chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of swelling of elbows in a 83-year-old female patient who received SHINGRIX for prophylaxis. In September 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced swelling of elbows, swelling arm, burning sensation, pruritus and hives. The patient was treated with triamcinolone acetonide, benzalconium chloride, salicylic acid. On an unknown date, the outcome of the swelling of elbows, swelling arm, burning sensation, pruritus and hives were not recovered/not resolved. It was unknown if the reporter considered the swelling of elbows, swelling arm, burning sensation, pruritus and hives to be related to SHINGRIX. Additional details were provided as follows: The reporter reported on behalf of his wife. After receiving SHINGRIX, the patient experienced swelling of elbows, swelling arm, burning sensation, pruritus and hives. The patient went to a dermatologist and was prescribed Triamcinolone but it was not relieving her symptoms. The reporter was going to have her try an Antihistamine next.
Patient scheduled for booster shot, checked in by front desk, who asked if he brought his vaccination card. He said no. I had to clarify with patient if he's getting the 3rd dose and he agreed. Gave him the shot, and while doing it I asked him when the last dose was given. He told me Dec 2021. I notified nursing supervisor and let the MD know. MD consulted patient before he left the site. No sign/symptoms of pain or discomfort during the stay.
It was reported that a 48 year old female received a Fluzone SV '01-'02 vaccination, lot # U0694Aa on 11/06/01 at 1;15 pm. By 3pm, she reported a rapid heart beat, heaviness & tightness in mid-chest and wheezing She is not, nor ever has been asthmatic. This lasted 45 minutes until 3:45 pm. Patient refused any follow-up. She said that the room where it was administered smelled "moldy" and this might have triggered a reaction.
-2/8/2021: received Dose #1 of COVID-19 vaccine (Moderna) -2/10/2021: received pembrolizumab 200mg IV for metastatic sarcoma (has had excellent response over last two years with almost no side effects) -2/13/2021: 5 days after receiving Dose #1 of COVID-19 vaccine (Moderna) - fever, body aches -2/14/2021: COVID PCR test negative -2/15/2021: presented to emergency room with fever (103.4F), body aches, epigastric pain; admitted to hospital for pancreatitis (CT: acute insterstitial edematous pancreatitis with moderate peripancreatic inflammatory change); Lipase, SGOT, SGPT, WBC elevated.  Infectious work up negative (no antibiotics given).  No previous history of pancreatitis.  Discharged from hospital on 2/18/2021. -2/19/2021: presented to oncology immediate care with rash (torso, back, scalp, arms) ? mildly itchy; started on prednisone taper -2/23/2021: returned to oncology immediate care with worsening rash, abdominal pain, vomiting; continue prednisone (80mg PO daily) -2/26/2021: dermatologist consult for generalized pruritic erythematous edematous eruption on face, torso and extremities; rash improving on prednisone, advised to start topical triamcinolone ointment. Elevated SGOT, SGPT. -3/17/2021: received pembrolizumab 200mg IV; pancreatitis and rash resolved. SGOT, SGPT slightly elevated.
Doses administered past the published expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry). On 07-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were reported.
Arrhythmias; Arm is hurting; This spontaneous case was reported by a consumer and describes the occurrence of ARRHYTHMIA (Arrhythmias) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21D) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure high and Acid reflux (oesophageal). Concomitant products included OMEPRAZOLE for Acid reflux (esophageal), METOPROLOL for Blood pressure high.    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 (Arm is hurting). On an unknown date, the patient experienced ARRHYTHMIA (Arrhythmias) (seriousness criteria hospitalization and medically significant). At the time of the report, ARRHYTHMIA (Arrhythmias) outcome was unknown and PAIN IN EXTREMITY (Arm is hurting) had not resolved.        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 treatment medications were provided. The patient has not been infected with COVID-19. The patient doesn´t have a history of Myocarditis/pericarditis.  Company Comment - This case concerns a 44 year old female patient with medical history of blood pressure high, who experienced the serious unexpected event of arrhythmia. The event arrhythmia occurred on an unknown date after the first dose of mRNA-1273 vaccine. Patient's medical history of blood pressure high remains a confounder. The rechallenge was not applicable. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-418012, MOD-2021-418016 (Patient Link).; Sender's Comments: This case concerns a 44 year old female patient with medical history of blood pressure high, who experienced the serious unexpected event of arrhythmia. The event arrhythmia occurred on an unknown date after the first dose of mRNA-1273 vaccine. Patient's medical history of blood pressure high remains a confounder. The rechallenge was not applicable. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.
