chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On an unknown date in 2010 the patient was vaccinated with VAQTA (also reported as hepatitis A vaccine (manufacturer unspecified) VAQTA could not be ruled out) (lot number and expiry date unknown) (dosing regimen and frequency unknown). No concomitant medications were reported. On an unknown date in 2014 the patient was administered with a dose of VAQTA (lot number and expiry date unknown) (dosing regimen and frequency unknown) (Received unspecified hepatitis A vaccine (VAQTA could not be ruled out) in 2010 and VAQTA in 2014 (inappropriate schedule of drug administration). No adverse effect was reported. The action taken with the therapy with VAQTA was unknown. The outcome of the events was unknown. The relatedness of the events to the therapy with VAQTA was unknown. There was no product quality issue reported. Additional information has been requested.
Headaches, total body fatigue, shortness of breath, brain fog, irregular menses.
13Jan98 Pt recv 1 dose vax. Nurse"missed & hit blood vessel & caused child to bleed more than usual" 17Jan98 Pt devel few spots. 20Jan98 Pt devel 100 pox,no fever/ itch. Chickenpox reported as "full blown". To MD 19Jan98. No exp to varicell
Chills; Fever; Headache; Nausea; Vomiting; Diarrhea; Irritable; This is a spontaneous report from a contactable other healthcare professional, the patient. A 33-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 24Mar2021 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. Medical history included Klippel Feil syndrome, ADHD (attention deficit hyperactivity disorder), depression and vertebrae fusions. Prior to vaccination, it was unknown whether the patient was diagnosed with COVID-19. The patient received unspecified medications within two weeks of the COVID-19 vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration in the left arm on 02Mar2021 at 16:00 (at the age of 33-years-old) as a single dose for COVID-19 immunisation and reported that she did not experience any adverse events after dose 1.The patient previously received RONDEC and CECLOR and experienced a drug allergy. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. On 24Mar2021 at 21:00, the patient experienced chills, fever, headache, nausea, vomiting, diarrhea and "irritable". Since the vaccination, the patient had been tested for COVID-19. On an unspecified date the patient underwent a nasal swab test and tested negative. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events chills, fever, headache, nausea, vomiting, diarrhea and irritable were resolved on an unspecified date in 2021.    No follow-up attempts are needed. No further information is expected.
Information has been received from a consumer concerning a 7 year old pt with no medical history and no allergies who on an unspecified date was vaccinated with a dose of MMR . There were no concomitant medications. The mother reported that her son has autism. She did not believe that it was from MMR vaccine live that her son had autism. She believes that he may have been autistic prior to being given the vaccine. The pt was diagnosed with autism after administration of the MMR vaccine live. Unspecified medical attention was sought. Upon internal review autism was determined to be an other important medical event (OMIC). Additional info is not expected.
2/18/21 about 2:30 pm started to not feel well.  By 3:30pm had extreme chills, aching all over, headache, loss of appetite  but no fever temp was 98.5.  By 7:30pm was feeling much better.  2/19/21  Just felt tired all day until 6pm when he started to feel very unwell, weak, aching and loss of appetite.  This lasted a few hours. 2/20/21  Felt well until he got up at 7:30am, then felt weak, sick in his stomach, some chills and generally not feeling well. We are assuming these are all just normal reactions to his 2nd shot.  We expect them to subside completely in a few days
This spontaneous report  as received from a physician refers to an unspecified number of patients of unknown demographics. Since 05-MAY-2014 the patients were vaccinated with VAQTA. The reporter stated that on 05-MAY-2014 onwards her refrigerator and freezer units began to have temperature excursions and VAQTA was improperly exposed to 29F for multiple unspecified excursions (many more than 2 cycles into the freezing range), and also to 49F for 12 hours. No known adverse effects. Lot # and expiration date of VAQTA was unspecified. All of the data listed here was reconfirmed with the reporter. No further information was available at the time of this report. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Approx 4 hours after injections, child vomited and had a generalized seizure. EMS called. Child was given intranasal VERSED of 5 mg. Transported to medical center. Pt required assisted ventilation. Child stabilized and transferred to another hospital.
