doses were not reported). It was reported that the vaccines were exposed to temperature of 31.8F during cumulative total of 28 hours. No adverse effect was reported. No PQC (product quality complaint) was involved. This is one of several reports received from the same source. Additional information has been requested.
During post-vaccination clinic pt reported nausea/vomiting, 6 days p VX.  Nausea continued for 1 week. At day 11 pt observed robust take including redness 10 cm induration, lymph agenitis, blistering. Also c/d migraines intermittently.
Gastric distention and vomiting developed 2 days after vaccines.  12/5/08 Reviewed hospital medical records of 10/29-11/1/2008. FINAL DX: abdominal distention & emesis Records reveal patient experienced complication s/p delivery & had been d/c from NICU on 10/25/08.  See by PCP 10/27, doing well.  Returned to PCP 10/29 w/emesis x 1 day, decreased UO, oral intake reduced, intermittent tacypnea, abdominal distention.  Readmitted to NICU.
This spontaneous report as received from the consumer who was the father of a 13 year old female patient. The medical history and concurrent conditions was not reported. On 23-JUL-2014 the patient was vaccinated with GARDASIL dose 3 (dosing regimen and frequency unknown), injection (lot no not provided). Other suspect therapy included hepatitis A virus vaccine (manufacturer unknown) first dose was given on same day (dosing regimen and frequency unknown). There was no concomitant medications reported. On 23-JUL-2014 the patient experienced passed out (medically significant) two to three minutes after receiving the vaccine and recovered immediately after the reaction. The event occurred in the physician's office. No treatment was given for the event. No lab diagnostics studies were performed. Laboratory test done was none. No product quality complaint was involved. The causality of the event to the suspect therapies was unknown. Upon internal review the event was considered as medically significant. This case is related to case number 1407USA013430 (same reporter link). Additional information has been requested.
Headache, Myalgia & Fever Narrative:  Fatigue, fever, and head ache
Information has been received from a physician concerning a 62 yr old white female pt with hypertension who on 22Dec04 was vaccinated in the right deltoid with a dose of pneumococcal 23v polysaccharide vaccine (lot649988/0692P). Subsequently, on an unspecified date, the pt experienced a hot feeling where injection was given, a fever, sore, red and swollen whole upper arm and was lightheaded. It was reported that the pt went to urgent care and got amoxicillin. It was reported that the pt's whole upper arm was sore, red and swollen for least 4 days. It was unk if the pt recovered. Additional information has been requested.
430 Coughing and tickly throat after FLUMIST. No hives, swelling lips/tongue, BENADRYL 25mg po at 440. Resp rate 18, no hives, swelling lips or tongue. 450 - Resp rate 18. No hives, swelling lips, diff breathing. Child states "felt medicine dripping in throat". 500 - Resp 18 "throat OK, not tickly".
Diagnosed with bells palsy.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm right, administration date 19Nov2021 16:00 (Lot number: FH 8030) at the age of 31 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Anemia" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FH8020, Location of injection: Arm Right, Vaccine Administration Time: 04:00 PM), administration date: 29Oct2021, when the patient was 31 years old, for COVID-19 immunization. The following information was reported: BELL'S PALSY (medically significant) with onset 07Dec2021, outcome "recovering", described as "Diagnosed with bells palsy.". The event "diagnosed with bells palsy." was evaluated at the emergency room visit. Therapeutic measures were taken as a result of bell's palsy (Steriod and antiviral). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19 Since the vaccination, the patient has not been tested for COVID-19
I had the worst most vivid nightmares ever. I woke up unable to move or speak, like I was having sleep paralysis. I never have events like that. I immediately fell back asleep to have even more vivid nightmare. I woke up freezing (way colder than with normal fever). I was shaking and ended up with a pounding headache and nausea. My entire body is now sore. All my muscles ache and it feels like even my skin hurts.
Left arm erythematous patch at site of injection within a few minutes. No other symptoms and no evidence of respiratory problems.
