chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vesicular rash to all extremities. Seen by PMD was told to use AVEENO bath and anti-itch cream.
Initial and follow up information has been received from a physician concerning a 17 year old white female student with no pre-existing medical conditions. On 10-Oct2006, at 4 PM, the patient was vaccinated intramuscularly with the first dose of HPV rL1 6 11 16 18 VLP vaccine (yeast) (Lot#654540/0800F). Concomitant therapy included an unspecified therapy (reported as "over-the-counter acne medication'). There were no illnesses noted at the time of vaccination.  The physician reported that when the patient left the office she was fine. That same day, the patient had been given desloratadine (CLARINEX) without positive result, by her mother and without physician consultation. On 11-Oct-2006, at 4 PM, the patient developed a rash which appeared on the ear tips, face, elbows, knee caps and around the belly button area. On 14-Oct-2006, the patient went to the emergency room (ER) but was not admitted for an overnight stay. The patient was treated with prednisone. The physician reported that she did not see the patient. The physician reported that the patient "had hives" and was given the steroids in the emergency room which she considered to be routine. At the time of this report, the patient had not recovered from the event. The physician considered the event to be non-serious. Additional information is expected.
Information has been received from a physician concerning a female healthcare worker who was vaccinated with a dose of varicella virus vaccine live.  Subsequently, the patient developed 19 pox-like lesions approximately 10 days to 2 weeks after vaccination.  The patient reported the lesions to be pruirtic with heads.  It was noted that she missed work and had a fever for approximately 10 days post-development.  Unspecified medical attention was sought.  There was no product quality complaint involved.  Additional information has been requested.
COVID-19; The doctor had advised her that she needs to wait 90 days before receiving the second shot; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 (COVID-19) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Breast cancer and Mastectomy (left breast cancer surgery).    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced COVID-19 (COVID-19) (seriousness criterion hospitalization) and PRODUCT DOSE OMISSION ISSUE (The doctor had advised her that she needs to wait 90 days before receiving the second shot). On 23-Mar-2021, PRODUCT DOSE OMISSION ISSUE (The doctor had advised her that she needs to wait 90 days before receiving the second shot) had resolved. At the time of the report, COVID-19 (COVID-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication information was provided. The patients treatment medication information included Bamlanivimab and another drug of which she does not recall.  Company comment: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.  Very limited information regarding this event/s has been provided at this time.  Further information has been requested.; 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.  Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
Narrative:  Patient was seen prior to administration of the 2nd dose of Moderna COVID-19 vaccination. He reported experiencing the following sx:  Extreme fatigue a/w vivid dreams (similar to when he had COVID in July 2020) the evening after the vaccination. O/n intermittent chills that he took hot shower to a/w.  Following day: fatigue improved, but was still present. Continued intermittent chills, new HA.  3rd day: improved back to baseline Reviewed common side effects of COVID vaccination and discussed when to see care + s/sx for which to seek emergency care. Patient with no further questions/concerns and stated a desire to proceed with vaccination.
GOT COVID; This spontaneous report received from a patient via a company representative concerned a 72 year old of unspecified 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 and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. Age at time of vaccination 8 decade old. The batch number was not reported. Per procedure no follow-up will be requested for this case. No concomitant medications were reported.  On SEP-2022, the patient experienced got covid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of got covid was not reported. This report was non-serious. This report was associated with a product quality complaint:
day 2 arm soreness. asymptomatic after for x6 days. Day 8 noted erythema, edema, warm rash around injection site.
Reactivated a head injury I sustained about 6 years ago.  Symptoms: trouble  walking; tiredness; head pain; trouble communicating with words (slightly incoherent) etc. This began immediately following the injection & is still here these 3 1/2 weeks later. I reported this to Urgent Care & have been resting very much etc.
Evening of 1/22 began to have low grade fever, body/muscle/joint pain and arm of injection site was itching, red and painful. 1/23 had headache, fever, body/muscle aches, joint pain, dizziness and arm of injection site had increased redness, swelling itching and pain. 1/24 symptoms continued. Woke up on 1/25 with less muscle/joint pain, mild headache, no fever, felt able to work so drove in to work. At approximately 0530am I began to feel my heart racing, I checked my pulse several times between 0530 and 0700 when I was relieved from my work station and heart rate was between 128-140.
