chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician referring to a 4-month-old patient of unknown gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 28-AUG-2017, the patient was vaccinated with improperly stored ROTATEQ orally, lot # M041184 with expiration date on 31-MAY-2018 for prophylaxis (dose was not provided). The vaccine was exposed to a temperature of 49 Fahrenheit degrees for 16 hours on 20-MAY-2017, 17-JUN-2017 and 21-JUN-2017. The vaccine was exposed to a temperature of 48 Fahrenheit degrees for 16 hours on 27-MAY-2017, 02-JUN-2017 and 03-JUN-2017. The vaccine was exposed to a temperature of 47 Fahrenheit degrees for 16 hours on 09-JUN-2017, 13-JUN-2017, 22-JUN-2017, 23-JUN-2017, 28-JUN-2017 and 29-JUN-2017 and for 70 hours on 30-MAY-2017. The vaccine was exposed to a temperature of 35 Fahrenheit degrees for 16 hours on 27-JUN-2017, 20-JUL-2017 and 28-JUL-2017 and for 46 hours on 17-JUL-2017 and 26-JUN-2017. The vaccine was exposed to a temperature of 34 Fahrenheit degrees for 16 hours since 29-JUN-2017 until 01-JUL-2017, on 03-JUL-2017, 06-JUL-2017, 07-JUL-2017, 19-JUL-2017 and 26-JUL-2017, for 40 hours on 05-JUL-2017 and for 46 hours on 10-JUL-2017. The vaccine was exposed to a temperature of 33 Fahrenheit degrees for 16 hours on 08-JUL-2017 and since 11-JUL-2017 until 15-JUL-2017 and on 27-JUL-2017. The vaccine was also exposed to a temperature of 32 Fahrenheit degrees for 16 hours on 22-JUL-2017 and 01-AUG-2017. Additionally, it was reported that digital data logger was not involved. No adverse effects were reported. There was no product quality complaint involved. This is one of several cases received from the same reporter.; Sender's Comments: US-009507513-1709USA012770: US-009507513-1709USA007325: US-009507513-1709USA012768: US-009507513-1709USA012769: US-009507513-1709USA012765: US-009507513-1709USA012764: US-009507513-1709USA012766: US-009507513-1711USA003163: US-009507513-1709USA012767: US-009507513-1711USA003162: US-009507513-1711USA003161: US-009507513-1711USA003160: US-009507513-1711USA003159: US-009507513-1711USA003157: US-009507513-1711USA003165: US-009507513-1711USA003158:
Racing heart very anxious  Vitals Signs: B/P: 170/74 HR: 142 O2Sat:98 Skin Signs: Clammy Circulation: Delayed  Resp.: Breath sounds clear bilaterally. Denies chest pain. Treatment: controlled breathing with guided imagery. Gave apple juice  Reassessment: @16:12 Vitals: B/P: 138/80 (right arm) HR:134 Reassessment @16:16 B/P 132/70 HR:134 Reassessment @16:20 HR:100 O2Sat:97 Treatment: Patient D/C from triage without incident- Laughing and talking. Husband in parking lot in his own car. Pt d/c home by self.
experiencing infertility; This spontaneous report was received from a consumer, who is a patient's parent and refers to a 33-year-old female patient. No information regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medications was provided.  On an unknown date in 2001, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injection (dose, route of administration, anatomical location, lot # and expiration date were not reported) for prophylaxis.  Since an unknown date, the patient was experiencing infertility. It was reported that the patient sought medical attention and received unspecified ovulation pills as a treatment for the event.  No further information was provided. The outcome of infertility was reported as not recovered.  The causality assessment between the event and human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) was not provided.
No treatment I used Latacane Patch Its a deep seated paiN that woN't go away. In the thigh of the right leg
symptoms of Kawasaki syndrome; reacted with febrile convultions; This case was reported by a consumer via interactive digital media and described the occurrence of kawasaki's disease in a 25-month-old female patient who received DTPa (DTPa vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of DTPa vaccine. On an unknown date, unknown after receiving DTPa vaccine, the patient experienced kawasaki's disease (serious criteria hospitalization and GSK medically significant) and febrile convulsion (serious criteria hospitalization and GSK medically significant). DTPa vaccine was discontinued. On an unknown date, the outcome of the kawasaki's disease and febrile convulsion were recovered/resolved.   It was unknown if the reporter considered the kawasaki's disease and febrile convulsion to be related to DTPa vaccine.  Additional details were provided as follows: The patient reacted with febrile convulsions. The reporter stated, during her 4 day hospital stay, someone recognized symptoms of Kawasaki syndrome and the patient was treated accordingly. It saved the her life. The reporter stated, they might never know if this was a coincidence but she had not received any more pertussis vaccines thereafter. The patient was 25 now and healthy.
