chrisvoncsefalvay/vaers-outcomes huggingface dataset:
the patient has been administered dose of vaccine which was improperly stored.; This spontaneous report has been received from a vaccine coordinator who was also a medical assistant concerning a patient of unknown age and gender. The patient's medical history, drug allergies, concurrent conditions and concomitant therapies were not reported.  On 29-MAY-2019, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) with lot number R002510 and expiration date on 25-JAN-2020 (dose, dose number, route of administration and anatomical location were not provided), for prophylaxis.   It was reported that on 19-MAY-2019, 20-MAY-2019 and in 2020 (conflicting information), the vaccine was exposed to a temperature above 9 degrees Celsius: 16.4 degrees Celsius for 5 hours and 30 minutes, and below 2 degrees Celsius: 0 degrees Celsius for 9.8 hours. There was no previous temperature excursion. The call was placed because of a Digital Data logger report.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA004562:
Patient has muscle pain in the arm several weeks after the fact, I advised her that this was not ordinary. Pt claims the muscle hurts when pressed.
Patient received her 2nd dose of Pfizer Covid-19 vaccine Lot #EN6199 in her left deltoid on 3/9/2021 around 4:07pm at Public Health Vaccination Clinic. While waiting in parking lot near ambulance, patient alerted medics for assistance. Patient was experiencing a rash that began near her right shoulder. Medics gave 25mg Benadryl. Rash worsened and spread across chest and to left shoulder. Medics then gave 0.3ml Epinephrine IM to patient, and rash resolved. Patient refused transport to a local hospital.
+SARS-Cov-2 PCR 1/5 Symptom onset: 1/7  Presented with: Dyspnea, dry cough, myalgias/arthralgias Identifiable exposures: Niece's mother in law Initial labs notable for: D-dimer 0.81, LDH 870, WBC 12.5 (L15.5% low), Hgb 10.4 CXR with left sided infiltrate Flu A/B and RSV negative -Admitted to facility: contact/airborne precautions -Supplementary Oxygen NCO2 previously, now off -Dexamethasone 6mg daily but given improvement and hypoxia likely d/t pulmonary edema in addition to hyperglycemia -- >d/c dex  -Encourage incentive spirometer use and prone positioning  -APAP PRN for pain/fever/Albuterol PRN for wheezing/Benzonatate PRN for cough
Lymphadenopathy and axillary pain at side of Moderna/covid vaccine, no fever, no chills. Dose #1
Patient developed PEA arrest from massive PE 6/19/21. Patient died 6/21/21
Swollen and painful gum lines. full facial angioedema, nausea, vomiting.
While getting ready for release from observation, Associate became pale, lost consciousness for < 10 seconds & vomited.  No injuries sustained related to episode (Associate broke right ankle/foot previous weekend).  She was immediately placed in reclining position with feet elevated.  She was kept for an additional 30 minutes, given crackers & oral fluids.  Fully recovered & sent home.
Tingling in right arm that extends to fingers.  Aches in joints on right hand & in right elbow.  Pain at injection site 3 weeks after vaccine. Tingling in legs has also developed predominantly at night...crawling feeling in legs RLS
No other AE; patient received VARlVAX after the product was improperly stored; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 19-JAN-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) 1 dosage form, lot number t010309, expiration date 24-MAR-2022 (route of administration not provided) for prophylaxis. The patient did not experience any other adverse event.  The vaccine underwent a temeprature excursion of -12.8 degrees Celsius (°C) for 9 hours and 6 minutes, with no previous temperature excursions. The call was due to digital data logger.
This spontaneous report was received from a physician via a company representative, referring to a 4 week old male patient. No information about the patient's medical history, concomitant medications or medical history was provided. On an unknown date, the patient was vaccinated with a dose of ROTATEQ for prophylaxis (drug administered to patient of inappropriate age). No adverse effects were reported and no product quality complaint (PQC) was involved.
Suspected vaccination failure; Continues to have shingles breakouts; This case was reported by a other health professional via call center representative and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated they had a patient who had both Shingrix vaccines and continued to have shingles break outs. The reporter further stated he/she did understand it was not 100 percent effective but at some time and wanted to know if there was a recommended 3rd Shingrix dosage. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The reporter consented to follow up.
On 10/11/21, the patient and her mother came in for a flushot. Documentation shows that this patient received Flublok which is only approved for patients 18 and older. There was no adverse effects, side effects, or illness from this.
