chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Since then I started feeling irregular heart beats.; I fainted.; I totally lost my consciousness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received BNT162b2 (BNT162B2), on 30Dec2021 at 11:30 as dose 3 (booster), single (Lot number: FL3209) at the age of 67 years, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose Number: 2, Batch/Lot No: ER8727, Location of injection: Arm Left), administration date: 25Mar2021, when the patient was 66-year-old, for COVID-19 Immunization, reaction(s): "I also felt dizziness in Jun2021 without any noticeable reasons"; BNT162b2 (Dose Number: 1, Batch/Lot No: EN6205, Location of injection: Arm Left), administration date: 04Mar2021, when the patient was 66-year-old, for COVID-19 Immunization, reaction(s): "I also felt dizziness in Jun2021 without any noticeable reasons". The following information was reported: SYNCOPE (medically significant) with onset 30Dec2021, outcome "unknown", described as "I fainted."; LOSS OF CONSCIOUSNESS (medically significant) with onset 30Dec2021, outcome "unknown", described as "I totally lost my consciousness"; HEART RATE IRREGULAR (non-serious) with onset 31Dec2021, outcome "not recovered", described as "Since then I started feeling irregular heart beats.". The events "i fainted.", "i totally lost my consciousness" and "since then i started feeling irregular heart beats." required emergency room visit. The patient underwent the following laboratory tests and procedures: Nasopharyngeal swab: Negative.  Clinical course: In the morning of 30Dec2021 at about 11:30 patient took Pfizer Booster on his left arm. Same day at night when he went to bathroom standing in front of the toilet, he fainted. He totally lost my consciousness suddenly. He did not know it lasted for how long, but he did not feel cold. When he came back to bed he saw clock time was 2:30 AM. The following morning he went to Emergency Room. The doctor said that the faint was probably related to the Pfizer Booster. Since then he started feeling irregular heartbeats. First, these irregular heartbeats came upon him once in a while, but now it comes up every day and every hour. Very often! It greatly affects his life. He also felt dizziness in Jun2021 without any noticeable reasons. He believed this was the start-up of Pfizer vaccine side effects. Adverse event resulted in: Emergency room/department or urgent care. Patient had no COVID prior vaccination. Patient tested COVID post vaccination. COVID test type post vaccination: Nasal Swab. COVID test result: Negative.
Fever of 101.2. Arthralgias. Chills. Malaise. H/A
Right upper arm started becoming red (quarter size) on 12/6/2017. Today right upper arm has an area of erythema entire back of arm. Warm to touch. Some tenderness to palpation. No induration. Cellulitis of right upper extremity. AUGMENTIN 400- 57/5ml oral suspension. (4ml orally every 12 hrs for 10 days).
Occasional sorness in hands; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Occasional sorness in hands) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    The patient's past medical history included Pain in hip (Hurt in joints in hips.). Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe rheumatoid arthritis.).   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free, Solution for injection in pre-filled pen. On an unknown date, the patient experienced PAIN IN EXTREMITY (Occasional sorness in hands). At the time of the report, PAIN IN EXTREMITY (Occasional sorness in hands) had resolved.            No concomitant medications were reported.  The dose patient received on 15-Dec-2021 was third/Booster dose.  It was unknown if patient was enrolled in a COVID-19 vaccine trial. The reporter causality of Humira was reported as reasonable possibility/probable for the event Occasional sorness in hands.  No treatment medications were reported.
This spontaneous case initially received on 01-Nov-2016, was reported by a non health professional and concerns a 65-year-old female patient. Weight: not provided; Height: not provided. Current conditions include COPD (chronic obstructive pulmonary disease). Concomitant medication: not reported. Administration of company suspect drug(s): The patient received AFLURIA for the prevention of seasonal influenza from 25-OCT-2016 to 25-OCT-2016. Dose regimen: 0.5 ml once, Route of administration: Subcutaneous. Batch number: Not reported. No additional suspect drugs. Adverse reactions/events and outcomes: The patient states the technician gave her the shot in the back of the arm and she did not feel the injection at all. The next day on 26-Oct-2016, she had pain in the triceps area (outcome: recovered / resolved). The pain is gone now. The patient thinks the injection was subcutaneous instead of intramuscular. Special circumstances: Incorrect route of drug administration. Reporter comments: The reporter considered the event non-serious and reports that it is unclear if the patient received AFLURIA or FLUVIRIN.
