chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a pharmacist via call center representative and described the occurrence of hives in a 54-year-old female patient who received BOOSTRIX (batch number YM7J9, expiry date unknown). Co-suspect products included ENGERIX B adult (batch number 24JP3, expiry date unknown) and Influenza vaccine unspecified. On 19th December 2015, the patient received BOOSTRIX .5 ml, ENGERIX B adult 1 ml and influenza vaccine unspecified. On 19th December 2015, 15 min after receiving BOOSTRIX, ENGERIX B adult and Influenza vaccine unspecified, the patient experienced hives and rash. On an unknown date, the outcome of the hives and rash were unknown. It was unknown if the reporter considered the hives and rash to be related to BOOSTRIX, ENGERIX B adult and Influenza vaccine unspecified.
Stomach cramping, black/green stool just once a couple hours after shot. Strong headache that lasted for about 5 days off and on.
Vaccine given 7/26/16, subsequently presented with Redness, Tenderness, same ache/pain a day or 2 after injection. This later advanced to small Blister at site of Injection.
premenstrual dysphoric disorder (PMDD); painful Premenstrual syndrome; among other severe symptoms; This spontaneous report was received from a lawyer regarding a case in litigation and referred to a currently 26-year-old female patient. No information was provided regarding concomitant medications, concurrent conditions or medical history. On 17-SEP-2021, the patient was vaccined with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection for prophylaxis(strength, dose,lot #, expiry date and route of administration were not provided). On unknown dates, the patient developed premenstrual dysphoric disorder (PMDD), painful premenstrual syndrome (PMS) and among other severe symptoms (ill-defined disorder). The outcome of all events was not reported. The lawyer considered the quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) caused th ose events.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021 at 3:20 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 03-Apr-2021 at 3:20 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 50.43 for dose administered on 03-Apr-2021.  No concomitant medications were reported.  Batch number 030B21A underwent temperature excursion on 03-Apr-2021 with temperature 34 degrees Fahrenheit at 09:00 AM. This vial was moved to fridge on 30-Mar-2021 and beyond use date for the vial was reported as 29-Apr-2021. Product moved to clinic on 03-Apr-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
Significant swelling left shoulder to mid-arm including articulital space and moderate swelling into shoulder blade. Bicep firm, red and warm to touch at 48 hours post administration. Parent had given po childrens Advil x 2.
Patient reported Fever, Chills, Patient states no medications or Dr. Visits were necessary. Currently still symptomatic with previously listed.
Vaccination site kind of hard like a lump; The arm at the vaccination site turn all red about 2 inches long and 1 inch across; Vaccination site kind of hurt; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (Vaccination site kind of hard like a lump), VACCINATION SITE ERYTHEMA (The arm at the vaccination site turn all red about 2 inches long and 1 inch across) and VACCINATION SITE PAIN (Vaccination site kind of hurt) 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.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced VACCINATION SITE INDURATION (Vaccination site kind of hard like a lump), VACCINATION SITE ERYTHEMA (The arm at the vaccination site turn all red about 2 inches long and 1 inch across) and VACCINATION SITE PAIN (Vaccination site kind of hurt). At the time of the report, VACCINATION SITE INDURATION (Vaccination site kind of hard like a lump), VACCINATION SITE ERYTHEMA (The arm at the vaccination site turn all red about 2 inches long and 1 inch across) and VACCINATION SITE PAIN (Vaccination site kind of hurt) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment details was not reported by the reporter.
Patient received a HD flu vaccine and experienced dizziness, unsteadiness, nausea, and felt faint for 3-4 days afterwards.
Received vaccine 2/3/23. Pt reports being dizzy and lightheaded after vaccine as well as sore arm later in day. On 2/4/23, pt reports arm was red. Arm was still red on 2/5/23. Pt came to pharmacy on 2/6/23 to speak to pharmacist. Pt's arm is pink and warm to touch down to the patient's elbow, but does not start until well below injection site. Based on pictures from 2/4/23, it appears to be lower than the previous day. Pharmacist advised patient to watch for further spreading, itching, and heat and to go to the urgent care if it worsens. Pharmacist advised to use loratadine and ice for relief.
Really bad nausea and a headache. I had those symptoms for a day and that's it. I was seen in by the doctor. On Friday,  the 12th, My doctor gave me nausea medicine and an IV fluids at the medical center - and also gave me Tylenol for headache. This is my first pregnancy; estimated date of delivery is on July 16th.
Redness and swelling of arm where vaccine administered.  No systemic symptoms.  Pain to touch.
5/9/2000 complained of swelling and pain at left deltoid injection site radiating to neck and chest. Evaluation occupational results negative. Naprosyn prescribed.
