chrisvoncsefalvay/vaers-outcomes huggingface dataset:
he was administered both PNEUMOVAX 23 and PREVNAR 13; This spontaneous report was received from a pharmacist concerning a family member, who was a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.           On 19-MAR-2020 the patient was vaccinated for prophylaxis with a dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) and pneumococcal 13v conj vaccine (CRM197) (PREVNAR 13) (dose, route, lot# and expiration date were not provided for any suspect therapy).
Background: pharmacy received 49 vials of Pfizer COVID vaccine (Lot number EN6199) on 5 March 2021 and stored them in the pharmacy refrigerator.   The doses were labeled with an expiration date of 10 March 2021 at 0701.   Since starting the COVID-19 vaccine program, the medical office has always used the doses before they approached the expiration date.  This time, there were 16 vials of the Pfizer vaccine that had not been used and set to expire. The labeled expiration date and time were clearly present on the outside of the bag containing the doses.  On the morning of 10 March 2021, a pharmacist retrieved 1 vial at 0754 and 7 vials at 1138 from that allocation and provided them to nursing for the day?s administrations.  The pharmacy placed those doses in a new amber bag and did not label the bag with an expiration date and time.   The nursing team received the vials, diluted and drew up 20 doses that were administered to patients before 1230.    The charge nurse did not question the expiration date until after 20 patients had been vaccinated.  At that time she messaged the pharmacist to verify the expiration date.  The pharmacist indicated that the label did not state am or pm and misinterpreted the expiration time for the doses as 7:01 PM rather than 7:01 AM.  There was not a defined double check at the time of distribution from the pharmacy to nursing  The remaining 11 vials were quarantined.  The pharmacy manager contacted the manufacturer.  According to Pfizer it?s recommended to use the thawed vaccine within 120 hours, but can be used up to 144 hours.  The doses in question were administered before 125 hours after they were thawed.  The remaining expired vials will be wasted and appropriate notifications sent.  Assessment: Twenty patients received Pfizer COVID vaccine 5 hours passed the labeled expiration date and time.  While exceeding the manufacturer?s recommended beyond use dating, the doses were within the acceptable 144 hours post thaw period and still safe for patient administration.  There was misinterpretation of the labeled expiration time by the dispensing pharmacist, the container of COVID vaccine vials provided to nursing was not labeled with an expiration date or time, there was not a double check on hand off, the nursing team did not double check the expiration date/time before dilution or administration.  Recommendation:  When repackaging COVID Vaccine vials for distribution to vaccination centers, a label including the expiration date and time should be placed on the new container.    When COVID vaccine is transferred from one location or department to the next, a double check of the product, quantity, integrity and expiration date and time may prevent a recurrence of this situation.
CHILD EXPERIENCED VOMITING AND DIARRHEA FOR 2 WEEKS FOLLOWING ADMININISTRATION OF ROTATEQ. CHILDS MOTHER DID NOT CONTACT OUR FACILITY BUT MADE US AWARE OF REACTION IN CLINIC TODAY.
Pain and swelling in arm. High blood pressure and high pulse rate. Given 100mg of Atarax ea day and 250mg Keflex 3 times a day. This was done by med check.
