chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a nurse refers to a patient of unknown age. The patient was vaccinated with dose 1 GARDASIL on 27-JUL-2011 and dose 2 on 16-NOV-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse event was reported. Inappropriate schedule of drug administration is not related to GARDASIL. Additional information has been requested.
After vaccination, right arm has muscle stiffness and pain from elbow up to shoulder. Hurt to touch and to move. Fingers on right arm felt swollen. Patient felt body chills and "cold" for the next 12 hours. Stiffness is slowly fading as time goes on.
Patient given Menquafi at 11 year and again at 12 year with no reported adverse event; Initial information received on 12-Sep-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 12 years old female patient who was given Meningococcal A-C-Y-W135 (T CONJ) Vaccine [Menquadfi] at 11 year and again at 12 year with no reported adverse event.  The patient's past vaccination(s) included MENQUADFI on 13-SEP-2022 with At 11 years of age. The patient's past medical history, medical treatment(s) and family history were not provided.   On 08-Sep-2023, the patient received a dose of suspect Meningococcal A-C-Y-W135 (T CONJ) Vaccine Solution for injection at 11 years and again at 12 years (lot U7673AB, with unknown strength, dose, expiry date) via unknown route in unknown administration site as prophylactic vaccination.  On 13-Sep-2022 and 08-Sep-2023, the patient received a dose of suspect Meningococcal A-C-Y-W135 (T CONJ) Vaccine at 11 years and again at 12 years with no reported adverse event (inappropriate schedule of product administration) (unknown latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the 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.
felt like she was injected with poison; never had this much pain before/pain in the strangest places; eye sockets feel like they are going to fall out; hard to hold her head up; armpit sore at injection site; cannot sleep; cannot rest; skin between her toes are horrendous; nerves are on fire; feels like a porcupine pricked her; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt like she was injected with poison), PAIN (never had this much pain before/pain in the strangest places), OCULAR DISCOMFORT (eye sockets feel like they are going to fall out), HEAD DISCOMFORT (hard to hold her head up) and VACCINATION SITE PAIN (armpit sore at injection site) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Fibromyalgia and Cancer. Concomitant products included ZOLPIDEM, AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL), AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL), LEVOTHYROXINE, DULOXETINE HYDROCHLORIDE (CYMBALTA) and DULOXETINE HYDROCHLORIDE (CYMBALTA) for an unknown indication.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced FEELING ABNORMAL (felt like she was injected with poison), PAIN (never had this much pain before/pain in the strangest places), OCULAR DISCOMFORT (eye sockets feel like they are going to fall out), HEAD DISCOMFORT (hard to hold her head up), VACCINATION SITE PAIN (armpit sore at injection site), INSOMNIA (cannot sleep), RESTLESSNESS (cannot rest), SKIN DISCOMFORT (skin between her toes are horrendous), NEURALGIA (nerves are on fire) and PAIN (feels like a porcupine pricked her). At the time of the report, FEELING ABNORMAL (felt like she was injected with poison), PAIN (never had this much pain before/pain in the strangest places), OCULAR DISCOMFORT (eye sockets feel like they are going to fall out), HEAD DISCOMFORT (hard to hold her head up), VACCINATION SITE PAIN (armpit sore at injection site), INSOMNIA (cannot sleep), RESTLESSNESS (cannot rest), SKIN DISCOMFORT (skin between her toes are horrendous), NEURALGIA (nerves are on fire) and PAIN (feels like a porcupine pricked her) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment for the events include ibuprofen, ice, heating pad.
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Reporter stated that because their facility was not been able to download the digital data logger, they have been put on hold by the State at the movement and were not administering the Moderna COVID-19 vaccine to the patients until an assessment was made by the State. The reporter also stated that there had been no power outages that would have impacted the Moderna vaccine. The reporter stated that however, because their facility was unable to download the digital data logger, they treated this issue as a temperature excursion. It was also reported that the data logger which was unable to download was for the months of Dec-2021, Jan-2022 and Feb-2022. Reporter stated that no adverse reactions were reported by any patients.  No treatment medications were reported.
