chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a consumer for GARDASIL, a Pregnancy Registry product, concerning her granddaughter (who she adopted) 17 year old with no pertinent medical history and no allergies who on 31-AUG-2011 was vaccinated with the second dose of GARDASIL and was pregnant. Also, another vaccine was given on that same date, but consumer did not known which one. After the vaccine administration her granddaughter had exam (results not provided) and urine test which confirmed she was pregnant. Consumer stated her granddaughter was not experiencing any problems, was healthy. The patient sought unspecified medical attention (she was in the office). No treatment was given for the treatment of the adverse event. It was reported that the date of LMP was on 10-JUN-2011. EDD was on 16-MAR-2012. Follow up information has been received. There has been no response to any attempts for outcome. The case is lost to follow up. Pregnancy outcome was reported as lost to follow up. No further information is available.
Complained of tongue/lip tingling and numbness evening of date receiving flu shot (11/04/2003).  Progressed over next 2 days to left sided facial paralysis.  Diagnosis: probable Bell's Palsy by PMD; placed on steroids.
Seems like it gave COVID; Fissures of skin/cracking of skin on fingers near cuticles; Little dizzy; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Seems like it gave COVID), SKIN FISSURES (Fissures of skin/cracking of skin on fingers near cuticles) and DIZZINESS (Little dizzy) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product IBRUTINIB (IMBRUVICA) tablet for an unknown indication.    Concomitant products included COVID-19 VACCINE for COVID-19 vaccination.   In June 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started IBRUTINIB (IMBRUVICA) (Oral) 420 milligram. In 2022, the patient experienced SKIN FISSURES (Fissures of skin/cracking of skin on fingers near cuticles) and DIZZINESS (Little dizzy). In June 2022, the patient experienced IMMUNISATION REACTION (Seems like it gave COVID). At the time of the report, IMMUNISATION REACTION (Seems like it gave COVID), SKIN FISSURES (Fissures of skin/cracking of skin on fingers near cuticles) and DIZZINESS (Little dizzy) had not resolved.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No known allergies were reported.  The reporter's causality for the event(s) of received Imbruvica, it seems like it gave COVID, little dizzy and cracking of skin on fingers near cuticles was not reported.  No treatment details were provided
0.9% NS diluent was not used for the Pfizer-BioNTech Covid-19 vaccine, when 0.3 mls was drawn up from the vial, not much was left should have enough for for 5 more doses. Diluent was recorded on the paperwork but not added due to stress and too much going on at that time and I got confused
received the first dose of Pfizer's COVIDs vaccine on 02Apr2021. On 05Apr2021, he was tested positive for COVID; This is a spontaneous report from a contactable consumer (patient himself) via a medical information team. A 41-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on 02Apr2021 (at the age of 41-year-old) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 05Apr2021, he was tested positive for COVID and was told that he could not receive his second dose until 90 days later. He was supposed to get his second dose this Friday. Caller was wondering if that was true or not. The patient underwent lab test and procedure which included COVID: Positive on 05Apr2021. The outcome of the event was unknown.  No follow-up attempts are needed; Information about lot/batch number cannot be obtained.
don't spit up sputum maybe once in a while; pneumococcal pneumonia; pneumococcal pneumonia; COPD; shortness of breath; had a pain in my side; sweat a lot; no energy; diabetes; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that the female patient of an unspecified age received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient had got pneumococcal pneumonia twice in a row within two months. Her last doctor in the hospital, the second hospital, put her into a breathing unit. And the doctor thought she had got chronic obstructive pulmonary disease (COPD). The patient had diabetes too and it came on suddenly. The patient didn't cough at all. The patient had a pain in her side and she sweated a lot. And shortness of breath and no energy. For the first time she was in the hospital for two weeks. Two months later she had the same thing happen to her all at once. And again she was sweating. She had pain in her side once in a while. Shortness of breath. No energy. And she was in the hospital for four days. That doctor sent her out oxygen unit home with her that she could not get rid of because the doctor thought she had COPD. The patient was at the moment undergoing lung tests to verify what she had because she didn't want it to happen again. As she said it was very sudden, she had no colds, she didn't wheeze. She didn't spit up sputum maybe once in a while. And she did spit up some for the hospital, the last hospital, but they never got it in the lab. The patient believed this was bacterial and not viral. The outcome of events was unknown.   No follow-up attempts are possible, information about batch number cannot be obtained.
Face (cheeks from under eye to jaw line on both sides of face) turned very red and blotchy.  At  one point, strange sensation in the throat then went away. Face redness lasted approximately 3 hours. Was also fatigued. Felt back to normal after 3 hours.
