chrisvoncsefalvay/vaers-outcomes huggingface dataset:
allergic reaction; Initial information received on 22-Apr-2019 regarding an unsolicited valid non-serious case received from a physician (pediatric allergist).  This case involves a patient of unknown demographics who experienced allergic reaction, while he/she received vaccines INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] and DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL].  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On an unspecified date of Mar-2018, the patient received a dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (lot number: C5248AA and expiry date: 21-Aug-2019) via unknown route in unknown administration site.   On an unspecified date of Mar-2018, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (expiry date: 30-Jun-2018) lot number not reported via unknown route in unknown administration site.   On an unknown date, following the vaccination the patient experienced non-serious allergic reaction (hypersensitivity).  Other relevant tests not reported.  Final diagnosis was allergic reaction.  It was not reported if the patient received a corrective treatment.  The patient outcome was not reported for allergic reaction.  List of documents held by sender: none.
Information has been received from a physician via a company representative referring to a male patient of unknown age. Information regarding concomitant medication, medical history and drug reactions/allergies were unknown. On an unknown date in 2014 (reported as 2 years ago), the patient was vaccinated with a dose of ZOSTAVAX (lot #, expiration date and dose were unknown; one time injection; subcutaneous). On an unknown date, the patient showed up with a shingles rash around C2 neck area on left side but no complaints of pain. The patient sought medical attention. No treatment was given for the event. It was unknown if lab diagnostics studies were performed. The outcome of the event was reported as recovering. The causality was not reported. Additional information is not expected as the physician doesn't want to be contacted.
1st dose 05Aug2021, 2nd not yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on 5th August 2021).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: 1st dose 05Aug2021, 2nd not yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 19-Apr-2023 A pharmacist called in to ask for information about a patient who did not receive the second dose. The reporter asked if the patient had to restart the vaccine series. The reporter did not provided information about first Shingrix dose (lot number, expiration date). The reporter consented to follow-up. Till the time of reporting, the patient did not receive second dose of Shingrix, which led to incomplete course of vaccination.
after the second shot her side effect was a bit of muscle pain whenever she pulled her arm straight; had a little soreness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 77 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Mar2021 (Lot number: ER8727) at the age of 76 years as dose 2, single. Relevant medical history included: "allergies" (unspecified if ongoing), notes: states she has allergies but this isn't something she has seen before; "yellow fever" (unspecified if ongoing), notes: had no reaction like this.; "cholera" (unspecified if ongoing), notes: had no reaction like this.; "small pox" (unspecified if ongoing), notes: Caller states she had small pox and diphtheria with no problems in her childhood.; "diphtheria" (unspecified if ongoing), notes: Caller states she had small pox and diphtheria with no problems in her childhood.; "measles" (unspecified if ongoing), notes: Caller states she had the measles before all the tests and vaccines. There were no concomitant medications. Vaccination history included: Bnt162b2 (she did not experience any side effects with the first shot , , DOSE 1, SINGLE, Pfizer Covid 19 vaccination dose #1 26Feb2021 in her left arm around 2-3pm. lot EN6202. Caller does not have NDC or expiry to provide.), administration date: 26Feb2021, when the patient was 76 years old, for COVID-19 Immunization, reaction(s): "she did not experience any side effects"; Flu shot, administration date: 1962, for immunization. The following information was reported: MYALGIA (non-serious), outcome "unknown", described as "after the second shot her side effect was a bit of muscle pain whenever she pulled her arm straight"; PAIN (non-serious), outcome "unknown", described as "had a little soreness".  Follow-Up (23Dec2021): Follow-up attempts are completed. No further information is expected.
Rash appeared, taken to doctor on day 3, sample was cultured and found to be Shingles.
Approximately 1-1.5 hours after vaccination when patient arrived home she experienced a nose bleed that lasted about 3 mins.  An hour later she experienced another one lasting a little longer. She has never had nose bleeds.  I told her to call er and see what action they wanted to do.  I told her to monitor for signs and symtoms of clotting for up to 2 weeks.
