chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt received 2nd dose of Pfizer on 4/23 , but had received Moderna as 1 st dose  on 3/29.  Pt showed no adverse reaction to Pfizer .Pt remained on site for about 45 minutes after dose.
medical assistant attempted to administer ActHib to patient, MA was able to administer only half of the dose, and other half shot out of the needle when the patient jerked away, so the patient got only about 0.25 mL with no reported adverse event; Initial information was received on 13-Apr-2021 regarding an unsolicited valid non-serious case received from other health professional (Inquiry number: 00559199).  It was reported that a medical assistant was able to administer only half of the dose, and other half shot out of the needle when the patient jerked away, so the patient got only about 0.25 ml of HIB (PRP/T) VACCINE [ACT-HIB] (lot number: UJ524AAB, expiry date not reported) (Suspension For Injection) via an intramuscular route for prophylactic vaccination (underdose).  It was a case of actual medication error due to vaccine underdose.  At the time of report, no adverse event 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 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.
Pt had developed severe rash about 3 hours after immunizations. Pt had fever and began walking abnormally on tiptoes. Pt unable to make eye contact.
This spontaneous report as received from a physician refers to a patient of unknown age. On an unknown date the patient was inadvertently vaccinated with a dose of VARIVAX (Merck) (Lot #, dose and route not reported) instead of ZOSTAVAX. It was staff error only. No adverse effects reported. It was not known if the patient sought medical attention. Additional information has been requested.
did not receive the 3rd dose/missed the 32 week cut off for the 3rd dose; No additional information or AE's reported.; This spontaneous report was received from a pharmacist who refers to her son, currently 8-month-old male patient. His medical history, concurrent conditions and concomitant therapies were not reported.  On an unknown date in November 2022, the patient was vaccinated with the first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2 ml by mouth, administered orally for prophylaxis (strength, lot #, and expiry date were not provided). On an unknown date in January 2023, the patient received the second dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2 ml by mouth, administered orally for prophylaxis (strength, lot #, and expiry date were not provided). The reporter stated that her son's physician refused to give rotavirus vaccine, live, oral, pentavalent (ROTATEQ) so she had to get it at another physician's office but realized she missed the 32 week cut off for the third dose. She stated the patient is about 2 days past 8 months (32 weeks, 2 days). At the time of reporting, the patient did not receive the third dose (incomplete course of vaccination). She confirmed the patient had no side effects or adverse reactions (no adverse event).
Patient had a red, hot, swollen arm under the injection site for 3 days. On days 4 and 5 the reaction site was itchy. By day 6 the adverse reaction had resolved. She was instructed by her Dr. to put an ice pack on it, and take some BENADRYL and TYLENOL or ADVIL.
PATIENT CALLED PHARMACY 4 HOURS AFTER RECIEVING THE NEW COVID BIVALENT (MODERNA) BOOSTER, STATING THAT HER LEGS WERE VERY ITCHY (NO RASH REPORTED. SHE WAS INSTRUCTED TO TAKE BENADRYL TO HELP COUNTER THE REACTION
COVID-19; COVID-19; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 26Sep2021 as dose 3 (booster), single (Lot number: Ff2588) at the age of 37 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Seasonal allergies" (unspecified if ongoing); "Known allergies: Penicillins" (unspecified if ongoing); "Known allergies: sulfa" (unspecified if ongoing); "Known allergies: cefalosporins" (unspecified if ongoing). Concomitant medication(s) included: QVAR, start date: 11Apr2017; ALBUTEROL [SALBUTAMOL], start date: 06Apr1993; ZYRTEC [CETIRIZINE HYDROCHLORIDE], start date: 05Jun2017; SINGULAIR, start date: 04Apr2022. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of drug ineffective, covid-19: PAXLOVID.; Sender's Comments: The causal association of lack of effect  and Covid 19 infection in relation to suspected vaccine BNT162B2 cannot be totally exluded.  Case will be reassess pending investigation.
Vaccines administer at approximately 2 pm on 3/12/07. At approx 4pm he noticed his lips and mouth were swollen. Mom noticed at 8pm and administered Benadryl. He had another dose of Benadryl in the morning.
