chrisvoncsefalvay/vaers-outcomes huggingface dataset:
idiosyncratic myocarditis; This spontaneous report was received from a pharmacist on behalf of his son, a 19 year old male patient. the patient's pertinent medical history, concurrent conditions or concomitant medications were not reported.  On an unknown date (also reported as "in the past"), the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (additional dosage regimen information was not reported).  On an unknown date (also reported as "within 3 weeks of GARDASIL 9"), the patient had pain in the chest. Then, he was admitted to ICU for 4 days and was diagnosed with myocarditis. It was mentioned that the physicians could not pinpoint what virus could have be lead to myocarditis, but it was diagnosed as idiosyncratic. Due to unknown reasons.  The patient was under care of an immunologist for unknown reasons and would have an unknown lab work done for immunology related reasons.  At the time of the report, the outcome of myocarditis was unknown. No causality assessment was provided.  Upon internal review, myocarditis was considered to be medically significant.
8/18/21: presents to the ED with tingling of left extremities since 10 am this morning. Per the patient, she tested positive for Covid-19 this weekend, but is currently feeling better. She adds that she is fully vaccinated (4/16/21 & 6/4/21). However, this morning she developed tingling in her left fingers and toes that has now started to progress to her mid arm and shin on her left side. The patient denies fever, loss of sensation, loss of movement, or any further complaints.  the course/duration of symptoms is worsening.  Location: Left upper extremity lower extremity. The character of symptoms is tingling. Was treated for r/o CVA. No covid related diagnosis or treatment. Discharged to home 8/19/21.
Pt complained his left arm swelled the evening of 10/13/10 at around 8 PM. The arm stayed swollen for roughly 3 days. Pt also at this same time experienced flu like symptoms. All issues have resolved as of this morning of 10/18/10.
Raised reddened rash at injection site, with itching x1 week, "48 hours after" used hydrocortisone cream to site.
Chest pain, chest tightness, tachycardia, shortness of breath,  throat tightness.
Arm that received pneumonia shot became red, swollen, painful and warm to touch the evening after the shot was given. Area extended from deltoid muscle to elbow. Inflammation resolved within one day. Treated with cold compresses.
fatigue, loss of appetite starting around 12:30 PM 5/2 napped from 2:00PM until 3:30 PM, no more fatigue fatigue, irritability, confusion, body aches set in around 6:00 PM around 8:00 PM started alternating between feeling hot and chills, and presumabliy a fever (did not take temperature) went to sleep for the night around 1:30 AM on 5/3. Sometime between then and 7:00 AM woke up in a sweat, so fever presumably broke awoke for the day around 8:20 AM but was still too fatiuged to go to work as of now still feel some fatigue and headache
9 hours after receiving the vaccine, around 5:00 PM on 3/21/2021, I experienced a fever, nausea, headache, soreness in muscles/joints, and chills.  The next morning, these symptoms had all gone away. A couple of days after the vaccination, I believe on 3/23/2021, I began experiencing unexplained back pain and shortness of breath. This pain was severe at time and I still have a dull pain in my back as of today, 4/15/2021.
Patient reported to me that she developed a rash to her extremities the evening of vaccination. She proceeded to take benadryl. Patient reported taking benadryl repeatedly Tuesday, Wednesday, Thursday, Friday and by Saturday morning she had to go to the ER to get some steroids. Patient stated that it was a hive reaction.
With the first shot on day seven I woke up with a Swollen red lump on my arm about the size of a golf ball. It felt feverish and lasted about three days. Also during the first week after the first vaccine I was extremely nauseous. I was also supposed to start my menstrual cycle that week. It ended up coming to an a half weeks late. After the second shot of Moderna about five hours later I had a large red welp on my arm. It continued to grow larger and more swollen over the next two days. On day three it is the size Of a softball but just slightly raised off of my arm. It is very hot to the touch and extremely tender.
Patient experienced pain in the injection site - having difficulty raising her left arm. On November 6th, she claimed there was 50% improvement.
Pt was in for a visit and stated he needed his 2nd Hep A vaccine. The immunization screen  was showing only 1 previous dose and the forcast was showing he was due for his 2nd Hep A. The vaccine was ordered and administered per protocol. After pt left the clinic, I noticed on the front screen that the patient had received a 2nd Hep A  on 8/10/20 that was never entered on his immunization screen. Therefore the patient received an extra dose of Hep A.