I observed a small white dot on my penis; I observed a small decolorized patch on my penis forehead; confirmed as Vitiligo; high level of depression; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202200321990 A 43 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 11Jun2021 15:00 (Lot number: EW0183) at the age of 43 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, lot_number=EW0169,, administration date=21May2021,, administration time=01:30, location=Left arm), administration date: 21May2021, when the patient was 43 years old, for covid-19 immunization. The following information was reported: PENIS DISORDER (non-serious) with onset Jul2021, outcome "not recovered", described as "I observed a small white dot on my penis"; SKIN DISCOLOURATION (non-serious) with onset Jul2021, outcome "not recovered", described as "I observed a small decolorized patch on my penis forehead"; VITILIGO (non-serious) with onset Jul2021, outcome "not recovered", described as "confirmed as Vitiligo"; DEPRESSION (non-serious) with onset Jul2021, outcome "not recovered", described as "high level of depression". The events "i observed a small white dot on my penis", "i observed a small decolorized patch on my penis forehead", "confirmed as vitiligo" and "high level of depression" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of penis disorder, skin discolouration, vitiligo, depression.  Additional information: The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. AE treatment: Applying ointments as prescribed by dermatologist
Initial case received from a health care professional on 24 March 2011. It involves a cluster of 3 patients who "did not convert" after receiving three doses of IMOVAX. Three patients received 3 pre-exposure doses of IMOVAX (lot number not reported), intramuscularly into the deltoid. After 45 days they had titers drawn, and "they did not convert"; per the reporter, REFIT results were less than 0.1IU/mL. No adverse events were reported. The patients were scheduled to receive a fourth dose of IMOVAX, and a titer was to be re-drawn. No additional information was reported.
According to the pt covid vaccine card, pt received orange cap 5-11yr covid dose. Per the immunization information system, pt recieved age appropriate dose. The clinic notified of their error. No side effects. Per the public health department, ok to give age appropriate dose today.
Information has been received from a licensed practical nurse concerning a 47 year old female patient with drug hypersensitivity to DEMEROL, who on 13-DEC-2007 was vaccinated SQ in the right arm, with a dose, 0.5 mL, of pneumococcal 23v polysaccharide vaccine (lot # 657526/0555U). Concomitant therapy included SYNTHROID. On 13-DEC-2007, the patient developed cellulitis in the arm where the vaccine was administered "from the injection site to her elbow." She visited the emergency room, and a complete blood count was performed (details and result not provided). At the time of this report, the patient was recovering. Additional information has been requested.
Arround sept 20 (I dont remember if it was before ar after) I started with a very loud tinnitus on my left  ear that is difficult to ignore. In general I do have some but not so loud. My vaccination was Pfizer  3/6/21 and 3/27/21. On 8/29/21 I got the Pfizer booster. Could this be the result of the booster?  Also On sept 20 I had  shot of Stellara1
Information has been received from a physician concerning a 5 year old male with a history of asthma who on 1/7/99 was vaccinated with a second dose of Hep B vaccine. Comcomitant vaccinations are MMR. On 1/7/99, the pt experienced redness, swelling, itchiness and a rash at the injection site. The pt was treated with ice and Benadryl.
TRANSIENT CEREBRAL ISCHEMIA 4/14/2023 HTN (HYPERTENSION) RIGHT FACIAL MUSCLE WEAKNESS 4/10/2023 HTN (HYPERTENSION) TRANSIENT CEREBRAL ISCHEMIA 4/14/2023 MIGRAINE RIGHT FACIAL MUSCLE WEAKNESS 4/10/2023 MIGRAINE
Fever of 102; severe shaking/chills; body aches; dizziness; fatigue; nausea; headache
First night I had headache and chills, some muscle soreness during the night.   10 days later I got the Influenza vaccine.   Day after influenza vaccine I started to get severe pain in lower back (near coccyx), both glutes and legs.  I could not sleep as lying down or putting my legs up made it worse.  The next moring I took dexketoprofen  and at night cyclobenzaprine with lysine cloxinate, but the pain barely subsided.  I had to go to the emergency room the pain was so severe (9 or 10) I had to sleep sitting down that night.  At the ER they took an xray, said they could find nothgin wrong there- They gave me an injection of tramadol with ketorolac, and told me to see a neurologist the next day.  Next morning I went to a neurologist and he diagnosed sacroileitis (I had gone bike riding 5 days before).  I asked if it might be because of the covid and influenza vaccines recently, but he attributed the pain more to the bike ride.  The bike seat was hard and I was sore in genital area from that, but I felt no muscle soreness nor discomfort day after the ride. (I had not ridden a bike for over 30 years though)  .   The neurologist gave me an injection of diprospan (betamethasone) and prescribed Celebrex and the Lysine and ciclobenzaprine.   The pain has subsided a bit, but still I feel tingling in feet and at night the back pain and glute pain keeps me up.
COVID-19 hospitalization, requiring oxygen. Concomitant Legionella bacterial pneumonia. Received 3 days of Paxlovid prior to admission.
