chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Unknown which patient may have received an inappropriately reconstituted dose; Unknown which patient may have received an inappropriately reconstituted dose; This case was reported by a nurse via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA415A, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The nurse reported that within the past month, It was discovered that in a box of Menveo, there was one vial of Men A and two vials of Men CYW.  It's unknown which patient might have received an inappropriately reconstituted dose of Menveo. It's also unknown if the second vial of Men A was damaged / lost etc or administered to a patient with the wrong diluent, which led to possible inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consent to follow up.
This case was reported in a Litigation report, from a physician concerning a 16 weeks old female patient who on 12-JAN-2005 was vaccinated with a second dose of RECOMBIVAX HB. Concomitant suspect therapy included DTaP, Hib (unspecified carrier) (manufacturer unspecified) and Polio (manufacturer unspecified). On 13-JAN-2005 the patient's parents brought her to the emergency room with a fever and reduced movement of her legs. The admitting diagnosis was occult bacteremia. A hospital summary stated that the principal diagnosis was reaction to diphtheria and tetanus toxoid immunizations. Another physician eventually diagnosed the patient with residual delays and encephalopathy-related adverse reactions to her second set of vaccinations, developmental delays (communication, social, adaptive, fine motor, and self help), possible hyperacusis (over-sensitive hearing) which could be due to abnormal central auditory processing, mild generalized hypotonia and poor body awareness, sensory processing dysfunction, developmental coordination disorder, sleep disturbance, mood swings, mild temper tantrums, social and separation anxiety, and obsessive compulsive traits. Another expert physician said that the patient's developmental delay seemed minimal, with no evidence of a static or progressive encephalopathy. The patient developed a transient fever and her failure to move her legs was a local reaction to the vaccinations and not from damage to her central or peripheral nervous system. Special Master stated that the patient's delay appeared to run in the family, other factors unrelated to vaccination included insufficient nutrition during the ages of five to eleven months and family history of speech delay and immaturity in adaptive and emotional skills. No further information is available.
Initial information received on 12-Nov-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves unknown gender and age of patient who experienced injection site redness, while he/she received vaccine Influenza Vaccine. The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided. At the time of the event, the patient had ongoing Food allergy (egg allergy).  On an unknown date (last year), the patient received a dose of suspect Influenza Vaccine produced by unknown manufacturer lot number not reported via unknown route in unknown administration site. On an unknown date, patient developed a non-serious injection site redness (injection site erythema) unknown latency following the administration of Influenza Vaccine. Lab data was not reported. Final diagnosis was injection site redness. It was not reported if the patient received a corrective treatment. The outcome of event of injection site redness was not reported. Documents held by sender: none.
Left Lower side of mouth swollen and inflamed gums extremely painful.  Then top right back gums also inflamed an swollen and bleeding .  Several taste buds  at the front of my tongue inflamed and very sore when tongue hitting back of teeth.  Finally sores behind bottom lip, one scabbed.    About 4 adverse mouth issues lasting a good week.  Day 10 and sores behind bottom lip still healing.
Information has been received from a pharmacist concerning a 73 year old female who on 24-DEC-2007 was vaccinated SC with a dose of Zostavax (Oka/Merck).  On approximately 11-JAN-2008 the patient developed transient, red spots that tingled.  It was reported that the spots were not blister like but appeared more like a rash.  The spots often appeared after exercise and generally disappeared after 2 days then reappear.  The spots also were reported to appear on different parts of the patient's body and not always the same location.  The patient was not seen by her physician.  No diagnosis were made.  The exact onset was unspecified but the patient was aware of the rash for at least 2 weeks.  At the time of report the patient had not recovered.  A product quality complaint was not involved.  Follow-up information received by the pharmacist indicating that the lot # of the vaccine was (658862/1415U) and it was administered on 24-Dec-2007 at 2:00 pm.  On 27-Dec-2007 at 11:00 the patient called the pharmacy to report that she was experiencing "flu-like symptoms", diarrhea and nausea.  It was unknown if the patient recovered.  On 25-Jan-2008, the patient called the pharmacy to report she was getting "transient red spots on her arms and legs that would tingle (mostly after she exercised) and then go away after a couple of days."  These particular events were originally reported with an onset of approximately 11-Jan-2008.  No further information is expected.
