chrisvoncsefalvay/vaers-outcomes huggingface dataset:
BELLS PALSY; This spontaneous report received from a consumer concerned a 5 decade (approximately 40 or 41 years) old female of unspecified race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number: unknown and expiry: unknown) dose, 1 total, dose number in series 1, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  The reporter texted to the company representative and reported that the patient which was a neighbor of reporter on an unspecified date suffered from bells palsy three weeks after receiving the JANSSEN covid-19 vaccine. According to reporter exact date of vaccination was unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of bells palsy was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211217733-COVID-19 VACCINE AD26.COV2.S-Bell's palsy. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
To whom it may concern: The follow narrative describes an adverse reaction to Azstarys in our 13-year-old daughter. As you see in the details, we believe the reaction is to non-active ingredients, specifically the artificial dyes in the medication. We are concerned that the exposure to dyes in Azstarys have created a new hypersensitivity to these dyes, including via other sources. However, there were many potentially confounding factors, so we have attempted to be thorough in our description of events. Please fee free to contact us if you have any questions. Our daughter is diagnosed with Attention Deficit Hyperactivity Disorder-Combined Type. She has been taking stimulant medication since 2018. Short and long-acting stimulants, including Concerta, Focalin and Vyvanse cause significant side effects, including appetite suppression, sleep disruption and severe mood swing during "rebound" from the medication. She began taking Azstarys on November 23, 2022 to see if these side effects would be reduced. She took Azstarys for five days in a row and it seemed to work really well. It was very effective for self-regulation and attention, and the mood swings during rebound were less pronounced. She had closer-to-normal appetite; in other words, Azstarys did not result in the problematic appetite suppression we've experienced with stimulants. On November 25, 2022 she received a COVID booster and on November 27, she received a flu shot. The night of November 27, she began complaining that he face was stinging and a little itchy. By 9 pm, she was developing what looked like bruises, hives, burns or lesions on her face. We gave her Benadryl and that seemed to stop the reaction. She had never reacted to flu or covid vaccines before (beyond mild local soreness at the shot location), so we didn't understand what the cause of the lesions might be. On November 29, we gave her another Azstarys and she developed new lesions. The doctors were still unsure of what caused the reaction. Since the lesions appeared to be some sore of allergic reaction, we followed the doctors' guidance and gave her Zyrtec for two weeks. When we restarted Azstarys again, we kept her on the Zyrtec for another 2-3 weeks. When we took her off the Zyrtec, she did not have more lesions, so we continued Azstarys. Over the winter holidays, she did not take Azstarys, as she was taking it only for school. She did not take Azstarys regularly in January, and we took another break from it because she was sick (with a bad cold). We restarted it on February 1, 2023. On February 6, she started developing new lesions so we stopped Azstarys entirely. With some concern that is might be related to the dye in the Azstarys, we also removed all food with artificial dye from her diet. She stopped developing lesions. On March 5, she ate foot with artificial dye. The next day, she developed a new lesions. In addition to the pain of the lesions when they form, and even more concerning, the lesions have results in lasting (and, we fear, long-term) hyper-pigmentation (spots that are darker than the surrounding skin). Please contact me for more photos of the lesions.
Started to notice severe left-sided lumbar spine pain, severe left iliac crest pain radiating down left leg to above knee area, lymphatic edema. Treatment with acupuncture and massage therapy has helped alleviate the severity of the previous mentioned symptoms to where they are now tolerable.   Slight chest heaviness and slight exacerbation of asthma symptoms which have been controlled with asthma inhalers.
large diffuse red rash with localized induration near the injection site, started within 2 hours after receiving fluzone high dose. the rash spread out from his left elbow to his left shoulder and was warm to touch.  the rash continued to get worse over the next 24 hours and is still present 72 hours after administration but appears to be improving slowly at this point.
Patient was not supposed to receive a dose of Menquadfi with no reported adverse event; Initial information received on 18-Oct-2023 regarding an unsolicited valid non-serious case received from other healthcare professional.  This case involves a 6 years old male patient who was not supposed to receive a dose of Meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 17-Oct-2023, the patient received 0.5 ml dose (frequency: once) of suspect Meningococcal A-C-Y-W135 (T CONJ) vaccine Solution for injection of lot U7675DB via route : (abbreviation not known; requested) in unknown administration site for immunization; however, patient was not supposed to receive a dose of menquadfi (wrong product administered) (latency: same day).  No lab data was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.
Patient was fully vaccinated with Pfizer (3/4/21 & 3/25/21).. Patient had SOB/cough for 3 days. Was admitted to hospital on 12/21/21 with COVID
The pharmacist on duty accidentally drew up a Moderna Pediatric vial instead of a Moderna Bivalent vial. No adverse reactions.
