chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Twinrix on 14Jan2023, received a late 2nd dose on 24Feb2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a male patient who received HAB (Twinrix) for prophylaxis.   Concomitant products included HEPATITIS A VACCINE + HEPATITIS B VACCINE (TWINRIX).   On 24-FEB-2023, the patient received the 2nd dose of Twinrix. On 24-FEB-2023, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: Twinrix on 14Jan2023, received a late 2nd dose on 24Feb2023). The outcome of the drug dose administration interval too long 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: 21-JUL-2023 A pharmacist reported that a patient received the 1st dose of Twinrix on 14January 2023, received a late 2nd dose on 24th February 2023 which led to lengthening of vaccination schedule. Possibly a late 3rd dose, as he had not received 3rd dose as of time of the report. The vaccine administration facility is the same as primary reporter. The health care professional was in car driving while giving the report she did not have patient details or lot number or expiration date. The health care professional consented to follow-up via email.
I have a history of SVT which happens twice a year normally. It has increased in frequency and severity since I got the second dose of the vaccine. My Arthritis has also been much more painful than normal. A few weeks after the second dose I was experiencing faintness and rapid heart rate when I tried to go on my normal walks. When I had the Supraventricular Tachycardia it was going up in heart rate and then I start to feel faint. I feel a tightness in my chest and it got higher than 200. I wore a Holter Monitor for two weeks. I have fainted four times. It has been five months and the symptoms did not improve until I was prescribed Flecainide. I also use some breathing exercises which help a little. I am scheduled for a Cardiac Ablation on 10/14/2021.
About an hour after getting the shot, the skin on my right arm was flushing before going numb. Then my shoulder went partially numb and it's still numb/frozen as of 2:20 am 26/June/2021. Over the course of nine hours from when I got the shot, starting at around 1 hour after, I started to get symptoms, which as of right now are still here. After my skin started acting up, my blood pressure dropped and my heart was pounding extremely hard in my chest and felt tight. My muscles have been going between losing muscle tone and being locked up extremely hard. I've been dizzy since about 3:00 pm 25/June/21, and it has progressively gotten worse to where I feel like I am going to pass out if I stand up. I have chills that make my chest tighten up and cause angina. I have been feeling  very faint since around 9:00pm. I've had a mild headache since around 2:30pm, and have been feeling like I am falling since about 1am. Breathing takes manual effort. I have been feeling dissociated and nauseous since about 6pm and cannot remember much from after 6pm. I am not sure whether it is a medical emergency or not but I can't afford to go to the er.
expired vaccine was administered; A spontaneous report was received from a healthcare facility staff member concerning an 82-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273)  and was administered expired vaccine.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 29 Jan 2021, the patient received planned dose of mRNA-1273 (Lot umber: 025L20A)  (it was not reported if this was dose 1 or dose 2) intramuscularly at unspecified site for prophylaxis of COVID-19 infection.  On 28 Jan 2021, the vaccine vial was punctured and was set to expire at 15:30. On 29-Jan-2021, the physician accidently administered the expired vaccine to the patient. The vial was discarded after the mistake was realized.  Action taken with mRNA-1273 in response to the event was not reported.   The event expired vaccine was administered, was considered recovered / resolved on 29-Jan-2021.; Reporter's Comments: This report refers to a case of expired product administered for mRNA-1273.  There were no reported adverse events associated with this case.
patient started feeling lightheaded when approaching the charting table post-vaccine. Pt went forward and sat on floor, but did not remember it happening. Patient was remembering the injection of Pfizer booster and felt nervous. Vitals taken blood pressure 130/80, heart rate 87, pulse ox 97%. After lying down vitals were retaken and lowered to 118/80. Heart rate was 91 and pulse ox was 97%. Patient left with her brother.
Hives developed 10 days after giving the MMR, PREVNAR, and flu vaccine at the 15 month well check.
Information has been received from a physician concerning a 14 year old female who on 21-JUN-2007 was vaccinated with the first dose of the Gardasil. Concomitant therapy included Menactra, DTaP (unspecified) and Varivax (manufacturer unknown), which were also administered on 21-JUN-2007. After receiving the Gardasil, the patient became woozy and slumped in her chair as if she was about to faint. Unspecified medical attention was sought. The reporter noted that the patient had not eaten lunch the day she received the vaccinations. The patient recovered within an hour. Additional information has been requested.
Approx 1hr after vaccine administration patient noted pain at site, also with a bruise the size of a quarter. Went to bed and pain at site increased, bruise side of 50 cent piece. Redness and warmth at injection site approximately 3"x3" also with "minor" swelling. In am site sore to touch. At 230 pm 10-14-16 area still warm to touch with very little swelling, bruise very faint and area still sore to touch. When vaccine administered did have slight bleeding.
