chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a female patient (demographics not provided) who on an unspecified date was vaccinated with the first dose of Gardasil vaccine (yeast) (lot# not provided). Subsequently the patient experienced a missed menstrual period. The patient sought unspecified medical attention. At the time of this report the patient had not recovered from the missed menstrual period. Additional information has been requested.
This is a spontaneous report from a Pfizer Sponsored program, from a contactable pharmacist. An adult female patient (a doctor) of an unspecified ethnicity received PREVNAR 13, via an unspecified route of administration on an unspecified date at single dose for immunisation. Medical history included ongoing latex allergy. The patient's concomitant medications were not reported. The patient's  arm became swollen on an unspecified date. The outcome of the event was unknown.
Green foul-smelling diarrhea. Started 5/2/04, no treatment was necessary lasted through 5/4/07
swollen upper arm /redness  and radiates toward the armpit areas .  Advised patient to take Benadryl and contact primary physician for further care
Patient received first dose of SHINGRIX 08/02/2018, about 48 hours later patient experienced severe swelling in her arms that progressed to her legs and she also developed a rash on her arms and lower legs initially that migrated up to her upper thighs. Patient was instructed to take BENADRYL and IBU by Rph on 08/04/2018. Patient saw primary care provider 08/06/2018 at which time she received a prescription for prednisone to help reduce the swelling and pain. Patient is being monitored by her physician who has told her to not take the second dose of SHINGRIX.
Dizziness; Nausea; Reportedly vomited; Feels soreness at the injection site; This is a spontaneous report from a contactable consumer (Pfizer colleague) reporting for the patient. A 30-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0171) via intramuscular route of administration in the left arm on 26Apr2021 at 09:30 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history included gallbladder removal at some point within the last year (unknown date in 2020). The patient has no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included paracetamol (TYLENOL), dextromethorphan hydrobromide/ guaifenesin/ paracetamol/ pseudoephedrine hydrochloride (DAYQUIL) and dextromethorphan hydrobromide/ doxylamine succinate/ ephedrine sulfate/ ethanol/ paracetamol (NYQUIL)); all taken for unknown indication from unknown date and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via intramuscular route of administration in the left arm on 05Apr2021 at 09:30 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. On 26Apr2021 at 10:30, within an hour of receiving his second vaccination the patient experienced dizziness and nausea. He reportedly vomited sometime after that. After vomiting, the patient stated that he took a nap and felt better but unsteady with no nausea. After a night's rest, the patient only feels soreness at the injection site and no other symptoms. 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. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event dizziness, nausea and reportedly vomited was resolved on an unknown date in Apr2021; whereas feels soreness at the injection site was resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
STAY ASLEEP / REST LONGER; INJECTION SITE ARM PAIN; FEELING TIRED; LOSS OF ENERGY; This spontaneous report received from a patient concerned a 74 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included high blood pressure, and other pre-existing medical conditions included patient had no known drug allergies. patient was taking multivitamins and multivitamins for the eye. The patient was previously treated with lisinopril for high blood pressure, and amlodipine for high blood pressure. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 180978 expiry: UNKNOWN) dose was not reported, administered on 27-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-JUL-2021, the subject experienced stay asleep / rest longer. On 15-JUL-2021, the subject experienced injection site arm pain. On 15-JUL-2021, the subject experienced feeling tired. On 15-JUL-2021, the subject experienced loss of energy. Treatment medications (dates unspecified) included: menthol/methyl salicylate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from injection site arm pain on 16-JUL-2021, and the outcome of feeling tired, loss of energy and stay asleep / rest longer was not reported. This report was non-serious.
Pt. said entire body was itchy including eyeballs and between toes and private area. Took 2 BENADRYL pt took 2 caps at bedtime and has been better ever since.
Pt called and stated right arm injection site swollen, tender and red. "Can't lift my arm." Spoke with her physician who recommended ice packs to site and Benadryl po every 4 hours.
pt recv vax & devel inj site rxn characterized by 10-40cm area of redness & pain;pt recovered;this is 1 of 11 pt from this facility to devel an inj site rxn p/flu vax lot#4978296;
Flushing / hot flash feeling all over body. Anxiety with hyperventilation and felt like he was not able to breathe with his mask on. Narrative:  Flushing / hot flash feeling all over body. Anxiety with hyperventilation and felt like he was not able to breathe with his mask on.  Other Relevant History:
Became ill with cold symptoms on 10/421, tested positive on 10/5/21 while traveling
SORE ARMS; LITTLE FEVER; 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, route of admin not reported, the batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-MAR-2021, the subject experienced sore arms. On 24-MAR-2021,the subject experienced little fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the little fever and sore arms was not reported. This report was non-serious.
got itchy; bumps; redness; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE PRURITUS (got itchy), SKIN DISORDER (bumps) and ERYTHEMA (redness) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse effect (No medical history provided). Concomitant products included LEVOTHYROXINE for an unknown indication.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (got itchy), SKIN DISORDER (bumps) and ERYTHEMA (redness). At the time of the report, VACCINATION SITE PRURITUS (got itchy), SKIN DISORDER (bumps) and ERYTHEMA (redness) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.      Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: Outcome was updated; 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.
