chrisvoncsefalvay/vaers-outcomes huggingface dataset:
April 17th 10:28 Took Vaccine 10:45 Reaction started with tightening of my throat and drank some water 11:00 ish gums started swelling and lips  tingling My hands and tongue started swelling and my face was  warm 11:15 ish-took 25 mg Benadryl via shot  12:27-arrived at ER for monitoring 2:22-took Pepsid and steroid ( dexamethasone) orally 4:00-50 mg of Benadryl orally 10:00 pm- 25 mg Benadryl and Pepsid tablet    April 18th  Symptoms: ? Face flushed and stretched ? Face and neck itchy / small hives ? Mentally scattered ? Auras  Headache  4:00 am - 50 mg of Benadryl oral 10:00 am - 25 mg of Benadryl oral 10:00 Pepsid  11:00 Tylenol 4:00 Tylenol  6:00 Benadryl 7:25 Imetrex
Information had been received on 28-JUN-2016 from the husband of a 60 year old female with penicillin allergy who reported that his wife received a dose of PNEUMOVAX 23 0.5ml intramuscular injection on 18-JUN-2016 (lot #/expiration date unknown by reporter). The next day, 19-JUN-2016, "the patient's arm went paralyzed near the injection site". The patient visited her doctor to seek medical attention and "currently has a peripherally inserted central catheter (PICC) line in her arm to help treat the paralysis". On an unknown date, patient underwent "blood work" (results not provided). Patient's present status was reported as not recovered. Concomitant medication and pertinent medical history were unknown by reporter. Patient's husband called to request compensation and assistance to pay for patient's medical bills due to her arm being paralyzed and having to use a PICC line in her arm. No further adverse event information was provided. Upon internal review, "the patient's arm went paralyzed near the injection site"/"currently has a peripherally inserted central catheter (PICC) line in her arm to help treat the paralysis" was determined to be a medically significant event. Additional information has been requested.
When attempting to enter patient information into the immunization Registry, patient could not be found when birthdate on consent form (September 12th, 2010) was entered as written. Attempted to enter patient as new when similar name came up with birthdate 4/16/2011, address matched that on consent form. Contacted patient's legal guardian to verify patient's correct date of birth.  Guardian verified patients date of birth as 04/16/2011. As incorrect date of birth was provided at time of vaccination, vaccine was administered as per consent form client was 12 years old. When correct birthdate was noted, it was discovered that patient under 12 years old received vaccine approved for 12 years and older. Guardian reports patients is doing well,  and does not have any adverse reactions to the vaccine administered.
First shot was Feb 5.  One week later my side effects started.  Headache, Fever (102), chills, body aches.  Started on Friday Feb 12 and ended on Sunday Feb. 14th.  Second shot was  Fri. March 5.   Immediate reaction this time with overnight chills and fever.  Fever never getting over 100.  Body aches, headache.  It was over by Sunday late in the day.  I then got a second reaction on Thursday March 18, 2021.  I left work at 10:30am with a fever starting. I got a 103 degree fever on Thursday and Friday.  Had all the same symptoms, Headache, body aches, joint pain, high fever.  Saturday I went to urgent care to rule out anything else.  He said it was probably from the vaccine.  Fever was finally starting to get lower and I felt ok on Sunday morning but the fever came back to 101.4 by the afternoon.  I have also experience numerous episodes of night sweats.  Waking up randomly soaked in sweat.  Today I came to workbut I am weak and tied.  This morning was a fever of 99.8.
Site: Pain at Injection Site-Medium, Additional Details: Patient came in to complain of shoulder pain/limited range of motion. She said it occured after having the first shingles vaccine administered. She did say she has a history of shoulder/back pain in same arm, but after the shot it got worse.