spasms on his left arm; nerve pain; general malaise; fever; muscle aches; This non-serious case was reported by a nurse via call center representative and described the occurrence of general malaise in a 65-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 20-SEP-2023, the patient received Arexvy (intramuscular, left arm). On 20-SEP-2023, less than a day after receiving Arexvy, the patient experienced general malaise (Verbatim: general malaise), fever (Verbatim: fever) and muscle pain (Verbatim: muscle aches). On an unknown date, the patient experienced spasms (Verbatim: spasms on his left arm) and nerve pain (Verbatim: nerve pain).  The outcome of the general malaise, fever and muscle pain were resolved (duration 2 days) and the outcome of the spasms and nerve pain were not resolved.   It was unknown if the reporter considered the general malaise, fever, muscle pain, spasms and nerve pain to be related to Arexvy.     It was unknown if the company considered the general malaise, fever, muscle pain, spasms and nerve pain to be related to Arexvy.   Additional Information: GSK Receipt Date: 13-OCT-2023 The reporter reported that the patient received Arexvy vaccine and on first day of vaccination patient had general malaise, fever, muscle aches, which was lasted for 2 days. The reporter also reported that the patient had spasms on his left arm and nerve pain from the left deltoid area all the way down to the fingers, which was not resolved. Not all information was available. The reporter consented to follow up.
8pm: Sharp, shooting pains in my head (similar to shingle pain).  3am on 04/10/21: Extreme fever, chills, body pains so intensive that I was screaming for over an hour, could not put a sheet on my body to warm up because the weight of the sheet caused more pain. This occurred for several hours. When finally able to stand upright, I was too dizzy to stand until approximately 12pm on 04/10/21.  Symptoms subsided and appeared to be gone by 8pm on 04/10/21.
I had difficulty breathing within the 1st hour which passed quickly  But all of my joints in my body's  Swelled up. It was difficult to walk for 3  Weeks. The swelling still persist in my right foot and it's been 6 weeks so I went to the doctor who had seen my foot a week before I had my 1st vaccination. I have developed cysts  On the tendons in my ankle that were not there when the doctor saw me a week prior to having the Vaccination. The  cysts are very fast growing and getting large making it more difficult to walk.   Pfizer needs to explain why this is happening it has happened to numerous people according to my doctor.  Pfizer needs to Let doctors know how to treat the cyst they have caused.
High fever, upto 101.5, severe myalagias, nausea, similar intensity as of my actual infection. Took Acetaminophen with no effect. Responded to Ibuprofen. Better on day 3 12/22/20
Post vax, the patient developed raised pustules scattered on her chest, back, legs, arms and face. The patient experienced bilateral swollen neck glands.
1/19/2021 vaccination *continued symptoms from 1st vaccine. Twitching in legs, can see the twitches in both legs. Weird strange pains that last 3-5 seconds on skin; come and go.  Internist, Neurologist referrals; no diagnosis as of yet.  Ongoing symptoms.
Tinnitus/high-pitched ear ringing (both ears) intermittently several times per day (all hours, no pattern, not co-occurring with other symptoms), even waking me in the middle of the night.  I've NEVER had this issue.  It begun the following evening after initially getting vaccinated.
Sore arm within 15 mins. Approx 12 hours later got migraine-level headache and experienced swelling and purplish bruising approx 10" around injection site. Had intense pain from neck all the way to fingertips for 1.5 days. Only slept about 45 mins the first night because every tiny moment of my left arm resulted in unbearable pain.  I couldn't get dressed or use my left arm for 1.5 days. Over the counter pain med did nothing to reduce the pain level. Didn't feel  better for more than 2 days.  Worst I've felt in over a decade.
Since waking up today child c/o pain in the leg at injection site with noted red hard raised area to right thigh. No fever or difficulty breathing.
Pt admitted 1/4/22 w/ stroke and found to be COVID+ (not ill enough to require COVID treatment). Pt did receive 3 doses of Moderna on 3/4/21, 4/1/21, & 9/27/21
Developed signs of autism by 5 months of age. Unknown if newborn dose of Hep B contained Thimersol. A 60-day follow up report received 7/29/2003 adds: Not recovered. Has autism. The medical record received on 1/6/04 confirms the diagnosis of autism.
