chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PNEUMOVAX 23 for pneumocaccal disease; Black eye; Sore arm; My eyes were hot after the shot; I received the first dose of PNEUMOVAX 23 in late 2020; This spontaneous report was received from a female patient reporting on herself, a 66-year-old female patient. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions, allergies or concomitant medications.  On an unspecified date in 2020, reported as "late 2020", the patient received the first dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) for pneumocaccal disease (strength, dose number, anatomical location, route of administration, lot number and expiration date were not reported).  On 17-DEC-2021, the patient was vaccinated with the second dose Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) in her right arm for pneumocaccal disease (strength, dose number, route of administration, lot number and expiration date were not reported). It was not on the exact date because she had received her COVID-19 vaccine and had to wait.  The same day, after the Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) vaccine, the patient had a sore arm (pain in extremity), and her eyes were hot after the shot.  The patient had tried not rubbing her eyes and she did not remember hitting her  eye. The patient did not know if she rubbed her eye or if she hit it while she was sleeping but her eyes were hot (abnormal sensation in eye) all day on 18-DEC-2021, reported as "Saturday" and when she laid down to go to bed. When she went to sleep, she did not have any other side effects but on 19-DEC-2021, also reported as Sunday, the patient woke up with a black eye that is a dark purple and looks horrible. I did not have this with the first dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) vaccine. Treatment was not given for the events.  The outcome of the events and the causal relationship between the events and vaccination with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) were not reported.
Report #2000027563-1 describes the occurrence of hallucinations in a child who rec'd Engerix-B. The report was from a physician. Allergies are unspecified. The pt has a pervasive developmental disorder (NOS) and a mood disorder. He takes clonidine (Catapres), fluvoxamine maleate (Luvox), and diphendydramine hydrochloride (Benadryl) On 9/1/00, the pt rec'd his first dose of Engerix-B. Four days later, on 9/5/00, he experienced hallucinations and screamed. The pt felt that he was being attacked by skeletons. He was then listless and lethargic for 3-4 additional days. Per the pt's mother, the pt had dilated pupils and dry mouth. The physician was unsure if the adverse events were related to Engerix-B. No treatment was given. As of 8/11/00, the outcome of the events is resolved.
given a dose reconstituted with MMR diluent; given a dose reconstituted with MMR diluent; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 28-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA721A, expiry date 31-AUG-2023) for prophylaxis.   On 17-MAR-2023, the patient received Menveo. On 17-MAR-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: given a dose reconstituted with MMR diluent) and inappropriate dose of vaccine administered (Verbatim: given a dose reconstituted with MMR diluent). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 29-MAR-2023 The supervisor reported one of her employees administered a dose of Menveo to a patient, reconstituting the dose with MMR diluent instead of the supplied CYW-135 liquid conjugate.   At the time of reporting, a repeat dose had not been administered. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. The patient was given a dose reconstituted with MMR diluent, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Shingles outbreak in multiple unilateral and linear areas on upper back and chest. This has never occurred before until reported. I had Mononucleosis in 1988.
3cmx3cm macular erythema on thigh and 1cmx0.5cm inguinal node reactive 2" to Varivax.
Three days after the vaccination I felt bad, but I thought that the symptoms were normal, due to the vaccine, until I saw small rashes on my leg and arm, which grew over time. I went to pharmacy where I got the vaccinated and they said "we are sure something had bite you", days later on July 6, 2021 I got to the emergency room because the rashes were bigger, the fever, the body pain, the pain in the eyes and my eyes red, When I arrived they made different types of blood tests, during that time they gave me pain reliever and a saline lock IV. I was discharged home and continued treatment with Doxycycline Hyclate twice a day for 10 days. They told me to make an appointment with a dermatologist and an allergist, the next day I woke up worse, my legs were completely red and in a lot of pain I could not get my legs out of bed, I had an appointment with my Doctor on Thursday June 8, 2021 and I waited to see him, that day I prescribed prednisone 20mg and improve.
+  Homan?s Sign Right upper LE localized tenderness  Warm to touch No MCR part A until 7/1/21 so not sought tx  Taking ASA 325 mg qd Thigh high compression Leg elevated/ bedrest
The day after vaccine was given, pt experienced the usual fever and chills but also experienced significant dysarthria.
Redness/rash/warmth from just below the injection site down to the elbow. No fever. Some soreness.