Pt received her vaccination at 01:05 PM and states almost immediately became dizzy. She requested assistance at 01:10 PM. She reported dizziness and "needing fresh air". She denied difficulty breathing, swelling, pain, nausea, numbness, tingling, or palpitations. She stated her only symptom was dizziness. She did not feel she was going to pass out. She did state "this happens to me with vaccines". She was offered water and began to feel better within 5 minutes. She waited for a full 30 minutes after vaccine and reported that all symptoms had resolved.  Vitals at 01:10 were BP 118/80, Spo2 97, heart rate of 43 (up to 60 at 01:30).
Information has been received on 06-JUN-2018 regarding a case in litigation from a lawyer and a male consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. In 2013, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route by a physician as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. In 2014, the patient was treated by a physician for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient has 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, and pain and suffering, and other damages. Additional information has been requested.
Vomiting, swelling of left hand, nausea. BP 118/81 (pulse 82), O2 sat 100%.
Pt recvd vax & exp nausea, vomiting & sl temp elevation (99.1); was een by MD sx have subsided;
FORGETFULNESS; MILD PRESSURE ON THE RIGHT SIDE OF SKULL; NERVOUSNESS; TINGLING SENSATION ON RIGHT SIDE OF SKULL AT CROWN TO NECK NEAR LYMPH NODES; NUMBNESS ON RIGHT SIDE OF SKULL AT CROWN TO NECK NEAR LYMPH NODES; This spontaneous report received from a patient concerned a 69 year old of unspecified 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, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced forgetfulness, mild pressure on the right side of skull, nervousness, tingling sensation on right side of skull at crown to neck near lymph nodes, and numbness on right side of skull at crown to neck near lymph nodes. Laboratory data (dates unspecified) included: Brain scan NOS (NR: not provided) no problem detected. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from forgetfulness, mild pressure on the right side of skull, and nervousness, and the outcome of numbness on right side of skull at crown to neck near lymph nodes and tingling sensation on right side of skull at crown to neck near lymph nodes was not reported. This report was non-serious.
I have not had my menstrual cycle since getting vaccinated; This is a spontaneous report from a contactable other HCP. A 30-year-old (Adult 18-64 years) non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left, on 23Feb2021 at 22:00 (at the age of 30 years), as single dose for covid-19 immunisation. The patient medical history included known allergies: Gluten from an unknown date and unknown if ongoing. Patient not diagnosed with covid-19 prior to vaccination. Patient was not received any other vaccine prior four weeks of vaccination and patient did not receive any medication prior two weeks of vaccination. Since vaccination patient not tested for covid-19. Patient reported I don't think you would call this an adverse side effect as its much more of an unexpected benefit or bonus. I have not had my mensural cycle since getting vaccinated on 23Feb2021 and I am absolutely thrilled with this. I am 100% not pregnant because that requires liking men. Honestly best thing I could ask for thank you so much If it discovered this is due to a certain compound or something in the shot I will gladly sign up for a clinical study. The outcome of the event was reported as unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
10/07/2022 experienced mild symptoms; fatigue, pain at injection site; headache; sore throat and hoarseness symptoms. I contacted my Physician via telehealth and was prescribed antibiotics.
Fever; Mild headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and HEADACHE (Mild headache) 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 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced PYREXIA (Fever) and HEADACHE (Mild headache). At the time of the report, PYREXIA (Fever) had not resolved and HEADACHE (Mild headache) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Site: Pain at Injection Site-Mild, Systemic: Fever-Mild, Additional Details: patient was concerned about 3 syringes that were in the basket-but they were all caped,none of them ever touched each other,patient never comlained about any adverse reaction,didnt have any bloody gause in the basket at all
pt recv vax & exp systemic rxn w/significant periorbital edema,a large red band around the inj site from the knee up to the pelvis,& streaks on face w/a bruised quality to them;more severe sx lasted 48-72hrs;local rxn or the vax site wk
BODY ACHES; CHILLS; LITTLE MUSCLES ACHE; This spontaneous report received from a patient via a company representative concerned a male 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: Unk) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination. The batch number was not reported. The company was unable to perform follow-up request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the subject experienced chills, body aches, and little muscles ache. Treatment medications (dates unspecified) included: paracetamol, and ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills, little muscles ache and body aches was not reported. This report was non-serious.
