chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PT was here for his 1st dose of Pfizer, to be administered by RN. RN reported to Clinical Site Supervisor and Charge Nurse that there was a manufacturing error with the needle that she had been using when she attempted to administer the dose to the PT?s left deltoid at 1300. She reports that the error was in the joint between the metal needle and the plastic hub, causing the vaccine to leak out at the joint instead of entering the tissue of the arm. (For clarity- this was NOT a leak between the syringe body and the luer lock of the needle hub, but between the metal and plastic components of the needle itself) . RN reported that she believes that PT did not receive any of the dose of Pfizer vaccine. This writer notified PT's mother and obtained permission to administer vaccine dose in the opposite arm. Both PT and mother were educated on s/s to watch for and how to respond to them, verbalized understanding. The proper Pfizer dose was administered at 1303.
tenderness, mild swelling of injection site; no redness; fatigue, headache, muscle pain, chills, I slept more; took some Tylenol.  32 hours later feel better.  Just wanted you to know since it was listed on the papers received when I got the vaccine.  Thank you.
Fatigue; chills; Fever; Muscle and body aches like carrying a heavy ball and chain; This spontaneous case was reported by a nurse and describes the occurrence of CHILLS (chills), PYREXIA (Fever), MYALGIA (Muscle and body aches like carrying a heavy ball and chain) and FATIGUE (Fatigue) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 026L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Feb-2021, the patient experienced CHILLS (chills), PYREXIA (Fever) and MYALGIA (Muscle and body aches like carrying a heavy ball and chain). On 08-Mar-2021, the patient experienced FATIGUE (Fatigue). At the time of the report, CHILLS (chills), PYREXIA (Fever) and MYALGIA (Muscle and body aches like carrying a heavy ball and chain) had resolved and FATIGUE (Fatigue) had not resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered CHILLS (chills), PYREXIA (Fever), MYALGIA (Muscle and body aches like carrying a heavy ball and chain) and FATIGUE (Fatigue) to be related.    No information regarding concomitant medication was provided.  No information regarding treatment was provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
On the 15th, I started getting body chills. On the 16th, in the morning, I couldn't taste or smell anything. I was still getting body chills. I started getting headaches and body aches. My body aches lasted for about 5 days. I had a runny nose - that lasted about a week, diarrhea (that lasted two weeks), fever (that lasted two days) and cough. I still have the cough and can't get rid of the cough. Still don't have my sense of taste or smell back. I took a COVID-19 test about 4 days after the first one that was positive and it was negative result, pharmacy. Five days later, my throat was hurting and they said it was like it was choking me; it was throwing my breathing off. They said I said had tonsillitis and that my tonsils were swollen. That was at Urgent care, too. I got an antibiotic and a steroid to treat that. That helped with those symptoms.
This spontaneous report was received from a licensed practical nurse refers to a patient of unknown age and gender. The patient's concomitant medication included sterile diluent. The patient's pertinent medical history, drug reaction and drug allergies were unknown. On an unknown date, the patient was vaccinated with improperly stored PROQUAD via subcutaneous route, lot # R024015 and expiry date: 19-FEB-2020 for prophylaxis (product storage error). No adverse effect reported (no adverse event). The vaccine underwent temperature excursion of 5.6 degree Celsius for 72 hours. Previously no temperature excursion was reported. The call was due to digital data logger. Product quality complaint was not involved.
Severe reaction. T greater than 104. Vomited 20 times in 18 hours. Began 8-12 hours post injection. Pt just notified us 11/26/2001 on her 15 month visit.
Got MENACTRA on right arm and TRUMENBA left arm on 5/31/16. But got sick next day, with low grade fever, muscle ache, headache, dizziness, and left arm swollen and painful.
Vaccinated with vial that might have had a temperature excursion; Vaccinated with vial that might have had a temperature excursion; Vaccinated with vial that might have had a temperature excursion; A spontaneous report  was received from a nurse concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was vaccinated with vial that might have had a temperature excursion.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 22 Dec 2020, the nurse reported a shipment was received. The vial arrived frozen and was placed in a freezer at recommended temperature.   On 02 Jan 2021, the freezer had failed, and the temperature alarm system did not alert anyone. It was noted that the freezer temperature at 5:50 AM was -5 degrees Celsius (C), at 7:50 AM the freezer was a 1.5 C. It remained between from 9.7 C at 12:51 PM then went to 8.3 C at 1:51 PM then down to -8.7 C at 2:51 PM.  On 03 Jan 2021 8:45 PM, the freezer returned to its normal temperature of -20.9 C, -1 C then went to 5.5 C at 11:56 PM.  On 04 Jan 2021, the temperature climbed to 19.4 C. On the same day, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20-2A, 025L20A, or 027L20A) intramuscularly for prophylaxis of COVID-19 infection and experienced vaccination with vial that might have had a temperature excursion  No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, vaccinated with vial that might have had a temperature excursion, was considered resolved on 04 Jan 2021.; Reporter's Comments: This report refers to a case of out of specification product use, product temperature excursion issue, and product storage error for mRNA-1273. There were no reported AEs associated with this case.
