chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient received a dose of FluLaval after an excursion; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incorrect storage of drug in a 35-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent) (batch number 39PF2, expiry date 30-JUN-2024) for prophylaxis.   On 24-OCT-2023, the patient received FluLaval Quadrivalent. On an unknown date, an unknown time after receiving FluLaval Quadrivalent, the patient experienced incorrect storage of drug (Verbatim: patient received a dose of FluLaval after an excursion). The outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 24-OCT-2023 The pharmacist stated that a patient received a dose of FluLaval after an excursion before GSK was called for a statement of stability.  It was a high of 70 degrees Fahrenheit for 24 hours, first excursion. The vaccine administration facility was the same as primary reporter. The patient received product after temperature excursion, which led to incorrect storage of drug. The reporter consented to follow up.
Following vaccination patient felt lightheaded. He was evaluated and was noted to be hypotensive. He was placed in the supine position with legs elevated and reevaluated at 15 minutes with persistent hypotension. He admitted to not eating or drinking since dinner the night prior. He was provided with fluids and began feeling better. He was re evaluated 30 minutes later and blood pressure was normalized at 120/80. He was feeling significantly better.
Day 8 (after receiving vaccine) my tongue swelled and was painful when speaking. Day 8 set on of nausea & weakness. Day 9 swollen tongue, weakness, very intense nausea, almost blacking out/everything starting to close in (happened multiple times). Day 10 slight tongue swelling, nausea and some weakness. Day 11 very slight tongue swelling, but not back to normal, moderately nauseous and black out while walking dog, not to the point of passing out though. Day 12 (today) still slight tongue swelling, just feels bigger in my mouth, mild nausea and still feeling faint. I have not had my menstrual cycle yet, it should start in roughly four days.
This case was reported by a other health professional and described the occurrence of soreness at the injection site in a 51-year-old female patient who received FLULAVAL (batch number 4597B, expiry date June 2015). This case was associated with a product complaint. Concurrent medical conditions included diabetes. On 17th October 2014, the patient received the 1st dose of FLULAVAL (intramuscular). On 18th October 2014, 1 days after receiving FLULAVAL, the patient experienced soreness at the injection site. On an unknown date, the patient experienced pharmaceutical product complaint. On 19th October 2014, the outcome of the soreness at the injection site was recovered/resolved. On an unknown date, the outcome of the pharmaceutical product complaint was unknown. The reporter considered the soreness at the injection site to be probably related to FLULAVAL. It was unknown if the reporter considered the pharmaceutical product complaint to be related to FLULAVAL. Additional information about the product complaint received on 19 November u2014: This is one of the 5 cases reported by the same reporter for the same vaccine (with the same lot number).
This spontaneous report was received from a medical assistant concerning 32 unspecified patients of unknown age and gender. The pertinent medical history and concurrent conditions were not reported. On an unknown date, 1 patient was vaccinated with VAQTA injection, lot # L027735, expiration date: 12-JAN-2017 (dose, route and anatomical location of administration were not reported); 5 patients were vaccinated with VAQTA injection, lot # L045713, expiration date: 14-JAN-2017 (dose, route and anatomical location of administration were not reported); 22 patients were vaccinated with VAQTA injection, lot # M011116, expiration date: 17-JUN-2017 (dose, route and anatomical location of administration were not reported); and 4 patients were vaccinated with VAQTA injection, lot # M011839, expiration date: 13-SEP-2017 (dose, route and anatomical location of administration were not reported); which were improperly stored. The lowest temperature excursion reported was 33.3 F for 2 hours and the highest temperature was 46.6 F for 30 minutes. The temperature excursion was detected by a digital data logger. No adverse effects were reported and no product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
anaphylactic reaction; This is a spontaneous report from a contactable consumer (parent). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient experienced anaphylactic reaction to the vaccine shot on an unspecified date. The outcome of the event was unknown.  Information on Lot/Batch number has been requested.
Rash started reportedly after HPV #2 in January 2017 with just a few lesions on upper abd., then after HPV #3 rash spread over thorax. Denies itching, fever. Rashy is scaley, oblong lesion about 2 cm over trunk and proximal legs. Pt reports rash began 1 day after HPV #3. Took BENADRYL without resolve. HPV #1 GARDASIL 11-3-16; HPV #2 GARDASIL 1-19-17; HPV #3 GARDASIL 5-22-17.