Information ahs been received from a nurse concerning a female with no prior history of drug reactions, who was vaccinated intramuscularly with the first dose of Gardasil. On approximately 09-JUL-2007 (also reported as "last 2 days"), immediately after the injection of Gardasil, the patient fainted. Subsequently, the patient recovered from the fainting. Attempts are being made to obtain additional identifying information to distinguish the individual patients in this report. Additional information will be provided, if available. The same source provided information on another patient, WAES #0707USA05068. 10/08/07 This is in follow-up to report(s) previously submitted on 8/14/2007. Initial and follow up information has been received from a nurse concerning a female between the ages of 13 to 16 years old with no prior history of drug reactions, who was vaccinated intramuscularly with the first dose of GARDASIL (Lot# 654741/1208F). On approximately 09-JUL-2007 (also reported as "last 2 days"), immediately after the injection of GARDASIL, the patient fainted. Subsequently, the patient recovered from the fainting. The same source provided information on another patient, WAES #0707USA05068 and WAES# 0709USA00163. Additional information has been requested.
Fever of 103 on 9/6/04. Approximately 6-7 pox lesions 13 days after varicella vaccine.
Meningococcal (MCV4P) given 8/27/12. Mother reported that he felt bad that night. Sore arm, the next day patient had headache, muscle pain, difficulty sleeping, and his spine "killing" him. Mom has been giving him ADVIL every 4-6 hrs for pain. Called mom on 8/29/12 reports son still feels bad with same symptoms. These symptoms lasted for 5 days f/u with mom on 9/10/12. Patient is at college  & doing fine now.
has had a fever since this time; her ileostomy had a blockage that day and she vomited all night; her ileostomy had a blockage that day and she vomited all night; it was very severe and sore and she is just getting over the soreness; This is a spontaneous report from a contactable consumer, the patient. A 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EL1283, first dose) solution for injection intramuscular in left deltoid on 18Jan2021 at 14:20 (at the age of 73-years-old) at single dose for COVID-19 vaccination. Medical history included ongoing type 2 diabetes, ongoing active carcinoid cancer of liver, ongoing Ileostomy from Jul2002, surgery in 2001, second primary colon tumor, acid reflux and neuropathy in feet and legs. Concomitant medications included amlodipine besilate for blood pressure, lisinopril for blood pressure, metformin, sitagliptin phosphate (JANUVIA) and gabapentin. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. The patient has had a fever since this time on 18Jan2021 and was very severe and sore and she is just getting over the soreness in Jan2021. Temperature was 102 F on 18Jan2021, 101 F on 19Jan2021, the having a fever in varying degrees like 99 F or 100 F after in Jan2021. On 18Jan2021, her ileostomy had a blockage that day and she vomited all night. Treatment for the event fever included ibuprofen (ADVIL). The outcome of the event fever was not recovered. The outcome of the events vomited and ileostomy had a blockage was unknown. The outcome of the event pain was recovering.
Narrative:  80yoM presents to ED on 9/17/2022 with chief complaint of chills x7 days and SOB. Home COVID test positive. Reports dry intermittent cough. PMH significant for HF, ischemic CMP with EF 31-38% with AICD, pancytopenia, cirrhosis with esophageal varices, AF not on anticoagulation due to GI bleed, COPD, DOE/chronic hypoxemia on 2.5L oxygen, and CKD II. Admitted and treated with dexamethasone 6mg IV x1 dose. Transferred 9/18/22.
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Nov2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 38 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Gout" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "recovered" (Oct2023) and all described as "COVID-19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Oct2023) negative, notes: Had tested negative on last day of treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid from 08Oct2023 to 13Oct2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300329760 Same patient, different product, different events;
Medication suspected of leading to the adverse reaction: Tetanus, diphtheria, and acellular pertussis vaccine - Tdap--0.5mL/IM- medications suspected of contributing or leading to the adverse reactions: Pt had similar experience to needles prior to the encounter. Reaction preventable -e.g., inappropriate or lack of dose adjustment, excessive dosing, known drug interaction, drug allergies, other contraindications, or inappropriate drug administration technique: No. Type of reaction: Idiosyncratic - unanticipated rare adverse reaction not dose related. Likelihood that the reaction was a result of the medication: Doubtful -no reasonable temporal relationship between the reaction and the drug. Result of the reaction on the level of care: Laboratory tests performed, observation initiated/increased, oxygen administered, vital signs monitoring initiated/increased. Outcome: pt. slid to floor, pale, not breathing, postured, seizure lasting 20 sec. pt. came around and A&O x3. Incident description: pt. was a visitor to facility and getting a Tdap vaccine. Pt. found on floor by elevator pale, not breathing then went into posturing. Possible seizure x20secs. pt. came around alert and oriented x3, still pale and nauseous to ED for assessment. Pt. stated she has fear of needles and does faint with them. Friends confirmed fear and went with pt. to ED.
