chrisvoncsefalvay/vaers-outcomes huggingface dataset:
FELT MISERABLE; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN, expiry: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported, per procedure no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced felt miserable. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of felt miserable was not reported. This report was non-serious.
Area injection site has been repeatedly sensitive with itching, scabbing. Also, experiences headaches, nausea and chest conjestion with flare-ups. Flare-ups started about 90 days after injection and recurr approx every 60-90 days thereafter. Experiencing unexplained anxiety/depression ocurring approx 120 days after injection. Recurs 60-90 days.
3:05 pt felt faint, was standing and assisted to chair, lower extremities elevated mother at side, appeared diaphoretic was alert. B/P  100/76 Pulse 98, 02 sat 99%. 3:07 pt feeling better sitting up in chair, monitored for additional 15 minutes. 3:20 B/P 104/74 Pulse 104, 02 sat 99%, left with mother ambulatory encouraged to follow up with PMD as needed.
Patient is an 81 year old female with PMH of DM, non-hodgkin lymphoma, HTN, dementia and recently diagnosed with a pancreatic tail lesion 1/31/22 and discharged home with VNA and palliative care. Patient was at home on hospice for approximately a week and developed nausea and vomiting and requested to come to the ED. Patient is A&O x3-4, unable to provide details of illness, history obtianed from ED record. As per ED record, daughterin law states that patient vomited 30 times and had poor Po intake. Patient denies chest pain and shortness of breath.
Information has been received from a certified medical assistant referring to an unspecified number of unspecified patients of unknown age and gender. On unspecified dates, the patients were vaccinated with an unspecified number of improperly stored doses of Oral, ROTATEQ (lot # L010837, expiration date 16-FEB-2017) (dose, frequency and route not provided) (incorrect product storage). No adverse effect was reported. The minimum of temperature was 0.8 degree C and the time frame was unspecified. There was no previous temperature excursion. There was no product quality issue (PQC) involved. This is one of several reports received from the same source. Additional information has been requested.
Within 15 hours of receiving the injection, I was unable to move my left arm from my left side and was in excruciating pain. I experienced complete immobility of this arm for 4 days and was unable to do basic activities (i.e. putting a shirt on and off, opening cupboards, driving, etc). My sleep was very poor due to the pain and fear of what this would mean for my life. I went back to the doctor's office where I had received the vaccination for guidance as to what to do next and she gave me an RX to help with sleep, suggested I use Menthol rub for the pain, use anti-inflammatory medication and gave me some static exercises to help support recovery.  She said this type of condition can take 6-9 months to heal. Since I wasn't finding much relief from the extreme pain and my arm mobility continued to be very limited, I sought out a Physical Therapist about a couple weeks after receiving the vaccination. After his initial examination, he described my condition as "frozen shoulder" and provided exercises to strengthen the muscles in the shoulder in a way that would work around the vaccination injury and give my arm mobility.  This was very helpful and slowly I found ways to deal better with the pain and began to have better movement of the arm and overall rehabilitation from the injury.  I worked with him for 3 weeks and he gave me exercises that I could continue to do at home for ongoing recovery.  I also sought out a chiropractor during this time, but the arm was too painful for any significant work to be done on it. Finally, I went to a massage therapist who provided therapeutic massage to help ease and relax the tightness in my neck and shoulder from the chronic pain I was experiencing.  This too was helpful as I found myself holding my body so tight as a result of the immense pain.  I have now, about 9 months later, regained almost all mobility with minimal limitations still present.  I can still feel the pain in my shoulder when I touch the injection site area and there are days it aches or I will have a shooting pain with a particular movement.  It can also feel painful at times when I do exercises like push-ups, but I started working weekly with a Physical Therapist again in April 2021 to help stabilize that shoulder joint with more focused exercises.  I last met with the Physical Therapist on May 13th, when he encouraged me to continue the shoulder strengthening exercises at home going forward and to continue these, as the shoulder would likely need this for ongoing stabilization.  This again is proving to be helpful.
