chrisvoncsefalvay/vaers-outcomes huggingface dataset:
redness looks rashy; discomfort in arm; large area of arm was red; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 97-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st June 2022, the patient received the 1st dose of Shingrix. In June 2022, 2 days after receiving Shingrix, the patient experienced injection site erythema and arm discomfort. On 28th June 2022, the patient experienced injection site rash. On an unknown date, the outcome of the injection site erythema, injection site rash and arm discomfort were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site rash and arm discomfort to be related to Shingrix.     Additional Information: GSK Receipt Date: 28-Jun-2022 Reporter's Comments: The patient self-reported this case. The patient stated that approximately 2 days after receiving her 1st shot of Shingrix on right arm, she noticed a large area of her right arm was red. The redness was 6 to 7 inches in diameter and 7 days after vaccination, the redness looked rashy. The patient also stated since receiving Shingrix, less than a week after vaccination, she had discomfort in her arm. The patient provided limited information. The reporter consented to follow up with herself and healthcare professional.
Shaking, generalized spells lasting 2-3 minutes, 1-2 times per day, normal after and between spells ever since 10/19/2001.
7/22/21 Left knee swollen upon waking up  Went to Ortho knee aspirated 2.5 vials of cloudy fluid sent for culture steroids injected oral steroids given 08/27/21 Right hand, knee swollen, shoulder neck painful,  8/0/21 Right knee aspirated 5 vials cloudy fluid, sent off for culture  Steroids injected oral steroids given Went tp GP in afternoon for back spasms, neck and shoulder pain also blood in urine  No UTI microscopic blood present sent for culture, Negative 9/21/2021 GYN, vaginal ultrasound ~ normal  Sent to Urologist for consult 10/8/21 Urologist consult CT Scan abdomen Normal but still microscopic blood in UA  Negative UTI  10/16/21  Loss of mobility due to Left leg weak, tingling  Right knee still swollen again    10/18/21  Right knee swollen Ortho appt too early to aspirate culture came back possible Gout Indomethicin 50mg TID  Not able to walk without Rollator for stability until 10/29/21 !!!!
body aches, joints/shooting pain; body aches, joints/joint, neck and shoulder pain after the first dose; fatigue; dozing on and off cause he's had no sleep; spasms; fever; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date: unknown), via an unspecified route of administration, administered at an unspecified anatomical location on 14Apr2021 08:00 as dose 1, single for COVID-19 immunization. The patient medical history included two surgeries in his spine. Concomitant medications were not reported. On an unspecified date in Apr2021, the patient experienced body aches, joints, fatigue, neck and shoulder pain. Patient states that he dozing on and off cause he's had no sleep because it started getting to him at 02:00-03:00. He had spasms and shooting pain from his fusion, and his bad bones, the patient had got a lot of broken bones (inaudible side effects). Patient later mentioned fever, back of his skull, the fusion in his spine was standard but it's kicking more. Patient was wondering if he can take aspirin or tramadol. The outcome of all events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sore arm Muscle fatigue (legs, arms) Headache Fever Night sweats, inability to sleep
Patient has been weak and having difficulty urinating for the few days.  Was unable to urinate this morning and made an appointment.  On the drive to the appointment, he felt the urge to urinate and urinated in a urinal he had with him.  The urine looked like blood with clots.  Patient admits that he has had some clots in his urine for past week, so he had taken plavix to break up the clots (plavix is not his medication).  Given weakness, difficulty urinating, and gross hematuria, patient was sent to the ER.  ER nurse was called and given report
About 2am the next morning after the vaccine I woke up with severe pain at the injection site.  My whole shoulder across the top of my back hurts.  When the weather changes it hurts even more. I am extremely tired and feel very weak since the vaccine
Painful paresthesia down both legs and weakness. 6/30/2008 MR received from Neurologist for DOS 4/3/2008. Seen with c/o onset of heavy aching pain in lower back area which radiates down the lateral aspect of the legs. Sleep disturbed 2' to pain. Also with one week hx of facial drooping of the R eyelid and R corner of mouth. Recent problems with constipation and dribbling of urine. PE (+) for R sided ptosis, weak eye closure and drooping of R side of lips. Muscle weakness of L hip flexors and extensors. Sensation intact. DTRs absent at knees and ankles and 1+ in the bilateral triceps. Gait high stepping.
