chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 03-Jul-2018 regarding an unsolicited valid serious case received from nurse. This case involves a 16 years old female patient who experienced hives, swelling of tongue and swelling of face and extra dose administered while she received vaccine MENACTRA. The patients past medical history, medical treatment(s) and family history were not provided. Concomitant medication was not reported. On 21-Jun-2018, the patient received a 0.5 ml second single dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot U5848AA (Exp: 31-Mar-2019) via unknown route in the left arm. On 03 Jul 2018, The patient developed a serious tounge and facial swelling without respiratory distress (swelling face) 12 days following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. This event was assessed as medically significant. On 03 Jul 2018, The patient developed a serious tounge and facial swelling without respiratory distress (swollen tongue) 12 days following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. This event was assessed as medically significant. On 03 Jul 2018, The patient developed a serious adverse event which started with generalized hives from "head to toe" (urticaria) 12 days following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. This event was assessed as medically significant. It was reported that patient had Menactra with first dose on an unknown date and she did not report any problem with first dose. It was also a case of extra dose administered. Final diagnosis was hives, Swelling of tongue, Swelling of face and extra dose administered. As corrective treatment her mother gave Claritin and she went to the Urgent care who sent her to the Emergency room (ER). The ER doctor gave her Benadryl and steroids and it resolved. The patient outcome is reported as Recovered / Resolved on an unknown date for hives, as Recovered / Resolved on an unknown date for tounge swelling and as Recovered / Resolved on an unknown date for facial swelling. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error; Sender's Comments: Patient experienced hives, Swelling of tongue and Swelling of face 12 days after vaccination. Time to onset is compatible with the role of vaccine. However, further information including patient's medical history, concomitant medications, previous vaccination and tolerance, laboratory investigations excluding other etiology would be needed to fully assess this case. Based on available information the role of vaccine cannot be assessed.
Information has been received from a pharmacist referring to her 11 year old daughter who had no drug allergies/reactions. The patient had a complete blood count drawn on 24-DEC-2014, which showed that her white blood cell count was normal. On 13-JUL-2015 the patient had her first dose of unidentified Merck HPV vaccine administered (name, lot number and dose were not provided) intramuscularly. Concomitant therapy included an unspecified meningococcal vaccine (manufacturer unspecified) which was also vaccinated on the same date. The patient had a routine follow-up complete blood count drawn on 04-SEP-2015 which showed that her white blood cell count was low (pharmacist stated the report did not include an actual value). No treatment was given for the adverse event. The patient had not yet had another follow-up complete blood count drawn to determine whether this issue had resolved. The pharmacist stated due to this issue, she was uncertain at this point whether patient would complete the Merck HPV vaccine series. Additional information has been requested.
had screaming, crying, fever, rash; had abn liver function; extremely lethargic 10-15 days;
no one could be sure the child had a febrile seizure; many years ago an unspecified child had a reaction to the VARIVAX vaccine; This spontaneous report was received from a physician referring on a child, male patient of unknown age. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions or allergies were not reported.  On an unknown date (reported as many ages ago), the patient was vaccinated with with varicella virus vaccine live (oka/merck) (VARIVAX) and (MERCK STERILE DILUENT) (strength, dose, route of administration, lot number, expiration date and indication were not reported).  On an unknown date, the patient had a reaction to the vaccine (vaccination complication) but no one could be sure if the child had a febrile seizure (febrile convulsion).  The outcome of vaccination complication and febrile convulsion was not reported. The relatedness between varicella virus vaccine live (oka/merck) (VARIVAX) and the aforementioned events, was related and for the febrile convulsion was unknown.
the first couple of days just soreness in arm from elbow up the back of head. On Sunday 1/18 has a small rash on chest in the evening.  had a welp on wrist when I woke up still had small rash.  as the day went on the rash spread and became whelp from head down to top of legs.    when I got up at 12:30 am Tuesday morning due to itching I also had something like a hot flash and felt sick to my stomach.  I spoke with the doctor in the office on Monday.  was directed to take Benadryl at night and xyzal 5 mg in the morning.  also was given a Rx for triamcinolone acetonide cream USP 0.1%. which does help with the itch when it is applied.  the rash/hives are still spreading.
Severe muscle & nerve pain, dizziness, burning all over like fire, headache, weakness, stabbing pains, itching, horrible sweats esp. at night, arthritis, systemic nerve pain, depression, can't work or excercise.
