chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient should have been provided the Pfizer Pediatric vaccine 0.2ml for her second dose. Although pharmacist had Pfizer syringe separated and marked, she accidentally provided this patient with a 0.25ml dose of Moderna - which was to be provided to the patient after her for their booster dose. RPh immediately realized the error, reported to the mother, paged the patient's MD to advise. Keep patient for extended observation period. Spoke to MD at 6:57pm, MD indicated that she expected the patient to be fine, but spoke to mother and scheduled appointment for next day to check child's condition. Patient left store at 7:13pm with her mother; patient appeared well. RPh contacted Dr again on Sat, 1-22-22 to check child's condition, no issues were reported. Md said they will continue to keep in touch with parent. Spoke to child's mother at 1:55pm on Sat 2-22-22, she said that patient was doing okay. Mother agreed to have RPh continue to check in on her daughter on Sunday. RPh reminded parent to watch for side effects other than what is normally reported; fatigue, headache, fever, chills, nausea and let us know. Parent verbalized her understanding.
lt arm swollen & red approx 4hr p/vax;arm painful;remains swollen 30OCT98;no redness noted has started itching 30OCT98 AM;
Angioedema both times; A spontaneous report was received from a health care provider concerning a patient (him/herself), age and gender not reported, who experienced angioedema.   The patient's medical history was not reported.    Concomitant product use was not provided by reporter.   On unknown date, prior to the onset of the symptoms, the patient received their second of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection.  Per voicemail, an adverse event was reported on both the first and second dose of Moderna vaccine. Angioedema both times, the second time was a little bit worse. The second dose lasted three days.   Treatment for the event included prednisolone, famotidine, and diphenhydramine.   The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.   The outcome for the event was considered resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Treatment for the event included prednisolone, famotidine, and diphenhydramine. Further information has been requested.
Red, warm to touch. Measured 60 x 60 mm (R)/deltoid & (L)/deltoid.
Suspected vaccination failure; shingles; This case was reported by a consumer via media and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The patient had reported for him/herself. The age at vaccination was not reported. The age group was not reported but was captured as an adult as per the vaccine indication. After receiving Shingles vaccine, the patient got shingles. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided.
Feeling "jittery" after waiting 15 minute observation period.  Noticed some tingling in back of scalp.  Vital signs at 12:10 were - BP 110/76, SPO2 98%, Respirations 16, and Pulse 72.  Patient was given water and crackers, encouraged to sit in observation area until feeling better.  Scalp tingling quickly subsided, states probably just nervous, discharged to home without any other concerns.
Pronounced mental ?fog? (slow, ?doped up? kind of mental state)?began subsiding roughly 30 hours after vaccination. Feeling mostly normal around ~40 hours (upon wake-up).
Within 24 hours of getting my 2nd COVID vaccine, I began to feel weak and achy. My neck and face got really hot while the rest of my body stayed cold. A small headache began to turn into a migraine. During the night, my body began to hurt beyond achy causing me to toss and turn. When I woke up in the morning, I couldn't stand even the littlest of pressure placed on my body. For example, my cat jumped on my leg and it felt like someone wacked me with a baseball bat because of how sensitive my body was. The only treatment used for myself during this time was Tylenol. It helped with the head aches. Overall, it took me about three nights to actually feel ok again.
The evening after receiving Prevnar, developed fevers to 102, hoarse voice, barky cough, and loose stools. Seen in office next day: afebrile, hoarse voice, stridorous with agitation. Treated as croup. Prescribed PO Decadron x 1 dose. 2 days after Prevnar dose, also noted to have periorbital petechiae but otherwise, no other new symptoms.
Large red rash patch on vaccine arm, about 3 inches in diameter, darker around the edge.  Appeared on Day 12 after the first shot.  Did not hurt, barely itchy only twice in two days, and just slightly warm to the touch.  Lasted two days; faded nearly away by the third day after its appearance.