ADVERSE EVENT:  POSSIBILITY OF STORING VACCINE IN UNAPPROVED FREEZER TREATMENT:            NONE OUTCOME:                NO ADVERSE SIGNS OR SYMPTOMS WHATSOEVER
hernia around colostomy opening; This spontaneous case was reported by a consumer and describes the occurrence of STOMAL HERNIA (hernia around colostomy opening) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    The patient's past medical history included Colostomy. Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe).   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate Free, Solution for injection in pre-filled pen. On an unknown date, the patient experienced STOMAL HERNIA (hernia around colostomy opening). At the time of the report, STOMAL HERNIA (hernia around colostomy opening) outcome was unknown.            No concomitant medication was provided. Treatment medication was not provided by the reporter.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  The reporter's causality for Humira for the event(s) of hernia around colostomy opening unknown onset and hernia around colostomy opening unknown onset was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in
Patient passed out during 15 minute post-vaccination  waiting period. Patient regained  consciousness & was breathing normally.  Patient was evaluated by EMS/EMT & released to mom.
Administered 8/11/09 for pre-employment. Last Td vaccine received 2005. First time receiving Tdap. Approximately 6 cm x 4 cm red area at injection site. Swollen glands in left axillary and left sub-mandibular/tonsillar lymph nodes (injection site left upper arm). Persistent headache x 3-4 days. Persistent generalized muscle aches x 4-5 days. Also, muscle ache/hard knot at site (not unusual per past history with Td vaccine).
I'm losing my voice"; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DYSPHONIA (non-serious), outcome "unknown", described as "I'm losing my voice"". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Slight swelling warmness and numbness on left side of my face and neck for 2 hours. Tingling in left foot
Felt miserable, felt all over terrible; Laid in bed shaking from the chills; Chills; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt miserable, felt all over terrible), TREMOR (Laid in bed shaking from the chills), CHILLS (Chills) and HEADACHE (Headaches) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 046B21A) for COVID-19 vaccination.     The patient's past medical history included Cancer (resulted in losing her right eye.) and Headache.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Mar-2021, the patient experienced FEELING ABNORMAL (Felt miserable, felt all over terrible), TREMOR (Laid in bed shaking from the chills), CHILLS (Chills) and HEADACHE (Headaches). At the time of the report, FEELING ABNORMAL (Felt miserable, felt all over terrible), TREMOR (Laid in bed shaking from the chills), CHILLS (Chills) and HEADACHE (Headaches) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient states she took lots of medications and declines in sharing this information as it is not relevant.She states that she does not have a stroke history and heart problems. No concomitant medication provided. No treatment information mentioned.  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.   This case was linked to MOD-2021-283822 (Patient Link).; 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.
pt recvd vax; w/in 72 hrs exp tingling toes;1 wk later,feet numb could not move;hosp;3 days dx w/ GBS;19oct urinary frequency;dx as inflammatory demyelinating polyneuropathy;
Felt like I had gotten the virus again.  Same symptoms, 104 degree temp. muscle ache, congestion, cough, nausea.  This time I could not move my left arm without pain.  After 3 days I could still not move to 90 degrees.  At 5 days can now  reach cups on first shelf of upper cabinets.  If I tried to move arm received a terrible stabbing pain in my left arm near the injection site,
This spontaneous report was received from a patient's mother and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 29-DEC-2016, the patient was inadvertently vaccinated with a dose of GARDASIL or GARDASIL 9 (dose, route of administration, lot# and expiration date were not reported). On an unknown date, the patient developed "a fever for 5 days, weakness, pale skin, loss of muscle tone, decreased sleep, decreased appetite, missed milestones and no weight gain". The outcome of the events was unknown. The relatedness between the events and GARDASIL 9 and GARDASIL was not reported. Additional information has been requested.
Swollen lymph nodes and slight rash under both arms 12 days after vaccine, lasted 5 days;  Severe pain in left knee 13 days after vaccine and lasted one day.
pt recvd vax & later the same day devel a rash described as "little red bumps" on the back & chest lasting approx 2 to 3 days;
Approximately 10-11 days after receiving the vaccine, the patinet began to complain of severe headaches. Around day 11-12, she was noted by family to have deterioration in ambulatory function and language skills, prompting a visit to a local ED. By day 13 she had lapsed into a vegetative state in which she could only yawn, moan and occasionally open eyes. MRI brain demonstrated significant, confluent T2 intensities in the subcortical white matter of the bilateral cerebral hemispheres.