Metallic taste in mouth - 5 min after injection Ringing ears - 45 min after injection Pain  at injection site - immediate after injection
Client received the 1st dose of Moderna COVID vaccine lot # 016C21A and expiration date 5/22/21 at 11:37am.  Client reports sudden onset of blurred vision to EMT and Nurse, within 5 minutes of sitting down.  EMT  and Nurse  provided client with a water bottle and took vitals. At 11:45am vitals: blood pressure:157/92 , pulse:72 , and oxygen:97%. PHN  arrives at 11:47am to find patient sitting up in chair alert and oriented x 4. Client reports her medical history includes high blood pressure, asthma and diabetes. Medications include metformin, norvasc, and albuterol. Client reports she has history of high blood pressure but never takes medication for it. Client reports no history of head injury. Client reports eating and drinking water before having her vaccine. Client denies having any chest pain, headache or dizziness.   At 11:50am vitals: blood pressure:172/89, pulse:78 , and oxygen:100%.  Client reports blurriness is coming and going. Client insists this is the only symptom.  At 11:55 am vitals: blood pressure:157/87 , pulse:70 , and oxygen: 97%. Client reports blurry vision is starting to get better.  At 12:00pm vitals: blood pressure: 149/86, pulse:73 , and oxygen:97%. At 12:05PM client reports pressure on her chest  and blurred vision improving.  At 12:05pm vitals: blood pressure:148/82 , pulse:73 , and oxygen:97%. PHN called 911 at 12:07PM. At 12:10am vitals: blood pressure:144/87, pulse:70 , and oxygen:97%.  Client alert and oriented and reports chest pain is better. At 12:15pm vitals: blood pressure:162/99 , pulse:73 , and oxygen:97%. At 12:16PM Fire Department assumed care. Client was walked out on a stretcher by paramedics at 12:27PM. Client was taken to Hospital.
Pt reaction at "4:30 yesterday, I had severe difficulty breathing, I got nauseated to my stomach, I had a hot flash and immediately had a cold flash and then I got dizzy and that only lasted twenty minutes. After that I just had a general shortness of breath feeling and then about 2 hours later I had another episode just like that one. All I've been having since then is a general shortness of breath, a little dizziness and on and off nausea".
She felt ill for 4 days (tiredness, achy, etc) then she developed an itchy rash on her face.
Patient stated she began to feel itchiness all over her body. Patient stated she has severe allergic reactions to ?everything in the air?. Accompanied to paramedic tent. Further evaluation completed by paramedics.
minor side effect: night of injection had vivid dream, and 2nd night after injection had another vivid dream when I do not typically have dreams  minor side effect of some chills 13 hours after injection that slight worsened, persisting until 36 hours after injection (resolved 1.5 days after injection) moderate pain at site of injection, onset 5 hours after injection and lasting until 2.5 days after injection
Fevers (T-max101.2), chills, body aches, dizziness, lethargy. Local arm tenderness, redness, and swelling. Lasting approximately 48 hours, with lingering symptoms for approximately 72 hours. Treatments included rest, hydration, ibuprofen 600mg po Q4H
no adverse event; 2 vials of MMRII were left out of the freezer for 9 hours/ one vial was inadvertently administered to a patient; This spontaneous report was received from a registered nurse and refers to a 12 month old male patient. No information regarding the patient's medical history was provided. His concurrent conditions included nasopharyngitis. The patient had no allergies. On 19-NOV-2020, at the age of 12 months, the patient was vaccinated inadvertently with incorrectly stored first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (recombinant human albumin (rHa)) (M-M-R II) vial, 0.5 ml, lot # S035352 with expiration date on 05-NOV-2021, subcutaneously in the left thigh for prophylaxis by medical assistant. Administered vaccine was left out of the freezer and underwent a temperature excursion of 70 degrees Fahrenheit for 9 hours. No adverse event reported. Digital data logger was not involved and there was no previous temperature excursions reported.