PT COMPLAINS OF RASH, FEVER, HEADACHE, SWELLING AND CHILLS THROUGHOUT THE EVENING AND CONTINUING THROUGH 24 HOURS AFTER VACCINATION.
vaccination to patient with improperly stored vaccine; No additional adverse events reported; This spontaneous report was received from a nurse referring to a currently 2-month-old patient of unknown gender. The patient's pertinent medical history, concomitant medications, and previous drug reaction or allergies were not reported.  On an unknown date of 2020, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) at a dose of 0.5 milliliter, for prophylaxis (route of administration, vaccination scheme frequency, anatomical location, were not reported; the lot number and expiration date were unknown by the reporter). The administered dose of the vaccine experienced a temperature excursion which went from 28 degrees Fahrenheit (F) to 33.9 (F), and then to 50.2 F in a timeframe of 7 hours and 10 minutes. There was not previous temperature excursions and the data logger was not involved. There was no adverse event reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2009USA009426: US-009507513-2009USA009550:
This case was reported by a pharmacist via a sales representative and described the occurrence of injection site pruritus in a subject of unspecified age and gender who was vaccinated with FLUARIX. On an unspecified date the subject received unspecified dose of FLUARIX (unknown). At an unspecified time after vaccination with FLUARIX, the subject experienced injection site pruritus. At the time of reporting the outcome of the event was unspecified.
Dizzy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 89 year-old female patient received bnt162b2 (BNT162B2), administration date 06Mar2021 (Lot number: EN6202) at the age of 89 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Diabetic" (unspecified if ongoing). Concomitant medication(s) included: GLIPIZIDE taken for diabetes mellitus; METFORMIN taken for diabetes mellitus; INSULIN taken for diabetes mellitus. Vaccination history included: Bnt162b2 (First dose), administration date: 15Feb2021, when the patient was 88 years old, for Covid-19 immunization. The following information was reported: DIZZINESS (non-serious) with onset 11Mar2021, outcome "recovering", described as "Dizzy". Therapeutic measures were not taken as a result of dizziness.  Additional information: Clinical course: It was reported that patient had her second shot on last Saturday (06Mar2021) and yesterday she was quite dizzy during the day and she was also a diabetic (medical history) so that's not unusual for her because some times when her sugar was low then she have a dizzy spell but it persistence to go on for rest of the day and then in the evening it was subsided but this morning when she got up she still dizzy. Patient stated that she had full of problems. When probed for any laboratory test, patient stated, she was scheduled for an appointment, but she hasn't had any blood work recently. Consumer stated, yesterday she slept better in the evening she hoped it would go away, she feels better already.  No follow-up attempts are possible. No further information is expected.
Only sore arm(extreme); This is a spontaneous report received from a contactable consumer (Patient) as part of Pfizer-sponsored program. A 77-Year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) administered in Left arm (Lot number EN5318), via intramuscular route of administration on 04Feb2021 10:30 AM as single dose, second dose administered in Left arm (Lot number EN6202), via intramuscular route of administration on 25Feb202110:15 AM as single dose at the age of 77 years for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient received two Cortisone injections in the shoulders and wants to know if it's ok to get the Cortisone shot while taking the vaccine. The event outcome unknown.  Additional information: On 25Feb2021, the patient again experienced sore arm.Patient medical History (including any illness at the time of vaccination)was none. Prior vaccinations (within 4 weeks) was None.Concomitant drugs was none.  Information on the lot/batch number has been requested.  Follow-up (16Apr2021): This is a follow-up spontaneous report from a contactable consumer. Updated information included: Patient age at the time of vaccination, Lot number, Administration time, Anatomical site of injection, Route of administration for dose 1, dosage regimen for dose 2.  No follow-up attempts are possible. No further information is expected.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Chill and fever (over 100 F) by the following morning, and coughing
On 3/14/00, the pt had a viral illness with fussiness and discomfort. On that same day, he received Extendryl and Comvax. He takes Tylenol.  On 3/14/00, the pt received an injection of Infanrix. On 3/14/00, the pt experienced constant irritability, a worsening of his baseline condition, after receiving his immunizations. The pt developed a fever greater than 104 degrees rectally. The pt was seen in a clinic as a first time pt on the day of admission (3/15/00) with extreme excessive irritability, extremely difficult to console. At that time, the fever was greater than 104. Due to the excessive irritability and  marked febrile illness, the pt was admitted for observation and further care.  At the time of admission, temp was 103/3, pulse 136, respiratory rate 40 even and unlabored. He was discharged on 3/17/00 with final diagnoses of irritability and reaction to DTaP.  He was treated with IV fluids and Tylenol. further treatment of pt during hospitalization is unknown as hospital discharge summary was not provided.  The most recent information received 4/27/00 reports the condition of the pt as fully recovered.
