chrisvoncsefalvay/vaers-outcomes huggingface dataset:
woke up with pain and a bump under her armpit but not on her arm; woke up with pain and a bump under her armpit but not on her arm; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in the left arm, administration date 23Mar2021 (Batch/Lot number: unknown) at the age of 42 years as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: COVID-19 vaccine (dose 1, Batch/Lot number: unknown), for COVID-19 immunisation. The following information was reported: AXILLARY PAIN (non-serious), AXILLARY MASS (non-serious) all with onset 25Mar2021, outcome "unknown" and all described as "woke up with pain and a bump under her armpit but not on her arm".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
The patient received her second dose of the Pfizer COVID vaccine around 8 a.m. on 5/3/21 in one of our outpatient clinics.  She reported no reaction after her first dose of Pfizer vaccine.  Within 20 minutes of receiving the dose, she had some numbness, tingling and uncontrollable jerking movements.  She also had some blueish discoloration of toenails.  Patient was reportedly weak and had to have assistance getting up onto stretcher prior to transport to hospital ER.  Patient also reported "full" feeling in her throat that resolved after being given benadryl IM prior to arrival of EMS.  She denied Shortness of breath.  Patient was transported to ER and was noted to have dystonia.  Patient was given benadryl and cogentin injection for jerking movements.  Dystonia improved some, but patient was admitted to hospital for observation.   After 24 hours, patient reports dystonia is better but is having some cerebellar issues probably due to medications that were given to stop the dystonia.  MRI is to be done and neurology will be consulted.
after recv vax 11 days later pt exp headache, low grade fever, fatigue, sore throat, swollen gland, rash of 8 areas that were crusted over.
Immediate onset of abdominal pain, nausea, vomiting, watery diarrhea, fever to 103.6, rigors, weakness, fatigue, muscle aches, ear aches, sore throat, cough, headache.
Dose 1 -Muscle twitched on injection into R deltoid.  Immediately after injection experienced warm and cold sensations through right arm,  intermittent pains along arm.   Was asked to be observed 30 mins  post injection.  Sent home.   Paresthesias (intermittent warm, cold, tingling sensations) continued with radiation into right axillary, and into neck.  Experienced  intermittent  facial tingling.  On day 3 post injection, started with burning eye discomfort in right eye.   Went to eye doctor to rule out eye infection.   No eye infection,  Instructed to use Refresh drops.   In 4 days subsided.   Day 7 experienced ear flushing and warmth that last 3 days and subsided.    Saw a neurologist to rule out nerve damage.   EMG was normal.   ANA titer was 1:40 with speckled and cytoplasma pattern.   My last ANA was negative when tested for inflammation due to back pain few years prior.     Neurologist  did not think this was an allergic reaction and since symptoms were gradually improving recommended second dose.   Symptoms fully resolved after 2 weeks  Dose 2 - Jan 19 , 2021 (21 days post) -  Decided to inject left deltoid to avoid trauma to right arm.     Was observed 30 mins and released.   No symptoms.     Moderate arm soreness x 4 days.   Day 3 post injection developed burning eye discomfort, intermittent tingling sensation in arm, warm/cold sensations.   Pain radiating to shoulder and neck.   Day 6  started very mild tingling and warm sensations in in cheek and chin area.  Also experienced intermittent prickly sensations in throat and sensation of throat tightness  predominantly on left side. (but no actual swelling).    Today (Jan 26, 2021) is Day 7 and these intermittent sensations are persisting.   Arm soreness has resolved.   Right eye burning discomfort improving.
injection arm soreness; diarrhea; fever on and off; chills on and off; nausea; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE PAIN (injection arm soreness), DIARRHOEA (diarrhea), PYREXIA (fever on and off), CHILLS (chills on and off) and NAUSEA (nausea) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical History was Provided by Reporter.  Concomitant products included WARFARIN SODIUM (COUMADIN) for an unknown indication.    On 09-Apr-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 VACCINATION SITE PAIN (injection arm soreness), DIARRHOEA (diarrhea), PYREXIA (fever on and off), CHILLS (chills on and off) and NAUSEA (nausea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and LOPERAMIDE HYDROCHLORIDE (IMODIUM) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (injection arm soreness), DIARRHOEA (diarrhea), PYREXIA (fever on and off), CHILLS (chills on and off) and NAUSEA (nausea) outcome was unknown.        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.   Concomitant medications were provided are High Blood pressure Medication, Coumadin, Medication for Acid Reflux. Treatment medications were provided are Tylenol and Imodium.
I had nausea, vomiting, diarrhea, fevers, and faint. Also had a pain in my right side my abdomen.