Site: Pain at Injection Site-Mild, Error: Wrong Dose of Vaccine - Too Low, Additional Details: upon administration vaccine squirted out of syringe instead of entering patient, leur lock of the syringe was faulty, prior to administration leurlock was tightened, pt preferred to be revaccinated with the quarter of the 0.5ml dose
This case is poorly documented. Information has been received from a consumer report which appeared in a television bulletin on 27-MAY-2008. It was reported by the mother of the patient that her 18 year old daughter was vaccinated with the first dose of GARDASIL on an unspecified date and was well tolerated. The second dose of GARDASIL, lot #, route and administration site not reported, was given in May-2007. Subsequently on an unknown date, the patient developed a thrombosis (not otherwise specified) and complained about weight loss, sleeping and circulatory disorder. Outcome was not reported. The reporter considered thrombosis, insomnia, circulatory disorder peripheral, and weight loss to be other important medical event. Additional information has been requested. Other business partner numbers include E2008-05381.
Had Covid/ PCR: Nasal Swab: Positive; Had Covid/ PCR: Nasal Swab: Positive; This is a spontaneous report from a contactable consumer (patient). A 41-years-old male patient received bnt162b2 (PFIZER COVID-19 VACCINE, Solution for injection, Lot number was not reported) via an unspecified route of administration on Feb2021 09:00 (at the age of 41-years-old) as dose number unknown, single for covid-19 immunisation. The patient medical history was not reported. Patient did not take concomitant medications (No other medications in two weeks). No other vaccine in four weeks. No covid prior vaccination. On 11Aug2021 (symptoms started), the patient had covid. On 15Aug2021, the patient underwent covid test post vaccination with PCR Nasal Swab test which resulted as positive. No treatment was given. The outcome of the event was recovered with lasting effects.  The lot number for the vaccine, [bnt162b2], was not provided and will be requested during follow up.
12 hours after receiving second dose of vaccine, small pain begin at injection site. Chills began too, and then I went to bed. After 5 hours, woke up with severe chills, body aches. Entire day (5/5/21) effectively incapacitated. Complete body ache. Slight headache. Chills lasted until late morning. DID NOT WANT TO MOVE. But also staying in place hurt. Tired. Approx. 34 1/2 hours after injection, time of this writing, still some body pain in hips and abdomen.  Did not have any adverse reaction from first dose.
Patient developed arm pain after receiving vaccination that didn't go away. Sought medical attention and was originally treated for possible infection which resulted in no improvement. Had MRI done and was told by physician that she had tears in rotary cuff and would need to follow up with an orthopedic physician for treatment options. Physician could not say it was related to vaccination, but patient thought she should report it as a possible adverse reaction anyways.
Nausea, constipation, bloating, trapped gas.  Bad stomach cramps to where he couldn?t stand up. Bent over . Then a low grade fever started
Individual met with medical provider in clinic on 3/29/22 morning 9am and relayed concern for swelling in ankles, feet. Medical provider documented this as "slight +1 edema BLE at ankles, very mild". Follow-up monitoring by provider team warranted D-dimer labs, and 3/30/22 provider documentation to reflect bilat +2 pretibial/ankle and foot pitting edema, pretibial area with diffuse PAD appears red casting, +dp, cap rf<3, musk: ilat ankle/foot/toes with full AROM w/o limitation. Encouraged ankle pumps, BLE elevation and increasing daily physical activity, knee ted hose given, reviewed d-dimer 0.88, will trial short course lasix and create f/u appt for eval, discussed low socium diet and reviewed s/s worsening and when to contact medical.
On 12/11/00, received call from mom, inquiring about any known connection between Hep-A vaccine and seizures. Reports child's "body jerks" when tired. Began within 1 week of getting Hep-A #1 vaccine on 10/20/00. Initially occurred only when falling asleep (night time and nap time). She describes as "when you're falling asleep and someone startles you". Family went on vacation 11/3/00, and on 11/4/00, child began having same thing during the daytime ("a few times a day"). Now it is occurring up to 30 X an hour. Seems to occur when most fatigued. Seen by doctor when she travels to this county clinic and the doctor has witnessed 1 time. Scheduled to have MRI on 12/21/00. Mom trying to think of anything new and different in the past 2 months. It is of note, that this pt's sister also received Hep-A #1 on the same date (same manufacturer and lot #) without noted adverse event. The plan is to re-admit child to hospital under Neuro-Science Institute for 3-5 days for observation. Mom reporting that frequency of episodes "about the same".
