chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to an adult female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 17-FEB-2012, the patient was inoculated with ZOSTAVAX at a grocery store pharmacy as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On an unspecified date, the patient was treated at a corporation (presumed to be patient's place of work) for a blistering vesicular outbreak that was diagnosed as herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Moderna 0.5ml IM given instead of 0.25ml for booster dose.
Myalgia, Fever, NauseaVomiting, chills, sore arm Narrative:
Staff stated that she was assisting a client registration at a vehicle so she was walking and talking at which time she felt an aura coming (fogginess/lightheadedness, nausea, feeling faint), Staff stated that she received the vaccine the day before and was starting to feel symptoms. Staff was visibly pale and advised to sit down. Staff asked to be laid on the ground because she felt faint at which time onsite life guards were notified. Blood glucose, Blood pressure, pulse rate and O2 saturation all monitored and with in normal limits. Staff stated that the symptoms were starting to resolve and asked to sit in chair. Another set of vitals was taken while the client was sitting and all vitals were with in normal limits. Patient's son (emergency contact) was notified and arrived onsite. Staff stated she felt better and was going to go home and lie down. Escorted to son's vehicle by wheelchair. Staff notified supervisor when she arrived home and per supervisor staff stated she was feeling better.
FLUZONE High Dose injection given in Rt. deltoid 10/4/14 - next day bruise developed on lower elbow - day after that 10/6 rash occurred - pt went to hospital.
Arm went numb about an hour after receiving vaccine.  Approximately 4 hours after vaccination I began having sharp pains in lower back, hips, down right leg, and feet. I had a full blown flare up for 3 days following vaccination.  Soreness in under arm of left arm.
itching of throat and tongue and feeling hot. pt removed some of his clothes and was given water to drink and ice packs to cool him. Also felt some numbness of his tongue. no respiratory distress noted and no coughing noted. signs were normal. pt continued to be able to talk and was alert at all times.
A non-serious spontaneous report of "FLUMIST administration to a 21-month-old" was received from a physician concerning a 20-month-old female. Neither relevant past medical history nor concomitant medications had been reported for this patient. The patient accidentally received FLUMIST on 29-Sep-2011,. There was no adverse event associated with this medication error; therefore, treatment and sponsor causality assessments are not applicable, and the event is considered resolved. This case will be submitted in accordance with MedImmune's FLUMIST post-marketing commitment for the indicated population of 2 years to 59 months of age.
hair line has been receding; 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 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ALOPECIA (non-serious), outcome "unknown", described as "hair line has been receding".  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
12/6/2007 9:00 AM Client reported Lt arm swollen, sore and red at injection site and moving toward armpit.  Site warm to the touch.  She was started on an antibotic and Benadryl. Immunization history flu 02/18/2005, pneumo 10/26/2004 & Td 12/09/1986.
Cold skin, profuse sweating, pale skin muscle flaccidity 100% Sat, 66 HR, clear lungs, equal and reactive pupils. Family member refers patient the same thing happen to him the first time. Doctor was notified, the lower extremities were raised and monitored for 30 minutes.
Fever (102.9), Chills, Aches in Shoulders and Thighs, Weariness
Information has been received from a registered nurse concerning a 8 year old white female twin who on 09-Jul-1996 was vaccinated subcutaneously in the left arm with a first dose of varicella virus vaccine live (lot number 616867/0243D). Illness at the time of vaccination were: on 14-Jun-1996 treatment for otitis media and bronchitis, on 24-Jun-1996, the patient was treated for viral syndrome and fluid in the right ear and was finishing clarithromycin (Biaxin). On approximately 02-Jan-2004, at the age of 7 years old, the patient had several days of sporadic vomiting, "then fevers" and developed chickenpox described as a breakout of lesions with "areas of cellulitis" and was prescribed cefadroxil (Duricef). The patient was seen on 15-Jan-2004 with less than 50 lesions on the face, trunk and extremities. The outcome was recovered, date of recovery was unknown. The reporter considered chickenpox, cellulitis, vomiting and fevers to be other important medical events. No further information is expected. (OMIC)
Vaccination / with an expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 15-month-old female patient who received DTPa (Infanrix) (batch number G5BE3, expiry date 25th February 2021) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated, about vaccination of a 15 month old female patient with an expired dose from infanrix the has been expirated since 25th February 2021. The reporter did not consent to follow up.
