chrisvoncsefalvay/vaers-outcomes huggingface dataset:
My daughter was fine on the first day.  She woke up the next day with a weird headache that her scalp hurt.  She went into work and started to feel poorly throughout the day.  When she came home, she went to bed at 4:30 pm as she had aches & pains, continued headache, felt nauseous, tired, and noticed her left leg where she had surgery previously was bothering her with pins and needles. I told her to go to bed and she would be fine the next day. On 5/26, her leg was giving her increased problems where she could not flex her foot, nerve pain in her leg along with numbness, and she still had the headache. I told her to call her primary care physician and the nurse had her go the the ER.  They ran no tests, but consulted with neuro on call and surgeon who performed surgery on her leg two years ago.  She was instructed to follow-up with a neuro and start PT.  We got her into a PT. The next day she continued to have same issues, but her leg pain increased.  She followed up via phone twice to primary where the nurse told her to go back to the ER. She had blood work, ultra sound and x-ray.  She saw neurologist on  6/2 and is scheduled for follow-up with an EMG on 6/14.  She has seen physical therapist 6x since 5/26 and still has numbness, nerve pain, etc.  The form from neuro office said left foot drop and parathesia. She has had headaches this week including a migraine on 6/8.
This spontaneous report as received from a registered nurse refers to a 16 year old male patient. On 20-AUG-2013 the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot# and expiration date not known). On 20-AUG-2013, the patient was accidently administered a dose of ZOSTAVAX as opposed to VARIVAX. This should have been the patient's second dose of VARIVAX in the series. The administration date of first dose of VARIVAX was unspecified. No adverse effect was reported. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. No information on their medical history or concurrent conditions was provided. On an unknown date unspecified patients were vaccinated with PROQUAD (Merck) (lot number, expiration date, dose route were not reported) that have been exposed to temperatures above 5F. No concomitant medications were reported. No adverse effects have been observed. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from a pharmacist refers to a male patient of unknown age. Medical history was not reported. On 29-MAY-2014 the patient was vaccinated with ZOSTAVAX, subcutaneous in the right buttock, lot number, strength and dosage were not reported. Concomitant therapy was not reported. The pharmacist informed that on 29-MAY-2014, he went to give to the patient the shot and the patient could not take the shot in his arms and requested in his buttock below the waist and above imaginary line above butt crack on the outer right buttock. The pharmacist used 5/8th needle and used 45 degree angle and inserted the whole needle and gave the shot. The pharmacist asked if he did anything wrong. Additional information has been requested.
body discomforts; some soreness of the arm; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (body discomforts) and PAIN IN EXTREMITY (some soreness of the arm) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     no medical history was provided by reporter.     On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced DISCOMFORT (body discomforts) and PAIN IN EXTREMITY (some soreness of the arm). At the time of the report, DISCOMFORT (body discomforts) and PAIN IN EXTREMITY (some soreness of the arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.     concomitant medication included high blood pressure medication,cholesterol medication no treatment information provided.
joint pain in both knees and elbows/pain in both hips/some joint pain on the right knee and hip; This is a spontaneous report from a contactable physician(patient). A 35-year-old male patient received the first dose of BNT162B2 (lot number: EKS730), via intramuscular in left arm, on 18Dec2020 09:45 AM at single dose for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered was hospital. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient was not tested for COVID-19. Relevant medical history was none. No allergies to medications, food, or other products. No other vaccines were received within 4 weeks prior to the COVID vaccine. The medications received within 2 weeks of vaccination included CBD oil drops. On Monday 21Dec2020 06:00 AM the patient started experiencing joint pain in both knees and elbows. Pain was moderate and fluctuating, the patient took some Tylenol and intensity of pain improved. On Tuesday, 22Dec2020 pain intensity decreased, however at night time the patient started experiencing pain in both hips, mostly on the right side. Today 23Dec2020 pain has disappeared from both elbows, left hip and left knee. The patient was still experiencing some joint pain on the right knee and hip, mostly when he was walking, if he was sitting down or not moving at all, pain is not present. Treatment Tylenol 500 mg P.O. (oral) q (every) 8 hours and CBD oil was received for the events. The outcome of the event was recovering.
Mother brought child for 3rd set of vaccines at 7mos. She reported that within 1 hour of receiving  vaccines on 01/03/2005 (2ndset) he developed large red bumps starting from all 3 vaccine sites. Rash covered both thighs up into diaper area. Physician observed at well child visit. No treatment.
