chrisvoncsefalvay/vaers-outcomes huggingface dataset:
woke up around 4-5 in the morning scratching at her neck; an itchy rash that was on her neck and extended to the back of neck, down to her stomach, legs, head, clavicles, and anywhere she can reach; injection site is tingling and pringling; lymph nodes in her right arm is swollen; This spontaneous case was reported by an other health care professional and describes the occurrence of PRURITUS (woke up around 4-5 in the morning scratching at her neck), RASH PRURITIC (an itchy rash that was on her neck and extended to the back of neck, down to her stomach, legs, head, clavicles, and anywhere she can reach), VACCINATION SITE PARAESTHESIA (injection site is tingling and pringling) and VACCINATION SITE LYMPHADENOPATHY (lymph nodes in her right arm is swollen) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     Concomitant products included CARBAMAZEPINE (CARBATROL), LEVETIRACETAM DIHYDROCHLORIDE (KEPPRA [LEVETIRACETAM DIHYDROCHLORIDE]) and CAMPHOR, DIPHENHYDRAMINE HYDROCHLORIDE, ZINC OXIDE (BENADRYL SKIN ALLERGY RELIEF) for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (woke up around 4-5 in the morning scratching at her neck), RASH PRURITIC (an itchy rash that was on her neck and extended to the back of neck, down to her stomach, legs, head, clavicles, and anywhere she can reach), VACCINATION SITE PARAESTHESIA (injection site is tingling and pringling) and VACCINATION SITE LYMPHADENOPATHY (lymph nodes in her right arm is swollen). The patient was treated with PREDNISONE ongoing since an unknown date at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, PRURITUS (woke up around 4-5 in the morning scratching at her neck), RASH PRURITIC (an itchy rash that was on her neck and extended to the back of neck, down to her stomach, legs, head, clavicles, and anywhere she can reach), VACCINATION SITE PARAESTHESIA (injection site is tingling and pringling) and VACCINATION SITE LYMPHADENOPATHY (lymph nodes in her right arm is swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Restlessness, anxiety, tinnitus, vertigo.  Prior to the second dose of the vaccine I wasn't under a doctor's care for any of those issues.   One or more of the above issues have impacted me daily since 3/30.   I visited the emergency room on 4/2 because my anxiety was so bad it felt like I was having a heart issue.
Information has been received from a Registered Nurse (R.N.) concerning a female patient with no pertinent medical history and no known drug allergies/drug reactions, who on 21-APR-2009 was vaccinated with the first 0.5 ml dose of VARIVAX (Merck) subcutaneously.  There was no concomitant therapy reported.  It was reported that "early this week" (approximately 04-MAY-2009) the patient had about 5 "pox" lesions on her body and a red area on her arm, at the injection site.  The patient sought medical attention via phone call.  There were no laboratory diagnostic tests performed.  It was reported that the patient was recovering at the time of the report.  Additional information has been requested.
Severe local reaction, H/A, confusion, ? fever, within 5 hours of receiving PNEUMOVAX vaccine - Right deltoid - 20 hours after vaccine pt has mild local reaction, mild headache, body aches.
Information and follow up has been received from a physician for the Pregnancy Registry for GARDASIL concerning a 25 year old female with a history of 1 pregnancy and 1 live birth who was vaccinated on 12-OCT-2007 with her first dose of GARDASIL (lot# 0530U). On 07-DEC-2007 the patient was vaccinated with her second dose of GARDASIL (lot# 655322/1211U) and became pregnant. Concomitant therapy included prenatal vitamins (unspecified). The patient's LMP was reported as 01-JAN-2008 with an estimated due date of 10-OCT-2008. The patient had an ultrasound on 01-JAN-2008 and the results of the test were IUG-6W4D. On 17-MAR-2008 the patient developed nausea and vomiting which were treated with PHENERGAN. At the time of this report it was unknown if the patient had recovered from nausea and vomiting. No further information was available.
Local swelling at site of injection with TTP since 4 days. No report of fever injection site warm to touch,
Patient came in the next day after getting the flu vaccine complaining of ringing in the ear, or tinnitus. Patient said the symptom started happening shortly after getting the flu shot.
Information has been received from a 38 year old female nurse who administered five vaccinations with a dose of Zostavax. During the time frame in which she administered the vaccines, she developed a shingles-like rash on the lower left-hand side of her back. Unspecified medical attention was sought and the rash subsequently resolved. A product quality complaint was not involved. Additional information has been requested.
