chrisvoncsefalvay/vaers-outcomes huggingface dataset:
received 3 SHINGRIX vaccines, dose 3 on Aug 30, 2021; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 65-year-old female patient who received Herpes zoster (Shingrix) (batch number 9ZJ25, expiry date 23rd January 2023) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 10th November 2020) and Shingrix (2nd dose received on 24th February 2021).   On 30th August 2021, the patient received the 3rd dose of Shingrix. On 30th August 2021, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 12-JUL-2022 Reporter's comment: Pharmacy intern reported that a patient received 3 Shingrix vaccines. The patient received 3rd dose of Shingrix vaccine into left arm. No symptoms or other information provided. The reporter did not consent to follow-up. Additional Supportive Information: The patient received 3 doses of Shingrix vaccine, which led to extra dose administered.
pt devel severe erythema & swelling @ the inject site w/in 48 hrs of receiving Tetanus toxoid adsorbed; pt was treated w/cephalexin for adverse event;
pt had unusual high pitch cry for 1 1/2 hrs; inc temp of 102 R noted;
Sleepy; Raised red areas; Raised area; Could hardly lift the arm to change clothes; Warm arm; Fever; chills; Bump on injection site, nearly 3 inches in diameter; Redness at injection site; Arm soreness; Heat coming from bump; COVID arm; Stomach itching; Heat at the injection site; Fatigue; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRURITUS (Stomach itching), PAIN IN EXTREMITY (Arm soreness), MILIARIA (Heat coming from bump), VACCINATION SITE WARMTH (Heat at the injection site) and VACCINATION SITE REACTION (COVID arm) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: FLU (Injection site reactions to the flu vaccine including redness extending beyond the injection site.). Past adverse reactions to the above products included Injection site redness with FLU. Concurrent medical conditions included Allergy to insect sting and Allergy to insect sting.    On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, the patient experienced VACCINATION SITE WARMTH (Heat at the injection site) and FATIGUE (Fatigue). On 02-May-2021, the patient experienced PRURITUS (Stomach itching). On 07-May-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness), MILIARIA (Heat coming from bump), VACCINATION SITE REACTION (COVID arm), VACCINATION SITE SWELLING (Bump on injection site, nearly 3 inches in diameter) and VACCINATION SITE ERYTHEMA (Redness at injection site). On an unknown date, the patient experienced SOMNOLENCE (Sleepy), ERYTHEMA (Raised red areas), MASS (Raised area), LIMB DISCOMFORT (Could hardly lift the arm to change clothes), SKIN WARM (Warm arm), PYREXIA (Fever) and CHILLS (chills). On 02-May-2021, PRURITUS (Stomach itching), PAIN IN EXTREMITY (Arm soreness), VACCINATION SITE WARMTH (Heat at the injection site), FATIGUE (Fatigue) and VACCINATION SITE ERYTHEMA (Redness at injection site) had resolved. At the time of the report, MILIARIA (Heat coming from bump), VACCINATION SITE REACTION (COVID arm), SOMNOLENCE (Sleepy), ERYTHEMA (Raised red areas), MASS (Raised area), LIMB DISCOMFORT (Could hardly lift the arm to change clothes), SKIN WARM (Warm arm), PYREXIA (Fever), CHILLS (chills) and VACCINATION SITE SWELLING (Bump on injection site, nearly 3 inches in diameter) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.    .   Most recent FOLLOW-UP information incorporated above includes: On 13-Jun-2021: Follow-up information  received on  13 Jun 2021 contains patient details include height and weight updated. Events(mass, fever, chills, arm discomfort and skin warm) updated. On 13-Jun-2021: Follow-up information  received on 13 Jun 2021contains non-significant information.