Blurred Vision, weakness, sleepy, tingling head, arms and legs. Numbness of limbs at night, increased muscle pain more in the legs, legs stiffness. Stomach discomfort with a later diagnosis of pancreatitis.
This case was reported by a physician via a representative and described the occurrence of maculopapular rash in a male subject of unspecified age who was vaccinated with TWINRIX (GlaxoSmithKline) for prophylaxis. Previous vaccination included TWINRIX (GlaxoSmithKline) given in December 2007 (around the 25th). Concurrent medications included allergy medication, blood pressure medication, and anti-hypercholesterolaemic. The subject had a history of allergies, high cholesterol and high blood pressure. On 2 January 2008 the subject received 2nd dose of TWINRIX at 1.0 ml following the accelerated dosing schedule. Sometime between the time the subject received the 2nd dose of TWINRIX and the day of reporting, 07 January 2008, the subject developed a maculopapular rash on his shin. The physician was unsure if the event was due to TWINRIX or if the subject suffers from "winter skin," meaning itchy skin due to winter weather. At the time of reporting the event was unresolved. On 09 January 2008, follow-up was received by the physician. It was reported that the subject experienced a papular rash on his legs after receiving the second dose of TWINRIX. Later on 09 January 2008, further follow-up was provided by the physician. concurrent vaccinations included TWINRIX that was received on 19 December 2007 and YELLOW FEVER vaccine given with either the first or second TWINRIX dose. concurrent medications were noted to include LIPITOR, SINGULAIR, VERAPAMIL and  AIRBORN. Medical history included a sulfa allergy and mild asthma. No history of adverse events following previous vaccinations. The physician reported that the 65 year old male subject received the second dose of TWINRIX on 02 January 2008 in his left arm at 10:30 Am. On 02 January 2008, 24 hours after receiving the second dose (accelerated dosing schedule), the subject developed a maculopapular rash on his shins (from the knee to the ankle). The subject was seen in the physician's office and the physician stated that the rash looks like a drug rash. The subject also experienced inappropriate schedule of vaccine administered. At the time of reporting, the outcome of the rash was unresolved. The physician considered that it was unknown if the events were related to the use of TWINRIX.
Initial and follow up information has been received from a health professional concerning an 85 year old female with no reported medical history who on 11/05/2004 was vaccinated intramuscularly in the left deltoid with a dose of pneumococcal 23v polysaccharide vaccine (lot # 649111/0287P).  It was reported that there was no concomitant medication and no laboratory diagnostic tests performed.  Subsequently the patient developed redness, pain, swelling, shaking and had a hard time sleeping.  In follow up, the healthcare professional reported that the redness, swelling and pain developed at the left deltoid injection site.  It was reported that the patient fully recovered.  No product quality complaint was involved.  It was also reported that there were 3 other patient who experienced adverse events after administration of pneumococcal 23v polysaccharide vaccine (lot # 649111/0287P).
3 members of my family who had Heart problems after taking the vaccines; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  An elderly male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed; unknown manufacturer), for COVID-19 Immunization. The following information was reported: CARDIAC DISORDER (non-serious), outcome "unknown", described as "3 members of my family who had Heart problems after taking the vaccines". Additional information: According to the reporter, these vaccines were dangerous. Just look at then news and you see all the healthy people dying from heart failure. The reporter had 3 members of my family who had heart problems after taking the vaccines.  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-PV202300014688 same reporter/vaccine/event, different patient;US-PFIZER INC-202300034770 same reporter/vaccine/event, different patient;
This spontaneous report as received from a physician concerns a patient who received the last dose of GARDASIL (lot #, dose and route not reported) in November of 2011 (last dose was reported to be the second dose of GARDASIL (lot #, dose and route not reported) and the first dose a few months prior to the second dose (exact date of first dose was unspecified, but reported to be more than 2 months prior to the second dose). The physician reported that the patient received both prior doses of GARDASIL at another facility (name of the facility was unspecified). The patient was in the physician's office today (06-MAR-2013) to receive the third dose of GARDASIL (lot #, dose and route not reported). No adverse event reported. Additional information is not expected.
I received the shot on Friday and had some soreness in my left arm that night and a lot of tenderness the next day, I couldnt even lean on my arm without feeling pain.  On Sunday, I woke up feeling like every muscle in my body hurt and had a fever by that night, I also have had diarrhea, chills, a rash, tiredness, and head ache.  On Monday my fever was up to 102.  It is now over a week later (Saturday September 15th, 2007) and I still have not gotten rid of cramping and diarrhea.  I was perfectly healthy before I got the shot.  I had to leave work early on Monday because I was still too miserable to handle it.
p/ pt recv vax approx 2 yrs later devel 30 pox.