Headache, Myalgia,  chills, swollen red arm Narrative:   Other Relevant History:
Per interview of mother: This reaction occurred when the child received her first dose of these vaccines but was not as severe. Hence, she did not think about it prior to getting the second dose not alert the provider. On 12/9/18, patient broke out in hives. Parent gave BENADRYL for symptoms. On the 10th, hives turned into large welts. Parent took patient to her family doctor 12/11/18 who recommended more BENADRYL vitamin C, and Oranges; and diagnosed the child with an allergy to the vaccines. Doctor told parent that child should not get any more vaccines in the future. Parent called Health Dept. on 12/13/18 and reported the event. Child was way better on that date with a bit of swelling on the face.
This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unknown date between 15-JUN-2017 and 06-JUL-2017, the patients received unspecified doses of ZOSTAVAX (lot#: M041085, expiration date: 03-JAN-2018; lot#: M044220, expiration date: M044220) (dose, frequency and route of administration were unspecified) for prophylaxis, in immunization series that were improperly stored. No adverse events were reported. It was stated that the vaccines were exposed to a temperature of 1 Celsius degree for a time frame of 65 hours and 5 minutes. There were no previous temperature excursions and a digital data logger was involved. This is one of several reports from the same reporter.; Sender's Comments: US-009507513-1707USA003300: US-009507513-1707USA003301: US-009507513-1707USA003302: US-009507513-1707USA002262: US-009507513-1707USA003298: US-009507513-1707USA003299:
This spontaneous report was received from a Licensed Practical Nurse (LPN), referring to multiple patients of unknown age and gender. The patients' medical history, concurrent conditions, drug and allergy history were not provided. On multiple unknown dates, the patients were vaccinated with improperly stored doses of VARIVAX lot number M023380, expiration date 11-MAY-2018, for prophylaxis (dose, frequency and administration route were not provided). Concomitant therapies included a properly stored sterile diluent (lot number M011786, expiration date 22-SEP-2018). The data logger registered a temperature range of minus (-) 14°Celsius (C) to -10°C during a time frame of 3 hours. There was not a previous temperature excursion. No adverse effects were reported. This is one of two cases from the same reporter. Sender's Comments: US-009507513-1709USA004385.
Chills; Shakes; No Appetite; Fatigue; Swollen Injection Site; This spontaneous case was reported by a nurse and describes the occurrence of CHILLS (Chills), TREMOR (Shakes), DECREASED APPETITE (No Appetite), FATIGUE (Fatigue) and VACCINATION SITE SWELLING (Swollen Injection Site) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 09L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced CHILLS (Chills), TREMOR (Shakes), DECREASED APPETITE (No Appetite), FATIGUE (Fatigue) and VACCINATION SITE SWELLING (Swollen Injection Site). In February 2021, CHILLS (Chills), TREMOR (Shakes), DECREASED APPETITE (No Appetite), FATIGUE (Fatigue) and VACCINATION SITE SWELLING (Swollen Injection Site) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   no concomitant medications are provided. treatment to the events not reported. stop date of all the events are given as feb-2021 second dose is given in deltoid muscle(unknown arm).
Starting on April 12th I had severe upper abdomen pain. this is roughly 1 week after the vaccine. I thought it was gas, but I never altered my diet and it is 4/13 at 10am and the pain is still there.
Patient states that she had a 3-inch, perfectly round, painless bruise around vaccination site that lasted two weeks post vaccination.
Patient received 0.25mL of Moderna Covid-19 Vaccine, Bivalent; No adverse Event; This spontaneous case was reported by a nurse and describes the occurrence of UNDERDOSE (Patient received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse Event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced UNDERDOSE (Patient received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse Event). At the time of the report, UNDERDOSE (Patient received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse Event) to be not related. No further causality assessment was provided for UNDERDOSE (Patient received 0.25mL of Moderna Covid-19 Vaccine, Bivalent).    No concomitant medications were reported.  No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Follow-up information included patient's age group updated.