Swelling, firmness, light redness and itching around injection site. Suddenly appeared a week after 1st dose. Applied ice and took an OTC allergy tablet with an antihistamine.
Symptoms including extreme fatigue began after second Anthrax approximately Oct 25. On Nov 10th, noted joint aching, stiffness both elbows and neck. In January noted aching stiffness and difficulty grasping objects decreased strength right hand with pain isolated in the metacarpophalangeal joint right hand.
Needles and pins on her hands; She couldn't stand up; She crawls on her fours to bed had a hard time getting into bed; Needles and pins on her legs; A spontaneous report was received from a consumer concerning a 90-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events needles and pins on her hands, she couldn't stand up, she crawls on her fours to bed had a hard time getting into bed, needles and pins on her legs.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 12 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 007M20A) via unknown route in the unknown site for prophylaxis of COVID-19 infection.  On 18 Feb 2021, the patient experienced the event(s) needles and pins on her hands, she couldn't stand up, she crawls on her fours to bed had a hard time getting into bed, needles and pins on her legs.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of event(s), needles and pins on her hands, she couldn't stand up, she crawls on her fours to bed had a hard time getting into bed, needles and pins on her legs was unknown.
NUMBNESS SPREADING UPWARDS FROM FINGERS TO SHOULDERS OCCURRING WITHIN 5 TO 10 MINUTES AFTER VACCINATION.
Post vax, the pt experienced an injection site reaction and flu-like symptoms. Unspecified medical attention was sought. The reported also reported an additional pt (WAES 01020057). Addtl info has been requested.
Syncopal episode with loss of consciousness x 3 minutes:  Patient became pale and complained of nausea. Head slumped forward.   Unable to arouse x 3 minutes.  Patient placed supine, ice pack applied.  Initial BP at time of incident 1:15 pm was 79/47.  BP at 1:25, 109/63.  Patient given juice.  Sat up on side of bed at 1:30pm without incident.  Patient walked with mother from facility at 1:40pm.
Patient has swelling and pain on upper arm with high temperature around 100 degree Celsius on Friday Evening (10/7/22). He was given Motrin and Benadryl at home. Patient was at the Doctor's office when they reported the adverse effect.
1 hour after vaccine, patient developed swelling and redness at injection site of Fluzone.  Hives, wheezing.  Patient returned to office treated with epinphrine, Benadryl, Albuterol reb, symptoms resolved within 15 minutes after epinphrine.  Patient observed for 2 hours with no further symptoms.
HAD A RED RASH ON MY UPPER BODY FROM MY NECK TO MY WAIST ON MY FRONT AND BACK AS WELL AS THE SIDES. TOOK BENADRYL AND IT WENT AWAY AFTER A DAY. NOTICED THE REASH THE MORNING WHEN I WOKE UP ON 11/21 AND TOOK BENADRYL THAT MORNING AND NIGHT AND THE RASH WAS GONE MORNING OF 11/22
No adverse event, patient received Moderna for 1st dose even though he's 16, so we had to give him his second dose
Information has been received from a healthcare worker referring to unspecified patients of unknown age and gender. On unknown dates the patients were vaccinated with PNEUMOVAX 23 (batch#/lot# L005563, expiration date 03-NOV-2016, dose and route were unknown) which were exposed to temperatures outside of the recommended range. No adverse events were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Information has been received from the registered nurse on 02-JAN-2014. It was reported th at GARDASIL vaccines were stored in improper temperatures and administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who had administered dose of GARDASIL on 29-JUL-2013 (lot # H021608, exp.: 13-AUG-2015). This is one of the report from the same source, linked reports. Additional information is not expected.