After getting both doses, he clarified he had COVID Dec2021; After getting both doses, he clarified he had COVID Dec2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 47-year-old male patient received BNT162b2 (BNT162B2), 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset Dec2021, outcome "unknown" and all described as "After getting both doses, he clarified he had COVID Dec2021". Clinical course: Clinical course:  Reporter want to know new variant it's included in the Pfizer booster and what was the age group allowed to take the shot by the FDA. Patient had both of the Pfizer COVID-19 Vaccines, the primary doses. he did not get the booster yet because he had the COVID virus. It's been 6-8 months since it's passed. He was inquiring about the new Bivalent Vaccine, but he was not gotten that yet due to having COVID in the past. After transfer reporter confirmed he was received both doses of the COVID-19 Vaccine. After getting both doses, he clarified he had COVID Dec2021. During interaction he mentioned he was filling out forms and in the process of getting the booster now. Patient got COVID the day was supposed to get the booster". While attempting to capture details he stated he was trying to fill forms out and requested someone call him back later. Informed Pfizer may follow-up and usually by mail.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Mild lips and tongue swelling on 2/3 day of injection. Friday headache in am treated with Tylenol. Did not persist. Neck ache along with mid to upper back, left arm and shoulder ache.  Treated with Tylenol before bed. Saturday fatigue began, by noon headache erupted. Fevers followed immediately, persisted through weekend and spiked at 102.4 and persisted at 100.5 to 101.5 through Monday 2/7/22. Body aches through neck, mid to upper back, through left side and shoulder / arm. Loud ringing persisted in ears. Mild throat irritation from nasal discharge when lying down. Fatigue and ringing in ears persist today 2/8/22.
Symptom onset was sudden - rigors, temp 102.3, bilateral cyanosis in hands. Difficult to take Tylenol because jaws became clenched. Symptoms resolved after the administration of Tylenol and ibuprofen. Extreme muscle aches the next two days and mild fever that was controlled with medication.
Patient came to office to receive her Bivalent Pfizer vaccine this morning 10/17/22 at 0910.   RN inadvertently pulled expired vaccine from refrigerator and administered.  Vaccine had expired Friday, 10/14/22 at 2030 and had not been discarded at close of business day.  Will work on better process for making sure expired vaccine is thrown away at end of day, but ultimately the expired vaccine was given to the patient.   It was kept refrigerated the entire time.   Mother and patient informed as soon as error was recognized.  PCP will follow up with plan and close follow up.
The adverse reaction was that I got a 5 day long menstrual period for the first time since 2012. I am 60 years old and past menopause since 2012, with no other menstrual bleeding, uterine problems or any gynecological issues during that intervening time. The period started about 2 hours after my 2nd dose of the COVID vaccine. It was a light period, not heavy, but more than just spotting...it did last 5 days, requiring a pad during all 5 of those days. I also had some fatigue and general achiness in my neck, back and joints, but that only lasted a day or 2. Unfortunately, I did not call my dr when this happened. For these reporting purposes, I guess that would have been helpful. I did call and make an appointment, but it will not occur until May 12, 2021. That is why I didn?t fill out the doctor and facility portions of this form. One last thing...I am not any kind of anti-vaxxer. I am a left-of-center suburban mom of 5 grown kids with a college education. (Not sure if that makes any difference here, but I offer it in the For-What-It?s Worth Dept.
Pfizer-BioNTech COVID-19 Vaccine EUA I received my 2nd shot on 3/26 in my left arm.  I had no reaction to either shot.  On Thursday, 4/1 I got a rash on my lower right arm.  I had just used a Brillo pad to scrub a pot.  Although I have used them many times with no problem, I thought maybe the soap got on my arm and irritated it and didn't think anything of it.  As the day went on, the rash got more red, burned, and started to form tiny blisters.  I had Clobetasol Ointment home and put that on it.  The blisters started healing but the rash is still red.  On Sunday, I felt an irritation on the same arm but near my arm pit.  When I got home, I found a similar rash (2 patches).  This burned just like the other rash.  I put the same ointment on.  Now I thought I better research because it seemed odd.  I read about other rashes but they were on the same injection site arm.  I thought I better report this just in case it is from the shot.  The original first patch is still red but does not burn.
