chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case, initially received on 02-Nov-2016, was reported by a health professional and concerns an 82 year old patient. Weight: not provided; Height: not provided. Concomitant medication: Not reported. Administration of company suspect drug(s): On 16-Sep-2016, the patient received AFLURIA. Dose regimen: Not reported, Route of administration: Intramuscular. Batch number: WT54306. No additional suspect drugs. Adverse event description: On 23-Sep-2016, a nurse reported that a refrigerator went in and out of (temperature) range while there was flu vaccine in it. On 16-Sep-2016, doses were administered (special circumstances: drug administration error without adverse event, incorrect product storage). Flu vaccine was first delivered to the vaccination facility on 15-Aug-2016. As the nurse reviewed the refrigerator temperature log, she stated that another excursion occurred on 15-Sep-2016. The doses arrived at 09:00 and were placed in a refrigerator that was at 10 degrees Celsius in the morning. Then the temperature remained at 9 degrees Celsius throughout the 15th and 51 doses were administered on the 16th at a flu clinic. The refrigerator was not back in range until 19-Sep-2016 at a temperature of 8 degrees Celsius. Temperature excursion identified: Log documentation reflected temperature excursions from 31-May-2016 to 23-Sep-2016 which ranged between 8 to 10 degrees Celsius. Vaccines had been given to patients between 31-May-2016 and 23-Sep-2016. On 04-Oct-2016, the remaining 42 doses of lot number WT54306 were discarded. The patients will be contacted for revaccination.
Parent states child c/o right arm pain Sunday 07/19/2009. Parent states right upper arm was red, swollen and warm to touch. Parent applied cold pack to area and gave Tylenol for discomfort. Vaccinations were administered Friday 7/17/2009. Right arm still has some swelling and is sore. Readness was not observed. ARNP in to see pt and recommended warm moist heat to area and to use OTC Ibuprofen for pain and swelling. To RTC if not better in 48 hours.
This spontaneous report as received from a consumer refers to a 81 years old female patient with high cholesterol, asthma, seasonal rhinitis, GERD and coronary artery disease. In approximately 2010, "about 2 and a half years ago", the patient was vaccinated with a dose of ZOSTAVAX (lot number not reported) under the skin. Concomitant medications included SINGULAIR, ZYRTEC, ZETIA, ZOCOR and PRILOSEC. In January 2012 the patient was found unconscious in her home. She had been there about a day or two when the police found her after responding to a welfare check requested by her niece. She was admitted to the hospital where she stayed in a coma for about 3-4 days. She was diagnosed with Bacterial Meningitis. Antibiotics were provided for the Meningitis through a PICC line. She says that after she came out the coma her daughter notices blisters on her face, in her face, and up her nose. There was no one on any other part of her body. The patient said no medication was given but she believes this was the shingles but she could not provide clear answer who diagnosed her with the shingles. The patient was moved to a nursing home after the hospital for about a month. The patient was still experiencing a part of her upper lip being pink and numb still. Also, the patient said she went to the dermatologist and was told that since he did not see her while she was experiencing the symptoms there was nothing he could do for her. The patient had blood work every three months. In March 2012, the patient had recovered. The patient had sought medical attention on unknown date. The patient's events were considered to be disabling and life-threatening by the reporter. Additional information has been requested.
Developed a rash starting near the middle of my back and extending about half way to my left side.  Rash looked like the start of shingles but never progressed to that (never had any blisters).  Rash did sting moderately.  Rash resolved by itself over a period of 6-7 days.  Rash appeared about 36 hours after 2nd shot of vaccine given 21 days after first shot.
This spontaneous case was reported by a consumer and describes the occurrence of PAROSMIA (Phantosmia (been smelling smoke)) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Medical history was not provided.  On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAROSMIA (Phantosmia (been smelling smoke)). At the time of the report, PAROSMIA (been smelling smoke)) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.No relevant concomitant medications were provided. No treatment information was provided. The patient had been smelling smoke from two weeks after receiving the second dose of the vaccine.Most recent FOLLOW-UP information incorporated above includes: On 30-Jul-2021: vaccine date updated and reporter added
Information has been received from a consumer concerning her niece a 13 month old female who "about a week ago" on approximately 09-Jun-2006 was vaccinated with a dose of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (+) varicella virus vaccine live.  On 12 Jun 2006 the patient developed a fever and rash of red bumps on her face and chest.  No other symptoms were even noted.  Medical attention was not sought.  There was no product quality complaint involved.