ED to Hosp-Admission Discharged   9/2/2021 - 9/6/2021 (4 days)  Hospital Hospital Course:  Patient is an 83 y.o. year old female with a past medical history of GERD, anxiety, depression, mixed hyperlipidemia and acquired hypothyroidism, who was admitted with severe acute on chronic hyponatremia.  A problem based hospital course has been listed below;   o Acute on chronic hyponatremia, severe and symptomatic: Her sodium was 111 on admission (sodium of 127 on 8/27/2021).  This is most likely due to severe dehydration related to poor oral intake due to severe malaise, nausea and vomiting.  Urine studies along with low serum uric acid levels are suggestive of SIADH.  She received hypertonic saline due to symptomatic hyponatremia.  Due to overcorrection of sodium, she was also placed on D5 infusion at 100 mL/h as per nephrology recommendations.  Her sodium appropriately improved after that and was 130 at discharge which is close to her baseline.  She was advised to restrict total fluid intake to less than 1800 mL/day and her Wellbutrin was discontinued.  She was clinically and hemodynamically stable at the time of discharge.  She was advised to follow-up with her PCP within 5 days with repeat blood work.     o COVID-19 infection: The patient presented with severe malaise, weakness, cough, abdominal pain, nausea and vomiting.  Chest x-ray revealed no evidence of discrete infiltrate and there was no persistent hypoxia.  She received dexamethasone 6 mg IV every 24 hour for 5 days during hospital stay.  She was discharged on dexamethasone 6 mg daily for 5 more days to complete a course of 10 days of dexamethasone.     o Hypophosphatemia: Her phosphorus was down to 1.1 on 9/4/21 which improved to 2.5 after multiple repletion with IV K-Phos.   o Mixed hyperlipidemia: She is not on statin due to intolerance.   o Acquired hypothyroidism: She is on levothyroxine 50 mcg daily.   o GERD: She is on Protonix 40 mg daily.   o Anxiety/depression: Her mood is relatively stable at this time.  Her Wellbutrin was discontinued due to hyponatremia/SIADH and if needed, she should be placed on alternative antidepression/antianxiety medication as outpatient.
SHe was dizzy immediately after. SHe reported tingle/itch in back of her throat
This spontaneous report as received from a nurse refers to an unspecified number of patients (gender and age unknown). The nurse reported that the patients may have received improperly stored VAQTA (lot number, route and dose were not reported. Over the past three months. No symptoms were reported. No other details were provided. This case is related to case MARRS # 1212USA004564 and case MARRS # 1212USA005493 (same reporter link). Additional information has been requested.
Day of vaccination March 3- 8:00 pm began to have chills, shaking, fever elevated quickly to 103 degrees fahrenheit. Severe headache, nausea continued through the night. Tinnitus, inner ear pressure causing dizziness. Began taking Tylenol every 6 hours starting at 9:00 pm.  March 4- 3:00 am fever began to fluctuate from 100- 102.7 , 9:00 am fever down to 99 but continued to fluctuate through the day from 99-101. Nausea gone, mild headache. Runny nose, slight wet cough. Last Tylenol at 6:00 pm.  11:00 pm - fever broke, sweating, mild headache.  March 5- 3:00 am sweating completed, dizzy, mild headache, sore lymph glands, fever gone.  9:00 am fatigue, minimal dizziness,  runny nose, mild headache, sore left sided lymph glands, no fever. 2:00 pm - continuing to improve but still fatigued.
Moderna COVID-19 Vaccine EUA Very sore arm Upset Stomach the following morning
Case number PHEH2013US015789 is an initial spontaneous report received from a pharmacist on 22 Jul 2013: This report refers to a patient of unknown age and gender. This patient received only Men C, Y, W-135 liquid conjugate component of MENVEO (batch number: unknown), intramuscularly, without being reconstituted with Men A component, on 22 Jul 2013. No adverse reaction was reported following this administration error.
