chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patient received the first dose at the age of 12, and the second at 15, not at 16 years of age with no reported adverse event; patient received the first dose at the age of 12, and the second at 15, not at 16 years of age with no reported adverse event; Initial information received on 09-Jun-2022 regarding an unsolicited validnon-serious case received from a pharmacist.  This case involves a 15 years old female patient who received the first dose at the age of 12, and the second at 15, not at 16 years of age with no reported adverse event while receiving vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, the patient received a 1st dose and a booster dose of 0.25 ml of suspect meningococcal a-c-y-w135 (d conj) vaccine (Drug Interval Dosage: twice; Drug Treatment Duration, form, strength, route, administration site, lot number, expiry date: not reported) for prophylactic vaccination.    On an unknown date the patient received the first dose at the age of 12, and the second at 15, not at 16 years of age with no reported adverse event (inappropriate schedule of product administration) and (Product administered to patient of inappropriate age) (latency: same day). The patient is now 22 and her school has declined the vaccine record because there is not enough time between the 2 doses. The pharmacist stated people had to be over the age of 18 to receive boosters, unless it is the COVID vaccines and boosters or the influenza vaccine.   Action taken was not applicable.  Outcome was unknown.    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.
After chewing a few minutes, the back right lower side of my tongue has an almost fatigue feeling of muscle pain and I'm too tired to keep chewing.
dizzy; very weak not able to do anything, very weak; pain moved to his left arm soon after the vaccination; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy), ASTHENIA (very weak not able to do anything, very weak) and PAIN IN EXTREMITY (pain moved to his left arm soon after the vaccination) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced DIZZINESS (dizzy), ASTHENIA (very weak not able to do anything, very weak) and PAIN IN EXTREMITY (pain moved to his left arm soon after the vaccination). At the time of the report, DIZZINESS (dizzy), ASTHENIA (very weak not able to do anything, very weak) and PAIN IN EXTREMITY (pain moved to his left arm soon after the vaccination) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported..  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-060798 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-060798:dose 2
NODULE ON RIGHT SIDE OF THE NECK UNDER JAW; MILD RASH ON FACE; RASH ON LEFT UPPER ARM AT VACCINATION SITE THAT SPREADS TO ELBOW; This spontaneous report received from a patient concerned a 43 year old female. The patient's weight was 179 pounds, and height was not reported. The patient's concurrent conditions included seafood allergies, alcohol user, and smoker, and other pre-existing medical conditions included the patient had no drug abuse or illicit drug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A,expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the subject experienced nodule on right side of the neck under jaw. On 06-APR-2021, the subject experienced mild rash on face. On 06-APR-2021, the subject experienced rash on left upper arm at vaccination site that spreads to elbow. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from mild rash on face, nodule on right side of the neck under jaw, and rash on left upper arm at vaccination site that spreads to elbow. This report was non-serious.
experienced urinary tract infection; Medical history included multiple sclerosis, immune suppressants a month ago for multiple sclerosis; Medical history included multiple sclerosis, immune suppressants a month ago for multiple sclerosis; This is a spontaneous report from a non-contactable consumer reported for herself. This female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown) via an unspecified route of administration on 18Jan2021 as a single dose for COVID-19 immunisation. Medical history included multiple sclerosis. Concomitant medications were not reported. The patient previously took immune suppressants a month ago for multiple sclerosis. The patient reported that she had first dose of the COVID-19 vaccine on 18Jan2021, and she had some reactions similar to those she usually got when she took steroids. The patient experienced urinary tract infection. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Treatment of COVID-19; Treatment of COVID-19; Pfizer, Dose: 1, 2, 3 / Moderna, Dose: 4, 5; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient received BNT162b2 (BNT162B2), on 23Jan2021 as dose 1, single (Batch/Lot number: unknown), in left arm, on 15Feb2021 as dose 2, single (Batch/Lot number: unknown), in left arm and on 15Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 18Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in left arm and on 28Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Past drug history included: Amoxicillin, reaction(s): "Allergy: Amoxicillin"; Bactrim, reaction(s): "Allergy: Bactrim". The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 18Apr2022, outcome "unknown", described as "Pfizer, Dose: 1, 2, 3 / Moderna, Dose: 4, 5"; VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19 included Paxlovid.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Two days post vax pt developed cellulitis characterized by a large, red area at and around the injection site.
