chrisvoncsefalvay/vaers-outcomes huggingface dataset:
vials associated with storage excursion likely did not maintain the activity necessary to fully protect against the SARS-CoV-2 (COVID-19) virus at time of administration.; 21 patients administered with expired vaccines/Dose administered after 30 days use by day or after manufacturer date of expiry.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (21 patients administered with expired vaccines/Dose administered after 30 days use by day or after manufacturer date of expiry.) and PRODUCT STORAGE ERROR (vials associated with storage excursion likely did not maintain the activity necessary to fully protect against the SARS-CoV-2 (COVID-19) virus at time of administration.) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (21 patients administered with expired vaccines/Dose administered after 30 days use by day or after manufacturer date of expiry.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vials associated with storage excursion likely did not maintain the activity necessary to fully protect against the SARS-CoV-2 (COVID-19) virus at time of administration.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (21 patients administered with expired vaccines/Dose administered after 30 days use by day or after manufacturer date of expiry.) and PRODUCT STORAGE ERROR (vials associated with storage excursion likely did not maintain the activity necessary to fully protect against the SARS-CoV-2 (COVID-19) virus at time of administration.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported.  Vial was stored in refrigerator on 17-Feb-2022 at 10.00 am. The vial did not undergo any temperature excursion. The analysis of the vials associated with storage excursion was completed and it was reported that the vaccine administered on 05-Apr-2022, 06-Apr-2022 and 07-Apr-2022, from lot number 026L21B likely did not maintain the activity necessary to fully protect against the SARS-CoV-2 (COVID-19) virus at time of administration.  No adverse events were reported.  No treatment medications were provided.   This case was linked to MOD-2022-536013 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 11-Apr-2022: Follow-up received included event verbatim updated.
After I withdrew the needle from the patient's arm after the injection a couple of blood drops came out.  Then the skin underneath (~2 cm area) began swelling up.  I checked on the patient the day after the vaccine and patient stated he was not swollen any longer, but that there was a small bruise under the bandaid.
Vaccine remained in freezer beyond manufacturer recommendation. After consultation with Pfizer revaccination recommended to ensure proper effectiveness.
The product was exposed to a low temperature of 1.7 degrees Celsius for 2 hours and 15 minutes/no AE; No patient involved, unknown reason of temperature excursion and stability data too not reported.
Chest palpitation, Chest Discomfort, Irregular Heartbeat, Shortness of Breath when I walk fast.
Menveo administered to a 13 yo patient; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 13-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA687A, expiry date unknown) for prophylaxis.   Previously administered products included Menveo (received 1st dose on 4th November 2019 of batch number AMVA125A).   On 27th June 2022, the patient received the 2nd dose of Menveo. On 27th June 2022, unknown after receiving Menveo, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 30-JUN-2022 Reporter's Comments: The reporter consented to follow up by email. Additional supportive information: The 13 years old patient received a Menveo vaccine as a second dose, which led to extra dose administered.
Received vaccine on Sunday 11/15/20.  Patient complained for muscle stiffness and redness at injection site that started the next day.  The rash is just red, not warm, no fever, no open sore or blisters.  Recommended acetaminophen or ibuprofen and benadryl.  Counseled for signs of possible infection and when to contact physician for further treatment.
Patient with scheduled appointment for Moderna booster bivalent. Patient received 0.25 at 1205 pm which is half the recommended amount. Patient was called and returned to clinic at approximately 330pm and received the another 0.25 Moderna bivalent vaccine booster and tolerated well.