Chills first 1 hr., body aches 8-9 hrs, nausea 1- 1-1/2 hrs., sinus drainage 2 hrs. ( had to sit up to keep from going to stomach), headache front and back. After 5-6 hours took Tylenol (no effect). Body aches start lessening about 7-71/2 hrs.  Second Tylenol. Took excederin for headache after 10-11 hrs. And headaches ended after 12 hrs. Still didn?t feel good all day but couldn?t sleep. Second day softer shot not feeling well - stomach ache all day and belching all day. Next 5 days feeling ok, but not bad to normal. Did have injection sight soreness and mild itching for 9 days.
feeling tired; almost flu-like; feeling sick; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (feeling tired), INFLUENZA LIKE ILLNESS (almost flu-like) and MALAISE (feeling sick) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044B21A and 044B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Jun-2021, the patient experienced FATIGUE (feeling tired) and INFLUENZA LIKE ILLNESS (almost flu-like). 10-Jun-2021, the patient experienced MALAISE (feeling sick). At the time of the report, FATIGUE (feeling tired), INFLUENZA LIKE ILLNESS (almost flu-like) and MALAISE (feeling sick) outcome was unknown.            Concomitant medications include Zenpak. No treatment medication were provided.
Vaccine given on July 15, 2021.  On Aug 13, 2021 pt woke with vomiting and substernal chest pain and fatigue.  He described as pressure or squeezing with some sharp pain while breathing. He was seen in ED on day of symptoms where he had labs, Echo and CXR.  All were normal.  Discharge diagnosis was gastroenteritis but at follow up (when I saw him) mom indicated that he never progressed to having typical AGE symptoms.  She also never treated him for such or used those prescribed medications.  He was tired and needed extra rest but symptoms self resolved over following days.
Lt. arm sore; unable to lift; pain radiates to neck; headache; unable to turn head. Took Tylenol & Ibuprofen without relief. Went to ER on 4/4/10; I.V. pain meds, home with oxycodone.
Sore arm, pain when moving arm up to shoulder, and tingling in the fingers one week post injection
vax recv 20MAY96, feverish that noc (did not take temp) arm to sore to use next day;22MAY could move arm back & forth & 23MAY could gently raise arm;did not consult MD;took ASA thru 24MAY
#1 = 011J20A on 1-6-21 #2 = 028L20A on 2-3-21 patient presented after sudden onset of chest pain early in morning and found to be covid +. ECG demonstrated diffuse ST elevation, troponins negative. CT without contrast didn't have much in it. He was found to be COVID rapid test+ and IGG negative. He was admitted into isolation, no oxygen needs. DDIMER was over 2000 and friction rub noted on physical exam.   Cardiology ruled out STEMI, thought maybe viral pericarditis - but wanted echo done after out of isolation. CTA was planned for AM on 4-28-21, but patient died 4-27-21 PM after being found down in room. ROSC was not able to be achieved despite aggressive resuscitation efforts
Covid 19, Fever, Chills, Body Aches, Headache, Left arm numbness, chest tightness
I became  dizzy and heart racing after 2 minutes of receiving  this vaccine.  I had a pulse oximetry. My heart rate was 132 (my normal is around 60). I told the  RN was having a reaction. I had brought my liquid benadryl in case I might have a reaction due to my severe food allergies. I immediately drank 50 mg of benadryl.  In 2 to 3 minutes my heart rate came down and I felt better. I was able to leave and drive home. I am an RN myself so I knew how to manage this situation.
gastrointestinal symptoms: chronic pain,  bloating, gas, distention, fatigue, globus, sour/bitter taste ongoing for a month
received FLUZONE HIGH DOSE QUADRIVALENT on 18SEP2022 then received another dose of it today; forgotten; Initial information received on 12-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age and unknown gender patient who experienced received fluzone high dose quadrivalent on 18sep2022 then received another dose of it today and forgotten while receiving vaccine influenza quadrival a-b high dose hv vaccine [fluzone high-dose quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 18-Sep-2022, the patient received a 2  dose of suspect influenza quadrival a-b high dose hv vaccine [fluzone high-dose quadrivalent]  lot UT7718BA Expiration Date: 30-Jun-2023  via unknown route in unknown administration site for Immunization.  On an unknown date the patient developed a non-serious received fluzone high dose quadrivalent on 18-sep-2022 then received another dose of it today (extra dose administered) and non-serious forgotten (memory impairment) (unknown latency) following the administration of vaccine influenza quadrival a-b high dose hv vaccine.  It was reported "MA reporting that a patient received FLUZONE HIGH DOSE QUADRIVALENT on 18SEP2022 then received another dose of it today. MA said the patient must have forgotten that they already received the vaccine. MA requesting for guidance moving forward".   Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Unknown for the event received fluzone high dose quadrivalent on 18sep2022 then received another dose of it today and was Unknown for the event forgotten.   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.
