chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of malaise in a 61-year-old patient who received FLUARIX QUADRIVALENT (batch number UI709AB ?, expiry date 30th June 2017) for prophylaxis. On 9th January 2017, the patient received the 1st dose of FLUARIX QUADRIVALENT (intramuscular) 1 dosage form(s). In January 2017, 7 days after receiving FLUARIX QUADRIVALENT, the patient experienced malaise, leg dragging, paronychia, photosensitivity, rash, fungal foot infection, muscle fatigue and appetite absent. On an unknown date, the outcome of the malaise, leg dragging, photosensitivity, muscle fatigue and appetite absent were recovered/resolved and the outcome of the paronychia, rash and fungal foot infection were unknown. It was unknown if the reporter considered the malaise, leg dragging, paronychia, photosensitivity, rash, fungal foot infection, muscle fatigue and appetite absent to be related to FLUARIX QUADRIVALENT. Additional details were provided as follows: The age at vaccination was not reported. The caller stated that one week after receiving the vaccine she experience malaise, light sensitivity, muscle fatigue, dragging of the right leg and no appetite. The caller stated these symptoms lasted between 2 to 3 weeks. The caller stated sometime during the last year, she developed an infection of cuticles of all 10 nails, a rash on both shins, a rash the size of a fifty cent piece on the left foot and a fungus on three toes on the left foot. The caller stated she has gone to her health care professional and these symptoms were getting better. The patient had denied permission to contact their physician. The caller stated employee at the Hospital Employee health department would be the best person to speak with pertaining to this adverse event. The caller did not had the email address. No additional information was provided.
10 days after injection, I had edema and swelling in my lower left leg and ankle.  4 days later after a 5 mile hike more extensive edema in entire lower left leg and ankle.  At first it was thought the edema was from a case of gout and a 5 day dose of prednisone was prescribed.  Seemed to help for a few day along with leg elevation and ice.  The in June, after no real improvement, and x-ray was made which discovered no gout.  A day later an ultrasound found a blood clot behind my knee.
This spontaneous report was received from a nurse and refers to an unspecified number of unspecified patients of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On unspecified dates, the patients received improperly stored does of GARDASIL lot # K006117 with expiration date 14-JAN-2017 and lot # K0096124 with expiration date 02-FEB-2017 (dose and route of administration were not reported). No adverse effect reported. No product quality complaint (PQC) involved. This is one of two reports from the same source. Additional information has been requested.
Screaming with back pain x 5-10 minutes. Same reaction following last years flu shot. Child recovered without any additional s/s.
The patient reports "feeling a little tickle in the throat and felt like it was closing" approximately 6 minutes after receiving the covid vaccine. Benadryl 25 mg PO given. B/P 180/90; P 96; R 18.  Observed for 30 minutes patient reported feeling better, denies itching able to tolerate liquids. Transported home with a parent. Advised to notify PMD for any further symptoms.
At 3:00 pm the patient's mother noticed the patient had a fever and the child had slowed down. The patient was treated with Tylenol. The patient complained of his head hurting him. The patient's temperature before the Tylenol was 104F. The patient had trouble breathing, his heart was beating hard, a possible seizure, his eye were up in his head, had a loss of consciousness and his temperature was up to 106F. The patient was taken to the hospital. The patient's temperature was 104F for the next 3 days. Two weeks later the patient was diagnosed with strep. The mother states the Dr says it was from Prevnar.
Employee reported reddness, itchy where shot was given. Developed hives; 2 hours after immunization, developed wheezing. She went home, took Benadryl.
Woke up with a mild throat irritation on the left side on 8/13, it resolved quickly. 8/14, woke up with a  minor sore throat, again only on the left side. By 8/15, it was a severe sore throat such that it hurt to swallow, but still only on the left side. 8/16, it had worsened to where there was a sharp pain on the left side of my throat when I swallowed or talked. Saw doctor, negative strep & covid tests. Swollen lymph nodes on left side of neck. 8/17, the throat was so painful, it hurt even when not swallowing or talking. Started antibiotics. By 8/19, still hurts to swallow and talk, but the pain isn?t as sharp or as intense.