A few hours after receiving injection right arm was sore and numb down to right hand and muscles in hand and forearm are tight (still having issue currently after 7 days), Headaches (still having issue currently after 7 days), Runny Nose, Sore Body (still having issue currently after 7 days in neck, shoulder, back and legs), Ringing Noise in Ears (Still hear ringing constantly has been 7 days), Tightness in my chest and heavy breathing (lasted 3 days - comes and goes for a few hours every few days).
At first, lightheaded, mild nausea and tired. Later felt achy and mild headache.
redness @ inj site w/in 7hr w/swelling resolved;24hr later devel red mac pap rash under eyes & few scattered lesions on extrem w/itching;
Client fainted.  Client had just recieved immunizations and was watching brother get immunizations when mom noticed her start to sway.  Client lost consciousness briefly.  PHN was lowering client to the floor when she regained consciousness.  Client was not injured during loss of consciousness.
CHILLS; BODY ACHES; FLU-BLOWN FLU; 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, batch number: Unknown) dose was not reported, administered on 07-APR-2021 08:00 for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported. The company is unable to perform follow-up to request batch/lot no. On 07-APR-2021 17:00, the subject experienced chills. On 07-APR-2021 17:00, the subject experienced body aches. On 07-APR-2021 17:00, the subject experienced flu-blown flu. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, body aches, and flu-blown flu. This report was non-serious.
Fatigue, Dizziness, Nausea, Large area of swollen red hot 4" under vaccine sight
Immediate feeling of dense cloudiness and heavy feeling right above my eyes. Reminded me of the feeling when I received torpodol (toradol? spelling?) for a migraine in the ER a few years ago.  I also immediately felt confused, slow, had a hard time thinking clearly and comprehending conversations and text I was reading. I was in the middle of reading a rather technical book for work and suddenly unable to concentrate or comprehend the content. This symptom lasted for less than 48 hours.  For the first 24 hours, I was extremely fatigued, less so in the second 24 hours, and back to normal after 48 hours.
I can't lift it / it's extremely painful to move; My arm is abnormally sore; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (I can't lift it / it's extremely painful to move) and PAIN (My arm is abnormally sore) 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 28-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-May-2021, the patient experienced MOBILITY DECREASED (I can't lift it / it's extremely painful to move) and PAIN (My arm is abnormally sore). At the time of the report, MOBILITY DECREASED (I can't lift it / it's extremely painful to move) and PAIN (My arm is abnormally sore) outcome was unknown.            No concomitant medication provided by reporter. No treatment medication provided by reporter.    Reporter did not allow further contact
Information has been received from a health professional concerning a patient (39 out of 40) who was vaccinated with Pneumovax 23 (lot number 651406/0620F).  It is unknown if the patient was vaccinated with the influenza virus vaccine (unspecified) on the same day.  Subsequently the patient experienced fever, pain at injection site, redness at injection site, swelling at injection site and red streaks on injection arm.  Subsequently, the patient recovered from fever, pain at injection site, redness at injection site, swelling at injection site and red streaks on injection arm.  The records of testing prior to release of the lot in question have been rechecked and found to be satisfactory.  The lot complies with the standards of the agency and was released.  Additional information has been requested.
Skin reaction: red patches and itching all over body especially on arms, back and abdomen.
allergic reaction with runny eyes and nose; allergic reaction with runny eyes; allergic reaction with runny nose; itchy face; sore left shoulder muscle; This is a spontaneous report from a contactable consumer (Patient, self-reported). A 74-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot Number: en6205), via an unspecified route of administration, in the right arm on 05Mar2021 at 09:15 (age at the time 74-year-old) at a 2nd dose, as single dose for covid-19 immunisation. The patient's medical history included esophagitis, possibly reacting to dairy (dairy intolerance), and left breast cancer. The patient had known allergies included very minor dairy allergy. Concomitant medication included levothyroxine, unspecified eye drops-cataract surgery and unspecified statin. The patient previously received of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot Number: em9809), via an unspecified route of administration, in the left arm on an unknown date in Feb2021, at a 1st dose, as single dose for covid-19 immunisation. 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. The patient was not tested for COVID-19 since the vaccination. The patient experienced allergic reaction with runny eyes and nose, itchy face, sore left shoulder muscle on 07Mar2021 at 07:30 AM. Therapeutic measures were taken as a result of the events included benadryl (1 at 4pm, 2nd at 7pm). The outcome of events was recovered on an unspecified date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Patient had a seizure lasting about 1 minute. After a short rest she was ambulatory and left on her own.
