chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse, concerning a 11 year old male patient, with no medical history or medicines and no allergies, who on 23-JUL-2004, was vaccinated subcutaneously with 0.5 mL dose of VARIVAX (Merck) (lot number not reported). On 20-APR-2010, the patient received intramuscularly the second 0.5 mL dose of VARIVAX (Merck) (lot number 665882/1409Y). Other vaccines administered the same day included ADACEL and MENACTRA. On 20-APR-2010, before leaving the exam room, the patient fainted. The patient recovered right away and with no apparent injury. The patient sought unspecified medical attention. This is one of several reports concerning siblings received from the same source (MSD, WAES# 1004USA04407). Follow-up information has been received from a registered nurse, who reported that on 20-APR-2010, at 09:00 am, the patient received in the right deltoid the second dose of VARIVAX (Merck). The nurse reported that the patient received on the same date a dose of ADACEL as part of his well-child examination. The patient tolerated the injection process and was waiting for his younger brother's immunization to be completed. When the patient stood to leave, his mother reported that he took several steps forward and leaned over. The mother thought that the patient was tying his shoe when he collapsed, striking his nose on the edge of the examination table footrest. The mother called for help and when the nurse arrived, she found the patient laying face down on the floor of the examination room. The patient was pale and diaphoretic. His pulse was normal but he was unconscious. The nurse rolled the patient onto his side in recover position and monitored him for approximately 45-60 seconds when the patient began to regain consciousness and respond to his name. The patient remained pale but his vital signs were stable. At that moment, the nurse was joined by a licensed practical nurse, who assisted in monitoring the patient. Temperature was 98.3, pulse (apical) was 88 and blood pressure was 100/60. The patient was responsive to questioning. The patient had no recollection of the event. Ice was applied to the contusion/abrasion on his nose. It was noted that he bit the inside of his lower lip which was bleeding slightly. Bleeding was controlled and he remained in the recovery position for approximately 15 minutes with continuous observation until the patient felt well enough to stand. The patient ambulated from the room on his own with an escort. No further information is available.
Fever and chills during the night on 11/03/2012 and blisters at the site of injection with redness on 11/5/2012.  Physician prescribed Valtrex 1gram 3 times daily for 7 days beginning in the afternoon on 11/5/2012.
Information has been received from a physician concerning a 4 year old patient with no known medical history or allergies who on 4/17/2002 was vaccinated with a dose of varicella virus vaccine live. On 3/15/2005 the patient developed breakthrough varicella. At the time of this report the patient had recovered. Additional information is not expected.
Information has been received from a medical assistant referring to a 18 months old patient of unknown gender. Information about concurrent condition, concomitant medication and medical history was not provided. On 13-SEP-2017, the patient was vaccinated with an improperly stored PROQUAD (dose, route, lot # and expiration date were not reported) for prophylaxis. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1709USA004852: US-009507513-1710USA014163:
measle like rash primarily on arms and legs; This is a spontaneous report received from contactable reporter (Consumer). The reporter is the patient.  A 74-year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 20Mar2021 09:00 (Lot number: EN6207) at the age of 74 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Allergy to vaccine" (unspecified if ongoing), notes: Zoster vaccine; "AB+ platelets allergy" (unspecified if ongoing), notes: AB+ platelets allergy; "contrast dye allergy" (unspecified if ongoing), notes: contrast dye allergy; "COPD" (unspecified if ongoing); "Invasive bladder cancer stage IV" (unspecified if ongoing), notes: Stage 4 Invasive Bladder Cancer with mets to liver survivor.; "Hypothyroidism" (unspecified if ongoing), notes: low thyroid; "Potassium low" (unspecified if ongoing), notes: low potassium; "heart" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Zoster shingle shot (I had a similar reaction to Zoster Shingle shot 19Jul2014 that lasted over 44 days when I reported to Merck), administration date: 19Jul2014, reaction(s): "similar reaction"; BNT162B2 (Dose 1, Single, Lot number: EN6203, Administration Site: Arm Left, Administered time: 09:15, The 1st shot only had the red mark on arm with injection that lasted 4 days.), administration date: 24Feb2021, when the patient was 74 years old, for COVID-19 immunisation, reaction(s): "red mark on arm with injection". The following information was reported: RASH MORBILLIFORM (non-serious) with onset 22Mar2021, outcome "not recovered", described as "measle like rash primarily on arms and legs". Therapeutic measures were not taken as a result of rash morbilliform.  Additional Information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had taken unspecified medications within 2 weeks of vaccination. The patient had not been diagnosed with COVID-19 prior to the vaccination. The patient had not been tested for COVID-19 since the vaccination. On 22Mar2021, the patient had experienced measles like rash primarily on arms and legs, started 2 days after injection and still happening. The patient did not receive any treatment for the reported event. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021388043 same patient, same drug, different AE, different dose of vaccine.