side effects from my second shot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects from my second shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (side effects from my second shot). At the time of the report, VACCINATION COMPLICATION (side effects from my second shot) outcome was unknown.            No Concomitant medications were provided No Treatment information provided
This spontaneous case, initially received on 20-Apr-2017 was reported by a other non-health professional and concerns a male patient of unknown age. Administration of Company suspect drug (s): On an unspecified date the patient was administrated with INN Flu Vaccine Seasonal (dosage, batch number, route of administration not reported). Patient was administered with GILENYA (dosage: 0.5mg, oral route, daily) on an unspecified date in 2015 and noticed increase in forgetfulness. Patient had FLAGYL, permethrin, pneumococcal vaccine, PROZAC allergies. Patient concomitant medications include baclofen, CHANTIX, gabapentin, GILENYA, vitamin b12, ZOLOFT. Adverse reactions/events and outcomes: It was reported that the patient had allergy to vaccine. Reporter's Assessment: The other non-health professional did not provide any assessment between the event and suspect vaccine. Causality was not reported.
Site: Itching at Injection Site-Mild, Site: Pain at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Systemic: Exhaustion / Lethargy-Mild, Systemic: Pt says she is experinecing visual changes in her left eye. It looks like spots are flashing in front of her left eye in various patterns.-Mild, Systemic: Visual Changes/Disturbances-Mild
I got my 1st Pfizer Covid-19 vaccination on 3/4/2021. No real adverse effects immediately - just a little sore right arm at the injection site and a watery, runny nose a day or so later that eventually stopped. I have allergies so I'm used to the runny nose symptom. However, on Monday evening, March 15, I noticed some slight pain where my lymph nodes are located underneath my jaw and close to my ear on the right side. There was a small lump that was tender to the touch, about the size of a small raisin or grape, under my jaw along my neck on the right side. To a much lesser extent, and barely noticeable, in a similar location, on my left side as well. I went to my primary care physician the next day, 3/16, who confirmed that I had swollen lymph nodes - and also told me they could notice them further down my neck as well, which I was not aware of previously. I had no other symptoms, e.g., no temperature, etc. They said that, yes, the swollen lymph nodes appeared to be consistent with earlier reports of swollen lymph nodes as a resulting side effect in some patients following a Covid19 vaccination, but also mentioned that often, this side effect was more noticeable several days after the vaccination. Since my swollen lymph nodes occurred nearly 10 days later, my PCP team said to go ahead and get the 2nd Pfizer vaccination as scheduled 3/25/21, but to return to their office two weeks later for another checkup to make sure there weren't any other issues going on.
On 4/8/21 and 5/6/21 the patient came into the clinic to get her covid vaccine. The patient refused to get the vaccine in her deltoid or her thigh and requested to receive the vaccine in her gluteus. For both injections the provider was consulted by the Medical Assistant and on both dates the MA was given the ok and asked to administer in the gluteus. When patient returned after the first dose on 5/6/21 patient was asked if there where any complications and patient declined and stated "she was just a little sore like after a normal injection for a day and then every thing was fine. " The second injection on 5/6/21 was again cleared to administer by provider and was administered.
after injection developed pain at site of injection and then yesterday developed redness, feels hot to site to tetanus injfecton.  reports lymphnodes hurt in axilla feels tired    cellulitis vs vaccine reaction  treat for infectoin, cephalexin twice daily, take probiotic cautioned risks  use ice, tylenol, ibuprofen as needed  call if not improving as expected not a guarantee you will have this happen in the future with vaccines  Med Current    :  Cephalexin 500 mg 1 by mouth twice a day
The patient received a 4 day expired vaccine.; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received a 4 day expired vaccine.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received a 4 day expired vaccine.). On 20-Oct-2021, EXPIRED PRODUCT ADMINISTERED (The patient received a 4 day expired vaccine.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
pt recvd vax; pt devel elevated liver function tests, gastrointestinal problems & severe headaches; pt seen by neurologist; MRI was nl; lab test revealed elevated urine bilirubin;
MASSIVE INSANE CHILLS; MASSIVE INSANE FEVER; This spontaneous report received from a patient via a company representative 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 ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced massive insane chills, and massive insane fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from massive insane chills, and massive insane fever. This report was non-serious.
Four children received an expired dose of PENTACEL on 4/28/15. The vaccines had expired on 4/19/15. The ages of the children were two, 4 months olds and two, 6 month olds.
