chrisvoncsefalvay/vaers-outcomes huggingface dataset:
nurse administered an expired Menactra vaccine to a patient with no reported adverse event; Initial information received on 16-May-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 34 years old male patient who was administered an expired meningococcal A-C-Y-W135 (D CONJ) vaccine [Menactra] vaccine to a patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included pneumococcal vaccine CONJ 13V (CRM197) (Prevenar 13) and HIB vaccine (Haemophilus Influenza Type B Vaccine) both for prophylactic vaccination (Immunisation).  On 16-May-2023, the patient received a dose of 0.5 ml (frequency: once every 4 years) of suspect meningococcal A-C-Y-W135 (D CONJ) vaccine (Solution for injection) (lot: U7208AA; expiry date: 10-Feb-2023; strength: normal) via intramuscular route in unknown administration site for prophylactic vaccination (Immunisation).  On 16-May-2023 the patient was administered an expired meningococcal A-C-Y-W135 (D CONJ) vaccine to a patient with no reported adverse event (expired product administered) (latency: same day).  It was reported, " Nurse wants to know what can be done and when to administer the next dose."  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event.  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 is a 29 year old male who developed extensive arm redness and swelling within 48 hrs of receipt of AVA # 8. He reported only minor swelling and redness with previous anthrax immunizations. Patient reports that during the first 24 hrs he had minor redness and swelling and that on the following day the redness and swelling extended form elbow to wrist. He did have itching at the site. Stated his skin felt hot. He denied fever or chills. On 28 May he went to his doctor who then contacted the HC. The physician stated that his arm was red, swollen and hot from shoulder to wrist. There was no fever or lymphadenopathy and nor was there evidence of cellulitis. The vaccine was administered subcutaneously in the tricep area. Management guidelines provided with follow up scheduled. During follow up conservation on 01 June patient reported that the swelling had decreased the following day and is currently doing better. He stated he was treated with rest and Allegra and did not require ibuprofen.
weak; fell; sprained her ankle; cannot move; This is a spontaneous report from a contactable consumer reporting for a patient (Reporter's mother) received from a Pfizer-sponsored program COVAX US Support. A 90-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL9261, NDC number and UPC number are unknown, Expiration Date: May2021), via an unspecified route of administration on 25Jan2021 at the age of 90-years-old as dose 1, single for covid-19 immunisation. The patient's medical history was none. The patient's concomitant medications were not reported. The patient's height and weight were not reported. There was no Investigation assessment. It was reported that the reporter has been assisting mom (patient) to get her shot and they had their first one about 3 weeks ago at 'Tier 2' (not clarified). The reporter got shot at that time as well, first one, since the reporter was assisting her. And there were no side effects or anything. She was walking around and just a couple of days ago, on Sunday, 14Feb2021, in the evening, she fell and she sprained her ankle and she cannot move. They have the second shot scheduled for today at 2:45. So, she could not make it. So, couple of things, let her reschedule that and reporter asked, should I get the second shot? It was reported that the patient was supposed to get second dose today but she fell a couple days ago and was weak on an unspecified date. She was unable to get second dose within 3 weeks. The patient did not receive treatment for adverse events. The outcome of events was unknown.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Patient had soreness next day. Then golf ball size swollen developed 2 inches below shoulder muscle 2 days afer. Erythema and hot to touch at swollen site.
Adverse reaction started immediately after receiving the shot. Throat started to swell making it difficult to swallow. Face, lips and eyelids were itchy.
Left arm edema, pain, erythema and grade fever since tetanus vaccine was given. Cellulitis/rash, given Keflex 500mg BID x 10 days.
At aprox. 8 pm on 11/10/11 I noticed a very large, stiff, warm, red bump at the site of vaccination.
Case number PHEH2013US025057 is an initial spontaneous report received from a pharmacist on 27 Nov 2013. This case refers to a 16-year-old male patient. Past medical history and concomitant medication were not reported. On 30 Nov 2013, he was vaccinated inadvertently vaccinated with FLUCELVAX (batch number: 006031A) intramuscularly. No adverse event was reported following this administration error. Following an internal review on 18 Aug 2014, a significant correction was done for the information received on 02 Dec 2013: The BPI labeling of the event "Inappropriate age at vaccine administration" changed from listed to unlisted and added second indication as "drug used in unapproved population".