This is a spontaneous report from a contactable nurse. A 17-year-old female patient received her first doses of TRUMENBA (Lot Number: S26985, Expiry date: 31Jan2019) at 0.5mL single IM injection left deltoid at 1:30 PM on 24Jan2018 as Prevention of meningitis B; HAVRIX (Manufacturer: GlaxoSmithKline, Lot Number: ZK374, Expiry date: 19Mar2020) at 0.5mL IM injection in right deltoid at 1:30 PM on 24Jan2018 as prevention of hepatitis A; GARDISIL 9 (Manufacturer: Merck, Lot Number: N010497, Expiry date: 15Jan2020) at 0.5mL IM injection in left deltoid at 1:30 PM on 24Jan2018 as Prevention of HPV; and her second dose of MENACTRA (Manufacturer: Sanofi Pasteur, Lot Number: U5839AA, Expiry date: 05Mar2019) at 0.5ml IM injection in right deltoid at 1:30 PM on 24Jan2018 as Prevention of meningitis A. Medical history included: allergic to bee venom (no other allergies). Patient received her first dose of MENACTRA. Concomitant medications were none. On 24Jan2018 at 1:30 PM, the patient received her vaccines. She stayed for a 15 minute waiting period and left the office at 1:45PM. At 7: 02 pm parent called reporting patient had significant upper lip swelling and some difficulty swallowing on 24Jan2018. Went to ER who noted significant upper lip swelling, throat and airway looked good; oxygen was 100%; tongue was not enlarged. When patient got to the ER, an IV was started and she was given SOLU-MEDROL, PEPCID, and BENADRYL by IV, (dosages for any of the medications that the patient received in the ER was unknown). She was observed for 1 hour in ER and nothing deteriorated but patient still complained of swelling. She was given another half dose of IV BENADRYL and oral dose of VISTARIL at that time. Patient had improvement so discharged home on oral Prednisone and ATARAX. She was fine the next day. Patient was not admitted overnight, she was discharged from the ER by 10:30PM 24Jan2018. The office followed up with the patient by phone the next day. She was not exhibiting any symptoms, so they did not request that she come to the office. Reporter did verify that the meningococcal group b rlp2086 and meningococcal vaccine a/c/y/w conj (dip tox) were given in different extremities. Events outcome was recovered on 25Jan2018.
Narrative:  PATIENT PASSED AWAY AT OUTSIDE NURSING HOME. UNSURE CAUSE OF DEATH BASED ON CHART REVIEW. Per chart review, this patients cause of death was not likely attributable to the COVID-19 vaccine.
This report describes the occurrence of swollen liver in a 13-year-old male who was vaccinated with hepatitis B vaccine recombinant (Engerix-B) for prophylaxis. This report was received from the pt's mother and has not been verified by a physician or other health care professional. The pt reportedly had no allergies. Concurrent conditions and medications were not reported. The pt's brother experienced an injection site reaction characterized by swelling, redness, inflammation, itching and tightness after receiving his 1st Engerix-B injection. On 09/17/2002, the pt reportedly received his 1st injection of Engerix-B (lot ENG5313A2). "Within a week" he experienced fatigue. Reportedly, he also experienced muscle pain, joint pain, general malaise and loss of appetite. His physician "ran a multitude of tests to rule out other possible causes (of the events)." Reportedly, he only found that the pt's liver was slightly enlarged and that the pt's bilirubin was slightly elevated. As of 11/22/2002, the events reportedly persisted. The Engerix-B immunization series was discontinued. This report has been linked to report A0387550A due to same family.
1-22-02 reaction started 1-23-02 red, raised. 4 inch long and 3 1/2 inches around hot to touch at DTaP site.
11/19/08 1200p Flu iz given--11/20/08 1200a pt awoke with itching, hives, periorbital swelling. 200p pt went to HC,given kenalog observed, released at 245p. Returned to HC at 400p with hives, tongue swelling, facial swelling,given epi,benadryl,started on zyrtec. Rx epipen. Drove home. 11/21/08 Recurrence of symptoms at home. Seen by PMD at emergency room and released. 11/22/08 Recurrence of symptoms, admitted to hospital on IV prednisone. 11/24/08 she remains hospitalized with plans to wean and discharge today. 12/10/08-records received-DOS 11/22-11/24/08-presented with history of facial rash and eye swelling, difficulty swallowing, seen in ED prior to this admission for these complaints. Started on steroids C/O feeling nauseated. Developed chest discomfort. Passed out at home, hives getting worse. Acute Allergic reaction with probably delayed hypersensitive reaction likely due to influenza vaccine.
