chrisvoncsefalvay/vaers-outcomes huggingface dataset:
PATIENT RECEIVED 1 DOSE OF MODERNA ON 07/13/2021 AT ONE LOCATION AND RECIEVED ANOTHER DOSE OF MODERNA ON 07/20/2021 AT DEPARTMENT OF PUBLIC HEALTH.
no adverse effects; patient was administered improperly stored PROQUAD; This spontaneous report was received from a medical assistant and refers to a 4-year-old patient. The patient's concurrent conditions, medical history, concomitant therapies, drug reactions and allergies were not reported.   On 10-SEP-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live, recombinant Human albumin (rHa) (PROQUAD) lot # S009759, expiration date 27-SEP-2019 (dose, anatomical location and route of administration were not reported) for prophylaxis. Concomitant therapies included properly stored sterile diluent. Administered dose of suspect vaccine experienced the temperature excursion from 15 degrees Fahrenheit to 46 degrees Fahrenheit (17.6F) for 56 hours and 40 minutes. Previous temperature excursion was reported as from 6 degrees Fahrenheit to 14 degrees Fahrenheit (6.2F) for 10 minutes. Data logger was not involved. No adverse effects were reported.
Extreme nausea and vomiting -> hospitalized arm swollen and hard to use. 1-17-12 readmitted - infection - was given an antibiotic I.V. - then released. 1-23-12 called patient - spoke with companion - she is better but still not feeling well & has been on a course of antibiotics from her primary physician.
I had soreness and swelling right after. They went away and I was fine. Then today I woke up to a bruise at the injection site and redness, swelling, warmth, and itchiness about an inch and a half below the injection site. There is also muscle soreness in that arm and maybe some numbness. Everything is mild.
Big lump on right side of neck; Pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm) and SWELLING (Big lump on right side of neck) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History Information was reported.     On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm). On 20-Mar-2021, the patient experienced SWELLING (Big lump on right side of neck). The patient was treated with NAPROXEN SODIUM (ALEVE) on 19-Mar-2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Pain in arm) and SWELLING (Big lump on right side of neck) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 25-Mar-2021 and was forwarded to Moderna on 25-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm) and SWELLING (Big lump on right side of neck) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History Information was reported.     On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm). On 20-Mar-2021, the patient experienced SWELLING (Big lump on right side of neck). The patient was treated with NAPROXEN SODIUM (ALEVE) on 19-Mar-2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Pain in arm) and SWELLING (Big lump on right side of neck) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided by the reporter.
2/3/21 "almost immediately, lump in the throat and voice got hoarse. I took Tylenol and I am drinking lots of water. I got a lumpy feeling in the throat with the first one but  my voice wasn't impacted"
Vertigo, chills, vomiting, and headache (still experiencing the above) treating with Meclizine & ADVIL.
pt recv vax 9OCT95 & devel redness @ inj site;no tx was necessary;pt has recovered;
Patient got up middle of the night to use the restroom feeling extreme dizziness.  Patient fainted while seated on the toilet, did not suffer any known injuries.  Regained consciousness and was still very dizzy.  Went back to sleep and woke up without dizziness. Fatigue and weakness for the next day. Patient feeling back to normal minus the rash on injection site and slightly worried about dizziness at the second shot scheduled for April 15th.
pt recv vax 4NOV96 & 1hr & 1/2 later lip & lt side of face became swollen;pt returned to MD office where was given DPH & adrenalin;the next day lip was still swollen & voice was hoarse;prescribed pred;
(L) arm very painful, hot to touch, erythema, nausea, headache.
felt like I had covid for 2 days but head ache started same day as shot and has not went away since I think it has been 30 days now 24/7 head ache never stops its driving me crazy cant think cant work cant do much of any thing
Pt experienced abdominal pain, fever to 102.2, headache, diarrhea, dizziness, and drowsiness.
Mother called three days after vaccination given, reporting redness and swelling approx. 7 hrs after vaccinated and did use cold compresses as instructed when counseled that am. Mom states she called the pediatrician 9/25/02 and was told to cont. cold compresses and Motrin. Mom states she also put Benadryl cream on it. Encouraged her to have evaluated by MD but never took him in. On 9/26/02 or 9/27/02 mom states skin split a little over site and I expressed concern over possible cellulitis but as of 9/27/02 she still had not taken him to MD.
The morning of April 13,2021,  I was taken to the emergency room with heart attack like symtems.  After blood test a CT was done and multipul blood colts were found in both my lungs.  I was then placed  on blood thinners a low salt diet.  I remained in the hospital until the April 16,2021.
Same day of the vax she had bleeding at injection site, had a 104 fever, clot in her lymph nods, high blood pressure, went to er and er did a blood test and told her that her blood was contaminated
Covid monitoring documentation. PT admitted 1/3/22 documented to have positive covid. PT received Janssen  3/31/21 Lot 1808980 for dose 1.
