chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received only the liquid component; Received only the liquid component; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 13-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA758A, expiry date 30th November 2023) for prophylaxis.   On 12th December 2022, the patient received the 1st dose of Menveo. On 12th December 2022, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 14-DEC-2022 Reporter's comment: The nurse reported that the patient received only the liquid conjugated component of Menveo (without the powder). The vaccine administration facility was the same as primary reporter. The reporter consented to follow up by fax. Additional Supportive Information: The patient received only the liquid conjugated component of Menveo (without the powder), which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.   Follow-up information received on 23-DEC-2022 Reporter's Comment: The reporter reported that they were in doubt about the patient involved on this adverse event. Additional Supportive Information: This case had been linked to the case US2022AMR192847, reported by the same reporter. Summary of Changes: Narrative updated.; Sender's Comments:  US-GSK-US2022AMR192847:same reporter
Throat was very tight; Couldn't really swallow; Chest felt tight; A spontaneous report was received from a consumer concerning herself, a 81-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced throat was tight/throat tightness, couldn't really swallow/dysphagia and chest felt tight/chest discomfort.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 5 Feb 2021, approximately 5 days prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 016M20A) Intramuscularly for prophylaxis of COVID-19 infection.  On 9 Feb 2021, the patient experienced throat was tight, couldn't really swallow and chest felt tight. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, throat was tight, couldn't really swallow and chest felt tight was unknown at the time of this report.
The first night, 1/20. I had chills, but manageable.  1/21 I was fatigued, but also manageable.  By the evening of 1/21 I could not stop shivering as I was sweating through 3 outfits a day (this lasted 4 days).  By 1/22 my temperature was up to a 103 and I couldn?t stand more than 10 minutes without fainting/passing out.  Fever was gone by 1/25 but still have extreme fatigue/dreams where I?m almost hallucinating to this day 2/7. Did a virtual doctors visit on 1/29 where I was put on 3 days of bed rest, but still struggle to make it through a normal work day.
I have experienced continuous but tolerable ringing in my left ear for more than 35 years.  There has been no ringing in my right ear.  Following my 2nd Moderna vaccination, I experienced increased ringing volume in my left ear and onset of temporary low level ringing in my right ear.  The right ear has cleared but the left ear ringing has not.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions and historical drugs was not provided. On 17-AUG-2018, the patient was vaccinated with a improperly stored VARIVAX subcutaneous, lot # N017395, expiration date 07-JUN-2019 (dose was not reported) for prophylaxis (product storage error). The vaccine was exposed to a range of temperature of -14°C to -10°C during 35 minutes. It was reported that there was not previous temperature excursion. It was reported that data logger was involved and that the vaccine was reconstituted with sterile diluent lot # N006325, expiration date 07-AUG-2019. No adverse effect was reported.
(L) upper thigh dime size red swollen warm area noted. Approx 2 1/2 cm x 2 cm.
12 hours after injection, I have pain in the lower back on the right side all the way down to knee. I also have a painful scattered rash with red raised bumps from my right groin to my knee.
Patient developed an allergic reaction shortly after receiving vaccines. Within 3-5 minutes after vaccines were given pt started sneezing. Pt then complained to mom of her throat "hurting and itchy". A CMA immediately evaluated patient and reported swelling of upper lip and red splotchy rash on pt's torso. I was then notified and observed patient noting severe swelling of lips and cheeks, blood-shot eyes, and patient complained of tiredness and became weak. An appropriate dose of BENADRYL was given after which patient vomited and lost bladder control and urinated.   Diffuse urticaria as well as angioedema. Supervising physician contacted who recommended epinephrine shot, DECADRON, as well as an ambulance transport to ER. 0.15 ml IM injection of 1 mg/ml epinephrine given prior to EMT arriving. No DECADRON given. Pt was assessed by EMT and taken to hospital for evaluation.
fever; fatigue; dry harsh cough; severe bilateral edema feet and legs; calf skin turned red; calf skin hot and tender; calf skin hot and tender; This is a spontaneous report from a contactable consumer (patient) reported that a 66-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was not reported), via an unspecified route of administration, administered in arm left on 18Feb2021 18:00 (at the age of 66-years-old) as a single dose for covid-19 immunisation. The vaccine was administered at the hospital. The patient medical history included high blood pressure and cholesterol both from an unknown date. The patient had known allergies. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number was not reported), administered in left arm on 28Jan2021 06:00 PM (at the age of 66-years-old) for covid-19 immunisation. Concomitant medications included losartan potassium (LOSARTIN); rosuvastatin; alfuzosin; and potassium; all were taken for an unspecified indication, start and stop date were not reported. A month after 2nd dose, started having daily fever with fatigue and dry harsh cough. This has continued for 4 weeks and in third week developed severe bilateral edema feet and legs. Then, the calf skin turned red, hot and tender; all on 12Mar2021 14:00 (as reported). All medical reports have come back normal and doctors were unable to diagnose the root cause which is why the patient suspected the Pfizer COVID vaccine may have caused this adverse reaction. The events resulted in doctor or other healthcare professional office/clinic visit and hospitalization. The patient was hospitalized for 5 days. Therapeutic measures were taken in response to the events as patient received Tylenol, Antibiotic and steroid. The outcome of the events was not recovered.   Information on the lot/batch number has been requested.