4/12 episode of loss of vision as a blindspot or aura and scintillating scotoma. 30 minutes of vision issues followed by headache.  (tunnel vision/dizziness/weakness/vomiting/stomach cramps after initial injection)
Within a few hours after the shot, I became dizzy.  The next day my symptoms were nausea, headache, dizziness, fever, vomiting, disoriented, trembling.  By the third day my legs and arms were numb.  On or about Dec 15, I first saw a MD and found out my blood pressure was dangerously high.  My symptoms continued so I returned to the MD.  I had additional blood work done and a CT Brain Scan.  Since I became ill I am unable to work and enjoy my normal activities.  My symptoms continue to be headaches and numbness in my hands and feet, and elevated blood pressure.  Some trembling in my hands.  My physician has prescribed medication and I am currently under her care. Per medical record, pt experienced lethargy and tinnitus. Nurse follow up on 05/14/04 states report is complete.
Patient contacted his primary care team and reported that 3 days after receiving the PREVNAR 13 vaccine, he developed a reddened, itchy area at the site of injection. He has taken BENADRYL OTC which he states relieves the itching. Primary care team instructed patient to come to urgent care if rash or itching worsens.
Information has been received from a physician concerning a female who was vaccinated with the second dose of GARDASIL (Lot not reported). Subsequently, the patient experienced fever, headache and was bedridden after receiving the second dose of GARDASIL. The mother of the patient called the clinic. The outcome of the patient was not reported. Additional information has been requested.
330pm - 6/25/14 Tdap given lt arm IM, then MCV4 rt arm IM. Pt c/o light headedness after MCV4 injection. Nurse went to raise the head of exam table when he was sitting and pt rolled forward off of table face first on floor. Initially pt was unresponsive then after several seconds was able to respond to mother. Staff called 911. Blood was noted around the mouth and chin, as patient turned self to side there was a deep gash to chin approximately 1" length, pressure applied. Pt. c/o teeth (front) hurting and feeling that his braces were broken. No other c/o head, neck or back pain. Nurses stayed with patient until the EMT's arrived which was within ten minutes of incident. EMT's assessed patient as he was lying on the floor then had pt. stand slowly with support to walk to the stretcher awaiting for him in the hall. Mother followed the ambulance in her car to the medical center at 345pm. 06/26/14 130pm TC to mom - patient received 16 stitches to chin, facial x-ray was negative, has an appointment with orthodontics on Monday 6/30/14, cap had come off of braces, c/o teeth being sore, PCP aware of situation.
Patient had facial swelling serious enough to be seen in the ER. Patient was told that it was a localized reaction to the vaccine. Swelling was gone the next morning.
She was just more tired than usual; Her arm wasn't very sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 04Mar2021 17:30 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Tylenol for headache. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunisation, reaction(s): "headache". The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "She was just more tired than usual"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Her arm wasn't very sore".  Additional information: Patient stated she read online that she shouldn't take TYLENOL before vaccine afterwards. But she did take TYLENOL before getting the vaccine. She wanted to know if that'll effect the vaccine.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
doses administered after more than 1 temperature excursion; doses administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021 at 9:55 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 30-Mar-2021 at 9:46 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In 2021, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 69.16 for dose administered on 02-Mar-2021 and 69.24 for dose administered on 30-Mar-2021.  No concomitant medications were reported.  Batch number 019B21A underwent temperature excursion on 30-Mar-2021 with temperature 33 degrees Fahrenheit from 09 AM. This vial was moved to fridge on 23-Mar-2021 and beyond use date for the vial was reported as 22-Apr-2021. Product moved to clinic on 30-Mar-2021.  Batch number 014M20A underwent temperature excursion on 02-Mar-2021 with temperature 27 and 36 degrees Fahrenheit from 09 AM to 03 PM. This vial was moved to fridge on 24-Feb-2021 and beyond use date for the vial was reported as 26-Mar-2021. Product moved to clinic on 02-Mar-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  No treatment medications were reported.