This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender, who on unknown dates were vaccinated with doses of GARDASIL (dose, route and lot # not reported). The nurse reported that on unknown dated, patients received dose 2 or dose 3 of GARDASIL late. No symptoms reported. The nurse also reported that she heard another unspecified clinic had an unspecified number of patients who had received dose 2 or dose 3 of GARDASIL late (dates not provided. Additional information has been requested.
PATIENT RECEIVED DOSE IN ARM AND QUICKLY BECAME LIGHTHEADED, ASKED FOR WATER, THEN PASSED OUT. PATIENT FELL ONTO FLOOR, AT WHICH POINT TECHNICIAN ADMINISTERING THE VACCINE CHECKED PATIENT FOR PULSE/BREATHING - NOTED PT WAS OK, AND CALLED FOR PHARMACIST FOR HELP.  PT AWAKE BUT CONFUSED ON FLOOR WHEN PHARMACIST ARRIVED, SLOWLY REGAINED AWARENESS AFTER LEGS PROPPED UP. HE DECIDED TO GET UP ONTO A CHAIR AND DRINK SOME WATER, PHARMACIST SAT WITH PATIENT UNTIL HE WAS FINE TO WALK TO WAITING AREA OUTSIDE OF PHARMACY. HE WAS OBSERVED FOR 25 MORE MINUTES (TOTAL 30) AND FELT FINE TO LEAVE ON HIS OWN ACCORD
My right side shoulder and neck locked up. Very painful and not able to move. That lasted three in the half months. I have to get therapy weekly and acupuncture. I was given muscle relaxers.
Information has been received from a physician concerning a 48 year old white female teacher with no allergies and a history of a splenectomy 25 years ago for Hodgkin's Disease who on 30Dec03, was vaccinated in the left deltoid at another practice with a dose of pneumococcal 23v polysaccharide vaccine. Within a minute of the vaccination the pt developed nausea, lightheaded, sweating/diaphoresis, chest tightness and coughing. There was no loss of consciousness.  Unspecified medical attention was sought. The symptoms subsided within 2 minutes without intervention and there was no reoccurrence. The physician thought this was a vagal reaction.  No product quality complaint was involved. Another pt had the same experience after the vaccination with pneumococcal 23v polysaccharide vaccine. No further information is expected.
auxillary lymphadenopathy on lt; local pain & redness; had 1st dose on 15FEB93 w/o problem; 15APR93 phone f/u; when last seen,lymph node not palpable-but tenderness in auxilla;
This spontaneous report as received from a medical assistant refers to an unspecified 15 year old patient. The patient's medical history, concurrent conditions and/or drug reactions/allergies were not provided. On an unspecified date the patient was vaccinated with GARDASIL, intramuscular (lot # / expiration date unknown) and 7 months later on 11-NOV-2016, the patient was vaccinated with GARDASIL 9, intramuscular (lot # / expiration date unknown). Concomitant medication was not provided. No adverse effects were reported. A PQC was not involved. No further information was provided. Additional information has been requested.
8/27/10 Mother stated had red area surrounding chicken pox vaccine site when he was 17 months old.
1 1/2 hrs after receiving flu vaccine c/o body aches. After 4 hrs had 102 temp. By the next morning had headache and severe sore throat x 4d. Could not eat/drink x 4d - dehydration. Consulted with PMD day after vaccination.
Cannot sleep; Very desperating; Arm where they got the vaccine is itching; The arm is red; This spontaneous case was reported by a health care professional and describes the occurrence of INSOMNIA (Cannot sleep), DEPRESSION (Very desperating), VACCINATION SITE PRURITUS (Arm where they got the vaccine is itching) and VACCINATION SITE ERYTHEMA (The arm is red) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     no medical history provided by reporter.  Concomitant products included VITAMIN 15 and MINERALS NOS, VITAMINS NOS (CENTRUM PLUS) for an unknown indication.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, the patient experienced INSOMNIA (Cannot sleep), DEPRESSION (Very desperating), VACCINATION SITE PRURITUS (Arm where they got the vaccine is itching) and VACCINATION SITE ERYTHEMA (The arm is red). The patient was treated with ALOE SPP., AVENA SATIVA, VITAMIN E NOS (GOLD BOND ULTIMATE ECZEMA RELIEF) (topical) for Itching, at a dose of 1 dosage form as required. At the time of the report, INSOMNIA (Cannot sleep), DEPRESSION (Very desperating), VACCINATION SITE PRURITUS (Arm where they got the vaccine is itching) and VACCINATION SITE ERYTHEMA (The arm is red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 29-Mar-2021: Merging duplicate case(MOD-2021-061067)  to this case. Additional information added contains no new information.