My shot hurt very bad, and my IMMEDIATE reaction was ?wow she shot me really high on my shoulder?. Thought that was strange, but didn?t think anything of it. Pain increased daily, and 3 weeks after my vaccine (after taking advil/tylenol daily) I was in such excruciating level 10 pain that I was losing sleep at night. I then found out about SIRVA from a friend, and after doing some reading, I was sure that?s what it was. I went to urgent care, and they knew nothing about it. They gave me muscle relaxers that didn?t do anything. I woke up a few days later with such intense throbbing/sharp pain that I was unable to move my arm/shoulder above my elbow. I went to the emergency room with a friend because I couldn?t even drive, and they also didn?t know what SIRVA was. They gave me oral steroid medication & an orthopedic referral for it it got worse. The meds helped a little, brought my pain down to a 6/7. Once the meds were complete, my pain increased, so I went to the ortho, who KNEW WHAT I WAS TALKING ABOUT, and diagnosed me with SIRVA after doing an x-ray. He told me to let him know how it was feeling a week later, since the steroids did help a bit. Unfortunately, the pain only got worse, so I went back in for a cortisone shot. That helped more than anything, and my pain is now down to a 2/3. I have been trying out some PT, but am honestly reading some crazy stories about chronic pain online that are scaring me and am afraid I will never have my arm at 100% again. The reason I am bothering with this form, is because I would love to be considered for any compensation for the nearly 3 grand in medical bills sitting on my desk. Of course on top of it, my last day at my last job was 3/31 (few days before getting vaccinated) and I just got a new job this week. These past few months have been a really really stressful time period, and I?m super angry that it?s just because I got vaccinated. Sorry for the rambling, but I really hope they raise awareness of this and alert untrained health care workers of the possibility, so that no one has to go through this again.
fever (not documented, warm to touch) start 12 hrs p/vax & lasted 3 days; p/3 days became lethargic & inconsolable; visited ER but no meds; no sz, listlessness;
Patient developed severe body aches and a severe headache that she described as someone squeezing her.  She had her vaccine at 1230 and started  with symptoms at 1330.  She took 1500 mg of acetaminophen.
Sever shoulder joint pain that was diagnosed by an emergency walk-in clinic Dr as arthritic in nature in the order of septic arthritis. Pain started as a lesser soreness in shoulder that quickly escalated into sever pain that limited range of motion and functionality.  Event began on a Friday morning and proceeded to increase through the weekend. A Dr was consulted on the following Monday (total of four days between onset and treatment). This event of severe shoulder joint pain occurred approximately 10 days after the previously reported swelling/inflammation/infection of the subclavicular lymph nodes on my left side ended (ie swelling of lymph nodes ) Also of note: tenderness and sensitivity with mild firmness of left nipple was also noted  prior to event and remains sensitive.
A few days after my vaccine I came down with Shingles and I urgently got an appointment with my doctor for an antiviral prescription. I had to take this for a week. After every covid-19 vaccine I had nausea, fatigue, and body aches. After the antiviral was finished, I was suffering from great amounts of fatigue, and the shingles symptoms were very painful. Shortly after the antivirals I did come down with a sinus infection. Currently, Sinus infection is lingering, however my shingles symptoms have resolved.
she takes an autoimmune suppressant, Tremfya, but did not disclose it when she got the vaccine; she takes an autoimmune suppressant, Tremfya, but did not disclose it when she got the vaccine; This is a spontaneous report from a contactable consumer via the Medical Information Team. A female patient of an unspecified age started to receive bnt162b2 (BNT162B2) , via an unspecified route of administration from 09Jan2021 to 09Jan2021 at a single dose for an unspecified indication; and guselkumab (TREMFYA), via an unspecified route of administration from 29Dec2020 to 29Dec2020 at an unspecified dose for an unspecified indication. Medical history included COVID from Mar2020. The patient's concomitant medications were not reported. It was reported that the patient got the first dose of Pfizer COVID-19 vaccine on Saturday 09Jan2021. She takes an autoimmune suppressant, Tremfya, but did not disclose it when she got the vaccine. The patient also reported to have a chest X-ray, an EKG, a stress echo test, and an MRI. Information on the lot/batch number has been requested.
Patient received VZV vaccine 8-27-08 to left leg, by the SC route.  Presented in office 8-29-08 with a 24 hour history of fever (101.5 ax), painful left leg with limping, and swelling at the injection site.  Right thigh circumference is 27 1/4 cm and the left thigh circumference is 33cm.  At the injection site there is an 80cm X 120cm area of erythema, which is sligtly firm, non-indurated, and warm to touch. There was no streaking and the child had full ROM of left leg.  Mom was instructed by MD to use ice, Motrin and Benadryl.  This was the second dose of VZV that patient received, his first dose was on 1-6-2003.