Chills on the same day starting approximately 9 hours after vaccine injection.  Little to no sleep that same night.  Very restless, tossing and turning, not tired - very awake (which is unusual).  Next morning, arose at 5am with moderate chills, moderate all over body aches, and moderate headache - very symptomatic of the regular flu.   Felt bad enough to call out of work.  As of this moment, roughly 33 hours later, it seems to be subsiding, but unsure if that's just the Advil. * Note:  Vaccine is "Janssen COVID-19 Vaccine EUA Lot # 1805031 administered.
4/29/08 - Morning following vaccine, red and swollen at injection site. Decreased swelling with ice. 5/6/08 - Rt lateral upper arm with erythema, blanching, below initial injection site with "knot" at presumed site. Not tender. No warmth. Vertical rectangle 3-4in x 2 in.
main adverse reaction is tinnitis with no relief to date; will consider this permanent damage.    Temporary reactions were 5-7 days intermittent fever, fatigue, headache, muscle aches.
2 1/2wk later-stiff neck then arms, hips, feet, achy joints;peaked after 1 1/2wk;still has achy hips w/inc activity;
Metallic taste in mouth rear part of tongue, loss of taste. Sore tonsils
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient was vaccinated with dose 3 of ROTATEQ (lot number 1807AA; expiry date 29-AUG-2013) on 01-OCT-2012. Dose and route of administration were not reported. The vaccine had been improperly stored (not further specified). No adverse event was reported. The nurse reported 4 other patients who received incorrectly stored ROTATEQ (case IDs 1210USA006259, 1210USA006260, 1210USA006261, and 1210USA006262) and 1 patient who received incorrectly stored MMR II (case ID 1210USA006263), all on the same day. Additional information has been requested.
Site: Redness at Injection Site-Medium, Additional Details: slight redness of arm. pt advised to see a doctor if symptoms progress
TERRIBLE PAIN IN LEFT ARM FIRST DIAGNOSED AS CERVICAL DISC, LEFT HAND NUMBNESS WITH M.  Nurse follow up on 11/01/04 states: "There is no new information."
Fever; Chills; Muscle aches; Strong headache; Photosensitivity; This is a spontaneous report from a non-contactable consumer, the patient. A 34-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ep7533) via an unspecified route of administration on an unknown date in 2021 (at the age of 34-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. On 25Mar2021, the patient experienced fever, chills, muscle aches, strong headache for duration of 24 hours and photosensitivity for the duration of 6 hours. The patient did not receive any treatment for the events. The clinical outcome of the events fever, chills and muscle aches were recovered on an unknown date in 2021 while the events strong headache and photosensitivity were recovered on an unknown date in Mar2021.  No follow-up attempts are needed. No further information is expected.
patient reported 20 minutes of visual hallucinations about 15-17 hours after 2nd dose of COVID-19 vaccine and passed out for possibly 5 minutes.  during fall she injured right low leg, but no evidence of DVT on exam today (6 days after fall).
Dizziness upon waking the next morning.; Muscle tension on left side of neck and jaw; Mild headache; This is a spontaneous report from a contactable healthcare professional. A 25-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6208) via an unspecified route of administration in the arm left on 13Mar2021 at 15:00 (at the age of 25-year-old) as a single dose for COVID-19 immunisation. The patient had no relevant medical history. The patient had no known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient has received any medication within two weeks of vaccination. On 13Mar2021 at 15:30, the patient experienced muscle tension on left side of neck and jaw and mild headache beginning 30 minutes after dose. On 14Mar2021, the patient experienced dizziness upon waking the next morning. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events muscle tension on left side of neck and jaw, mild headache and dizziness was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Information has been received from a RN and follow up information from a nurse practitioner concerning an approx 50 yr old female pt who in 2004 (exact date not specified) was vaccinated with a dose of pneumococcal 23v polysaccharide vaccine (lot647797/0987N). Within 24 hrs of receiving the vaccination, the pt experienced injection site reaction with 4cm raised hot area on arm. The pt also developed temp of 103 F, malaise, poor appetite and the pt felt ill. Follow up information noted the pt also developed diarrhea. Unspecified medical attention was sought. The pt was treated with diphenhydramine hydrochloride (Benadryl). The nurse practitioner reported it took approx 1 week for the events to recover. The nurse practitioner felt that the events were related to the pneumococcal 23v polysaccharide vaccine. The nurse also reported a pt (age and gender not reported) experienced similar symptoms with raised hot area at site with fever (WAES0409USA01096) and a male pt who experienced similar symptoms (WAES0409USA01642). Additional information has been requested.