Pfizer-BioNTech COVID - 19 Vaccine EUA  Had injection at about 1230 on 12/22/20, woke up at 6am on 12/23/20 with chills, fever of 100.1, headache, dizziness, body aches, sore arm. I had COVID 3 months ago and some of these side effects are worse now then when I had COVID.
Localized reaction..redness around injection site measuring 4 1/4? horizontally and 2 3/4 vertically ..immunization given at Pharmacy with no reaction other than localized tenderness to touch until 10-22-2018. Reaction reported to Family Medicine but pay phone call. Allergy medication taken at home.
Information has been received from a healthcare worker concerning a male who on 22-Oct-2008 was vaccinated subcutaneously with the first dose of PNEUMOVAX 23 (batch# 659147/1381U, injection site not reported). Subsequently, the patient's arm became red and very sore. At the time of the report (23-Oct-2008) the patient had not recovered. Additional information has been requested.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49-year-old female patient (not pregnant) received bnt162b2 (BNT162B2 NOS), on 01Mar2023 at 12:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 48 years, in right arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures (Paxlovid) were taken as a result of drug ineffective, covid-19 from 27Aug2023 to 01Sep2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300295290 same reporter/patient, different product/event;
Developed satellite lesions near the vaccination site.  Total of 4 lesions developed. No treatment given. Resolved on its own after 2 weeks.
Sore arm; Inappropriate age at vaccine administration; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 5 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Nov2021 10:45 (Batch/Lot number: unknown) at the age of 5 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 10Nov2021, outcome "unknown", described as "Sore arm"; PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious) with onset 10Nov2021, outcome "unknown", described as "Inappropriate age at vaccine administration". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: Facility where the most recent COVID-19 vaccine was administered was hospital or pharmacy. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There was no list of any other medications the patient received within 2 weeks of vaccination. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. Device Date was 11Nov2021. Patient did not have any allergy with drug.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Medical history, current conditions and concomitant medications were not provided. On 11-NOV-2015, the patient was inadvertently vaccinated with improperly stored dose of VAQTA lot # L000718, expiration date 28-APR-20177 (dose and route were not provided). No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
Swelling left arm; Urinated on herself; Fell up the stairs; Did not eat for 2 days; Stayed in bed for 2 days; Caller states she did not recognize her family.; feeling sick; after the first dose; fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 67 year-old female patient received bnt162b2 (BNT162B2), administration date 05Jan2022 (Lot number: FH8020) at the age of 66 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Acid reflux" (unspecified if ongoing), notes: Verbatim: Acid reflux; "Covid", start date: Sep2021 (unspecified if ongoing), notes: had got Delta virus last Sep and whole month of Oct Further clarification Unknown.; "dealt and held in hospital whole month", start date: 2021 (unspecified if ongoing). The patient took concomitant medications. The following information was reported: MALAISE (non-serious) with onset 06Jan2022, outcome "not recovered", described as "feeling sick; after the first dose"; PYREXIA (non-serious) with onset Jan2022, outcome "unknown", described as "fever"; SWELLING (non-serious), outcome "unknown", described as "Swelling left arm"; URINARY INCONTINENCE (non-serious), outcome "unknown", described as "Urinated on herself"; FALL (non-serious), outcome "unknown", described as "Fell up the stairs"; DECREASED APPETITE (non-serious), outcome "unknown", described as "Did not eat for 2 days"; BEDRIDDEN (non-serious), outcome "unknown", described as "Stayed in bed for 2 days"; MEMORY IMPAIRMENT (non-serious), outcome "unknown", described as "Caller states she did not recognize her family.". Therapeutic measures were taken as a result of malaise, pyrexia.  Additional information: Patient said that she took the Pfizer Covid-19 Vaccine yesterday and she felt sick after the taken the Pfizer Covid-19 Vaccine, first dose."  Consumer stated, "she got her first dose. She had Covid in Sep but didn't get hospitalized until Oct she dealt and held in hospital whole month (history). They give in her arm. Patient was on acid regimen (further not clarified), Nitro (further not clarified). Patient had acid reflex. Patient take lot of medication and told them whatever medication she was on." Patient had an accident and broke her ankle. Patient also stated that, she fell up the stairs but did not break her ankle. Patient scheduled to get her second dose on 26Jan2022. She stated, she got her first vaccine on 05Jan2022, and the next day, she urinated on herself, and then fell up the stairs. Caller stated she did not eat for 2 days and stayed in bed for 2 days. She did not recognize her family. Caller stated, her appointment for her second vaccine is 26Jan2022, and she does not drive. Also mentioned that, had got Delta virus last Sep and whole month of Oct (Further clarification Unknown). The report was related to a study or programme.  No follow-up attempts are possible. No further information is expected.