Initial unsolicited report received from a non-health care professional on 15 Feb 2017. This case involves a 32-year-old female patient who was vaccinated with a dose of FLUZONE QIV (batch number: UI643AE, Expiry date: 30-JUN-2017) by intramuscularly in left deltoid on 12 January 2017. Patient had no ongoing illness at the time of vaccination, pre-existing physician diagnosed allergies, birth defects, medical conditions and concomitant medications. On 12 January 2017, 12 weeks 3 days following the vaccination, the patient had developed influenza A virus infection. It was suspected vaccination failure case. The patient required ER or doctor visit. Lab data included rapid flu test showed positive for A strain and swab sent out to state come back as influenza A/H3. Corrective treatment was not reported. On an unspecified date the patient was recovered from the event. Upon medical review, the case was considered as serious due to important medical event: flu / Influenza A/H3/ flu symptoms and suspected vaccination failure. List of documents held by sender: none. Sender's Comments: This is a case of possible vaccination failure (serology tested positive for group A) in a 32-year-old female patient after INFLUENZA QUADRIVAL A-B VACCINE. As with any vaccine, influenza vaccination may not protect 100% of vaccinated individuals. However, additional information on patient's immune status at the time of vaccination (medical history, concomitant medication), previous vaccinations, infectious work-up results are needed to further assess this case. Based on the available information, vaccination failure cannot be confirmed.
Rash (spots) on legs, stomach and arms. Rash does not itch, burn or cause discomfort.
Breakthrough case admission after 2 vaccines Moderna 1/29/21 Lot# 007m20a;  mODERNA 2/25/21 lOT# 010a21a
9 days after vaccines pt developed erythema multiforme was seen in office 10/18/04.
Janssen COVID-19 Vaccine EUA Pain started in right shoulder joint, by next morning was in right hip joint.  Went to ER, given oxy and toradol, next day, pain was diminished in right but migrated to left shoulder joint, and wrist joints and finger joints of both hands.  Minimal swelling in hands.  Went to PCP on day 5, prescribed prednisone that helped greatly, pain still present but markedly less.  Joint pain now in knee joints also.
Vial stored post puncture vial was stored under refrigerator; Doses were administered to patients from a Moderna COVID-19 vaccine vial that was punctured more than 12 hours prior; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses were administered to patients from a Moderna COVID-19 vaccine vial that was punctured more than 12 hours prior) and PRODUCT STORAGE ERROR (Vial stored post puncture vial was stored under refrigerator) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses were administered to patients from a Moderna COVID-19 vaccine vial that was punctured more than 12 hours prior). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial stored post puncture vial was stored under refrigerator). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses were administered to patients from a Moderna COVID-19 vaccine vial that was punctured more than 12 hours prior) and PRODUCT STORAGE ERROR (Vial stored post puncture vial was stored under refrigerator) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was provided.  On 31-Mar-2022, The vial was initially stored in the refrigerator.  On 21-Apr-2022 at 10:20 am, The vial was first punctured.  On 23-Apr-2022 at 9:50 am - 4:05 pm, The vaccine was administered.  The patient has not reported any adverse reactions to the expired dose administered.   Post puncture vial was stored in refrigerator and the vial did not undergo any temperature excursions.  The vial was not exposed to room temperature for more than 24 hours.  No treatment drug was reported.