Pain / swelling initially at injection site then increasing 6 inches down from injection site/Sore, swollen, hot to the touch; Pain / swelling initially at injection site then increasing 6 inches down from injection site/Sore, swollen, hot to the touch; Pain / swelling initially at injection site then increasing 6 inches down from injection site/Sore, swollen, hot to the touch; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from a sales representative.  An elderly female patient (not pregnant) received rsv vaccine prot.subunit pref 2v (ABRYSVO), in Oct2023 as dose number unknown, single (Batch/Lot number: unknown), in arm for immunisation; for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), VACCINATION SITE SWELLING (non-serious), VACCINATION SITE WARMTH (non-serious) all with onset Oct2023, outcome "recovered" (Oct2023) and all described as "Pain / swelling initially at injection site then increasing 6 inches down from injection site/Sore, swollen, hot to the touch". It was unknown if therapeutic measures were taken as a result of vaccination site pain, vaccination site swelling, vaccination site warmth.  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v, rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.
LEFT side numbness- ear, face, cheek, lower lip, tongue, neck.  The numbness felt like novacaine .  LEFT gland pain.
Severe pain at injection site while vaccine being given. Increased pain and soreness to right shoulder joint, 24 hours later unable to move right shoulder continued with pain and decreased ROM. Saw ortho Dr. on 10/7/16 PT on 10/10/16, continue with PT to improve ROM.
On 7-24-2022, I woke up feeling hot with a temp of 101.2, head congestion, cough, sneezing, oxygen level 95% with slight shortness of breath, extreme headache, cold sweats, blue colored feet with edema, muscle stiffness and pain all over. I took a home COVID-19 test with positive results. I sent an email to my primary care doctor. On 7-25, the doctors office called me back and they ordered a chest x-ray and prescribed PAXLOVID. I started taking the medication on the evening of 7-25. I took the chest x-ray on 8-2 which showed lungs were hyperaerated. I feel a little better today and I am moving easier. I am reporting a break through case of COVID-19.
Information has been received from a registered nurse concerning patient of unknown age and gender. The patient's concurrent conditions, medical histories and concomitant therapies were not reported. On 25-AUG-2017, the patient was vaccinated with improperly stored VARIVAX injection (lot # N000683, expiration date 06-JAN-2019; strength, dose, frequency and route were unknown) for prophylaxis, which was exposed to temperature excursion of -14 to -10 degrees Celsius for 1 hour. The previous temperature excursion was -9 to 8 degrees Celsius for 1 hour. Data logger was involved. No adverse effects were reported. No product quality complaint (PQC) was involved.
Patient received original Pfizer a day after the FDA approved the Pfizer Bivalent vaccine. Pharmacy did not have any bivalent vaccine yet and patient needed vaccination for travel purposes.
I have had extremely painful reaction to my second dose yesterday; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (I have had extremely painful reaction to my second dose yesterday) 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 VACCINATION COMPLICATION (I have had extremely painful reaction to my second dose yesterday). At the time of the report, VACCINATION COMPLICATION (I have had extremely painful reaction to my second dose yesterday) outcome was unknown.            Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
6 days post injection woke up with 2 inch circle of bright red rash around injection site. Minor itching.  Lasted 6 days.
HAD SHOT IN LEFT ARM - AT 6:00PM LEFT HAND WENT NUMB.  AT 8:00 HAD SEVERE CHILLS & HIGH TEMPERATURE WHICH LASTED FOR 24 HOURS.  HUGE BODY PAIN & COULD NOT MOVE ANYTHING.  NECK & HEAD HURT SO BAD I COULDN'T STAND TO MOVE.  I COULDN'T LIFT ARMS TO DRINK WATER.  SON TOOK CARE OF ME ALL DAY THE DAY AFTER THE SHOT.  HAD BRAIN FOG.  COULDN'T THINK WHAT I WANTED TO DO OR WHAT I WAS DOING.  LASTED FOR A WEEK.  AFTER A WEEK I TRIED TO DO MY USUAL WORKING OUT ROUTINE, BUT WHEN I TRIED TO RIDE THE ELLIPTICAL I BROKE OUT IN A HUGE SWEAT AN ALMOST PASSED OUT.  THAT LASTED UNTIL 2/22/21, WHICH WAS YESTERDAY, WHEN  I WAS FINALLY ABLE TO RIDE ELLIPTICAL WITHOUT ANY ADVERSE REACTIONS.   (I'M 86, BUT A VERY ACTIVE 86.  I PLAY TENNIS 2 TIMES A WEEK & WHEN WEATHER IS NICE I RIDE MY BIKE FOR 15 MILES A COUPLE TIMES A WEEK.) LIFT WEIGHTS 3 TIMES A WEEK AFTER RIDING ELLIPTICAL FOR 45 MINUTES.  NOT A TYPICAL 86 YEAR OLD PERSON.