I had coughing, congestion, extreme fatigue is how it started in 11/01/2022 it worsened my doctor did a CT scan and found spots that could indicate an infection. My doctor prescribed doxycycline 11/22/2022 and I began to feel a little better. My doctor also prescribed benzonatate on 11/18/2022 and prednisone on 11/22/2022. Albuterol was also prescribed on 11/22/2022 and an inhaler ARNUITY ELLIPTA as well. OTC guaifenesin XR and TYLENOL. Follow up CT scan showed numerous nodules still present but some faded. Follow up CT scan recommended in 3-6 months.
In addition to fatigue, fever, muscle aches, joint pain  I have dry mouth- excessive thirst   I have chest congestion- funny feeling in chest.  I am still experiencing adverse event
Hard knot at vaccine site; Injection site itch; Injection site red; A spontaneous report was received from a physician concerning a 64-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced hard knot at injection site/injection site induration, injection site itch/injection site pruritus and injection site red/injection site erythema.  The patient's medical history was not provided. Concomitant medication list was not provided by the reporter.  On 28 Dec 2020 , approximately nine days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 039k20a) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 6 Jan 2021, nine days after receiving mRNA-1273, the patient reported that she developed  1" diameter hard knot at the vaccine administration site that was red and itchy. Treatment given for the event included two cold packs as she could not take antihistamine because she was working.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events; hard knot at injection site, injection site itch and injection site red was unknown.  The reporting physician assessed the events hard knot at injection site, injection site itch and injection site red as related.
Faint/dizzy. Occurred day of shot. Three days after shot very strong that caused a panic attack. Faint/dizzy lasted for a week straight. Spells come up randomly.
Slight tickle in the back of the throat, escaladed to a cough/cold. Treated with vitamin C and Mucinex DM. Six weeks later and still hasn't gotten better. Saw my PCP on 12/31/15 at 9am. No other treatments were given than what I've already been doing.
?1/6/21 hospitalization after her 1st dose on 1/2/21 ?2/15/21 hospitalization and 2/28/21 death after 2nd dose on 1/16/21
After the vaccination pt had seizure for about 5-7 second and perfusily sweat . immediately when saw seizure emergency services was called
Felt dizzy , headache at base of neck . Face was swelling lymph nods armpits . All joints were hurting , chest and heart pain. Body was hot but no fever. Have not recovered form theses symptoms .
"FELT LIKE KIDNEYS WERE GOING TO FALL OUT, INSOMNIA & INCREASED URINATION Q 15 MIN LASTING 3-4 DAYS."
19 days post vaccine, I developed breakthrough vaginal bleeding. I had not had a period post ablation for greater than 10 years. Bleeding was mild to moderate and has lasted one day so far.
About 6:30 PM, headache began, a few hours later he became nauseated. Was sleepless and vomited about 12:00 midnight. He remained headachy and nauseated for several hours. Felt shivery. Awoke this AM (6/21/17) feeling somewhat better. Throughout the day he has continued to improve.
Day of vaccine. Bright red flushing throughout my body. Looked like sunburn. Lightheaded, very tired, headache and feeling shaky. My arm was swollen and redness act injection site Day 2. Low grade fever. Very tired. Achiness. swollen arm. Redness at injection site. Slight headache.  Day 3. No fever. Some tiredness. Arm still swollen and tender. Still redness at injection site.
noc of 14FEB96 pt had a fever & a real bad rxn on skin;5:30-6:00 had convuls & went to hosp ER & it was felt that pt had a virus infect;hives all over body;feet are swollen & feet & hands are purplish;h/a off & on;tired a lot;
Severe chest pains and shortness of breath (Myocarditis and Pericarditis detailed as potential side-effects by the CDC).  I had experienced similar side-effects earlier this year around the time of my previous two vaccinations, but didn't connect those symptoms with the vaccine until this most recent episode.  The onset was so specific, and sudden (less than 24 hours) after my third dose- I was positive it was a reaction to my third booster.  It felt like I was having a heart attack, so I went to an urgent care facility where a dr. confirmed my suspicions that I was having an adverse reaction to the vaccine.