I was pregnant with a baby boy, and the due date was 09/14/2021. I took my first vaccine of pfizer-biontech (Lot: EW0175) on 05/28/2021. On 05/30, I started feeling short of breath and soreness on both upper arms on the afternoon. The shortness of breath lasted several hours and ended before I went to bed on 05/30. The soreness on arms lasted more than 12 hours till the afternoon of 05/31. I did no take any medicine.  No other obvious reaction after the night of 05/31/2021. However, I started to feel fewer activities of the baby fewer than 5 days after the vaccination.  On 06/08, I went to hospital and took an ultrasound to check the status of baby for the concern of no feeling of baby movement. The examine results were read by my ob doctor as everything normal of the baby with normal-high amount of amniotic fluid that makes mom feel less movement. We did see the baby moved. But he was less active than what we saw on ultrasound before (20-week gestation). Another thing noticeable is that baby did not practice breathing during the 45 min ultrasound. The ob reads it as normal to not see it so frequently on 26-week gestation.   On the evening of 06/11, I went to have an emergency care as I still could not feel the baby's movement. The doctors confirmed that my baby boy stopped heart beating and the death time was within 2-3 days.  During 06/15-06/17, I was hospitalized to do labor induction of the baby. I took oral misoprostol for inducing the labor (3 times, two pills the 1st time, three pills the 2nd and 3rd time). I took both tylenol and ibuprofen for the fever caused by misoprostol. I took epidural around 1pm of 06/16 for anesthesia. The baby came out around 5pm of 06/16 and identified as stillbirth.   On 07/16, I took my second doze of pfizer-biontech vaccine (Lot: EW0191) . I am in observation of my reactions.
On July 30th I woke up with altered taste. Nothing that week had shown signs of it whatsoever. I assumed it wouldn?t last long but I am still experiencing it 3 months later? Any foods with garlic, onion, coffee/chocolate, meat/poultry, acidic foods, and most tomato based products taste & smell the way garbage smells. Anything cooked in certain oils / that is pickled also smells and tastes fowl.
Patient arrived to the mass vaccination clinic to receive his 2nd dose of the Moderna COVID-19 vaccine. First dose in the two dose Moderna series was administered on 2/9/21. Patient inadvertently injected with the Pfizer-BioNTech COVID-19 vaccine instead of the Moderna vaccine at 9:53 am on 3-9-21. Patient denied any adverse effects at the time of the vaccination or during the post vaccination monitoring period. Patient again denied any adverse effects during a provider post vaccination follow-up phone call on 3-9-21 at 1:00 pm.
About 36 or so hours after receiving the second dose of the COVID-19 Pfizer vaccine (vaccine given 8/14/21), 14 year old male patient awoke from sleep around 1am on 8/16/21 complaining of substernal chest pain that was 8/10 in severity without any associated shortness of breath, lightheadedness, palpitations, syncope, or other symptoms. The pain improved to 3/10 with Tylenol prior to presenting to the emergency department.
This spontaneous report as received from a registered nurse refers to an unspecified number of unspecified patients. No information regarding the patients' pertinent medical history, concurrent conditions or concomitant therapies was provided. On unknown dates in 2016 (reported as "unspecified dates since 29-SEP-2016"), the patients were vaccinated with doses of improperly stored PEDVAXHIB lot # M020101, expiration date 07-MAR-2019; lot # M010440, expiration date 09-DEC-2018 (dose, route and site of administration were not reported). There were no adverse effects reported. Administered doses of vaccines experienced the temperature excursion of 51.8 degrees Fahrenheit for 30 days. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.
screwed the needle onto the end and there was a needle malfunction; only about 1/2 of the vaccine went in and the other 1/2 leaked out at the hub; vaccine administered at subcutaneous route/ no AE; Initial information regarding an unsolicited valid non serious case was received from pharmacist via Agency (Reference number- 00880523) and transmitted to Sanofi on 01-Dec-2021.  This case involves a 60-year-old female patient receiving INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] who experienced screwed the needle onto the end and there was a needle malfunction (needle issue) and only about 1/2 of the vaccine went in and the other 1/2 leaked out at the hub (underdose) and vaccine administered at subcutaneous route (incorrect route of product administration).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 01-Dec-2021, the patient received a 0.5 mL total dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [injection, strength: standard, frequency: once, lot UT7377JA, expiry date: 30-Jun-2022] via subcutaneous route in the left deltoid for prophylactic vaccination.  It was reported "Pharmacist states that she attempted to vaccinate a patient with FLUZONE QUADRIVALENT PFS. She attached a "Medical Needle Pro Edge Safety Device 25g x 1 inch needle" to the FLUZONE QUADRIVALENT PFS. The needle attached securely, however when the pharmacist attempted to administer the vaccine, only about 1/2 of the vaccine went in and the other 1/2 leaked out at the hub where the needle attaches to the syringe. The Pharmacist asks if she should reinject the patient or if the vaccine was valid."  This case is medication error due to Inappropriate route of vaccination and vaccine underdose (latency same day).  At time of reporting, no adverse event was 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 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.