pt recv vax & p/vax pt fell into nurse;arms stiff, eyes closed, back arche, full body shakey symetrically lasting 5seconds;open eyes when name called;BP 100/70;c/o h/a;pt belch & nausea;blotchy pink color;
Information has been received from a physician concerning a female patient who on 22-MAR-2007 was vaccinated with a 0.5 mL dose of Zostavax. On 25-MAR-2007 the patient experienced swelling and redness at the injection site. Unspecified medical attention was sought. No diagnostic laboratory tests were performed. A product quality complaint was not involved.  Additional information has been requested.
Son began experiencing flu-like symptoms on evening of 11/18/20.  Complaining of not feeling well, chills, fever. On Friday, 11/19/20 stayed either in bed or lying on sofa most of day.  Ate some dinner, Tylenol for fever.  Began having difficulty "finding" words.  Ex:  At dinner, conversed but would try to say a word, but another word would come out.  Saturday morning, woke up, came downstairs, not feeling well, no appetite.  Tried to call work to tell boss could not come in but has confusion with words, and could not dial the telephone number.  thinking that he may be dehydrated, I went to store for Pedialyte and fruit.  He took Tylenol and went back to bed.  Early in afternoon, while watching a movie with his father, son began violently convulsing and having a seizure.  Paramedics were called and worked hard to stabilize him.  Suspecting a "brain bleed", they contemplated transporting him to Hospital in case of surgery but felt "he would not have made it."  He was taken to Hospital and stabilized and ventilated. Currently in ICU.
Vaccines administered, patient began staring and jerking.  Patient came to quickly, vital signs were taken.  Patients' mom reports history of seizures - not related to vaccines, no medication taken.
Patient given Td vaccination. Before leaving stated she felt fine; walk out with father. Father states she fell to ground outside in parking lot. Patient found by staff on ground moaning and groaning; responsive to smell and touch but unable to stand by herself. Skin warm to touch, pulse weak/steady. Breathing with difficulty. Patient assisted to room, vomited small amount of undigested food matter. Complained of headache; resting on floor with feet up in chair. After about 10 minutes, stated she felt better. After leaving clinic, patient began experiencing headaches. The intensity increased during the afternoon. During the evening of 7/31, she was presented to ER where she was diagnosed as having a concussion due to her fall. She was admitted for 23 hour observation and was dismissed Friday evening 8/1/03. Patient stated she did not recall falling in the clinic parking lot or her time at home that afternoon. She regained her mental orientation while at the hospital. There was no localized reaction or signs at the vaccination injection site. As of today, she stated that except for a bump where she hit her head on the ground, she feels ok.
Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Shakiness-Mild, Systemic: Weakness-Mild, Additional Details: UPON ARRIVAL, PATIENT REPORTED FEAR OF NEEDLES AND ANXIETY REGARDING UPCOMING APPOINTMENT. AFTER VACCINATION, PATIENT SAT IN WAITING AREA FOR OBSERVATION FOR APPROXIMATELY 10-15 MINUTES. UPON EXITING, PATIENT EXPERIENCED A FALL INSIDE THE STORE. PATIENT DENIES HITTING THEIR HEAD DURING THE FALL. PATIENT WAS EVALUATED BY EMS WITH SUBSEQUENT NORMAL VITAL SIGNS. PATIENT REFUSED ADDITIONAL CARE BY EMS. THEY WERE OBSERVED FOR ANOTHER 10-15 MINUTES UNTIL THEIR SISTER ARRIVED TO TRANSPORT THEM HOME.
Pt.  Was a 54 Y/O M, A+OX4  that experienced an adverse reaction after being vaccinated. After vaccination, patient became pale and experienced dizziness at the sight of his own blood. Pt. Has a history of a fear of blood but disclosed this information after being vaccinated. Patient did not lose consciousness nor experience any fall.  Pt. Was placed in supine position with head supported by nurses and given a snack with water. Vaccination clinician was LVN and Medical Oversight clinician was NP . Pt. V/S were HR:62 B/P:115/73 02 Sat:97% at 1327.  Patient was kept in observation area for 30 minutes. Pt. Remained stable and was alert and oriented with no further occurrences. Pt. Verbalized feeling well before leaving clinic. Pt. Was accompanied by his spouse.
