chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 Treatment; COVID 19 Treatment; Sunday I tested negative w/ a home test, Monday symptoms returned stuffiness, post nasal drip, cough; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 65-month-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Lot number: FG3527), in right 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's relevant medical history included: "high blood pressure" (unspecified if ongoing); "cancer treated" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DISEASE RECURRENCE (medically significant) with onset 22Aug2022 at 20:00, outcome "not recovered", described as "Sunday I tested negative w/ a home test, Monday symptoms returned stuffiness, post nasal drip, cough"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive; Negative. Therapeutic measures were taken as a result of drug ineffective, covid-19. Therapeutic measures were not taken as a result of disease recurrence.  Clinical course: Reporter stated that, patient had no known allergies. Therapeutic measures were taken as a result of drug ineffective, COVID-19 included Paxlovid 13Aug2022 to 18Aug2022.
Information has been received from a nurse referring to multiple unspecified patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. On unknown dates these patients were vaccinated with unspecified number of doses of improperly stored GARDASIL (dose and route not reported; lot # K009482, expiration date 06-MAR-2017; lot # K011325, expiration date 08-APR-2017; lot #K011562, expiration date 08-APR-2017). No adverse event was reported. This is one of two reports received from the same reporter. Additional information has been requested.
Second dose was April 7, 2021.  Had menstruations April 12, for about 7 days.  April 24 took dose of Take Action Levonorgestrel 1.5mg., and started menstruations/spotting April 30- May 10. Had menstruations again May 17-May 23.  May 29 took another does of Take Action Levonorgestrel 1.5mg., Had menstruations for 2 weeks,  June 4-June 19th, with heavy flow and discharge on June 15th only, and with upset stomach last day.  Normal period July 17-24.
Hardness at arm of injection; Blood pressure went high again; Warm at arm of injection and feels the heat goes though her body; No appetite; Body burning, like heat inside body; Turned black my knuckles in my hand; Unpleasant feeling in chest area; Doctor says it is anxiety; Fatigue, couldn't get out of couch; Pain at injection site; Headache; This spontaneous case was reported by a health care professional and describes the occurrence of INDURATION (Hardness at arm of injection), BLOOD PRESSURE MEASUREMENT (Blood pressure went high again), VACCINATION SITE WARMTH (Warm at arm of injection and feels the heat goes though her body), DECREASED APPETITE (No appetite) and BURNING SENSATION (Body burning, like heat inside body) in a 53-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 Hypertension (Controlled).   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Mar-2021, the patient experienced INDURATION (Hardness at arm of injection), BLOOD PRESSURE MEASUREMENT (Blood pressure went high again), VACCINATION SITE WARMTH (Warm at arm of injection and feels the heat goes though her body), DECREASED APPETITE (No appetite), BURNING SENSATION (Body burning, like heat inside body), KNUCKLE PADS (Turned black my knuckles in my hand), CHEST DISCOMFORT (Unpleasant feeling in chest area), ANXIETY (Doctor says it is anxiety), FATIGUE (Fatigue, couldn't get out of couch), VACCINATION SITE PAIN (Pain at injection site) and HEADACHE (Headache). The patient was treated with LOSARTAN for Blood pressure high, at a dose of 25 mg, 2 pills at night; METOPROLOL SUCCINATE for Blood pressure high, at a dose of 25 mg once a day; ESCITALOPRAM OXALATE (LEXAPRO) at a dose of 10 UNK and SERTRALINE HYDROCHLORIDE (ZOLOFT) for Depression and Anxiety, at an unspecified dose and frequency. At the time of the report, INDURATION (Hardness at arm of injection), BLOOD PRESSURE MEASUREMENT (Blood pressure went high again), VACCINATION SITE WARMTH (Warm at arm of injection and feels the heat goes though her body), DECREASED APPETITE (No appetite), BURNING SENSATION (Body burning, like heat inside body), KNUCKLE PADS (Turned black my knuckles in my hand), CHEST DISCOMFORT (Unpleasant feeling in chest area), ANXIETY (Doctor says it is anxiety), FATIGUE (Fatigue, couldn't get out of couch), VACCINATION SITE PAIN (Pain at injection site) and HEADACHE (Headache) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.
Redness Swelling Warmth all the way around arm. Spoke with patient on Monday and her arm is doing much better. Also on Friday evening she could not raise her arm up.
Intense chills, muscles and joints, pains which lasted through the night and ended in the morning. headache
Grandmother states child was "fine" after vaccines until 3 days later. Had fever up to 102.9 (4:15am Thursday 5/24) called ambulance to home: family declined transport to hospital. Saw doctor on 5/27/04 and was told it was not his ears. States had mild rash on chest / back. Left leg still swollen approximately 25mm induration but redness almost gone. Temp at 100 pm today 100.9. Child active/playful on visit today.