COVID-19; COVID-19; Moderna dose number: 1, Date: 16Apr2021; Pfizer-Biontech dose number: 2, Date: 08Oct2021; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 at 17:00 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), on 08Oct2021 at 17:00 as dose 2, single (Batch/Lot number: unknown) and on 15Apr2022 at 17:00 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 16Apr2021 at 17:00 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes type II" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing); "obesity" (unspecified if ongoing); "asthma" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Tetracycline, reaction(s): "Drug allergy". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 08Oct2021 at 17:00, outcome "unknown", described as "Moderna dose number: 1, Date: 16Apr2021; Pfizer-Biontech dose number: 2, Date: 08Oct2021"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included PAXLOVID (Covid-19 treatment) from 09Feb2023 to 14Feb2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
pain at injection site; mild headache; some fatigue; This is a spontaneous report from a non-contactable Consumer via social medica site. This female Consumer (patient) of unknown age reported for herself that she received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number/Exp. date unknown), via an unspecified route of administration on 19Jan2021 at single dose for an COVID-19 immunisation. The patient medical history included rheumatoid arthritis, on blood thinners for prevention of blood clots (she has been previously hospitalized for treatment of blood clots). Historical vaccine included first dose of BNT162B2 on approximately 30Dec2020 and experienced pain at injection site (kind of dull pain, very similar to a tetanus shot) on first day of vaccination and took some Tylenol so patient could sleep and woke up next day feeling fine. Concomitant medication included adalimumab (HUMIRA). On 19Jan2021, the patient received her second dose of BNT162B2 and experienced the same kind of pain at injection site, mild headache, some fatigue. The patient took Tylenol again and stated that she was still able to do her normal daily household activities (laundry, tidying up, plying w/ dogs, vacuuming, and making sure (son) actually does his school work). Therapeutic measures were taken as a result of events pain at injection site, mild headache, some fatigue included Tylenol.  No follow-up attempts are possible. Information regarding Lot/Batch No. cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021058015 Same patient, different dose
Injection site pain, swelling, tenderness and redness;  fatigue, headache, muscle pain, chills, nausea and fever (101), some lightheadedness
glossitis  pharyngitis  periorbital cheilitis   attempted oral nystatin - without resolution of symptoms   attempted Diflucan - without resolution of symptoms   happened with both vaccines and lasted 2-3 weeks
Information has been received from a pharmacist concerning a 48 year old female with no pertinent medical history and sulfonamide allergy and drug hypersensitivity to triptophans and codeine who on 21-SEP-2009 was vaccinated intramuscularly with a dose of PNEUMOVAX (LOT # 663152/0024Y).  Concomitant therapy included CITALOPRAM.  On 21-SEP-2009, after vaccination, the patient experienced bruise at the injection site.  The patient also received less than recommended amount because the drug leaked during the vaccine administration.  No lab diagnostic was performed.  The patient sought unspecified medical attention.  No further information was available at this time of the report.  On 19-OCT-2009, follow-up information received from the pharmacist.  It was stated that the dose received on 21-SEP-2009 was the patient's first dose of PNEUMOVAX in "R/L".  After the shot given, the patient developed a large bruise on arm.  It was also stated that it seemed like some vaccine leaked/sprayed out of syringe when shot given.  The patient was completely fine after shot given other than bruise.  He had recovered on an unspecified date.  No further information is available.
Increased ringing of the ears (tinnitus) and flare up of fibromyalgia. Approximately 2 ½ hours after vaccine dose was administered. For the next couple of days, I am monitoring to see if the flare up will subside. This was my first dose of the vaccine.
Patient has develped tinnitus that is still occuring in his left ear and started 2 days after the vaccine was given
Infant went to sleep day of vaccine at 23:00 and did not wake up until 12 noon next day.  Mom fed infant at 17:00 but child slept through feeding.  Then seemed fine.  No fever.
Two days following vaccine infection, noticed severe heart arrhythmia, for several days.  Very sore arm where vaccine was done.  This seemed to pass, then a heart attack.
lower right side back pain, Knee joints hurt and all of his joints hurt; lower right side back pain, Knee joints hurt and all of his joints hurt; This is a spontaneous report from a contactable consumer reported for himself.   A 72-year-old male patient stated received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), on unknown date (at the age of 72-years-old) at single dose for COVID-19 immunization. Relevant medical history included arthritis and concomitant medications were not reported. Right after the vaccination the patient experienced lower right side back pain, Knee joints hurt and all of his joints hurt, but they subsided. The patient had received a flu shot 4-5 months before and he took some herbs. The patient was not sure if it was his arthritis or the vaccine.     Information about batch number was not available and is going to be requested.
I felt I had a fever, sluggish, off balance. I didn't think anything of it b/c I had a flu shot before and the symptoms would pass. However the next day (10/7/2010) I started having nose bleeds.  I went to work and I still felt off balance and when I got home my nose started to bleed. The nose bleeds started coming everytime I move around. I went to the doc on 10/8/2010. My fam doc said a flu shot doesn't cause nose bleeds b/c my nose was bleeding at the time of service the doctor sent me to Hospital. The attending physician also dismissed that fact that it could be related. Again - I haven't a nose bleed since I was a kid so I find that to be strange being that I haven't had a nose bleed in yrs and now all of the sudden my nose is bleeding constantly.