ELEVATED TEMP OF 102, BODY ACHES, SHAKEY, DIZZY, HEADACHE, ELEVATED HEART RATE
Myalgia, Arthralgia, lethargy, fatigue The morning after receiving the vaccine, the patient reported feeling lethargic fatigued. He described experiencing generalized bodyaches. He took two tablets of cetirizine 10mg in case he was having an allergic reaction.
Aches (full body) and fainted. Admitted to emergency room at a local medical center (stayed 1 day) then transferred to a second medical center.
rash on hands,feet,elbows,knees lasting for 10 days&hands swollen&itchy
Information has been received from a health professional concerning a 7 year old male who on 9/24/98 was vaccinated with 1 dose of varicella virus vaccine live (site unk) (lot number unk). Subsequently, it was reported that on 6/11/01, the pt was dx'd with a "mild case of chicken pox". Unspecified medical attention was sought. It was reported that in the spring of 2001, there was a very large chicken pox outbreak in the area. It was not specified whether or not the pt had an exposure to these cases. The reporter also indicated that the pt was not given close to the expiration date and that vaccine lot numbers were not similar in the other cases reported. Subsequently, the pt recovered. No further information is available.
This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient administer the vaccine on the 22-Aug-2022 and 23-Aug-2022 after the use by date 21-Aug-2022, to two pediatric patients), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 22-Jul-2022 and administered on the 22-Aug-2022 and 23-Aug-2022) and NO ADVERSE EVENT (No Adverse Event) in a child patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 prophylaxis. No Medical History information was reported. In August 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient administer the vaccine on the 22-Aug-2022 and 23-Aug-2022 after the use by date 21-Aug-2022, to two pediatric patients). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 22-Jul-2022 and administered on the 22-Aug-2022 and 23-Aug-2022) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The patient administer the vaccine on the 22-Aug-2022 and 23-Aug-2022 after the use by date 21-Aug-2022, to two pediatric patients), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 22-Jul-2022 and administered on the 22-Aug-2022 and 23-Aug-2022) 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 (The patient administer the vaccine on the 22-Aug-2022 and 23-Aug-2022 after the use by date 21-Aug-2022, to two pediatric patients) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 22-Jul-2022 and administered on the 22-Aug-2022 and 23-Aug-2022). No concomitant medications was reported. The vial did not undergo any temperature excursions. No treatment  medications was reported.
Patient received Moderna vaccine as 1st dose on 2/24/2021 and attempted to restart a new series of the COVID vaccine. He received Pfizer vaccine on 5/25/2021.
3 min post vax pt had a near syncope episode; pt stated felt like blood rushed out of her; some jerking; almost fell, but remained coherent
Hives all over the body started the 3rd after the second dose until now, fatigue, pain on the arm where I was given shot (left arm)
Patient had bruising after his vaccination and states that his left arm is very sore still. He can not lift anything with it.
Seizure; No recollection of anything that happened between 2000 and 2100 hours; Very foggy, not thinking properly, repetitive in what he was saying; Very foggy, not thinking properly, repetitive in what he was saying; Very foggy, not thinking properly, repetitive in what he was saying; Not comprehending; He was very cold; Very tired; Very Sweaty; Headache; This is a spontaneous report from a contactable consumer (Patient's wife).   A 53-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 1 via an unspecified route of administration on 19Apr2021 12:30 (Lot Number: EW0164) as SINGLE DOSE (at age of 53 years old) for covid-19 immunisation.  Medical history included ongoing epilepsy diagnosed with this when he was 15 years old, seizure from an unknown date and unknown if ongoing (then at 2015 he had a seizure). Concomitant medications included levetiracetam (KEPPRA) 1250 mg, daily (250mg; 5 pills a day) taken for epilepsy from an unspecified start date and ongoing; carbamazepine (CARBAMAZEPINE) 1000 mg, daily (200mg; 5 pills a day) taken for an unspecified indication from an unspecified start date and ongoing.  Family Medical History Relevant to events was none. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 19Apr2021, the patient experienced seizure, Very foggy, not thinking properly, repetitive in what he was saying, very distant, like he was looking at his wife but not seeing her or hearing her, Headache, He was very cold, Very tired, Not comprehending, Very Sweaty, No recollection of anything that happened between 2000 and 2100 hours. The patient received his vaccine yesterday 19Apr2021 at 1230.  