Injection site - hot, swollen, and itchy. Spread out from inj. site lasted about 1 week, spread about 4-5" diameter.
ANAPHYLAXIS, INIT 3/21/2022 ABNL MUSCULOSKELETAL SYSTEM IMAGING
pt recv 2 doses of vax & 10OCT96 a VZV serology test was negative;
Dry cough; Feels like he was coming down with a cold; Could not go to sleep; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Could not go to sleep), COUGH (Dry cough) and NASOPHARYNGITIS (Feels like he was coming down with a cold) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included COPD.   On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Dec-2020, the patient experienced INSOMNIA (Could not go to sleep) and NASOPHARYNGITIS (Feels like he was coming down with a cold). On an unknown date, the patient experienced COUGH (Dry cough). At the time of the report, INSOMNIA (Could not go to sleep), COUGH (Dry cough) and NASOPHARYNGITIS (Feels like he was coming down with a cold) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medications included unspecified cold medicine. Concomitant therapy included an oxygen tank.  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.   Most recent FOLLOW-UP information incorporated above includes: On 09-Apr-2021: updated event outcome and action taken (received second dose); 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.
Patient mother and father was called and informed about what happen. Per mother patient had no reaction to vaccines. Patient is schedule for skin integrity check for 02/08/2019 with doctor.
Patient here for 2nd dose of Pfizer Covid-19 vaccine. No h/o allergies or significant medical history.  LPN arrived on scene after vaccinator was yelling for help. Patient was "in and out of consciousness", awake and alert and then would have LOC for a few seconds and then become awake and alert again. This happened about 4 times with LOC with also some "convulsing like movements in the arms". Emergency responders and clinical lead,  RN called. Patient laid back in seat as far as the seat would go, face pale and lips white. Pulse-ox put on and BP taken, 36 bpm (according to pulse-ox) and oxygen level 89%, BP 100/54. LPN gave epinephrine injection at this point at 1151, 0.3mg IM in right thigh. HCP arrived on site, patients VS after epi: pulse 76, 100/76, O2 sats 94% at 1155. Patient awake and alert, oriented to person, place and time. Lips and face pink. Care turned over to Paramedics who arrived on site at 1200.
had a headache after the shot; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (had a headache after the shot   ) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (had a headache after the shot   ). At the time of the report, HEADACHE (had a headache after the shot   ) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medication was reported. Treatment information was not provided.
Neuropathy, chills, pain, sweating under the care of an internal MD. Doctor referred to a neurologist and rheumatologist also went to chiropractor and acupuncturist
Received vaccine #2 in rt deltoid at 10:30 AM Day 1: 1/27/21 (Wednesday) began to have whale sounds/gas and pain in lower abdomen in GI tract, then explosive diarrhea about 6 hours post Vaccine #2, Had chills and fever throughout the night; at 24 hours post vaccine developed a baseball sized swollen hard area to right axilla, very painful. Injection site swelling. and warm to touch, Symptoms continued through Sunday then area under axilla had reduced but right breast was bright pink and tender to touch, lymph nodes/glands on right side of jawline swelled and right ear became blocked and painful. I had some antibiotics for prophylaxis that I began to take 2/10/2021 and now area at jawline is improving and ear pain is improving. Teeth on right side at back feel like there is extreme pressure there. On 2/8/21 began having vision issue in left eye and pain in back right occipital area. took 2 baby aspirin and issue resolved. Experiencing nerve tingling in left side of face and lip all week. Comes and goes. Still having diarrhea and lower GI issues.
Non-malignant tumor in arch foot was extremely sensitive and sore for 24-30 hrs. the day after the second injection and then add no other time before after the second injection.