Initial report received on 15 December 2008 from a health care professional. A 12-year-old female patient who had no concurrent illness, but who has seasonal allergies that are being treated with CLARITIN, had received a dose of MENACTRA (lot number U2842AA) and a dose of "Hep A" vaccine (manufacturer not unknown, lot number AHAVB320AA) on 08 December 2008. The route and site of administration of both vaccines were not provided. Early in the morning four days post-vaccination, the patient could not move the left side of her face and she was taken to the emergency room for evaluation. The patient was diagnosed with facial palsy and started on steroids (not specified) and was then discharged to home. It was not reported whether any diagnostic tests or laboratory data were performed. At the time of this report, the patient's recovery status was "unknown." Documents held by sender: None
I came home from having the shot and by 7:15 p.m. I couldn't raise my arm.  By 9:00 p.m. I was shaking in so much pain it was like I had a baby without medicine,  I had pain so bad at night I slept for two hours on Thurs, Fri, Sat, and Sun.  for only about two hours each night.  Used ice for the first 24 hours and then switched to heat per advice of patient advisory nurse I called on Thursday night.  By Monday, I still was not better. Couldn't even lift my arm up to my shoulder.   I called my Patient Care Coordinator who contacted my doctor and sent an urgent message at 8:00 a.m. By 2:00 p.m. on Monday I still had not heard anything.  I contacted my Patient Care Coordinator again and she indicated she had sent an urgent message to my doctor at 8:00 a.m.  I waited until 6:15 p.m. and my doctor still had not called me.  I went to Urgent  Care because I could not use my left arm.  Couldn't dress myself.  My husband helped me get dressed and put shirts on for almost a week.  When I went to Urgent Care, the doctor said he had the second COVID shot and the pain should go away and laughed because he said I had a "robust immune system."  He prescribed 800mg ibuprofen for me and that did nothing.  I am taking Aleve p.m. to this day to sleep and still waking up after four hours.  I use a heating pad throughout the day and especially at night to go to sleep.  Thursday will be 30 days since I received the shot.  I also called Glaxo-Smith Kline who is listed as the manufacturer.  I had someone who looked up "canned information" that had been provided and said I could have pain up to 30 days as has been reported.  This is not normal pain.  When your lymph nodes were as hard as rocks on the left side and pain is shooting down into your hand for the first two weeks, that is not normal.  This is also just occurring on my left arm.  And it was fine before I received this second shingles dose.  The first one I had a bit of soreness for a day and nothing else.  My husband received both doses.  Second dose he was tired and had a bit of a fever overnight, but nothing else.  What I want to know is this permanent?  Pain never goes away. And the lack of help I received from my own doctor is appalling.
I did not notice any symptoms immediately, but started noticing bruises appearing on my arms and legs.  I did not remember hitting the areas where the bruises were appearing.  In May, my heart was beating irregularly, so I had to go to the ER.  They drew bloodwork, but did not tell me at the time my platelet count was a little over 40,000.  It was not until 9/24/21 that  I was told that my platelet count was at 37,700 due to another condition for epiploic appendigitis.  I have never bruised easily in my life and when my platelet counts were tested in the past I was normal.  On 10/11/21, I started a 4 day high dose steroid treatment.  My platelets responded and went up to 188,000 on 10/15/21, but on 10/22/21 started to drop again and were at 125,900.  I will now have to go for 4 monoclonal antibody treatments starting on 10/29/21.
A vial of vaccine from Friday 6/11/21 was accidentally left on the counter at the end of the day. On Monday 6/14/21, another nurse thought it was vaccine thawed out for that day's vaccine clinic on the counter and 2 doses were drawn and given to 2 patients.
Patient developed right lower extremity heaviness, numbness approx. 15 minutes post vaccination. EMS was activated, sent to ED.
Migraine with aura on 6/28/22 and 6/29/22
A non-serious spontaneous report of we administered expired FLUMIST was received from a health professional concerning a four-year-old female patient. Neither medical history nor concomitant medications have been reported. The product expired on 20-Feb-2010. The patient received the expired FLUMIST on 22-Feb-2010. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age. Additional information was received on 08-Jun-2011: Reporter confirmed that the patient did not experience any late occurring adverse events.
Redness, pus, itching reported 9/11/14 8 days after getting. Responded to hydrogen peroxide/NEOSPORIN and just red/itching now.
We had an allergic reaction to something 3 days later, face swelled mildly,  got a rash on face. But his congestion worsened. Yes
itchy skin all over body; Welts; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy skin all over body) and URTICARIA (Welts) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     Concomitant products included OLMESARTAN MEDOXOMIL (BENICAR), METFORMIN, POTASSIUM, DILTIAZEM, ACETYLSALICYLIC ACID (ASPRIN) and ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP) for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (itchy skin all over body) and URTICARIA (Welts). The patient was treated with PREDNISONE at a dose of 4 doses. At the time of the report, PRURITUS (itchy skin all over body) and URTICARIA (Welts) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Localized redness, swelling, itching, mild pain at site of immunization only. No generalized effects.
At time of administration, pt. complained of a sharp, traveling pain down the arm where shot was given. Pain has progressed and become persistent requiring around the clock ADVIL. Additionally, pt stated she has reduced range of motion (difficult to drive/dress herself).
Began feeling nausea 1230. Increased w/ talking. Emesis at 205 and 245. General achiness. Denies temp. Denies rash. Denies difficulty breathing.