Patient called today (3/13/06) and complained that right arm was sore. He had flu shot on 11/03/05. Said it started several weeks after vaccination.
Arm just being sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 70 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Arm just being sore".  Additional information: It was reported that the patient was fine with her arm just being sore, but nothing bothering her.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient complained of dizziness at 11:13  after receiving first dose. Vital signs were normal. Patient drank 8 oz water at 11:15, then another 8 oz 11:29. At 11:40, patient was asymptomatic, vital signs remained normal.
Mother called our clinic and stated child had a red rash around injection site of Varicella and had a fever.
Within four hours after injection I started to experience extreme vertigo accompanied with dizziness to the point I couldn?t walk or stand without completely blacking out. These were accompanied by complete brain fog and confusion, making it hard to speak. I have continued to get light headed episodes with position changes & standing, black outs almost to the point of passing out, continued vertigo making me nauseous, and weight loss. I have gone to PT for vestibular treatments with little improvement. It has been almost 2 months since vaccination and I still experience black outs, vertigo, and dizziness multiple times a day.
A non-serious spontaneous report of expired FLUMIST given was received from a registered nurse concerning a 49 year-old female, It was discovered 21 days after dosing that the patient was given expired FLUMIST. The reporter indicated the FLUMIST expired at the beginning of the flu season. There was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from error that occurred shortly after the product expired. Additional information received on 09-Apr-2009: product complaint investigation results.
Awoke on day 2 with a complete subconjunctival hemorrhage of right eye.  No white showing at all.  Deep, dark red, almost black in color
Body weak almost 1 hour after the flu shot, there was no strength, pressure in my head, then my throat felt dry and raspy, body weak. Then I started sneezing a lot, and my nose was runny. 6 days later now, and I still feel sick. I felt good before the shot.
red and swollen around the injection site and extending in a large area on her upper arm. Warm to touch
Adverse Side Effects on 4/7/2021 11:10 - 1:10      Numbness and tingling sensations throughout body, random sites of itchiness with no visible rash 1:10 - 8:00pm      Fatigue, arm of injection site extremely sore and tender   Adverse Side Effects on 4/8/2021      Fatigue
Approx 20 min - 40 min after injection felt dizzy and had loud ringing in ears This has NOT stopped since ...I was scared and had vertigo and needed help to walk back to pharmacy (I walked approx 50 feet away after waiting) -- I stayed at pharmacy for 1 hour ....I called my PCP Dr. -- he wanted to go to ER but I didn't want to go because I have medical trauma and did not want to go by ambulance --- The ringing is terrible -- I went to see a allergist ....she recommended I got to ENT --- I went on 03/17/2023 to ENT and provided that information and he feels this is an autoimmune respone to the vaccine and this makes sense to me ....
discomfort in her arm; "had a bit of heat"; redness; it was "festering"; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (discomfort in her arm), SKIN WARM ("had a bit of heat"), ERYTHEMA (redness) and SKIN WEEPING (it was "festering") in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced LIMB DISCOMFORT (discomfort in her arm), SKIN WARM ("had a bit of heat"), ERYTHEMA (redness) and SKIN WEEPING (it was "festering"). At the time of the report, LIMB DISCOMFORT (discomfort in her arm), SKIN WARM ("had a bit of heat"), ERYTHEMA (redness) and SKIN WEEPING (it was "festering") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication was not reported. Treatment medication was not reported. The patient was fine until 07-Mar-2021 when she started experiencing events.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Follow up received on 21-JUL-2021 ,Containing Consumer wanted the forms to be mailed to their mailing address
c/o fell out of bed at home, severe pain. Sent to hosp from dialysis center due to pain, +COVID 5 days prior to admit requiring 4L O2 at home. No fractures on xrays. rt shoulder aspirate done (48 ml serosanguineous fluid removed). Steroid injection given. Remdisivir X 3 days and decadron (stopped)  given. shoulder aspirate confiremed septic arthritis, going to OR.  blood cultures +MRSA. Vanc for 6 weeks following shoulder surgery. MRSA sepsis from femoral dialysis cath.  Cath removed.  Shoulder Debribement completed. pt becoming more confused. moved to ICU due to confusion and tachypnea. On bipap with FiO2 at 40-50%, became unresponsive, Intubated. Unable to give Toci or Bari. MRI - shows multiple embolic CVA. sever
Information has been received from an 17 year old female consumer and her mother without pertinent medical history and with penicillin allergy who on 14-MAY-200 was vaccinated with the first dose of GARDASIL (route and lot # unknown). There was no concomitant medication. The patient experienced a little pain on the injection site that lasted for a week after receiving the first dose of GARDASIL. And when the patient received her second dose of GARDASIL "the last month", in October 2009, she developed the pain on the injection site again and she had the pain since the time she received the second dose. The patient's mother stated that the pain was still there when the patient moved her arm. No lab diagnostic studies performed. The patient did not seek medical attention. At the time of this report the patient had not recovered. Additional information has been requested.