Information has been received from a healthcare worker concerning a 6 month old male with no reported medical history and no allergies who on 15-OCT-2007 and 19-OCT-2007 presented for his third oral dose of ROTATEQ and promptly vomited the dose. Concomitant vaccination on 15-OCT-2007 included PEDIARIX. On 19-OCt-2007, the staff attempted to again administer the third dose of RotaTeq (lot # 655868/1375F) and reportedly he vomited again. It was reported that the patient sought unspecified medial attention. There were no laboratory or diagnostic tests performed. At the time of this report, it was reported that the patient had recovered. A product quality complaint was not reported. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 22-SEP-2014, the patient was vaccinated with an improperly stored ZOSTAVAX (dose and route of administration were unknown), lot number J014811, expiration date: 21-FEB-2015 (also reported as 21-FEB-2014). No adverse effects were noted. This is one of several reports from the same source. Additional information has been requested.
feel tired; covid symptoms; This is a spontaneous report from Pfizer program. This is a spontaneous report from a contactable consumer, the patient. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had Covid vaccine on Monday and on Wednesday he started to feel tired and had Covid symptoms. He wanted to know if that was normal or not. Outcome of the event was unknown. No Follow-up attempts are needed. No further information is expected.
the surgical site of my breast has statues to ache, burn and pain increases the I raise my arm
On 9-21 mother picked child up from school child complains of not feeling well. 9-22-child woke up with bottom lip swollen and under eyes swollen-Mother took child to PCP-seen by Nurse practitioner-Dx as a viral infection. As day went on child C/O neck pain, stomach pain itching. Rash on face, back, legs, swollen feet, toes. Mother took child to ED at Medical. MD Dx of reaction to Flu vaccine. Mother states MD at Medical Center Dx child as reaction to flu vaccine. Prescribed Prednisone and told mother give BENADRYL and Ibuprofen. On Sunday 9-24-17 child continue with rash and stated pain in neck and stomach. Mother took child back to Medical Center and the doctor increased Prednisone dose and continued with BENADRYL and Ibuprofen. Child was out of school until 9-28-17. Mother states has called and nurse (school) stated child in clinic and C/O not feeling well again. Mother also appeared. The child has a thickness to her Tongue on 9-22-17 along with the other symptoms stated. Mother states that went away. Mother states "has taken the Flu shot ever since she could take it and has never had any issues." Mother reported to Health Department on 9-28-17.
On 4/25, redness to right arm around injection site, slight warmth. I placed moist warm compresses on the site, took Ibuprofen. 100 temp. On 4/26, redness spreading across arm, very hot to touch. Continued Ibuprofen. Fever 102, goes down with ibuprofen. 4/27, no fever. Right arm has large area of dark red, pain to touch, hot to touch. 4/28, redness spreading toward axillary area with soreness and pain. Arm very hot to touch with red streaks. Physician assessed. Order for Clindamycin was given, cool and warm compresses for 5 minutes bid.  To followup in 2 days if redness and heat has not decreased.
Same day as vaccine, pt awoke with a fever of 101.6, was given motrin and water. After 5 minutes, started having seizures, all extremities involved, eyes wide open, lasted for 3 minutes.  Pt then stopped breathing for about 1 minute.
Immediately had a headache, not severe. Next day felt like COVID again. Aches, nausea, headache, 3 episodes of not being able to breathe in or out, lasting a few seconds. Some wheezing that started the day after the shot that continued for about 24 hours, did use inhaler(albuterol). All symptoms pretty much over by 72 hours after. Did not seek care at this time. Did talk to heart doctor today and will follow up with them about getting the second shot.
Initial unsolicited misuse report received from a nurse via other company (Pfizer) (Manufacturer Report Number: 2016451165) on 03 Jan 2017. This case involves 61 year old female patient who was vaccinated with 0.1 ml dose of INFLUENZA QUADRIVAL A-B INTRADERMAL VACCINE (Batch number: UT5573AA, Expiry date: 30 Jun 2017 and site of administration was not reported) administered intramuscularly on 02 Nov 2016. The patient medical history include hypertension and hyperlipidemia and the patient had no relevant drug history, drug allergies and family history. The patient concomitant medications were Lipitor daily from 31 May 2016 and Coreg daily from 24 Feb 2015. On 03 Nov 2016, one day after vaccination, the patient developed arm swelling and arm nodule. It was a case of inappropriate route of vaccination (influenza vaccine given intramuscular instead of intradermal). No laboratory test was performed. The patient had not received any corrective treatment. On 04 Nov 2016, the patient recovered from arm swelling and the outcome of event arm nodule was not reported. The reporter assessed the causal relationship between the INFLUENZA vaccine and the events arm swelling and arm nodule as reasonable possibility. List of documents held by sender: none.