Awful, brain-cell killing fever (above 102 degrees Fahrenheit); it was the worst fever I've had in at least ten years. The worst of it lasted for 8 hours or so and kept me from falling asleep; I felt like I was going crazy. The symptoms dampened after drinking water but still lasted for two-three days; no doctor/hospital was visited for the event. Even today, March 24, 2022, I feel as if my brain does not work as well as it did before 09/03/2022
Post vax, the patient developed a large 8 x 10cm area of redness, firmness and warmth on the lateral thigh.
Case number PHHY2012US051486 is an initial literature report received on 12 Jun 2012. Authors searched VAERS for reports of adverse events (AEs) in pregnant women who received INFLUENZA vaccine from 01 Jul 1999 through 30 Jun 2009. This case refers to a pregnant female patient (age not specified). She was vaccinated with INFLUENZA (manufacturer and batch number: unknown) at an unknown gestational age, on an unspecified date between 01 Jul 1999 through 30 Jun 2009. On an unknown date after vaccination, the patient experienced menorrhagia. The outcome of the event menorrhagia and outcome of pregnancy were not known. The causality was not reported. The VAERS system does not allow for active follow-up of adverse events among pregnant women; thus, pregnancy outcome data are not available for women who had an adverse pregnancy event. Authors concluded that no unusual patterns of pregnancy complications or fetal outcomes were observed in the VAERS reports of pregnant women after the administration of INFLUENZA vaccine.
For both injection I developed a red rash half way down my left arm and my lymph node under my left armpit swollen to the size of an egg for about 1 week ( very painful ) treated at home with lots of ice! Below is normal side effects but decided to list them as well. Severe headache for (3) days / took OTC ibuprofen did not help Severe pain in both legs  (2) days, nothing I did helped even laydown the pain was there  Mild fever 101 along with chills ( 1 ) day Sleep for over 29 hours
Patient requested "high dose" of vaccine; I briefly glanced at the patient's age., saw that she was over 60, and processed and administered vaccine for High Dose 65+ when should have received regularly quadrivalent. Patient experienced no adverse reactions to vaccine.
Information has been received from a nurse practitioner concerning a 4 year old female with a history of eczema who on 04-SEP-2004 was vaccinated with MMR II, 0.5 ml SQ.  It was reported that the patient had a negative titer for mumps.  The patient did not seek medical attention.  No product quality complaint.  Additional information has been received from a nurse practitioner indicating that the 5 year old female patient did not get immunity to mumps and is allergic to eggs so she was unable to obtain a second dose.  Additional information is not expected.
At 3:24pm I gave the patient both Shingrix and Adacel vaccines, and advised patient to wait for 20 minutes in order to monitor. After 20 minutes, patient complained of being "a little dizzy". I told patient to wait a little more. Patient waited for another 10 minutes. Patient said she can be able to drive home now and asked me what she should do in case the dizziness got worse. I counseled her that if it got worse on the road while driving, she should pull over and call 911, and that while at home she should lay flat and raise her legs above heart level, but call 911 if it got worse. I called patient two hours later to make sure she arrived home safely. Patient arrived home safely and no more dizzy
9/29 not feeling well, getting chest congestion, phlegm, fever continuously, congested sinus. Took 2 ADVIL and over the counter medicine. Symptoms are getting worse. Called doctor 3x.
Severe congestion, nasal discharge, chest pain, severe headaches, fatigue for over a month.  Treated first for sinus issues, amoxicillin. Still got worse, they put on singular, got worse. Then treated with steroids, nasal sprays, additional antibiotics. All failed. Chest x-rays normal, but massive sinus swelling, inability to breathe at all through nasal passages.   ASSESSMENT AND PLAN Impression 1 left septal deviation 2 chronic sinusitis-with acute flare 3 nasal polyps Plan I have placed her on XHANCE 2 sprays twice a day and write her with samples as well as her prednisone taper. The risks and benefits of oral steroids were reviewed with her all questions were answered and plans agreed upon. I will see her back in a couple weeks make sure her symptoms have resolved. . CHIEF COMPLAINT NP SEVERE CONGESTION  HPI .....  *  Patient is a very pleasant 46-year-old female seen in consultation from Dr. for evaluation of her nasal congestion. She is been having severe nasal congestion over the last month after receiving her Covid 19 immunization. The next day she had severe nasal congestion with copious amounts of rhinorrhea and postnasal drainage. She was placed on a course of amoxicillin without improvement. She has tried using a nasal saline irrigation which caused severe pain and pressure in both of her ear as well as a severe headache. She was placed on Singulair and Flonase without improvement. Her sense of smell has been diminished but still present and she reports no loss of taste. She feels she is chronically blowing her nose with thick copious amounts of mucus production. She denies any dysphagia or odynophagia has had no hoarseness or cough. She did take a recent Covid test which was negative.  HIGH CRITICALITY ALLERGY TO PFIZER COVID VACCINE
Patient called pharmacy 4/17/21 and wanted pharmacist to report that she started experiencing tinnitus about 1 week after receiving vaccine which is still ongoing. She is aware of that side effect from Janssen clinical trials. Pharmacist encouraged patient to follow up with her primary care physician as well.