This spontaneous case was reported by a physician assistant and describes the occurrence of PERIPHERAL SWELLING (left arm swelling), FEELING HOT (warmth to the area) and ERYTHEMA (redness) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, the patient experienced PERIPHERAL SWELLING (left arm swelling), FEELING HOT (warmth to the area) and ERYTHEMA (redness). At the time of the report, PERIPHERAL SWELLING (left arm swelling), FEELING HOT (warmth to the area) and ERYTHEMA (redness) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. Treatment drugs included cold compress. This case was linked to US-MODERNATX, INC.-MOD-2021-081439, US-MODERNATX, INC.-MOD-2021-081427 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2021-081439: US-MODERNATX, INC.-MOD-2021-081427:
nausea; bouts of throwing up; watery diarrhea; chills; achy joints; fatigue; sore arm; This is a spontaneous report from a contactable consumer (patient). A 61-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EN6205) via an unspecified route of administration in left arm on 08Mar2021 at 09:30 (At the age of 61-year-old) as single dose for COVID-19 immunization at Hospital. Medical history of the patient included under active thyroid and osteoporosis. Patient donated blood three days before. Patient had no known allergies. Concomitant/other medications in two weeks included Levothyroxine daily. Patient did not receive any other vaccine in four weeks of COVID-19 vaccine. Patient had no COVID prior vaccination and was not tested for COVID post vaccination. On 08Mar2021 at 12:30, patient experienced biggest symptom, which was constant nausea, with three bouts of throwing up over a two-day period, watery diarrhea for three days, chills, achy joints, fatigue, and a sore arm. Patient did not receive any treatment in response to the AE. Outcome of the events were recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Information was obtained on request by the Company from the government via the Act concerning a 25 year old female with a history of molluscum contagiosum opposite side who on 08-JUN-2007 was vaccinated IM in the right upper out quadrant of the hip with a dose of Gardasil (lot # 657868/0523U). Concomitant therapy included LEVORA. On 13-JUN-2007 the patient was seen for painful swollen lymph nodes right inguinal area and tenderness from area of injection to lymph not. White blood cell count was not elevated. The patient's status was not reported. The original reporting source was not reported. The VAERS ID is 281914. No further information is available.
Patient developed acute encephalitis and stroke-like symptoms following vaccination, failed SLUMS score at her clinic visit. Symptoms persisted overnight prompting ER visit and admission. Patient had severe COVID-19 in December 2020 requiring 20 day hospitalization, stay was complicated by development of altered mental status thought to be stroke but imaging did not confirm this and it eventually improved.
A SPOT SHOW UP AFTER VACCINE; This spontaneous report received from a patient concerned a 32 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no relevant medical history and no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: unknown) dose was not reported, administered on 20-SEP-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: risankizumab (form of admin unknown, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe chronic plaque psoriasis. No concomitant medications were reported.  On 2021, the patient experienced a spot show up after vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with risankizumab was not reported. The patient was recovering from a spot show up after vaccine. This report was non-serious.
pt recvd vax; approx 9:30pm, mom states pt became limp, white, lips dusky; dec t; unresponsiveness 10-15 mins; responsive on the way to er;
I had a racing heart beat, I had a pounding heart beat; This spontaneous case was reported by a pharmacist and describes the occurrence of PALPITATIONS (I had a racing heart beat, I had a pounding heart beat) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     The patient's past medical history included Arrhythmia.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2020, the patient experienced PALPITATIONS (I had a racing heart beat, I had a pounding heart beat). At the time of the report, PALPITATIONS (I had a racing heart beat, I had a pounding heart beat) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication was reported.  Patient took second dose on 26-JAN-2021 in right arm (lot no.-012M20A)   This case was linked to MOD-2021-322985 (Patient Link).
TOOTHACHE Narrative: 59 yo male with PMH of PTSD, memory loss, sleep apnea, low back pain reported a severe toothache in his Left Upper Molar area that lasted x3days, resolved with Amoxicillin and Ibuprofen post vaccination 3/1/2021 (first covid19 vaccine dose). This ADR was reported on 3/22/2021 when he returned for his second dose. Unsure of correlation.