Did not receive 2nd dose 25-35 days after the 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Did not receive 2nd dose 25-35 days after the 1st dose) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Did not receive 2nd dose 25-35 days after the 1st dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Did not receive 2nd dose 25-35 days after the 1st dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication was reported. No concomitant medication was reported.
pt recvd vax & devel profound & permanent brain damage, motor impairment & learning disabilities;
Headache, Myalgia, Fever, Fatigue, arm soreness Narrative:
PATIENT STATED FELT DIZZY AND FAINTED AT TIME OF ADMINISTRATION. THE PATIENT WAS RESPONSIVE WITHIN 1 MINUTE AFTER FALLING TO FLOOR AND WALKED OVER TO POST-IMMUNIZATION AREA FOR OBSERVATION. SHE STATED THAT SHE FELT FINE AND DID HAVE A BIT OF A SORE ARM AROUND THE ADMINISTRATION SITE. SHE STATED THAT IT FELT LIKE HALF OF THE PAIN OF A TETANUS SHOT. SHE DID TAKE A GLASS OF WATER AND STATED THAT SHE HAD RECENTLY EATEN. 911 WAS CALLED AND THE PATIENT EVALUATED AND WALKED OUT OF STORE. NO MEDICATIONS ADMINISTERED A TIME OF EVENT.
Ambulatory c/o headache, vomiting, body aches/fatigue and fever ever since receiving J&J vaccine last Thursday. Denies COVID contacts. PMH DM, taking Zofran w/ poor relief. 52 y/o M presents for evaluation of persistent nausea and vomiting s/p receiving the Johnson and Johnson COVID vaccination on 6/24/21. Pt endorses a 5 day hx of myalgias, nausea, and vomiting. He has not been drinking much water over the past couple days. He has not been checking his sugars regularly. Reports associated myalgias.
shingles; This spontaneous report has been received from a lawyer regarding a case in litigation and refers to a 70-year-old female patient. The patent's concurrent conditions, medical history and concomitant medications were not reported. On 04-SEP-2012, the patient was administered zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiry date were not provided) for prophylaxis. As a result of her receipt or zoster vaccine live (ZOSTAVAX), In November 2012, the patient was caused to suffer shingles, including any and all of its sequelae. As a result of her receipt of zoster vaccine live (ZOSTAVAX), she had been caused to suffer severe personal injuries, pain, suffering and emotional distress, as well as to incur substantial economic damages. As a result of the foregoing acts and omissions, the patient was caused to suffer serious and dangerous side effects including shingles, as well as other severe and personal injuries which are permanent and lasting in nature, physical pain and mental anguish, including diminished enjoyment of life, as well as the need for lifelong medical treatment, monitoring and/or medications. As a result of the foregoing acts and omissions the she requires and/or will require more health care and services and did incur medical, health, incidental and related expenses. The patient is informed and believes and further alleges that she will in the future be required to obtain further medical and/or hospital care, attention, and services. As a foreseeable, direct, and proximate consequence of zoster vaccine live (ZOSTAVAX), the patient suffered shingles and other related health complications. In addition, she requires and will continue to require healthcare and services. The patient has incurred and will continue to incur medical and related expenses. She also has suffered and will continue to suffer diminished capacity for the enjoyment of life, a diminished quality of life, increased risk of premature death, aggravation of preexisting conditions, activation of latent conditions, and other losses and damages. The patient's direct medical losses and costs include physician care, monitoring, and treatment. She has incurred and will continue to incur mental and physical pain and suffering. The outcome of shingles was considered to be not recovered. The reporter consider the event to be related to zoster vaccine live (ZOSTAVAX).  The event of shingles was determined to be disabling by the reporter.
Patient reported a reaction that started in her left arm (injection arm). Patient experience redness, soreness, and heat at the injection site. The swelling spread to below her left elbow and to her left inner thigh. Small, itchy blisters also appeared on her arm and thigh. Patient has pictures of the reaction.