A non-serious Spontaneous report of partial dose was received from a nurse practitioner concerning a 45 year old female. On 13-Oct-2008, the patient received a dose of FLUMIST in the left nostril, which ran back out of the nostril. The patient did not receive administration into the right nostril. There were no adverse events; however, the clinic recommended that the patient receive the traditional vaccine shot next month. There was no adverse event associated with this medication error; therefore treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved.
This spontaneous report was received from a medical assistant refers to a patient of an unknown age and gender. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On 12-JAN-2018, the patient was vaccinated with improperly stored (at a temperature excursion of 0 degree centigrade to 1 degree centigrade for 5 hours) PEDVAXHIB lot # N003537 (expiry date: 17-NOV-2019) for prophylaxis (dosage not reported). A digital data logger was involved. No adverse effects reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1804USA011627: US-009507513-1804USA011628: US-009507513-1804USA011629.
raised red and itchy bumps on back of left arm 5 days received the 1st covid vaccine in the same arm / 2 inch by 5 inch patch above elbow in upper left arm; raised red and itchy bumps on back of left arm 5 days received the 1st covid vaccine in the same arm; raised red and itchy bumps on back of left arm 5 days received the 1st covid vaccine in the same arm; This is a spontaneous report from a contactable nurse (patient). A 65-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot number and Expiration date were not reported), via an unspecified route of administration (administered on the left arm) on 04Mar2021 10:00 (at the age of 65-years-old) as 1st dose, single dose for COVID-19 immunisation. Medical history included diabetes, high blood pressure, and penicillin allergy all from an unknown date. The patient's concomitant medications were not reported. Prior to vaccination, the patient has not been diagnosed with COVID-19. The patient didn't receive any other vaccines within 4 weeks prior to COVID vaccine. The patient has no other medications in 2 weeks. On 09Mar2021 18:00, the patient experienced raised red and itchy bumps on back of left arm 5 days received the 1st covid vaccine in the same arm / 2 inch by 5 inch patch above elbow in upper left arm and raised red and itchy bumps on back of left arm 5 days received the 1st covid vaccine in the same arm. No treatment was received for the events. Since the vaccination the patient has not been tested for COVID-19. The outcome of the events was not recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
My lips, my cheeks inside and out, my jaws and the back of tongue all went numb; My lips, my cheeks inside and out, my jaws and the back of tongue all went numb; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date in 2020 at single dose for COVID-19 immunization. Medical history included gastroparesis. Concomitant medication included lisinopril. In 2020, the patient reported she had an odd reaction to the COVID vaccination, her lips, my cheeks inside and out, her jaws and the back of tongue all went numb. There was no investigation assessment. No treatment was received for the events. The outcome of the events was resolved by itself in 2020.    Information on the lot/batch number has been requested.
Pt woke up crying w/temp of 104; mom gave APAP; Pt was very irritable & crabby; To MD who confirmed the rxn to be fr the immun;
Information was received on 14-JUN-2017 from a lawyer regarding a case in litigation concerning a female patient of unknown age. The patient was inoculated  with a dose of ZOSTAVAX (lot and expiration not reported) vaccine on or about 30-SEP-2011 at a medical center as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On  or about 02-MAY-2012 the patient was treated by a nurse practitioner at a medical center for a painful  vesicular outbreak that was diagnosed as severe herpes zoster, or shingles. The patient has been prescribed  pregabalin (LYRICA) to help manage painful symptoms. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering and other damages. Additional information has been requested.
This medically confirmed spontaneous report (initial receipt: 17-Oct-2012) concerns a patient, who had an 'allergic reaction' to a 'flu vaccine' (manufacturer, brand name and batch number were not provided) on an unknown date. The event outcome was not reported.
The day post vaccine child c/o pain (sharp) in right hand (vaccine given in left arm) then later in day child c/o pins & needle parasthesia X 4 extremities & sharp pain both lower legs.  Helped by warm bath.  Pulse was 120 @ event.