Approx 6-7 hrs p/vax, both lower legs of pt became swollen & red to above the knees; Seen in ER; Given DPH; w/in 1/2 hr redness disappeared & swelling dec; Hospitalized; Next morning sx almost gone; sl. bluish discoloration under skin;
PATIENT HAD J & J as a first Covid vaccine.  When she was eligible for a booster, she received Moderna 0.25ml.  In the past week, she became eligible for a 2nd booster. She received Moderna 0.5ml.... She should have only had 0.25ml because she is not immune compromised. Therefore, she received twice the amount that she was supposed to get.  She said that she felt more chills, headache, and fatigue this time around. When I contacted her -two days later- she said that she felt pretty normal. I asked her to please reach out to pharmacy if there were any changes in how she felt. She said she would.
Swelling of arm from elbow to should, all redness and itchy too, started the next day. Itchy eyes and redness on face 4 hours after vaccine. Next day - Fatigue, severe chills, headache, nausea
Itchy rash all over body. Rash started clearing up after about 12 hours with Benadryl
Shortness of breath; Fatigue; Vomiting; Chills; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath), FATIGUE (Fatigue), VOMITING (Vomiting), CHILLS (Chills) and NAUSEA (Nausea) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, the patient experienced DYSPNOEA (Shortness of breath), FATIGUE (Fatigue), VOMITING (Vomiting), CHILLS (Chills) and NAUSEA (Nausea). At the time of the report, DYSPNOEA (Shortness of breath), FATIGUE (Fatigue), VOMITING (Vomiting), CHILLS (Chills) and NAUSEA (Nausea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were provided.  The patient did not take any treatment.29 year old male patient called to report that he received moderna vaccine on his left arm on 13mar2021 and experienced fatigue, vomiting, chills, nausea and shortness of breath. No treatment taken and symptoms have resolved
patient received the Moderna vaccine at 4:30 pm.  Patient waited in observation lot for 15 minutes and proceeded to vacate the area.  Patient returned to the site at 5:35 p.m. with hives on neck and tingle in throat.  Pulse 92, 02 95%, and Blood pressure 142/92, and temp at 98.3. Patient has history of reaction to welbutrin.  Patient administered 50 mg of Diphenhydramine HCL at 5:38 p.m. Pulse at 92, 02 99%, BP 134/84 and temp 98.4 at 6 p.m.  Patient recovered and left in her friends vehicle at 6:53 p.m.
Medication Error NOT ADE  COVID vaccine clinic. vaccinator reported to pharmacy that she believes she administered a dose of 0.1ml to a patient as opposed to the necessary 0.5ml that is required.   Patient had left building by the time error was discovered.   We were able to identify who the patient was who received the underdose.  We contacted Janssen for recommendation on either administering the additional 0.4 mL dose or a full 0.5 mL dose.   Janssen had no recommendations for partial dosing, split dosing and we were instructed to follow up as we felt most appropriate.   We ultimately administered the additional 0.4 mL partial dose to the patient.    In reviewing incident with involved Pharmacy staff, it appears that unintentionally a 1 mL syringe was given to this vaccinator amongst the standard 3 mL syringes used to administer the 0.5 mL dose.  It was reported to me that the vaccinator self reported that when she was drawing up the intended dose of 0.5 mL she did not recognize that she was using a 1 mL syringe.  Vaccinator drew the dose back to the first major marking on the syringe (0.1mL).  On the 3 mL syringes the first major marking is 0.5 mL.    The Pharmacy staff reported that the 1 mL syringe packaging and the 3 mL syringe packaging are nearly identical.  After this incident Pharmacy staff segregated all 1 mL syringes to ensure 1 mL syringes were no longer supplied to any vaccinator.  Going forward Pharmacy, whenever possible,  will work to prevent any 1 mL syringes from being sent to a Moderna or J&J clinic were the doses are 0.5 mL.
Had 1st shat on the evening of February 12th at around 5:30 PM - next day, had some slight soreness in the injection area - subsided after several days - 2 weeks later (2/26), my left arm in the site injection area started to itch - then I got swelling, redness about4-5 inches in circumference surrounding the injection site - area was also warm - not hot. Have not had a fever.  2nd dose is scheduled for Friday evening,  March 12th @ pharmacy.