Patient fainted approximately 10 seconds after receiving FLUARIX. When she was lifted to chair, she was alert, but immediately started convulsing. The seizure lasted for about 15 seconds. Paramedics took vitals were w/in normal limits. Followed-up next day - asymptomatic. Refused MD referral.
Increase in anger and agitation.  He is unable to tell us what is wrong, but it occurred the day after the vaccine was administered.  Not acting like himself.
Information has been received from a physician assistant concerning a 5 year old male who on 15-AUG-2003 was vaccinated with a 0.5 ml dose of varicella virus vaccine live (Oka/Merck). Additional suspect therapy included measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) given in the other arm. "Ten days after vaccination" on 25-AUG-2003 the patient developed about 20 lesions all over the body. Unspecified medical attention was sought. Subsequently, the patient recovered. No further information was provided. There was no product quality complaint involved. Additional information has been requested. The patient's twin brother had the same experience after vaccination with varicella virus vaccine live (Oka/Merck) and measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) WAES# 0708USA01604.
Thur-Fri 6/6-6/7/19,  HIVES, left hip area.  Sat-Sun 6/8-9/19, back of top of both legs.  Mon-Wed 6/10-12/19, right hip area,                              Wed 6/12/19 inside (elbow bend) left arm.  Thu-Fri  6/13-14/19  inside right (elbow bend) arm.  Fri 6/14/19, left inside wrist.      Sat-Sun 6/15-16/19, left side back of head at hair line.  MONDAY 6/17/19 NONE to report.  Tue 6/18/19 over night, left forearm( stayed all day).  Wed 6/19/19 one starting, above belly button, 2nd top front of right leg, left side chin, backside right butt.  Thursday, Friday (until this point) NONE!!!
Left arm and shoulder pain, lympoadenopathy, and restricted movement. Pain killer, topic pain lotion, and exercise. Lasted close to 1 year with 80-90% recovery in movement.
1/28/21 - 9 pm nasal stuffiness/congestion; 1/29/21 - 2 am low grade fever 100.2; continued symptoms of malaise, weakness and joint soreness; around 12 pm increased lethargy, weakness unable to get up from chair - needed to use wheelchair.  Difficulty breathing - pulse ox 87-90%.  Dipped to 85% twice.  Most symptoms including SOB resolved within 6-7 hours.
gets the flu; Initial information regarding an unsolicited valid non-serious case received from a non healthcare professional (patient's wife ) via Agency through social media on 27-Nov-2020 .   This case was linked to cases 2020SA344447 (for wife)   This case involves male patient of unknown age who gets the flu (influenza) , while the patient received vaccine Influenza vaccine.  The patient's medical history, past medical treatment(s), concomitant therapy, vaccination(s) were not provided.  The patient's family history included patient 's wife experienced sever reaction to vaccinations and flu shot which found out after patch test.  On an unknown date, the patient received suspect Influenza Vaccine produced by unknown manufacturer (lot number and expiry date not reported)at an unknown dose via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, (latency: unknown) after starting the suspect vaccine therapy, it was reported that the patient got one vaccination every year and got the flu (influenza), and it was informed him that it was a different strain.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.  There will be no information available on batch number for this case.
Severe neuropathy pain throughout day after.  Gabapentin was ineffective, so took 800mg ibuprofen twice during the day.   Back to normal the following day.
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On an unspecified date in 2016 the patient was vaccinated with ZOSTAVAX, 1 DF, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 16-AUG-2016, the patient was treated at a medical facility, for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
Redness, warmth and swelling from left deltoid to above (L) elbow. Pt given PNEUMOVAX 23 on 2/25, symptoms started 2/26 evening.
Raised warm, red, itchy, 5cm x 6cm lump at injection site.