Information has been received from a registered nurse concerning a 30 year old male patient with no pertinent medical history and no drug reactions or allergies who on an unknown date was vaccinated with MMR II (lot # not reported). There was no concomitant medication. The nurse reported that the patient who recently immigrated was nonreactive and nonequivocal for rubella, equivocal for mumps and reactive to rubella. The nurse stated that the patient thinks he might have received the vaccine in the past but he was not sure. The patient sought medical attention at the physician's office. Follow up information has been received from a registered nurse concerning a 30 year old male patient with no pertinent medical history and no drug reactions or allergies who on an unknown date was vaccinated with a dose of MMR II (dose, route and lot number not reported). The registered nurse reported that she did not have additional information to provide on this patient. No further information is expected. No further information is available.
Fever. Chills. Headache (exasperated when looking up). Lethargic. Slept the entire night, day, and second night  following vaccine. Was awake for only 4 hours during a 24 hr cycle. Tested negative for COVID
Headache, Arthralgia, Fever, chills, severe fatigue,  Narrative:
episode of passed out; severe allergic reaction at injection site; injection arm is irritating; itchiness; injection arm is hurting; redness; swelling at injection site; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (episode of passed out) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blind (patient is legally blind in the left eye). Concomitant products included QUETIAPINE FUMARATE (SEROQUEL) for Seizure, PARACETAMOL (TYLENOL), CYCLOPENTAMINE, ESZOPICLONE, CLONAZEPAM (KLONOPIN), VITAMIN B COMPLEX and CYANOCOBALAMIN (VITAMIN B12 FORTE) for an unknown indication.    On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (episode of passed out) (seriousness criterion medically significant), VACCINATION SITE PRURITUS (itchiness), PAIN IN EXTREMITY (injection arm is hurting), IRRITABILITY (injection arm is irritating), INJECTION SITE HYPERSENSITIVITY (severe allergic reaction at injection site), VACCINATION SITE ERYTHEMA (redness) and VACCINATION SITE SWELLING (swelling at injection site). At the time of the report, LOSS OF CONSCIOUSNESS (episode of passed out) outcome was unknown and VACCINATION SITE PRURITUS (itchiness), PAIN IN EXTREMITY (injection arm is hurting), IRRITABILITY (injection arm is irritating), INJECTION SITE HYPERSENSITIVITY (severe allergic reaction at injection site), VACCINATION SITE ERYTHEMA (redness) and VACCINATION SITE SWELLING (swelling at injection site) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Jan-2021, SARS-CoV-2 test positive: Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication not reported. Treatment medication not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
82 yo man pmh of dementia (minimally verbal at baseline), prior stroke, gout presents with hip pain and hypernatremia.  The EMS offload say the patient fell 2 to 3 days ago in his facility and has had right hip pain since then. Emergency room department called facility who denies the patient ever fell. However he was diagnosed with COVID-19 on January 6, 2022 after an outbreak in the facility. On my interaction with the patient he was nonverbal they would not let me move his right hip. In the emergency department he was afebrile, pulse 84, blood pressure 118/79. Chemistry of hyponatremia 156, chloride 122 creatinine 0. 79. CBC with mild cytosis 12.4. CT of the hip showed no visible fracture though occult still possible. Also noted groundglass opacities in left lung. Patient was discharged back to Skilled Nursing facility on 01/17/2022. Skilled Nursing Facility: for Rehab and Healing. Patient expired on 02/05/2022.
Patient had a grapefruit size knot on arm where injection was and was bright red, very hot and swollen. To this day, a knot is still there but smaller.
Approximately 2 weeks post vax on 01/15/1991, this pt developed coughing and crying. On 01/16, he developed rhinorrhea. The pt began Amoxil on 01/17. He did not have a fever or decreased appetite. The pt bruised easier for a few days. He developed ecchymosis on head, petechiae on face, bruises on legs, and ecchymosis on hard palate. On 01/18, the pt experienced  nose bleeds and blood in stools. That same day he was hospitalized. Blood chemistry results indicated thrombocytopenia. The pt received IV GG and his platelet count rose on 01/21. The following day, he was discharge and subsequently recovered.