Pt stated the day after that her arm was sore- I advised her that this was normal for a few days after given an intramuscular shot. I told pt to call be back to next day if it still hurt and I never heard from her. I told her to take MOTRIN to relieve soreness.
Felt tired a day after the first shot for a day and felt tired for 3 days after the second shot.
This spontaneous report was received from a certified medical assistant (also reported as healthcare worker) refers to a female patient of unknown age with no pertinent medical history and drug reactions/allergies. On an unknown date the patient was vaccinated with MMR II (lot #, expiration date and route not reported). Concomitant medications included birth control pills (unspecified). The patient had received unknown number of doses of MMR II on an unspecified date. On an unknown date the patient experienced equivocal titer results for rubella. The event did not resolve at the time of this report. The patient sought an unspecified medical attention. Causality was not reported. Additional information has been requested.
First experienced swelling and redness at injection site. Also was hot. Now swelling has gone away and is only lightly warm. She did not feel she needed to see MD.
Swelling, redness and pain at L deltoid muscle, beginning about 10 hours? after vaccine given.  Also, feeling quite tired. Today is 2 days post-vaccination and swelling and tiredness are slowly beginning to lessen.
Area where I had the shot is swollen; Shoulder area where the shot was put is swollen; Swelling and pain on left shoulder; Pain radiated to right shoulder; This is a spontaneous report from a contactable consumer (patient) reported. A 88-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EP7534, Expiration date: unknown), via an unspecified route of administration, administered in Arm Left on 26Mar2021 (age at vaccination was 88 years) as dose 1, single for COVID-19 immunization. The patient previously included ongoing high blood pressure and breathing from an unknown date. Concomitant medication included tiotropium bromide (SPIRIVA) taken for Breathing from an unspecified start date and ongoing. On 26Mar2021 the patient experienced swelling and pain on left shoulder and pain radiated to right shoulder. On an unspecified date the patient experienced area where she had the shot is swollen; shoulder area where the shot was put is swollen. Patient had the injection, clarified as the Pfizer Covid-19 injection today, 26Mar2021, and she was having issues on her left side. On her left shoulder and it's swollen, the pain radiated over to her right shoulder. Patient clarifies that it is not swollen on right side, it is just swollen on the left side. Patient can feel the swelling on the left side. Patient was unable to provide an outcome as she cannot really say. She can still feel it for the swelling and pain on left shoulder. Patient takes a lot of medications and declines to go through medications at this time. The area where patient had the shot was swollen. The outcome of the events swelling and pain on left shoulder and area where patient had the shot was swollen; shoulder area where the shot was put was swollen was unknown. The outcome of the event swelling and pain on left shoulder was not resolved, and pain radiated to right shoulder was resolving and unknown for other event.  Follow-up attempts completed. No further information expected
Sore arm; Body aches; Headache; Chills; Quick jabbing (needle pricking) pain that lasted for just a second on right side of back skull and repeated every 5 minutes or 10 minutes mostly for about 5-6 hours until I fell asleep.; This is a spontaneous report from a contactable consumer, the patient. A 53-years-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the left arm on 30Apr2021 at 08:45 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. Medical history included migraine (due to hormone). The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medications included sumatriptan (MANUFACTURER UNKNOWN), 100 mg for unknown indication, from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the left arm on 03Apr2021 at 08:30 (at the age of 53-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine.  It was reported that patient experienced after 36 hours of second vaccine, on 01May2021 at 22:00, the patient experienced quick jabbing (needle pricking) pain that lasted for just a second on right side of back skull, and repeated every 5 minutes or 10 minutes mostly for about 5-6 hours until I fell asleep. After waking up next morning (48hours after the shot), had only one jabbing pain. On 02May2021 the patient experienced sore arm, body aches, headache and chills after about 18 hours. By 28 hours after, she was feeling almost normal except some arm soreness until this back head needle pain started. she had taken one Tylenol after 27 hours due to minor forehead headache, and headache was gone soon. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the headache which included treatment with tylenol. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event body aches and chills, quick jabbing (needle pricking) pain that lasted for just a second on right side of back skull, and repeated every 5 minutes or 10 minutes, jabbing pain and body aches was recovered in Apr2021. The clinical outcome of the event sore arm was not recovered at the time of report.  No follow-up attempts are needed. No further information is expected.