Information has been received from a consumer concerning her 4 year old daughter with a history of an abdominal hernia who on an unspecified date was vaccianted with a dose of Varivax (Oka/Merck). There was no concomitant medication. On 29-JUN-2006 the patient began to break out in a rash after her sister (WAES#0607USA00899) has been diagnosed with chicken pox on 28-Jun-2006. She had approximately 6-10 lesions and no fever was noted. At the time of the report the patient has recovered. No medical attention was sought though the physician's office was informed of her case. There was no product quality complaint involved. Additional information has been requested.
Administration error - 12 year old was given her 1st COVID vaccine with 5-11 year old formulation
Patient reports to me today that 2 days after getting shot on 5/20/21 that "she felt inflammation in her chest" that lasted for about 2 days. She used dssolvable ASA under her tongue to relieve discomfort. Symptoms went away after 2 days and she reports today that she feels fine.
Drug allergies to pneumococcal vaccine; This spontaneous report was received from a nurse and refers to a female patient who was 72-year-old at the time of reporting. Her concurrent conditions included breast cancer, papillary thyroid cancer, hyperlipidemia, Meniere's disease, hypertension, hypothyroidism and diverticulitis. Her drug allergies included allergy to ciprofloxacin, erythromycin, penicillin, metronidazole, rosuvastatin, tetracycline, dust and mold.  On an unknown date, the patient was vaccinated with pneumococcal vaccine (manufacturer unknown) (dose, route of administration, anatomical location, lot # and expiration date were not provided) for prophylaxis. On an unknown date, she experienced drug hypersensitivity. Outcome of the event was unknown.  Causal relationship between suspect therapies and pneumococcal vaccine (manufacturer unknown) was assessed as related.  This is one of two reports received from the same reporter. ; Sender's Comments:  US-009507513-2204USA006002:
I noticed patient's irritability the night of the injection; another adverse reaction was a mild rash that looks like keratosis pilaris on his legs, which started on 5/12.
DEAD; This spontaneous report received from a consumer via social media concerned a female of unspecified age, race and ethnicity. 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, batch number and expiry date were not reported) dose was not reported, 1 total administered on an unspecified date in MAR-2021 for covid-19 prophylaxis The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient died from unknown cause of death. It was unspecified if an autopsy was performed. It was reported as "dead following J and J Covid vaccine". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20230244421.; Sender's Comments: V0: 20230242008-Dead. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Medical history and drug reactions/allergies were not reported. On approximately April 2013 (reported as about 18 months ago), the patient was vaccinated with ZOSTAVAX, first dose, 0.65 ml subcutaneous, (lot number reported). On 13-OCT-2014, the patient was a accidentally vaccinated with a second dose of ZOSTAVAX, 0.65  ml subcutaneous. Concomitant medication was not reported. The patient should have received an unspecified flu vaccine and not ZOSTAVAX. No adverse effect reported. Additional information has been requested.
Information has been received from a nurse referring to a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant therapy were not reported. On 22-AUG-2017, the patient was vaccinated with VARIVAX (lot # N002204, expiration date 19-JAN-2019) (route, dosage and frequency were not reported) which was improperly stored. The sterile diluent used to reconstitute the VARIVAX was properly stored. No symptoms reported. The vaccine was stored at -1.6 degree centigrade for 15 hours. The vaccine had previous temperature excursion which was stored at a temperature from -9 degree centigrade to 8 degree centigrade for 30 hours and 15 minutes. Data logger was involved. No further information was provided. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1708USA010754: US-009507513-1708USA010756: US-009507513-1708USA010757: US-009507513-1708USA010762: US-009507513-1708USA010759: US-009507513-1708USA010760: US-009507513-1708USA010761.