This spontaneous report was received from a pharmacist, referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 25-OCT-2015, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (lot# L016427; expiration date: 13-APR-2017) (dose and route of administration were not provided). Concomitant therapies were not reported. No adverse effects reported. The pharmacist explained that the RECOMBIVAX HB doses were not involved in a previous temperature excursion and this time the temperature and time from were: .4C for 22 hours 52 minutes and 8.6C for 112 hours 5 minutes. This is one of several reports received from the same source (original report 1602USA004808). Additional information has been requested.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 73-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (presented numerous times prior to getting SHINGRIX). Previously administered products included ZOSTAVAX (still got shingles afterward). In November 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX and her arm was sore. She also said she received the ZOSTAVAX shot in the past but still got shingles afterward. For tolerance to 2nd dose, refer case US2019058196.
fever 106 R devel 6 hrs p/vax & accompanied by generalized sz x 5-10 mins; vomited x 3 & limp & sleepy x 1 1/2 hrs;
While in monitoring room client noticed red blotches on arms. No other signs or symptoms noted.  b/p 168/98 patient reported that it would be high before b/p was taken, stated he has high blood pressure.  PSO2 97 %  pulse 59.  Skin pink warm and dry.  Respirations even and unlabored.  Client monitored until 2pm, stated he was going to see his friend who is an ER doctor for a follow up.  Informed to seek medical attention if any other symptoms or shortness of breath occurred at any time.
Weakness in left arm where injection was given (about 15 minutes after injection). (20 mins to 1/2 hr.) Paleness, confusion, dizzy, heart palpitations, shaking and high B/P.
Information has been received from a registered nurse concerning a 9 year old white male student with a penicillin allergy who on 11 December 1995, was vaccinated subcutaneously with a first dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (Lot # 0615025/1310B). On 21 March 2005, the patient was seen in the office and diagnosed with chicken pox. Per the mother, the child had "50-60 lesions over the head, face, chest, back and groin, in all stages." No relevant diagnostic laboratory tests were noted. Subsequently, on an unspecified date, the patient recovered. It was also reported that a sibling had a similar experience on 04 April 2005 (WAES#0505USA02576). Additional information is not expected.
This non-serious spontaneous case, initially received from other non-health professional on 02-Nov-2018, concerns a 51-year-old, adult patient of an unspecified gender. It was reported that, the FLUCELVAX QIVc vaccine underwent temperature excursion for the first time. The vaccine was out for around 48 hours and it reached 11.6 degree Celsius. On 17-Oct-2018, the patient was administered FLUCELVAX QIVc [route of administration: intramuscular, anatomical location: left deltoid, batch number: 252230, expiry date: 31-May-2019 and dose: not reported] which underwent temperature excursion. At the time of this report, no adverse event was reported. This case 201805452 was cross linked to original case 201804863 due to same reporter.
Headaches, body aches, chills, fever, nasal congestion, sinus pain/pressure for 11 days after receiving the 1st dose of Moderna.
Complained of itchy throat and feeling funny.  Difficulty swallowing.  25 mg Oral Benadryl given
pt states that after the ninth day after taking the vax she developed a itchy, red, swollen warm 3" rash around the injection site on her right arm.  Pt will contact her PCP regarding her symptoms.no
First started feeling very cold, then had shaking chills/ rigors for about 2 hours. Before rigors stopped had onset of headache. Had the worst headache I?ve ever had with fatigue and nausea for the next 24 hours. Felt better with symptoms resolved in approximately 36 hours.
The rash was really red; The rash was really itchy; I started developing hives on that evening and it was also itching; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (The rash was really red), RASH PRURITIC (The rash was really itchy), PAIN IN EXTREMITY (sore arm) and URTICARIA (I started developing hives on that evening and it was also itching) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Nov-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 06-Dec-2021, the patient experienced URTICARIA (I started developing hives on that evening and it was also itching). On 09-Dec-2021, the patient experienced RASH ERYTHEMATOUS (The rash was really red) and RASH PRURITIC (The rash was really itchy). The patient was treated with PREDNISONE on 07-Dec-2021 for Adverse event, at a dose of 20 mg; CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) on 08-Dec-2021 for Adverse event, at a dose of UNK, qd (1 daily) and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 09-Dec-2021 for Hives, at a dose of 25 mg three times a day. At the time of the report, RASH ERYTHEMATOUS (The rash was really red), RASH PRURITIC (The rash was really itchy), PAIN IN EXTREMITY (sore arm) and URTICARIA (I started developing hives on that evening and it was also itching) outcome was unknown.            Concomitant medications were not provided Patient also experienced itching and rash was really red On 07Dec2021, Patient was worse that morning. She went to the emergency room. The Dr thought it might be food related. They gave her Prednisone 20mg in the emergency room. They also prescribed Zyrtec 1 daily. On 08Dec2021 Patient started taking Zyrtec 1 daily. On 09Dc20211, the rash was really red & itchy. She went to the emergency room at 9:30a.m The Dr thought there may be a connection to the booster dose. They gave her 2 Benadryl 25mg & 2 Prednisone 20mg, while in the emergency room. They also prescribed Benadryl 25mg 3 times/day until the hives are gone. The hives are typically bad in the mornings.   This case was linked to MOD-2021-407222, MOD-2021-407223 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-Dec-2021: Follow-up received on 09-Dec-2021. It contains No New Information
A company representative reported that a child received Prevnar and subsequently developed invasive pneumococcal disease. As of the date of this report, no further information was available. This event was considered medically important.
