chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse referring to a female patient of unknown age. On an unknown date in 2012, the patient was vaccinated with her first dose of ZOSTAVAX (lot #, dose and route were not reported). On 25-FEB-2015 the patient was vaccinated with her second dose of ZOSTAVAX (lot # was not reported), 0.65 ml, subcutaneously, which was considered as an extra dose. After the patient received the second dose of ZOSTAVAX she remembered that she already received the ZOSTAVAX in 2012. No adverse effect was reported. Additional information has been requested.
Still sick (headache became migraine all hours of wake, feverish no fever, sweating through clothes, chills, muscles weak and sore, joints MAJOR pain all joints, chest tight, hard to breathe
Information has been received from a certified medical assistant and a health care worker concerning an 82 year old female who in October 2003, was vaccinated with a dose of PNEUMOVAX 23. The certified medical assistant reported that on 08-OCT-2008, the patient was vaccinated with a second dose of PNEUMOVAX 23 (lot #661528/0867X). The certified medical assistant reported that on 09-OCT-2008, the patient saw the oncologist and had pain, warmth and redness of the arm. On 10-OCT-2008, the patient was seen in the physician's office and the symptoms had resolved. This is one of several reports, received from the same source. Additional information has been requested.
Extreme body chills, slight fever, body aches, dry heaving, extreme headache, tired, pain in chest when inhaling. These symptoms lasted 2 days, then I started having vision problems went to eye doctor on 03/26/2021 and got diagnosed with asteroid hylaosis.
body wide pain from head to feet; Anxiety; felt like i could not breathe, couldnt get enough air; heart rate was 148; fever 101F; extremely tired and fatigue; Pain in arm; This spontaneous case was reported by a nurse and describes the occurrence of PAIN (body wide pain from head to feet), ANXIETY (Anxiety), DYSPNOEA (felt like i could not breathe, couldnt get enough air), PAIN IN EXTREMITY (Pain in arm) and HEART RATE ABNORMAL (heart rate was 148) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Jan-2021, the patient experienced PAIN IN EXTREMITY (Pain in arm). On 08-Feb-2021, the patient experienced PAIN (body wide pain from head to feet), ANXIETY (Anxiety), DYSPNOEA (felt like i could not breathe, couldnt get enough air), HEART RATE ABNORMAL (heart rate was 148), PYREXIA (fever 101F) and FATIGUE (extremely tired and fatigue). At the time of the report, PAIN (body wide pain from head to feet), ANXIETY (Anxiety), DYSPNOEA (felt like i could not breathe, couldnt get enough air), PAIN IN EXTREMITY (Pain in arm), HEART RATE ABNORMAL (heart rate was 148), PYREXIA (fever 101F) and FATIGUE (extremely tired and fatigue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  Treatment information was not reported.  Action taken with mRNA-1273 is not applicable.   This case was linked to MOD-2021-018913 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-Jul-2021: Non significant follow up received and contains updated reporter contact information.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Inappropriate age at vaccine administration; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration). On 16-Jun-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Inappropriate age at vaccine administration) 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 medication reported.  No treatment information reported.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 03-SEP-2014 the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot# and expiration date were not reported) that was exposed to a temperature excursion with a high temperature of 32 degrees F (Fahrenheit) with an excursion time of 3 hours (date unspecified). This dose of ZOSTAVAX vaccine had a prior temperature excursion up to 39 degrees F for 144 hours (date unspecified). No adverse effect was reported. No PQC (product quality complaint) was involved. Additional information has been requested.
Client needed varicella vaccine as well as MMR vaccine for work. ZOSTAVAX given in place of VARIVAX in error. No adverse effects reported. Client had 2 doses VARIVAX in childhood but negative varicella titer.
Within two hours of injection, greater than normal injection site pain. Within six hours, diarrhea / mild nausea (no vomiting). Insomnia that night accompanying whole-body aches/pains/malaise.  Pain most notable in extremities. Nausea more significant at 12 hours (i.e. 6AM) but no vomiting. Significant lethargy all day 1/22/2021. Pain/nausea gone by 6PM but lethargy remained.  Slept most of the day. Symptoms gone by following morning (1/23/2021), so roughly 36 hours.   Overall these were symptoms consistent with a really bad case of the flu, minus the respiratory symptoms.  I often work through illnesses like the flu.  Couldn?t work through this.
Right ear began ringing on 3-24 right when I woke up. Didn't go away until some time when I was asleep on the night of the 25th, or early on the 26th.