1st dose 4 years ago, 2nd not received; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 79-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose about 4 years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 18-Oct-2022 Reporter's comment: The reporter consented to follow-up with health care professional. Additional supportive information: Till the time of reporting, the patient did not receive second dose of Shingrix, which led to incomplete course of vaccination. The vaers details were reported for the first dose of Shingrix.
inc body temp, refusing to sit up, fussiness evening of vax 15OCT96;seen @ urgent care;condition improved 16OCT96 until inc body temp 103 that evening;seen in MD office 17OCT96;febrile sz seen @ hosp;seen in MD office 18OCT96 for f/u;
Administered with expired vaccine; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered with expired vaccine) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032N20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 08-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered with expired vaccine). On 08-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Administered with expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were reported.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-314570, MOD-2021-314573, MOD-2021-314805, MOD-2021-314545, MOD-2021-314555, MOD-2021-314567, MOD-2021-314810, MOD-2021-314810 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 15-Sep-2021: Follow-up information included no new information
I got the expected sore arm for a few days. The day of the shot I started getting a headache, that soon got pretty bad, and my neck and spine started hurting, so bad that by that night I could hardly sleep. Eventually I took two Advil to help me sleep, and the next morning I did feel slightly better, but by nightfall the next day it came on hard again, again I took two Advil to help me sleep, hoping things would improve over time. This is day 5 and I've still got the headache and my spine is stiff and generally feels like my spinal cord doesn't have room in channel in my spine. That is how I would describe this feeling I've had.  My doctor doesn't call me back, I've called to ask if I should even bother with the booster in a couple more weeks, at this point I'm thinking no I won't get the booster as it is expected to hit harder and I don't want to mess with my spine. So far I'm just riding it out.
Provider ordered ADACEL and staff gave ADACEL. Patient should have had DAPTACEL ordered and given.
Symptoms = Arm swelling Signs = Red Time Course = 10 minutes post injection Treatment = Sent patient to her OBGYN.  They said arm swelling went down.  They monitored patient.
flu like symptoms; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms) in a patient of an unknown age and gender 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Severe dermatitis and osteoarthritis started a month after first injection; Osteoarthritis started a month after first injection; This is a spontaneous report from a contactable reporter (consumer or other non HCP). The reporter is the patient.  A 58-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 01Apr2021 at 13:00 (Lot number: EN6201) at the age of 58 years as dose 1, single for COVID-19 immunisation. The patient had no relevant medical history. The patient did not receive any concomitant medications. The following information was reported: DERMATITIS (non-serious) with onset 02May2021, outcome "not recovered", described as "Severe dermatitis and osteoarthritis started a month after first injection"; OSTEOARTHRITIS (non-serious) with onset 02May2021, outcome "not recovered", described as "Osteoarthritis started a month after first injection". The events "Severe dermatitis and osteoarthritis started a month after first injection" and "Osteoarthritis started a month after first injection" were evaluated at the physician office visit. Therapeutic measures were taken as a result of dermatitis and osteoarthritis.  Additional Information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient reported she had no health insurance but had paid to go to 8 different doctors. Reacts due to weather or stress. Patient reported this was not in family history and never had before. Treatment received for dermatitis and osteoarthritis included Cortisone. Since the vaccination, the patient had not been tested for COVID-19. The patient also received bnt162b2 (BNT162B2), administered in left arm, administration date 21Apr2021 at 13:00 (Lot number: EO7533) at the age of 58 years as dose 2, single for COVID-19 immunisation and bnt162b2 (BNT162B2), administered in left arm, administration date 01Feb2022 at 13:00 (Lot number: FJ6369) at the age of 59 years as dose 3 (booster), single for COVID-19 immunisation.
Developed shingles; A spontaneous report was received from a consumer, concerning his wife, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced shingles.    The patient's medical history was not provided. No relevant concomitant medications were reported.   On 28 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number unknown) intramuscularly for prophylaxis of COVID-19 infection.  On unknown date in Dec 2020, after vaccine administration, the patient developed shingles.   Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, shingles, was unknown.; Reporter's Comments: This case concerns a female patient experienced a non-serious unexpected event of herpes zoster. The event occurred on unknown date in Dec 2020 after first dose of the study medication administration on 28 Dec 2020.  Very limited information regarding this event has been provided at this time.  Based on temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Menveo reconstituted with sterile water; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 11-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA728A, expiry date 30th September 2023) for prophylaxis.   On 17th November 2022, the patient received Menveo. On 17th November 2022, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution. On an unknown date, the outcome of the wrong solution used in drug reconstitution was unknown.   Additional Information: GSK receipt date: 21-Nov-2022 Reporter's comment: The reporter consented to follow-up. Additional supportive information: The patient received a dose of Menveo incorrectly reconstituted with sterile water, which led to wrong solution used in drug reconstitution.
Patient developed a rash and nerve pain down the right leg a few days after the vaccine. This has progressed and today appears to definitely be Shingles - Herpes Zoster.
dizziness (vertigo); sensitive stomach; dry heaves; chills; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness (vertigo)), ABDOMINAL PAIN (sensitive stomach), RETCHING (dry heaves) and CHILLS (chills) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Systemic lupus erythematosus (Lupus: but is not on an immunosuppressant medication).    On 18-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced DIZZINESS (dizziness (vertigo)), ABDOMINAL PAIN (sensitive stomach), RETCHING (dry heaves) and CHILLS (chills). On 26-Feb-2021, RETCHING (dry heaves) and CHILLS (chills) had resolved. At the time of the report, DIZZINESS (dizziness (vertigo)) and ABDOMINAL PAIN (sensitive stomach) outcome was unknown. Not Provided          No concomitant medication reported  No treatment medication reported  Action taken with mRNA-1273 in response to the event was not applicable.
