chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fluarix PFS, potentially be defected, made a spray; 10 or 15% of the vaccine made a spray; This case was reported by a other health professional via call center representative and described the occurrence of incomplete dose administered in a 9-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number ZG474, expiry date 30th June 2022) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 10th November 2021, the patient received Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. On 10th November 2021, unknown after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced incomplete dose administered. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the incomplete dose administered and pharmaceutical product complaint were unknown.   It was unknown if the reporter considered the incomplete dose administered and pharmaceutical product complaint to be related to Fluarix Tetra Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional information was provided as follows: The reporter stated that the vaccine could potentially be defected and, while he was injecting, 10 or 15 percent of the vaccine made a spray to the side of the patient which led to incomplete dose administered.  The reporter wasn't sure if the needle or syringe was the issue, he did not mention accidental exposure. Since, reporting day was the last day of the reporter in the pharmacy, he decided not to provide last name and requested a follow-up directly with the pharmacy by a call back.
"I feel like my head is underwater...I'm having difficulty hearing and there's constant ringing in my ears. Some sounds are very muffled and other tones are very intensified.  It's an odd feeling and doesn't make me feel well."
Individual comes to mass vaccine administration clinic .Consent form and risks were reviewed with the individual prior to receiving vaccination. Individual received 1st dose of Moderna Vaccine, Lot # 015M20A, NDC 80777-273-10, 7/29/21 expiration. Individual was given 0.5ml of Moderna Vaccine IM and then escorted to waiting room for monitoring for 30 minutes. Individual had no reactions to the vaccine or complaints but after 13 minutes at 3:53 pm she started with a seizure and was unconscious. 911 was called and her vitals monitored. 3:59 pm pulse 62, O2 98%, BP 125/77 blood sugar 77.Smelling stick was used and individual slowly woke up. Staff from the center she came from came over and states that individual does have a history of seizures. Paramedics on the scene asses individuals vitals and share that she had a seizure and left since individual signed not to go to the hospital 4:05 individual took a clonaepam 0.125 from her purse and took it po. Individual remained stable and alert 4:14 individual was assessed again vital 110/83, pulse 60, O2 96% Patient was stable the rest of her 30 minutes post vaccine administration individual left stable with staff. Individual motioned that she was feeling better since she does not speak Individual was given follow up vaccine appointment in 30 days but was told she needed to get a note from her provider that she is able to have a second vaccine.
This spontaneous report as received from a consumer refers to her sister of unknown age. On an unspecified date the patient was vaccinated with a dose of ZOSTAVAX (lot # batch # unspecified) route, dose and location unspecified. On an unspecified date the patient "didn't feel well" for a few days after the ZOSTAVAX injection. At the time of report, the outcome of the event was unknown. Additional information has been requested.
My arm had been slightly, mildly painful for a few days but that got better, then it started itching on day 7 after I had filled out that days vsafe. It itched pretty bad for all that evening and this morning and seemed to have a few tiny places that felt like tiny bubbles, and a slight pinkness. But now the itching it pretty much completely gone, and not pink anymore. So I guess the itching only lasted less than 24 hours.
Arm was very sore, body had significant aches all over, was very tired with very little energy.  Symptoms started day after vaccination and were severe for two days but tapered off within the next two days.
I started noticing that after I urinated, I still felt like I needed to go. At the time, they thought it was a UTI, so, they gave me an antibiotic. I thought I recovered, but a few days later I started having the symptoms again. I'm still having trouble with my overall digestion. They aren't quite sure what the problem is. I have an appointment with a gastroenterologist 4/15/22.