COVID pneumonia; I had a sore arm that was red and swollen around the injection site; I had a sore arm that was red and swollen around the injection site; I had a sore arm that was red and swollen around the injection site; It was very raised and warm to the touch for about 3 days; COVID-19; I had pneumonia one other time; I had pneumonia one other time; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 13), in 2016 as dose number unknown, single (Batch/Lot number: unknown) for immunisation; pneumococcal vaccine polysacch 23v (PNEUMOVAX 23 [PNEUMOCOCCAL VACCINE POLYSACCH 23V]), in 2016 as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history included: "idiopathic CHF" (unspecified if ongoing); "Hashimoto's thyroiditis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), PNEUMONIA (medically significant) all with onset 2016, outcome "recovered" and all described as "I had pneumonia one other time"; COVID-19 PNEUMONIA (medically significant), outcome "unknown", described as "COVID pneumonia"; VACCINATION SITE PAIN (non-serious), outcome "unknown", VACCINATION SITE SWELLING (non-serious), VACCINATION SITE ERYTHEMA (non-serious), outcome "recovered" and all described as "I had a sore arm that was red and swollen around the injection site"; VACCINATION SITE WARMTH (non-serious), outcome "recovered", described as "It was very raised and warm to the touch for about 3 days"; COVID-19 (non-serious), outcome "unknown". It was reported that patient has had pneumonia since being vaccinated initially in 2016. The patient then reported to have pneumonia one other time in Jan2018. The reporter also stated that when I had COVID-19 (on an unspecified date), the patient was also diagnosed with COVID pneumonia. Therapeutic measures were taken as a result of vaccination site pain, vaccination site swelling, vaccination site erythema, vaccination site warmth which included Benadryl.  The reporter considered "I had pneumonia one other time" not related to pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein).  The information on the batch/lot number for pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) has been requested and will be submitted if and when received.; Sender's Comments: The association between the event lack of effect (Pneumonia) with PREVNAR 13 can not be fully excluded.
Pt observed another pt having reaction and stated to provider, "I think I am freaking out."  He stated that his chest felt tight. He denied any itching, rash, difficulty breathing, SOB, numbness/tingling. EMT/medics were on site and immediately responded to pt. Initially pt was diaphoretic with thready pulse. Vitals were pulse 54-62, blood pressure 100 palpabale, pulse ox 92-98, respirations 24. Pt was safely transferred to the floor where vitals were observed for 15 minutes lying supine with feet elevated.  Continued stable in ranges stated ablve. He  was then transferred to sitting position safely and then  to standing position safetly. His vitals were continuously observed for the next 30 minutes by medical/EMT. Pt was able to ambulate freely at time of discharge and denied any  advserse effects
Developed fatigue, muscle aches, chills, low grade temperature of 99.4, and night sweat.
03Jan90 pt vax;  24Jan90 exp severe pain in left shoulder & hip, as well as adenitis in neck region.  Tx w/ antibiotic.  Adenitis resolved.  Arthralgia persisted.
Dizziness with HA with intermittent mid-sternal  burning CP x 3 days; room is spinning; CP lasts few seconds, nothing makes/worse better; Denies any CP at this time; non-radiating; 325mg Tylenol at 0515.  CHIEF COMPLAINT & HPI:  27 yo M with fatigue, bodyaches, chills, headache, and gastritis after covid vaccine on tuesday.  no numbness or weakness.  Pt endorses peripheral vertigo.  no nausea/vomiting.  no anginal chest pain.  no cough/SOB.
Evening of the day vax recvd pt became very fussy & cried 6-730PM then vomited twice-went to sleep; pt then awakened & cried 9PM-MN inconsolable; mom states this episode of irritability was worse than pt has exp @ any other time;
Arm so sore 4 hours after shot, could not lift it.  Sore, fever, not swollen, could not use for 5 days.  7-3 seems to be ok.  Glad I don't need another one.