Information has been received from a LPN concerning a 6 year old male with no allergies or medical history who on 23 Jun 2000 was vaccinated with a 0.5ml dose of Varivax (lot # 634506/1770J). There was no concomitant medication. ON 12 Apr 2006 the patient presented with about 20 vesicular lesions spread over his scalp, trunk arms and legs. No other symptoms were noted. No labs were done. At the time of this report the patient was recovering. No product quality complaint was involved. Additional information has been requested.
This case was reported by a healthcare professional and described the occurrence of herpes flareup in a subject of unspecified age and gender who was vaccinated with Hepatitis Bvaccine (manufacturer unspecified). On an unspecified date the subject received unspecified dose of Hepatitis B vaccine (details unknown). At an unspecified time after vaccination with Hepatitis B vaccine, the subject experienced herpes flareup and herpetic mouth sore. At the time of reporting the outcome of the events was unspecified. The healthcare professional had inquired as to whether getting the Hepatitis B vaccine would cause a herpes flare up causing sores in mouth. No further information was provided.
Fever, chills, flu-like symptoms began about 3 hours after vaccination administration. Noticeable discomfort in shoulder joint began immediately upon administration of the vaccination (during insertion of the needle and prior injection of the vaccine) to the point where I commented about this one hurting. Note: Vaccination was given high up on the shoulder area. I did not observe the angle of the injection (upward angle, parallel to floor, or downward angle). I'm not one to complain about needles as I'm a long term blood donor and have received many needle pokes. Shoulder pain is making it difficult to raise my arm above shoulder height. Noticeable pain begins when elbow is raised to 45 degree angle and beyond or when pushing against an object with that arm. Note: this pain began at vaccination administration but has progressively gotten worse over a five hour period.
Severe nausea and vomiting for 24 hours, extreme headache, lethargy and fatigue for 4 days, muscle and joint pain for 3 days
compromised immune system after injection series led to extreme herpes simplex outbreak that has lasted to present day with bleeding ulcerations
Vaccination site rash; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Vaccination site rash) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced VACCINATION SITE RASH (Vaccination site rash). At the time of the report, VACCINATION SITE RASH (Vaccination site rash) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Myocardial infarction: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication use was not provided.  Treatment information was not provided.
I had a stroke on November 8th. I began having PVC heart palpitations on Aug 1. They lasted about a week. They came back for several days at a time in the weeks after. I began having dizzy or lightheaded spells in October. I then had a stroke on November 8th. I am 34 years old and was healthy.
Patient was noticing a hard time swallowing 15 minutes after vaccination.  She thought her throat may have been dry. She did not notice any swelling in mouth or around mouth.  She took a sip of water and felt better.  I gave her one benadryl 25mg capsule and had her stay an additional 15 minutes.  At the end of the full 30 minutes she did not have an issues swallowing but did have a stomach ache.  She did not have any other symptoms and her mother thought it was nerves.  I instructed them if anything changed or if she had any additional symptoms to go to the ER and follow up with me as soon as possible.
27JUL97 had injury to rt hand pt recv vax & 29JUL97 c/o pain rt upper arm, shoulder, rt side of neck, rt side of face, around rt ear to forehead;
Pt ordered HepB vaccine. Box of  read 4/12 exp date. Box opened for first time, vaccination removed & given to patient. Afterwards nurse was entering lot & exp date noticed individual vial was dated 3/12/11. Apparently this error occurred at manufacturer's end as the clear wrap was in place, not opened.
Erythema, doesn't move left arm T 100.0, increased redness, started one day after vaccination. Warm to touch, swelling and erythema extends upper arm to near elbow.
Background: About two years ago I felt like my heart was pounding.  It lasted about 6 weeks.  I did see a cardiologist who said I had extra heart beats.  This past March 4 , 2021 I had my 2nd Covid shot.  About 1-2 weeks later my heart started pounding again.  I didn't associate it with the vaccine.  I went to cardiologist again who did testing and again said extra heart beats but I am fine.  It all lasted about 4-.5 months (hadn't felt it since about end of July or beginning of August).  Now, Sept 26 I had Pfizer booster.  Three days later after dinner I felt heart pounding.  It lasted a few hours but gradually got so it wasn't pounding badly.  Woke up fine.  After lunch it started again for about an hour.
(R) deltoid - 3 cm wide bump - Iced for 10 mins bump went down.
Injection given at 3:30 pm. Symptoms at 6:30 pm. Sudden onset sore throat, runny nose, fever 101 degrees. At 10:00 PM woke up with palpitations BP 85/50, HR 131. Woke up next morning eyes red, crusty swollen. Upper lip swollen. Took PREDNISONE 30mg, BENADRYL .25mg. S/S improved by 6:00 PM.