Significant Swelling at injection site, approx the size of my palm or width and hight of 4 fingers. also redness and slight rash, slightly warm to touch. the swelling was easy to see standing in mirror looking at both arms, mild pain, no fever, I noticed this about 6 days after injection. and it lasted about a week. no treatment needed.
Post vax, the pt developed a fever. The pt recovered. This is one of several pts from this facility who had an adverse experience following vax.
Went to Dr's office appt. 11 AM.  Went in for refills on meds.  Then I was told I would be given 2 shots, 1- flu 2- H1N1 shot.  40 minutes after the shot was given, 1st I got dizzy, pain in my shoulder up neck to head!  That was just in 40 mins.  after the shots.  Then I was deathly sick for 4 days.  Puking, wetting my pants as I was throwing up.  Burning up with fevers 105.  (Rash) breaking out on right breast.  1-11-10 at 11 AM cold chills, my throat felt like it was closing up; I had to pull my neck down, & raise my head all the way back, so I could get air thru my throat.  I took a breathing treatment at my house in my room.  I have no car, no phone!  Nothing to get a hold of help.  I am disable & have been since 2005.  A girl friend of mine, stopped by.  Anyway all I could do was throw up, leak, couldn't even get up, when I tried to go to the bathroom I couldn't even do it I had to come right back to my bed:  I got to dizzy but lay down again.  Shaking, cold sweats, headache.  I felt so bad I was deathly sick.  The #2 second day, still throw up & have rash on my right breast only.  But still so sick I had to stay in bed, couldn't get out was still sick.  Sweats 102 degrees could breath a little better.  (3rd day) I could get up out of bed today, but had to stay covered up!  Then mid day I had the diarrhea that wouldn't stop!!  Still have cold sweats and had the diarrhea for 3 more days!  Weak and still not feeling good.  Couldn't eat anything, tried eating chicken noodle soup but on the broth for 3 days, and water or diet soda!  Day 4, 5th. weak diarrhea, sleep a lot.  I know my immune system is down, and had been for over 2 years now!!  I have (COPD), (agoraphobia), (panic disorder), (Diabetes), (major depression/ recurrents).  My right arm up thru my neck is still sore and hard to move, even hard to use and this is the 7th & 8th day.  On the 19th of January 2010.  I'm still weak, but up moving around better!  On the 18th I had diarrhea again, and a fever of 101.2 degrees and this was Monday a week after my shots!!  Still week and must take it easy today.  Thank God I feel a lot better on 19th of January 2010.
No additional adverse effect reported; lots that underwent temperature excursions were admnistered; This spontaneous report was received from a registered nurse, concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, and previous drug reactions or allergies.  On 03-AUG-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot number T017685, which was verified to be a valid lot number, expiration date reported and upon internal validation established as 21-MAY-2022), for prophylaxis (dose, frequency, route of administration, anatomical location and vaccination scheme were not reported) (product storage error). The administered vaccine experienced a temperature excursion of 14 degrees Fahrenheit to 46 degrees Fahrenheit (24.8 degrees Fahrenheit) during a time frame of 30 minutes.   There were a previous temperature excursions n an unknown date: 6 to 14 degrees Fahrenheit (5.9 degrees Fahrenheit) during a time frame of 8 minutes, 6 to 14 degrees Fahrenheit (6.8 degrees Fahrenheit) during a time frame of 18 minutes and 6 to 14 degrees Fahrenheit (8.4 degrees Fahrenheit) during a time frame of 17 minutes.  No additional adverse events were reported.  This is one of ten reports received from the same reporter.; Sender's Comments:  US-009507513-2108USA001125:AM US-009507513-2108USA001040:AL
Not immunocompromised; Pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (Not immunocompromised) and VACCINATION SITE PAIN (Pain at the injection site) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 061E21A, 032L20A and 026L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced OFF LABEL USE (Not immunocompromised) and VACCINATION SITE PAIN (Pain at the injection site). At the time of the report, OFF LABEL USE (Not immunocompromised) had resolved and VACCINATION SITE PAIN (Pain at the injection site) outcome was unknown.            Concomitant medications were not reported. Treatment medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Follow up document received contains Initiative.
I contracted COVID about 4 days after the vaccine. I also went to a birthday party during this time and the symptoms were relatively mild. I was told to take PAXLOVID. It started out as a congestion, and then as it came up it did become hard to breathe. I slept for 4 nights on my recliner just because I was so stuffed, and after 5 days, it was gone.