Major swelling of all lymphnodes in the body. Achey joints and muscles. Low grade fever/fever like symptoms. Tiredness and shortness of breath at times. Headaches. Lethargy. I called the clinic for advice but they didn't know how to help, I'm going to get an appointment with the doctor.
Breakthrough infection August 12, 2022; last vaccine date before infection May 15, 2022
I started getting symptoms of a dry cough. I got a positive at home COVID-19 test. I just had a cough and at nights I couldn't sleep. I did a telehealth visit and was called in cough medicine. The cough lasted for 1 week. I consider this a mild case.
fever,scream,twitching,sz (multiple) starting 6 days p/vax (t104 in ER);complex febrile seizure;6 days p/vax t101-screaming lasted seconds but twitching & sz had started-to ER t41.5 C/106.7;
Severe upper arm, shoulder pain-- unable to use right arm for over 24 hrs/unable to sleep night after injection, ROM still limited after 48 hrs/ still having severe soreness. Using heating pad, OTC TYLENOL, ALEVE.
HIVES AND ITCHING TO BOTH ARMS FOLLOWING SECOND INJECTION OF MODERNA. ALSO STARTED TO COMPLAIN OF A HEADACHE. PT WAS ADMINISTERED ZYRTECH 10MG PO. PT ALSO TOOK ON HER OWN 2 TYLENOLS (650MG). PT WAS RELEASED TO HER OWN CARE HOME AT 945AM WHEN SYMPTOMS RESOLVED.
I had a mild fever and chills, fatigue, muscle aches, sinus pressure, runny nose, and runny eyes. I also had phlegm drainage in the chest and a cough. This was the worst I had felt in a long time. I took a home antigen test and got a positive result. We called the doctor, and I was prescribed Paxlovid. I took the Paxlovid for five days. It wasn't about the seventh day that I noticed an improvement, though I still had some COVID-19 symptoms. On the eighth day, I felt markedly better and was able to get up and move around.
Fluid like ball at site of injection. surrounding area is red and itchy and patient said they were in pain at the time of injection but symptoms gotten red after.
little bit of a reaction light headed after 5 minutes.   vitals were low, so observed for 30 minutes after being light headed.  Patient was found unresponsive and pronounced dead later that day.
A medical assistant reported that a 5 year old child received an injection of Acel-Immune on 04/06.00. Two days later, the child developed an injection site reaction described a "cellulitis". This is 1 of 8 patients from this facility who developed an injection site reaction following receipt of 3 different lots of Acel-Immune.
Developed rash to (L) thigh-macular/papular that progressed to full body. Fever concurrently symptoms to same area (L thigh) as vaccine given: Two day after vaccines given and one day amoxicillin ended. No vesicles. Unclear if vaccine related vs amox related-rash progressed to more dusky/purplish,? erythema multiforme. Fever resolved in 3 days, rash improving. Recovering.
BLACK STOOLS  2 days ago (Tuesday) she started with watery, black stools  It was very frequent.  Wednesday - it was still black but not as often  Thursday - This morning it has been brown.  No pain or cramping.  No dizziness.
tested positive for Covid 19; tested positive for Covid 19; body aches; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 48 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 14Dec2021 (Lot number: EL00196) at the age of 48 years as dose 3 (booster), single, intramuscular, administered in arm left, administration date 16Feb2021 (Lot number: EL3247) as dose 2, single and intramuscular, administered in arm left, administration date 26Jan2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: IMMUNISATION (medically significant) with onset 14Dec2021, outcome "unknown", described as "booster"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 29Dec2021 07:00, outcome "recovering" and all described as "tested positive for Covid 19"; PAIN (non-serious) with onset 27Dec2021 07:00, outcome "recovering", described as "body aches". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (29Dec2021) positive, notes: Nasal Swab. Therapeutic measures were not taken as a result of vaccination failure, covid-19, pain.  Additional Information: if other vaccine in four weeks: No .If covid prior vaccination: no
This spontaneous report was received from a Certified Medical Assistant concerning a 20 year old female patient. On 17-JUL-2013, the patient had a mumps virus antibody immunoglobulin G (IGG) titer drawn with a result of 0.91 which was equivocal and negative titer for hepatitis B (MARRS # 1310USA011931). On 24-JUL-2013, the patient was vaccinated with a dose of M-M-R II (lot # H017437; expiration date 29-SEP-2013), 0.5 ml, subcutaneous. On 13-SEP-2013, the patient was vaccinated with a dose of M-M-R II (lot # H018945; expiration date 18-OCT-2014), 0.5 ml, subcutaneous. On 12-SEP-2013, mumps virus antibody IGG titer was drawn. The result of this titer was 0.90 which was negative. No more titers were obtained. At the time of the report, patient outcome was unknown. Additional information has been requested.