STATES IMMEDIATE PAIN AT INJECTION SITE TRAVELING DOWN ARM.  BY LATER EVENING- DIFFICULT TO LIFT ARM, TENDER TO TUCH.  PATIENT USED HEAT AND PASSIVE ROM WITH SOME RELIEF.  BY SUNDAY EVENING- BETTER MOVEMENT, BUT FINGERS "TWITCHY".
One month before the vaccine, I had a case of shingles and it was a relatively non trivial case and it wasn't just mild, it really set me back. I had fever and the skin lesions and it went away with prednisone. I thought it was over but 2 days after the first shot I broke out again pretty badly and it went back down and I thought it was over. It lasted for 2 weeks but it didn't completely go away.
This case was reported by a healthcare professional and described the occurrence of intussusception in a 6-month-old male subject who was vaccinated with ROTARIX (GlaxoSmithKline). Previous vaccination included 1st dose of ROTARIX (GlaxoSmithKline) given on 25 March 2009 and ROTATEQ (manufacturer unspecified) given on 15 May 2009. Concurrent vaccination included PENTACEL (manufacturer unspecified), ACTHIB (manufacturer unspecified), ENGERIX B (GlaxoSmithKline) and PREVNAR (Wyeth Labs) all given on 17 July 2009. There were no concurrent medications. On 17 July 2009 at 11:09 the subject received 2nd dose of ROTARIX (oral). This was actually the 3rd dose of rotavirus vaccine as ROTATEQ was given to the subject inbetween doses of ROTARIX. An extra dose was administered. It was noted that the lot number for the ROTARIX diluent given with dose 2 was A41DA860A with an expiration date of 25 September 2011. On 18 August 2009, in the evening, 1 month after vaccination with ROTARIX, the subject experienced intussusception with pain, fever, abdominal mass and lethargy. The healthcare professional considered the events were clinically significant (or requiring intervention). The subject was seen by his physician and administered a barium enema as treatment which seemed to straighten everything out. At the time of reporting, the subject was at home resting and was reportedly improved. The subject's physician did not think the events were caused by ROTARIX.  9/23/09  PCP records received dated 8/18/09-9/17/09 with DX:  Intussusception. Pt presented 8/18/09 with vomiting, watery stool and excessive drooling. T'=99.2'F.  Abd mass palpated in LLQ. Sent for outpt US which was (+) for IS. Barium Enema done with reduction of the IS.  Observed in pcp office and d/c home doing well.  Returned 9/13 09 after episode of vomiting. Abd exam WNL.  (+) R OM.
Approx. 3 x 4 area of raised erythematous plaque on left deltoid corresponding with injection site location. Low grade fever 99.5 and 1 episode of emesis. Tx: BENADRYL topical/oral, ibuprofen/TYLENOL OTC/PRN, cool compress.
chest pain, started 2 days after 2nd pfizer vaccine, went to primary care doctor who did an ECG, show sT wave changes, they sent to ER immediately.  Was sent to Cardiac care unit, had echocardiogram and cardiac cath showing pericardidtis and myocarditis.
Information has been received from a consumer concerning currently 15 year old female patient with no pertinent medical history and no drug reactions/allergies who on an unspecified date, was vaccinated with the second dose of GARDASIL (lot # and route not reported) 0.5 ml. There was no concomitant medication. Consumer reported that on an unspecified date, minutes after getting her second GARDASIL dose, the patient had a seizure and was taken to the emergency room (ER) of an unspecified hospital. They did a magnetic resonance imaging (MRI) of her brain and the diagnosis was a conversion, which was a misfiring of the electrons in her brain due to traumatic bodily injury. Since this happened, she had had headaches, passed out all the time. she had tingling in her hands and feet, blurry vision, pain in her rib area, and a loss of memory of the last three years. She went to an unspecified neurologist, who could not pin it to the vaccine. She had missed 55 days of school since the event started. The patient's mother said that physician dismissed the idea that it was due to the vaccine, so she switched to an unspecified doctor in the same practice. The consumer had been to the emergency room (ER) multiple times. It was reported that the events occurred after reintroduction. It was also reported that these events were a significant disability. It was not know if the days of school the consumer missed were consecutive and if the patient was ever admitted to the hospital. At the time of the report, the patient's outcome was unknown. Therapy with GARDASIL was discontinued after the events happened. Additional information has been requested.
Within 24 hours a fever of 101.3 and extreme fatigue set in.  1" raised red lump at injection site with redness, pain, and itching.  Benedryl and Tylenol taken as indicated on package and symptoms were mostly alleviated in 36 hours.  Redness and itching remain at swollen injection site 72 hours post injection.