her husband could have been exposed or contracted COVID-19 on that Friday before receiving his vaccine; He has a little stuffiness, and coughs up a little phlegm when clearing his throat; He still has his sense of taste and smell, although he feels his smell is diminished; He still has his sense of taste and smell, although he feels his smell is diminished; received his first dose last Friday and has tested positive for covid; This is a spontaneous report from a contactable Consumer. This Consumer (Patient's wife) reported for a male patient that. A 60-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 22Jan2021 (Batch/Lot number was not reported) intramuscular on arm left at single dose for covid-19 immunisation. Medical history included She woke up that Friday, 22Jan2021 feeling very ill with a headache. The patient's concomitant medications were not reported. It was reported that The caller's husband received his first Pfizer COVID-19 vaccine last Friday, 22Jan2021. That Sunday, her daughter tested positive for COVID. Her husband went and got tested and was positive. If he was positive and is due to having second shot, should he be getting it reporter questioned. He technically could have had COVID when he received his first vaccine. She did not know. She explains he did not have any symptoms, she clarifies further he has mild symptoms. Caller clarifies further her daughter does not live with them. She came home on her birthday on 21Jan2021. Her daughter works from home. She has no idea where she contracted COVID-19. She has gone nowhere. It's all a mystery. She woke up that Friday, 22Jan2021 feeling very ill with a headache. Her daughter tested positive on Sunday, 24Jan2021. Therefore, her husband could have been exposed or contracted COVID-19 on that Friday before receiving his vaccine. Obviously, they are not certain. He has mild symptoms. She clarifies her husband has been stuffy for months. He has a little stuffiness and coughs up a little phlegm when clearing his throat. He still has his sense of taste and smell, although he feels his smell is diminished. When attempting to confirm when these symptoms began, she states its unknown. It was just been chronic. He feels fine. He would never say he has COVID based on how he is feeling. He was due to get the second shot and she is just trying to determine if he should get it or if should wait questioned. They both went through a drive-thru clinic on 27Jan2021 and had the nasal swab. They got the results yesterday, 28Jan2021, and her husband tested positive. Outcome of the events was unknown.   No further information was provided or obtained.
Lost hearing in right ear within 8 hours of receiving vaccination. Hearing never returned. Three separate hearing tests confirmed hearing loss.  PCP and ENT both unable to find any other cause of hearing loss.  Was given a steroid injection in the ear with no change.  MRI revealed no tumor, etc. and was determined to be normal.  Still no return of hearing.  ENT recommending cochlear implant.
Swelling and erythema 8cm x 8cm at vaccine site < 2:40 after administration (left deltoid)
606 doses were given after expiration date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (606 doses were given after expiration date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant information was reported.  The date of placed in refrigerator was on 21-Sep-2021 and vaccine did not underwent any temperature excursion. No other adverse events were reported for patient.  No Treatment information was reported.
Report received from Pt's private MD stating dizziness after H1N1 vaccine possible labyrinthitis - B/P also elevated 162/98 - MD instructed to keep hx of B/P readings prescribed ANTIVERT 25mg 1/2 tablet 3x days to return PRN - MD reported as H1N1 flu reaction.
Swollen, red, painful itching arm that appeared 9 days after the vaccine. Has continued to get worse for the last 5 days
Extreme pain after injection. 2 days later swelling. Erythema below site and toward the chest. (No erythema at injection site). Warm to touch.
Breathing problems: Woke up with a barking cough, couldn't get full breaths, lips with blue tinge all through the night until morning. Held her in a steamy shower to open her lungs and then in our bed with a humidifier. Was better by the following afternoon.
after second dose, severe headache; continued ear infections; vertigo; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old non-pregnant female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: ER8727) via an unspecified route of administration on 31Mar2021 (at the age of 52-years-old) on left arm as dose 2, single for COVID-19 immunization. Medical history included penicillin allergy. Concomitant medications were reported as none. Prior to the vaccination, the patient was not diagnosed with COVID-19 and was not tested for covid post vaccination. The patient did not receive any medication within two weeks of vaccination. 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 VACCINE; Solution for injection; Lot number: EN6206) via an unspecified route of administration on an unknown date in Mar2021 at 09:45 (at the age of 52-years-old) on left arm as dose 1, single dose for COVID-19 immunization. On an unknown date the patient experienced severe headache and continued ear infections with added vertigo. Patient was now post-vaccination two weeks. The events resulted in doctor or other healthcare professional office/clinic visit. Steroid treatment was started 5 days after 2nd dose of vaccine. The patient had not recovered.  No follow-up attempts were needed. No further information was expected.