Took Vivotif capsules daily; A spontaneous report was received from a pharmacist on 04OCT2022. It described a female patient (unknown age) who "took Vivotif capsules daily" (PT: Inappropriate schedule of product administration). The patient took the Vivotif (typhoid vaccine live oral Ty21A) (lot number: unknown) for immunisation. It was reported that the patient got confused and took Vivotif capsules daily instead of every other day. The outcome of the reported event was not applicable.  Action taken with Vivotif with respect to the reported event was not applicable.  No additional information was reported.  Company comment: It was reported that a consumer took Vivotif capsules daily (inappropriate schedule of product administration). Vivotif dose should be taken every other day, and the causality of inappropriate schedule of product administration is assessed as not applicable to Vivotif considering the nature of the event. The case is considered non serious as per medical assessment.; Sender's Comments: It was reported that a consumer took Vivotif capsules daily (inappropriate schedule of product administration). Vivotif dose should be taken every other day, and the causality of inappropriate schedule of product administration is assessed as not applicable to Vivotif considering the nature of the event. The case is considered non serious as per medical assessment.
general fatigue and achiness within 12 hours, weakness in arm, localized reaction showed heat, swelling, dry skin and itching
tested positive for Covid; tested positive for Covid; This is a spontaneous report from a contactable pharmacist (patient) reporting for herself. A 37-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date in Mar2021, as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on an unspecified date, as DOSE 1, SINGLE for COVID-19 immunization. On an unspecified date, the patient had drug ineffective and tested positive for covid-19 and was wondering how long she had to wait after that diagnosis to get her booster dose. On an unspecified date, the patient underwent lab tests and procedures which included sars-cov-2 test which showed positive results (she has since tested positive for Covid). Outcome of the event was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the known safety profile of the vaccine BNT162B2, a causal relation between the events Drug ineffective, Covid-19 and the administration of the vaccine cannot be excluded.
18FEB chills, h/a, nausea;20FEB h/a, sore arm, reddened, warm arm 3cm x 5cm;
Arm a little sore dose 1 Arm a little sore,  short term fatigue next day  2DVT?s  relation to vaccine unknown
Red rash all over other parts of the body; Burning sensation; Itching; Irritation; This spontaneous case was reported by a consumer and describes the occurrence of IRRITABILITY POSTVACCINAL (Irritation), RASH ERYTHEMATOUS (Red rash all over other parts of the body), BURNING SENSATION (Burning sensation) and PRURITUS (Itching) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included ESTRADIOL, LEVOTHYROXINE SODIUM (SYNTHROID), ATENOLOL, IMIPRAMINE, VITAMIN C [ASCORBIC ACID], CALCIUM, MULTIVITAMIN [VITAMINS NOS], FISH OIL, MELATONIN, TOCOPHEROL (VITAMIN E [TOCOPHEROL]), VITAMIN A [RETINOL] and PHYTOMENADIONE (VITAMIN K [PHYTOMENADIONE]) for an unknown indication.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced IRRITABILITY POSTVACCINAL (Irritation). On 07-Feb-2021, the patient experienced RASH ERYTHEMATOUS (Red rash all over other parts of the body), BURNING SENSATION (Burning sensation) and PRURITUS (Itching). At the time of the report, IRRITABILITY POSTVACCINAL (Irritation), RASH ERYTHEMATOUS (Red rash all over other parts of the body), BURNING SENSATION (Burning sensation) and PRURITUS (Itching) outcome was unknown.        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.   Treatment included Lisinopril and Triamcinolone-Acetonide
With in 2 days of immunization a fine red rash spread all over from face to feet, knots were also note on Lt VL. No respiratory distress.