On 19Apr2021 by 1500 he was very foggy, not thinking properly, and repetitive in what he was saying.  He was very distant, like he was looking at the consumer but not seeing her or hearing what she was saying.  He was very cold, very tired, and not comprehending.  Then at 2015 he had a seizure. She called the paramedics, her husband was very sweaty on 19Apr2021 and that point and had no recollection of anything that happened between 2000 and 2100 hours.   Patient was not taken to the Emergency Room or admitted to the hospital. Her husband is completely aware and recovered now.  Consumer reported on 19Apr2021 he had a headache that is persisting since the seizure. The consumer reported that her husband is epileptic, but he hasn't had a seizure in over 10 years and hasn't missed any doses of his medication. Patient was evaluated by the Paramedics that came to his home but was not taken to the Emergency Room. Relevant Tests were none. Outcome of Seizure was Recovered/Resolved with Sequel on 19Apr2021. Outcome of Very foggy, not thinking properly, repetitive in what he was saying, He was very cold, Very tired, Not comprehending, Very Sweaty was recovered on 19Apr2021. Outcome of headache was not recovered. Outcome of No recollection of anything that happened between 2000 and 2100 hours was unknown.
Pt was given her 1st/Hep B series vaccine, pt reports that her arm became red from injection site to her elbow approx 2-3 hours after injection lasting approx 2 days. No rash or SOB. Pt reports history of many allergies as a child. No latex allergy.
having aches and a fever of 100.2 so far; having aches and a fever of 100.2 so far; This is a spontaneous report from a contactable consumer (patient's wife).  A male patient of an unspecified age received the bnt162b2 (BNT162B2; Lot Number, Expiration Date, NDC and UPC: unknown), via an unspecified route of administration on 17Dec2020 at 11:30 at a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported. On 17Dec2020, the patient experienced: having aches and a fever of 100.2 so far.  The patient underwent lab tests and procedures which included body temperature: 100.2 on 17Dec2020.  The clinical outcome of the events was unknown.  The batch/lot numbers for the vaccine, BNT162B2, were not provided and will be requested during follow up.
Pt states her arm was feeling heavy in the arm she was vaxed in(left arm). Pt states on 1/15 she was tired and had headache, chills and nausea, on 1/16 pt says everything went away except her arm was red, tender and swollen. Swollen bigger then a softball. Pt says she has the same AE with the first and second vax
After getting the doses of the Covid her migrains were out of control; Caller got her second dose 2 days ago it sent her cronic pain into a flair up; She litterly was lying in bed in tears; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program Support (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "imunnocompramised" (unspecified if ongoing); "Migrains" (unspecified if ongoing); "heart problems" (unspecified if ongoing), notes: heart problems about 2 months ago; "histarectomy" (unspecified if ongoing); "chronic pain" (unspecified if ongoing), notes: chronic pain for 16 years. Concomitant medication(s) included: HYDROCODONE taken for pain, start date: Apr2021, stop date: Apr2021. Past drug history included: Simponi for imunnocompramised; Botox for Migraine, reaction(s): "Chronic pain", notes: had this done 2 to 3 weeks prior to getting the vaccines; Hydrocodon for Hysterectomy. Vaccination history included: Bnt162b2 (1st dose), for COVID-19 Immunization. The following information was reported: MIGRAINE (non-serious), outcome "unknown", described as "After getting the doses of the Covid her migrains were out of control"; PAIN (non-serious), outcome "unknown", described as "Caller got her second dose 2 days ago it sent her cronic pain into a flair up"; CRYING (non-serious), outcome "unknown", described as "She litterly was lying in bed in tears". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Swelling of lips and tongue with itchy throat. Constant skim rash and itchiness of the face. Skin is irritated and sensitive to touch along the face
12 hours after receiving injection, was asleep and awoken with whole body shaking severely. Temperature was 102F, smashing headache, join pain in armpits, elbows, knees, lower back, right side of neck very sore. Very nauseous. Symptoms lasted for 6-8 hours after onset.  Lethargy for 24 hour period following first symptoms
patient came for Pfizer covid 19 vaccine but she had the JJ covic -19 vaccine in March.