This case was considered medically important. Information regarding PREVNAR vaccine was received from a healthcare professional regarding a patient who experienced received vaccine subcutaneously instead of intramuscularly and subcutaneous atropy secondary to vaccination. The patient received a dose on an unspecified date. Relevant medical history was not provided.  Concomitant medications were not reported. On an unspecified date, the patient received the vaccination subcutaneously instead of intramuscularly. The child did not have redness or swelling but had an indentation at injection site which was diagnosed as subcutaneous atrophy secondary to vaccination. The outcome if the event is unknown. No additional information was available at the time of this report.
A nurse reported the occurrence of injection site cellulitis in a 3-year-old male who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix). The pt's medical history, concurrent conditions and concurrent medications were not specified. On 09/19/2002 the pt received his 4th injection of Infanrix (lot DTPA571A2) into the left upper leg. 36 hours later, the pt developed injection site cellulitis. The pt was seen in the local ER. The reporter considered the event to be related to Infanrix administration. Comment: This report has been linked to report A0382391A, A03836783A, A0386784A and A0386785A due to same reporter.
On 6/12/2009 MMR, Varicella, PCV7, and Hep A given on 6/22/2009 pt seen in office Dx with herpes simplex without mention of complication. Then on 7/7/09 pt RTC for Re-eval DX with herpes zoster w/o complications.
severe dizziness; nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (severe dizziness) and NAUSEA (nausea) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No adverse event reported).   On 11-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced DIZZINESS (severe dizziness) and NAUSEA (nausea). On 14-Feb-2021, DIZZINESS (severe dizziness) and NAUSEA (nausea) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Feb-2021, Blood test normal: normal. On 14-Feb-2021, Computerised tomogram: Normal.
Client was vaccinated with Moderna Booster  0.25mL on 10/26/2021 at 1212pm. About 20 minutes later, he reported lip numbness that started 5 minutes after vaccination. Upon assessment, no swelling of lips or face noted. Pt denied swelling in the throat or trouble breathing and denied any other symptoms other than a mild headache that he had before he came in. He also reported NO allergic reaction to first two doses of Moderna. Pt instructed to go to Urgent Care to follow up with an MD. He verbalized understanding and left the COVID vaccine clinic around 1242pm.
Expired vaccine used; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 24-Nov-2021: Significant Follow Up Appended _  Dose Information Updated.
had the shot but got the shingles anyway/suspected vaccination failure; got the shingles/ in his eye; got the shingles/ forehead into his hairline; This case was reported by a contact via interactive digital media and described the occurrence of Suspected vaccination failure in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), ophthalmic herpes zoster (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure, ophthalmic herpes zoster and shingles were unknown.   It was unknown if the reporter considered the vaccination failure, ophthalmic herpes zoster and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient's wife. The age at vaccination was not reported. The patient got Shingles after vaccination. The patient had shingles in his eye and forehead into his hairline. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, laboratory confirmation, time to onset of shingles were unknown at the time of reporting.
Approximately 9 hours after receiving the Janssen COVID-19 Vaccine EUA, I experienced sudden fatigue followed by onset of severe muscle and joint pain including severe head pain followed by severe chills followed by fever and excessive sweating. I was very dizzy and felt disoriented. I was in bed when all this happened and was already wearing warm clothes under the covers. The muscle and joint pain was so severe, I couldn't grip anything including my cell phone (my wrists were in sharp pain). The head pain was so severe I was sensitive to light regardless of how dim it was. I felt like my toes were curled, but that could have been me "bracing" and tightening up due to the total body pain. I could move very little. It was very strange. These symptoms persisted through the night. The following morning at around 9am, I still had a very bad headache that made me nauseated and continued to be sensitive to light. Some of the joint and muscle pain tapered down enough for me to get out of bed to go potty but it was exhausting to walk 5 feet to the bathroom and then get back in bed. I still ran a mild fever. At around 1pm I took a Tylenol that helped subside the symptoms but felt wiped out all day. By the following day (Monday), I was feeling better getting more energy and by that Monday evening, I felt like nothing ever happened. I'm sure these just fall into perhaps the more severe level of the side effects, but I was frightened by the intense sharp muscle and joint pain to the point I couldn't even grip anything.