Information has been received from a physician and a practice manger referring to a patient of unknown age and gender. On 28-SEP-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (lot # K014191, expiration date 10-MAY-2017). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time of the first time was 56 hours with the lowest recorded temperature of 34 Fahrenheit degree (the highest recorded temperature was not reported). The storage criteria and the type of excursion for this vaccine was refrigerator (R). This is one of several reports received from the same source. Additional information has been requested.
Patient received the vaccine without incident. He came back after two hours complaining that he went and worked out and now had red dots on his legs and abdomen. He wouldn't show them to us. We assessed him for other symptoms which was all negative. We gave him 50mg of liquid diphenhydramine and told him to repeat the dose every 6 hours as needed for these symptoms.  We checked on him twice in the next 30 minutes. He was doing well. We explained that if they worsen or if he noticed facial/oral swelling and/or breathing issues to call 911 immediately. He understood.  My clinical services manager checked with him last night and this morning and he was doing well.
This spontaneous report as received from a pharmacist refers to a currently 58 year old male patient of with Crohn's disease, irritable bowel syndrome and abnormal blood pressure. Concomitant medications included unspecified blood pressure medications. The patient had no drug reactions nor allergies. On an unknown date, the patient was vaccinated with ZOSTAVAX (lot #, expiry date, dose and route of administration not reported). On an unknown date, the patient experienced shingles. The pharmacist reported that the patient had pain and itchiness in an unspecified location of the body. The patient sought medical attention (he saw a doctor). No lab diagnostics studies were performed. The patient was treated with VALTREX. The outcome of herpes zoster was reported as recovered (on an unknown date). The relatedness between shingles and ZOSTAVAX was not reported. Varicella Zoster Virus Identification Program packet was declined. Additional information has been requested.
On 7/31/99, the pt experienced swelling, sensitivity, redness, and hardness at the injection site. No temp was taken
High blood pressure that started immediately after giving shot, 5 minutes after shot patient said face was warm and did not feel right.
Patient was walking out of the room and start to faint, CNA saw him and held on to him RN and another CNA came to assist, placed in W/C.  Dr notified and patient assessed, placed on exam table. Pt was monitored, lunch was given, and he ambulated with steady gate, PERRL, A&O X's 3, at 1155 am. Gaurdian was told by RN if any problems return to ED ASAP.
Patient developed shingles across her belly to her back about 3 inches in width. Patient said it was itchy and red blister. Patient has a history of shingles.
had syncope episode; This spontaneous report was received from a medical assistant via a company representative and refers to an 11-year-old female patient. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 16-SEP-2019, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot# 1614897, expiration date 20-SEP-2021, intramuscularly (exact dose and site of administration were not reported) for prophylaxis. On the same day, the patient had a syncope episode. The patient was already lying down and was given crackers and water. The outcome of syncope was reported as recovered/resolved on the same day after receiving the treatment. The patient sought medical attention. It was unknown whether the patient had any laboratory tests performed. The relatedness between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.  Upon internal review, syncope was determined to be medically significant.
9JAN98 knot, sl swelling, tenderness @ site;10JAN98 more severe tightness w/pain;11JAN98 severe pain-no response to pain in muscle (like spasm) shoulder to elbow-can't move or else lt arm;
dizzy; her body felt itchy; abdominal pain; vomited; A spontaneous report was received from a consumer concerning a 85-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events dizzy, body felt itchy, abdominal pain, vomited.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 26 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 013L20A, 010M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 26 Jan 2021, the patient experienced the event(s) dizzy, body felt itchy, abdominal pain, vomited.  Treatment details included Not provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), dizzy, body felt itchy, abdominal pain, vomited was unknown.
Tinnitus in both ears. Started with mild ringing which I noticed and commented to friends/coworker asking if other had same issue. The ringing seems to have gotten louder and more noticeably one year later.
This spontaneous report as received from a registered nurse refers to a female patient of unknown age. On an unkonwn dates (reported as several years ago, number of years was unknown) the patient was vaccinated with the first two doses of GARDASIL (exact dose, route, lot# and expiration date were not reported) and at the time of the report (reported as "now") the patient was in the office asking if she could receive the third PQC (product quality complaint) was involved. Additional information has been requested.