Mom reports before bed gave respiratory treatment because child was starting to get sick with wheezing. Fever became very high where child was hallucinating, moaning, shaking, kicking his legs and flailing. His hands and feet were very hot. Mom gave ibuprofen and it did seem to calm him down to the point he was able to rest some. In the morning he continued to act very tired like he does not feel good.
Patient/self developed acute papulovesicular rash on bilateral palms and a few lesions on bilateral soles. Viral exanthem present on chest and arms. Disease process most consistent with coxsackie virus.
Client had completed 15 min observation time and was leaving facility when she approached EMT to inform her she felt chest pressure. EMT walked with client back to observation and asked her to take a seat at 1845 for further assessment. Client present today with Father. PHN arrived at 1849, client sitting upright on chair, alert and oriented x4. Vitals at 1849: blood pressure 130/75, pulse 96, oxygen sat 98%. PHN  asked client to describe what she was feeling. Client stated when she sat down at about 3 mins she felt "stabbing pain at middle of chest" that lasted about 5 minutes. Per client no pain at this time, just  a "slight pressure". Client denied chest pain, shortness of breath, headache, or pressure radiating anywhere else in body. PHN spoke with Father who responded client had no reaction to 1st Pfizer dose, history of asthma, client uses Albuterol inhaler as needed and no known allergies. PHN Father we would keep client longer in observation to complete 30 mins, Father agreed. Vitals at 1854: blood pressure 122/68, pulse 92, oxygen sat 98%. Client reported "low pressure at middle of chest". Per client diminishing, but still present. Vitals at 1859: blood pressure 124/68, pulse 86. Client reports same chest pressure, but "not bothering". Client stated she knows when it's asthma related and this is different. Last vitals at 1910: blood pressure 124/62, pulse 83, oxygen sat 98%. Client reported pressure "just there, slightly", not improving or worsening, not radiating.  At 1912 PHN  spoke with Father, offered to call paramedics for further assessment, Father declined. PHN gave client and Father ER precautions and advised to follow up with provider. Client left facility at 1915 with steady gait.
horrible chills; extreme abdominal pain with vomiting; extreme abdominal pain with vomiting; muscle aches; sensitive lymph nodes in the neck on the side where vaccine was given; joint pain; This is a spontaneous report from a contactable consumer or other hcp reporting for herself (patient). A 24-year-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Batch no/ Lot Number: not reported; expiration date: unknown) via unknown route of administration in left arm on 10Apr2021 10:45 AM (at the age of 24-year-old) as dose 1, single for covid-19 immunization at . Patient's medical history was not reported. Known allergies included Naproxen and cats. Concomitant medications included caffeine, paracetamol [EXCEDRIN TENSION HEADACHE]. Patient wasn't COVID-19 positive prior to vaccination and was not tested for COVID-19 post vaccination No other vaccine was administered within four weeks of vaccination. On 13Apr2021 at 23:00, day 4 of vaccination patient experienced horrible chills, extreme abdominal pain with vomiting, muscle aches and joint pain, sensitive lymph nodes in the neck on the side where vaccine was given. No treatment was given in response to the events. Outcome of all the events was not recovered.  The batch/lot number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Myalgia, NauseaVomiting, Reported neck stiffness, joint pain and nausea lasting approximately 24 hours
Loss of consciousness about 5 minutes following vaccine administration. Muscles contracted with arching. As patient regained consciousness he still had vision loss. Complained of nausea for about 24 hours but no vomiting. Dizziness and headache persistent for about 36 hours. Patient with severe fatigue for about 24 hours and gradually improving over next 48 hours.