Information has been received from a registered nurse concerning a 23 year old female who on 25-JUN-2007 was vaccinated with a third dose of Gardasil (Lot # 657737/0522U).  On 27-JUN-2007 the patient developed unusual swelling of the upper left forearm, and the injection site was very hard and red.  The patient contacted the physician and went for a follow-up visit and was treated with ADVIL, BENADRYL, and ice.  On 29-JUN-2007 the patient recovered.  Additional information has been requested.
Small rash appeared near injection site (left shoulder) on 1/9/21 pm (vaccine received 1/2/21). It increased in size by morning 1/10/21 am. By 1/11/21 am, it was 3in by 3in. Red, swollen patch, warm to touch.
Febrile seizure 6/13/03. Admitted to hospital. Increase WBC 33,000. Rx: Rocephin. THe hospital record received on 2/26/04 states leukocytosis.
Presented to ED w/hx of harsh, nonproductive cough (4/7) & subsequent positive COVID-19 test (4/13) despite receiving Pfizer vaccines (1/21 & 2/16).  Continued to have worsening cough w/occasional SOB, generalized weakness affecting daily activities and poor oral intake.  Found to be febrile, hypotensive w/increased confusion.  Imaging revealed opacity of R middle lobe & bilateral lower lobe consolidation concerning for pneumonia.  Was admitted for additional management of sepsis & acute hypoxic resp failure secondary to COVID-19 on 4/22. Treated w/dexamethasone & started on ceftriaxone for asymptomatic Ecoli UTI. Pt ultimately discharged (4/29) w/extended antibiotic course for MSSA bacteremia w/ID follow-up on 5/24
Redness, warmth to touch, itching, some swelling with no pain. Occurred on upper right arm. Noticed by mother of patient 10/12/2016. The whole right upper arm appears red.
approximately 6 weeks after 2nd dose I developed sensory disturbances and motor weakness along my left arm and hand which lasted approximately 5 minutes which then resolved spontaneously. 10 days later the sensation returned but lasted 4-5 days and recurred several times a day. During the second episode one of the events was accompanied by involuntary  tonic flexion of 3 fingers in my left hand.
Heavy menstrual bleeding lasting for more than ten days following first and second dosage of Pfizer vaccine. still currently experiences three months after first dosage
approx. 2 days after receiving the vaccine , her arm became red and swollen with a red spot with a white pus pocket. Had shooting pain down right side of body( head to toe) began to lose sensation in the right arm . Went to ER. Was prescribed antibiotics and pain meds and a muscle relaxer. Flu like symptoms occurred on day 4 .  Now has an URI infection . Being treated by PCP.
pt recv vax 12MAR99 & 22MAR99 pt exp a high temp, joint pain, a high sed rate & low WBC's;pt was adm to hosp 2 days later w/the same sx;
Information has been received from a registered nurse, for VARIVAX (Merck), a Pregnancy Registry product, concerning a 21 year old female patient who on 15-MAR-2010 was vaccinated with a first dose of VARIVAX (Merck) (dose and route not reported) (lot number 665503/1165Y). On 12-APR-2010, the patient received a second dose of VARIVAX (Merck) (dose and route not reported) (lot number 665503/1165Y). The nurse reported that the patient may had been pregnant at that time. The patient's last menstrual period was on 17-MAR-2010. No adverse reactions reported. The patient sought medical attention through an office visit. Follow up information has been received from a licensed practical nurse  who indicated that on 27-APR-2010 the patient experienced spontaneous abortion, 6 weeks from LMP. It was unknown whether the fetus was normal or products of conceptions were examined. At the time of the report, the outcome of the patient was unknown. All telephone attempts to obtain follow-up information have been unsuccessful. Upon internal review, spontaneous abortion (<20 weeks) was considered to be an other important medical event. Additional information is not expected.
got the shot and booster and still got the shingles/suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine and Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: got the shot and booster and still got the shingles/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 22-JUN-2023 This case was reported by a patient via interactive digital media. The reporter stated that the shingles vaccine was not full proof. The patient got the shingles shot and booster and still got the shingles. The reporter further stated that more work needed to be done on the shingles vaccine. 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 follow up would not possible as no contact details were available.