At around 1330 a few minutes after pt received 1st dose of Pfizer COVID vaccine he stated that he needed to take off his mask for a little bit because he did not feel well. Pt states that he was having a tingling and numbing sensation on his lips and tongue. Pt denies having any SOB or difficulty breathing. He states that he has never had a bad reaction to a vaccine before. PT is diaphoretic and speech does sound slurred. PT denies any dizziness or faint feeling. He states that he is a little bit light headed. Pt is ok to sit in the chair. Dr. notified of reaction and came to immunizations clinic to assess. PT continued to have tingling sensation in his lips and continues to not feel good. PT was transferred to the ER via wheelchair at around 1355 pt was alert when transferred
A physician reported the occurrence of sensory polyneuropathy in a 47 year old female who was vaccinated with Lyme disease vaccine recombinant OspA (LYMErix) for prophylaxis. The subject was in "excellent health" prior to September 2001. The subject received no concurrent medications. *The subject experienced no adverse events following previous vax's. On 8/8/00, 11/3/00, and 9/18/01, the subject received her 1st, 2nd, and third LYMErix injections, respectively. 28 days following the 3rd LYMErix injection, on 10/14/01,* she experienced "extreme" fatigue, muscle pain, (mostly in her trunk which varied in intensity), and sensory polyneuropathy characterized by burning and numbness in *her arms, trunk, and legs.* These events occurred sometimes at the same time. The physician stated that the subject's laboratory studies and magnetic resonance imaging (MRI) of the brain and the spinal cord were all normal. Lyme titer was positive. A Western blot was sent by the local hospital to a tertiary hospital, which returned the Western blot saying that "it was unable to interpret the results due to Lyme vaccine." The subject has reportedly been seen by a neurologist, a rheumatologist, a "spinal specialist", and two rehabilitation specialists who have referred the subject back to the vaccine provider. The events have gotten progressively worse and has resulted in disability. As of 9/18/02, the subject was unable to work due to extreme fatigue and muscle pain and was unable to drive or to get out of bed without help. *As of 10/1/02, the MD reported the events of sensory poolyneuropathy and paresthesia, fatigue, and muscle pain persisted. The reporting MD stated that the events were possibly related to LYMErix administration.*
pt recv vax 16SEP96 pt seen on 9SEP96 & local rxn measuring 35x46mm;pink slightly raised area;
Initial report was received 30 March 2011 via lay press report. According to the lay press article, a hospital's community health manager stated they saw "a "breakout" of people getting the flu who had been vaccinated" and the Department of Public Health had recommended health care providers submit tests again from people getting the flu who had already been vaccinated. The article did not provide the influenza vaccine name, the vaccine manufacturer's name or the vaccine lot number. The article did not specify the number of patients who experienced the event and identifiers were not provided for any of the patients. Outcomes were not reported. No additional information was provided. Follow-up information was received 17 May 2011 from a health care professional. The reporter provided patient identifying information for one female patient who contacted the reporter after she was diagnosed with influenza and questioned how she still got the flu. The patient had been vaccinated in December by another provider (vaccine manufacturer, lot number, route/site and exact date of administration was not reported). The reporter told the patient that she had heard of others in the community that had also gotten the flu after being vaccinated, but none of those people had reported the events directly to her. She stated she also explained that the vaccines cover three strains and it was possible for the strain in the community not to match what was in the vaccine and that vaccine efficacy was not 100 percent. The patient then contacted their state department of public health. The article was then published. The reporter had no contact from anyone else. Outcome was not reported. No additional information was provided. Documents held by sender: None.
Presented to health center 7-5-06 at 9 AM for evaluation of complaint of sore tender left deltoid since 1/day post vaccine. Observed circumferential rash pattern varied sizes raised and flat red areas measuring largest 1X2" and smallest less than 1/2". No complaints of itching. Patient evaluated by health center nurse and Immunization Nurse consultant. Advised over the counter anti-inflammatory and call medical provider today for evaluation.
Initial fatigue the afternoon I received the second dose. Slight soreness in arm and itchiness around the injection site. On 04/03/2021, approximately 9:30AM, I began having sharp, stabbing chest pains in my left chest. I have experienced these pains before, typically following recovering from an illness.  Likely pericarditis.
Red swollen area around immun site, soreness under lt arm; could not lift arm because of pain numbness in lt arm;
Nerve in arm feel affected. Cannot lift arm without pain. Pain goes up to neck.  I waited to send this in to see if pain subsided. It did not. I cannot lift my arm and it (the pain) goes up my neck. My husband got the flu vaccine on the same day and has the same problem. Please advise.