Information has been received from a healthcare worker referring to an unspecified number of patients with unknown age and gender. On unknown dates the patients were vaccinated with doses of improper stored LIQUID PEDVAXHIB (lot # K025006, expiration date 22-JUL-2017) (dose and route were not reported). No adverse experiences reported. This is one of several reports received from the same reporter. Additional information has been requested.
Pt came into store and received a FLUVIRIN at 130pm on 9/15. Pt waited about 10-15 minutes before and seemed fine. Pt returned at 230-245 stating he had hives and trouble breathing. Called 911 immediately. EMTs showed up and took patient to ER.
approx 1/3 of the pts treated w/Engerix-B inject failed to respond or had borderline titer levels produced p/the 3rd dose; 60 to 70 pt have been treated to date;
Patient was standing about 10 minutes after the vaccine was given and had dizziness with brief syncope.  His vitals were assess and he was noted to have a low blood pressure that improved quickly.  He was alert and oriented after the syncope.  He was transported via EMS to the emergency room for monitoring and evaluation due to concern that he may have hit his head when he fell.  Patient also reported that he had not had anything to eat or drink the day of the vaccines.  His glucose was normal.
Pt recvd vax & 5 days following vax pt devel a localized, discrete, papular, rubella-like rash on the side of the neck & upper arm; No further details were provided;
VACCINE STORED AT INAPPROPRIATE CONDITION BEFORE ADMINISTRATION; This spontaneous report received from a health care professional concerned a 20 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808980, and expiry: 20-JUN-2021) dose was not reported, administered on 14-MAY-2021 10:19 for prophylactic vaccination. No concomitant medications were reported. On 14-MAY-2021, the subject experienced vaccine stored at inappropriate condition before administration. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of vaccine stored at inappropriate condition before administration was not reported. This report was non-serious.
Initial report received from a health care professional on 17 April 2007.  A male patient (date of birth, age not specified) complained of pain and soreness in the limb where he was vaccinated with Fluzone (lot number, route, site and date of administration not reported).  The symptoms have lasted "almost a year".  The patient's recovery status was unknown.
This spontaneous report has been received from a male consumer of an unknown age via a company representative reporting on himself. The patient's relevant medical history, concurrent conditions, and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX subcutaneously (strength, dose, frequency, lot number and expiration date were not reported) for prevention of shingles. Subsequently, on an unknown date, the patient felt a "bit funny" and he was not his usual self (feeling abnormal), he also was tired and sick. At the time of this report, the outcome of feeling abnormal, fatigue, and malaise was unknown. The causality assessment between feeling abnormal, fatigue, and malaise with Zoster Vaccine Live (ZOSTAVAX) was not reported. Additional information is not expected as there was no contact consent provided.
not feeling well; fever; weak; cold; tenderness / pain when touching her arm; incorrect dosing schedule; Bruising of arm; This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included INFLUENZA VIRUS VACCINE INACTIVATED (FLUZONE QUADRIVALENT) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of injection site pain (1st dose received on 11th September 2019, refer linked case US2019AMR189574). Concurrent medical conditions included shingles (2019).   On 15th October 2019, the patient received the 2nd dose of Shingrix. On 9th October 2019, the patient received FLUZONE QUADRIVALENT. On 15th October 2019, less than a day after receiving Shingrix, the patient experienced feeling unwell, fever, weakness, cold, pain in arm and drug dose administration interval too short. In October 2019, the patient experienced bruising of arm. The action taken with FLUZONE QUADRIVALENT was unknown. On an unknown date, the outcome of the feeling unwell and fever were recovered/resolved and the outcome of the weakness, cold, bruising of arm and drug dose administration interval too short were unknown and the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the feeling unwell, fever, weakness, cold and pain in arm to be related to Shingrix.  Additional information received were as follows: The patient received Shingrix on her right arm. The patient had pain when touching her arm which was unresolved. The patient did not feel well. The patient had 108 degree F. fever and was not feeling well overnight. The patient's fever resolved but she still felt weak, but better overall. The patient was also unbelievably cold at night after the second injection. The patient also received Fluzone Quadrivalent shot 2019-2020 on her right arm. The patient was questioning if her symptoms were related to the flu shot or the fact that she got the Shingrix vaccine too early. The patient also reported that she received the second shot of the Shingrix in her right arm where there was a bruise remaining from her Fluzone shot in the same arm. The reporter consented to follow up. It was unknown if the reporter considered the injection site pain, feeling unwell, fever, weakness, cold, tenderness, feeling abnormal and drug dose administration interval too short to be related to Fluzone Quadrivalent shot 2019-2020 as well.