little abnormal; coughed; hip pain; dry throat; This is a spontaneous report from a Pfizer-sponsored program. A contactable male consumer (patient) reported. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown), dose 1 via an unspecified route of administration on 15Mar2021 as dose 1, single for covid-19 immunisation. The medical history and concomitant medications were not reported. The patient experienced a little abnormal on 21Mar2021. He said he coughed a little, he had hip pain and dry throat on an unspecified date in Mar2021. Therapeutic measures were taken as a result of hip pain with meloxicam. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Oct2021 at 08:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 64 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19. Clinical course: Patient did not received other medication in 2 weeks. Patient did not have known allergies. Patient anti-viral details: Paxlovid (Lot number: unknown), start date was 22May2022 and stop date was 26May2022 for COVID-19 treatment.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Vaccine on 5/5/2021 on 5/11/2021 the patient went into cardiac arrest.  The patient has a history of Acute respiratory failure with hypoxia, on O2
Received Pfizer vaccines on 3/26/21, 4/16/21 Tested positive for COVID by PCR on 10/31/21. admitted to Hospital on 10/30/21  for confusion.  Asymptomatic for COVID 19
Redness and swelling (2 cm radius) on left thigh. No discharge. Normal leg movement.
My ears ring non-stop.  I wake up - ringing - and then all day !  This has NEVER happened until after the shot.  It does not stop. There are no loud noises.
Patient states she has a dull pain when raising her arm ever since she got the shot. She states the shot was in the middle of the deltoid area and has consulted a doctor who said it may be nerve pain. She has used TYLENOL, ibuprofen, and heating pad, none of which have taken the pain completely away.
It is stated that child seemed off during the day-not eating as well. Woke screaming at 10 am. Inconsolable for 7 hours. Slept for 5 hours then became irritable off and on for 24 hours. She has been followed closely over a 2 week period. Fever for 24 hours on 3/8/00. Developed URI-also possible GI reflux.
Sore and swollen arm. Unable to use for several days.  Got a red rash on face neck chest with bumps all over rash area.  Loss of hair    Second Shot all the symptoms got worse and hives on chest. Feet swollen so I could only wear crock shoes. Have lost about half of my hair and constant itching on head face neck chest and privates.  No energy. Sick all days long. Balance was off.   After second shot went to Dr. he put me on anti itch pills and steroids.  First time steroids for one week. Cleared up while on medication but got sicker when I stopped taking medication and all symptoms came back immediately. Second time put on steroids for 2 weeks. Same thing happened. Got sicker after medication again. Then he had me do scan of head.  To my pelvis. Scan showed problems and he referred me to specialist.
pt was given vax on 21OCT92 & one 10NOV92 pt recvd 2nd dose pneumococcal vax & deltoid swelled w/redness & pain;
This spontaneous report was received from a healthcare worker refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 12-AUG-2014, the patient was vaccinated with the first dose of GARDASIL (route of administration, anatomical location, lot number and expiration date were not provided). On 12-OCT-2015, the patient was at the healthcare worker's office to receive the second dose in the hpv series but, she/he was vaccinated with a dose of GARDASIL 9 (route of administration, anatomical location, lot number and expiration date were not provided). There were no concomitant medications provided. No adverse effect was reported. There was no product quality issue involved. Additional information has been requested.
Swelling and redness in upper left arm, 5cm width x4cm length for 3 days where the DTaP was given.
Pt developed flu symptoms (chills, fever, shaking) and red/swelling at injection site since 11/16/16 - Pt got both FLUZONE HD and PNEUMOVAX 23 on same left arm - As of 11/19/16 flu-like symptoms get better, just redness at injection site.
On 03/26/2021 patient stated via telephone call at this clinic that, "For the last two days after the vaccine he had experienced left side weakness and numbness from his hand to his feet effecting his ability to walk." Patient was advised to seek medical attention via the ED.
Mom left message that patient had a large dark colored spot where vaccine was given, office closed at 12:00 so was told to go to ER/urgent care.