Pt reports fever to 101, slight rash on arms and headache.  All resolved within 24 hours.  No further issues.
Inconsolable crying lasted about 2 hours, hive appearance rash on face, red whelps around the mouth. Rash continued for 2 weeks scheduled appointment with doctor. Doctor diagnosed eczema and said to use steroid cream on face. Still had issues with rash/hives/eczema on face. Dr recommended an allergen specialist to be seen. Allergens diagnosed as egg, dairy, and peanuts. Span/Time of events-2 months from the date of adverse event onset.
pt. reports tightness/clenching in throat with trouble swallowing 4 hrs after first injection and a sore arm that lasted for 3 days. Add: Pt. given allergy referral information. Did not receive 2nd dose.
On May 25, 8 days after my 2nd pfizer dose, i noticed a small rash on my chest (I thought it was actually a cluster of mosquito bites at first). I didn't think much of it.  At the time of my 2nd dose of pfizer, i was 27 weeks pregnant. The rash appeared on my chest at 28 weeks pregnant. 11 days after my 2nd pfizer dose and 3 days after the small rash appeared on my chest, on May 28, 2021, i went to an obgyn appointment and received 2 more vaccines: a RhoGAM shot in my butt (I have type O- blood) and a Tdap vaccine in my left arm -- both routine shots to get at 28 weeks of pregnancy. 3 days after those shots were administered, on May 31, a rash appeared on my right upper arm area. By June 2nd (16 days after 2nd pfizer and 5 days after tdap and rhogam) the rash on my arm and chest intensified, and i had bumps and rash forming in small patches on my stomach, legs, and neck/jawline. The rash was extremely itchy and uncomfortable. It seemed to spread very rapidly if it was touched. It looked like bug bites at first but would quickly spread into larger patches. I was unable to do regular things like exercise and wear regular clothes or use my regular products on my skin. On June 3rd I saw a dermatologist who prescribed me an antihistimine pill and a steroid cream,, and who said it might have just been a rash that happens sometimes to pregnant women, but perhaps the vaccines were involved. She said the rash could be "Atopic Eruption of Pregnancy (AEP)." I also saw my obgyn on June 7, and she also took a look at the rash. With the help of the steroid cream and the antihistimine pill, the rash stopped spreading by June 8 and stopped icthing and irritating me by June 11. It is now June 16 and the rash is starting to fade. I am now 31 weeks pregnant.
Severe vaginal haemorrhage, hospitalised for 3 days to treat infection of the womb. Blood loss 1.5-2 litres.
Upper extremity, swelling shoulder to elbow on right side, red and indurated by deltoid.
Patient was given a dose of vaccine that expired 1 day after the expiration date of the vaccine.  We have called Pfizer for recommendation as for to revaccinate or not.  Pfizer told us to give patient another dose b/c they don't have stability data.  We are trying to reach out to the patient to come in for another dose.
pt recv vax 1MAR97 & on 12MAR97 pt devel 5 spots on chest & stomach on thigh & 1 on neck;
Pt began feeling lightheaded after receiving the vaccine. 1146: 100% 91 132/88 Pt was given water and asked to drink the whole bottle. Symptoms resolved. 1148 98% 70. 1150 126/84 96% 74
At onset, rash covering upper portion of chest, mildly itchy. Over the following approximately 48 hours, the rash spread progressively down torso to waist. After reaching waist on front of body, it continued at top of back and moved down progressively to shoulder blades. When it reached this point, it was still present everywhere it had already appeared. After the approximately 48 hours of spreading, it retreated in the reverse progression over the course of about 72 hours. So it gradually cleared on the back, then cleared on front of torso starting at waist and cleared gradually moving up the torso.  No medication was taken at any time to treat the rash or any other condition/illness.  Waited until 2nd vaccine dose to ask vaccine clinic if I could treat it if it reoccurs. They suggested Benadryl unless it becomes more serious than what was described to them.
Patient has swelling, redness, itching, rash and hot to touch at site started on the 7th day after vaccine No treatment done
When trying to ambulate in the morning to get out of bed, patient was not able to walk very well, with unsteady gait and weakness in legs. Notified Neurologist when finally arriving at work, patient has M.S.