received Pfizer vaccines on 4/20/21/5/11/21; tested positive for COVID by PCR on 7/29/21 Unknown if symptoms
24 hours post vax, pt experienced inconsolable screaming that lasted for 1.5 hours.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:  The reporter is the patient. A male patient received BNT162b2 (BNT162B2), on 20Jul2021 as dose 1, single (Lot number: Unknown) and on 10Aug2021 as dose 2, single (Lot number: Unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "unknown"; PAIN (non-serious), outcome "unknown", described as "Body ache"; HEADACHE (non-serious), outcome "unknown"; RHINORRHOEA (non-serious), outcome "unknown", described as "Runny nose"; NAUSEA (non-serious), outcome "unknown"; NASAL CONGESTION (non-serious), outcome "unknown", described as "Congestion"; OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "Sore throat". Additional information: Reporter stated that he had adverse event of the COVID-19 Vaccine. Patient said that he had first shot back on 20Jul2021 and then other on 10Aug2021. He wanted to know the symptoms that he had and wants to find out what kind of symptoms he had. Patient mentioned he had fatigue, body ache, headache, sore throat, congestion, runny nose, nausea and however doesn't have shortness of breathing. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Swollen lymph nodes under left arm and in chest area presenting 4 days after shot and persisting for 3-4 days with pain. Severe fatigue presented 3 days after shot persisting for 4-5 days. Chest pains.
14 yo pt received a Moderna booster shot for a non-approved age group. No adverse effects reported
Pt recd 3 vaxs 3Aug89, 12Sep 89, 23Jan90. Titer was neg. Refused 4th dose of vax.
Case number PHEH2014US022975 is an initial spontaneous report received from a consumer on 13 Nov 2014. This report refers to a patient whose identifiers were not reported. The patient's medical history was not reported. The patient's current condition included egg allergy and concomitant medications were not reported. The patient was administered a dose of FLUVIRIN (batch number: not reported) intramuscularly in error on 12 Nov 2014. No adverse events were reported following the maladministration.
Patient presented at pharmacy today 12-10-18 at 230pm, reporting that she had reaction to immunizations received one month prior on 11-12-18. Lower section of Right arm was red and showed signs of being scratched with small scab like areas (looked like patient scratching self). It didn't appear inflamed (swollen or hot to touch), it was just red on the arm. Patient stated that itching started about one week after receiving immunizations, she didn't report pain, only itching. She only reported to us today.
INFECTION IN RIGHT ARM AT INJECTION SITE (CELLULITIS) CHILLS THRESH ON TONGUE HEADACHES
Onset of fever 2/13/2022. O2 SATs in the low-mid 80's beginning 2/14/2022. Treatment included: Oxygen via NC and hospital admission.
Felt intense fatigue and malaise accompanied by chills and nausea . Small rash on my left hip.
Patient reported symptoms of tongue tingling and throat numbness 5min following injection of Pfizer vaccine. Patient was given 25mg and monitored for 30min. Following 30min observation, vital signs were stable, exam unremarkable but symptoms persisted. Patient provided additional 25mg of Benadryl. Following additional 30min monitoring, symptoms resolved. Patient was allowed to return home with a friend to drive them.
Strong stomachache, dizziness, pain in the left arm, nausea,  chills.
nausea, malaise, chills, diarrhea, bone pains, & gen weakness;lasted about 48hr;never had gastric sx w/flu shot before;
Initially scratchy throat, followed by very hot spells but no increase in temperature.  Later severe body aches and mild headache.  I took zinc (5mg) twice daily as well as Vitamin C..  Also Paracetamol for pain.  Symptoms persisted mildly for just under one week after which my energy returned.