Extreme worsening of osteoarthritis in right knee, almost cannot walk the pain is so bad, started the morning after the second dose. It gets a little better the more I walk on it, but if I sit for more than a few minutes and then try to walk it's so bad I need a cane. I never ever used a cane before.
Not sure if actually got thevaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Not sure if actually got thevaccine) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Mar-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (Not sure if actually got thevaccine). On 15-Mar-2021, PRODUCT ADMINISTRATION ERROR (Not sure if actually got thevaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.; Sender's Comments: This report refers to a case of Product Administration Error for mRNA-1273 (Lot #: 047A21A)  with no associated AEs.
Patient had rash that started at elbow on vaccinated arm and progressed to her wrist. Reaction began 2 hours after vaccination and as of 4/7/21 patient still had rash on her arm.
Subsequent to receiving one dose of varicella virus vaccine live the pt experienced injection site reactions characterized by induration, erythema and itching which covered an area 8 cm in diameter and lasted 2 weeks. The pt sought medical attention for her experience. The pt recovered.
Patient reported having sore arm, reddness, swelling at injection site and pain in arm.
COLD SWEATS; HOT FLASHES; HOT SWEATS; HAND WARM TO TOUCH; HIVE REACTION ON LEFT THIGH TO LEFT ANKLE; TIRED; HEADACHE; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included sulfonamide allergy, marijuana occasionally, non-alcohol user, and cigarette smoker, and other pre-existing medical conditions included the patient never had any flu shots .The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: 1805025 expiry: 25-MAY-2021) dose was not reported, administered on 21-MAY-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-MAY-2021, the subject experienced cold sweats. On 21-MAY-2021, the subject experienced hot flashes. On 21-MAY-2021, the subject experienced hot sweats. On 21-MAY-2021, the subject experienced hand warm to touch. On 21-MAY-2021, the subject experienced hive reaction on left thigh to left ankle. On 21-MAY-2021, the subject experienced tired. On 21-MAY-2021, the subject experienced headache. Treatment medications included: ibuprofen. The action taken with covid-19 vaccine  was not applicable. The patient had not recovered from tired, cold sweats, hot flashes, headache, hot sweats, hive reaction on left thigh to left ankle, and hand warm to touch. This report was non-serious.
This spontaneous report as received from a health care professional refers to an unspecified number of patients. This is a market research program conducted. It was stated in the last 3 months, the reporter had seen or heard about a new protocol to give PREVNAR 13 first then give PNEUMOVAX23 (dose, route, lot # and expiration date were not provided) and then 10 years later do PNEUMOVAX23 again which was considered an inappropriate schedule of drug administration. At the time of the report, the patient's outcome were unknown. Additional information has been requested.
Inconsolable crying after vaccines patient re-evaluated in office at 4:40. Per Dr. will administer 2 vaccines only at next well baby visit, no indication that we should not vaccinate child at all.
On 03/31/21, 12 days after I received my first Moderna  vaccine, I woke up with a rash at the injection site. Today I noticed the area wasn't quite as red, but the area has grown. It was about 3" by 1.5" the first day, and today it is about 3" by 2.5". It does not feel irritated, not itching or burning. Just thought it was strange that it appeared 12 days after the injection was given and wanted to report it.
Tinnitus - Left Ear - plus some hearing loss .  The tinnitus comes and goes, and seems to also be related to my neck position
Patient presented to the pharmacy to get a covid vaccine and told this reporter that he hadn't been vaccinated yet. It turns out that he had already received a dose of the Janssen vaccine at a different pharmacy. Therefore the vaccination on 9/30/21 was unnecessary.
Fever, Headache, Body Aches, Chills, Night Sweats, Fatigue, Sore Arm
Information has been received from a physician concerning a 64 year old female patient, with hypertension, high cholesterol, osteoarthritis and allergy to certain bandage tapes causing blistering, who on 05-MAY-2012 at approximately 10:30am, was vaccinated with a dose of ZOSTAVAX (Merck) (lot# and dose not reported) in the left arm. Concomitant therapy included Hydrochlorothiazide (manufacturer unknown), simvastatin (manufacturer unknown), COLACE and meloxicam. Physician reported that on 05-MAY-2012 following the vaccination, the patient experienced cellulitis reaction, pruritis, large hematoma, swelling, erythema, hyperemia and "centrally locating weeping vesicle". Reported stated that the patient told him, that after the pharmacist gave the ZOSTAVAX (Merck) injection, the pharmacist stated "this is the wrong needle". Physician believed the pharmacists possibly gave ZOSTAVAX (Merck) IM instead of SQ. The patient sought medical attention - she saw a doctor. As the treatment the physician instructed patient to ice area this day and see primary physician in the following day and went to the emergency if reaction worsened or if developed a fever. At the time of reporting, the patient's status was not recovered. Patient in a lot of pain with use of left arm, limiting the patient's activity of daily living and limiting occupation activities was considered to be disabling. Additional information has been requested.