left on the cooler after shipment for 3 days with no reported adverse event; patient was administered with FLUZONE HD with no reported adverse event; Initial information received on 11-Sep-2023 regarding an unsolicited valid non-serious case received from a physician.  This case involves patients of unknown demographics who were administered with influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent] after left on the cooler after shipment for 3 days with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patients received a dose of suspect Influenza Quadrival A-B High Dose HV Vaccine formulation, strength: not reported lot UT8104AA expiry date: 30-Jun-2024 via unknown route in unknown administration site for immunization and left on the cooler after shipment for 3 days with no reported adverse event (product storage error).  On an unknown date patients were administered with fluzone hd with no reported adverse event (poor quality product administered) on the same day following the administration of Influenza Quadrival A-B High Dose HV Vaccine.  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event left on the cooler after shipment for 3 days with no reported adverse event and was Unknown for the event patient were administered with fluzone hd with no reported adverse event.  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.
Administration vaccine error.  It is suspected that the vaccine was administered with a 1/2" needle syringe instead of a 1" needle syringe.
Strange feeling from from my head to my toes, throat starting to close up, Hands went completely cold, face & body  turned red along with bums all over bodying Took  a Zyrtec. Next morning called the pharmacist and she told me to take got Benadryl instead. Also said I should  have call 911. Went to doctor the next he told  to keep on keeping Benadryl.  Rash lasted about 7 days. My face peeled  on left side and flaked off my body.
Arm red and swollen, indurated, nonerythematous, slightly swollen area, left lower deltoid area, 6cmx6cm.
PATIENT RECEIVED SECOND DOSE TOO SOON - TWO DAYS BEFORE ELIGIBLE WINDOW.
Got the shot On 3/29/2021 on day 4 in the evening patient was sleeping and patient heart started racing really fast woke her up had to breath in and out to calm down to slow her heart rate; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 29Mar2021 at 12:30 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history included high blood pressure, cholesterol and allergic to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Concomitant medications included losartan potassium (LOZARTEN) used for unknown indication from unspecified dates, unknown if ongoing. The patient previously received pethidine hydrochloride (DEMEROL) and experienced drug allergy. On 02Apr2021 at 22:30, in the evening, the patient was sleeping and her heart started racing really fast, she woke up, had to breath in and out to calm down to slow her heart rate. No therapeutic measures were taken as a result of the event. The event did not result in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event heart started racing really fast, she woke up, had to breath in and out to calm down to slow her heart rate was recovered on an unknown date in Apr2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Within 5 minutes of receiving vaccine dose reported feeling a change. Erythema on chest and shoulders observed as well as Hypertension BP up to 172/104 and fever up to 101. This persisted for 20 minutes even after 50mg of Benadryl was administered. Ultimately an emergency response was initiated and taken to ED.
neck rash within 5 minutes, general malaise at 15 minutes and light headedness. lasted about 1 hour. individual sent home once feeling stable.
Severe swelling surrounding injection site; hot to touch surrounding injection site; This is a spontaneous report from a contactable 42-year-old female Health care professional who reported for herself that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: Fck9231) intramuscular at single dose for COVID-19 immunisation on 11Jan2021 at 12:00 pm. Relevant history included allergy with sulfa. Relevant concomitant drugs included lamotrigine (LAMICTAL), propranolol. The patient was not pregnant at the time of vaccination. The patient experienced severe swelling, hot to touch surrounding injection site since 11Jan2021 at 13:00. Symptoms remained for 11 days after administration. No treatment was received. The outcome of events was resolving.  The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19. Since the vaccination, the patient had not test for COVID-19.