I had pain/tenderness under right arm pit and into the right side of my right breast for 2 days. I did receive my vaccination in the right arm.
Chest tightness and trouble swallowing 45 minutes after vaccine. Went to the ER 2 hours into symptoms. Treated with 50mg Benadryl, 60 mg prednisone and famotadine. Discharged from hospital continuing to have difficulties swallowing.
temp last 2-3d; rash all over; APAP; 22AUG95 no temp just cranky
arm sore for 1 week. still some residual pain. might be coincidence but i have broken out in rash, itch, burning sensation ( fells like sunburn) 4 times since shot. episodes last about an hour.
About 10 minutes after the injection, patient experienced hot flash, then her throat started to become scratchy (did not feel like it was closing), tingling in the upper and lower extremities followed by the stomach.  After 45 minutes, patient was still experiencing symptoms and was sent to the ED for evaluation.
Patient reported pain in left arm that started the evening after receiving vaccine. FLUZONE HD. Patient seen doctor 7 days after vaccine administration on 8-20-15. Dr ruled pain to be caused by tendonitis.
Passed out. Patient approached me and said she didn't feel well and might pass out. Patient took two steps with me and passed out. Assisted patient down to the ground. When patient regained consciousnesses, moved patient to wheelchair and brought her to recovery cot. Vitals remained stable. Assisted patient onto cot, obtained vitals and gave her two Hi C beverages. Patient had no oral intake today. Patient sat for 17 minutes and felt better. Patient sat in general recover for 10 minutes and then left.
This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapy were not provided. Since 10-NOV-2016, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lots # L045117 exp date 06-OCT-2018 and M010212 exp date 21-JAN-2019) (dose and route not reported) for prophylaxis. The vaccines were exposed to 33.8 Fahrenheit degrees for 1 hour 25 minutes. The call was placed because of a Digital data logger. No adverse experiences were reported. As of 06-FEB-2017, all telephone attempts to obtain follow-up information have been unsuccessful. This is one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1612USA001949: US-009507513-1612USA001950: US-009507513-1612USA001952: US-009507513-1611USA009104.
child was given 3 doses of Rotarix/extra Dose; This non-serious case was reported by a other health professional and described the occurrence of extra dose administered in a 6-month-old male patient who received Rota (Rotarix lyophilized formulation) (batch number NK245, expiry date 27-JUN-2023) for prophylaxis.   On 20-MAY-2022, the patient received the 3rd dose of Rotarix lyophilized formulation. On 20-MAY-2022, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced extra dose administered (Verbatim: child was given 3 doses of Rotarix/extra Dose).The outcome of the extra dose administered 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: 12-OCT-2023 The patient was given 3 doses of Rotarix, which led to extra dose administered. This was 1 of 9 linked cases, reported by the same reporter.; Sender's Comments:  US-GSK-US2023130319:different patient same reporter US-GSK-US2023AMR142496:different patient same reporter US-GSK-US2023AMR142497:different patient same reporter US-GSK-US2023AMR142499:different patient same reporter US-GSK-US2023AMR142500:different patient same reporter US-GSK-US2023AMR142501:different patient same reporter US-GSK-US2023AMR142502:different patient same reporter US-GSK-US2023130319:different patient same reporter US-GSK-US2023AMR142512:different patient same reporter
Pt stated she was unable to raise left arm when taking her shirt off and had instant pain over the left anterior portion of her shoulder.  She had immediate nausea and did vomit.  Small movements produced pain at time of follow up visit.  She stated the pain seem to be traveling up her neck and down through her back at times.  She was advised by NP to take Aleve one tab twice daily.  She was also given Darvocet N 100.  Also advised to use Tylenol 2 tabs for breakthrough pain as she needs to.