This spontaneous report was received from a medical assistant and refers to multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, concomitant medications, pertinent medical histories and drug reactions or allergies were not provided. On unknown dates, the patients were administered multiple doses of improperly stored VARIVAX (dose, route of administration, lot # and expiration date were not reported). Administered doses of vaccines underwent an unknown temperature excursion, which lasted for an unknown time frame. There was no previous temperature excursion. A digital data logger was involved in recording the excursion. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA002966: US-009507513-1709USA007015: US-009507513-1709USA007016: US-009507513-1709USA007017: US-009507513-1709USA007018.
Starting Friday afternoon, noticed numbing of right tongue and progressed to swelling of upper cheeks and lower eye lid, drooping of right corner of mouth.  Was unable to lift right eye brows and cannot close right eye fully,  Denied loss of taste, still able to eat, drink, and talk. Also had allergy symptoms of fatigue and congestion.  Took Allegra.
Patient received first COVID vaccine given at 3:10 pm approximately. Patient monitored closely at approximately 3:40pm began experiencing itching on left arm by injection site and up in hairline. Noted red patches, no hives, Provider on site made aware of patient itching. No issues with breathing, swallowing able to talk in complete sentences. She was eating a snack and drinking juice without issue 3:45 pm itching both arms and upper back plus up in hairline, complained of chest being heavy. Provider assessed lung sounds lungs clear per provider 4pm this writer notes red patches under chin and on side of face, noted patient scratching their back. Checked shoulder areas hives noted. Provider over to assess. Adult Anaphylaxis Kit accessed and guidelines followed Per Provider, Dr, IM Benadryl given 25mg from Anaphylactic kit. Injection given in Right deltoid no issues noted. Per provider Epinephrine pen 0.3mg given in right upper thigh. Oxygen saturation is 99% and heart rate 121.  4:05pm Patient noted to be shaking she states "this is normally what happens after the Epi Pen" Blood pressure checked and was 121/71 4:15 shaking has subsided she states breathing better 4:17pm reported to RN that breathing normal and patient reports minimal itching. 4:20pm Provider spoke with patient advised to go home and rest Patient understands not recommended to have second shot. Patient was driven back to her work location by employer to get her vehicle. Provider cleared patient to drive home.  Patient symptoms had resolved speaking clearly with no issues
1 week after her MMRV vaccination, my baby developed a fever, it spiked to 103.2 F at 3am and then dropped to 101F. 2 days after that; Sun 6/3; she woke up covered in red dots; we went to urgent care and they said it was an adverse reaction to her shots.
I had the expected side effects of the vaccine during the evening following my second dose---chills, aches and fatigue.  I thought it was over the following day, but it tended to recur every few days, primarily during the night, but occasionally during the day.  The reoccurrences were primarily muscle aches that migrated from my upper legs to my upper arms and occasionally to my head.  Sometimes it seemed to settle in my left knee and hip and was noticeable during the day--this involved more joint pain than muscle pain, so I'm not sure it was related to the vaccine.   The pains seemed to dissipate after 3 weeks, but is still occasionally present as of yesterday, after almost 3 months.
No adverse reaction took place however the patient called inquiring about TB testing and a technician informed her that we did that here. She came to the store and requested TB, the pharmacist at drop off immediately typed in Tdap. It was verified, sold and the patient filled out the form for BOOSTRIX Tdap vaccine. When giving her the shot, I verified the patient and DOB but did fail to describe the particular vaccine she was receiving, assuming that it was correct. After administering the vaccine she asked when she was to come back to get it read. That is when we realized she wanted the TB test, not the Tdap vaccine.
Patient developed redness, swelling, and itchiness at injection site 1 week after Covid shot. She called doctor and they were going to have her come in but symptoms resolved the next day.
Patient woke up 3 days later with hives all over his body.  Patient complains of severe itching on his legs and moderate itching over the rest of his body.  Patient did no go to the Emergency room because he denies having any other symptoms or doing anything different such as changing soaps/detergents and has not eaten anything different.