Flu-like symptoms with 101 F fever, muscle ache, inflamed left upper arm warm to the touch, infection with confirmed allergic reaction by doctor. Patient was prescribed Cephalexin 500 mg 1 po TID x 7 days. Prednisone 20 mg 1 po QD x 3 days. Triamcinolone Acet 0.1% cream apply small amt Q 6 to 8 hrs.
This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. Pertinent medical history, concurrent conditions, drug reactions or allergies were not reported. On an unknown date the unspecified number of patients were vaccinated with an improperly stored dose of ZOSTAVAX (dose, dose number, route, anatomical location, lot number and expiration date were unspecified). Concomitant therapies were not reported. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
9/12/21: Called to report covid positive result from 9/11/21. Still symptomatic- runny nose, HA, body aches, fever. Advised to quarantine x10 days since s/s first appeared and at least 24hrs passed since fever without use of fever-reducing meds and s/s have improved/resolved. Pt to also f/u with PCP. Pt will need to clear for RTW when done with quarantine and s/s improved/resolved. Pt fully vaccinated. Antibodies testing ordered. Instructed pt. to complete covid antibodies testing when done with quarantine.   HISTORY 9/11/21: Pt returned on 9/10. She started to experience s/s today, 9/11. Pt did not get preflight travel testing. States her family members had preflight testing done and were all negative. Pt instructed to quarantine while results are pending; however, if negative then no longer needs to quarantine.  Pt will get results from healthcare portal within 24-72 hours.  Pt informed to call the hotline as soon as results are available and at that time will get a date of when to get clearance for RTW. Pt to call hotline with date of symptom resolution. Pt instructed to update manager.
ACUTE NON ST ELEVATION MI 4/18/2023 CHEST PAIN ACUTE NON ST ELEVATION MI 4/18/2023 ADVANCE DIRECTIVE DISCUSSED W PATIENT
Pt developed rash to both arms and chest. Pt developed edema to left arm. Pt developed erythema to right arm. Chest had fine, urticarial lesions. Pt was seen in ER and given Benadryl IM on 5/5/01.
I received my flu shot on 10/15/2020.  Afterwards the area became red, swollen and hot to the touch.   The next day, 10/16/2020, the redness and swelling had spread, it had also hardened into a knot and it was still hot to the touch.  By the evening of 10/16/2020 the area was continuing to grow in size.  I marked the outside edges with a sharpie marker to be able to determine how much it was increasing in size and also took some pictures.   The next morning, 10/17/2020, the area had only increased slightly in size and the redness had drastically decreased but was still hard and hot to the touch.   On 10/18/2020 the area wasn?t red but had more of a purple hue deep under the skin.  It was less swollen but still hard and it wasn?t as hot as it had been.  A few times throughout the day on 10/18/2020 I reached behind me for something or reached over my head into a cabinet.  Each time I would get what felt like a sharp muscle cramp that started at the injection site and shoot down the back and front side of my upper arm. On 10/19/2020 the area is still hard but less swollen, only slightly warm to the touch and is not discolored but it has a constant aching pain at the injection site.  When I dropped my daughter off at school I tried to reach behind me to pick up her lunch box from the back seat (something I can normally do with no issues) and had severe pain, starting at the injection site and going down the front and back of my upper arm.  I also had no strength and couldn?t pick up the lunchbox.  The remainder of the day movement in any direction caused increased pain starting from the injection site and going down the front and back of my upper arm.  I took ibuprofen, 600 mg, three times throughout the day on 10/18/2020.  Each time it helped for a few hours but then the pain would come back.    On 10/20/2020 there is a discolored area that is a faint brown color at the injection site.  There is still a constant aching pain at the injection site.  When I move my arm, I get a shooting pain down the front of my arm to the bend at the elbow and up the arm to my shoulder.  There is no longer any pain down the back of my arm.
shot area became very red; shot area became very red and angry; shot area became very red and angry and felt hot to the touch.; This case was reported by a other health professional via interactive digital media and described the occurrence of injection site erythema in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 1 week after receiving Shingrix, the patient experienced injection site erythema, injection site discomfort and injection site warmth. On an unknown date, the outcome of the injection site erythema, injection site discomfort and injection site warmth were unknown.   It was unknown if the reporter considered the injection site erythema, injection site discomfort and injection site warmth to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was captured as adult as per the vaccine indication. About a week after getting Shingrix, the patient received regular allergy shot. About an hour later the shot, the are became very red and angry and felt hot to the touch. The patient was aksing, was this common and if it was caused by allergy shot.