Diverticulitis arteries; I had a blood clot after ultra sound; sore arm/Feel sore arms after the first dose; spinal nerve damage/Spinal nerve pain; Legs are burning hot now; Pain felt in calf and thigh; Bone density test/Ultra sound bad; This is a spontaneous report from a contactable consumer(patient). An 84-years-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 intramuscular, administered in Arm Left on 01Feb2021 11:30 (Batch/Lot Number: EN5318) as SINGLE DOSE, dose 2 via an unspecified route of administration, administered in Arm Left on 22Feb2021 11:30 (Batch/Lot Number: EN6200) as SINGLE DOSE for covid-19 immunization. Medical history included angina from 2002 and ongoing, She says she has angina, and if she would have beating problems can she take a Nitro, cholesterol, depression from 2008 to an unknown date, blood pressure, anxiety from 2018 to an unknown date, arthritis from 1998 and ongoing Illness/AE: Arthritis Onset Date: 1998-2002 Stop Date: Ongoing , hypertension from 2002 and ongoing, blood cholesterol increased from 2002 and ongoing, ongoing urinary tract infection On and off, coronary artery disease from 2005 to an unknown date On and off, Family medical history included Mother coronary artery disease Died on 18Oct1967 and Father 1936 other. Concomitant medications included amlodipine taken for blood pressure abnormal from 2017 to an unspecified stop date; atorvastatin taken for blood cholesterol abnormal from 2002 to an unspecified stop date; bupropion taken for depression from 2008 to an unspecified stop date; buspirone taken for anxiety from 2008 to an unspecified stop date; carvedilol taken for blood pressure abnormal from 2002 to an unspecified stop date, 2x a day carvedilol 12.5. On an unspecified date, the patient experienced diverticulitis arteries, had a blood clot after ultrasound, sore arm/feel sore arms after the first dose, spinal nerve damage/spinal nerve pain, legs are burning hot now, pain felt in calf and thigh, bone density test/ultrasound bad. The patient underwent lab tests and procedures which included blood test: unknown results, computerized tomogram: diverticulitis arteries- On and off, investigation: unknown results. Comments: Going to pain clinic. On always, ultrasound scan: bad on Comments: Ultrasound bad, urine analysis: unknown results on comments: on and off. Treatment received for the events sore arm/feel sore arms after the first dose and spinal nerve damage/spinal nerve pain. Outcome of all events was unknown  Follow-up (29Mar2021): This is a follow-up report combining information from duplicate reports 2021138557 and 2021162095. The current and all subsequent information will be reported under manufacturer report number 2021162095.
On 12/01/00, the patient received Fluvirin vaccine in the left deltoid. Immediate pruritis at the site, Prescribed Ice. At 10 PM the axillary adenopathy, left arm acne. 12/02/00, malaise and flushed from 12 thru night and day: burning of both legs, PM of 12/02/00, at 6 PM  gradually lost sensation, then strength in both legs (Sat evening). 12/3/00, unable to move legs by 12 AM, crawled to bedroom, later dragged in to be seen by MD at 10 AM (Sunday).
My menstrual cycle has been consistent (occurring every month) and there have been no changes for the past 10 years. One week before the 1st Moderna COVID-19 vaccine date, my period arrived like normal. Exactly one week after taking the first dose, I received my period once again (twice in 1 month). This is very abnormal. There were no other factors affecting my lifestyle. I believe the vaccine has contributed to my abnormal period and this should be made aware to all volunteers prior to receiving their vaccine.
Information has been received from a physician concerning a patient (age and gender not reported) who on 25-JUL-2007 was vaccinated with a dose of Zostavax (Oka/Merck) (lot # not provided).  The patient started to notice bumps that were chicken pox like bumps on 26-JUL-2007.  The patient called the physician on 07-AUG-2007 reporting that they had more bumps.  The outcome was not reported.  No further information is available.
First vaccine I could feel the vaccine go into my body and down into my legs. It was a very strange sensation. I felt very fatigued 30 min after the vaccine but ignored it because it was not normal to have symptoms after the first vaccine. That night i did feel a litlle bit of swelling in my lips that continued into the next day but it was not severe. The muscle aches, joint pain and allodynia the 2nd day were so severe I don't really remember any other symptoms i may have had. I took Benadryl and Tylenol and slept for 2 days straight. After the 1st vaccine I did have shortness of breath for about 3 days post. Then I received the 2nd vaccine, I did not feel it go in this time. About 30 min after the second vaccine I felt very fatigued. About an hour later I started to feel slight swelling in my lips that increased and around 2 1/2 hours my eyes and lips were noticeably swollen and I was flushed. My husband noticed my ears and cheeks were bright red.   I felt my heart racing and took my pulse it was around 120. I felt dizzy and like there was a lump in my throat.   I requested an appointment via video call from  the emergency line.  I  didn't feel like I was having trouble breathing and stayed calm, my pulse went down to 100 after about 20 min. while waiting for my video call. I spoke to the doctor and they recommended going to the ER. I asked since the pulse went down and it felt like I was slowly reacting, if I could try taking Benadryl and see how I felt. She said that was ok but if I felt any difficulty breathing to go to  the ER right away. I took 50 mg of Benadryl and felt better and rested. The next morning lips and eyes were swollen again but a little worse. Difficulty swallowing persisted as well as severe muscle pain, joint pain, and allodynia.  The symptoms were worse with 2nd vaccine. Noticed shortness of breath just walking up and down steps. These symptoms lasted a little bit longer.  4 days after the vaccine I noticed  the lip swelling was not getting better so I called my PCP. He recommended taking the next 2 days off , rest with benadryl and tylenol. I listened and felt good enough to go into work. It is now 4 weeks since i had the vaccine and i am still experiencing  some symptoms that seem to be in relation to after i eat. That includes lip swelling, tightness in the muscles around my throat (feel as if they are strained), stomach burning, indigestion, heartburn.  Called PCP again who recommended I see an allergist/immunologist.