Child received 3rd dose of Pediarix, Prevnar and Rotateq on 6/15/07. Mom took child with her on errand including a trip to the nail salon. Once there an episode of twitching and jerky movement, of arms legs and head, were noted with episode of shortness of breath, these resolved and mom brought child back to office for exam due to above.
Pt experienced blurred vision, severe headache, and entire left side of his body was numb for 2 1/2 hours. Right side was tingly also.
About 3 minutes after injection began having tachycardia in the 110?s.  This also happened with first injection.  Also experienced palpitations, and some nausea and lightheaded ness.  This lasted for about 25 minutes.  Went to the ER  and was monitored.  Had couple more episodes of tachy/palpitations/shakiness and nausea.  Given Zofran for the nausea.  About 90 minutes later felt better.  Rest of day, some nausea returned along with expected fatigue and headache until 28 hours after injection.
Lower leg weakness and tingling. Taken by ambulance to hospital. It was treated as an allergic reaction and she was released the same day.
Went to ED on 1.12.21 after experiencing tremor, tingling in feet/arms, loss of appetite and fatigue.  Work up by neurology includes MRI and EMG.
Menstruating since 3/30/21. Today is 4/11/21. My period has never lasted more than 5 days.; This is a spontaneous report from a contactable healthcare professional. A 41-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 right arm on 28Mar2021 at 16:15 (at the age of 41-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no allergies to medications, food, or other products. Concomitant medications included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) 60 mg, colecalciferol (VITAMIN D3), mecobalamin (VITAMIN B12) and ascorbic acid (VITAMIN C), all taken from unknown dates for unspecified indications. 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 right arm on 07Mar2021 at 16:15 (at the age of 41-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. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 30Mar2021, the patient experienced menstrual period and it had been continuing till 11Apr2021. It was reported that the patient's period never lasted more than 5 days. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event menstrual cycle started on 30Mar2021 and continuing till 11Apr2021 was not resolved at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Mother noticed knot had formed where injection (DTaP) was given. Became red and now is red and warm with 2cm diameter induration with 1cm/1.5cm fluctuance. Treated with Augmentin. Then incision and drainage done 11/13/02 with 2cc pus expressed and packed with gauze. It will be followed.
fever, body aches, chills, headaches all for 48 hours starting on 12/31/2020
Low grade temp; chills; fatigue.  No treatment.  Other than tired, was better the next day.
Developed redness at Tdap site 36 hours after injection, then full body urticaria. 8/1 Injection, 8/2 urticaria seen at f/u 8/3 given steroids/ATARAX/Famotidine.
Patient is 17 years old  and  8 months. , and received at Pfzier booster shot (3rd dose ) when the FDA approval is for ages>18 years and up. No complications and adverse events reported from patient. No adverse events occurred upon administration
PATIENT REPORTED SEVERE ARM REDNESS, TENDERNESS BELOW INJECTION SITES. FEVERISH FOR ABOUT 24HRS.
Mom stated to this nurse her daughter ran a fever up to 103 couple days after her vaccines.  Stated had a bruise area on her leg, but mom stated she had fat legs.  Mom stated she never had to take her to the doctor or anywhere else and she is doing fine.
Hospitalized 11/20/21-still currently admitted; COVID-19 positive 11/20/21; fully vaccinated  ASSESSMENT / PLAN: Patient is an 85yo male with PMH that includes dementia, HTN, HLD, hypothyroidism who is presents with weakness and was found to be COVID positive.      #COVID-19 COVID positive on 11/20/21. Received Pfizer vaccine x 2 in February. Symptoms include dyspnea on exertion, unclear date of onset. Stable on RA.  - Order CXR - Lovenox - Decadron, remdesivir not indicated, may consider if worsening respiratory status  - Consider MAB  11/22/2021 note: COVID-19 Recent increased weakness and falls most likely due to COVID-19 infection or potentially deconditioning. B12/folate WNL. TSH elevated at 9.6, T4 WNL less likely to be due to hypothyroidism. Plan -Monoclonal antibody being administered today -does not qualify for other COVID treatments as patient on room air -PT/OT ordered -Consult to care manager -PMR consult- recommend SAR or home with assistance 11/24/2021 Note: Discharge Coordination/Progress: Patient's spouse requests to take patient home today.
PT REPORTED ARM SWELLING PAIN IN ARM AND NECK, HEADACHE, DIZZINESS, AND THROAT TIGHTNESS. NO TIME COARSE OR TREATMENT MENTIONED.