Shaking chills, headache, subjective fever, stuffiness starting 6 hrs after Johnson and Johnson vaccine Noted bumps day after vaccine around a superficial vein along L lateral forehead associated with soreness.   She had some hyperventilation which also subsided Had HA for 2 days. No clear  vision changes, wears contact Had R ear redness briefly but also resolved
This pt received first dose of vax on 04/27/1999. On 06/03, the pt developed an erythemous, papular rash and a low grade fever. The reporting physician was concerned because there was a rubella outbreak in the area. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a 71 year old female patient. The patient's medical history included allergy to latex. On an unspecified date the patient was vaccinated with a dose of ZOSTAVAX VIAL 19400 PFU subcutaneously, lot # and dose unspecified. As the reporter pushed the plunger to give the injection, ZOSTAVAX began to leak out of the syringe onto the patient's skin. Reporter stated that he then tightened the needle and administered the remaining volume. On an unknown date the patient experienced a reddened area "the size of a sardine" surrounding her injection site where she received ZOSTAVAX. The reporter stated that he placed a small bandage over her injection site when she received the dose of ZOSTAVAX. The reporter also stated that when he was initially administering the dose of ZOSTAVAX to the patient, she moved slightly causing the slip-tip hub of the needle to dislodge from the syringe tip. He believed that was the reason that some of the solution from the dose was "lost" during the administration procedure. The outcome of the patient was unknown. PQC filed. Reporter stated that the patient would come into the pharmacy to be examined, and if she developed a rash, he would follow the procedure in the VZVIP. VZVIP faxed to the pharmacist. Additional information has been requested.
Patient developed cerebral venous sinus thrombosis (superior sagittal vein) and a large right occipito-parietal intracerebral hemorrhage.  He developed epilepsy ~ a month prior to his presentation and there was a possible meningioma seen on a prior MRI - he was started on levetiracetam and had a follow-up appt  but had his hemorrhage first.  The patient had a seizure upon arrival and was intubated.  Ultimately, we have pursued palliative care this afternoon.
pt recvd vax;2 hrs after vax, excessive crying, vacant stare, drooling at mouth, hand tremor;to er, 2hrs observ;no rxn; advised ped DT in future
C/o dizziness and weakness approx 45 mins after receiving vaccine. Lasted 4 1/2 hours. Seen at ER given Benadryl. No co/ rash, SOB. Injection site sore no redness.
Nicolau syndrome; This literature-non-study case was reported in a literature article and describes the occurrence of EMBOLIA CUTIS MEDICAMENTOSA (Nicolau syndrome) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   LITERATURE REFERENCE: Nicolau syndrome after glatiramer acetate injection in close proximity to administration of SARS-CoV-2 mRNA vaccine. Neurol Neuroimmunol Neuroinflamm    Concomitant products included GLATIRAMER ACETATE for an unknown indication.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EMBOLIA CUTIS MEDICAMENTOSA (Nicolau syndrome) (seriousness criterion medically significant). At the time of the report, EMBOLIA CUTIS MEDICAMENTOSA (Nicolau syndrome) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered EMBOLIA CUTIS MEDICAMENTOSA (Nicolau syndrome) to be possibly related.    Nicolau Syndrome After Glatiramer Acetate Injection in Close Proximity to Administration of SARS-CoV-2 mRNA Vaccine  Company Comment: This literature case report concerns a 59 year-old female whose medical history is not available, who experienced the unexpected serious event of Embolia cutis medicamentosa (reported as the LLT: Nicolau syndrome). The event occurred after the second dose of an mRNA vaccine administration whose brand is not provided. Conservatively the case is considered valid. The administration of Glatiramer Acetate Injection in close proximity to mRNA vaccine is a confounder/co-suspect for the event.  The benefit-risk relationship of mRNA1273 vaccine is not affected by this report   Reporter did not allow further contact; Sender's Comments: This literature case report concerns a 59 year-old female whose medical history is not available, who experienced the unexpected serious event of Embolia cutis medicamentosa (reported as the LLT: Nicolau syndrome). The event occurred after the second dose of an mRNA vaccine administration whose brand is not provided. Conservatively the case is considered valid. The administration of Glatiramer Acetate Injection in close proximity to mRNA vaccine is a confounder/co-suspect for the event.  The benefit-risk relationship of mRNA1273 vaccine is not affected by this report
50% hearing loss from having shot; This case was reported by a consumer via interactive digital media and described the occurrence of partial hearing loss in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced partial hearing loss. On an unknown date, the outcome of the partial hearing loss was unknown.   The reporter considered the partial hearing loss to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient got the shingle shot and 50% hearing loss from having shot.