Teeth-chattering chills Complete loss of appetite Alternating slight fevers Headache Injection arm pain:  stiffness, pain when raising arm, pain and swelling in the armpit General feeling of unwellness Muscle aches on left (injection) side of body (above complaints continued all day Saturday 2/5/22 and into Sunday 2/6/22)
84 yo F h/o HTN, AZ, CAD s/p CABG and PCI, COVID +12/12, asym received COVID vaccine on 2/9 with no immediate reaction p/w altered mental status on 2/10.  At 3AM on 2/10, pt was weak and could not stand without support.  Later in AM, found by husband incoherent, feverish and diaphoretic-- > Called EMS, found to be hyponatremia 129 and received 500mL NS.  Suspect post vaccine inflammatory response and patient started on Isolyte and PRN APAP for fever.  She improved overnight with IV hydration and supportive care and was discharged home on 2/11/21.
I went for my colonoscopy on 4/05. As they were prepping me for the procedure, the nurse advised that I had an irregular heart beat. They did an EKG and decided against the colonoscopy. They immediately put me on medication to slow my heart rate down. They kept me over night on the medication for my heart and planned to proceed with the colonoscopy the next day. That next day, I felt a strange sensation and the doctor's ran in and informed me that my heart quit beating for 8 seconds. They consulted another cardiologist who decided that I needed a pace maker. They transferred me by ambulance to (Privacy) where they put in the pace maker and shocked my heart. However, my heart is still beating too fast. They have put me on a blood thinner to attempt to prevent any clots that would cause a stroke. They also prescribed a medication to help with the rapid heart beat. On 4/21 the doctor did another EKG which showed that my heart beat was still elevated, so the doctor would like me to have an ablation on 5/31 which I am still waiting for.
Loss of movement in arm for several days. After 3 weeks I still have pain in my arm.