COVID 19 Treatment/Covid rebound after taking PAXLOVID and testing negative; COVID 19 Treatment/Covid rebound after taking PAXLOVID and testing negative; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality. The reporter is the patient.  A 44-year-old male patient received BNT162b2 (BNT162B2), on 01Apr2022 as dose number unknown, single (Lot number: FM0698) at the age of 44 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: XARELTO; ATORVASTATIN; VALSARTAN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "not recovered" and all described as "COVID 19 Treatment/Covid rebound after taking PAXLOVID and testing negative". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results, notes: Treatment of COVID-19; Negative, notes: testing negative; Positive, notes: Covid rebound after taking PAXLOVID. Therapeutic measures were taken as a result of drug ineffective, covid-19 which included PAXLOVID from 18May2022 to 23May2022.  On 01Jun2022, according to product quality, a complaint sample was not returned. No related quality issues were identified during the investigation. There is no impact on product quality, regulatory, validation and stability. Agency concluded that the reported defect was not representative of the quality of the batch and the batch remained acceptable. The NTM process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed. The complaint for "PFIZERBIONTECH COVID-19 VACCINE" was investigated. The investigation included reviewing the involved batch records, deviation investigation, an analysis of the complaint history for the reported lot and product type. The final scope was determined to be the associated lot(s) of the reported lot FM0698. A complaint sample was not returned. No related quality issues were identified during the investigation. There was no impact on product quality, regulatory, validation and stability. Agency concluded that the reported defect was not representative of the quality of the batch and the batch remained acceptable. The NTM process determined that no regulatory notification was required. The reported defect could not be confirmed. No root cause or CAPA were identified as the complaint was not confirmed.  Additional information: The patient had no known allergies.
None observed directly, within 30 min, after vaccine administration at the Health Dept. Mother notified Health Dept. on 5/17/2012 to report that her infant had expired at home in the early AM of 5/15/2012. She stated she called 911 when she determined her infant was unresponsive and that the Emergency Personnel had pronounced her "dead" on arrival.
Patient reports she cannot walk without holding on to something, and that she is "all over the place". Reports vomiting and a fever.
Cramping, burning pain in right hand, wrist, thumb, palm, index finger in radial nerve distribution. Mild at first getting significantly worse over the next 6 hours.  Weakness in thumb and index finger. Improved by 50% overnight.  Symptoms still present now 20 hours post injection.
Both sides lymph nodes swollen and painful.  Started on 3/5/2021.  Daily pain and pulsing pain continued through May 15, 2021.  Pain subsided by mid-May but both lymph nodes stayed swollen through September 2021.  There was no treatment.     I had an annually scheduled  mammogram in August 2021  (not related to swelling) and discussed lymph nodes with radiologist who said that there have been reports of swollen lymph nodes.  A benign cyst was found in right breast.
date of vaccination (Approx.): 2015, 2016; This spontaneous report has been received from a lawyer, via a Plaintiff Fact Sheet from a case in litigation for zoster vaccine live (ZOSTAVAX) (MARRS # 1705USA014981), concerning an approximately 63-year-old female patient. The patient's medical history, concurrent condition and concomitant medication were not reported.  On an unknown date in 2015, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown) for prophylaxis (strength, dose, route, lot#, and expiration date were not reported). On an unknown date in 2016, the patient was vaccinated with another dose of Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown) (inappropriate schedule of product administration).; Sender's Comments:  US-009507513-1705USA014981:
Day 1-3: Fatigue, injection site soreness, fever ranging 98*-102* Day 3-8: Normal Day 8-11: Itching that turned to a rash/bumps on feet, toes, ankles, palms, fingers, wrists, elbows, and knees
This spontaneous report was received from a physician and refers to a 6 month-old patient of unknown gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies. On 09-JUN-2017, the patient was vaccinated with improperly stored dose of PEDVAXHIB (exact dose, dose number, route of administration were not reported; lot# reported as N00236 with the expiration date of 24-OCT-2019) for prophylaxis. The administered dose of PEDVAXHIB underwent multiple temperature excursion between 34 and 54 Fahrenheit degrees, which lasted for 16 hours, since 19-MAY-2017. Digital data logger was not involved to capture the temperature excursions. There were no previous temperature excursions reported. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1709USA007325: US-009507513-1709USA012766.