Information has been received from a healthcare worker concerning a patient of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 28-APR-2015, the patient was vaccinated with a dose of improperly stored PROQUAD (Merck), lot # K016425, expiration date 26-MAR-2016 (dose and route not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because the physician did not wish to be contacted.
This patient had slight erythema and swelling in his left shoulder and upper arm, for 3 days.
pt recv vax 27JAN96 & 1AUG97 pt exp unusual rash that looked like herpes zoster on both sides or rt arm, but the lesions had not vessiculated;pt also had blisters on palm of hand & 6 scattered plaques of papules;? contact allerg dermatitis;
On 8/17/01, pt's arm was red and swollen. He was put on RX Duricef 500mg 3/4 tsp BID X 7 days.
I had a sore arm, headache and chills on April 9 and 10.  On April 11, I woke up about midnight with chills, headache, sore lymph node in left arm and nausea.  I had vomiting and diarrhea with severe dizziness and felt like I was going to pass out.
Patient had received Pfizer for his first dose. We do not have Pfizer available, so he was given Moderna for his second dose. No adverse events occurred after administration of the Moderna vaccine.
Right arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Right arm soreness) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002C21A and 036C21A) for COVID-19 vaccination.     Concomitant products included WARFARIN, DILTIAZEM, LISINOPRIL and VITAMIN D [VITAMIN D NOS] for an unknown indication.   On 25-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-May-2021, the patient experienced MYALGIA (Right arm soreness). At the time of the report, MYALGIA (Right arm soreness) outcome was unknown.            No treatment medication was reported.    This case was linked to MOD-2021-253962 (Patient Link).
Patient states the day after receiving TDAP she felt dizzy, body aches, trouble breathing, very tired.  She stated "she knows her body and wanted to report this" to make sure she did not get the shot again.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient received BNT162b2 (BNT162B2), on 03May2021 as dose 2, single (Lot number: EW0167) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (ongoing); "Anemic" (ongoing); "glaucoma" (ongoing); "allergy" (ongoing). Concomitant medication(s) included: FLUTICASONE PROPIONATE (GLUCOCORTICOID) nasal taken for hypersensitivity (ongoing); AMLODIPINE [AMLODIPINE BESILATE] taken for blood pressure measurement (ongoing); FEXOFENADINE HCL taken for hypersensitivity (ongoing); FERROUS SULFATE taken for anaemia, start date: 2022 (ongoing). Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: EW0161; anatomical location: left arm), administration date: 15Apr2021, when the patient was 70-year-old, for Covid-19 Immunization. The following information was reported: VACCINATION SITE MASS (non-serious) with onset Nov2022, outcome "not recovered", described as "All of those doses were administered into her left arm. She noticed a knot on her left arm where she had been administered those doses a couple of weeks ago, around beginning of Nov2022". Therapeutic measures were not taken as a result of vaccination site mass.  Additional information: It was reported that there was a knot on her left arm where the patient had been getting Pfizer Covid-19 Vaccines and booster doses. Caller clarified that the patient had received 3 doses of Pfizer Covid-19 Vaccine in total including the first two doses, and then the third dose which was her booster. All of those doses were administered into her left arm. The patient noticed a knot on her left arm where the patient had been administered those doses a couple of weeks ago, around beginning of Nov2022.The patient was going to go get the updated version of the vaccine booster, whatever it is, but then noticed this knot on her left arm so thought the patient should find out if its ok to get another dose with her having the knot on her left arm before doing that. She got all her doses in the left arm because she gets a sinus shot in her right arm for allergies. The patient was taking concomitant medication One-A-Day Vitamin 1 daily as Multivitamin multimineral supplement.
Widespread, intensively severe muscle pain (esp. lower back, shoulders, neck). Large muscle weakness. Headache. Fever ranging from 101.2 F - 102.1 F. Listlessness.