Similar Rx to 1st dose w/ SOB, chest tightness, & CP that resolved after approx 1hr in medical observation.  Obtained baseline VS prior to dose.  Vax admin at 1115, SOB reported @ 1125.  Benadryl 50mg PO admin @ 1133 for SOB w/ CP/heaviness.  1141 - VSS and symptoms reported as resolving and "much better"  Lungs CTAx5 lobes, Pt AOx3 w/ intermittent smiling/talking.  Symptoms resolved and VSS and released w/ family at 1207  1112 - BP 126/86, HR 68bpm, RR 16, O2 100% RA 1125 - BP 180/127, HR 87bpm, RR 20-24, O2 98% RA 1130 - BP 144/98, HR 87bpm, RR 20, O2 99% RA 1141 - BP 147/93, HR 75bpm, RR 18, O2 98% RA 1200 - BP 137/82, HR 66bpm, RR 18, O2 97% RA 1207 - BP 139/90, HR 67bpm, RR 16-18, O2 97% RA
NOISE ON MONITOR ALERTED MOTHER TO CHECK ON CHILD.  MOM OBSERVED CHILD LAYING ON BACK IN CRIB, EYES ROLLING BACK, WEIRD NOISE COMING FROM MOUTH. SHE WAS UNRESPONSIVE AT FIRST, THEN ASKED FOR MOM AND A CUP. HER ARM WAS LISTLESS AND UNABLE TO HOLD CUP. SHE WAS WEAK AND HER CHEST WAS SUCKING IN. SHE WAS UNABLE TO STAND STRAIGHT. TAKEN TO ER AND WAS NORMAL BY THE TIME SHE WAS SEEN. TOTAL EPISODE LASTED 30 TO 40 MINUTES.  ER REFERRED HER TO NEUROLOGISTS. 11/20/2009 ED records for 11/15/2009, patient with seizure like activity, fever and runny nose. Tx: Diazepam 11/20/2009 ED records for 11/15/2009,Dx seizures  patient with seizure like activity, fever and runny nose. Tx: Diazepam  12/08/09 MR received for DOS 11/14/09 DX; seizures.  Pt c/o eyes rolled back, inability to talk, stiff limbs, weakness. By the time Pt admitted to the hospital, condition improved.  Pt discharged in a good condition.  12/08/09 Neurology consult for DOS 11/17/09. DX: seizures.  Neurologist believes Pt experienced seizures without fever.  The night before seizure, Pt had seizure and cold symptoms.  Neurologist believes Pt had seizures without fever. Physician recommended not taking the second dose of H1N1 vaccine.
This case meets criteria for vaccine breakthrough review. SxS for 1 week of fevers, cough, diarrhea, vomiting, and loss of appetite.
Patient vaccinated 5/10/2021, 4/20/2021. Hospitalized 1/8/22 with COVID.
Ecchymosis - checked in on 9/26/14 and it is resolving on its own.
A few hours after being vaccinated, I experienced dizziness, fatigue, body aches and chills. Within 24 hours diarrhea and weakness.  Unable to report to work.
Not so much adverse than great. I had a migraine that morning and knew not to take my medication before the shot.  I muddled through the day and was going to take prescription meds that evening. Within 10-15 mins after receiving my shot, my migraine went away. I don't get them often, but it has never gone away on its own.  I also noticed a small pea size cyst on my forearm has diminished greatly in size since my vaccine. I don't know if all this is coincidence, just thought I would report it.
Headache, chills, jaw pain, followed by swollen sublingunal gland, neck sensitivity, double vision, constant headache, neuropathy.
Colloquial erythema noted (6cm in diameter) noted to MMR and varicella injection sites of Pt's both upper legs. Erythema decreased after 30 min. no other s/sx noted.
This spontaneous report was received from a Registered Nurse and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was reported. On an unknown date, the patient was administered with the second dose in the series of GARDASIL 9 (dose, route of administration, injection site, lot# and expiration date were not reported) at a less than recommended internal. No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Nausea; Vomiting; Chills; Diarrhea; This is a spontaneous report from a contactable consumer. A 46-year-old female patient (patient herself) received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on 24Apr2021 (Batch/Lot number was not reported) as single dose for covid-19 immunization. The pa-tient's medical history and concomitant medications were not reported.  The patient experienced nausea , vomiting, chills, diarrhea on an unspecified date. It was stated that Side effects that had been reported with the vaccine. The outcome of the events was unknown.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Pt recv vax on 2/16/99; on same day pt exp fever (101-104); tx=Tylenol
flu-like symptoms; This is a spontaneous report received from a contactable consumer (reporting for her daughter). A 17-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on 01Apr2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the second Pfizer COVID-19 vaccine dose yesterday, 01Apr2021. The patient was experiencing flu-like symptoms today, 02Apr2021. The outcome of the event was not recovered.     No follow-up attempts are possible; information about lot/batch number cannot be obtained.