pt recvd vax & 1 hr later began shaking while sleeping & awake; eyes rolled back & was incoherent, could not cry; pt was limp; pt taken to ER; meds given;
Started to feel itchy on right neck area approximately 5:25  5 minutes after receiving .  Denies problems with breathing.  No respiratory distress.  Lungs ctabl, no stridor, no jvd.  RR 12 unlabored even.  CV  Blood pressure 143/93 97 99% on RA  after deep breaths BP 125/88 96b 99% O2 sat.  Consulted with Medical Director called 911 for evaluation.  Paramedics called and evaluated employee.  They  recommended on site observation and Benadryl.  One 3-4 mm raised blanched wheal at right neck observed, "itchy" scratched x1 when itched.  "Tried to  not scratch"  Denies any respiratory difficulty.    Benadryl 25 mg given 6:21 PM,  6:52  employee doing well   98 %   85  heart rate  132/88  16  referral provided for if needed follow up care.
Death Hypokalemia LBBB (left bundle branch block) Pneumonia Anemia Hypoxia Fever Multifocal pneumonia Pneumonia due to COVID-19 virus2.82 Sepsis
Initially after second vaccination, I had a temperature of 101, chills, severe headaches, severe muscle aches.  However, since finishing the series, I have now been experiencing severe intermittent headaches weekly that require me to medicate.  I never experienced regular headaches prior to the vaccinations.  There have been no other changes in my lifestyle, and these began directly after finishing the second shot.
My arms swelled, developed a rash, and a fever. I had severe pain in my arms and shoulder joints. Then I ran a fever of 104.7 for the four days. I am still having joint pain in my shoulders and itching in my arms. I alternated 800mg ibuprofen and Tylenol as instructed by my doctor.
At about 6 AM on 5/5/2023, I had minor nasal stuffiness, itchy eyes, chills, and minor aches. I felt like I was developing a cold. I took a home antigen test and got a positive result. I called my doctor's office and had virtual visit with a PA that afternoon, and I was prescribed Paxlovid. She also advised me that I could take OTC medicines if I needed to, but I needed to cease taking the atorvastatin while I was on Paxlovid. I began taking Paxlovid that night and took it for the entire five-day course. I began to feel better after 24 hours. The aches and chills were gone, and the stuffiness and itchy eyes were less severe. At one point, I had been sneezing a lot, also, but that went away after I took the Paxlovid. The only issues I had at this point were the mild stuffiness, itchy eyes, minor fatigue, and the aftertaste caused by the medication. At the end of the five days, I tested positive again, though the line was very faint. I tested again on 5/12/2023 and 5/14/2023 and got a negative result. On the night of 5/15/2023, I began to get stuffiness and itchy eyes again. On 5/16/2023, I tested positive again, though the line was very faint. I had a virtual visit with my doctor later that day. We decided that I should not take Paxlovid again, unless my symptoms worsened in the following 48 hours. Since then, my symptoms have gotten better. At the present time, I feel pretty good. I have very little stuffiness and no itchy eyes or fatigue.
pt stated arm was feeling numb. pt refused medical attention. was given Benadryl once 25mg tab. pt wait and monitored for 30 minutes and was ok upon leaving. pt was not in  respiratory distress.
got the shot on 4/27/20 at 1am woke up with muscle pain, headache, chills.  at 6am low grade fever 99.7.  after that her temp was normal.  Patient felt better within 48 hours after vaccination.
HA 0 energy heat and knot at injection site Chills  low grade Temp.
Very sick; This case was reported by a consumer via call center representative and described the occurrence of sickness in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingrix.     Additional Information: GSK Receipt Date: 02-MAY-2022 Reporter's comment: The patient was very sick from first and second was scheduled for the day of reporting; asked would patient be just as bad.
Redness, hot, some welling, slight itching of the right arm where the shot was injected.
Waitng the required 15 minutes after inoculation, both ears began ringing simultaneously. I made the pharmacist aware and she said to see if it diminished-it did not. I went to a outpatient clinic about 3 weeks later - reported ringing...said to report it to the CDC and contact an ENT. Ringing is 24/7.
Within an hour patient reported metallic taste in her mouth and  her tongue and her upper mouth area felt like it was burnt and this persists
Patient fainted within 10 minutes of receiving vaccine. Patient was woke up within 30 seconds of fainting. Upon awakening patient did experience nausea and vomiting. Medical intervention was not necessary. Patient was able to leave pharmacy on own power.
This spontaneous report as received from a nurse refers to a 10 months 16 days old male patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours), ROTATEQ lot # K016313, exp. date: 31-MAY-2016 and lot # K011663, exp. date: 20-MAY-2016 (dose and strength unspecified) oral. No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.