Day 1 to Day 6:  painful Left arm   Day 3 to current Day 7: area red, hot, swollen and intense itching, w/redness increasing in diameter each day.  Now the size of a baseball, and waking me frequently during the night w/ intense itching.  Lethargy, nausea on Day 7
Pain at injection site, generalized fatigue, ache  ~10 hours post-injection-  Chills, leg muscle cramps ~16 hours post-injection Nausea, headache ( passed out for several seconds ) ~19 hours post-injection Completely fine ~42 hours post-injection
Large lump under the right arm.; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN), via an unspecified route of administration in the right arm on 20Mar2021 at 12:00 (at the age of 51-years-old) as a single dose, for COVID-19 immunisation. The patient had no medical history. The patient did not have any allergies to medications, food, or other products. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) for unknown indication from an unknown date. The patient previously 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 an unspecified date at 11:30, as a single dose for COVID-19 immunisation. 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 20Mar2021 at 16:00, the patient experienced large lump under the right arm. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. It was unknown if the patient received any treatment for the event. The clinical outcome of large lump under the right arm was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
SLUGGISH; TIRED; HEADACHE; BODY ACHES; SHAKING; MUSCLE ACHES; CHILLS; FEVER; DID NOT SLEEP WELL; This spontaneous report received from a patient concerned a 46 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included alcohol user, and other pre-existing medical conditions included the patient has no known drug the patient has no drug abuse or illicit drug usage the patient does not smoke. the has no diagnostic data available.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 14-MAR-2021 13:00 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 14-MAR-2021, the subject experienced did not sleep well. On 14-MAR-2021, the subject experienced fever. On 14-MAR-2021 23:30, the subject experienced body aches. On 14-MAR-2021 23:30, the subject experienced shaking. On 14-MAR-2021 23:30, the subject experienced muscle aches. On 14-MAR-2021 23:30, the subject experienced chills. On 14-MAR-2021 23:30, the subject experienced headache. On 15-MAR-2021, the subject experienced sluggish. On 15-MAR-2021, the subject experienced tired. Laboratory data included: Body temperature (NR: not provided) 100.8 F. On 15-MAR-2021 06:00, treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, shaking, muscle aches, chills, fever, and headache on 15-MAR-2021, had not recovered from sluggish, and tired, and the outcome of did not sleep well was not reported. This report was non-serious.
Lipoma on left thigh at site of PEDIARIX injection. Rx: supportive care.
I had all premenstrual syndrome, several weeks leading up to it. Sunday evening I started spotting and I started a period and got heavy and heavier last about 3 to 4 days. I went to my primary care doctor, He thought it was caused by vaccine. It had been 14 months since I had a cycle. If I over exert myself I notice my fibroids feel sore.
Headache, Myalgia, extreme fatigue, joint pain unable to complete household work. Narrative:
reduction of the pain I had been experiencing since July in my right shoulder joint.; This is a spontaneous report from a contactable consumer (patient). A 81-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration in Arm Left on 21Jan2021 at 08:30 as single dose for COVID-19 immunisation. Medical history included pain I had been experiencing since July in my right shoulder joint from Jul2020. The patient had no known allergies. The patient's concomitant medication(s) included amlodipine besylate 5mg  and atorvastatin 20mg. The patient did not take other vaccine in four weeks. The patient did not had COVID prior to vaccination and did not tested for COVID post vaccination. On 21Jan2021 at 12:00, the patient experienced reduction of the pain she had been experiencing since July in my right shoulder joint. When the patient lifted her right arm and moved it in a counter-clockwise 360 degree circle, the pain had been reduced about 90% and the movement was no longer painful. The joint is not 100% but much improved. The patient was delighted with the result. She wondered if anyone else has experienced any reduction in osteoarthritis pain after receiving Pfizer COVID-19 vaccine. The outcome of the event was unknown.  Information on the Lot/batch number has been requested.
Resident developed full body, red, itchy rash. BENADRYL 25 mg administered x 2 days without any resolution. Currently receiving Predisone 40 mg x 5 days.
Site: Bruising at Injection Site-Severe, Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Severe, Additional Details: Pt filled out a survey.  She was very unhappy with her vaccination.  She said the pharmacist stood over her, complained about her day, and was very aggressive when she gave the vaccine.  There is still a bruise after 8 days.  You can still see the hole where it was injected and there is a spider vein above the injection site that was not there before.  Her bruise is lightening up, but injection looked fairly high on the arm. She has been taking pictures showing the progression after the vaccinat
After 5-10 minutes of injection,  patient complained of headaches and chest tightness. Blood pressure was measured, sbp 160. Patient refused 911 call.  After deep breathing and drinking water, patient felt better.