I had a few of the normal side effects. The adverse side effects  included disorientation, change in vision (blurry), hives, occasional mild shooting pain sensations throughout arms to fingers, legs, and face. Four consecutive days of alternating lower eyelid twitching.   Three weeks out I experienced unexplained bruises on my left calf.
Patient reports feeling "weird" and "rushing in chest", tingling and numbness near trachea
chest pain; signs of super ventricular tachycardia; swelling on the right side of my face; Frequent palpitations; From the knees down, both legs felt numb into her feet; Could not stand; shortness of breath; Premature ventricular contractions; A spontaneous report was received from a consumer concerning a 55-years-old female patient , who received  Moderna's COVID-19 vaccine(mRNA-1273)  and experienced the following: chest pain, could not stand (dysstasia), shortness of breath (dyspnea), signs of supraventricular tachycardia (supraventricular tachycardia), swelling on the right side of face (swelling face), from the knees down, both legs felt numb into the feet (hypoaesthesia) , frequent palpitations (palpitations), premature ventricular contractions, a lot of them (ventricular extrasystole).  The patient's medical history was not provided. Relevant concomitant medications as reported included metoprolol .  On 29 Jan 2021, prior to the onset of events, the patient received their second of two planned doses  of  mRNA-1273(Lot/batch:013L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On an unspecified date the patient experienced events swelling on the right side of face , signs of supraventricular tachycardia , frequent palpitations . On 01 Feb 2021, the patient experienced shortness of breath and a lot of premature ventricular contractions (this was confirmed by patient's doctor on an EKG).  On 05 Feb 2021, the patient reported they were starting to get in trouble. They woke up on 06 Feb 2021 with chest pain and very short of breath. From the knees down, both legs felt numb into the feet. By the end of the day, the patient could not stand. The patient's cardiologist prescribed metoprolol which was helping some. On an unknown date, the patient ended up in the emergency room (ER) with chest pain.  An echocardiogram didn't show much. The last week of February 2021 (dates unspecified) the patient reported they went to the ER again for chest pain. At that time, the numbness and tingling had gone away. The patient was admitted for two nights to the local hospital and while there had a poor exercise test and signs of superventricular tachycardia. Treatment included an increase in metoprolol, but the patient still had frequent palpitations. Metoprolol was again increased to control and monitor the heart. The patient is wearing a heart monitor.    The patient received both scheduled doses of mRNA-1273 prior to the event(s); therefore, action taken with the drug in response to the event(s) is not applicable.  At the time of the report, the outcome of the events ,swelling on the right side of face,signs of supraventricular tachycardia , frequent palpitations, shortness of breath, premature ventricular contractions, chest pain, and could not stand, was unknown .  At the time of the report, the outcome of the event from the knees down both legs felt numb into the feet, was considered resolved .; Reporter's Comments: The events were consistent with increased risk of cardiovascular complications associated with age of patient. Company assessed the events to be unlikely related to company product.
Patient had ZOSTAVAX vaccine and few days later she developed a quarter size rash around injection site of redness and spreading. Patient went to clinic and received cephalexin and MEDROL DOSE PK.
Information has been received from an RN from an allergy practice concerning a young female child with a severe egg white allergy, who had a history of an ER admission in the past and a less severe episode with an epinephrine therapy who was vaccinated with a 1:100 dose of MMRII, intradermally. There was no reaction in a scratch test, however, there was a very large immediate reaction (about a 50 cent piece side wheal) at intradermal injection. The pt sought unspecified medical attention. Additional information has been requested.
A non-serious spontaneous report of "administration of FLUMIST to 23-month-old" was received from a nurse practitioner, In the USA, involving a 23-month-old male. ON 25-Sep-2009, the patient received FLUMIST. There is no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. This case is submitted in accordance with MedImmune's post-marketing commitment on accelerated reporting for the newly indicated population of 2 years to 59 months of age for FLUMIST.