2 days following receipt of AVA #4: new onset SOB, chest tightness, palpitations, dizziness, sweaty hands lasting 1.5 hrs with residual feeling of fatigue; these symptoms recurred at least once daily and lasted for slightly over a month but no recurrence since returned Feb 2009; 4 days post vaccination: new onset right eyelid swelling with scaling but no redness/pain/discharge; itching/burning red rash over forehead, nasal bridge, cheeks, & behind ears (same distribution of underlying chronic seborrheic dermatitis); "red & white spots" over chest; recurrent stomach cramps without N/V/D/constipation; new sensation of dysphagia "like tennis ball stuck in throat" no choking on liquids/solids; 2 weeks later he represented to the ER with recurrent SOB, persistent rash, & eyelid swelling; medical evaluations in theatre yielded reportedly normal labs & CXR; diagnoses included viral conjunctivitis, stress, possible allergic reaction to unknown agent, GERD, abdominal pain, dysphagla; prescribed ALLEGRA, BENTYL, eye drops, inhaler with incomplete relief; Seen by dermatologist early Mar 2009 who prescribed DESONIDE cream for facial seborrheic derm with good results.  Current symptoms include intermittent abdominal cramps, nausea, fatigue, facial rash.  SM reported previous large local reaction to AVA #3 and AVA #4 with swelling to below elbow, malaise, muscle/joint pains lasting a week, not treated.  PMHX: seborrheic derm, GERD, anxiety/depressive disorder.  He was not taking meds for GERD or previously prescribed cream for seborrheic derm at time of vaccination; he was well prior to & at time of vaccination; reported no prior allergies to drugs, foods, insects, latex.  Referred for Allergy evaluation 3/10/2009, r/o possible allergic reaction to AVA - presentation deemed inconsistent with IgE mediated allergic reaction to AVA; symptoms possibly attributable to other causes/underlying conditions to include seborrheic dermatitis, thyroid disorder, anxiety, GERD.  TFTs normal, head CT negative
UTI infection; Yeast infection; Rash all over patient body; This spontaneous case was reported by a pharmacist and describes the occurrence of URINARY TRACT INFECTION (UTI infection), FUNGAL INFECTION (Yeast infection) and RASH (Rash all over patient body) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URINARY TRACT INFECTION (UTI infection), FUNGAL INFECTION (Yeast infection) and RASH (Rash all over patient body). At the time of the report, URINARY TRACT INFECTION (UTI infection), FUNGAL INFECTION (Yeast infection) and RASH (Rash all over patient body) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   ? No treatment information was provided.
Patient presented to the pharmacy with swelling and redness around the injection site. She stated this began to develop the night following the injection. Patient stated the area felt warm to the touch. Pharmacist recommended BENADRYL and hydrocortisone cream. Pharmacist stated they would follow up with the patient.
Blisters on his chest; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-healthcare professional) from medical information team. The reporter is the patient. A 85-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04Apr2021 10:00 (Lot number: EB8737) at the age of 85 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient concomitant medications were not reported. The following information was reported: BLISTER (non-serious), outcome "recovering", described as "Blisters on his chest". The event "blisters on his chest" was evaluated at the physician office visit.  Additional Information: Patient has received both doses of the Pfizer BioNTech Covid 19 vaccine. His first dose was on 04Apr2021, and he developed blisters on his chest last lasted for a month and did not resolve before receiving the second dose. He received his second shot on 04Apr2021. He now has blisters on different areas- arms, legs, chest and some on his back. His chest was the worst part of it and he has bad scars left from them. Some were berry small and some were quite large, smaller than a penny about half an inch by quarter inch. The small ones were like a ball point pen. He has dry skin and tryies to keep lotion on them. Skin is itchy but not sure if its from the blisters. He has one blister on his arm and one on his leg. He has burst some but he saw his doctor told him not to burst anymore and was prescribed some cream that he still has to pick up from the pharmacy. He saw his family doctor and he could not find any reason why they would be developing. He received his 2nd shot last Saturday on 04May2021, LOT: EW0172, Left arm injection, and is continuing to get blisters all over his body. Caller asked if anyone has had this problem before. The Pharmacist had not seen any one with this reaction. Caller added the blisters are leaving bad looking scars. Caller added after the second vaccine the blisters continued. Caller added he was lucky he is in very good health for his age. Patient not visited Emergency Room.  No follow-up attempts are possible. No further information is expected.
One day after I received vaccine, I experienced moderate dizziness that came in waves over the course of 4 hours. 2 days after (today) I felt some lingering dizziness when I bent forward and moved my head around.
Broken blood vessel at the corner On the lid of my right thigh starting from the corner up on the top eyelid. I had to strange dizzy spells about a week out from having my second shot and again about a week and a half another dizzy spell. Today is 23 days out from getting my second shot. There?s no soreness at the eye area and my eye ball is totally unaffected. No redness in the eye at all.
Severe and sudden (1 hour onset) depressive episode beginning on 3/19/2021 and lasting for one week--brief moments of suicidal ideation. This was followed by a mixed mood state of high energy/little sleep and dysphoria. This ended on 4/1/2021. Also during this period: episodes of brain fog and attention deficit; an episode of pain in all ligaments/tendons without any proximate cause; episodes of hot flashes in the afternoons.