12-5-09 Woke extremely lethargic with a fever of 103.7F. Gave Tylenol. After Tylenol wore off fever returned at 104.7F.  Gave Tylenol, then two hours later Motrin.  Fever stayed down around 101 overnight. Next morning (12-6-09) fever at 102F.  Gave Tylenol.  Brought fever down to 100.7F where it eventually tampered off the next day (12-7-09).  Extreme lethargy during entire fever.
Limited AE/report husband adverse reaction to the Moderna vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Limited AE/report husband adverse reaction to the Moderna vaccine.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Limited AE/report husband adverse reaction to the Moderna vaccine.). At the time of the report, VACCINATION COMPLICATION (Limited AE/report husband adverse reaction to the Moderna vaccine.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment medications were provided.
arm sore, swelling up neck to shoulder, lump swelled w/in 8hr;
Fever, chills, body aches, minor pain at injection site. Acetaminophen 1000 gave temporary relief but symptoms returned after 4 hours.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID 19 INFECTION; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age, sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total administered on 23-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 30-JUL-2021, patient had a positive covid-19 test (suspected covid-19 infection and suspected clinical vaccination failure). The patient also mentioned was sick while reporting.. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected clinical vaccination failure and suspected covid 19 infection was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000189454.; Sender's Comments: V0 20210826210- COVID-19 VACCINE AD26.COV2.S-suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.
Pt given flu shot 10/19/11. Pt pain started 10/21/11. Pt complained of radiating pain from (L) arm up to shoulder which lasted 7 days. Pt was told to take oral analgesic and f/u with PCP.
From midnight  4/8 until 2pm, I had shooting, burning pain from my right mid thigh to my knee that exploded like a firework when it got to my knee. It was in 10 second intervals for 14 hours straight.  I tried Tylenol, didn't help. I could not sleep. I thought it was over, but at 10 pm 4/8 I had the same pain, but it was on my left side and in 30 second intervals. Also at this time I had same burning, shooting pain from mid inner  left arm  that exploded at the armpit into left shoulder.
Local swelling/redness 2 " X 2" right arm. No complains of pain. Apply cold compresses/Motrin/Monitor site.
lowest temperature reached 23.1 F and the total excursion lasted 112 hours with no reported adverse event; Initial information was received  on 03-Jan-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 7 months old male patient who experienced lowest temperature reached 23.1 f and the total excursion lasted 112 hours with no reported adverse event while receiving vaccine diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine [Pentacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine (lot: UJ664AAA, Expiry date: 04-May-2022) via unknown route in unknown administration site (form, strength: unknown) for immunization.  On 30-Dec-2022 the patient experienced lowest temperature reached 23.1 f and the total excursion lasted 112 hours with no reported adverse event (product storage error) (unknown latency) following the administration of diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine.  Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, ipv and HIB VACCINE (Pentacel) was not applicable.  At time of reporting, the outcome was Not Recovered for the event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Information was received from a registered nurse who stated that some improperly stored VARIVAX (lot numbers M032495, expiration date 06-JUL-2018 and M032494, expiration date 06-JUL-20018) were administered to unspecified patients on unspecified dates (dosages and routes of administration not provided).  No adverse effects reported. Temperature > 5° F but < 14°F; time frame: 30 minutes. Previous temperature excursion: > 5°F but < 14°F for 2 hours. Cumulative total with current excursion is 2 hours 30 minutes. Call was reported to be because of a data logger. Additional information is not expected.
This spontaneous report was received from a physician via a company representative and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 20-JUL-2015, the patient was vaccinated with a dose of improperly stored VAQTA (10Pk 50U/1 mL) lot number K008984, expiration date of 21-OCT-2015 (route of administration was not reported), which was stored 3 times with the following lowest temperatures: 34F (1.11 Celsius degrees) for 88 hours, 32 F (0 Celsius degrees) for 152 hours and 33 F (0.55 Celsius degrees) for 40 hours. No highest reported temperatures were reported. The type of storage was refrigerator. No concomitant therapies were reported. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several cases from the same reporter. Additional information has been requested.