ADVERSE OUTCOME: patient experienced tonic clonic seizure not sustained minute after injection He told our staff this happens every time he has blood drawn or an injection? Dr. in office aware at time of vaccination and present and documented below. Came in for COVID-19 vaccine. 10 minutes after shot (L) deltoid. He was sitting and said to me he was feeling dizzy and immediately he had convulsion and became pale. We called 911. It lasted 1-2 minutes. Dr. came to see him, he had irregular heartbeat, feeling very tired and weak BP (L) arm 100/60 at 4:15pm. 2nd reading after 10 minutes (L) arm 112/78 p-64. He mentioned he has same reaction after injections, or blood draw. He did not want to be taken to hospital. Pt left at 5:00 with his aunt. He is visiting. When I entered the the patient was having convulsion, clonic phase, stiffening arms and legs. The consciousness came back in 1-2 minutus; he could communicate with me. He said he could breath fine. His heart rhythm was still irregular. Blood pressure was checked. He could not walk because he was too tired. 911 called. 911 cleared patient, BP and heart rate regular and stable per staff. Discharged with family member ambulating on his own, alert and oriented. Plan: must see PCP neurologist. NOT to receive second vaccine unless has complete diagnostic work up and clearance. Should have second injection vaccine in a monitored hospital setting with paramedics.
Approximately 45 minutes after I received the shot, the index finger and thumb of my left hand went completely numb and my index finger turned almost white. The numbness subsided about 20 minutes later but my fingers were tingly and hurt. Shortly thereafter, my left toes were also tingly and numb. By that evening, my right hand and foot were also experiencing tingling and numbness and by the next morning my legs and arms bilaterally were experiencing the same sensations. My upper right back is also involved, with a central area radiating the pins/needles feeling with soreness around it almost like a backache. The severity and location of the pins/needles/numbness changes. For example, when I was taking a walk earlier, my feet and hands increased significantly with the pins/needles feeling and receded some as I was at rest. As I am typing now, my hands, upper back, and lower right leg are the most noticeable with the tingling. I have taken some Benadryl, which reduces the sensations some but does not take it away entirely. I am now three days post injection, and I am concerned that I am experiencing an allergic reaction of some sort that is affecting my nervous system.
(L) arm cellulitis - on KEFLEX and BENADRYL temp 101.3 seen in E/R.
I have a fever of 101.2; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date (lot number: EP7534; expiry date: unknown) at the age of 69-years-old, as dose 2, single, for Covid-19 immunisation. Medical history included ongoing high blood pressure (takes medication so it's under control). Concomitant medications included losartan and hydrochlorothiazide taken for unspecified indications, start and stop dates were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) for Covid-19 immunisation. The patient experienced fever of 101.2 on an unspecified date. Outcome of the event was unknown.   No follow-up attempts are possible. No further information is expected.
Starting to feel numbness on the left side of my face; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Starting to feel numbness on the left side of my face) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (Starting to feel numbness on the left side of my face). At the time of the report, HYPOAESTHESIA (Starting to feel numbness on the left side of my face) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported. Treatment medication was not provided.
Pneumovax: swelling of arm from shoulder to elbow that lasted for less than 2 weeks, 102 fever, redness at site for less than one month. Tetanus booster had same localized reaction less than one week but no fever.
Full body splotchy rash persisting up to 7 days. Patient recommended to use Benadryl and contact primary care provider in case course of prednisone is indicated.
swelling of left arm; It was red. The color changed. It was a pinkish red color, but not her normal color; It felt heavy; couldn't lift her arm up; She was feeling numbness in the finger tips.; Her arm hurt, it was very sore; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (BNT162B2, solution for injection, Batch/Lot Number: EW0169), via an unspecified route of administration on 27May2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date in 2021, the patient experienced swelling of left arm and had puffy whole arm. It was red. The colour changed. It was a pinkish red colour, but not her normal colour. It felt heavy. She couldn't lift her arm up. She was feeling numbness in the finger tips. Her arm hurt. It was very sore. Patient was concerned about the numbness in her hand. It was on the side she got the shot. It was for a couple of days, maybe 3 or 4 days. It took a couple of days to be back to normal. She went back yesterday to get second shot and it seemed they didn't recommend it until she spoke to CDC or spoke to her doctor because of the symptoms.The outcome of the events were recovered on an unknown date in 2021.   Follow-up attempts are needed. Further information is requested.
4cm X 5cm indurated, erythematous area on right arm, non-tender but firm.
Patient immediately started sweating, turned pale, complaining of dizziness and blurred vision. We observed him for approximately 30 minutes. Sweating stopped; coloring became better and normal vitals were seen before he left.