Date and time not documented.  Child's left fist became clenched and patient was having a seizure.
Redness/Swelling/Pain at injection site. Patient self treated with OTC pain medications (tylenol/aleve) and ice pack.
Increased occurrence of HSV flare ups. Prior to vaccination 0-2 flare ups per year requiring PRN treatment. Since vaccination 4 flare ups (Spring 2021, July 2021, Oct 2021, Jan 2022) requiring PRN treatment and now (for the first time ever) daily prophylaxis. Clinical note from treating MD stating booster series contraindicated. Each flare up of HSV risks corneal scarring which could lead to blindness and the need for cornea transplant.
Second vax, vax burned when going into arm this time, started feeling tired three hours later. Had a full dinner, went to bed at 10:00. Woke at 4:00 am feeling very achy. Went to kitchen for ibuprofen, took two. Started feeling very nauseated. Went to master bathroom to urinate, and started feeling like I was going to faint. Tried to make it three steps to my small sofa outside bathroom door. That?s the last thing I remember. My husband heard me fall. I had fallen chin first on hardwood floor. He found me lying in a pool of blood. Before going to ER in the next 15 minutes, i had an extreme bout of diarrhea. At ER, I learned that I had Broken both my condyals in jaw and fractured lower mandible. At ER and hospital on 2/2, threw up multiple (about 7-8) times, even with anti-nausea drugs in IV. Doctor put an anti-nausea patch behind my ear but not sure if it helped. Had surgery to set it on 2/3/21.
NO APPETITE AND NOT EATING; SHORTNESS OF BREATH; CHILLS; BLOATED; STOMACH FEELS FUNNY; THROAT FEELS SWOLLEN; HEAD COLD; TIRED; BREATHING FEELS FASTER WHEN LAYING DOWN; ACHY; BACK OF CALVES AND LEG ACHING; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included the patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and  expiry: UNKNOWN) dose was not reported, administered on 14-MAY-2021 for prophylactic vaccination. Concomitant medications included acetylsalicylic acid, and ibuprofen.  On 24-MAY-2021, the subject experienced breathing feels faster when laying down. On 24-MAY-2021, the subject experienced achy. On 24-MAY-2021, the subject experienced back of calves and leg aching. On 24-MAY-2021, the subject experienced tired. On 26-MAY-2021, the subject experienced head cold. On 26-MAY-2021, the subject experienced throat feels swollen. On 27-MAY-2021, the subject experienced bloated. On 27-MAY-2021, the subject experienced stomach feels funny. On an unspecified date, the subject experienced no appetite and not eating, shortness of breath, and chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from no appetite and not eating, had not recovered from head cold, stomach feels funny, throat feels swollen, breathing feels faster when laying down, back of calves and leg aching, achy, and tired, and the outcome of bloated, chills and shortness of breath was not reported. This report was non-serious.
Five days after vaccine administered as 0.5mL SQ in R upper arm, patient developed itching and redness at the site of injection.  Area of erythema and induration measured 10 x 6 cm on the day after onset.  She was treated with diphenydramine and the redness resolved after 5 days.  Four other vaccines (Hep A, influenza, Typhoid Vi, MMR) administered in PMD's office on 11-23-05.  Yellow fever ordered by PMD and at SHS.
Soreness; Chills; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Soreness), CHILLS (Chills) and MYALGIA (Body aches) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 039A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-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, the patient experienced PAIN (Soreness), CHILLS (Chills) and MYALGIA (Body aches). At the time of the report, PAIN (Soreness), CHILLS (Chills) and MYALGIA (Body aches) outcome was unknown.            Concomitant drugs were not reported.  Treatment medications were not provided.  It was reported that after dose 2 patient experienced normal stuff. Patient did not experience any side effects after first dose.   This case was linked to MOD-2022-436384 (Patient Link).
no adverse event; temperature excursion of 47.9 F for 47 min on 01-DEC-2022; This spontaneous report was received from a certified medical assistant (CMA) and referred to an 18-month-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 16-DEC-2022, the patient was vaccinated with the third dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, lot #W006596 has been verified to be a valid lot number, expiration date was reported as 11-OCT-2024, administered intramuscularly for prophylaxis in left thigh (strength and dose was not provided).  The administered dose of the vaccine experienced a temperature excursion (product storage error) since 01-DEC-2022. The vaccine administered were stored at temperatures excursion of 47.9 Fahrenheit (storage in clinical practice) for 47 minutes. Digital data logger was involved. No adverse event was reported (no adverse event).  This was one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2301USA009088:
Red swollen area on left arm, red area measured approx 5cm x 2cm. Pt was given allergy injection that morning in the same arm. Pt's mother was advised to give pt benadryl.