Soreness in her arm, feet and leg after vaccination; Soreness in her arm, feet and leg after vaccination; This is a spontaneous report from a contactable female consumer (reporting for herself). A female patient of an unknown age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: UNKNOWN), via an unspecified route of administration on 30Mar2021 as a single dose for COVID-19 immunization. The patient's medical history included blood clot in leg. The patient's concomitant medication included warfarin 5mg daily for history of a blood clot in her leg (per patient) and the patient did not realize she was supposed to notify the vaccination provider that she was on blood thinners prior to receiving the vaccine. The patient wanted to know if she should be concerned about being on a blood thinner and receiving the Pfizer COVID-19 vaccine tomorrow or why this was on the Fact Sheet. It was reported that vaccinating persons with increased bleeding risk, providers often avoid giving intramuscular injections (not just this vaccine) or choose alternative routes because of the risk for hematoma formation after injections. The Pfizer-BioNTech COVID-19 Vaccine can only be administered as an intramuscular injection. On an unknown date, the patient experienced soreness in her arm, feet and leg after the first dose of the Pfizer COVID-19 vaccine, she was asking if she would be sore after her second dose and how long that will last. The patient want to know if the timing of the second dose of the Pfizer COVID-19 vaccine must be 3 weeks after the first dose was given. The clinical outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Patient was vaccinated 1 week too soon. Should not have received 2nd dose until on/after 11/19/21.
Patient said she experienced flu-like symptoms as well as nausea, vomiting, and diarrhea, and several welts on the same arm she received the vaccinations. She reported this to the pharmacy six days after receiving the shots and stated she was still a bit fatigued and had a mild rash on her right arm, but was no longer experiencing the other symptoms.
Patient injection site swelled immediately. Injection site was very itchy. Vaccine leaked out of injection site. I removed the syringe from patient's arm and discarded remainder in sharps container.
Pt reported arm redness in a half-band around her arm, warm to the touch, and some swelling starting Sunday night.  Went to primary care provider on 1/27/2020, provider stated the vaccine may have been administered lower than desired or may have hit a vessel, prescribed steroid.  Thursday morning pt reported reduced redness, reduced swelling.
Petachial Rash on lower legs.  Bruising with lace like pattern on abdomen.
Info has been received from a registered nurse concerning a pt who was vaccinated for the 1st time with a dose of pneumococcal vaccine 23 polyvalent (Lot #641532/1353L). Concomitant therapy included "some type of allergy medicine" including loratadine (CLARITIN), cetirizine hydrochloride (ZYRTEC) or fluticasone propionate (FLONASE). Subsequently the pt experienced a lot of pain in the axilla (injection was given in the deltoid) and had an episode of vomiting the night after receiving the vaccination. The pt sought unspecified medical attention. Additional info has been requested.
Information has been received from an office manager concerning a 61 year old female who on 01-OCT-2007 was vaccinated with a dose of Zostavax. There was no concomitant medication. On 02-OCT-2007 the patient developed swollen glands and on 03-OCT-2007 the patient experienced fever. Unspecified medical attention was sought. it was reported that the patient's husband was the physician in the same office. At the time of report the patient had not recovered. A product quality complaint was not involved. Additional information has been requested.
Paralysis legs intermittent; Disoriented; Malaise; Fatigue; Fever; A spontaneous report was received from a consumer concerning an 85-year-old, Asian, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fever (pyrexia), malaise, fatigue, disorientation, and intermittent leg paralysis (diplegia).  The patient's medical history included stroke and hypertension. No relevant concomitant medications were reported.  On 16 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 039K202A) intramuscularly for prophylaxis of COVID-19 infection. On the same day, the patient experienced symptoms of fever, malaise, fatigue, disorientation, and intermittent leg paralysis.   Treatment for the event included acetaminophen.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome for the event fever and disorientation was reported resolved on 20 Jan 2021.The outcome for the event paralysis legs intermittent was reported resolved on 22 Jan 2021. The outcome for the event fatigue and malaise was reported as resolved on 23 Jan 2021.; Reporter's Comments: Very limited information regarding this events has been provided at this time.  Further information has been requested.
This is report # 1 of 3, one for each Gardisil administered.  Mother stated to me on 05/18/07, that 24 hours after Gardisil vaccine, patient had fever, and then developed flu-like symptoms.