10/18/2021 Pt called sore throat ,cough,chest congestion and headaches.  Exposure to COVID-19 virus   Registered Nurse Specialty:  Emergency Medicine Progress Notes    Signed Encounter Date:  10/19/2021 Patient is here for MAB Infusion O2 sats > or = 90%   Signs of potential reaction reviewed with patient.   Tolerated IV start and MAB infusion without complication.   Pt has access to pulse oximeter and thermometer for home monitoring
Swelling, pruritis L upper arm 1cm firm nodule at injection site. Shot given 10/09/2002- pt seen 10/15/2002 Pain , erythema at injection site. Itchy achy arm with red rash.
Had chest pain, and EKG elevation - initially thought STEMI- had cardiac catheterization which showed normal coronary arteries.  had troponin elevation with peak troponin 1.31.  ECHO showed focal WMA. Cardiac MRI showed LGE indicative of myocarditis.  Treated for acute myopericarditis, with Motrin and Colchicine for pericarditis. Symptoms resolved and was discharged
Pt. went home and took nap after vaccination. Woke up several hours later with throat closing. Went to ER with severe allergic reaction including numbness from waist-up, blurry vision, tachycardia, inflamed airway and extreme shortness of breath. Was treated with BENADRYL and IV steroids. Was released when symptoms resolved.
FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and batch number: 1805022 expiry: UNKNOWN) dose was not reported, administered on 12-MAR-2021 17:30 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 103 F, 100 F. On 13-MAR-2021, treatment medications included: paracetamol. On 13-MAR-2021 02:00, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever. This report was non-serious.
R09.02 HYPOXIA 4/26/2023 COPD (CHRONIC OBSTRUCTIVE PULMONARY DISEASE)
Pt recv Lymerix booster 15-Oct-99, around ovulation day. Last period 1-Oct. 7-Dec-99 pt now 9 wks, 3 days pregnant saw dr. Found she miscarried.  Scheduled D&C same day. Has 2 children, had norm pregs, no miscarriages.
Two Hours Post-Vaccination (4/8/21) - 36 Hours Post-Vaccination (4/10/21) - Heavy & achy feeling in right leg (thigh, lower leg and ankle), achy feeling in right neck/shoulder, mild fatigue and slight headache.   36 Hours Post-Vaccination (4/10/21) -  present (4/18/21)  - Heavy & achy feeling in right leg continues. If I sit for more than 30 minutes, I feel the need to stand & walk around. Otherwise, it is a very uncomfortable, achy feeling in my right leg if I continue to sit. Right side of neck & right upper back (near shoulder & neck) continue to feel achy as well.  4/17/21 - 4/18/21 - Intermittent tingling in right hand.
Nausea, lightheadedness, near syncopal episode, fevers, joint pains, headache
Partial dose [Underdose] Luer locking device on the barrel back sprayed on me/needle on the luer lock and the luer lock piece came off/popped off of the leur lock [Syringe issue]  This spontaneous case, initially received from a pharmacist on 01-Nov-2018, concerns a 72-year-old, elderly female patient.   The patient had not received any other vaccines.   It was reported that during administration, when the needle was put into the luer locking device which was secure, luer locking device on the barrel back sprayed on the reporter and the PFS vaccine medicine was sprayed out. The needle on the luer lock and the luer piece came off. It was not a bad luer lock, but it just popped off the luer lock. The syringe was damaged near the luer lock (explicitly coded as syringe issue). There were no signs of leakage.   On 01-Nov-2018, the patient was administered a partial dose of FLUAD TIV [influenza vaccine, inactivated influenza virus surface antigen (subunit), egg-derived, MF59, route of administration: intramuscular, anatomical location: deltoid, batch number: 250783, expiry date: 30-Apr-2019 and dose: not reported] (explicitly coded as incomplete dose administered) for influenza prophylaxis.   No adverse events were reported after vaccination.   The reporter assessed this case as non-serious.   Follow up received from a pharmacist on 01-Nov-2018: The patient's date of birth, age (72 years) and gender (female) was added in the patient tab. The product start date (01-Nov-2018), route of administration (intramuscular), anatomical location (deltoid), expiry date (30-Apr-2019) and indication (influenza prophylaxis) was added in the product tab. The event onset date (01-Nov-2018) for all the events was added in the event tab. The narrative was amended was amended accordingly.