EVERYTHING SORE; BACK HURT; STOMACH SWELLING; DIZZINESS; CAN'T SLEEP WELL; FEELING OF MIGHT DIE AT ANY TIME; TEMPERATURE; ARM SORENESS; NOT FEELING WELL; This spontaneous report received from a patient concerned a 63 year old male. 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 not reported, batch number: Unk) dose was not reported, administered on 25-AUG-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On AUG-2021, the patient experienced everything sore. On AUG-2021, the patient experienced back hurt. On AUG-2021, the patient experienced stomach swelling. On AUG-2021, the patient experienced dizziness. On AUG-2021, the patient experienced can't sleep well. On AUG-2021, the patient experienced feeling of might die at any time. On AUG-2021, the patient experienced temperature. On AUG-2021, the patient experienced arm soreness. On AUG-2021, the patient experienced not feeling well. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the everything sore, back hurt, stomach swelling, temperature, dizziness, not feeling well, can't sleep well, feeling of might die at any time and arm soreness was not reported. This report was non-serious.
PATIENT DEVELOPED WHAT LOOKS LIKE FIRE ANT BITES ON BOTH ARMS. INTENSE ITCHING. SEEN AT CONVENIENT CARE ON 10-13-17. GIVEN BACTRIM DS, MEDROL DOSEPAK, HYDROCORTISONE 1% CREAM.
10/13/2003: Received pneumococcal vaccine.  Had previous vaccination in 1997.  That evening patient noticed red area at vaccination site about 50 cent piece size with tenderness.  10/14/2003: Redness about 4 cm by 6 cm in size, more tender.  Started running low grade temperature.  10/15/2003: Site is very tender 8cm by 8 cm, warm to touch.  Still has low grade temperature.
This 27 year old received primary SPV on 8/1/2014. Approximately 8/18/2014 he began to notice single red dots to his chest and right arm (SPV given to left deltoid). These "mosquito bite" like dots did itch. He denied any other lesions, macules or skin rashes, no chest pain, breathing difficulty, arthralgia, myalgia, headaches or other systemic reactions. His SPV site was still moist with gray like edges and a dark center. On 8/20/2014 these red dots spread to bilateral legs and fingers. The macules to his right upper chest seemed patchy but he had been scratching the site. There were no lesions to palms of hands or soles of feet with no systemic symptoms. He presented to nearby ER on 8/20/2014 after awakening with left ankle pain and pain to his great toe. He recalls being told his x-rays were negative and labs ("inflammatory studies") were borderline and to see a rheumatologist but he could have a bunion and his ankle may have cellulitis. He was prescribed BACTRIM for his "cellulitis", a tapering dose of prednisone (60-50-40-etc) for the rash and tramadol for the pain. On 8/21/, 8/25 and 8/29/2014 he reported his rash stabilized and was resolving (1-3 macules on arms/hands/legs). He had followed up with rheumatologist and was advised his red left ankle and later toe was diagnosed as gout (confirmed elevated uric acid). His SPV site was drying and beginning to scab after leaving open to air (while alone).