Have pain in right arm from injection; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA6780) via an unspecified route of administration in the right arm on 20Jul2021 at 16:00 (at the age of 60-years-old) as a single dose for COVID-19 immunisation. The patients' medical history included type 2 diabetes and depression. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had no known allergies to medications, food or other products. The patient received unspecified medications within two weeks of the COVID-19 vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 21Jul2021 at 02:30, the patient experienced pain in right arm from injection and reported that he had no side effects. The adverse event did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. Therapeutic measures were not taken as the result of the event. Since the vaccination, patient had not been tested for COVID-19.  The clinical outcome of the event pain in arm was resolved on 21Jul2021.
Monovalent COVID 19 Booster Vaccine was administered incorrectly, since the FDA removed the authorization to use it as a booster.
Marked swelling under the arms, around the jaw and neck, and breast tissue tenderness, increasing in severity during menstrual cycle, but present pretty much constantly. Have also noticed an increase in cholesterol and blood pressure per scans and tests at doctor's office, though no changes in vegan diet have been made. Increased water intake and use of OTC ibuprofen.  Saw, PA-C in May of 2021 and Jan of 2022 but was told that it was not anything to worry about. Saw current primary care doctor, who referred me to Dr., an ENT who expressed concern and has ordered a CT scan.
11/24/2022 I had typical cold symptoms. A runny nose, a cough and sinus drainage. I had no fever. It ran its course, became a little worse. I had a telehealth visit a few days later and was given prescriptions for cough, does not know name, and a nasal spray. After a couple of weeks, I recovered.
Systemic: Headache-Mild, Additional Details: Patient reports slight headache post vaccination, also indicated that he had not eatan all day. Provided patient with 7Up, patinet reported that he headache went away, and was due to not eating in the morning. Follow up call to the patient at the end of my shift, patient reported no headache and flet back to normal.
Patient presented with swollen upper-right arm lymph node, recommendation included applying ice in the affected area and Tylenol 325 mg  every 4-6 hours if discomfort persist or continues. counsel to monitor for improvement for the next 10 days and if worsen an assessment for a primary care provider might be needed.
At about 9PM the evening I received the vaccine I started getting extreme all over body joint pain and muscle pain to the point that Tylenol did not help, I had to take a Norco. The pain returned four hours after the Norco wore off and I had to take a second Norco. I do not have chronic pain or any problems with pain.
RPh administered vaccine into left deltoid at 11:45am patient stated arm hurt and felt tingling in left arm/hand.  Patient felt too lightheaded to move so remained seated until about 12noon was able to move patient to waiting/observation area with Dad.  RPh continued to check in on patient.  12:20pm patient stated felt tired and still was having tingling in arm and soreness.  12:40pm patient presented back at Pharmacy counter stating she was having "tightness in the throat" and "getting worse". EMS contacted, then 12:45pm RPh administered EPiPen into left leg and patient taken to hospital for further evaluation/cardiac monitoring.
This is a spontaneous report from a contactable physician from a Pfizer-sponsored program. A 68-year-old male patient of an unspecified ethnicity received clindamycin HCL (manufacturer unknown), PREVNAR 13 at single dose for immunization, Bupivacaine HCL (manufacturer unknown), azithromycin (manufacturer unknown), ciprofloxacin (manufacturer unknown), chlorthalidone, trimethoprim, torsemide, moxifloxacin HCL, enoxaparin, metolazone and sulfamethoxazole all via an unspecified route of administration from an unspecified date at unknown dose for an unspecified indication. The patient's medical history and concomitant medications were not reported. The patient experienced allergy on an unspecified date with outcome of unknown. Pfizer is a marketing authorization holder of Clindamycin HCL, Bupivacaine HCL, Azithromycin, Ciprofloxacin in the reporter's country. This may be a duplicate report if another marketing authorization holder of Clindamycin HCL, Bupivacaine HCL, Azithromycin, Ciprofloxacin has submitted the same report to the regulatory authorities. Follow-up attempts are completed. No further information is expected. Follow-up (18Feb2019): additional information received from the same contactable Physician includes new suspect drugs added.
This spontaneous report was received from a nurse regarding an unspecified patient of unknown demographics. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 05-FEB-2018, the patient was vaccinated with expired ZOSTAVAX lot# N014942 with expiry date of 02-FEB-2018 for prophylaxis (dose and route of administration was not reported). The nurse reported that the ZOSTAVAX did not have any temperature excursion prior to administration. No adverse event was reported. No product quality complaint (PQC) was involved.
Mom reports (with 12/7/05 visit) that with 11/9/05 dose of Dtap in the evening patient's left arm swelled from shoulder to elbow, hot to touch.  Mom did take temp swelling lasted 4 days started to decrease by 2nd day once swelling down arm bruised.  warm compresses and Tylenol helpful.