This spontaneous report was received from a nurse prescriber via a Company representative, referring to a female patient of unknown age. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unknown date, the patient was vaccinated with her first dose of GARDASIL or GARDASIL 9 (it could not be confirmed which vaccine was administered) (lot#, frequency and route of administration were unspecified) for prevention of HPV (Human papilloma virus) (prophylaxis), and fainted as soon as the injection was administered. The patient was in the office at the time the adverse event occurred, and was fine within 20 seconds (recovered).  No treatment was administered for the patient's experience. It was reported that no intervention to prevent serious criteria was necessary, that syncope was not significant disability or incapacity or life threatening, and the patient was not hospitalized. No product quality complaint was involved. The relatedness assessment between syncope and GARDASIL or GARDASIL 9 was not provided. Additional information has been requested.
Patient became extremely dizzy, reported back to pharmacy then vomited. Symptoms began approximately 10 minutes after receiving the vaccine. He was given meclizine 25mg x2 for dizziness/unsteadiness. Approximately 20 minutes after this initial symptoms patient vomited again but stated he was less dizzy than initially.  Symptoms gradually resolved and patient left the store feeling mostly normal approximate 70 minutes after receiving the vaccine.
Pain Limited movement of right arm/Pain in bicep radiating to scapula/. Unable to do ADL?S saw my NP on Sept 28 due to severe pain, and unable to use right arm without severe pain.PT ordered. No. Relief to this date Of. 10/09/2020.  I have had 2 PT appointments.  No change even with Mild Passive exercises.
This case was reported by a consumer via call center representative and described the occurrence of neuropathy peripheral in a 75-year-old female patient who received SHINGRIX. The patient's past medical history included depression. Concurrent medical conditions included cholesterol. On 20th April 2018, the patient received the 1st dose of SHINGRIX. In April 2018, 1 day 2 hrs after receiving SHINGRIX, the patient experienced fatigue and activities of daily living impaired. On 20th April 2018, the patient experienced neuropathy peripheral (serious criteria GSK medically significant), pain, discomfort and insomnia. In May 2018, the patient experienced pimples. On an unknown date, the patient experienced rash acneiform. The patient was treated with VALIUM and TYLENOL. On 21st April 2018, the outcome of the pain was recovered/resolved. On an unknown date, the outcome of the neuropathy peripheral, fatigue, activities of daily living impaired and pimples were not recovered/not resolved and the outcome of the discomfort, insomnia and rash acneiform were unknown. The reporter considered the neuropathy peripheral, pain, fatigue and pimples to be related to SHINGRIX. It was unknown if the reporter considered the discomfort, insomnia, activities of daily living impaired and rash acneiform to be related to SHINGRIX. Additional information was received as follows: The patient received concomitant products included LEXAPRO generic and Statin. On 20th April 2018, at 01:00, the patient received SHINGRIX on right arm. On 20th April 2018, at 03:00, 2 hrs after receiving SHINGRIX, the patient experienced neuropathy which was down her arm, across her shoulder and down her spine and pain. On 21st April 2018, the patient experienced fatigue at (03:00 hrs) and activities of daily living impaired. The patient took VALIUM but it did not help and she drank some scotch but that only made the pain worse. Three to four days before the reporting date, the patient started to experience a breakout on her face. The patient described it as looking like pimples. They are scattered all over her face. The patient was noticing that there were new spots every day. The patient stated that neuropathy and fatigue were not as severe, but they were still there and still affecting her daily life and kept her from doing some things. The patient had spoken to her physician who told her not to do anything and would check on her weekly.
Spontaneous rashes on neck, chest, arms and hands. Dermotographia developed over the next 10 days. Never before had these symptoms, and allergist can?t identify any cause.
may have been given 3 doses of Shingrix; This case was reported by a consumer via call center representative and described the occurrence of extra dose administered in a 66-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date) and Shingrix (received 2nd dose on an unknown date).   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were provided as follows: The reporter was the patient. The patient received 3rd dose of Shingrix, which led to extra dose administered. The patient had usual side effects.
8 hours after vaccination: Body aches Fever Diarrhea  Headache....... all lasted for 12 hours
11/10/06  PHONE CALL REPORTING REDNESS, INFLAMMATION, SWELLING NOTED TO WRIST.  AUGMENTIN 875 BID X 7 DAYS ORDERED.