Extreme  fatigue, headache, muscle pain, joint pain, chills, violent nausea and vomiting, fever of 101, and diarrhea. After 2 weeks, I am still not normal
This spontaneous report as received from a other via market research agency refers to a patient of unknown age. It was reported that patients over age 65 were recommended with PNEUMOVAX23 (dose, route and frequency unknown). The outcome of recommended for all over 65 was unkonwn. The reporter asked whether booster in five years would be necessary for children with high risk. The reporter considered recommended for all over 65 to be not related to PNEUMOVAX23. Additional information has been requested.
103 degree temperature from around 3am until 10am: took Tylenol 500mg at 6am when I woke up for too much body sweats. Slept for the next day only waking up 2-3 times to drink water and took Tylenol again for headache on upper right side of head hurting minimally less the first away from right side.
About a month after i got the first Covid vaccine jab 4/12/2021, I started having double vision when walking more than 20 minutes. The problem has gotten progressively worse at this point I have frequent headaches, double vision (over lapping images in field of vision), mostly after dark. soreness in the right side of my face. I often have to close my right eye to drive a car or watch TV..  I have had 5 jabs so far (I've continued to get covid boosters and vaccinations when available because my wife is a cancer survivor and I'm concerned for her health).  I've seen an optometrist twice an ophthalmologist and an Ear eye nose and throat specialist. They can't help me.
Pfizer-BioNT ech COVID-19 Vaccine EUA.  Rise in body temp from 94.3 to 99.6, than to 100.3.  Body temp returned to 98.3 after a couple of hours rest.
9/10/2021- Headache, arm pain 9/11/2021- Headache, arm pain, body aches, fatigue, red splotches below injection site. 9/12/2021- Headache, red splotches below injection site 9/13/2021- Headache, red splotches increasing below injection site ( 3 large areas) 9/14/2021- Rash developed under arms  and initial 3 large areas increased redness.  9/15/2021- rash spread all over body 9/16/2021- Rash still spreading over body and initial 3 large areas are still present.
Information has been received from a medical assistant concerning a 5 year old female with no known allergies and no prior medical history who on 8/20/02 was vaccinated in the left arm with a dose of MMR II (641017/1097L). Concomitant vaccination included poliovirus vaccine inactivated in the left arm, DTaP in the right arm and hep A vaccine in the right arm. Later in the day on 8/20/02, the pt was seen in the physician's office for cellulitis, in which redness and swelling extended from shoulder to elbow and Keflex was prescribed. The pt was afebrile. On 8/22/02, the pt was taken to the ER for continued discomfort. On 8/23/02, the pt was seen again in the physician's office and the redness was reported as "down" and she was finishing the Keflex. The reported expressed a concern regarding to the lot number. The records of testing prior to release of this lot have been checked by GMP compliance and found to be satisfactory. The lot complies with the standards of the center for biologics evaluation and research and was released. It was also reported that another child (WAES0208USA04192) received a dose of MMR II (641017/1097L) and had a local reaction. In addition, three other children received a dose of MMR II (641017/1097L) and none had a reaction. Additional info has been requested.
Td given on 07/10/06, IM injection to Left deltoid. States that in AM on 07/11/06, area was purple and itchy, with "knot about the size of a quarter. Came in to PH office on 07/12/06. Reddened area 6cm wide, warm to touch, firm. States that area is painful to touch.
Jerking or arm and neck/head during sleep (while falling asleep and during REM sleep). Accompanied by episodes of inconsolable painful crying during sleep and possible night terrors. Movements lasted for a few months. EEG was given to check for seizure activity, results were negative. Neurologist diagnosed myoclonus caused by vaccines. Pediatrician and Neurologist agreed that the movements were caused by the DTaP vaccine.
This spontaneous report was received from a registered nurse referring to a 31 year old patient with unknown gender. Information about concurrent condition, concomitant medication and medical history was not provided. On 02-DEC-2016, the patient was inadvertently administered a dose of PROQUAD (lot#, expiration date, dose and route unknown) instead of an intended dose of M-M-R II; and also inadvertently administered a pediatric dose of RECOMBIVAX HB instead of an intended adult dose. This error did not occur due to product confusion but rather the provider who administered the dose was distracted and selected the incorrect products. No dose of M-M-R II was administered. No adverse effect was reported. Additional information has been requested.
Severe body aches, Severe arm pain, Severe Headache, nasal congestion, Chills, Temperature of 99.6 despite 400mg Ibuprofen every 5 hours.  With my first vaccine, 3 weeks ago, I was in the bed for 22 hours with chills and severe headache.