24 hours after the vaccine, a red rash appeared below the injection area with mid pain and itchiness. On the 2nd day, hives appeared on the neck area. These came and go in about an hour or 2.  After 4-5 days rashes appeared on the face, hands, and back. It spread more when itched. It started as Urticaria and now is more as dermatographia. I took steroids for 7 days with Pepcid and Allegra. Currently just taking Allegra to control the itch and rashes.
Headache and chills around noon on Sep16. Left work early. Shivering, muscle pain, joint pain at about 4 pm that day. Nausea, altered sense of taste and low grade fever by 6 pm. Treated with acetaminophen and bedrest. Isolated self due to concern for COVID infection. Improved the following morning, but still had mild headache and muscle/joint pain. Symptoms completely resolved by 5 pm on Sep17.
Patient reported fever/chills/sweating/tiredness/sensitivity to light starting the night after receiving a flu and pneumonia vaccine and continuing through the next day.
A cluster of 3 patients who received YF Vax lot# UF045AA and Adacel lot# C2731AA and experienced adverse events, which are detailed in cases 2007-02925, 2007-02926, 2007-02927.
THE PATIENT REPORTED SWELLING THE LYMPH NODE OF THE LEFT ARMPIT (THE SAME ARM WHERE THE VACCINE WAS GIVEN); IT IS BIGGER THAN THE SIZE OF AN EGG AND HE REPORTS SOME PAIN. NO FEVER OR OTHER SYMPTOMS. HE REPORTED THIS TO THE PHARMACY ON 10/13/21. THE VACCINE WAS GIVEN ON 10/8/21 AND THE SYMPTOM STARTED ON 10/11/21. HE HAS NOT CALLED THE DOCTOR DUE TO THIS OCCURING PREVIOUSLY AFTER THE MODERNA VACCINE (WHICH OCCURRED IN THE SAME ARM) EARILER THE YEAR. FOR THE MODERNA VACCINE, HE WENT TO THE EMERGENCY ROOM AND THEY COMPLETED SCANS. HE REPORTED THAT IT WENT AWAY IN 10 DAYS. IN THIS PARTICULAR CASE, HE HAS NOT YET CALLED THE DOCTOR. I TOLD HIM TO LET HIS DOCTOR KNOW, AND TO GO TO THE DOCTOR OR ER IF IT DOES NOT GO AWAY IN A FEW DAYS, GETS BIGGER, THE PAIN GETS WORSE, FEVER DEVELOPS, OR HAS TROUBLE BREATHING, ETC.
This spontaneous report as received from a healthcare worker refers to a 2 patients of unknown age and gender. The reporter stated that those two patients were administered a dose of PROQUAD (Merck) (dose, units, route of administration, anatomical location were not reported) that was improperly stored. No adverse events were reported. This is one of several reports from the same reporter. Additional information has been requested.
Mom called to say the next day- the child's left leg swelled a lot, Lasted 3 days, Child had #4 DTaP and child never ran a fever or acted like it hurt her. Mom states acted same, just swollen.
This non-serious medically confirmed spontaneous report (initial receipt 28-OCT-2014) concerns an adult patient. On 27-OCT-2014, the patient received intramuscular AFLURIA (batch number not reported) at 0.5 ml. The AFLURIA pre-filled syringe that was administered to the patient underwent temperature excursion at 68 degree F for 48 hours. No adverse events were reported. Outcome was not reported. Reporter's comments: The reporter assessed the events as non-serious.