There was a soreness in my arm the day after getting the COVID-19 Vaccine and the next day I really noticed that it was a deep pain and soreness that was so tender that I could not even sleep on my right arm. I was back getting my Flu shot about two weeks or so later and I mentioned this to the nurse that was giving me my shot and she said this was something that a lot of people were experiencing. In November or December, I saw my PCP and the pain was still there and I mention this to my PCP, and he said if it does not go away in a few months to let him know but that he has a lot of patients reporting this, but it is going away eventually. It is not hurting all the time but there is some pain that still comes and goes and when I do use that arm a lot the spot will get sore.
On 5/18/04, swelling and redness to right arm, complaints of itching at injection site. Swelling 3.75"x2.5". DTaP and MMR given at site. Keflex given.
Acute swelling of tongue, leading to raw and cracking skin throughout mouth, sloughing of skin. Intense pain and unable to consume solid foods. Secondary symptoms include fatigue associated with headaches (temple area), neck and jaw soreness. The onset of symptoms occurred within 12-15 hours of the shot, but were definitely present upon awakening the next morning. Given that I am in excellent health, was well rested (just off leave), and am not taking any other medication, the Anthrax vaccination is the probable culprit for these reactions.
Patient has had anaphylactic reactions in the past and carries and Epi-pen on her person. About 10-15 minutes post vaccination, patient was able to detect swelling around the eyes, lips and tingling in the throat. She proceed to administer her own epi-pen. A second epi-pen was administered by the patient and pharmacy activated EMS with monitoring.
Client reported feeling weak after vaccine administration. After monitoring x about 30 minutes client transported by ambulance to hospital for further evaluation subsequent to cardiac history.
pt recv vax & devel two hives;pt did not have an adverse exp p/the first or second dose of hep b;
immunocompromised pt got 0.5ml instead of 0.25ml for 4th dose, we don't know if there ere any side effects waiting for pt to call us back , this was error
After vaccinations given, the next day Pt woke with HA, nausea, cramps, 'buzzing in ears", dizziness, and pale.
flare of her ulcerative colitis; got a severe reaction, severe inflammatory response; blood loss; anemia; bone loss; weight loss; 57 years old patient was administered Fluzone High-Dose; 57 years old patient was administered Fluzone High-Dose; Initial information received on 11-Nov-2019 regarding an unsolicited valid serious case received from a nurse.  This case involves a 57 years old female patient who got a severe reaction, severe inflammatory response (inflammation), blood loss (haemorrhage), anemia (anaemia), bone loss (bone loss), weight loss (weight decreased) and flare of her ulcerative colitis (colitis ulcerative), while she received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing colitis ulcerative.  On 11-Oct-2018, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot UJ030AA via unknown route in unknown administration site.  On an unknown date, the patient developed a severe flare of her ulcerative colitis (colitis ulcerative), got a severe reaction, severe inflammatory response (inflammation), blood loss (haemorrhage), anemia (anaemia), bone loss and weight loss (weight decreased) (unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE. These events were assessed as medically significant. The patient was hospitalized for these events (hospitalization duration 3 days).  It was also a case of inappropriate age at vaccine administration and overdose.  Other relevant tests not reported.  Final diagnosis was severe flare of her ulcerative colitis.  Corrective treatment not reported.  The outcome was unknown for all the events.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.; Sender's Comments: This case concerns a 57 years old female patient who experienced colitis ulcerative after vaccination with FLUZONE HIGH DOSE. The time to onset was unknown. However, patient's medical history, medical condition at time of vaccination and lab test ruling out alternate etiologies were not reported. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
I developed headaches, constant after my booster vaccine. It is so bad, and then it comes and goes. It got worse around 02-10-2022. I have seen multiple doctors and I am taking migraine medication Sumatriptan 50mg. MRI of the brain was normal. I also had a sleep study. I also have tinnitus, which is ongoing. It was my ENT doctor who had me do the MRI and sleep study. I continue with the migraine headaches and dealing with the pain. Lot# provided on the card was 330305D or 336365D but could not make out the numbers.