Became nauseous and clammy after getting shot. Hands and arms became numb and I was unable to move my hands. About 5 minutes later the numbness went away. Vitals during this episode were normal. Health department workers were not concerned and told me it was due to me being nervous. The day after the vaccine I became nauseous again. Left arm was shaking violently and numb. Lasted about 1 1/2 hours. Shaking decreased but is still observed. My family doctor was called but I did not receive a call back.
pt recvd vax;exp flu-like illness, chills & yellow pus in eyes following both doses of vax;
pt recv vax 23SEP96 320PM & 4PM started feeling achy all over, chills & heat flashes, nausea, squeezing heart pound, weakness;no SOB;heart pain did not radiate anywhere;saw MD in ER 24SEP96;MD told pt sx from vax;
When I received the injection I immediately felt an electric current flow up to the right side of my neck. It passed quickly though. Around eight hours later I developed stiff muscles in my right neck. It became twice the size and was very swollen. I called my PCP and I was told to use moist heat. I used a warm washcloth and kept heat to it. I did not take any medication until the following morning. I took Motrin at 6:00AM. The next day I still felt sore and it took a few days for the muscle ache to go away. Two weeks after the vaccination I started having numbness in my hands and feet. I figured it would just go away and didn't pay much attention to it. 05/25/2021 my right hand was very numb and my right arm was very achy. I went to urgent care because of worry for a blood clot. While at urgent care, I saw a physician, he ruled out a blood clot, but he said that I may have Peripheral neuropathy. I was told to follow up with my PCP and it was suggested to see a neurologist.
Coughing two days after vaccine administered parent states child has been coughing since patient being eval for other cough sources parent wanted report.
Headache, Myalgia, Fever, SkinRash, Diarrhea,  "I had a very sore Left arm, considerable pain in the Left Axilla, chills, fatigue,  headache, light headedness, body ache and a fever Tuesday night onwards that  lasted a few days. Friday evening I developed itching which had increased  considerably and  Narrative:  Employee emails: **************** "Dear Wonderful Members of  the COVID Team, Hope that all of you are fabulous as we are at our end and  staying healthy and happy. I was asked to reach out to you and notify you regarding  my allergic reaction to my second dose of the Pfizer vaccine. I had my first dose  on Tuesday, February 16, 2021 in the morning and experienced soreness in the left  arm and pain with moving it for a day or two starting Tuesday night. I also had  chills Tuesday night, chills, body ache and diarrhea Wednesday night and chills  and fever, Sunday evening onwards for a few days. All was good and then I had  my second dose on Tuesday, March 9, 2020 in the afternoon. I had a very sore Left  arm, considerable pain in the Left Axilla, chills, fatigue, headache, light  headedness, body ache and a fever Tuesday night onwards that lasted a few days.  Friday evening I developed itching which had increased considerably and I got  some hives and a rash Saturday onwards with throat restrictions, left greater than  right. Benadryl, Claritin, Zyrtec did not provide any relief and I was unable to  have clothes on due to the increased itching. I went to the Urgent Care on Sunday  and they put me on Famotidine along with Cetrizine and emollients, and Benadryl  at night, to no avail. On Monday I saw my PCP who examined me and started me  on 5 mg Prednisone which did not help and after consulting with an Allergist, I  was put on a course of 20 mg a day for 2 days, 10 mg a day for 2 days and then 5  mg a day for 2 days. The itching decreased and finally subsided by this past  Saturday. The body aches are there (some) but I can handle all of that. The itching  was crazy. I know that I will do Great!! Thank You for your kind time and for all  you do. Have a great week. Happy Spring!! Kindest Regards, patient"   Other Relevant History:
Saturday, January 23rd I received my second COVID vaccination around noon. Later that day I developed the typical extremely sore arm.  Sunday January 24th: I started to feel just a general malaise and had some headaches, like I was coming down with something, but other than that felt fine.  Monday January 25th: I was at work and started developing a sore throat, chest tightness with some shortness of breath, myalgias, fatigue, nausea, and minor chills, although I never had a fever.   Tuesday: symptoms were slightly worse  Wednesday January 27th: I went to work thinking all these symptoms were still just from the vaccine as I hadn't felt any sickness symptoms before getting the vaccine and hadn't had an exposure I was aware of. While at work, I asked other coworkers if they had any similar symptoms to the vaccine and was told I should call employee health since I was still having such bad symptoms and really didn't feel too great. I called the employee health line and told them all my current symptoms which were all the same still. They told me that the sore throat and chest tightness with shortness of breath were definitely not from the vaccine and to leave work and get tested. I did this and my test came back negative. Because I was still having bothersome chest tightness, the employee health line also told me to go to the ER, thinking it could be something else significant.   