8/10 epigastric pain, nonradiating with severe arthralgias. Positive for rhinorrhea and wheezing cough. No fever or chills.
red, hard swollen leg x 2 hr, crying x 2 hr; fussy throughout noc; fever 100 till about 7PM; better mood p/that;
No symptoms until about 5 hours after vaccination, then felt mildly ill for the next few days (fatigue, slight achiness, loss of appetite). At midnight on the fourth day after the vaccination (March 29), felt extreme vertigo when turning over in bed. Woke up that morning (March 30) and still had extreme vertigo (had to crawl to bathroom). Had had vestibular migraines in the past, so assumed that was the cause, but this was much more severe and unrelenting. Saw nurse practitioner the following day (March 31), who diagnosed BPPV (benign paroxysmal positional vertigo). Saw physical therapist that afternoon, who confirmed diagnosis but was unable to provide treatment because of the extremity of the symptoms. Treated (apparently successfully) April 1, and was told that I "might feel lousy for a few days." Did not substantially improve until approximately June 12, but then plateaued and had two further recurrences, leading to second appointment with NP, plus one to two physical therapy sessions a week. Continuing to have mild symptoms, but have improved over the past week.
patient erroneously received expired dose of Tenivac/no AE; Initial information was received on 02-Mar-2021 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 54 year-old male patient who was erroneously vaccinated with expired dose of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (expired product administered).  The patient's medical history, past medical treatment(s), vaccination(s) and family history were not provided. No concomitant therapy was given.   On 01-Mar-2021, the patient received 0.5 mL dose (Single dose vials) of suspect DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT (lot C5578AA; Strength = standard and expiry date 28-Jan-2021) via an intramuscular route at the right deltoid for prophylactic vaccination.  Caller asking was they need to revaccinate a person who got an expired Tenivac.  It was a case of  actual medication error due to expired vaccine used (latency was on same day).  At the time of report, no adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
During post-vaccination observation, Patient complained of feeling warm all over, slight nausea, and itchy rash on hands that progressed to upper arm during the next fifteen minutes; no angioedema, dyspnea, lightheadedness or other symptoms.  Vital signs remained nominal at all times. 30 minutes following oral administration of diphenhydramine 50mg,  all symptoms had resolved.
Swelling my eyes significantly; Having my tongue go somewhat numb; Difficult to swallow; Feeling worse; Some feverish feelings; Hives all over my body, especially on my face; Chills; Couldn't stop shaking; This is a spontaneous report from a contactable consumer (patient, self-reported). A 28-year-old female patient (who was not pregnant at the time of vaccination), received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: ER8732 and expiry date was not provided), via an unspecified route of administration, in arm left, on 26Mar2021, at 14:00 as single dose for COVID-19 immunisation. Patient medical history was not reported. She did not have any known allergies. Concomitant medications included estradiol valerate, progesterone and cyanocobalamin (VITAMIN B12). Patient stated that she first experienced some feverish feelings, chills and hives 30 minutes following her vaccination. She drove home from the hospital and was feeling a bit off, but mostly okay. By the time she got back, she was feeling worse, around 4 PM. By 5 PM she had broken out in hives all over her body, especially on her face, swelling her eyes significantly and having her tongue go somewhat numb, starting to make it difficult to swallow. She also had significant chills, and couldn't stop shaking, and ended up being admitted to the ER. After being given antihistamines, the swelling went down and eventually the chills stopped after monitoring in the hospital. The patient was hospitalized for the events on an unknown date in Mar2021. Treatment received for the events. The patient was not diagnosed with COVID prior vaccination. The patient had not been tested for COVID post vaccination. The patient did not receive any other vaccine in four weeks of vaccination. Outcome of the events was recovered on an unknown date in Mar2021.
Information has been received from a nurse referring to an unspecified number of unspecified patients. Their medical history, concurrent condition and concomitant therapy were not provided. Since 21-JUL-2016, the patients have been administered doses of PEDVAXHIB (lot number and expiration reported as L042835, 19-AUG-2018 and M001814, 15-OCT-2018). All of which were improperly stored. No adverse effects have been reported. There was no prior excursion. This report is for data logger. Additional information has been requested.