On 9-7-10, mother called the Co. H.D. to report child had a "red rash" on legs, in bends of arms and wrists and abdomen. "Egg sized" bruises around waist. Was taken to Primary Care Provider who referred child to the hospital. Stayed one night.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in Nov2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 44 years, in left arm for covid-19 immunisation.The patient's relevant medical history included: "known allergies sulpha drugs" (unspecified if ongoing), notes: known allergies sulpha drugs. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Mar2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Fatigue  Muscle or body aches  Headache  Sore throat  Congestion or running nose
pt received vaccine, within 1 minute had SOB, used ProAir inhaler. Pt was very distressed, 911 was called, EpiPen was administered in left thigh. pt was very pale and ears began to turn blue. EMS arrived and pt was doing better. She was assessed and did not go to the hospital.
Swelling, redness, burning. Swelling at site continues to increase. Currently 6 inching long, 2-1/2 inches wide with darker red spot in middle about 2" by 2".
Mother noticed droop in left side of face after nap today (02/15/05), otherwise child acting normal.
Ache; Unable to hold her phone; Puffiness on her hands including her knuckle, wrist, palm and to her forearm; Fever; Nausea; Joint pain (Relative to knuckle); Pain in her hands and feet; Puffiness and pain in her feet; This a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, batch/lot number: unknown) via an unspecified route of administration on 23May2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Previously, the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, batch/lot number: unknown) via an unspecified route of administration on an unknown date as a single dose for COVID-19 immunization. On an unknown date, the patient experienced fever, nausea, and ache. However, the worst part that the patient reported and was seeking recommendation on about the pain in her hands and feet. The patient experienced puffiness and pain in her feet went away after a week, however the pain and puffiness on her hands including her knuckle, wrist, palm and to her forearm was intolerable to the point that she was unable to hold her phone. The patient took Tylenol and other pain medications but seem not to work. There were also reports of joint pain (relative to knuckle) and injection pain but not in particular on the hand area specific to the locations she reported but having no information. The outcome of the events ache, unable to hold her phone, puffiness on her hands including her knuckle, wrist, palm and to her forearm, fever, nausea and joint pain (relative to knuckle) was unknown and recovered/resolved from puffiness and pain in her feet, pain in her hands and feet on an unknown date.   Information on the lot/batch number has been requested.
A couple came in to receive their flu shots. The woman was supposed to get Fluad and the husband was to get Fluvax. The intern administered the vaccinations and got them mixed up so administered Fluad to the gentleman (58 years old) and the Fluvax to the woman.
Patient called the day after she got the vaccince and said that her arm and shoulder were in pain. She asked if she should go to doctor. Told pt that some pain and soreness was normal, but if it was bad enough that she was having a hard time moving it or that it was preventing her from her normal daily activities, then she should go to her doctor. Pt said she was probably going to go to the doctor.
After a few minutes, patient reported faint, dizzy warm, clammy, and numbness in her joints. We provider an ice pack, fanned her, and water. Parents wanted EMS to be called, which we did. The patient started to feel better while we waited for EMS to come. Patient had no breathing issues or redness at injection site. EMS came and took over care
color pale, hands became cyanotic, poor perfusion in nail beds, t104, lethargic as EMT; emergency room MD claims pt looked fine @ arrival but would do basic workup;
Nurse calling to report that a drop of VARIVAX went into her eye after administration to a patient; the hub of the needle popped against the patient.; Nurse calling to report that a drop of VARIVAX went into her eye after administration to a patient; This spontaneous report as received from a nurse and refers to a 49-year-old female patient. No information on medical history, current condition or concomitant medications was provided.      On 29-MAR-2023 after administration of varicella virus vaccine live (oka/merck) (VARIVAX) lot # U030161 and expiration date 28-SEP-2023 for prophylaxis (exact dose and route of administration were not provided). The vaccine was administered by the nurse and a drop of varicella virus vaccine live (oka/merck)(VARIVAX) went into her eye as the hub of the needle popped against the patient (occupational exposure to product, needle issue and accidental exposure to product).
AFTER RECEIVING THE VACCINE, SHE SAID SHE WAS HAVING AN ALLERGIC REACTION. ON SITE EMS RESPONDED. BP 114/72 HR 72. SHE REFUSED FURTHER EVALUATION OR CARE.
Do not know Vaccine Lot, Route, or Site. Experiencing Dizziness and slight upset stomach day after vaccination and continuing through today (5 days after vaccination).
SHE INITIALLY THOUGHT HER THROAT WAS CLOSING IN ADDITION TO HER LEFT ARM WAS TINGLING. LEFT ARM WAS SITE OF INJECTION. ON SITE EMS RESPONDED. HER THROAT FELT OPEN AT THIS POINT. BUT LEFT ARM WAS STILL TINGLING. VITALS BELOW. SHE FELT BETTER AND WAS RELEASED TO HOME