chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. On an unknown date in 2013, the patient was inoculated with ZOSTAVAX as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. On an unknown date in 2014, the patient the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX (vaccination failure) vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. The patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was unknown. The causality between the events and ZOSTAVAX was considered to be related.
02Jun2021 first dose; 18Aug2021 with second dose; she was having some wheezing which was keeping her up at night; she was having some wheezing which was keeping her up at night; had persistent cough; The caller states it was really bad, she couldn't eat; This is a spontaneous report from a contactable consumer (patient). A 42-year-old (currently) female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on 18Aug2021 (at the age of 41-year-old) (Batch/Lot number was not reported) as dose 2, single for covid-19 immunisation. The patient had no medical history. The patient had concomitant medications but she was not on any new medications, she reported that everything was the same and had been on the same meds, the only thing that was different was this shot. The patient previously received bnt162b2 on 02Jun2021 for covid-19 immunisation and experienced Bell's Palsy and was still persisting. In 2021, the patient experienced having some wheezing which was keeping her up at night. The patient reported that she was having some wheezing which was keeping her up at night and she was given an inhaler and Z-pak of antibiotics after the second dose. She also had persistent cough and her doctor ran the test to see if she was exposed to COVID or had COVID. The patient stated she knew she could still get COVID even after having the vaccine, but the test was negative in 2021. She has a checkup with her doctor on the 2nd (as reported) and her primary was going to tell her if she possibly has COPD or if it was bronchitis. The patient stated that the Bell's Palsy developed some time in between the two shots and the Bell's Palsy was still persisting, it's gotten somewhat better. Her speech was still off and face was still skewed but it's not where it used to be. She completely had everything done that was needed to determine what she had was Bell's palsy. In 2021, the patient stated that it was really bad and she couldn't eat. The patient initially stated she was 228lbs, but then she may be 220lbs. She was roughly 220-228lbs, she hasn't weighed in a while. There were no additional vaccines administered on same date of the Pfizer suspect, no prior vaccinations (within 4 weeks), and no events following prior vaccinations. Outcome of event persistent cough was not recovered; and outcome of the rest of events was unknown.  The lot number for bnt162b2, was not provided and will be requested during follow up.
Falls in the equivocal range for measles and mumps; This spontaneous report was received from a consumer refers to a 15 year old male patient. The patient's medical history, concurrent condition and concomitant history were unknown. On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (strength, dose, frequency, route of administration, lot # and expiry date unspecified) for prophylaxis. On an unknown date in 2019 (also reported as "recently"), the patient's measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II)-titer showed the patient was immune to Rubella, but falls in the equivocal range for Measles & Mumps (antibody test negative). The reporter also stated that he would love to give to the patient only the vaccines he needs, and vaccines that do not contain RA273, WI-38, or MRC-5. The outcome of antibody test negative was unknown. Causality assessment was not provided by the reporter.
Shot given to patient in ER, Local Hive/rash on right deltoid area with low grade temp.
19 y/o male into clinic for MCV4 to complete college entrance immunizations.  Denied any problems with vaccine in past - actually had MCV4 on 8/5/05 @ 13 y/o.  Administered vaccine and as PHN applying Band-Aid, client began to slump over.  Ammonia wafted below nose and another PHN assisted in lowering client to floor.  Woke up during transfer.  BP 128/66, P 76,reg.  Kept client lying still for 10 minutes. BP 120/70; pupils reactive to light.  Slowly assisted to sit, then to stand.  Had not eated breakfast - crackers and juice given.  Client left clinc on own.  Called end of day - doing well.  Called 8/9/11 - doing well.
Within 1 hour of shot, I got very bodyaches & very tired. Approximately 4 hours later-vomiting stomach ache. this lasted 4 days; did not take any medicine-I just let it run its course.
This spontaneous report was received from a healthcare professional referring to a 12 months old female patient. Information about the patient's medical history and concurrent conditions was not reported. On 23-OCT-2015, the patient was vaccinated with an improperly stored dose of VARIVAX lot # L008270, expiration date 11-MAR-2017, (dose and route of administration were not provided). Concomitant medication was not reported. No adverse effects were reported. This is one of several reports received from the same source. Additional information is not expected as all scheduled follow up information was received.
Information has been received from a registered nurse concerning her daughter who was vaccinated with hepatitis A virus vaccine live inactivated (0.5 ml). Subsequently the patient experienced reaction the next day on her neck and face. The reaction resolved in a few days. Unspecified medical attention was sought. No product quality complaint involved. Additional information has been requested.