First booster on 27-Dec-2021 and second booster on 18-Apr-22; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First booster on 27-Dec-2021 and second booster on 18-Apr-22) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 084J21A, 0D2A21A, 013A21A and 078J21A) for COVID-19 prophylaxis.     Patient had no known drug allergy.  Patient has never been diagnosed with or tested positive for COVID-19.  Concurrent medical conditions included Vitamin D deficiency since 21-Feb-2022 and Gout. Concomitant products included ALLOPURINOL from 28-Dec-2018 to an unknown date and ERGOCALCIFEROL from 26-Jan-2019 to an unknown date for an unknown indication. On 04-Mar-2021 at 5:19 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 01-Apr-2021 at 5:39 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 27-Dec-2021 at 10:38 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 18-Apr-2022 at 3:10 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 18-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First booster on 27-Dec-2021 and second booster on 18-Apr-22). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First booster on 27-Dec-2021 and second booster on 18-Apr-22) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Weight was reported as 204. No treatment medications were provided. This case was linked to MOD-2022-503273 (Patient Link).
Urticaria 24 hrs post immunization administration. Urticaria scattered over body. Recommended Benadryl elvir 4-6 hrs prn; to ER if SOB; RTC if symptoms persist.
During injection, felt burning in arm, across the top of shoulder, and up my neck into my head.
Patient had arm soreness and itching the night she received the vaccine.  A rash over her face, neck, chest, and arms developed within 48 hours  There are two other patients who apparently had the same reaction from bottles in the same box.  Unfortunately, I do not have their names.  This is information from one of the medical assistants in the office.
Information has been received from a physician concerning a 15 year old female who on 05-JUL-2007 was vaccinated with her first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast). Concomitant therapy included hormonal contraceptives (unspecified). On 05-JUL-2007 the patient experienced numbness in her arm and the patient felt faint. On 08-OCT-2007 the patient was vaccinated with her second dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) and the patient fainted. The patient sought unspecified medical treatment. Subsequently the patient recovered from numbness in her arm, feeling faint, and fainting on an unspecified date. Additional information has been requested.
I am concern of having an adverse effect. I may have been Covid + at time of my immunization. Through exposure from my son . I unknowingly received immunization and one week after have developed a rash , heart palpitations
Several weeks after receiving her second dose of the moderna vaccine pt reports armpit pain and swelling that has now gone into her upper back, clavicle and neck on the left side.
Lightheaded and fainted within 3 minutes of the shot.; Lightheaded and fainted within 3 minutes of the shot.; This is a spontaneous report from a contactable consumer reported for himself. This 38-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 10May2021 16:45 Right arm at 1st dose, single (lot: Ew0182) for covid-19 immunisation. Medical history included COVID-19 from 01Feb2021 to 05Mar2021. Prior to vaccination, the patient diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. He experienced Lightheaded and fainted within 3 minutes of the shot on 10May2021. Events resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care. Lab data included Nasal Swab on 01Feb2021: Positive, on 05Mar2021: Negative. Since the vaccination, the patient has been tested for COVID-19: unknown result. Cat skan was received for the events. Outcome of the events were recovered.  No follow-up attempts are needed. No further information is expected.
Patient was given 0.25mL instead of 0.5mL Moderna as second dose. Wrong order was made.   Healthcare provider(s) at office consulted with both Moderna and CDC. Pt travelling out of country on 1/11/2022. Pt reported sore arm after administration. Decision was made mutually with consult and MD & NP at medical office where administration occured  Resolution/Treatment: Pt given full-dose of Moderna (0.5mL) on 1/8/2022. 2 dose series is complete.
Covid Arm, swelling, redness, itching. At this point it's been 8 days.
Constant pressure at the back of his knee/putting pressure on right knee/hearing creaking and cracking from left knee; pain in his knee; Leg discomfort; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (Constant pressure at the back of his knee/putting pressure on right knee/hearing creaking and cracking from left knee), LIMB DISCOMFORT (Leg discomfort) and ARTHRALGIA (pain in his knee) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced LIMB DISCOMFORT (Leg discomfort). On 18-Apr-2021, the patient experienced MUSCULOSKELETAL DISCOMFORT (Constant pressure at the back of his knee/putting pressure on right knee/hearing creaking and cracking from left knee) and ARTHRALGIA (pain in his knee). At the time of the report, MUSCULOSKELETAL DISCOMFORT (Constant pressure at the back of his knee/putting pressure on right knee/hearing creaking and cracking from left knee), LIMB DISCOMFORT (Leg discomfort) and ARTHRALGIA (pain in his knee) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided. Treatment information was not provided.