Same day -fatigue, slept for 4 hrs. 4pm to 8pm. Increasing generalized pain, fatigue, and discomfort first night, through next day.  101 fever.   Severe flu symptoms. Started to abate on Wednesday.
I am a floater that is normally scheduled at locations that carry only Pfizer. I had never administered Moderna booster before. I used an outdated job aid that was posted in the pharmacy as a guide for dosing. It wasn't until a patient had inquired about the booster being half the dose, that I second guessed the dosing and looked it up elsewhere. The patient was injected with 0.5 ml instead of the 0.25 ml . Steps have been taken to report the medication error to upper level management including recommendations to prevent future immunization errors from occurring at this particular store.
Symptoms were undiagnosed but correlated to minor myocarditis which included shortness of breath due to chest pain in the heart area, lasted for about 12 hours and treated with 600 MG of ibuprofen, stopped shortly after treatment.
Pt had fever and went to ER night after received 3rd Gardasil injection - fever = 103 F. Given in ER - Acetominophen 1gm, Ibuprofen 600mg.
Approximately 20 minutes after receiving the Moderna vaccine, I became short of breath. I used my rescue inhaler and it did little to relieve my symptoms. The symptoms were generally mild so I left the location. As I was driving home, by lips and mouth began to feel numb and tingling and the shortness of breath continued. The entire episode resolved within 2 hours with no further complications.
pt recv vax 4DEC97 & immed post vax pt devel erythema (2inches in diameter) around the inj site w/itching;pt recovered the following day;
Hard knot the size of an egg in the armpit in the injected arm.; This is a spontaneous report from a contactable consumer, the patient. A 26-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 27Apr2021 at 13:30 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma. Concomitant medications included levonorgestrel (MIRANA) Intrauterine Device (IUD) used 7 years for birth control. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 08Apr2021 at 14:00 (at the age of 26-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  On 27Apr2021 at 13:30, the patient experienced hard knot the size of an egg in the armpit in the injected arm. The clinical outcome of the event hard knot the size of an egg in the armpit in the injected arm was not resolved.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Left upper arm pain and swelling. Left axillary lymphadenopathy. Vesicular rash in axilla. Another patchy, erythematous rash on left upper arm. General malaise.
At 9:30 pm on 10/17/2018: chills, low-grade fever, body aches, strong headache, cardiac arrhythmia and tachycardia. All symptoms, except the strong headache, resolved about 3:00 am on 10/19/2018. The headache resolved by 5:00 pm on 10/19/2018. Symptoms were treated with bed rest, fluids, and TYLENOL. I have a history of mild arrhythmia and tachycardia episodes, so I monitored my blood pressure and oxygen saturation at home.
developed a rash on my face - 1 week after my second shot; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of RASH (developed a rash on my face - 1 week after 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) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH (developed a rash on my face - 1 week after my second shot). At the time of the report, RASH (developed a rash on my face - 1 week after my second shot) outcome was unknown.            Concomitant product use was not provided. Treatment information was not provided.
Dose possibly administered past 12 hours; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose possibly administered past 12 hours) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose possibly administered past 12 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose possibly administered past 12 hours) had resolved.            No concomitant medications were reported.  Treatment medications were not provided by the reporter.
DIZZY; LITE HEADACHE; FATIGUED; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, expiry: UNKNOWN) .5 ml, administered on 09-MAR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow -up to request batch/lot numbers. No concomitant medications were reported. On 09-MAR-2021, the subject experienced dizzy. On 09-MAR-2021, the subject experienced lite headache. On 09-MAR-2021, the subject experienced fatigued. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the dizzy, lite headache and fatigued was not reported. This report was non-serious.