Breakthrough case admission after 3 vaccines  Pfizer 3/1/21 lot# EN6207; Pfizer 4/1/21 lot# EW0150;  Pfizer 12/20/21 Lot# FE3594
Patient called/came in 9/16/11 in the morning. Red, raised rash up right arm and across chest. Patient reported "little" pain today compared to yesterday.
Information has been received from a nurse practitioner concerning a 15 year old male patient with Stevens-Johnson syndrome and no drug reaction/allergies, who on approximately on 17-NOV-2010 was vaccinated with a first dose of GARDASIL (Lot # not reported) (4 days ago, reported date as 08-DEC-2010). The nurse reported that on 04-DEC-2010 about three weeks after vaccination, the patient had a flare up of Stevens-Johnson syndrome. The patient had a fever, high white cell count, blisters on his mouth, lips and genitals and was diagnosed with a bacterial infection. He also had cardiac arrhythmias and required a cardiac monitor and evaluation of his cardiac enzymes. He was hospitalized on 05-DEC-2010 and released on 07-DEC-2010. He was prescribed with antibiotics and steroids for 6 months. At the time of the report, the patient was  recovering. Flare up of Stevens-Johnson syndrome, cardiac arrhythmia and bacterial infection were considered to be immediately life-threatening by the reporter. Upon internal review flare up of Stevens-Johnson syndrome and hospitalization were considered to be an other important medical events. Additional information has been requested.
"out of it" x 2d after vaccination. Mom stated has been lethargic and cries all the time since initial vaccination.
Chest Pain; patient stated he took a few ibuprofen 200mg tabs to try and relieve chest pain however no symptom relief. advised patient to seek medical attention based on package insert recommendation
Patient arrived to work at approximately 11am. At 11:45pm she stated her throat started to feel itchy and notified staff to alert her supervisor of possible allergic reaction to vaccine. Patient then started to complain of difficulty breathing and requested her EpiPen. EpiPen was administered to her right thigh, 911 was notified of symptoms. Patient had a syncopal episode, was guided to the floor and started convulsing. She was placed on her side during convulsions which stopped after approximately 20 seconds and reoccurred for approximately 45 seconds to 1 minute. Patient became alert and oriented x3 after convulsions stopped. Fire Rescue arrived and at approximately 12:05pm and patient was sent to Hospital for further evaluation.
Patient called the pharmacy Thursday 9/2/21 at about 12:43p to say that she had a reaction to her vaccine. Pt stated that she got an itchy rash on her face and chest that started Saturday. On Monday she went to her doctor and her doctor referred her to an allergist to see if she should get the second dose. Pt said she used benadryl cream and benadryl oral at night and zyrtec during the day. She denied any other symptoms.
12 hr p/vax pt devel erythema @ the inj site which progressed to involve the lateral aspect on arm from shoulder to sl above the elbow;seen by MD 26JUL was prescribed Keflex;27JUL hosp for 2 days for tx of cellulitis;
Received TDAP and MCV on 8/4/10 at 330PM started with swelling and hives 20 hrs later Rxn 17 x 12 cm urticarial erythem patch on (L) upper arm.
Information has been received from a physician concerning a 24 year old female with no pertinent medical history reported and no known drug allergies who "over six months ago" was vaccinated intramuscularly with first 0.5mL dose of GARDASIL (lot number not reported). There was no concomitant medication. The physician reported that the patient "got a little light headed and fell back. When she asked the patient what happened, the patient said that she had not eaten all day". The patient recovered later that same day. Since, the patient had gotten her second and third 0.5mL doses of GARDASIL (lot number not reported) and did not have an adverse event with either shot. No lab studies were performed. The physician attributed this adverse event to her not having eaten all day. the patient sought unspecified medical attention. Additional information has been requested.
Mother called, his arm was red with a speckled red rash, same day as vaccine was given. Doing fine now.
getting just exhausted feeling; pain in my joints and everything; I start chilling; took my temperature; its a 102.3; this shot made me sick; I had the COVID booster shot yesterday; I had the COVID booster shot yesterday; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 3 via an unspecified route of administration on 03Oct2021 as dose 3 (booster), single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received two doses of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE in Feb2021 for covid-19 immunisation. The patient had the COVID booster shot on 03Oct2021 at the pharmacy and has been fine up until about 2 O'clock this afternoon and started really getting just exhausted feeling, everything and then the patient just had pain in the joints and everything, then when the patient got home and started chilling, the patient just took the temperature probably about 15 minutes ago and it's a 102.3 and he/she didn't what to do. The patient hasn't been sick in and didn't know when but this shot made him/her sick. The patient has already had the two Pfizer shot back, the series, back in Feb2021. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
I have a large patch of redness, about the size of a large index card....bigger than a dollar bill.  Today it is not only painful but hard. It soreness occurred on day 2 ( same day I took a 3 hour nap and then slept 10 hours the same night), the redness on day 3.  It is now day 4. I have tried ice packs, ibuprofen, and last night I used a burn cream with Lidocaine that was the most relieving. Today it is still hot and red yet getting better.