Information has been received from a physician for the Pregnancy registry for GARDASIL, concerning a 25 year old female with no drug allergies and no medical history who on 22-Sep-2008 was vaccinated with the second dose of GARDASIL. Concomitant therapy included vitamins prenatal. Subsequently the patient determined to be pregnant. A urine pregnancy test on 07-Oct-2008 was positive. The pregnancy questionnaire was received on 15-Oct-2008, which indicated that the patient had two previous pregnancies and one full term (40 weeks birth) Date of LMP was 06-Aug-2008 and EBD is 13-May-2009. Second dose of GARDASIL was reported as 22-Sept-2008 (lot# 0573X). No history of reported pre-term deliveries, spontaneous terminations, elective terminations, fetal deaths and birth defects. On 07-Oct-2008, the patient was prescribed prenatal vitamins. Follow-up information from a physician revealed that the patient experienced no infections or illness but hypertension (date unknown) during pregnancy. The hypertension was treated with Pro Cardia XL 30mg, oral daily on 05-Jan-2009 (duration not reported). During the patient's pregnancy, she underwent the following diagnostics tests: on 25-Dec-2008, a Quad screen showed a negative result. Ultrasound done on 04-Dec-2008, 08-Jan-2009 and 27-Mar-2009 showed normal results. On 22-May-2009, 41 Weeks from the LMP, the patient delivered a normal, healthy female baby weighing 7 pounds 4 ounces with a length of 18.75 inches. No complication occurred during labor/delivery. The baby had Apgar score of 7/9 and congenital anomalies. Additional information is not expected.
SEVERE MIGRAINE, CHILLS, NAUSEA FOR 12 HOURS. TOOK EXCEDRINE BUT NO REDUCTION IN SYMPTOMS. I TYPICALLY HAVE 2-4 MIGRAINES PER YEAR.  I HAVE HAD 5 SINCE 02/17/2021.
Pt recvd flu vax & w/in 48 hrs the pt devel baseball-sized induration;
This is her 2nd reaction to the Covid vaccine: Employee received the Pfizer vaccine dose #2 on 09/17 at the vaccine event. The injection was in the right upper arm in deltoid. Started have symptoms after vaccination (09/17): Sore and redness at injection site and warm to touch, sore throat of tightness and tingling, light head, dizziness. Elevated BP (164/98). Advise to put cold compress on site and take ibuprofen or Tylenol for soreness of arm at injection site, to call back if symptoms worsen, PCP follow up due this is the 2nd reaction.
This spontaneous report was received from a healthcare worker refers to unspecified number of patients of an unknown age and gender. The patients' concurrent conditions and medical history were not reported. On an unknown date, unspecified number of patients were vaccinated with improperly stored VARIVAX (Merck) (lot # L015045, expiration date 29-APR-2017). No adverse events were reported. Additional information has been requested.
Moderate Headache, Nausea, Mild body aches/feeling clammy, Injection site pain/swelling
Severe headache for 24 hours and off and on for a few days along with fatigue.  Lymph nodes under right arm swelled up 2 days after injection and remained swollen and painful for several day.
On November 12th I went to the Emergency Room as I thought I was having a stroke. Half of my face was paralyzed. I was given two CT-scans of the brain and an MRI of the brain before they made the diagnosis of Bell's Palsy.
Mom reports child woke up morning after immunization with a sore arm.  Center of area is black and blue with red area around the bruising. Today (10/26/15) she reports area is "baseball size".  She denies fever or rash.  Has been treating with cool compresses and Ibuprofen. Child has been in school, continues with normal ADL's.
Patient accidentally was given the wrong dose of vaccine- a Pfizer 6mos to 4 yr dose.  No adverse events. She had mild arm soreness at site of injection and arm pit soreness in the 1-2 days after the injection.
Information has been received from a nurse who reported that a patient said that on an unspecified date her friend was vaccinated with a dose of GARDASIL. Subsequently the patient's friend had her menstrual cycle and it was very heavy and abnormal. The patient's outcome was unknown. It was unknown if the patient sought medical attention. This is one of several reports received from the same source. Additional information has been requested.