SARS coronavirus Apr2022; SARS coronavirus Apr2022; This is a spontaneous report received from contactable reporter(s) (Nurse and Physician).  A 68-year-old female patient received BNT162b2 (BNT162B2), on 26Feb2021 as dose 1, single (Batch/Lot number: unknown), on 19Mar2021 as dose 2, single (Batch/Lot number: unknown) and on 24Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 68 years for covid-19 immunisation. The patient's relevant medical history included: "Osteoporosis" (unspecified if ongoing), notes: History of osteoporosis; "Colitis" (unspecified if ongoing), notes: H/O Colitis; "Diverticulitis" (unspecified if ongoing), notes: H/O Diverticulitis; "Depression" (unspecified if ongoing), notes: H/O Depression; "Anxiety" (unspecified if ongoing); "Anxiety disorder" (unspecified if ongoing); "cholecystectomy", start date: 2000 (unspecified if ongoing), notes: History of cholecystectomy: 2000; "Actinic keratosis" (unspecified if ongoing); "Former smoker", start date: 01Jan1978, stop date: 01Jan2016, notes: Smoking statue-Former smoker , Packs per day: 1 , Years smoking: 38; "sleep" (unspecified if ongoing), notes: Indication: sleep. Concomitant medication(s) included: ALENDRONATE oral taken for osteoporosis; DULOXETINE oral taken for depression, anxiety; LORAZEPAM oral taken for anxiety; MIRTAZAPINE oral taken for sleep disorder. Past drug history included: Codeine, reaction(s): "Allergies: codeine". The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Apr2022, outcome "unknown" and all described as "SARS coronavirus Apr2022". The patient underwent the following laboratory tests and procedures: Body mass index: 23.8; Body surface area: 1.6; Body temperature: 97.3 Fahrenheit; Screening: Negative.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on available information and temporal association the causal role of suspect product cannot be excluded for reported events Case will be reviewed on receipt of FU information.,Linked Report(s) : US-PFIZER INC-202300253915 Same patient, different vaccine dose and different event;
While waiting at the pharmacy the requested 15 minutes after getting the shot, I started to feel intense tingling in my left arm (the arm that received the shot) and achiness in my elbow and wrist.  The intensity gradually lessened but did not go away. I spoke to the pharmacist who suggested that I wait another 15 minutes. After a total of 30 minutes, the intense tingling had lessened (but was still present) so after talking with the pharmacist again I left to go home.   As I was heading home the tingling moved to my head, neck and upper chest and I began to feel a tightness in my throat. I was able to swallow but had the sensation that my throat was closing up.  After several hours the sensation had not gone away
After 2 weeks of receiving vaccine I felt soreness in my knees & feet & hands.  My hands have been extremely painful & swollen, ever since, especially at night.  I have tried Motrin, Naprozen & Celebrex.  They have lessened the symptoms but have not gone away completely.  I still wake up at night with pain & swelling.
* Immediate headache; ache radiated from left side of forehead down to left side of gums. Left arm tingled and semi-numb. Base Dr. took BP immediately and was elevated; however, not alarming. * Fever (100.5-101.7 monitored myself ), chills, extreme exhaustion, severe headache, skin (all over) extremely sensitive, all symptoms for the next 3 days. * Today, Fri 19 Mar, feeling about 95% back to normal
No further AE; temperature excursion; This spontaneous report was received from a practice manager 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 11-AUG-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) 1 injection, lot # 1621929, expiration date: 06-DEC-2021 (injection site and route of administration were not provided) for prophylaxis.  On 04-AUG-2020, the administered dose experienced the temperature excursion of below 2 degrees Celsius (C) (1.1 C) for 27 hours and 45 minutes and above 9 degrees Celsius (9 C) for 1 hour and 15 minutes. The digital data logger was involved. No previous temperature excursion had occurred. No further adverse events (AE) were reported.  This is one of multiple reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1621929; expirationdate: 06-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other;  followupadditionalinfo :Yes; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:same reporter
Severe erythema at injection site progressed to inner aspect right arm with itching -> systemic allergic response to pertussis component of vaccine.
Within 2 hours of receiving the MMR vaccine my daughter had a total of 4 Febrile seizures witching ~ 20 minute time frame. She had to receive CPR and oxygen to regain consciousness and was transported to Hospital. 2.5 days later she still has a consistent fever and has developed measles type rash
The patient became very pale and he could not see anything for few minutes.  The patient felt better after 5-10 minutes
developed a red patch from shot site developed a red patch / to under my arm; Was swollen on part of it; This case was reported by a consumer and described the occurrence of erythema of extremities in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced erythema of extremities and local swelling. On an unknown date, the outcome of the erythema of extremities and local swelling were unknown.   It was unknown if the reporter considered the erythema of extremities and local swelling to be related to Shingrix.  Additional details were provided as follows: The age group was not reported, however it was captured as an adult as per vaccine indication. The age at vaccination was not reported. The patient had a shingle shot and developed a red patch from shot site to under the arm, it was swollen on part of it. The patient asked it there was anything to worry about. The patient would be due for the second shot soon and had signed up for COVID shot at the end of December.