I went to the ER the night of January 27th to get my symptoms all checked out as told to. Everything came back ok and the ER doctor wanted me tested for COVID again Friday around the 48 hour mark to verify it wasn't the virus. She also told me that if it came back negative, she was sure it must be my reaction to the vaccine.  Thursday January 28th: I stayed home per guidelines from employee health and still had all the symptoms listed on Monday. After a two hour afternoon nap, I finally felt like I was turning the corner. My sore throat felt better besides a huge lump still in my throat and my chest tightness with shortness of breath subsided. I still had bad myalgias, fatigue, headaches and a general sense of not feeling so great.  Friday, January 29th: Feeling slightly better again, main symptom is bad myalgias, especially my neck and small lump in throat. I got retested around 12:30 pm and it came back negative for COVID as well as negative for strep.   Saturday: Feeling almost 100% better besides sore neck still.
arm swelling, rash, itching,aching in joints;DPH for itching;
They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients; Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival; They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients), PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939906) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival). At the time of the report, EXPIRED PRODUCT ADMINISTERED (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients), PRODUCT STORAGE ERROR (They just recently found out that the vials are received in refrigerated temperatures and not frozen/ They have been accidentally administering refrozen vials to their patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Frozen vials, removed and transported at refrigerated temp, re-frozen at ti me of arrival) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.   Patient ID reported. On 08 Sep 2021, vaccine was moved to fridge and vaccine administered post 30 days from the initial storage at 8 degree Celsius, total duration of the excursion refrigerated temperature for maximum of 4 hours.  Treatment information was not reported.   This case was linked to MOD-2022-496015 (Patient Link).
Vasovagal episode, pale skin and ringing in ears - recovered completely after 10 mins. (LOC less than 30 seconds).
Hospitalization 12/27/21 2nd Pfizer covid vaccine: 2/19/21, EL9267, IM, R arm
she recently received 1st dose of covid on 4/1/21 and then went for 2nd dose on 4/7/21, instead of waiting 3 weeks. pt denies any symptoms/concerns,
Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Tingling (specify: facial area, extemities)-Mild, Additional Details: Numbness tingling in left leg. has felt weak. feels better now 90% better she states but still wants us to report it.;
Loss of taste and smell; loss of taste and smell; This is a spontaneous report from a contactable healthcare professional, the patient.  A 56-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EH9899), via an unspecified route of administration in the right arm on 23Dec2020 at 11:00 (at the age of 56-years-old) as a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported.  The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19.  The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Dec2020, the patient experienced loss of taste and smell, reported as non-serious. The patient was not treated for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcomes of the loss of taste and smell were not recovered.
Rash/hives on left arm 11 days after. Itching, swelling, redness, heat.  Benadryl, cold compress, cortisone cream.  Start 1/22 in the morning as small red spot, by the afternoon I had severe itching and raised welts.  Over the next 4-5 days it got bigger covering most of my upper arm.  Called doctor - they didn?t call me back. Called virtual clinic and she diagnosed as vaccine reaction. Finally went down Wednesday or Thursday (1/27 or 1/28).   Still some slight itching.
Terrible stomach pain to point of not eating or drinking for two days, thought I was dying, almost went to hospital. Started Saturday at 4 and pain did not go away at all until Monday at noon then it got a little better. It stopped completely Tuesday. I didn?t poop at all while I was hurting.
Mother reported on 11/23/09 that child developed little red bumps on her neck around 4 days after vaccine. Developed fever on 11/15 or 11/16/09. MA dx'ed on 11/17 as ear infection. Put on antibiotic.
Patient was on rapid schedule for Twinrix. He got a dose on day 21 AND day 30. It should have been one dose between days 21-30. Patient is fine and did not experience any adverse events.