Bad muscle pain, headache, redness and soreness of injected arm, loss of appetite, queasiness, malaise. Arm soreness went away at day five after shot. Other symptoms remain as of today, day 6 post shot.
Patient was given 2nd dose of Moderna in primary series 7 days early. Pt. tolerated well. Parent of child called and notified of timeline on when to return for valid vaccination.
fever; chills; fatigue; nausea; headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), PYREXIA (fever), CHILLS (chills), FATIGUE (fatigue) and NAUSEA (nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, the patient experienced HEADACHE (headache). On 10-Apr-2021, the patient experienced PYREXIA (fever), CHILLS (chills), FATIGUE (fatigue) and NAUSEA (nausea). At the time of the report, HEADACHE (headache), PYREXIA (fever), CHILLS (chills), FATIGUE (fatigue) and NAUSEA (nausea) was resolving.            No concomitant medication reported. No treatment was provided.    Reporter did not allow further contact
It began with shortness of breath, it sound like he was running while sitting still. Then the next day, he did that all day. Then that evening, we started to take a walk, and he couldnt hardly walk, cause he couldnt get his breath, and we had to take baby steps and come back to the house, and he only took maybe 50 steps, and that was around 7:00 pm in the evening. The next morning, soon as the doctors office open, when I got up, I was told that it was probably just a side effect from the shot and maybe wait until Monday to come in, and I said no he has to be seen today, this is really bad. That was on September 15th. They said ok, they will see him, I took him down, and Dr (whose in the same practice with our pcp). He sent him to the hospital for a chest xray, as he thought he had pneumonia and bronchitis, and he gave him docicylene, and prednisone. When he finished taking that, he still had shortness of breath. He was coughing and so tired, he could hardly move. The next appointment was on October 2nd, and he saw Dr (same practice with our pcp). Then she sent him to the hospital (Hospital) he had blood work done and she prescribed him with lasix, on October 9th we went back to see her when he completed the meds, and she sent him back to the hospital for more xray and blood work. The fluid was still there in one of his lungs, and then she gave him another fluid pill, and had him to come back on October 16th, she said lets give it a week to see if things level out, and they didnt, so I messaged her cause things were not better, she stated to call the cardiologist (Dr), spoke to nurse, she told me to take my husband to er to have them give him iv lasix to remove the fluid. Oct 23rd, we went to er, and after he was examined, they admitted him, gave him lasix, bloodwork, still fluid, they gave him more lasix, so they kept him overnight. He spent 2 nights at the hospital. They did an echo, saw a clot in the left lower lobe ventricle of his heart. They transported him to hospital: They found no blood clots, they released him after 3 nights there, and his heart function decreased from 30% to under 20% fraction. Discharged on 27th or 28th.
Swollen area and redness around injection site. Painful, holding heat and has a knot.
Nausea; Vomiting; Chills; Migraine like headache; This is a spontaneous report from a contactable consumer (patient). A 32-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: unknown), via an unspecified route of administration (left arm) from 18Dec2020 (01:15 PM) to 18Dec2020 13:15 at single dose for COVID-19 immunization. The patient's medical history included PDA (Patent ductus arteriosus) ligation, fatty liver disease, and anxiety. Concomitant medications included melatonin, escitalopram oxalate (LEXAPRO), balsalazide sodium (BALZIDE), multivitamin, and prebiotic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. The patient experienced nausea, vomiting, chills, and migraine like headache the night after she received the vaccine (18Dec2020 07:00 PM). There was no treatment received for the reported adverse events. The outcome of events was recovering. This case is reported as non-serious.   Information on the lot/batch number has been requested.
pt brought in to the ED after being found hypoxic at home. Treatments included zithromax 500mg daily, decadron 6mg iv daily, remdesivir daily, vitamin c daily, vitamin d daily, zinc daily, rocephin 1 g iv daily, and s/s insulin daily
Severe pain at injection site lasting 5 days.  Swelling, redness about 3 inches in diameter that diminished some each day.   Itchiness developed the last two days.
Fever 100.5 shakes ,chills ,vomiting awake but couldn't move. Hot red rash growing over marked line very swollen very painful