Mom reports:  6-10-05 to 6-19-05  Child hospitalized for pneumonia and bronchitis.  Treated with IV antibiotics. 6-21-05 2pm  Into Health Department for immunizations.  Mom says she gave 1 ml of Pediatric Tylenol after she left clinic.  3-4 hours later patient started throwing up.  Had fever of 99.1 - 99.2 (rectally).  Developed small red bumpy rash over upper front chest that faded from mid-axillary area toward spine.  Also had rash on back side of both arms down to the elbow.  Mom called pediatrician, but did not return her call over the next 2 hours.  She then called a doctor who follows patient for cystic fibrosis.  Was told to bring patient to hospital.  Mom says patient was admitted with an elevated WBC.  Patient had a spinal tap for meningitis which was negative.  Was treated with IV fluids and Rocephin.  Discharged on day 3.  Mom states that doctor was undecided if this was a viral illness or a reaction to immunizations. Records rec'd 10/19/2005, additional symptom -- anemia Discharge summary states irritable. msv
The day after I received the 2nd dose I developed a strange and extremely painful type of headache. Ever since then I have that same type of headache about once a week. No over-the-counter meds, heat or ice, sleep, etc. will help subdue it. The worst of it lasts a whole day. The head then lightly lingers for 1-2 days after. This headache impedes on my ability to work and go about daily activities.
Information has been received from a Registered Pharmacist concerning a 57 year old female with a history of being admitted to hospital for nausea and vomiting and no drug reactions or allergies, who on approximately 18-JAN-2010, was vaccinated intramuscularly with a 0.5 ml dose of PNEUMOVAX 23 (lot # 667690/1158Z, expiration date: 26-JAN-2012). There was no concomitant medication. On 18-JAN-2011 the patient's arm became swollen after receiving the PNEUMOVAX 23. Patient received "supportive" treatment for the arm became swollen. No Lab Diagnostic studies were performed. At the time of the report, patient was recovering from arm became swollen. Patient sought unspecified medical attention. Additional information has been requested.
I woke up in the middle of the night around 1AM,  to my heart racing, so much so that my phone and watch woke me up to see medical attention. I had around 104 degrees fever and had chills. I was also throwing up and nauseous. I took Tylonal, Advil, and went back to sleep. I then had extreme fatigue.  I didn't start feeling back to normal until Wednesday after being vaccinated on Sunday.
Six days after the second vaccine, I had a sub-conjunctival hemorrhage involving almost the entirety of my right eye. There had been no trauma or other precipitating incident. My vision was fine, and there was no pain. It cleared up in about 2 weeks. I had never had this before. I hove no bleeding disorders or eye problems. I wasn't convinced this was associated with the vaccine, but I'm now personally aware of THREE other people who had significant sub-conjunctival bleeds after the second Covid vaccine dose (all Pfizer). Two had some other symptoms after the injection,  one did not. I was otherwise fine, and did not see a doctor (I work with ophthalmologists who said give it time, and if it didn't clear up I should get checked out)
Generalized seizure on 3/26/2003.  26 days post vaccination; started Dilantin; had seizure in June 20002; tx to hospital.
This spontaneous report was received from an office manager and refers to a 4 months old male patient. The patient's pertinent medical history, drug reactions or allergies and concomitant medications were not reported. On 02-AUG-2016, at the age of 4 months, the patient was inadvertently vaccinated with a dose of GARDASIL 9 injection, intramuscularly (site of administration, dose, lot number and expiration date were unknown). No adverse effect was reported. No further information was provided. Additional information is not expected as no consent for contact was given.