Within 30 minutes of the first dose, I felt warm and a tad bit dizzy.  I assumed this was because I was nervous about getting vaccinated.  Got home and felt better that day.  The next day I began to feel very hot on the inside of my body.  Like inside I was on fire.  Like a menopause hot flash but more intense.  I had already been through menopause and the hot flashes were no longer occurring due to menopause.  I called a friend and she advised her husband experience intense heat following Pfizer vaccine.  No one else I spoke to experienced this.  I got my second shot 4 weeks later as scheduled.  I saw my GYN in May 2021 to ask about the hot flashes and whether I needed to take anything for them.  He said no, to just deal with them using fans and layered clothing.  The hot flashes continued regularly until mid-October, when they suddenly ceased.
red warm welt at injection site; red warm welt at injection site; red warm welt at injection site; This is a spontaneous report from a Pfizer-sponsored program. A contactable nurse reported same event for two patients. This case was for report 1st of two reports. A 8-month-old female Infant received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, lot number DL2971, Expiry Date: 30Nov2022), intramuscular at Thigh Right on 13-JAN-2021 at the 8-month-old at 0.5 mL, single for immunization.  The medical history included Pulmonary hypertension and Foramen ovale patent, all from 25Sep2020(diagnosed on 25Sep2020). The concomitant medications were none. The patient was 11 pounds 6 ounces at time of vaccination. Patient received vaccine on 13Jan2021 in Right Thigh, on 14Jan2021 a warm red welt at the injection site was reported. Treatment was a cool compress to the site and the welt resolved in a couple of days. The outcome of the event was recovered in Jan2021.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021058526 same reporter/drug/event, different patient
Client received Yellow Fever vaccine at 10:30 AM on 6/2/03. Approx 24 hours later started experiencing chest pains which were slightly relieved with rest. Presented to ER, placed on cardiac monitor for 1/2 hour. No meds or labs or other treatments. Sent home and pain subsided by approx 6 PM.
Lightheaded and dizzy.  Became nauseaous and 2 hours after onset, got sick.  Slight fever and chills.  Dizziness lasted about 2 more hours after getting sick.  Then just fatigue for the rest of the day.  Only slight fatigue and achiness the next day.
Swelling and a red rash at the injection site, and fevers the next day when she woke up.
vaccine administrated beyond use date after the thaw process; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine administrated beyond use date after the thaw process) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030h21b) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine administrated beyond use date after the thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccine administrated beyond use date after the thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported vaccine administrated beyond use date after the thaw process. There was no patient that had any adverse reactions and no reports of any reactions after the administration of the vaccines.  No treatment information was provided by the reporter
Patient reports she became extremely cold the evening of her vaccine and has remained cold constantly since then. In addition, patient states she has developed a very dry mouth and extreme thirst. Patient states there has been no fever or other symptoms during this period. Patient reports no new medications or changes in routine outside of the flu vaccine. Patient was referred to her doctor for evaluation. Patient was convinced these symptoms were from the vaccine and requested we report as an adverse event on her behalf.