Per parent, the night of immunization patient had a fever. The next day patient complained of headache, child was sent to school. About an hour later seen at nurses office with complaint of fatigue. Child laid down about 1 hr - nurse noted patient was gurgling, stiffening body for about 5 min. Pt treated at hospital. Pt has since had another seizure in Dec. Dx's epilepsy by neuro. on KEPPRA.
Approximately 13 hours after my 2nd Covax injection I developed severe pain in right arm injection site, so severe I could not sleep, and then shortly thereafter I developed chills, fever, severe headache associated with nausea, body aches(very sore) and fatigue.  Symptoms started to abate Sunday afternoon, with a residual milder head ache going into today, Monday 3/1/2021.
itchy red rash appeared in right armpit about 2 weeks after the 2nd vaccination; 4 months later it is still there and the rash has spread to the left armpit as well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 13Apr2021 10:00 (Lot number: EL9265) at the age of 50 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient took concomitant medications. Past drug history included: Sorbitol, reaction(s): "Allergy", notes: all artificial sweeteners (aspartame, acesulphame K, sorbitol, sorbitan), mushrooms, cleocin; Cleocin, reaction(s): "Allergy"; Aspartame, reaction(s): "Allergy"; Acesulphame k, reaction(s): "Allergy"; Sorbitan, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Product COVID 19, brand: Pfizer, lot number: EP6955,, lot unknown: False,, administration date: 21Mar2021,, administration time: 04:15 PM, Dose number: 1, vaccine location: Right arm), for Covid-19 immunisation. The following information was reported: RASH ERYTHEMATOUS (non-serious) with onset 27Apr2021, outcome "not recovered", described as "itchy red rash appeared in right armpit about 2 weeks after the 2nd vaccination; 4 months later it is still there and the rash has spread to the left armpit as well". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of rash erythematous. Additional information- It was reported that the patient did not suffer from Covid-19prior vaccination. The patient also under went  for covid tested post vaccination No follow-up attempts are possible. No further information is expected.
Patient received first COVID vaccine (Moderna) on 2/4. On 2/9, patient states he had fevers, chills, headaches, and loss of taste and smell. He was tested through his workplace via Saliva PCR on 2/11, which resulted positive on 2/14. Symptoms began to resolve around the date of 2/21 for about 2 days. On 2/23, he started experiencing numbness in his fingers and toes along with severe nausea, vomiting, and diarrhea. He became so weak and ill, he presented to the hospital and was admitted on 2/26. During his hospitalization, he was seen by neurology, completed several tests including a lumbar puncture, nerve conduction study/EMG who diagnosed him with "likely some variation of AIDP, very possible mixed demyelinating/axonal variant".
Vaccine expired on 13 Oct 2021 and placed in refrigerator on 29 Oct 2021; Doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 13 Oct 2021 and placed in refrigerator on 29 Oct 2021) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expired on 13 Oct 2021 and placed in refrigerator on 29 Oct 2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses were given after expiration date) and PRODUCT STORAGE ERROR (Vaccine expired on 13 Oct 2021 and placed in refrigerator on 29 Oct 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. HCP stated that there was a confusion between the expiration date printed in the carton and the expiration date when the QR code was scanned.Vaccine was placed in refrigerator on 29 Oct 2021. Vials did not undergo temperature excursion. No adverse events were reported. No treatment medications were reported.
As soon as the injection went into my arm, I felt a tingling from the site of the shot to my wrist.  I thought the next day, the pain was from having an injection, and that it would go away.  However, my arm continued to hurt, so much so that I couldn't raise my arm, put a seatbelt on, carry/lift anything.  I went to my primary care doctor, on 11/22/21 and another visit on 12/14/21.  The doctor put me on a week of steroids, with no effect, and then prescribed indomethacin (50 mg) twice daily for a month.  Once the month of medicine was done, the pain came back as strong as before.  I called for a neuro consult, as Doctor thinks the pharmacist hit a nerve.