Patient to get Moderna 0.25ml booster dose. Nurse drew up and gave 0.02ml dose. Patient returned from waiting area and given full 0.25ml dose.
got a headache since  the morning after getting their first dose; got pain in the injection site, and that has gotten worst; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (got a headache since  the morning after getting their first dose) and VACCINATION SITE PAIN (got pain in the injection site, and that has gotten worst) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062521a) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Sep-2021, the patient experienced VACCINATION SITE PAIN (got pain in the injection site, and that has gotten worst). On 17-Sep-2021, the patient experienced HEADACHE (got a headache since  the morning after getting their first dose). At the time of the report, HEADACHE (got a headache since  the morning after getting their first dose) and VACCINATION SITE PAIN (got pain in the injection site, and that has gotten worst) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment information was unknown.
Side effects; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Side effects) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     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 IMMUNISATION REACTION (Side effects). At the time of the report, IMMUNISATION REACTION (Side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant medication was not reported by reporter. Patient got moderna and had side effects and stated that most Pfizer people he knew had a less. The treatment medication was not reported by reporter.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
11/5, 11/6/22 experienced itchy rash on inner thighs, resolved in 2 days after taking diphenhydramine. 11/7-11/14/22 experienced numbness, weakness in legs. Seen in ED on 11/15/22 had mri of T spine with finding of narrowing of spine, blood clot ruled out. Was advised by neurosurgeon her symptoms were related to narrowing of thoracic spine. 11/29/22 patient reported the reaction, was advised to be seen on 11/29/22 11/29/22 patient states her numbness weakness in her legs has improved, she ambulated to appointment today unaided
No additional AE/PQC.; nbound call from a medical assistant with a physician on the back line reporting AE for VARIVAX.  TE case filed under 02458467. AE details were provided by medical assistant. No symptoms reported. No additional AE/PQC.  ?    Names of vaccines invol; This spontaneous report was received from a medical assistant and refers to a 7-year-old male patient. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history.  On 26-JUL-2023, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX), 0.5 mL, subcutaneously, second dose, in the right arm, lot number X006983 with expiration date 07-MAR-2025, and with hepatitis a vaccine, inactivated(VAQTA) lot number X003792 with expiration date 21-JUN-2024, second dose (dose, route and anatomical location were not reported) all vaccines for prophylaxis. The vaccines were exposed to -12.48 degrees Celsius for 1 hour and 30 minutes, there was previous temperature excursion. No additional adverse events were reported.
One of our medical assistants gave Dtap/IPV (Kinrix) to a 4 month old. The patient was due for Dtap/IPV/Hib (Pentacel), which should have been given during this visit
Severe pain "mialgia" severa weakness sensation, diziness, throat inflamed, fever, headache, pain in eyes these have lasted already 3 days and ongoing now.
Hives and fever (104) on 12/8/04. Prescribed Tylenol suppository and Pediapred. 12/9/04: recheck, no fever, rash resolving.
joint issue; This is a spontaneous report from a contactable nurse (patient herself). A 40-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EL3249), dose 1 via an unspecified route of administration on 12Jan2021 (at the age of 40 years old) as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications was not reported. The patient stated, on the first one she was taking Celebrex (treatment), the first vaccine and she stopped that shortly after that, that is why she stopped it on the January 21. It was treatment for like a joint issue. She stated she took 1 Ibuprofen when she needed it. On an unknown date in 2021, the patient experienced a joint issue. The patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection), dose 2 via an unspecified route of administration on 02Feb2021 (Batch/Lot Number: EL9264) as dose 2, single for covid-19 immunisation. For the causality, patient stated, she did not know. She thought it went right after because she was within 72 hours she thought after 24 hours right after the second one that she had and then it went away and came back like she said. Therapeutic measures were taken as a result of joint issue. Clinical outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Pt recv vax on 12/14/98; on 1/21/99 pt exp strep throat, right upper leg aching, limping x 48 hr; tx=Ceclor
body aches; muscle aches; chills; extreme fatigue; high less fever; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PAIN (body aches), MYALGIA (muscle aches), CHILLS (chills), FATIGUE (extreme fatigue) and PYREXIA (high less fever) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     No medical history reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Jan-2021, the patient experienced PAIN (body aches), MYALGIA (muscle aches), CHILLS (chills), FATIGUE (extreme fatigue) and PYREXIA (high less fever). On 14-Jan-2021, PAIN (body aches), MYALGIA (muscle aches), CHILLS (chills), FATIGUE (extreme fatigue) and PYREXIA (high less fever) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.