Patient received Pfizer COVID-19 Bivalent Booster vaccine which was beyond the manufacturer recommended use time of 10 weeks at the refrigerated temperature.  Agency has been in direct contact with the vaccine manufacturer regarding this issue. Pfizer has data to support the stability of the vaccine up to 45 days at refrigerated temperatures. The vaccine given was within this range which is supported by the above data. Clinically, the patient is considered to have adequate protection against COVID-19 from this vaccine dose compared to if the dose was administered within 10 weeks. Thus, there are no additional clinical recommendations at this time. Patient should continue to receive the recommended COVID-19 vaccination doses on the usual schedule.
Tachycardia and palpitations. Currently on holter monitor for SVT. Followed up with PCP and did receive 2nd dose without issue.
Information has been received from a registered nurse concerning her 7 month old son. The pt's two brothers broke out with chicken pox in 10/01 (WAES 01104874 and 01110666). In approximately 10/01, the pt was vaccinated with varicella virus vaccine live for "post-exposure prevention". In approximately 10/01, the pt developed "one spot under hair" Additional information has been requested.
Information has been received from a nurse referring to a patient of unknown age and gender. On 06-MAY-2016 the patient was vaccinated with an expired dose of PNEUMOVAX23 (lot # K018183 with expired date of 04-MAY-2016; strength, dosage, frequency and route unspecified). No adverse effects were reported. Additional information has been requested.
VACCINE ADMINISTERED TO PATIENT 45 MINS PAST 6 HOUR EXPIRATION DEADLINE; This spontaneous report received from a pharmacist concerned a patient of unspecified age and 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 (suspension for injection, route of admin not reported, batch number: unknown) dose was not reported, administered on 07-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 07-JUN-2021, the subject experienced vaccine administered to subject 45 mins past 6 hour expiration deadline. The action taken with covid-19 vaccine  was not applicable. The outcome of vaccine administered to patient 45 mins past 6 hour expiration deadline was not reported. This report was non-serious.
Soreness in arm, could not lift arm for 48 hours, flu like symptoms started that night, on day 6 after vaccine still have sore throat, headache, severe stomach pains, ears ache, sore throat.
No sings or symptoms reported; Temperature excursion; This spontaneous report was received from an administrator referring to a patient of unknown age and gender. The patient's medical history, concomitant medications, drug allergies, or reactions were not reported.   On 09-APR-2021 and 23-APR-2021, a Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) (lot # T035379 has been verified to be a valid lot number for Pneumococcal Vaccine, Polyvalent (23-valent), expiration date 31-MAY-2022) was exposed to a temperature of 49.0 to 48.7 Fahrenheit degrees respectively  for a time frame of 1 hours and 15 minutes cumulative.  On an unspecified day between 09-APR-2021 and 12-MAY-2021, the  patient was vaccinated with 1 single dose of  the previous mention Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis (strength and administration route were not provided) (product storage error). No digital data logger was involved, non previous excursions were reports and no sing or symptoms were reported (no adverse event).  This case is linked with several same reporter cases. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T035379; expirationdate: 31-MAY-2022; deviceage and unit: 0 ; operatorofdevice: Unknown; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2105USA002866: US-009507513-2105USA002935: US-009507513-2105USA002943: US-009507513-2105USA002937: US-009507513-2105USA002938: US-009507513-2105USA002940: US-009507513-2105USA002941: US-009507513-2105USA002942: US-009507513-2105USA002934: US-009507513-2105USA002933: US-009507513-2105USA002936: US-009507513-2105USA002932:
15 mins after the first pfizer vaccine for covid 19. I felt flushed and hot like hot flashes. 30. mins later i felt like I was going to pass out and then had hypogycemic episode. I took tylenol and stayed in the hospital for 3 hours and left after i felt better. Still feel bad but not as bad. Taking tylenol around the clock now.
High fever which did not immediately respond to acetaminophen or ibuprofen. Chills, aches, and severe fatigue. Severe pain in arm at injection site; inability to move arm. At 36 hours after vaccine, dime-sized welt appeared two inches below injection site. At 48 hours, welt increased to size of an orange. At 72 hours, welt increased to size of a grapefruit.
On (09/24/2008) Dr. gave our daughter the Hep. A shot which is not required by the state to take. The doctor on the day of her annual physical check-up told us that she was "fine" and can play sports. A few days later she became weak, had stomach pain, and was losing a lot weight this leads us to believe that Hep. A caused this to happen. Still up to this day the right arm where the shot was injected causes her pain. We believe that this shot attack her organs and damaged her immune system resulting in her having mass, losing a part of her kidney, and undergo multiple treatments. At first we were told that this is curable but now a doctor has admitted to us that the cure rate is only twenty-five percent. She is now living day to day for survival.