Site: Pain at Injection Site-Mild, Systemic: Seizure-Mild, Additional Details: PATIENT HAS A HISTORY OF SEIZURES AND AFRAID OF NEEDLES AS DISCUSSED WITH MOTHER PRIOR TO ADMINSTERING COVID VACCINE. Covid vaccine was given as normal adminstration IM. Patient was counseled to wait 15 minutes, after 5-10 minutes patient seized and mother caught her as she fell from cahir. I immediately contacted 911 and gave the mother ice packs
Concern/Data:Presents with local reaction to MMR injection received 03/09/10. Outer Upper Rt arm has firm, red, warm area size of palm. Tender to touch. Also, has body aches and headache. Symptoms started approximately 19:00 03/09/10. Has been taking Ibuprofen.
This medically confirmed spontaneous report (initial receipt 17-JUL-2014) concerns a female patient. On an unspecified date, the patient received unspecified flu vaccine (batch number and manufacturer not provided).  On an unspecified date, the patient experienced flu-like symptoms and became very sick. It was reported that the patient experienced flu-like symptoms and became very sick after receiving an unspecified flu vaccine on two different occasions.  Outcome ws reported as recovered.
Pt recvd 2nd dose of vax 07DEC89 & devel erythema nodosum below left knee w/enlargement & erythema across front & back of left-lower extremity. Left leg was swollen & warm, rt leg had small erythematous patches, arthralgia & t of 100.8.
He had sudden sensironeural hearing loss in his right ear two weeks after receiving the Shingirx.
Difficulty bre-athing; Swelling of face and throat; A fast heartbeat.  Pt went to the ED where he was treated with solu-medrol, pepcid & benadryl and monitored over 2 hrs.  He continued to report fever, chills, sore throat, mild to moderate difficulty breathing over the next 2-3 days.  He refused further recommendations to return to ED and on 3/20/21 admitted to feeling better
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown demographics. No concurrent conditions or medical history were provided. The nurse reported that since unspecified date, the improperly stored VARIVAX (Merck) injection (dose, route of administration, indication, lot# and expiry date unspecified) was administered to those patients. No concomitant medications were reported. No adverse effects were reported. Additional information has been requested.
11/11/2021 Vaccination administered, between 10-2pm. 12/14/2021 1PM I blacked out for a period of time until 05:30PM ET. I was rather highly functional, speaking, characteristic behavior. Repetitiveness in behavior and speaking. Failing to recall to repetitiveness, example, I forgot episodes during this blackout time. A friend shared some things that happened during this time. I had tingling from fingers to my elbows in both arms. I may have repeated that. This accumulated with short term memory loss, repetitiveness, could not find keys, etc. She took me to the ER. Was admitted as a TIA patient but discharged with a different diagnosis. Ruled out TIA. 12/20/21 neurology appt. Did NOT have a TIA. DVA. We spoke about other things. Hypertensive encephalopathy; diagnosis by eliminating all others. BP was dangerously high. Everything else was high. I do / did have DVA. 06/2017 thought I had had a TIA. But was rather TGA.
First GARDASIL shot given 7/21/14. Second shot 10/22/14. 6 weeks she had full blown symptoms of neck, head all over body pain, falling down. Have done blood, MRI, chest X-ray etc. Saw doctor almost daily saw a pediatric neurologist. Diagnosis: Autoimmune reaction.
Vertigo, lost hearing temporarily in left ear. Tinnitus with dizziness occurred later that afternoon around 1:00 PM. Following day around 10:00 AM patient reports of tinnitus and dizziness.
5Jan98 Pt recv 1 dose vax. 13Jan98 Pt devel localized red itchy rash at inject site.
01/17/2023, I had a slight gunky throat in the evening. 01/18 I had an occasional cough and a tickle in my throat. I had no fever and I tested negative with an at home test. It started getting worse in the evening with queasiness, chills, low back pain, upper abdominal bloating and an overwhelming sense of uneasiness. I still had a gunky throat, post nasal drip, slight cough. It felt a lot like my side effects from all the previous COVID-19 vaccines I had except for the cough. On 01/19, I had not slept all night. I tested that morning and it was positive with a home test. I talked to my doctor's nurse first thing in the morning. I had no appetite, but I did have fatigue, drenching night sweats and chills. I started PAXLOVID around 02:45PM on the 19th and did the standard 5 day course with my last day being 01/24. I slept well that night and felt a lot better although I was still tired and had a lot of night sweats. By 01/21, I was moderately better. My appetite was better and I was less tired. I had minimal sweats. By 01/22, I felt almost normal. I did do subsequent home tests on 01/24 and 01/26 that were negative.