Patient was given expired vaccine as her second dose. Patient was still present when the error was caught. (from previous error event, we were aware that patient should be getting a new dose on opposite arm- was given, and asked pt to stay in the store for extra time, and informed potential se)
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. On 08-MAR-2018 the patient was vaccinated with improperly stored GARDASIL 9 (dosing details were not reported) (lot # N020353, expiry date: 28-APR-2020) for prophylaxis (product storage error). The vaccine was stored at a temperature of 47 degree fahrenheit to 77 degree fahrenheit (59.6 degree fahrenheit) for a time frame of 8 hours. No adverse effects reported. Previous temperature excursions was reported as "yes". There was a digital data logger involved. No product quality complaint involved. This is one of the several reports received from same reporter. Sender's Comments: US-009507513-1804USA004718.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 05-OCT-2012 the patient was vaccinated with an expired dose of ZOSTAVAX (Lot# 670382/0218AA, expired on 16-MAY-2012, dose and route not reported. No adverse experience had been observed or reported. It was not known if the patient sought for medical attention. Additional information has been requested.
A physician reported that a patient received a Prevnar vaccine and 4 to 10 days later developed diarrhea.
pt had just finished playing soccer when had a sz lasting 4-5m, according to teenage witnesses;
NOTE: DTaP #5 and IPV #4 was the first time this specific combination vaccine noted above was given to this patient.  Mom had wanted the 4 year vaccines for patient to be given with DTaP-IPV and MMR on 9/25/2019 AND the Varicella vaccine to be given 1 month later. However, when they came for the nurse visit with dad, he was given all three at one time by the MA who was not aware of mom's preferences, and there was no objection by dad to doing all three at one time.  ~1 hour afterwards, when mom saw patient, she felt he had a blank stare on his face and was not responding to mom.  She felt he did not look with it.    Last time he got the vaccine he had regression of his milestones and stopped making eye contact and stopped talking.  He just finally started getting better.  Mom is terrified that he is regressing again or WILL regress again.  Rash and redness of the anterolateral thigh developed on 9/26/2019. RASH DESCRIPTION: Red blotchy rash on left thigh - large Chickenpox like rash - looked like vessicles (fluid filled blisters) on a red base, some popped and started scabbing.  Initially on shins, arms and neck. On 9/27/2019, when patient was brought to clinic, more lesions had developed.  ASSOCIATED SYMPTOMS/ROS (all started on 9/26/2019): Some aggression - pushing more than normal 3 accidents while previously potty trained. Pushing more buttons repeatedly, has not done this for a long time before this last set of vaccines.. More dazed than normal, seems more fatigued than normal. Per patient, he is feeling better on 9/27 than he was on 9/26. He continues making eye contact, responding to questions and remains alert.  Mom concerned he has a possible underlying inflammatory process/problem.
Slight pain, swelling and itching at injection site. Experienced fatigue,  joint pain, and headache that caused some discomfort for approximately 24 hours after the injection. All side effects responded to regular strength Tylenol.
The patient left the pharmacy and went out to dinner. While at dinner he began to shake uncontrollably and became confused. The wife reported the patients eye began to roll into his head and at that point she called 911. He was taken to the hospital where they began to run test. The wife contacted the pharmacy to inform us of what happened. At that point they hadn't determined the cause of the medical event.
she still has a dark bruise on her arm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE BRUISING (she still has a dark bruise on her arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jan-2021, the patient experienced INJECTION SITE BRUISING (she still has a dark bruise on her arm). At the time of the report, INJECTION SITE BRUISING (she still has a dark bruise on her arm) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.
The patient was administered his first dose of Pfizer Pediatric Covid-19, but the vial was not diluted prior to administration.  The patient was given 0.2ml of undiluted Pfizer Pediatric.  Parents have been notified and instructed to watch for side effects of fever, sore arm, fatigue.
Fevering x 2 days with rash x 1 week that started on right thigh (RVL) where PCV-13 vaccines was administered. Mom notified us of event on 7/17/12, she monitored.
Severe swelling, heat, and pruritis, with circumferential redness centered at the vaccine site but affecting the majority of the brachium. Progressed overnight in size and severity and has since remained overall static with the redness and swelling extending in the dependent directions (medial and distal).
8 hours of 101 degree fever, Swollen lymph node on side of injection, nausea
approx 20min p/vax pt facial cheeks became very erythemic which was still sl present 11MAY98;
2 days p/vax had convuls; very high fever was taken to ER; pt was at hosp for 2 days
p/3rd hep B vax-1mo later pt exp sxs of numbness in legs, diff walking