Patient hospitalized for 6 hours after having a cardiac catheterization on 5/11/2021. He was also hospitalized on 5/12/2021 for TAVR. These visits are within 6 weeks of receiving COVID vaccination.
Pt recvd rubella vax & 10 days later devel rash which remitted in 3 to 7 days;
Decrease in appetite; Vaccine was administered to a 3 year old child; This is a spontaneous case, initially received from a physician on 11-Jan-2019, concerns a 03-year-old, female child patient.   The patient did not have any medical history. The patient did not receive any concomitant medications.  On 11-Jan-2019, the patient (under age of 4 years) was administered with Flucelvax QIVc [influenza vaccine, subunit influenza virus vaccine polyvalent, cell culture derived, dose: 0.5 ml, route of administration: intramuscular, anatomical location: thigh, batch number and expiry date: not reported] (explicitly coded as inappropriate age at vaccine administration) for influenza prophylaxis.  On an unspecified date, the patient experienced decrease in appetite.  The outcome of the event was recovered.  The reporter assessed this case as non-serious.  Follow up received from a physician on 05-Feb-2019: The patient details were added in the patient tab and a new event 'decreased appetite' was coded in the event tab. The narrative was amended accordingly.; Reporter's Comments: A 03-year-old female patient (under age of 4 years) was administered Flucelvax QIVc (inappropriate age at vaccine administration) and experienced decreased appetite after unspecified time of vaccination.  The causality of the event decreased appetite was unassessable due to lack of onset latency. The company assessed the causality of the event inappropriate age at vaccine administration as not related to the suspect vaccine due to accidental nature of the event.
Received pneumococcal polysaccharide vaccine age 65 and over: Site of injection swollen down to 2" above elbow for 5 days plus body aches and pain (Flu like symptoms).
Around 4 pm, I administered vaccine to patient's left arm  in presence of mother. Patient bleed a little and I compressed until bleeding stopped and bandaged site. Patient was sent out of vaccination room while I provided vaccination to brother. After brother left room, was informed that patient felt dizzy and hot. Had patient sit down and attempted to assess for EPIPEN necessity. Mother and Father refused EPIPEN and asked for liquid Benadryl instead. Assessed patient for anaphylaxis and patient was still only dizzy and hot. Offered EPIPEN again but was refused. Gave patient liquid Benadryl and had patient wait in room for 15 min after.
No adverse events know as of now. No symptom, signs, etc known as of now. Pt was given vaccines by another CMA and pregnancy was unknown to all parties. Pt came to office on 8/16/17 to establish care w/ Dr. Patient requested OBC but denied being sexually active - last cycle 7/28/17. Pt. was given OBC and given vaccines listed above. Pt took OBC in months September and October. Pt returned 10/25/17 for 2nd HPV vaccine. Pt returned 11/9/17 reporting positive home preg. test. Blood HCG was positive in office, pt sent for OB U/S and measured 38 weeks plus 3 days.
Patient developed soreness/pain in shoulder immediately after receiving vaccine. Pt continues to have pain despite anti-inflammatory medications, CORTISONE shot.
I didn't feel poorly until I went to the dentist on 5/25. They did a panoramic x-ray and said that one of my sinuses were completely full. I came home and called my doctor because I had had a sinus infection in March. I did a tele visit with her and she advised that I give it a few days and see what happens. That night, I was feeling really bad. At the advise of my daughter, I took an at home COVID test and that was positive. I was still feeling badly that next morning, so I took another COVID test which was also positive. I was feeling body aches, fatigue, fever like (I did not have a thermometer.) I spoke with my doctor again to inform them of my positive results. She prescribed a round of PAXLOVID. I finished that yesterday morning, 5/31. The medication didn't really help my symptoms, but the very last morning, 5/31, I woke up feeling better.