Case number PHEH2016US023456, is an initial spontaneous report received from a nurse on 13 Sep 2016. This report refers to a 62-year-old patient of an unknown gender. Medical history was not reported. Concomitant medication was not reported. The patient was vaccination with FLUVIRIN (batch number: 1515701, expiry date: not reported) at a dose of 0.5 ml intramuscularly into left arm on 01 Dec 2015. It was reported that, the patient received FLUVIRIN that has been exposed to 8 to 10 temperature excursion and it was administered to unknown number of patients. No adverse event was reported following this medication error.
Series of 3 Hep B shots on:  June 1999, October 1999 and January 2000.  A couple of weeks after the 2nd shot  had cough and wheezing and on January 1, 2000 diagnosed with Asthma and doctor prescribed inhalers.
Inappropriate schedule of product; This spontaneous report has been received from a pharmacist referring to a 43 years old female patient. Concurrent condition, historical condition and concomitant therapy were not reported.   On 17-JUL-2020, the patient received first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, unit, lot# and expiration date were not reported) for prophylaxis.   The patient wanted the pharmacist to have two doses total. The second dose had not yet been administrated. The patient dosed outside of recommended dosing schedule.
Arm began to be very, very painful beginning at 5pm, same day.  Same day, that evening and for the next 36 hours, fever (101 degrees); aches; chills; sweats; very painful arm and aches all over body; raging headache.  After about 48 hours, it was all gone, as if nothing had ever happened.  I am fine now.
PAIN AND SWELLING OF LYMPH NODES ON LEFT NECK, ARMPIT, AND GROIN X3-4 DAYS, OTC TREATMENT WITH PAIN RELIEVER AND ANTI-INFLAMMATORY MEDICATIONS.
Headache, Myalgia, Fever, Diarrhea, NauseaVomiting, fatigue Narrative:
After the vaccine. I was having shortness of Breath and extreme weakness. I also had a feeling of bee stings. I talked to doctor, she had me get a CAT Scan, MRI and Ultrasound.  It was found that I have a nodule on my lung, and I need a biopsy on my thyroid, they found a mass there. I am still waiting on my appointment for my Biopsy.
Patient experienced itchy eyes, itchy/throat closing, bronchitis, wheezing three days after receiving 2nd moderna dose
Patient noted that arm was somewhat painful at injection site and warm around injection site the next day but that they had a better reaction than previous vaccine they received. No treatment has been requested at this time, they just wanted to make me aware.
Swollen glands in neck, wheezing, cough, flushing of face, increased heart rate, discomfort in mouth and throat.
Information has been received from a registered nurse via a company representative concerning his teenage son of unknown age. Information regarding concurrent condition and medical history was not reported. On an unknown date the patient was vaccinated with GARDASIL (dose, strength and lot # were not reported, intramuscular). Concomitant therapy was not reported. The reporter said that the patient experienced lightheadedness that resolved within minutes on an unspecified date shortly after injection of GARDASIL. The reporter did not report that which GARDASIL product was involved. The patient was in doctor's office at the time to seek medical attention. There was no treatment given for the event. There was no lab diagnostics study performed. Additional information has been requested.
This spontaneous report was received from a licensed practical nurse refers to multiple unspecified patients of unknown age and gender. The patient's pertinent medical history, allergic reactions and concomitant medications were unspecified. On unspecified dates, the patients were vaccinated with improperly stored GARDASIL 9 lot # M011117, expiry date 07-DEC-2017 (dose, strength, vaccination site, route unspecified). No adverse effect were reported. Product quality complain (PQC) was not involved. No further information was provided. This is one of three reports received from the same reporter. Additional information has been requested.
A nurse reported that a 21 month old child received Typhoid Vaccine and Hep A immunoglobulin on 1/21/99. Later that evening, the infant developed a fever of 103 (rectal). The child recovered.
Started off with sudden chills not even eight hours after receiving the vaccine. Chills slowly processed into a fever. By 7 pm, the fever progressed to 103.7 deg F. By 11 pm, I started to have nausea. Throughout the night I continued to have chills and sweats with episodic vomiting. The next morning I had terrible body aches and restless leg syndrome. I still had a fever and a lack of taste. It wasn't until 48 hours after receiving my vaccine that my symptoms eventually subsided.