Pt recvd vax 28MAY92 & SAT PM fever 101; stayed @ 100 until tuesday; lymphs elevated-48; WBC 3.2; following Sat hives appeared chest & back x 24 hrs;
swelling on the chest; swelling on shoulders; swelling of the lymph node on both side of the neck; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL CHEST PAIN (swelling on the chest), JOINT SWELLING (swelling on shoulders) and LYMPHADENOPATHY (swelling of the lymph node on both side of the neck) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Asthma.    On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced MUSCULOSKELETAL CHEST PAIN (swelling on the chest), JOINT SWELLING (swelling on shoulders) and LYMPHADENOPATHY (swelling of the lymph node on both side of the neck). On 28-Jan-2021, MUSCULOSKELETAL CHEST PAIN (swelling on the chest), JOINT SWELLING (swelling on shoulders) and LYMPHADENOPATHY (swelling of the lymph node on both side of the neck) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
Approximately 8 hours post injection, pt had fever, severe L deltoid pain, malaise, headache. Lasted for 12 hours. Pain decreases each day. Injection site pain still present somewhat day 3.
* Headache - alleviated by drinking lots of water or Gatorade - I believe it's actually dehydration; I do drink lots of coffee but no more than normal so the headache is unusual. This was worst the day after the shot; mostly resolved after that. * Intestines feel like I've eaten bricks, and defecation changed to be more dense and perhaps darker. Not constipated. Gatorade also seems to help intestines feel better. This was worst the day after the shot. * Did get tired feeling a little more easily/faster than usual. * Some soreness in shoulder about a 4 square inch area surrounding shot; mostly resolved after two days All the above-listed reactions much better two days after the shot, and better still three days after shot. Not entirely resolved yet.
Received phone call from mother on 1/8/19 at 2:00PM-states patient has been extremely fussy, cranky, not sleeping since 1/7/19 at 7:00PM. No fever but extremely irritable. (R) thigh-red area the size of quarter with dark red center. Had a red rash (fine) over torso from 1/11/10-1/12/19. Redness in (R) thigh faded by 1/15/19. Mother states can still feel lump in thigh. Mother also states after 3-4 days patient was less fussy and able to sleep better.
INJECTION SITE BRUISE (2 INCH IN SIZE); SKIN PEELING AT THE INJECTION SITE; RASH ON INJECTION SITE; INJECTION SITE TENDER; FEVER; This spontaneous report received from a patient concerned a female of unspecified age. 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: 1805029, and expiry: UNKNOWN) dose was not reported, administered on 27-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. O n 14-APR-2021, the subject experienced injection site bruise (2 inch in size). On 14-APR-2021, the subject experienced skin peeling at the injection site. On 14-APR-2021, the subject experienced rash on injection site. On 14-APR-2021, the subject experienced injection site tender. On 14-APR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from fever on 14-APR-2021, and had not recovered from rash on injection site, injection site tender, injection site bruise (2 inch in size), and skin peeling at the injection site. This report was non-serious.; Sender's Comments: V0:As per standard protocol, MAC comment not required for non -serious cases
Chest pressure, typically occurs later in the day and more frequent at night; requires deep breaths consciously; frequency lessens after a week but still occuring 9 days after the second shot.  Splitting headache at the crown of the head, area shrinks with each passing day but still around 9 days after the second shot.
swollen leg @ inj site, t101.3 for several days-also has viral illness on ATB 6SEP95 fever 100.2 & rash;
Patient said she was having the heaviest and worst menstrual cycle of her life.  She reported this to our pharmacy about 8 days after getting her shot and the menstrual cycle started about two days ago.  She said it is very heavy bleeding.  Dark and clotty like blood.  Does not seem to be slowing down.
Shoulder, neck and arm pain. Pain continued to escalate through Monday. Severe pain in shoulder. Three Motrin doesn't help pain. Today is Tuesday and pain continues.
Patient was inadvertently given Pfizer for second COVID vaccine instead of Moderna, as would have been indicated because her initial vaccine was with Moderna.   No negative reaction otherwise. Patient safety report filed at our own institution given the error.
This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history was not reported. On 01-OCT-2015, the patient was vaccinated with improperly stored dose of GARDAIL lot # K010215 (expiration date: 05-MAY-2017) dose 2 (route and site of administration were not provided). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Information has been received from a healthcare worker (immunization official) referring to a 5 year old patient. The patient's medical history, concurrent condition and concomitant therapy were not reported. On 06-JUL-2015, the patient was vaccinated with a dose of (Oka/Merck) VARIVAX, lot # K010440 (expiration date, dose and route not reported), which was improperly stored. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Redness, swelling, warm to touch, firm, itches, no fever, no tenderness.  Mom and child states can't lift arm, can move arm back and forth and fingers.  Temperature 97.4.  06/11/2003, advised mom to take to pediatrician, tylenol, pain/fever.
This case was reported by a consumer via call center representative and described the occurrence of laceration of finger in a 49-year-old female patient who received MENVEO (batch number M17102, expiry date August 2019), (batch number 175301, expiry date unknown) and (batch number SR967, expiry date unknown) for prophylaxis. This case was associated with a product complaint. On 21st August 2018, the patient received MENVEO. On an unknown date, the dose was an unknown dose. On an unknown date, the dose was an unknown dose. On 21st August 2018, immediately after receiving MENVEO, the patient experienced laceration of finger. On an unknown date, the patient experienced pharmaceutical product complaint. On an unknown date, the outcome of the laceration of finger and pharmaceutical product complaint were unknown. It was unknown if the reporter considered the laceration of finger to be related to MENVEO. Additional details reported as follows: The age at vaccination was not applicable for this report. The case was reported by the Office Manager. The batch number 175301 corresponds to MenCWY part and SR967 corresponds to Men A part of vaccine. Upon receipt of the box, the reporter could hear something rattling around in the box. When opened, there was broken glass throughout the box. When trying to determine how many vials were affected, the reporter cut her hand. There did not appear to be any damage to the box or the tray. There was no evidence of leakage, everything was dry. None of the vaccines were administered and the entire box was available for return. The entire box would be replaced. The patient had denied permission to contact their physician.
about 10-15 minutes the patient reported difficulty breathing...specifically she reported she felt her Throat tightening/closing. After receiving an Epi-pen she confirmed prior experience with allergic reactions. No allergic reactions were reported to vaccines of medications before receiving the dose.
Severe headaches beginning 8/14/2021 that have bot been expierenced prior. Headaches continue.
Received expired dose of the Moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired dose of the Moderna vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired dose of the Moderna vaccine). On 18-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Received expired dose of the Moderna vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were mentioned. No treatment details were reported.  Patient had no adverse events.   Most recent FOLLOW-UP information incorporated above includes: On 14-Dec-2021: Added information on occurrence of no adverse events and Reporter's first name and postal code updated.
pain at injection site; extreme swelling and pain in left armpit, side of chest and down arm; Pain in left armpit, side of chest and down arm; Pain in left armpit, side of chest and down arm; Pain in left armpit, side of chest and down arm; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 34 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01Apr2022 17:45 (Lot number: fj9946) at the age of 34 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing); "If COVID prior vaccination: Yes" (unspecified if ongoing). Concomitant medication(s) included: IBUPROFEN. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 01Apr2022 18:00, outcome "not recovered", described as "pain at injection site"; PERIPHERAL SWELLING (non-serious) with onset 01Apr2022 18:00, outcome "not recovered", described as "extreme swelling and pain in left armpit, side of chest and down arm"; AXILLARY PAIN (non-serious), PAIN IN EXTREMITY (non-serious), CHEST PAIN (non-serious) all with onset 01Apr2022 18:00, outcome "not recovered" and all described as "Pain in left armpit, side of chest and down arm". Therapeutic measures were not taken as a result of vaccination site pain, peripheral swelling, axillary pain, pain in extremity, chest pain.  Additional information: The patient did not received other vaccine in four weeks. Patient was not tested for Covid post vaccination.If COVID tested post vaccination: No.Facility type vaccine Pharmacy or Drug Store. If other vaccine in four weeks: No  Follow-up attempts are completed. No further information is expected.
This case was reported by a physician via call center representative and described the occurrence of tingling in a 17-year-old female patient who received BEXSERO. On an unknown date, the patient received the 1st dose of BEXSERO. On an unknown date, 1 day after receiving BEXSERO, the patient experienced tingling, numbness, headache and nausea. On an unknown date, the outcome of the tingling, numbness, headache and nausea were unknown. It was unknown if the reporter considered the tingling, numbness, headache and nausea to be related to BEXSERO. Additional details were provided as follows: The reporter stated that the patient after receiving BEXSERO experienced parastheia, tingling and numbness from her hip down to her toes. The patient also had headache and nausea. No further information was provided.
Writer went and got immunizations for patient ready and brough to two different coworkers to make sure everything looked good. Was told the immunizations were correct and writer and two coworkers walked into the room and gave the patient her immunizations. As writer was trying to document the vaccinations, writer noticed that instead of just the MMR vaccine the patient was given the MMR+V (proquad). Patient's mother was notified and told to watch for fevers and rashes and that the patient did end up getting a double dose of the varicella vaccine in the MMR+V and the plain varicella vaccine. Writer checked on the patient and there had been no changes.