No side effects after the first dose. However with this second dose booster shot about four days after receiving it, sudden and substantial hearing loss occured. In addition to hearing loss it feels as though the ears are fful of liquid and need to pop but nothing helps,
Fever of 103.5 f/39.7 c Extreme muscle pain nausea dizziness (almost fell) headache weakness
UTI symptoms began within 2 weeks of receiving 2nd dose. Went to a walk in clinic and received 5 days of Macrobid for positive urine culture, 3 days after finishing that course, went back to walk in with a raging UTI and severe pain. Then was given 5 days of Bactrim. After that course of antibiotics finished, the provider called and said my UTI was resistant to Bactrim and put me on 7 days of Macrobid. UTI symptoms continued for 3 weeks.
within the five minutes i felt it in my nerves and i got pinched nerves in both arms it did go away after 10 minutes and next day i had diarrhea and upset stomach
Pfizer vaccine was administered outside of clinic- reported by patient- ? NO LOT NUMBER WERE SUPPLIED -------------------------------------------------------------------------------------------------------------------------------  ACUTE NON ST ELEVATION MI 4/4/2023 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED
Fever, vomiting, diarrhea, dizziness, headache. Onset several hours after administration of vaccine. Symptoms gradually resolving one subsequent few days.
c/o numbness at site of injection. Numbness from left deltoid distally to left hand. No other symptoms noted. Monitored for 30 minutes.
Morning after the 2nd dose of vaccine I developed chills, body aches, malaise/fatigue. It lasted approximately 5-6 hours and then started to improve.
At 4m visit ROTARIX was given. 2m visit ROTATEQ was started.
100.4 fever Significant body aches Significant Fatigue  Headache Joint Pain
Patient suffered from cardiac arrest  and past away due to underlying medical conditions on 9-28-2021.
Arm pain for 1 day  After 2 days I developed ringing in my ears (Tinnitus). It is constant & is a high pitched tone. It is driving me crazy!
Headache, Sedation, Myalgia, Arthralgia, NauseaVomiting, chills and fatigue. pain at the injection site. Narrative:  Other Relevant History:
Narrative:  60yo male pt who reside at rehab was transferred from facility care to SNF for higher level of care required on 1/30/2019 with Diagnosis: Huntington's chorea. Pt died on 7/24/21 with no info provided on pt's death. Likely not related to pt's death given 5 months since covid vaccine was given prior to death & pt's debilitating disease.
Fever 100.4, full body aches, chills, injection site soreness, weakness, dizziness, nausea, low back pain; Fever 100.4, full body aches, chills, injection site soreness, weakness, dizziness, nausea, low back pain; Fever 100.4, full body aches, chills, injection site soreness, weakness, dizziness, nausea, low back pain; Fever 100.4, full body aches, chills, injection site soreness, weakness, dizziness, nausea, low back pain; Fever 100.4, full body aches, chills, injection site soreness, weakness, dizziness, nausea, low back pain; Fever 100.4, full body aches, chills, injection site soreness, weakness, dizziness, nausea, low back pain; Fever 100.4, full body aches, chills, injection site soreness, weakness, dizziness, nausea, low back pain; Fever 100.4, full body aches, chills, injection site soreness, weakness, dizziness, nausea, low back pain; This is a spontaneous report from a contactable other-HCP (patient). A 28-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EJ1686), via an unspecified route of administration on 07Jan2021 13:45 at single dose for covid-19 immunization. Vaccine location was left arm and it was the second dose. Patient is not pregnant. The facility type vaccine was hospital. Patient took the first dose of BNT162B2 on 17Dec2021 13:45 (lot number EK5730) at arm left for covid-19 immunization. The patient medical history was not reported. Concomitant medication included famotidine and birth control. The known allergies included Cefzil. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced Fever 100.4, full body aches, chills, injection site soreness, weakness, dizziness, nausea, low back pain on 08Jan2021 00:15 with outcome of recovering. Patient didn't receive treatment for the adverse events. The events were reported as non-serious.
The pt reported experiencing nausea and body aches, not feeling well. The pt experienced a hive type rash. Presented to ER. Given Benadryl for treatment. No further treatment needed.
On arrival for 3 dose of Hepatitis B vaccine indicated problem after dose 2 (5 months ago) Swelling rt arm, Temp 99.9, Bubbling at area of injection. Severe pain rt arm. Dose 3 not given. Referred to PCP.
Fatigued all day.; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigued all day.) and PYREXIA (Low grade fever) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.    On 10-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced FATIGUE (Fatigued all day.) and PYREXIA (Low grade fever). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, FATIGUE (Fatigued all day.) and PYREXIA (Low grade fever) outcome was unknown.            Concomitant medications included unspecified blood pressure and heart medications. Action taken with mRNA-1273 in response to the events is not applicable.