they both have covid; they both have covid; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two patients (herself and her husband). This is first of two reports. A female patient of an unspecified age (reported as 70, unit unknown) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were unknown), via an unspecified route of administration on 18Jan2021 at single dose for COVID-19 immunization. The patient's medical history included pneumonia. The patient's concomitant medications were not reported. The patient reported that she received the first dose of the Pfizer COVID vaccine on 18Jan2021, and her husband on 20Jan2021. She was diagnosed with COVID last Thursday (04Feb2021). She said she got it from her husband. They both have COVID and received antibodies (from (company name)) as it was mild case. She said she and her husband were congested, had fatigue, and the antibodies made a difference. She had pneumonia before. The patient stated so many people can only take the first dose due to side effects or some other reason. She wanted to know the time they needed to wait to get the second dose of the vaccine and asked if it was 90 days. The outcome of the event was unknown.   Information about the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021171730 Same reporter, drug, and events; different patients
Patient was given the Adult dose of Engerix today, unfortunately the adult dose had been placed on the pediatric shelf.. Upon realizing the error the CMA notified Dr. and management. Dr. immediately had poison control called, they verified that there will be no harm to the child, that this would count towards the dosing schedule, and to watch for localized reaction. Dr. instructed our staff to call patients mother.
Myalgia, Fever,  pain at inj site, f/c, body aches
This nurse was called to the monitoring area to assess a patient. Patient was sitting in chair AAO x 3. Stated he felt like his heart was racing and he felt dizzy. RN obtained VS: 158/100, HR 142, pulse ox 98%. This nurse informed patient EMS was going to be called. Patient reports a PMH of COPD and Htn. Stated he did not take his medications this morning which included Lisinopril. He was concerned the medications would interact with the vaccine. Patient had dose #1 of Pfizer Covid vaccine (Lot # EN6207, exp. 7/31/21). Patient was slightly diaphoretic. VS reassessed: BP 160/98, HR 131, pulse ox 99%. Patient denied any chest pain or tightness, no difficulty breathing. Patient reported feeling his throat was itchy. Stated he felt hard to swallow. At that time, this nurse advised she was going to administer the epi-pen. Patient refused. Stated he wanted to wait. Symptoms did not subside. Nurse offered Benadryl to which patient agreed. EMS arrived. They stated they would administer the Benadryl. Final BP was 160/100, HR 114, pulse ox 98%. Patient left without further incident.
Swollen, hard, painful lymph node in left armpit (same side as injection site). Pain meds already taken 3x day for chronic hip pain, additional alternating heat and ice. Resolved by 1 November.
Redness, swelling, pain, and tenderness around injection site, also headaches, feverish, and eyelid swelling.
18MAR91 pt vax; exp h/a, fever, rash, dizziness.
Patient experienced a headache, nausea, and loss of appetite the evening and day following his COVID vaccination. Patient stated he had previously had Covid several months before and had similar symptoms while he was Covid-positive.
Information has been received from a physician and a practice manager referring to a patient of unknown age and gender. On 22-SEP-2014, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 (strength: 0.5 ml, lot # K005797, expiration date 21-MAR-2015). This specified lot number vaccine was exposed to temperature excursion once. The total cumulative excursion time was 48 hours with the lowest recorded temperature of 1 Celsius degree (the highest recorded temperature was not reported). The storage criteria and the type of excursion for this vaccine was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Within 15 minutes after vaccination "flushed with noted erythema of face/ant chest with complaints of itchiness of face/chest, with tachypnea, wheezing and reported sensation of throat swelling w/ shortness of breath."
Needle broke; Did not receive the full dose; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced did not receive full dose and needle broke.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 22 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. During vaccine administration, the needle broke, and the patient did not get the full dose. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The events, did not receive full dose and needle broke, were considered resolved on 22 Jan 2021.; Reporter's Comments: A spontaneous report from a consumer concerning a female patient who experienced non-serious events of did not receive full dose (Incomplete dose administered) and needle broke for administration of mRNA-1273 (Lot number: unknown expiration date-unknown).  There were no reported AEs associated with this case of did not receive full dose and needle broke.
My period started on April 12,2021 and ended April 17,2021, but it stated again on April 21, 2021 with two third less blood flow and ended on April 25, 2021. It didn?t happen before that there were less than 22-25 days between my two periods.  On May 14, my period stated again and I took my second vaccine shot (Pfizer, EL9264) on May 8,2020, and I took my first shot (Pfizer Ew 0153) on April 17,2021.
the patient was given shot and after 5 minutes in waiting area he passed out while sitting in chair.  He was immediately revived and taken into counseling area and place on floor.  He was given water and cold compresses to neck and forehead.  After 5-10 minutes we was sitting up in chair and feeling better.  He waited another 10 minutes before standing and walking out with his mother. I contacted mother at 5:00 p.m. and patient took a nap and is fine.
My period arrived 3 days early - beginning on April 8 (1.5 days after administration of the first dose of my Covid vaccine). It then took 4.75 weeks before my next mensuration cycle began on May 12. Prior to this I was on a regular 28 day cycle.