Diagnosed them with Shingles; States they cannot sleep; pain, not just on the arm, but also on their shoulder, neck, back and down the arm. The pain isonly getting worse and worse, so much that it makes them jump and make sounds; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PAIN (pain, not just on the arm, but also on their shoulder, neck, back and down the arm. The pain isonly getting worse and worse, so much that it makes them jump and make sounds), HERPES ZOSTER (Diagnosed them with Shingles) and INSOMNIA (States they cannot sleep) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, the patient experienced PAIN (pain, not just on the arm, but also on their shoulder, neck, back and down the arm. The pain isonly getting worse and worse, so much that it makes them jump and make sounds). On an unknown date, the patient experienced HERPES ZOSTER (Diagnosed them with Shingles) and INSOMNIA (States they cannot sleep). The patient was treated with VALACICLOVIR HYDROCHLORIDE (VALTREX) at an unspecified dose and frequency. At the time of the report, PAIN (pain, not just on the arm, but also on their shoulder, neck, back and down the arm. The pain isonly getting worse and worse, so much that it makes them jump and make sounds), HERPES ZOSTER (Diagnosed them with Shingles) and INSOMNIA (States they cannot sleep) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment information provided.
This spontaneous report as received from a pharmacist refers to a 72 year old female patient with no drug allergies. Medical history and concurrent conditions were not reported. On 22-MAY-2014 the patient was vaccinated in the left arm with first dose of ZOSTAVAX (subcutaneous, lot # J012659, expiry date: 01-JAN-2015). Concomitant medications were not reported. On 22-MAY-2014 the patient experienced redness at the ZOSTAVAX injection site. The pharmacist reported that on 22-MAY-2014 the patient also developed a "dull burning or skin sensitivity from the neck to the right shoulder, from above the right wrist into the right hand, from ribs to waist, and from below the right knee to the top of the right foot". It was reported that no treatment was given and no lab diagnostics were performed. The patient sought medical attention and called the pharmacist. It was reported that on an unknown date in 2014 the patient recovered from the injection site redness. At the time of this report the patient did not recovered from dull or skin sensitivity. The relatedness between ZOSTAVAX and injection site redness, dull burning or skin sensitivity was not reported. PQC was not involved. Additional information has been requested.
pt recvd vax; bulging fontanelle; seen in er & released; recovered;
approximately 10 minutes after vaccine was administered, patient started seizing for about 15 seconds and passed out.
At approx. 915 AM child rec'd VZV vaccine - tolerated well - left the clinic and returned shortly after appeared pale c/o N/V, VS 88/41, P-70, 02 Sat 100. After becoming disoriented with his eyes rolling EMS was called. He was transported. VS WNL.
Red big spot on site of injection; Itchiness; Natural soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Red big spot on site of injection), VACCINATION SITE PRURITUS (Itchiness) and MYALGIA (Natural soreness) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included METFORMIN, METOPROLOL SUCCINATE, HYDROCHLOROTHIAZIDE, LOSARTAN and PARACETAMOL (TYLENOL) for an unknown indication.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Red big spot on site of injection), VACCINATION SITE PRURITUS (Itchiness) and MYALGIA (Natural soreness). At the time of the report, VACCINATION SITE ERYTHEMA (Red big spot on site of injection), VACCINATION SITE PRURITUS (Itchiness) and MYALGIA (Natural soreness) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Some discomfort; Mild headache; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (Some discomfort) and HEADACHE (Mild headache) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DISCOMFORT (Some discomfort) and HEADACHE (Mild headache). The patient was treated with TRAMADOL at an unspecified dose and frequency. At the time of the report, DISCOMFORT (Some discomfort) and HEADACHE (Mild headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-094832 (Patient Link).
2/5 cough, wheeze, short of breath on exertion, placed in O2
Right upper arm swollen and warm-tender to touch. MEDROL dose pak ordered per Dr. Encouraged patient to alternate heat and cool compresses to right arm and elevate.
Within about 4 days there was loss of eye contact, loss of speech or words, hand flapping, less interested in play, less social, squealing loud sounds, irritable.