Patient received first dose of Pfizer COVID vaccine today, 7/30/21.  Immediately after immunization was administered, patient stated that she was dizzy and stated it was due to being nervous about getting a shot.  Patient moved to the waiting area, where she complained of being hot and "flushed".  I gave her an ice pack from the pharmacy.  Patient denied other symptoms at that time other than a burning sensation in the arm that she received the vaccine.  I tested the patient's blood pressure, which was 127/101, pulse 102.  A repeat measurement approximately 5 minutes later was 124/82, pulse 94.  Patient again denied any difficulty with breathing, but did state that she was "upset to her stomach.".  Patient was moved to the counseling area for additional privacy and began to vomit, dizziness and that "she was not feeling good".  Patient became less alert at this time and I asked the pharmacy team to call EMS/Code White.  EMS arrived and evaluated patient, stating that it was likely this was due to a "panic attack".  EMS took patient out of store on a stretcher.
EXTREME SHORTNESS OF BREATH; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included asthma. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805020 expiry: UNKNOWN) dose was not reported, administered on 30-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported.  On 30-MAR-2021, the subject experienced extreme shortness of breath. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of extreme shortness of breath was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment is not required as per standard procedure as case assessed as non-serious.
Guillain Barre following dT. Bell's Palsy. Per annual report- He still has muscle weakness from his Guillain Barre. Discharge summary states weakness, abnormal gait. msv Medical records state otitis media. msv
Big, swollen lump, at the top of her leg, almost to the bend in the thigh, on her right leg; Patient was diagnosed with a swollen lymph node; This is a spontaneous report from a contactable consumer or other non hcp reported for patient (sis-ter-in-law). A 64-year-old female patient received second dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EN6207; Expiration Date: Jul2021), via an unspecified route of administration in arm left on 18Mar2021 (at the age of 64-years-old) as 2nd dose, single for COVID-19 immunisation. The medical history of the patient included ongoing stroke. The concomitant medications of the patient were not reported. The patient previously received first dose of BNT162B2 (solution for injection, Batch/Lot number: EN6203; Expiration Date: 30Jun2021), via an unspecified route of administration in left arm on 25Feb2021 (at the age of 64-years-old) as single dose for COVID-19 immunisation. Investigation Assessment was reported as yes. The additional Vaccines Administered on Same Date of the Pfizer Suspect was reported as no. No prior vaccines within 4 weeks prior to the COVID vaccine. The AE(s) following prior vaccinations were reported as no. The family medical history Relevant to AE(s) was not provided. On 20Apr2021 the patient was diagnosed with a swollen lymph node and experienced big, swollen lump, at the top of her leg, almost to the bend in the thigh, on her right leg on an unspecified date. The reporter stated the patient had a side effect, stated the patient went to the doctor, where they did an ultrasound, and the patient was diagnosed with a swollen lymph node. The reporter stated she called for her sister-in-law because sometimes she cannot find her words, from a previous stroke, but she was able to talk on the phone. She states they had made an appointment to see another doctor next week. She stated that the patient had noticed the lump for a couple of weeks but brought it to the reporter attention on 16Apr2021 and because the patient did not showed the lump for a couple of weeks, she assumed the lump happened after the second vaccine. The patient underwent lab tests and procedures which included ultrasound: was diagnosed with a swollen lymph node on 20Apr2021. The outcome of the event Big, swollen lump, at the top of her leg, almost to the bend in the thigh, on her right leg was reported as not resolved and the outcome of the event patient was diagnosed with a swollen lymph node was re-ported as unknown.  No follow-up attempts are needed. No further information is expected.
Had a fever and headache, took a home COVID-19 test and was positive. Contacted doctor and was prescribed Remdesivir. Took full course of medication and started feeling better. Still have a small cough.
Johnson & Johnson.  Fatigue, muscle ache, head ache, starting the morning after the vaccine.  Cold sores on my nose and the roof of my mouth two days later.  Nine days later, I am healing and feel much better. I am still a little tired.