Patient reports local erythema and  musculo-skeletal pain at injection site, as well as intermittent tremor of right arm, headache, and subjective fever.
Upon Disease Investigation date of 8/19/2021 case had received both doses of the Moderna vaccine and reported the following symptom onset of 8/14/2021; subjective fever, chills, runny nose, new olfactory disorders, headache, cough and nausea. Still symptomatic.
Dizziness, chills, fainting, fell on floor teeth went through lip,shortness of breath
This case was reported by a physician via sales rep and described the occurrence of fever in a adult male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever and pain. The patient was treated with ALEVE. On an unknown date, the outcome of the fever and pain were recovered/resolved. It was unknown if the reporter considered the fever and pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient's body temperature was 100 and was aching. The patient felt better within hours. This case was linked with the case US2018GSK142191, reported for further dose of SHINGRIX. Lab Comments: On an unknown date, body temperature was 100.
Pt was inadvertently given 1ml of FLUZONE instead of correct 0.5 ml dose.  Pt reported a sore arm X 6 days but no other adverse events.  Soreness  has resolved now.
pt recvd vax & hive-type rash over entire body & face that reportedly started 25OCT95 AM;t100.8 R;parent giving Motrin 24OCT95 & pt won't eat/drink & no stools or wet diapers;referred to MD
Shot administered on  3/18/21 . Mild side effects within 24 hours (fever, sores arm and body). Five days later a small rash like a scratch appeared on my left arm,  6 hours later the rash was extended through my arm and it was swollen . Arm was warm. The following day contacted my doctor to report symptoms. Benadryl prescribed and taken before bed on 3/24/21.  Rash diminished considerably the following morning
facial paralysis; blisters; rash; painful limbs and eyes; painful limbs and eyes; This is a spontaneous report from a contactable consumer (father-in-law of patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient's medical history and the concomitant medications were not reported.  It was unknown if any other vaccines given the same day or 4 weeks prior or if patient had any problems with vaccines in the past. The patient experienced fa had blisters, rash, severe facial paralysis immediately after receiving the shot. She also had painful limbs and eyes on an unspecified date. She went to the doctor to get the second vaccine and the doctor refused to give it to her. She had been to her primary care provider, as well as an allergist, and neurologist about this as well. Reporter stated this need to be examined by Pfizer and she and Pfizer need to know what was going on. The patient had spoken to a Pfizer nurse over the phone and got no satisfaction. The outcome was not recovered for the reported events.  The information regarding lot/batch number has been requested.
Patient vaccinated on 5/31/06 with Menactra (lot U1822AA).  Culture confirmed meningococcal disease on 4/28/08.  Blood culture was positive for Neisseria meningitidis serogroup C.1/5/09-records received for DOS 4/30-5/2/08-DC DX: Meningococcemia. Presented with C/O feeling bad and neck and back pain, body aches, fevers up to 102 and chills. C/O headache at time of discharge and underwent a blood patch.
This spontaneous report was received from a certified medical assistant concerning unspecified number of patients of unknown age and gender. No medical history or concurrent conditions were reported. On unknown dates, between 02-AUG-2015 and 31-AUG-2015, the unspecified patients were vaccinated with ROTATEQ that was improperly stored, oral route (dose and strength were not provided). Co-suspect or concomitant therapies were not reported. The lot numbers reported for ROTATEQ were: L000569 with expiration date on 13-JUL-2016, K009753 with expiration date on 28-APR-2016 and K014826 with expiration date on 28-MAY-2016. This is one of several reports from the same source. Additional information has been requested.
Hepatitis B Vaccine (09-AUG-2002, 10-JAN-2003, 11-APR-2003); Hepatitis B Vaccine (09-AUG-2002, 10-JAN-2003, 11-APR-2003); This spontaneous report has been received from a health care professional via medical records from a case in litigation for quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) or hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (MARRS# 2207USA008600), concerning to a 5-month-old female patient. Information regarding the patient's pertinent medical history, concurrent condition and concomitant medication was not provided.  On 09-AUG-2002, 10-JAN-2003 and 11-APR-2003, the patient was vaccinated with hepatitis b vaccine (recombinant) (manufacturer unknown), respectively, all for prophylaxis (inappropriate schedule of product administration). The dose, strength, route, lot number and expiration date were unknown.   This is one of three cases concerning the same patient.; Sender's Comments:  US-009507513-2207USA008600: US-009507513-2305USA008516: