chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient guardian  called 10/28/2020 and reported patient was sent home from school with mild rash to right side of neck (front and back) and ear that was fine red bumps and mildly irritating/itchy. She reports patient had a mild headache when sent home. No fever, no swelling, no problems breathing or swallowing/eating.  No irritation, redness, rash, or drainage at site of vaccine admin. She states she took him to fast pace to be evaluated and nurse advised to monitor and continue regular meds and patient was cleared to go back to school next day on 10/28/2020. HD RN contacted patients guardian 10/29/2020 to check up on patient and she reports patients rash is going away and he was back in school 10/28/2020 with no concerns.
This case was reported by a healthcare professional and described the occurrence of shaking in an infant female subject who was vaccinated with Pediarix for prophylaxis.  The healthcare professional is the grandmother of the subject.  The healthcare professional reported that, "three more babies" experienced shaking and crying following receipt of Pediarix, however, subject identifiers were not provided. On an unspecified date on or before 30 September 2005, the subject received a dose of Pediarix.  At an unspecified time after vaccination with Pediarix, on an unspecified date on or before 30 September 2005, the subject experienced shaking and crying.  The outcome of the events was not reported.
about 3-4 minutes post h1n1 nasal vaccination i experienced elevated bp, heart racing, mild brochoconstriction. resolved within 5 minutes, without any other symptoms.
BRUISES ON ARMS AND LEGS; LIGHT HEADED; LITTLE OFF; This spontaneous report received from a patient concerned a 32 year old male. 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: 207a21a, and expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 09-APR-2021, the subject experienced light headed. On 09-APR-2021, the subject experienced little off. On 10-APR-2021, the subject experienced bruises on arms and legs. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bruises on arms and legs, and the outcome of light headed and little off was not reported. This report was non-serious.
Headache, ( within 6 hours), body aches(24 hours after injection)
Approximately 4 weeks after receiving her second shot, she started noticing shortness of breath.   When I was visiting with her, the week after holiday, I noticed that she was wheezing.  She had not had any acute symptoms related to her asthma prior to this instance.  Her symptoms have been controlled with Fasenra, Breo and Incruse.   She is now experiencing shortness of breath after walking 15 feet.  She becomes short of breath when going from her bed to bathroom and when walking from her bed to the kitchen.   Majority of her time is now spent in bed due to the difficulty breathing.   She has difficulty completing ADL and requires a wheelchair when visiting her doctors.   Mom also reports that she "looses her breath" occasionally when sitting in bed.  She has seen her pcp, pulmonologist, had an MRI and a stress test.  So far,
leg pain like squeezing rubber bands around leg; vertigo; Nausea; Red left eye; Left ear pain; Left side of face numb; Severe leg burning starts; This is a spontaneous report from a contactable consumer (patient).   This 50-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number ER8734), via an unknown route administered administered at left arm, on 05May2021 13:15 (at the age of 50-year-old) at single dose for COVID-19 immunisation. Historical vaccine includes the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number EA0170), on 14Apr2021 (at the age of 50-year-old) at single dose for COVID-19 immunisation and developed severe burning in legs on 14Apr2021 and flu like symptoms on 15Apr2021. Relevant medical history included latex allergy and hypothyroidism. Relevant concomitant medications included levothyroxine sodium (SYNTHROID) for hypothyroidism and ethinylestradiol, ferrous fumarate, norethisterone acetate (LO LOESTRIN FE). On 05May2021 at 13:45 (1/2 hour after second vaccine) left side of face numb completely numb for about 20 minutes, severe leg burning started at midnight. On 09May2021, she woke up with red left eye and left ear pain. On 09May2021, the patient nausea. On 09May2021 (at 20:00), the patient had vertigo. On 10May2021, appointment with physician and no bacterial infection in ear was determined, advise again of leg heat and left face numbness. On 13May2021, leg burning turned to leg pain like squeezing rubber bands around leg, left face numbness increased. The events required physician office visit, but no treatments were given. The patient had not recovered from  the events.  No follow-up attempts are needed. No further information is expected.
Receive 0.3 ml of Pfizer vaccine. Discovered later that vial had been diluted with 1.6 ml instead of the recommended 1.8 ml normal saline. Patient experienced Dizziness, BP 173/83, HX HTN, took BP meds.  Symptoms resolved and released home. Patient contacted by phone 03/11/2021 and still reported Dizziness; BP 173/83 currently just has injection site soreness but feels fine.
fever, stomach ache, headache that night.  went to urgent care that night, just treated with ibuprofen and fluids.  Fine next morning.
pt recvd vax 27SEP93 pt was hospitalized w/meningitis; pharmacist felt that pt exp was life threatening & reported that condition was not good;
Pt reported "chills and aches all over the body for a couple of days",  he also had a red and swollen arm from shoulder to elbow.  The arm is still red, but the swelling went down.
It started with ear fullness and ringing for a moment. No symptoms until 4am the next morning. I then have chills, body aches, fatigue. It felt similar to the flu without the stomach symptoms.
Full body urticaria that changes locations throughout day, affecting anywhere from 10% - 75% of skin, as well as mouth.  Rash has been constant for 72 hours at time of report.
Verbal report; redness (1/2" X 1"), slight swelling and tenderness to site of DTAP.
Cycle 14 days late  Muscle spasm in back  Heart issues  54 BPM have to wear  a heart monitor
Redness, pain, swelling, and warm to touch of right upper arm. Patient also complaint of itching of right upper arm, states symptoms started on 8/26/13. Swelling and redness approx. 20 mm, small amount of swelling of left upper arm.
patient received a dose from an expired Moderna vial; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received a dose from an expired Moderna vial) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 068H21A, 037F21A and 076C21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 03-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Dec-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jul-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Jul-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received a dose from an expired Moderna vial). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received a dose from an expired Moderna vial) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 as dose 4 (booster), single (Lot number: GJ2524) at the age of 35 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 06Dec2021 as dose 3 (booster), single (Lot number: FJ8762) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 27Feb2021 as dose 1, single (Lot number: 041L20A) and on 27Mar2021 as dose 2, single (Lot number: 031A21A) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient is treated with Paxlovid for covid-19 from 29Mar2023 to 03April2023. Patient had a bitter taste in her mouth the entire time she took Paxlovid. She also had diarrhea intermittently.  No follow-up attempts are possible. No further information is expected.
sob, headache, fatigue, joint /muscle pain, fever. Worst part is the right shoulder joint/muscle pain. This pain is very bad it has kept me up for 2 night  and pain still present
The patient had no adverse reaction. She received a Quadracel for her 3rd dose of Dtap and Polio because she was behind and receiving multiple vaccines this vaccine was given in error.
Sore arm; Headache; This spontaneous case was reported by a nurse and describes the occurrence of LIMB DISCOMFORT (Sore arm) and HEADACHE (Headache) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     NO medical history information was reported.     On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced LIMB DISCOMFORT (Sore arm) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 05-Feb-2021, HEADACHE (Headache) had resolved. On 06-Feb-2021, LIMB DISCOMFORT (Sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-011917 (E2B Linked Report). This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 08-Feb-2021 and was forwarded to Moderna on 08-Feb-2021.    This spontaneous case was reported by a nurse and describes the occurrence of LIMB DISCOMFORT (Sore arm) and HEADACHE (Headache) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     NO medical history information was reported.     On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced LIMB DISCOMFORT (Sore arm) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 05-Feb-2021, HEADACHE (Headache) had resolved. On 06-Feb-2021, LIMB DISCOMFORT (Sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-011917 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-011917:
Vaccine was given too high on the shoulder.  It was given only 1 finger breath below the acromion process.  Soon after (less than one hour) the injection was given, I (the patient) began having pain in the shoulder above the injection site and into the neck. I also began having a stiff neck with decreased ability to turn my head to the left and slightly decreased ability to turn my head to the right.  The next day (9/22/2023), I called the office to report the problem and suggested that a VAERS should be filled out, but was told that it was not necessary as I did not have any redness or swelling at the injection site. I was also told I could be seen if I wanted the site to be checked for swelling or redness, but since there was not any, I chose not to drive the 11 miles to the office.
Information has been received from an unspecified healthcare worker, for GARDASIL, a Pregnancy Registry product, concerning a 19 year old female patient. On 07-NOV-2012 at 12:15 PM, the patient was vaccinated with a third dose of GARDASIL IM (dose not reported) (lot number reported as 1397). There was no illness at the time of vaccination. It was reported that the patient was pregnant at the time of vaccination (adverse event onset was reported as 23-JAN-2013). The LMP and EDD was not known. There were no lab diagnostic studies performed. The outcome of the pregnancy was unknown. Lot # 1397 is an invalid lot number for GARDASIL. Follow up information has been received from a registered nurse which reported that lot# 668261/1397AA, expiration date: 09-APR-2013. Additional information has been requested.
fatigue, headache, muscle aches, joint aches, nausea, fever, chills, head congestion, minor shortness of breath, duration of all 36 hours
Dizzy spells that come and go, also feeling of ear ache and discomfort that happened within an hour of receiving the vaccine. They have not completely gone away since receiving the vaccine on 03-05-21.
Chills, Feverish and fatigued for 2 days only.   Arm hurt from shoulder to wrist, large red spot size of a tennis ball at injection site .  Slightly swollen and warm to the touch.
PCR test for COVID-19 and it was positive; Lost of taste; Lost of smell; episode of heavy sweat; hypersensitivity in the torso and waist, I touch it and it hurts; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (Lost of taste) and ANOSMIA (Lost of smell) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jan-2021, the patient experienced ANOSMIA (Lost of smell). On 17-Jan-2021, the patient experienced AGEUSIA (Lost of taste). At the time of the report, AGEUSIA (Lost of taste) and ANOSMIA (Lost of smell) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No treatment information was provided.   Reporter did not allow further contact
Currently showing symptoms of Covid; Currently showing symptoms of Covid; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration on an unspecified date as dose 1 single for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date, the patient experienced currently showing symptoms of COVID. It was reported that patient traveled to the country to get vaccinated, she already received the first dose of the Pfizer Covid-19 vaccine. She was currently showing symptoms of Covid, but she had not been tested yet. Her second dose was scheduled for July 19th. She asked If I tested positive, can I get vaccinated or how long should I wait. The outcome of the events was unknown.  Information on the lot/batch number has been requested. Additional information has been requested.
patient developed flushing and throat tightness after vaccine which quickly resolved, then repeat episode 30 minutes later, given 25mg PO Benadryl, observed another 30 minutes, eyes developed swelling was given Benadryl 25mg PO and sent to ER
Moderate to severe headache lasting 10+ days. There is no outcome as of yet. My doctor advised me to "contact the coronavirus hotline" and take extra-strength Tylenol. Today is the 11th day since my 2nd shot and I don't know what to do.
Patient was administered the vaccine less than 23 days since dose #1. (dose # 09/01/2021).
mother got really sick when she took her second one; 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 ILLNESS (mother got really sick when she took her second one) in a female patient of an unknown age 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (mother got really sick when she took her second one). At the time of the report, ILLNESS (mother got really sick when she took her second one) outcome was unknown. Not Provided          No concomitant medication details were provided. No treatment medication details were provided.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: follow-up
No additional adverse effects reported; a 6 month old patient was administered PNEUMOVAX 23 instead of PREVNAR 13; This initial spontaneous report as received from a medical assistant referring to a 6 months old patient of unknown gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.  On 11-MAR-2020, the patient was administered with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot# S029265 with expiration date 31-MAR-2021, dose detail and route were not reported) instead of pneumococcal 13v conj vaccine (crm197) (PREVNAR 13), for prophylaxis (wrong product administered). The pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was administered with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23 SYRINGE (DEVICE)). No additional adverse effects reported.   For pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23 SYRINGE (DEVICE)), the lot number was not available and the serial number was not available.   combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S029265; expirationdate: 31-MAR-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Besides my normal menstrual cycle, I have had prolonged bleeding throughout the month. Bleeding is very heavy with large clots.
Second dose was 27th of march. I saw my PCP on the 27th of April for the headaches. A week or two after second dose they began to be a daily occurrence and then they turned into a 24-hour situation. It was like a migraine, but I've never had them before.
COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 36 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Peanuts" (unspecified if ongoing). If vaccine received: Yes. Other medication in 2 weeks: Yes. Concomitant medication(s) included: LEVOTHYROXINE; ZOLOFT.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
pt recvd vax;endurated lump w/ blisters, hot to the touch, lump size of silver $, occured 8 days p/ vax;no tx necessary;
Lip swelling, shortness of breath, fatigue. Started 10/18/21, one day after 2nd covid vaccine.
Very uncomfortable right now; Tight chest; Shortness of breath; Accelerated heart rate; I''m not feeling so well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1, Lot: EM9809), for Covid-19 Immunization, reaction(s): "Tight chest"; Bnt162b2 (Dose:1, Lot: EM9809), for COVID-19 immunization, reaction(s): "Shortness of breath", "Accelerated heart rate"; Bnt162b2 (Dose:2, Lot: EN6198), for COVID-19 immunization. The following information was reported: DISCOMFORT (non-serious), outcome "unknown", described as "Very uncomfortable right now"; CHEST DISCOMFORT (non-serious), outcome "unknown", described as "Tight chest"; DYSPNOEA (non-serious), outcome "unknown", described as "Shortness of breath"; HEART RATE INCREASED (non-serious), outcome "unknown", described as "Accelerated heart rate"; MALAISE (non-serious), outcome "unknown", described as "I''m not feeling so well". Relevant laboratory tests and procedures are available in the appropriate section.  Follow-up (15Nov2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Presented to the ED c/o dyspnea x 2 days. Pt was 88% on RA in triage. Associated symptoms include cough, congestion; admitted for acute hypoxemic resp failure d/t COVID-19; tx w/remdesivir, steroids, abx, Vit C, zinc, O2 therapy; weaned to room air; home w/HHC
DTaP #5 adm 073107. Telephone call from mom on 080207 reporting left upper arm swollen, hot to touch, et red. Instructed to use cold packs, et to call doctor 080207 pm - mom reports doctor started patient on prednisone, cold packs et Tylenol for age.