Felt tiredness; headache; Arm, neck and shoulder pain (where she received shot); Could not sleep well; Hives on forehead and cheek; Felt chills; This spontaneous case was reported by a health care professional and describes the occurrence of INSOMNIA (Could not sleep well), URTICARIA (Hives on forehead and cheek), CHILLS (Felt chills), FATIGUE (Felt tiredness) and VACCINATION SITE PAIN (Arm, neck and shoulder pain (where she received shot)) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Anemia since 10-Oct-2020. Concomitant products included IRON from 01-Jan-2021 to an unknown date for Anemia.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced INSOMNIA (Could not sleep well), URTICARIA (Hives on forehead and cheek), CHILLS (Felt chills) and VACCINATION SITE PAIN (Arm, neck and shoulder pain (where she received shot)). On 04-Jan-2021 at 4:00 PM, the patient experienced HEADACHE (headache). On 04-Jan-2021 at 6:00 PM, the patient experienced FATIGUE (Felt tiredness). The patient was treated with IBUPROFEN at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 04-Jan-2021, URTICARIA (Hives on forehead and cheek) had resolved. On 05-Jan-2021, INSOMNIA (Could not sleep well) and FATIGUE (Felt tiredness) had resolved. On 06-Jan-2021, HEADACHE (headache) had resolved. At the time of the report, CHILLS (Felt chills) and VACCINATION SITE PAIN (Arm, neck and shoulder pain (where she received shot)) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Most recent FOLLOW-UP information incorporated above includes: On 24-Mar-2021: follow up received on 24-Mar-2021, medical history added, concomitant medications added, events added, treatment information updated.; Reporter'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.
pt recv vax 29JAN97 or 29MAY97 & 29OCT97 pt presented to clinic w/unresolving varicella lesions on the right thigh;
Left arm-deltoid injection site: erythema, warm to touch, induration, pruritis, c/o pain.
Initially immediately reacted with swelling, redness, soreness, numbness from the tips of my fingers. Reported to clinic two days later on 7/10/2014. Only one nurse was working that day and I later found out she did not record any notes. She did give me ice packs and told me to take Benadryl. For months had trouble with housework, working out, sleeping, chores. Soon thereafter the injury affected my arm movement. I found it hard to lift my arm. Seemed to improve but didn't go away. Greatly affected my life. At about 5 months the onset of extreme pain returned. It is now almost 2 years since vaccination date but I am still suffering from dull achy pain and have trouble sleeping as a result. I am still suffering. I have no medical insurance and this is really hard. Please note I do not know what time exactly I was given the vaccine. I do know that the onset of adverse reaction was pretty much immediate, say within an hour. I have entered 6:00 pm, as I this would have been at 1 hour after the clinic closed that day. Also, I don't want to lose what I have entered. Please correct the Date Vaccine Administered from 7/14/2014 to 7/8/2014.
Patient said large red mark and knot in shoulder and was seen by a quick clinic and given an antibiotic.
chills, fever, n/v, h/a x >24hr;onset of chills 6hr post vax;
Onset severe headache that went away, dizziness that diminished when he lay down, two previous nights of stomach cramps
This initial spontaneous report as received from a lawyer regarding a case in litigation refers to a female patient of unknown age. The patient's medical history, concurrent conditions, and concomitant medications were not provided. On an unspecified date in 2013, the patient was vaccinated with ZOSTAVAX (dose, route, and lot number not provided) as recommended for routine adult health maintenance and for the long-term prevention of shingles. The vaccine did not prevent shingles as intended and, on an unspecified date, the patient contracted a persistent strain of herpes zoster. On an unspecified date in 2015, the patient was treated for the onset of a vesicular rash which was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain, suffering, and other damages.  The outcome of vaccination failure and herpes zoster was unknown. The reporter considered vaccination failure and herpes zoster to be related to ZOSTAVAX. Additional information has been requested.
Extreme fatigue day of and pain in injection site. Next day site was swollen, itchy, and warm.
Hard, red, hot, itchy lumps under the skin at the injection site, about three inches both directions - occurred about 17 hours after the injection. This was accompanied by about 10 hours of chills (no cycling to heat, just chills all day) and nausea. I take the regular flu vaccines every year and never had any reactions to them, so this came as a surprise to me. The first COVID19 (Moderna) injection caused no symptoms of any sort, not even a sore arm. This one caused this weird under-the-skin hot rash-like thing, which may have started in the night when I was asleep, but was clearly annoying by morning. Later that evening I took an antihistamine, which relieved all symptoms, including the nausea. And the following day I seemed to have an abundance of more energy, taking another long hike. I do want to note that I took an 11.4 mile climbing hike the day after my first  vaccine, and again, a long hike today, just a day and a half after the second.  Knowing my own body well, I would say this was a mild allergic reaction to some component in this vaccine, since it was ended with one single does of antihistamine.