Patient called on 10/08/19 and informed employee, he woke up on 10/6/19 (Sunday) and stated he had flu symptoms, then on 10/08/19 he had red blotches under arm pit as of 10/07/2019. He stated he was feeling the pain on 10/7/19 and saw red blotches on 10/08/19 when he looked in the mirror. Employee suggested to use Benadryl gel and tablets and to call MD in the morning. I called him on 10/09/2019 to see if he had followed up with his MD, he stated he did not and asked me to call his MD for him. Md's office stated that he had to call himself. On 10/10/19 his Nurse practitioner called and stated that he had shingles and his blisters were ready to pop out. She stated he was very infectious and was prescribed Valtrex 1gm ( 1 tablet tid).
soreness of arm; soreness around the shot area; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (soreness of arm) and VACCINATION SITE PAIN (soreness around the shot area) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 031L20A) for COVID-19 vaccination.     No Medical history was provided.  Concomitant products included LEVOTHYROXINE for an unknown indication.   On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MYALGIA (soreness of arm) and VACCINATION SITE PAIN (soreness around the shot area). At the time of the report, MYALGIA (soreness of arm) and VACCINATION SITE PAIN (soreness around the shot area) outcome was unknown.            Concomitants included Multivitamins once dialy Treatment information was not provided.
A report was received from a health care professional on 12Nov03, concerning an unspecified number of vaccinees under 4 years who have inadvertently received Fluvirin on unspecified date. On an unspecified date vaccinees under 4 years inadvertently received Fluvirin IM. The vaccinee did not experience any adverse symptoms at the time of reporting. There was insufficient information to determine the reporters causality assessment. Update 1, 07Jan04. A follow up report was received from a health care professional concerning a 2 year old male vaccine who inadvertently received Fluvirin on 07Nov03. On 07Nov03, the vaccinee inadvertently received Fluvirin. The vaccinee did not experienced any adverse symptoms at the time of reporting. No follow up pending, all information received. Multiple report cross reference with: PJP200301062, PJP200400063, PJP200400064, PJP200400065, PJP200400066, PJP200400067, PJP200400068, PJP200400069, PJP200400071, PJP200400072, PJP200400073, PJP200400074, PJP200400075, PJP200400076, PJP200400077, PJP200400078, PJP200400079.
Experience a lot of heat in my body and had intense tingles from head to toe. Started sweating profusely, then became very very cold. The nurse at the pharmacy took her temp and it was 95.3. Had to stay at drug store for an hour, then started feeling better and left.
pt exp numbness in hands 19NOV90; sharp pain in lt shoulder 22NOV90 @ noon; thigh pain Thursday in evening; Seen by MD 23NOV90;
Pt has swelling, redness, clean fluid weeping at injection site. Also claims injection site is "hot".
NO ADVERSE REACTION.  SHE HAD HISTORY DOSE OF MMR YEARS BACK.  PER POLICY SHE NEEDED MMR #2 DOSE AND 2 STEP TBST.   MMR# 2 DOSE WAS ADM 6/1/2022, THE SAME DAY AS TBST #1.  PER PPROTOCOL TBST #2 TO COMPLETE THE 2 STEP IS DUE 1-3 WEEKS AFTER THE FIRST NEG TBST.  NURSE ADMINISTERED TBST #2 6/17/2022. AFTER PLACING THE SKIN TEST NURSE REALIZED THERE IS SUPPOSE TO BE 4-6 WEEK INTERVAL BETWEEN LIVE VIRUS VACCINE AND TBST PLACEMENT AND IT HAD ONLY BEEN 2 WEEKS AND 2 DAYS SINCE MMR DOSE.  DO REACTIONS TO NOTE.
Small, dime size, raised red welt at injection site for Varicella (RA/SC). Welt appeared 10 days after injection.
pt recv vax 16OCT98 & 22NOV98 pt exp a local rxn @ inj site, about the size of a soft ball, hard to touch, red & itching; This is in follow-up to report(s) previously submitted on 03/01/1999. Information has been received from a physician concerning a 5-year-old Caucasian male with an allergy to amoxicillin who on 16-OCT-1998 and 20-NOV-1998 was vaccinated with the first and second dose of RECOMBIVAX HB IM respectively. On approximately 22-NOV-1998 the patient experienced a local reaction at the injection site approximately 4 inches in diameter which was hard to touch, red, swollen and itching. The patient experienced no rash. The patient was treated with ice, heat and BENADRYL. On an unspecified date, the patient recovered. No further information is available.
I have had repeated migraines and an increase in disrupted sleep to the point that this last migraine I cannot see straight or clearly my vision is really bad and I feel dizzy.