NKA. Given Hep A vaccination and she c/o pain followed by nausea and dizziness. She looked pale & jerked twice. Assited by another RN and a Nurse practicioner. Pt. was responsive, Vitals: 87/41, HR up 50-61, O2 sat 100%, resp. 18, still dizzy, assisted to get to bed and given water. Blood sugar was 119, given more to drink orange juice since she said she was on bike race earlier that morning and did not eat. B/P is up to 117/70, HR 64, 100%Sat, resp.16, says she is alright. Assisted to get up and walked without dizziness. Given food to eat. Pt. eventually was sent home stable after treating her for approx 1 hr. Husband was called by patient and updated.
Right upper thigh mild erythema with swelling and streaking extending to knee, cellulitis.
Tachycardia, dizziness (patient history of PSVT). Stress from her job and vaccine administration caused her to have a "flare-up" of her condition which made her have these symptoms. Patient treated herself by massaging carotid artery and lying down, we supervised. Patient recovered within 15 minutes feeling better and confident she's fine due to her experience in past.
C/O redness and increased warmth at left arm injection site. Instructed to place cool compress on injection site. Instructed to use OTC BENADRYL every 6 hours PRN.
Patient's mother states that her daughter has flu-like symptoms and pain around the sternum area. Afebrile.
Patient admitted to hospital with altered mental status and fever. Found to meet SIRS criteria by recurrent fever and tachycardia, but no white count and otherwise hemodynamically stable. Urine cultures and blood cultures were drawn and did not demonstrate growth. Body imaging was done without e/o of infection. Patient started improving 1 day after admission (2 days after the second Pfizer COVID vaccine) without much intervention save for supportive care (antipyretics, antiemetics, etc.)
Symptoms developed on 7-24-21, including fever, cough, fatigue, myalgia, trouble breathing. Patient was hospitalized for COVID-19 on 8-4-21 at hospital. Release date unknown.
some pain problems; This is a spontaneous report from a contactable pharmacist. A 16-years-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 20Apr2021 as SINGLE DOSE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient's historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as SINGLE DOSE for covid-19 immunization. The patient experienced some pain problems on an unspecified date in Apr2021. On 21Apr2021 patient started taking Medrol (Methylprednisolone) dosepack 4mg. The patient's mom was concerned if there was an interaction with the COVID vaccine, if her daughter was going to be immunocompromised by taking a steroid. Later caller specified that the patient was not immunocompromised, she was healthy, she just had some pain problems and the doctor prescribed the steroid. Outcome of the event was unknown.    No follow-up attempts are needed. No further information is expected. Batch/lot num-ber not obtained.
Delayed rxn. 8 day after vaccine, red hard raised itchy lesion appearred at vax site., along with a 1.5" diameter red rash, hard red and hot. This lesion was 3" ABOVE injection site lesion. It is still present todY, Jan, 22.
Patient received vaccine at day 16 following the first dose rather than the suggested range of 21 days after first dose.
Thigh Pain and scabbed over rash X 2 months duration.  Mother is quite certain this rash occured after his immunization.
On 1/8/03, in the afternoon, injection site was red and swelling. On 1/9/03 at 13:20, had 4cm erythema, warm, induration and tender to touch. RX: Zyrtec po now and in the AM. On 1/13/03, pt reports that redness and heat went away "a little swelling and some tenderness. On 1/22/03, N/C. Derm reaction to TD injection.
The patient called on 11/05/12 and reported that she was given a flu shot on 9/24/12 and that her left arm from her elbow down to her hand had been painful and slightly swollen since that day. She stated the reason she had not reported before this date was that she thought the symptoms would improve with time. She stated she had an appointment with her private physician scheduled on 11/9/12.