Severe arm pain from shoulder to fingertips, joint pain, muscle pain, ache, and burning /tingling. Weakness in right hand and finger joint feel tight and swollen.
Possible reactivation of latent HPV.  Pt say she was positive for HPV 20 years ago but then it cleared and she has only had normal paps since until 3/25/22 when her pap came back positive again for HPV.
urticaria/dermatographia, prednisone, zyrtec, pepcid, benadryl, still healing (itchings, raised skin)
Hepatitis A vaccine not received; 1st dose on 15Jun2022, 2nd on 18Aug2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 74-year-old female patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, HAB (Twinrix) for prophylaxis and hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included HEPATITIS A VACCINE + HEPATITIS B VACCINE (TWINRIX) and HEPATITIS B VACCINE (HEPLISAV-B).   On 18th August 2022, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, the patient received the 3rd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 18th August 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device and not applicable after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the drug dose administration interval too long and incomplete course of vaccination were 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: 08-FEB-2023 Reporter's Comment: The reporter was a pharmacist. The reporter reported that the patient received first dose of Twinrix vaccine on 15th June 2022 and the second dose on 18th August 2022. The patient received a dose of Heplisav b on 28th December 2022. The reporter wanted to know how would the patient continue with the Twinrix series when the patient did not receive the hepatitis A portion from the Heplisav b. The reporter did not provided the additional details. The reporter did not consent to follow up. Additional supportive information: The patient received 2nd dose of Twinrix late than recommended time frame, which led to lengthening of vaccination schedule. Till the time of reporting, the patient did not receive the 3rd dose of hepatitis A antigen, which led to incomplete course of vaccination. Note: As the patient did not received hepatitis A component of the Twinrix vaccine the event incomplete course of vaccination was coded conservatively. As the Heplisav b is a non GSK product and we cannot took medication error for Heplisav-b it was captured as concomitant product.
After the vaccine, about 10 minutes, my lower back experienced an intense throbbing  pain,  so much that I could not drive.  I waited about 10 minutes until  pain subsided.  I drove home and the pain is gone, but my lower back is still sore.
Information has been received concerning a pt who on 12/02/94 was vaccinated with varicella vaccine. There was no concomitant therapy. The pt's Mother reported that on 06/20/00 , the pt developed a breakthrough rash. The reporter indicated that the pt had a good case, but less than 50 lesions, no fever or other symptoms. It was noted the the pt had a varicella like rash. the pt sought unspecified medical attention. On an unspecified date, the pt recovered.
pt recv vax SEP95 & pt broke out w/chicken pox, devel flu like sx & had no immunity;no further details were provided;
This spontaneous case was reported by a pharmacist and describes the occurrence of INCORRECT DOSE ADMINISTERED (got a booster dose instead of a second dose) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Dec-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jan-2022, the patient experienced INCORRECT DOSE ADMINISTERED (got a booster dose instead of a second dose). On 14-Jan-2022, INCORRECT DOSE ADMINISTERED (got a booster dose instead of a second dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.  Patient was scheduled for Second dose on 12Jan2022 but did not attend second dose schedule. Patient had returned to the facility and then the pharmacist wonders if they should get the patient half dose or not.   This case was linked to MOD-2022-453434 (Patient Link).
Left arm pain, tingling, burning started 3 hours after received flu shot. Described (L) elbow to little finger arm swelling for 24 hours. Symptoms started to resolve 40 hours post vaccination.
MESSAGE FROM PT REAGRDING A REACTION SHE'S HAVING WITH FLU SHOT. PT WANTED TO DISCUSS POTENTIAL CAUSES. SHE REPORTED SHE HAD THE FLU SHOT ON 10/30 AND ABOUT 2 DAYS LATER HAD SOME ITCHINESS ON HER ARMS. SHE THOUGHT IT WAS SOME DRY SKIN SO SOME LOTION TOOK CARE OF THE ISSUE A BIT. BUT LATER NOTICED SMALL PRICKLY HEAT HIVES ON BOTH ARMS THAT WERE SUPER ITCHY. SHE STILL HAVE SOME ITCHINESS FROM IT BUT IT HAS GOTTEN BETTER AND HER SKIN IS STILL TEXTURED BUT NO MORE RASH IS VISIBLE.