Patient felt woozy(dizzy) within minutes after vaccine administration. patient sat down in chair and was given water and an icee and placed an ice pack on neck for observation. She was observed for 30 minutes and had no further complications
This spontaneous report received from a parent concerned a 28 year old female of an unspecified race and ethnic origin. 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, and batch number were not reported, expiry: unknown) dose was not reported,1 total administered on 06-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 07-MAR-2021, following day after vaccination the patient experienced fever and vomiting and couple of months after vaccination she experienced COVID-19 infection. The patient never felt better starting from the month of AUG-2021 to DEC-2021 which was coded as suspected Covid-19 infection and in the late DEC-2021, patient was hospitalized (date unspecified) for pneumonia and after 15 minutes of breathing treatment, patient could not see and the CT (computed tomography) scan was performed which was normal and following day MRI (Magnetic resonance imaging) showed a blood clog in her brain, and doctors told that she had a stroke. The patient can talk but had memory loss and peripheral vision issue. On an unspecified date, the patient experienced suspected clinical vaccination failure. The number of days of hospitalization was not reported and it was unsure if the patient discharged from the hospital. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the memory loss, stroke, suspected Covid-19 infection, suspected clinical vaccination failure, pneumonia, fever and vomiting was not reported. This report was serious (Hospitalization Caused / Prolonged, and Other Medically Important Condition). This case, from the same reporter is linked to 20220322057. Sender's Comments: 20220322480- Covid-19 vaccine ad26.cov2.s -PNEUMONIA, STROKE, SUSPECTED CLINICAL VACCINATION FAILURE. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Flu shot 10/25/17. Had significant local reaction (L) shoulder start next day. Erythema, edema, soreness and red papules. Asked me about it at doc visit 11/1/17. Resolved on its own by 11/2/17.
Site: Pain at Injection Site-Medium, Additional Details: Patient said arm is very painful when moves & feels pain on back of shoulder/neck when moves his arm. no redness, bruising, or swelling observed. He said pain started later that evening
10/13/2009 - Febrile Seizure after vaccination 03/17/2010 - Febrile Seizure after vaccination 04/25/2011 - Febrile Seizure after vaccination 02/28/2012 - Febrile Seizure after vaccination  ** High fever, stiffness during seizure, vomit *** During the previous incidents, we took our daughter to the emergency room. This latest one 02/28/2012, we did not.
Flu like symptoms for 4 days, 102 fever, chills, body aches, sore throat unable to swallow. Diagnosed with strep throat in the medical aid unit on 10/3. Symptoms started within hours of taking flu shot. Influenza Quadrivalent Lot: FCVMDV252228.
5OCT96 pt exp a rash w/a fever of 101-103 x 2 days;9OCT96 pt collapsed on the floor while walking or tripped & fell & began to cry;pt was not observed when fell;pt would not put weight on lt leg;diff walking;MD unsure if weakness or injury;
I was vaccinated on April 22, 2021 with the First Dose and on April 27, 2021 I tested positive for Covid in Antigen Test and confirmed with PCR test on April 29, 2021.
fever spike of 100.5F; general malaise.; sore arm; patient received booster dose on 08Aug2021.; patient received booster dose on 08Aug2021.; This is a spontaneous report received from a non-contactable consumer(patient)via company representative. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE - solution for injection; lot number- FC3180, expiry date not reported) via an unspecified route of administration, on 08Aug2021, at dose 3, single for covid-19 immunisation. The patient's medical history include HIV positive.The patient concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE - solution for injection; lot number EL0142, expiry date not reported) via an unspecified route of administration, on 12Jan2021, dose 1, single for covid-19 immunisation and experienced arm pain the next day followed by fatigue and malaise  for 5 days. Patient also reported periodic severe headaches lasting several hours during this time then BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE - solution for injection; lot number EL3247, expiry date not reported) via an unspecified route of administration, on 02Feb2021, dose 2, single for covid-19 immunisation and experienced no reaction. The patient experienced a sore arm on next day followed by five days of general malaise on 09Aug2021. On day 2 10Aug2021 post vaccination patient experienced a fever spike of 100.5f which lasted about six hours per report.. The outcome of the events was unknown at the time of report  No follow-up attempts are possible. No further information is expected
Wheezing started within 10-15 min after MMR and VARIVAX injection. Slight puffy lips and stable visual signs. POS decreased 95% - CTA afterwards 99 % within 30 minutes.