Information has been received from a physician and a 72 year old female consumer with thyroid disorder, cholesterol, acid reflux and sulfa allergy and a history of chickenpox as a child, who on 07-NOV-2007 was vaccinated with a dose of ZOSTAVAX (Lot #658398/1087U) in her left deltoid. Concomitant therapy included LEXAPRO, "gilzedene" (unspecified) and unspecified therapies for thyroid disorder, cholesterol and acid reflux. The patient did not experience a rash at the injection site or elsewhere within 42 days of the vaccination. The patient reported that on 04-AUG-2008, she experienced pain and on 06-AUG-2008 she developed a rash and went to her physician on 07-AUG-2008. The physician reported in conflict that the patient first developed a rash on 04-AUG-2008. On 07-AUG-2008, the patient was diagnosed with shingles on the right side from her chest to her back, right trunk anterior and posterior from below the breasts to waist from T1-T11. The doctor gave VALTREX and hydrocodone, but the patient did not take hydrocodone. The patient took ibuprofen. As of 18-AUG-2008, the herpes zoster persisted. There was no product quality complaint. Additional information is expected.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. On 06-JAN-2017 at 14:00, the patient was vaccinated with improperly stored VARIVAX injection (lot # M035142) ( expiration date, dose and route of administration were not reported). The vaccine underwent previous temperature excursions. The number of previous excursions, time frames and values of incorrect temperature were unknown. No adverse effects were reported. Digital data logger was used. Product quality complaint was not involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA008441: US-009507513-1704USA000389: US-009507513-1704USA000390: US-009507513-1704USA000391: US-009507513-1704USA000392: US-009507513-1704USA000393: US-009507513-1704USA000394: US-009507513-1704USA000395: US-009507513-1704USA000396: US-009507513-1704USA000397: US-009507513-1704USA000398: US-009507513-1704USA000399: US-009507513-1704USA000400: US-009507513-1704USA000401: US-009507513-1704USA000402: US-009507513-1704USA000403: US-009507513-1704USA000404: US-009507513-1704USA000405: US-009507513-1704USA000406: US-009507513-1704USA000407: US-009507513-1704USA000408: US-009507513-1704USA000409: US-009507513-1704USA000410: US-009507513-1704USA000411: US-009507513-1704USA000412: US-009507513-1704USA000413: US-009507513-1704USA000415: US-009507513-1704USA000416: US-009507513-1704USA000417: US-009507513-1704USA000418: US-009507513-1704USA000419: US-009507513-1704USA000420: US-009507513-1704USA000421: US-009507513-1704USA000422: US-009507513-1704USA000423: US-009507513-1704USA000424: US-009507513-1704USA000425: US-009507513-1704USA000426: US-009507513-1704USA000427: US-009507513-1704USA000428: US-009507513-1704USA000429: US-009507513-1704USA000430: US-009507513-1704USA000431: US-009507513-1704USA000432: US-009507513-1704USA000433: US-009507513-1704USA000434: US-009507513-1704USA000435: US-009507513-1704USA000436: US-009507513-1704USA000437: US-009507513-1704USA000438: US-009507513-1704USA000439: US-009507513-1704USA000440: US-009507513-1704USA000441: US-009507513-1704USA000442: US-009507513-1704USA000443: US-009507513-1704USA000444: US-009507513-1704USA000445: US-009507513-1704USA000446: US-009507513-1704USA000447: US-009507513-1704USA000448: US-009507513-1704USA000449: US-009507513-1704USA000450: US-009507513-1704USA000451: US-009507513-1704USA000452: US-009507513-1704USA000453: US-009507513-1704USA000454: US-009507513-1704USA000455: US-009507513-1704USA000456: US-009507513-1704USA00045
Redness, itching, rash on upper left arm starting 3 to 4 hours after admin. Went to MD 9/20/11 and treated with prednisone and CLARINEX.
Fever of 101.8 degrees the morning after immunization that did not respond to TYLENOL for initial 8 hours and redness, swelling and pain at site of injection fever down after 10 hours and redness also improving.
Pt developed redness and swelling at injection site for over a week. Now 3 months later the site is still painful, but without lump or redness.
I just wanted to report an incident that occurred after receieving  the first dose of the covid vaccine. It was not one of the possible reaction from covid vaccine but rather administrator error in injecting the vaccine.  The symptoms appeared about 3 hours after receiving the vaccine,  now have numbness, tingling, pain and burning sensation on my left pam in the arm of given vaccine.   Obviously, the person giving the vaccine, hit the nerve.
When I got up the morning after the flu shot, I was extremely clammy, sweating, and nauseous.  I vomited several times.  Throughout the day, I remained light headed and periodically clammy, then hot and cold.  I stayed in bed all day, not eating anything until evening.  The next day I was okay.
Slight increase in pulse for approximately 3 hours after the injection.  Duration 45 minutes to an hour.  Eye lids puffy approximately 20 hours after the injection.   Unknown duration.