Reconstituted with a non-GSK solution; This case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 4-month-old patient who received Rota (Rotarix lyophilized formulation) (batch number 7L2D7, expiry date 24th February 2021) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 9th December 2022, the patient received the 2nd dose of Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On 9th December 2022, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced wrong solution used in drug reconstitution. On an unknown date, the outcome of the wrong solution used in drug reconstitution was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 13-Dec-2022 Reporter's comment: The reporter consented to follow-up. Additional supportive information: The patient received a dose of Rotarix which was reconstituted with a solution that was not provided by GlaxoSmithKline, which led to wrong solution used in drug reconstitution.
COVID-19 vaccine for age 5-11 years with beyond use date of 1/31/2022 was administered on 2/16/2022. Pfizer-Biontech for sent to assess beyond expiration date excursion of 16 days
Vasovagal syncope- immediately after injection of the vaccine, patient felt light-headed and transiently loss consciousness (experienced vasovagal syncope). Pt regained consciousness within 1minute of episode and subsequently felt nauseous and turned pale. Pt was laid done on exam table and his blood pressure was immediately taken. First two readings were inconclusive/unable to detect BP either due to machine error or hypotension. After 5 minutes BP. Reading was 85/43. Pt was given water and elevated his legs. Waited in the exam room for another 10 minutes. Physician rechecked his vital signs and observed as being normotensive (90/57) with a pulse of 68 bpm. No further complications or adverse affects were noted when patient left office 25 minutes after the injection was given.
sever leg pain; She has pain in the legs, hips and groin area; She has pain in the legs, hips and groin area; severe headache; intense chills; needle pain started after the vaccine which comes and go/ in the whole body, arm legs, chest, back, ankle.; second dose was  more colorful; second dose was  more colorful; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received second dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number was reported), via an unspecified route of administration on 25Mar2021 as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history included vision changes about 3 years ago. Concomitant medications were reported as none. Historical vaccine included first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number was reported), via an unspecified route of administration on 04Mar2021 for COVID-19 immunization. On 25Mar2021, the patient reported that second dose was more colorful and experienced random pins and needle pain started after the vaccine which comes and go, it is in the whole body, arm legs, chest, back, ankle. On an unspecified date, the patient experienced sever leg pain which was unbearable for 2-3 days, pain in the legs, hips and groin area, next day woke up with severe headache and intense chills. The patient reported that she was seeing a neurologist for random pins and needle pain. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
When seen for a well visit - Patient reports that she feels like she has had some dizzy spells at times and fainted once at school (not with exercise) - she currently says that she gets fatigued a lot more easily and has palpitations with exercise now - this has been going on for a few weeks; Will have some chest tightness and pain when it happens, but she feels fine right now. This started a few weeks after her last COVID vaccine dose, which was received elsewhere. She has never had asthma issues and did not need an inhaler except when she had bronchitis in the past. This is happening during inside workouts.
Redness, soreness, swelling, heat after 2 days - treatment - CEPHALEXIN 500mg.
pt recv vax 30DEC97 & devel T101 on 31DEC97 & 1JAN98;devel T103.3 had febrile sz lasting 2-3min;dx pharyngitis/URI;
I first gave the patient her Pfizer booster shot in her left arm with nothing remarkable happening, and the patient did not seem in distress.  Shortly after I was administering her Fluzone vaccine into her right arm, and within seconds she whispered that she thinks she is going to faint, and almost immediately lost consciousness.  She was seated and I was able to catch and hold her head upright, and she started convulsing and clinching her teeth while unconscious.  This lasted approximately 60 to 90 seconds.   My technician called 911 while I was assisting the patient.  When she eventually came to, she asked if she had a seizure.  She was not completely aware for another few minutes, and felt nauseated.  Eventually squad came and assessed her, and the patient refused to be taken to the hospital.  She called her father and waited for him to pick her up and take her home.
EMPLOYEE RECEIVED HEP B ON 8/23/2011. DONOR PASSED ON 9/1/2011. UNKNOWN IF SHOT ASSOCIATED WITH DEATH.
Administered Varicella vaccine #2 in patient right deltoid. A hive appeared immed. after injection (before a bandaid could be applied) Patient c/o itching. Phone physician and he ordered cool compress and benadryl 25 mg po. Hive on larged to size of a dime and 30 minutes after injection-hive was almost gone and not itching.
Nausea, diarrhea, abdominal cramping, fever, burning at the site of injection and chills
Patient called in late November reporting decreased range of motion in the vaccination arm since about a week after receiving her second shingles vaccination.