That night, I was doing my basic exercises and I noticed hot flashes. I was noticing PVC. Saturday, I started having acute GI symptoms. I was experiencing gas, rumbling, and pain. These symptoms got progressively worse. I got to a point where I had to force myself to eat. I lost 10lbs in about 2-3 weeks. It's possible that this was a coincidence. I went to see the dr. on Feb 23rd. He thought it was anxiety. He gave me medicine that caused my heart rate to go way too high. Then I ended up having to go to the ER for my heart rate. It is now almost 6 months and I am better, but I am not completely back to normal. I am getting my appetite back, but I do have some food sensitivities. I have gained back 5 lbs that I lost. I did receive the 2nd dose and the symptoms I was experiencing did not change. I still notice PVC from time to time.
This spontaneous report as received from a healthcare worker refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 22-SEP-2015, the patient was vaccinated with expired dose of ZOSTAVAX (unknown strength, dose and route) lot # K008885 with expiry date of 20-SEP-2015. Concomitant medications were not reported. No adverse effects were reported. There was no product quality complaint involved. Additional information has been requested.
Around 8pm the day I got my shot, i started feeling chills while putting kids to bed. I went to bed and around midnight started sweating profusely. I tossed and turned, couldnt sleep. At one point, I tried to get up and had numbness in both legs. I made it to the bathroom and back to bed. I stayed in bed the entire next day drinking liquids but no appetite. By Sunday evening, I started feeling better.
Narrative:  Fully vaccinated but was admitted to hospital d/t COVID-19 infection
This case was reported by a consumer via Interactive Digital Media and described the occurrence of vaccination failure in a 4-year-old female patient who received DTP vaccine (A or W not known). Co-suspect products included DTP vaccine (A or W not known) and DTP vaccine (A or W not known). On an unknown date, the patient received the 1st dose of DTP vaccine, the 2nd dose of DTP vaccine and the 3rd dose of DTP vaccine. On an unknown date, unknown after receiving DTP vaccine, DTP vaccine and DTP vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and whooping cough (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure and whooping cough were unknown. The reporter considered the vaccination failure and whooping cough to be possibly related to DTP vaccine, DTP vaccine and DTP vaccine. Additional details were provided as follows: This case was reported by the patient's parent. The age at vaccination was not reported. The patient had 3 DTP (A or W unknown) shots by the time she was 4 years old. She contracted whooping cough at 4 years old anyway. The reporter stated that she highly that the patient has got the whooping cough from her grandparents. Also stated that the patient might have spread whooping cough to other people. This case was considered as suspected vaccination failure because the primary vaccination schedule and laboratory confirmation was unknown. The reporter had not given consent to contact them further. The case had been linked with the case US2017GSK139598, reported by the same reporter.
Swelling, soreness, and redness at injection site on left arm. My shot was given pretty far back in my arm, and not in the deltoid muscle.
Pt received ZOSTAVAX vaccine July 2012 from pharmacy. Pt came by another pharmacy early October 2017 and said she has shingles. She is taking an antiviral and is healing. She said her mother died of shingles complications and that's why she received the shingles vaccine. I'm reporting so you are aware she received ZOSTAVAX but still had shingles 5 years later.
Initial unsolicited report received from healthcare professional (registered pharmacist) on 29 April 2015. This case is linked to the case 2015SA057712 (same reporter, different patient) A female patient, whose age, medical history and concomitant medication were not reported, had received first dose of ADACEL (batch number: U5213BA, expiration date and dose not reported) intramuscularly in left deltoid on 27 April 2015. It was reported that patient had not received any previous dose of ADACEL. Pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as unknown and the patient had no illness at the time of vaccination. On 27 April 2015, same day after vaccination, patient had experienced redness at injection site and also injection site was hurting. On 28 April 2015, one day after vaccination, the patient's blood pressure was increased. Other laboratory investigation and corrective treatment were not reported. At the time of this report, patient had not recovered from the event of redness at injection site/injection site hurting and the event of BP increased was recovering. List of documents held by sender: none.
BODY FLUSHING, CHEST PAIN PATIENT EVAULATED BY EMS FOR 40 MIN VITALS STABLE AND SYMPTOMS RESOLVED