Severe abdominal pain / felt very uncomfortable; A spontaneous report was received from a physician on 20MAR2023 regarding a female patient (mid-30s) (patient 1) who experienced "severe abdominal pain / felt very uncomfortable" (PT: Abdominal pain) following the administration of VIVOTIF capsule (Typhoid vaccine live oral Ty21A; lot number: unknown) for immunisation.  The patient did not take any medications concomitantly. The patient had no relevant allergies or medical history.  It was reported that on an unknown date in 2023, "last month", the patient experienced severe abdominal pain with no other symptoms due to Vivotif. The patient felt very uncomfortable for 2 to 3 days and had to go to the emergency room where she possibly underwent a computerised tomogram (CT) scan. Reportedly, the hospital did not find anything and thought it was a coincidence with the vaccine and had no reason to suspect anything else.   The outcome of the reported event was unknown, at the time of this report.   The action taken with Vivotif with respect to the reported event was unknown.  No additional information was reported.  Based on the information available in the document three individual case safety reports 23000101 (patient 1), 23000102 (patient 2) and 23000103 (patient 3) were created and cross-linked into the database.  Company comment: A consumer took Vivotif for immunisation and experienced severe abdominal pain / felt very uncomfortable (abdominal pain). Further information regarding the event, medical history and concomitant medications is limited. Considering the case information, the causality of abdominal pain is assessed as possible with Vivotif. The case is considered non-serious as per medical assessment.; Sender's Comments: A consumer took Vivotif for immunisation and experienced severe abdominal pain / felt very uncomfortable (abdominal pain). Further information regarding the event, medical history and concomitant medications is limited. Considering the case information, the causality of abdominal pain is assessed as possible with Vivotif. The case is considered non-serious as per medical assessment. 23000102:Linked case (Patient 2) 23000103:Linked case (Patient 3)
20 min. after receiving her second moderna dose this client with a previous h/o severe allergic rxn c/o shortness of breath and her upper lip tingly, the client agreed to be checked by EMS, BP elevated at 160/100, O2 sat 96% P 108. EMS called approx 5 min. in to my assessment pBP still high 152/86, LSCTA per EMS, they offered to take her to be observed if she wanted but told the  client her lung were clear and that lip and tongue tingling could be anxiety. The client agreed to go home and take her inhaler and some benadryl and see if that helps her sx and if not she would seek emergent care prn. The client went back to work 50 min. after injection and planned to have co workers assist her if needed. Client signed refusal of transport for the medics.
pt recvd vax & exp bumpy rash on chest & arms; treated w/topical cream for itching;
Patient attended a Spanish speaking vaccine clinic. There was a language barrier despite a translator and patient was given a moderna vaccine although she is only 17 years old.   She has had no side effects.
Pt's mom called this office approx. 4hrs after receiving shots stating that the pt had fever and was crying uncontrollably. Mom took the pt to the physician for the red and swollen right leg. Baby was sent home with Benadryl and solumedole.
PROBLEM WITH TONGUE; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced problem with tongue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of problem with tongue was not reported. This report was non-serious.
I am 35 yrs old I received my first dose of gardasil in Jan 08 afterwards i had terrible back muscle spasms, I didnt think much of it but this has happened in dose 2 and 3.  I got my 3rd dose last week and my muscle spasms in my back are so bad i have had to use muscle relaxers and bengay etc.  I have a hard time doing my daily activities, terrible pain and discomfort.
She started having seizure soon after her MMR vaccination. She was seizure free for about 2 years and then she needed the shot again for school and since then she has been having seizures again. She is now 15 and they are getting worse.