Second dose of DTAP vaccine administered at 4 months of age at approximately 5PM along with HIB, IPV and PCV7 vaccines.  Age appropriate dose of acetaminophen was given shortly thereafter.  At 7PM, patient began screaming inconsolably for another hour.  During this hour she also experienced a series of 3 convulsions, which lasted for less than one minute.  Her head and body were jerking uncontrollably.  She did not have a fever.  At 11PM she suddenly stopped screaming and looked around in a dazed/confused manner.  No additional reactions were noted.
Patient is a healthcare worker that provides direct patient care. Pt. received 2nd dose of Pfizer COVID19 vaccine on 1/27/21.  Pt reported COVID like symptoms starting 4/18/21 and tested COVID positive on 4/22/21.
heart problem after the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DISORDER (heart problem after the vaccine) in a 69-year-old male patient 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 CARDIAC DISORDER (heart problem after the vaccine). At the time of the report, CARDIAC DISORDER (heart problem after the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided by the reporter. No Treatment information was reported.
Pt accidentally received Pfizer COVID-19 vaccine instead of Hepatitis B.  Explained to pt what happened and discussed possible side effets. Verbalized understanding. Pt then received Hep B vaccine as intended.
1/26/21- Tuesday.  5:00PM Received vaccine in upper right arm. Monitored at site for 30 minutes, no adverse reactions. Released. Drove home about 20 minutes from site.  7:00PM to 10:00PM ? Had dinner, began to feel soreness at injection site. Soreness continued to increase throughout the evening.  10:00PM  Went to bed at 10PM, had difficulty going to sleep due to injection site soreness. Restless.  11:00PM ? 1:45AM Began to get more intense chills, numbness in legs, some sweating, shaking. Could not get warm. Could not sleep. Very uncomfortable. Continued to escalate. 2:00AM Woke up my girlfriend (partner) in bed next to me and she observed the following. Sat up in bed. Complaining of feeling flush, sweating, nauseated. She said I seemed to ?black out?, starting at her, breathing loudly. She had to ?shake me? to get me to respond back to consciousness. She told me I felt very clammy, and pale ? felt quite warm, I complained of a headache. Event last around 30 minutes then I began to get more chills. I took some Ibuprofen for the headache. Eventually was able to go back to sleep, but some not a restful evening. 1/27/21 ? Wednesday  Awoke around 7:30AM ? Still a little pale, lethargic, drained with headache most of the day. Ate normal meals.  Injection site soreness continued for 2 more days. Subsided 1/29/21. 1/29/21 ? 1/31/21  Continued to improve. No more adverse reactions, no headache, no chills, no elevated temperature. 2/1/2021 Back to normal.
Patient became incoherent for a few seconds while sitting in a chair in the observation area. Pharmacy manager went to observe patient and ask how she was feeling. Patient's head started to droop to the side for a few second and her shoulders made shrugging movements for a few seconds. During this time I called 911, while individual waited with the patient seated in the chair. Patient became more coherent in a few seconds and could speak and smile normally. Ambulance came and patient went with paramedics.
Had initial arm discomfort after receiving her flu vaccine in her left deltoid. Discomfort improved although 6 weeks post vaccination patient has continued experiencing on and off soreness and weakness to her left arm since receiving her vaccine, ie., unable to shoulder press 10 lbs due to arm weakness.
pt recv vax 2JUL92 & 1MAY96 pt exp subacute sclerosing panencephalitis;pt mom indicated that the CDC said SSPE is caused by measles virus probably through immun. This is in follow-up to report (s) previously submitted on 05/29/1997; 05/29/1998; 05/21/1999. Information has been recieved from the mother of a 5-year-old female who on 02 Jul 92 was vaccinated with MMR II. On 01 May 96, the patient experienced subacute sclerosing panencephelitis. The patient's mother indicated that the CDC said "SSPE is caused by measles virun probably through immunization. " No futher details wre provided.
Aches and pain from head to toe.  Severe pain all over for 3 days.  4th a little better. 5th day was able to get out of bed. Worse then the shingles that I had in the past. Left arm is still sore.