Injection in left arm - severe pain (myalgia) began within 2 to 3 hours. Had almost total loss of function in arm. Moderate headaches. Pain has now diminished slightly.
sx started 20MAY92 @ 5PM w/stomach ache, not feeling well, diarrhea started @ 830PM; no fever, no other sx present;
This spontaneous report has been received from a medical assistant and refers to an unspecified number of patients of unknown ages and genders. The patients' medical histories, concurrent conditions, drug allergies/reactions, and concomitant therapies were not reported. The medical assistant reported that on unspecified dates, an unspecified number of patients were vaccinated with improperly stored doses of VARIVAX (lot # M038226, expiration date 07-SEP-2018; doses, routes of administration, and frequencies were not reported) for prophylaxis. The vaccine data logger measured a temperature range from minus 9°C to 8°C for a total time frame of 4 hours and 50 minutes. There was no previous temperature excursion. No adverse effects were reported, and no product quality complaint (PQC) was involved. This is one of two reports from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA011300.
Pain and about 1 inch dark red spot surrounding injection site. Red area (though not as dark ) continues and surrounds the dark red spot. It  is about  6 inches across.total. Both are warm to the touch four days after the injection.
Fever Body aches Difficulty breathing Excessive sweating and urination Migraine Lethargic Nausea/vomiting Weight loss
Clinic went on vacation, vaccine expired while gone. We now have a double check policy in place to prevent this from happen again. Child had not signs or symptoms. Filled out VAERS report secondary to gave shot that was outdated by accident. Patient had no adverse symptoms.
Patient briefly lost consciousness and turned pale after immunization was administered. She quickly recovered and stayed in the pharmacy for 30 minutes. She stated she felt fine with multiple probing questions.
Pt. states that after receiving the 2nd dose of Shingrix 10/28/2021, started experiencing symptoms that evening of fever (100.0) and muscle aches. No noted Primary visit/communications. Still continuing to experience symptoms.
Gave MMRV SQ in (L) tricep-hematoma formed immediately with sm amt bldg. marked erythema noted at injection site. Gave KINRIX (R) deltoid with same reaction. Gave Hep A (L) anterior thigh with no reaction.  Used 25-g x 5/8 inch needle. Presented with generalized erythema and rash on arms, face, back, and torso. Post vaccination today was seen for kindergarten boosters prior to above sx. Mother denies any previous reactions. Vital signs stable here - wt. 20 kg, HR-80 RR-18 O2 sats-99% R/A. No sign of anaphylaxis - no respiratory distress, tongue edema, difficulty swallowing. Skin warm to touch immediately at arm injection sites. Skin "blotchy" with diffuse rash noted. This 5 yr old youngster is very fair skinned - Blue eyes and blonde haired. Because of the concern for anaphylaxis, we recommended an eval at ED. Patient was stable to transfer via private car. ED record - given Rx for the following: Ranitidine 105 BID, BENADRYL 12.5 mg TID x 3 days, Prednisolone 21 mg BID x 3 days, Epinephrine 0.15 mg IM x 1 PRN anaphylaxis (EPIPEN auto-injector). Update 3/22/18 - Mother sent child to school today. Patient c/o (L) arm and shoulder pain this A.M. The patient is a 5 y/o M who presented to the ED w/ a c/o a rash that began around 3:15 pm. Mother reports that pt had vaccine shots around 3:15 and began to develop a rash throughout his arms, face, back and legs. Pt denies any trouble breathing, throat tightness, abd pain, or diarrhea. There are no further complaints.
Patient was given an expired vaccine with no adverse event; Initial information regarding an unsolicited valid serious case was received from other health professional via Agency (Reference number- 00322432) and transmitted to Sanofi on 19-Oct-2020.  This case involves an 61-year-old male patient who was vaccinated with 0.5 ml dose of diphtheria-2/tetanus-5 adsorbed toxoids no preservative adult [Tenivac] on 19-Oct-2020 (lot U5854AA, expired on 25-Jan-2020 ) via intramuscular route in the right deltoid for prophylactic vaccination (expired vaccine used).  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  It was a case of actual medication error due to expired product administered (unknown latency).  At the time of report, patient had not experienced any adverse events.  Disclaimer: This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  No further relevant information was reported.