Pt began to notice soreness and extreme tenderness at injection site the same evening of the vaccination. They were unable to sleep on that side of their arm. It felt as if it were bruised. That soreness and tenderness has still not resolved as of today, 9/30/12, and pt can still not sleep on left side. They also have a 3.5cm oval red spot where injection was given, which appeared the evening of the injection day and has still not resolved. The red spot is warm to the touch. Pt's most concerning symptom is a knot/lump that developed the day after receiving the shot (9/28). The knot is located just beneath the skin on top of the collarbone, about midway. It is approximately 2cm in size and is mostly round. It is extremely painful to touch, but is mostly is moveable, even though it feels quite firm.
Cold sore lower lip for the first time in 5-7 years (approximately.) occurred less than two weeks after vaccine. Scar still somewhat visible 3 weeks later. No other known cause (no illness, fever, damage to tissue).  Had old Zovirax tablets and acyclovir cream. Did not respond to either. Healed over after two full weeks. Scar still slightly visible on inspection.
Feelings of having a fast-beating, fluttering, or pounding heart. Strange left chest tightness sensation.
Fever 100.6 to 101.0, muscle aches, fatique, chilled.  Went home from school ill.
Sore arm; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and HEADACHE (headache) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002C21A and 035B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-May-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and HEADACHE (headache). At the time of the report, PAIN IN EXTREMITY (Sore arm) and HEADACHE (headache) outcome was unknown.            No concomitant products was provided by the reporter. No treatment information was provided by the reporter.
Rec'd Engerix-B on 8JAN90, experienced a flare-up of arthritis. Also had shoulder aches, numbness & tingling of hands & fingers, & "felt bad" for six weeks. Pt required no tx from MD to date shoulder aches & joint discomfort continue.
A little bit of tiny soreness in my arm; It is about the same that I would get from a flu shot; This is a spontaneous report from a contactable nurse (patient) and another nurse. This nurse reported similar events for two patients. This report refers to the wife.   A 77-year-old female patient received first dose of BNT162B2 (lot number: EL3246, expiry date: 30Apr2021), via an unspecified route of administration on 06Jan2021 at single dose in the right arm for "to prevent getting Covid/COVID-19 vaccination". There were no medical history and concomitant medications. The patient previously took a flu shot and had soreness in her arm. The patient stated, "I am fine. I am not having any symptoms at all. A little bit of tiny soreness in my arm, it is about the same that I would get from a flu shot but that's it I am not sick, I don't have any temperature". The outcome of the event was unknown.; Sender's Comments: Linked Report(s) :PFIZER INC-2021028796 same reporter/drug, different event
Severe Muscle aches, mild fever, malaise (36 hours); 2 weeks later: Shingles
Pediatric dose given instead of adult dosage. Pt. accidently received Pediatric dose of hepatitis B rather than the adult dosage. No adverse outcomes noted. Pt will receive adult dosage one month after pediatric dose given.
Initial information received on 11-Dec-2018 regarding an unsolicited valid non-serious case received from a consumer/non-HCP. This case involves Infant patient who received only diluent of ACT-HIB. The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant therapy were not provided. On an unknown date, the patient received a dose of suspect HIB (PRP/T) Vaccine lot number not reported via unknown route. It was a case of actual medication error due to Inappropriate reconstitution technique. It was unknown whether adverse event occurred. 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 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.
chills, nausea, vomiting, fever, and stomach pain - 16 hours. Treated with acetaminophen.
pt started getting a burning, sharp stabbing pain, like a pen point, on the top of her head and then it would give her a headache.  The a stabbing pains would come and go in a different spots on her head and would always give her a headache.  The pain wakes her up while sleeping.  Today, 5/13/21 it has been over 2 months she has been having these sharp uncomfortable sharp pains to her head but they are not as frequent as before.
Patient had MRI on 3/3/21 and a lung nodule and breast nodule was found on her right side which was the side she received the vaccine on. They do not know if malignant or not at this time. She has a follow up on 3/15/21 for a chest CT scan and will get a biopsy done soon.
Patient reports arm was sore and could not lift arm--patient feels that she got an infection from vaccination--patient planned on going to After Hours Clinic
Vaccine reaction (local) left arm. Area is red, swollen, (+) pain shoulder and warm to touch in a 6" X 5" area between shoulder and elbow. No fever. No systemic symptoms. ZYRTEC a.m./ BENADRYL  pm, ice, ADVIL > intervention given.  Follow-up - Box 8: None of the above.
Pt had systemic reaction 2 hrs post-inject receiving 2nd dose of Hep B vax; BP to 148/110 (nl 100/60), pulse to 140; dizziness & nausea; approx 4 hrs later sx returned & itchiness; some muscle twitching;