I got the booster vaccine on Wed 05/11/2022, I had typical arm soreness not bad that day, and the next day I still had the soreness but felt a little blah like tired but not horrible, on Sat I woke up with severe pain in my arm at the injection site, and it got worse and worse and then I decided to go to urgent care on Sunday Morning. At the urgent care the Dr. was concerned that it was heart related so she sent me to the ER and they did an EKG and the checked my enzymes and everything was fine, they gave me some medication for the the pain and it helped a little bit but the advised that I go see an orthopedist the next day. I went to see someone on Monday the 16th which was a shoulder specialist, he took an x-ray of my shoulder and he could not see anything wrong, but felt like the way I moved it could be related to my neck so he gave me a steroid, and he wants me to see a spine specialist to get an MRI on Sat, and to see the Spine Specialist on the 25th of this month and I hope to have more info after that. He also wants to see a physical therapist and I saw her yesterday but she would like to wait for the MRI to be done before she dos anything in fear that something else could go wrong. I a experiencing a lot of weakness in my left arm, I cannot raise it and use it like I use to, the steroid is starting to finally work and I am still in pain and weak but not as severe.
Muscle soreness in area of vaccine injection when moving the arm or when touching the area; This is a spontaneous report from a non-contactable consumer, the patient. A 40-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the left arm on 04May2021 at 10:30 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3247) via an unspecified route of administration in the left arm on 13Apr2021 at 10:30 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. On 04May2021 at 12:00, the patient experienced muscle soreness in area of vaccine injection when moving the arm or when touching the area. The event did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event muscle soreness in area of vaccine injection when moving the arm or when touching the area was resolving at the time of this report.  No follow-up attempts are possible. No further information is expected.
pt recvd vax & exp red, raised, hive rash over entire body; pt also devel itchy skin & swollen face & eyes;
nod on the side where he got the injection/ hurt so bad that he taught there were kidney stones and they were going to explode and pain/hurt so bad that he taught there were kidney stones and they were going to explode into one code; pain was plank like kidney stones pain; throwing up black vomit; running a small fever; nod on the side where he got the injection; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PAIN (nod on the side where he got the injection/ hurt so bad that he taught there were kidney stones and they were going to explode and pain/hurt so bad that he taught there were kidney stones and they were going to explode into one code) and FLANK PAIN (pain was plank like kidney stones pain) in a 59-year-old male 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 was provided.  Concomitant products included SIMVASTATIN (ZOCOR), VALSARTAN and METFORMIN for an unknown indication.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced PAIN (nod on the side where he got the injection/ hurt so bad that he taught there were kidney stones and they were going to explode and pain/hurt so bad that he taught there were kidney stones and they were going to explode into one code) (seriousness criterion hospitalization), FLANK PAIN (pain was plank like kidney stones pain) (seriousness criterion hospitalization) and VACCINATION SITE INDURATION (nod on the side where he got the injection). On 16-Mar-2021, the patient experienced PYREXIA (running a small fever). On an unknown date, the patient experienced VOMITING (throwing up black vomit). The patient was hospitalized on 16-Mar-2021 due to FLANK PAIN and PAIN. At the time of the report, PAIN (nod on the side where he got the injection/ hurt so bad that he taught there were kidney stones and they were going to explode and pain/hurt so bad that he taught there were kidney stones and they were going to explode into one code), FLANK PAIN (pain was plank like kidney stones pain), VACCINATION SITE INDURATION (nod on the side where he got the injection), VOMITING (throwing up black vomit) and PYREXIA (running a small fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood glucose: (High) blood glucose was high. In 2021, Blood pressure measurement: (High) spike in blood pressure. In 2021, Norepinephrine increased: (High) spike in his norepinephrine level.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
pt recvd vax & 12 hrs p/vax exp lt thigh rash; pt was seen by MD; tx w/Cortaid;
I started getting nauseous in about 30 minutes. Then, I felt generally sick all over for several days. I got canker sores in my mouth and throat.  By saturday, I also had a low grade fever. I was very tired.