A couple of days of having the 4th dose vaccine I had an enlargement of my scrotum and  went to the doctor.  This happened after the 3rd dose on Nov 8; on Nov 11th I had to see the doctor due to the scrotum swelling (2 1/2 inches). The Dr said it would go away  that it happens sometimes with the vaccination. I lived with it because it wasn't too large (7.5 inches). But in the month of May I had to go to the Dr. On May 12th the Doctor had to do a procedure to drain it.   Then on June 9th I had the 4th dose vaccine and then June 11th the swelling of my scrotum occurred again (3.5 inches on left side). Now I'm having to wait until it becomes unbearable and then will go for another surgery to drain it.
On 10/29/2021 I started having pain, swelling, tenderness, and swollen lymph nodes. I went to urgent care on 11/03/2021. They did an examination but no medical tests. It was cellulitis on my scalp secondary to psoriasis. I received Doxycycline, which was started on 11/03/2021. It is mostly cleared up.
This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 50-year-old male patient who received SHINGRIX. Previously administered products included SHINGRIX with an associated reaction of pain in extremity (On 23rd January 2018, the patient received 1st dose and experienced flu like symptoms (refer case US2018075854)). On 20th April 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). In April 2018, less than a month after receiving SHINGRIX, the patient experienced pain in arm and influenza-like symptoms. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the pain in arm and influenza-like symptoms were unknown. It was unknown if the reporter considered the pain in arm and influenza-like symptoms to be related to SHINGRIX. Additional details were reported as follows: The patient received 2nd dose and experienced arm pain and flu like symptom.
Unspecified abdominal pain on 2023-05-15, Other complications following immunization, not elsewhere classified, initial encounter on 2023-05-16.
Severe joint pain, multiple parts of my body. Hx of joint pain. Recent flare up required prescription treatment by dr.
I got high dose flu vaccine and at the same time I got a Covid (Covid-19 Vaccine); I couldn't stand; I couldn't walk; I couldn't get off the floor and I didn't know if I could; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (FLU VACCINE VII) (Batch/Lot number: unknown) as dose number unknown, single. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose no: 1), for COVID-19 immunization; Bnt162b2 (Dose no: 2), for COVID-19 immunization. The following information was reported: DRUG INTERACTION (non-serious), outcome unknown, described as I got high dose flu vaccine and at the same time I got a Covid (Covid-19 Vaccine); DYSSTASIA (non-serious), outcome unknown, described as I couldn't stand; GAIT DISTURBANCE (non-serious), outcome unknown, described as I couldn't walk; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome unknown, described as I couldn't get off the floor and I didn't know if I could. The events i got high dose flu vaccine and at the same time i got a covid (covid-19 vaccine), i couldn't stand, i couldn't walk and i couldn't get off the floor and i didn't know if i could were evaluated at the emergency room visit. Therapeutic measures were taken as a result of dysstasia, gait disturbance, loss of personal independence in daily activities.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-up (29Nov2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Pt right, upper to inner arm 5-6 inch redness. Below the deltoid. Swollen, hot to touch, fever. Taking ibuprofen and Tylenol. Took Benadryl.
Chills; Fever (99.8); Aches that night; Rash and some hives on my right chest area; Rash and some hives on my right chest area; Two dime size red blotches on my back, right side again; This is a spontaneous report from a contactable consumer (patient).  A 61-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA, solution for injection, Batch/Lot Number: EN6198) (at the age of 61-years), via an unspecified route of administration, administered in arm left on 11Mar2021 01:15 PM as dose 2, single for covid-19 immunization. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (at the age of 61-years-old), dose 1, on 18Feb2021 01.15 PM for covid-19 immunization. Patient had no known allergies. The patient relevant medical history includes multiple sclerosis. The patient concomitant medications includes glatiramer acetate (Daily injections (20mg/ml)). The patient was not pregnant at the vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that the patient got the 2nd vaccine on Thursday and felt fine until Saturday night. The patient had chills, fever (99.8), aches that night and on Sunday, the patient developed a rash and some hives on her right chest area, directly under the right breast. The patient also had two dime size red blotches on her back and right side again. The patient had no problems with breathing. The patient did not received any treatment for adverse event. Prior to vaccination, patient did not diagnosed with covid-19. Since the vaccination, the patient did not tested for covid-19. On 14Mar2021, the patient went to lab test which includes: body temperature 99.8 (unit not reported). The outcome of the events was recovering.  No follow-up attempts are needed. No further information is expected.
Information has been rec'd from RN concerning a pt who on 4/25/97 was vaccinated sc in the arm with a 1st dose of varicella virus vaccine live (lot#620615/1340D). There were no illnesses at the time of vaccination. In May 2000 the pt experienced full blown chickenpox with greater than 100 lesions. The pt was seen in the physician's office. His 2 siblings had a similar experience following vaccination with varicella virus vaccine lie (WAES 00051888 and 00061175). Additional information has been requested.