After the first shot I had very mild symptoms, minor injection site soreness; a little tired/fatigue; This is a spontaneous report from a contactable consumer. A male patient of an unknown age received bnt162b2 (BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on an unknown date for COVID-19 vaccination. Medical history and concomitant medications were not reported. The patient stated that he'd gotten the second Pfizer covid vaccine yesterday. Per the patient, "I didn't feel anything more than a mosquito bite sensation when I got the second shot. After the first shot I had very mild symptoms, minor injection site soreness and a little tired. I've had the shingles and flu vaccines and with those I had mild to no symptoms. He got the first vaccine and just had mild symptoms such as injection site soreness and fatigue the following day a little bit. On the second day, he also had this and that was about it. On second shot that he got two days ago, it was pleasant. The injection was like a mosquito bite. He told the nurse that gave it that she was very good. He was at home yesterday expecting to feel something and he has not had any side effects. Outcome of the events was unknown.  Information on batch/lot number was requested. Follow-up attempts are completed. No further information is expected.
headache; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (headache) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     The patient's past medical history included Surgery. Concurrent medical conditions included Blood pressure. Concomitant products included CARVEDILOL and VITAMINS NOS for an unknown indication.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Jan-2021, the patient experienced HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HEADACHE (headache) had not resolved.            Treatment drug Tylenol when going to bed (did not specify the frequency)
Client received his first dose of COVID vaccine and the Flu vaccine today (Pfizer Pediatric COVID vaccine lot: FL0007 exp: 03/16/22 on his left arm and the Flucelvax lot: 308497 exp: 06/30/22 on his right arm). Ancillary approached EMT table asking for water and snack, because client was not feeling well. EMT came over to the client and started doing the assessment. EMT noted upon assessment that client's skin was pale, client appeared weak and client was leaning forward and clutching his head. Client reported that he had a headache with a 4/10 pain scale that happened immediately after the last vaccine was administered. The last vaccine administered was the Flucelvax. EMT escorted client to the gravity chair by the observation area. Client was able to ambulate without any assistance. EMT obtained first set of vitals at 11:04 AM: Blood pressure: 94/76, Pulse Rate: 86, Respiration Rate: 16 and Oxygen Saturation: 98% and gave the client water. Upon sitting  on the gravity chair and drinking water client verbalized, "I feel better." RN and EMT assisted with tending to client. Client's father reported that client has no chronic medical history, he's not taking any medications and only has mild allergies to dust. Father informed EMT that client does get anxious in situations like these. Client completed 30 minutes observation with no other reactions. Second set of vitals was obtained at 11:37 AM: Blood pressure: 94/72, Pulse Rate: 78, Respiration Rate: 16 and Oxygen Saturation 100%. Client's father reported that client does look better. RN educated client's father on ER precautions and when to follow up with the Pediatrician. Client left the facility with his family and ambulated without any assistance at 11:38 AM.
Flulaval vaccine given IM in left deltoid on Friday, 10/21/22.  Pt. emailed this nurse on Monday, 10/24/22 stating that she developed a painful "rash".  Pt instructed to come to  Clinic for assessment.  Pt. presents with several large, red whelps on LLE , 3 on RLE and one on each arm.  Areas raised, red, painful to touch.  Pt. reports that she woke up at about 4:00am on 10/22/22 with severe itching on both legs.  As time progressed, she noted several areas on her legs that were painful and made it difficult to walk.  States that as time progressed, she developed more red, painful areas.  Denies any breathing difficulties or SOB at this time.  Instructed to use hydrocortisone cream and Diphenhydramine.  Encouraged patient to go to her PCP walk-in clinic for assessment and treatment.  Instructed to go to ER if any breathing difficulties occur.  Emailed and spoke with patient on 10/25/22.  Pt. states that the OTC medications have helped some but areas are still painful and red.  Denied any new whelps.  Denies any breathing difficulties. States she already has an appointment with her PCP on 10/28/22 and will have PCP assess and treat as needed.
This spontaneous report as received from a registered nurse refers to an unknown number of patients of unknown age and gender. On 30-JUN-2014, the patients were inadvertently vaccinated with improperly stored doses of RECOMBIVAX HB (lot # not reported). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Information has been received from a pharmacist via her brother who was told by a neurologist that a female patient who received a dose of GARDASIL developed amyotrophic lateral sclerosis (ALS). The patient was seen by a neurologist. The outcome of the event was unknown. Upon international review, amyotrophic lateral sclerosis was considered to be an other important medical event. Additional information has been requested.
pain; pain; bedridden; pain; body aches; Fatigue; fever; This spontaneous case was reported by a consumer and describes the occurrence of EYE PAIN (pain), EAR PAIN (pain), BEDRIDDEN (bedridden), MYALGIA (body aches) and FATIGUE (Fatigue) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced MYALGIA (body aches), FATIGUE (Fatigue) and PYREXIA (fever). On an unknown date, the patient experienced EYE PAIN (pain), EAR PAIN (pain), BEDRIDDEN (bedridden) and HEADACHE (pain). The patient was treated with NAPROXEN (MOTRIN [NAPROXEN]) at an unspecified dose and frequency. At the time of the report, EYE PAIN (pain), EAR PAIN (pain), BEDRIDDEN (bedridden), MYALGIA (body aches), FATIGUE (Fatigue), PYREXIA (fever) and HEADACHE (pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   Reporter did not allow further contact