all COVID 19 "shorts" and the two booster also stopped their shingles/ this third booster did not, they broke back out a week after 3rd booster; all COVID 19 "shorts" and the two booster also stopped their shingles/ this third booster did not, they broke back out a week after 3rd booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, Batch/Lot number: unknown), for COVID-19 immunization, reaction(s): "stopped their shingles"; Bnt162b2 (dose 2, Batch/Lot number: unknown), for Covid-19 immunization, reaction(s): "stopped their shingles"; Shingrix shots (dose number unknown, Batch/Lot number: unknown), for immunisation, reaction(s): "shingles were still coming monthly". The following information was reported: HERPES ZOSTER (non-serious), DISEASE RECURRENCE (non-serious), outcome "unknown" and all described as "all COVID 19 "shorts" and the two booster also stopped their shingles/ this third booster did not, they broke back out a week after 3rd booster".  Additional information: The reporter shared that all COVID 19 "shorts" and the two booster also stopped their shingles. This third booster did not, they broke back out a week after 3rd booster. The reporter knew the Pfizer shots for COVID were not for shingles but it was an added benefit. Even after they got varicella zoster vaccine rge (cho) (SHINGRIX) shots, their shingles were still coming monthly. So reporter was guessing the 3rd booster was not as strong. Maybe Pfizer could increase it.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202200068023 same patient/drug, different dose number/event;
c/o mouth/tongue swelling 0923 given benadryl 50mg; lungs clear 0925 symptoms improving, can swallow more easily 0927 famotidine 40 mg given 0930 BP 140/84, sent to observation for 30 minutes
No adverse reaction or event, Mom came with a child who was not yet 12 years old (11.5 years old) and booked the appointment as for a 12 year old for covid  vaccine. Physician administered the vaccine but realized after the administration that child was not 12 yet. Mom was approached and admitted that she was aware that's it only for children 12 and above and wanted to give it to her child. we reported this  and they advised us also to report this to VAERS as administration error. We implemented additional age/dob check before administration.
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered 24 hours post punctured), PRODUCT STORAGE ERROR (The vial was first punctured on 01-Aug-2022 at 9:30 AM post puncture the vial was stored in fridge and administration of vaccine on 02-Aug-2022 at 9: 15 am and 9:30 AM) and NO ADVERSE EVENT (No adverse event) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013B22A) for COVID-19 prophylaxis. No Medical History information was reported. What On 02-Aug-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Aug-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered 24 hours post punctured). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was first punctured on 01-Aug-2022 at 9:30 AM post puncture the vial was stored in fridge and administration of vaccine on 02-Aug-2022 at 9: 15 am and 9:30 AM) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered 24 hours post punctured), PRODUCT STORAGE ERROR (The vial was first punctured on 01-Aug-2022 at 9:30 AM post puncture the vial was stored in fridge and administration of vaccine on 02-Aug-2022 at 9: 15 am and 9:30 AM) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered 24 hours post punctured) and PRODUCT STORAGE ERROR (The vial was first punctured on 01-Aug-2022 at 9:30 AM post puncture the vial was stored in fridge and administration of vaccine on 02-Aug-2022 at 9: 15 am and 9:30 AM). Patient had no allergy and never tested positive for COVID. No concomitant medication was reported. Number of doses/vials was 2/1. Vials were initially refrigerated on 14-Jul-2022. Vial did not undergo any temperature excursion. Total amount of time the vial was exposed to room temperature range 8 to 25 degree Celsius= 46 to 77 Fahrenheit was 30 minutes. Time of administration to 2 patients were on 2-Aug-2022 9:15 and 9:30 AM. No treatment medication was reported. This case was linked to US-MODERNATX, INC.-MOD-2022-620931. Most recent FOLLOW-UP information incorporated above includes: On 04-Aug-2022: Follow-up was received and case validity updated, patient identifier added, suspect dose details added and narrative updated. Sender's Comments: US-MODERNATX, INC.-MOD-2022-620931: same reporter 2nd patient.
Symptoms started showing up either on the day of the injection or the second day after the shot but did not get noticed. On the 29th of September I, the husband, noticed that the color of her arm was deep red to pink around the edge of the muscle. Took my wife to immediate care and had her examined and they diagnosis it as cellulitis of the left upper limb.
pt recv vax & AUG92 lab eval revealed neg anti-HBs p/3rd dose of vax;7AUG93 lab eval revealed hepatitis B surface AB was neg,serum LDL 176.1 & triglycerides 211;
I generally very lousy, sick, nauseated, diarrhea and I lost my smell a few days later.