Severe chills, pain in right ear, vertigo, confusion, mild fever, nausea, vomiting all for 1 day, then total loss of hearing in right ear second day after vaccine. mild swelling and redness at injection site. Main adverse event is the loss of hearing in right ear with vertigo and tinnitus that has not recovered after 2 courses of prednisone. 8/24/20 for 12 days and 9/3/20 for 6 days.
She got her first anthrax vaccination in 12/02. One week after receiving the vaccination she developed a frontal temporal headache that was not associated with any nausea or change in appetite, It was associated with photophobia, however. It was also associated with runny nose and congestion. The runny noses started as a clear liquid and developed into a green mucus discharge. She had no fever but did report fatigue, myalgia, achy  bones and arthralgia. This lasted about a week after which the headache and associated symptoms resolved and she was back to normal. She had no trouble until she got second anthrax vaccination in June of 2003. At that time she developed identical symptoms, also starting one week after receiving the vaccination in resolving after about a week's time. Her third vaccine, in the end of January 2003, was followed by the same series of events. She got her fourth vaccination in July 2003 while deployed. At that time, she was under the stresses of being deployed which included little sleep, walking around and heavy gear and all the other stresses that go along with that. This time the effect, which started about three weeks after the vaccine, was more pronounced. Not only did she developed a headache and associated flu like symptoms, she also developed chest pain, difficulty breathing and her lungs felt "cold". This was while she was in Iraq. She was treated with Albuterol but that didn't help. This time, the headache was worse, it was more incapacitating and it was more occipital location. When she had the headache while she needed to do with sleep. She developed a persistent cough. This time it took a few months for her to get back to normal. When she redeployed from Iraq she received her fifth vaccine, in July 2004. About one month later she again developed the headache and its associated symptoms. This time the headache was even stranger still. The pain was all around her head and into her neck. Again, she needed to rest and sleep. Overall, the quality of the headache was the same as it had been however. She still has that headache. It has never gone away. It only gets a little better when she rests. On 11/19/2004, she had a spell associated with a time when the headache was worse that involved a thickness in her jaw and tongue that made her speech slow. Also she felt a thickness in her hands which made them slow to move. She went to the emergency room. She came back to normal after a couple of hours but it took a little bit longer for her jaw muscles to relax. Along with the headaches she reports poor short term memory. She also reports joint pains in her wrists, elbows and shoulders. She does not have any fevers.
redness, swelling and ultimately desquamation of anterior upper arm, lasted about three weeks used hydrocortisone with relief no hives no fever no chills
Sever swelling of lymph nodes in armpit of left arm.  Some swelling of lymph nodes in right arm.
I received my first Moderna vaccine 3/27/21, on 4/3/21 woke up with COVID arm rash. I took some Benadryl and put an icepack on it, and it went away within 48 hours. I received my second vaccine and 5/10/21 I woke with elbow pain in the arm I received my vaccine. I was in pain if I tried to pick up a cup, and I could not make a fist. I am still experiencing these symptoms, then on 6/1/21 I woke up with COVID arm rash close to my elbow.  I took Benadryl and used a ice pack but the rash is still on my arm.
This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. The patient's medical history, current conditions and concomitant medications were not reported. On unknown dates since July 2015, the patient were inadvertently vaccinated with improperly stored doses of PNEUMOVAX 23 (dose, route and lot number were not provided). No adverse reactions were reported. This is one of several reports received from the same source. Additional information has been requested.
debilitated in bed for 5 days; exhausting reaction / experienced it with the initial shot; Debility; This case was reported by a consumer and described the occurrence of bedridden in a 77-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced bedridden, exhaustion and debility. On an unknown date, the outcome of the bedridden, exhaustion and debility were unknown.   It was unknown if the reporter considered the bedridden, exhaustion and debility to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. After receiving the 1st of vaccine the patient was totally debilitated in bed for 5 days.  The patient did not expect to have such an exhausting reaction to the booster shot, even though patient had experienced it with the initial shot. For tolerance after 2nd dose of Shingrix, refer case US2020AMR106672.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR106672:same patient (2nd dose)