elevated liver enzymes; pancreatitis; severe epigastric pain; severe pain in her lumbar and sacral region; inflammatory arthritis; This case was reported by a consumer via call center representative and described the occurrence of pancreatitis in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included amoxicillin trihydrate (Amoxicillin) unknown for sinus infection and tylenol #3 (nos) (Tylenol #3) for an unknown indication.   Concurrent medical conditions included herpes simplex and sinus infection. Concomitant products included valaciclovir hydrochloride (Valacyclovir).   On 4th February 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient started Amoxicillin at an unknown dose and frequency and Tylenol #3 at an unknown dose and frequency. On 6th February 2020, 2 days after receiving Shingrix and not applicable after starting Amoxicillin, the patient experienced sacral pain and inflammatory arthritis. On an unknown date, the patient experienced pancreatitis (serious criteria hospitalization and GSK medically significant), elevated liver enzymes (serious criteria hospitalization) and epigastric pain. The patient was treated with ibuprofen (Advil). The action taken with Amoxicillin was unknown. The action taken with Tylenol #3 was unknown. On an unknown date, the outcome of the pancreatitis and inflammatory arthritis were recovered/resolved and the outcome of the elevated liver enzymes, sacral pain and epigastric pain were unknown.   It was unknown if the reporter considered the pancreatitis, elevated liver enzymes, sacral pain, inflammatory arthritis and epigastric pain to be related to Shingrix. It was unknown if the reporter considered the pancreatitis, elevated liver enzymes and epigastric pain to be related to Amoxicillin.  Additional details were reported as follows : The patient received Shingrix vaccine in her right deltoid intramuscularly and about two days later she had severe pain in her lumbar and sacral region, more towards the right compared to the left, and was diagnosed with inflammatory arthritis of the lumbar and sacral region by an orthopedic doctor. The patient was on Advil for her pain 600 mg every 6 hours. The orthopedic doctor prescribed Tylenol #3. The patient was having sinus infection and was on amoxicillin. So she took amoxicillin and one dose of Tylenol # 3 and after 2 hours customer started to experience severe epigastric pain and she was hospitalized with pancreatitis for 2 days with elevated liver enzymes and the pancreatitis resolved in 2 days. The inflammatory arthritis resolved in 3 days. The patient's had past medical history of herpes simplex and was on valacyclovir and did not know if she experienced the inflammatory arthritis because she had a diagnosis of herpes simplex. The patient did not receive second dose of the Shingrix vaccine yet. The reporter consented to follow up.
mom states pt broke into a rash laster in the day p/vax in the AM went to ER who dx urticaria;pt went home w/instructions to take PDH 3x a day until rash went away;
Redness, pain, warmth and swelling in L upper arm adjacent to injection site. Starting the day after administration, worsening, seen in ED on 4/21/2019 and started on Bactrim for concern of cellulitis. Returned to ED on 4/22/2019 for further eval.
RA like flare ups; immune system ruined; weakness; not able to work; changed nuero including balance; changed nuero including balance; This case was reported by a consumer via interactive digital media and described the occurrence of rheumatoid arthritis flare up in a patient who received DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis.   On an unknown date, the patient received Tdap Vaccine. On an unknown date, unknown after receiving Tdap Vaccine, the patient experienced rheumatoid arthritis flare up (serious criteria GSK medically significant), immune system disorder, weakness, activities of daily living impaired, balance disorder and neurological impairment. On an unknown date, the outcome of the rheumatoid arthritis flare up, immune system disorder, weakness, activities of daily living impaired, balance disorder and neurological impairment were unknown.   It was unknown if the reporter considered the rheumatoid arthritis flare up, immune system disorder, weakness, activities of daily living impaired, balance disorder and neurological impairment to be related to Tdap Vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient had Tdap in 2012, patient's immune system was ruined, RA like flare ups, weakness, changed nuero including balance, the patient was not able to work.
Enlarged tender lymph nodes on left side of neck/clavicle area - Irritated area on (L) deltoid where bandaid was placed. Will see physician 6/25.
Genital ulcer on right labia, dark brown-black in color, extremely painful. Received  valacyclovir 500 mg BID X10 days.  Hydrocodone-acetaminophen 325 mg X10 days. Topical lidocaine cream in order to urinate. Any contact urine made with the ulcer was excruciating. Urgent care believed it was herpes, was swabbed for all STDs. All of which came back negative. Referred to my OBGYN who did an additional swab & blood test for herpes as well. All labs came back negative.  Post 10 day valacyclovir course ulcer scabbed over & sloughed off, taking off small portion of inner labia. Mucosa grew back & current appearance is returned to pre ulcer baseline. Was diagnosed with idiopathic vaginal ulcer by OBGYN.
This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's concurrent condition, pertinent medical history, concomitant medication, drug reactions or allergies were not reported. On 12-APR-2021, the patient was administrated with expired HPV rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # R016970, expiration date was 22-MAR-2021, 1 dosage form, strength and route were not reported) for prophylaxis (Expired vaccine used). No additional adverse event reported.