This case was reported by a consumer via call center representative and described the occurrence of shingles in a 57-year-old female patient who received SHINGRIX for prophylaxis. Co-suspect products included PNEUMONIA VACCINE for prophylaxis. The patient's past medical history included shingles (in hip area, 4 years before the reporting date). Concomitant products included PROZAC. On 9th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml and PNEUMONIA VACCINE. On 9th July 2018, less than a day after receiving SHINGRIX, the patient experienced shingles, pain in arm, localized erythema, skin warm, contusion, local swelling, erythematous rash and blotchy. On 10th July 2018, the patient experienced fever and nerve pain. The patient was treated with Valacyclovir and levofloxacin. On an unknown date, the outcome of the shingles, pain in arm, localized erythema, skin warm, contusion, local swelling, erythematous rash, nerve pain and blotchy were unknown and the outcome of the fever was recovered/resolved. It was unknown if the reporter considered the shingles, pain in arm, localized erythema, skin warm, contusion, fever, local swelling, erythematous rash, nerve pain and blotchy to be related to SHINGRIX. Additional details were provided as follows: The patient SHINGRIX on the left arm along with a Pneumonia vaccine that was given in same arm on same day about a half inch apart. On the same day of the vaccinations, but later, the patient had swelling of the upper arm in the size of a softball. The whole top of her upper arm area was hot, red, painful and bruised. Late Tuesday, on 10th July 2018 into Wednesday, 11July 2018, the patient began to experience pain that was the nerve pain that usually accompanies shingles. She also noted a fever of 103 that started on Tuesday (latency of 1 day after vaccination). On 12th July 2018, the patient went to the local emergency room and after 5 hours she was diagnosed with shingles on her arm and released with a prescription for Valacyclovir 500 mg 2 tablets by mouth 3 times daily and Levofloxacin 750 mg 7 tablets total. The patient stated she had red, rash, blotches on her left arm. A 50 cent piece size area just below the injections and then a dime size one and another quarter size one with smaller red spots that were not all connected going up to top of her arm. The contact details of physician was provided. It was unknown if the reporter considered the shingles, arm pain, localized erythema, skin warm, contusion, fever, local swelling, erythematous rash, blotchy and nerve pain to be related to Pneumonia vaccine.
Information has been received from a physician concerning a 7 month old patient who on 06-OCT-2009 was vaccinated with the first dose of ROTATEQ (lot number: 664068/0319Y) (dose and route of administration not reported). On 08-DEC-2009 was vaccinated with the second dose of ROTATEQ (lot number: 664648/1034Y) (dose and route of administration not reported). On 08-MAR-2010 was vaccinated with the third dose of ROTATEQ (lot number: 664779/1439Y) (dose and route of administration not reported). on 15-MAy-2011, the patient was diagnosed with laboratory confirmed rotavirus gastroenteritis. The baby had several office visits but did not require hospitalization and there was no sequelae. At the time of the report, the patient's outcome was unknown. Follow up information has been received from the physician who reported that the 7 month old male patient with no preexisting allergies, birth defects or medical conditions at the morning of 06-OCT-2009, was vaccinated with the first dose of ROTATEQ (lot number: 664068/0319Y) orally. At the morning of 08-DEC-2009, was vaccinated with the second dose of ROTATEQ (lot number: 664648/1034Y) orally. At the morning of 08-MAR-2010, was vaccinated with the third dose of ROTATEQ (lot number: 664779/1439Y) orally. The patient had diarrhea and his sibling too following prior vaccination third dose. There was no illness at the time of vaccination. On 14-MAY-2011, the patient had vomiting and diarrhea episode with rotavirus after adequate vaccination. The patient sought medical attention. Positive rotavirus elisa assay was reported. At the time of the report the patient had recovered. Additional information is not expected.
Within 3 hours, induration, warmth, erythema and pain-inferior to injection site, left deltoid.  Will follow complete resolution of all symptoms for 1 week.
Two days post-injection, patient reports that the area of injection is now red, indurated, warm, and hard. He also reports that the area is itchy and hurts when touched.
A few days after the Gardasil injection, my body started to feel pinprick sensations everywhere.  In addition to the random pins/needles, I also became sensitive to touch. Normal fabric on my skin would feel like pins.  Then, for the next few months, I would get muscle pain -- especially in my limbs and feet.  Then on 8/6/2008 I began to experience muscle spasms/twitches -- many twitches every minute of every day. It's now more than three years later and they still twitch.  I did not draw a connection to the Gardasil so I decided to get the second injection on 10/14/11.  Two days later, the pin pricks and muscle pain started again.  Now, I'm feeling the same muscle aches again.
Patient's wife reported back to the pharmacy on 12/13/18 of a photo of her husband's neck which had a raised, itchy, red rash. There were multiple raised areas along the back side of the neck and some looked like they may form small blisters. The wife, stated that the patient developed the rash the day after the vaccine and there were no other changes in diet, medications or use of products in their home. She confirmed that he had not seen a physician for the rash and has been applying NEOSPORIN which seems to help but the rash then pops up in another area. I consulted her to try to have patient seek a physician's consult and to possibly consider using topical Hydrocortisone to help alleviate the itch in the meantime.