chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a pharmacist via a company representative refers to a patient of unknown age and gender. No medical history or concurrent conditions were reported. On an unknown date the patient was vaccinated with PNEUMOVAX23. No dosage information, route of administration or lot number was reported. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced pneumococcal meningitis (considered as medically significant per manufacturer). It was unknown if the patient received any treatment for the adverse event. The outcome of pneumococcal meningitis was unknown. The reporter did not provide a causality statement. It was added that the reporter was not sure if the patient received PNEUMOVAX23 in the past. No further information was provided. Follow up information has been received. On 02-APR-2013 a phone call was placed to the pharmacist, he had heard about this patient from an infectious disease specialist who was asking his opinion on pneumococcal vaccines. He was not sure if the patient actually received the PNEUMOVAX23. The health care professional contacted during telephone follow/up could not supply the following information: patient name, date of birth, dates of vaccination, lot number, date of event, recovery status, healthcare provider name and contact information. Additional information has been requested. This is a corrected report. Date learned was changed from 13-MAR-2013 to 12-MAR-2013. Therefore a new case was created (MARRS 1304USA002643) and MARRS (1303USA007284) is being deleted from our files in PNEUMOVAX 23.
Drowsy; feverish; muscle pain; inactive; This is a spontaneous report received from a Pfizer sponsored program  from a contactable consumer. A  male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), the second dose, via an unspecified route of administration on 05Mar2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization. He got some side effects that are written on the fact sheet. (Drowsy, feverish, muscle pain, inactive.). Outcome of events was unknown.  Information on lot number/batch number was requested.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 69-year-old female patient who received SHINGRIX for prophylaxis. On 13th February 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 13th February 2019, several hours after receiving SHINGRIX, the patient experienced pain in arm and headache. On 14th February 2019, the patient experienced muscle pain, injection site induration, injection site warmth, appetite absent and fever. In February 2019, the patient experienced insomnia and blurred vision. On an unknown date, the outcome of the pain in arm, blurred vision, muscle pain, injection site induration, injection site warmth and appetite absent were not recovered/not resolved and the outcome of the insomnia, fever and headache were unknown. It was unknown if the reporter considered the pain in arm, insomnia, blurred vision, muscle pain, injection site induration, injection site warmth, appetite absent, fever and headache to be related to SHINGRIX. Additional details were received as follows: At about 4 pm, the patient received SHINGRIX in an unknown arm. In the evening of vaccination day, the patient experienced sore arm and she had a headache. In the night at 1 am, 9 hours after vaccination, the patient woke up with insomnia and found that she couldn't read because her vision was blurry. One day after vaccination, the patient experienced fever, muscle aches, pain from the top of her arm down to her hand, blurry vision and hardness and warmth at the injection site with no appetite. The reporter did not consent to follow up.
Within 24 hours post vax, the pt experienced stiff shoulders, which resolved in one week. In 5/99, the pt received his 2nd dose, within 24 hours post vax, he experienced right arm stiffness and muscle pain the right deltoid, this also resolved in one week. In 4/00 the pt received his 3rd dose, 24-48 hours post vax, the pt experienced joint stiffness, right deltoid pain, joint pain, fever, sore throat, lethargy, tiredness, and generalized muscle pain. The fever, right deltoid pain and sore throat resolved in a few days. The remaining symptoms are ongoing. The most recent information received on 6/27/00 report the outcome of the event is ongoing.
lymph nodes were swollen/she has swollen lymph nodes under her arm and in her groin; This is a spontaneous report from a contactable consumer. A 53-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection; Batch/Lot Number: EM9809; Expiration Date: Jun2021), dose 1 via an unspecified route of administration, administered in Arm Right on 11Feb2021 18:30 as dose 1, single for covid-19 immunisation (at the age of 53-year-old). Medical history included was none. The patient's concomitant medications were not reported. Caller states that she called earlier and spoke to someone about her Pfizer BioNTech COVID-19 vaccination and a side effect that she is experiencing. Caller states that she received her first dose and the very next day noticed her lymph nodes were swollen. Caller states that she did read that swollen lymph nodes is one of the side effects. She is due to receive her second dose on Thursday and states that it has gotten better but still a little swollen. Caller would like to know if she should expect this to get any worse. The caller said that right after her vaccination, she noticed swollen lymph nodes. She said that it is a listed side effect on the paperwork that she received. It is contraindicated for her to get the second dose with still having swollen lymph nodes. The caller said that she has swollen lymph nodes under her arm and in her groin the day after the vaccination. She said that she noticed more swollen lymph nodes on the left side of her body. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of the event was recovering.  No follow-up attempts are possible. No further information is expected.
Patient received both Pfizer COVID-19 vaccine and Shingrix vaccine on 7/23/2022.  Soon after, she noted swelling of arm leading down to lymph node region, as well as, redness at injection site. The redness lingered for about 2 weeks. She saw PCP after 2 weeks; recommended cold compresses to area. Increased allergy medication (cetirizine) to 2 tablets daily rather than 1 daily.
Patient received under diluted dose of Pfizer 5-11 vaccine. No adverse effect reported at this time.
Dizziness Vomit Shortness of breath Palpitations Accelerated pulse
Client received the second dose of COVID vaccine @ 9:12 am.  Client complained of feeling dizzy and nauseous and vomiting twice @ 9:40 am.  Client also complained of head ache and feeling tired.  Client denies allergies, only medical conditions is polycystic ovary syndrome.  Vital signs within normal limits.  Client was placed in zero-gravity chair and observed.  Vital signs remained stable, symptoms resolved @ 10:00am, client reported only feeling tired at this time.  Instructed when to seek medical attention, family present.  Left observation area with steady gait at 10:10 am
nausea; weird sensation; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a PFIZER sponsored program (159558). The reporter is the patient.  A male patient received first dose of bnt162b2 (BNT162B2, Batch/Lot number: unknown) administration date 25Feb2021 as DOSE 1, SINGLE for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NAUSEA (non-serious) with onset Feb2021, outcome "unknown", described as "nausea"; FEELING ABNORMAL (non-serious) with onset Feb2021, outcome "unknown", described as "weird sensation".  Additional Information: The caller got the first dose of the COVID-19 vaccine on 25Feb2021. Then 3 days after the first dose, he started experiencing nausea and a weird sensation. He needed information for not taking the second dose which was scheduled on 18Mar2021, as was scared of the side effects.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Information has been received from a nurse concerning a 19 year old female who on 08-JUL-2008 was vaccinated intramuscularly in the left deltoid with her first dose of GARDASIL vaccine (yeast) (lot# 660555/0279X). On 08-JUL-2008 the patient fainted almost immediately after receiving her first dose, The nurse reported that they gave the patient some juice and had her lie down until th symptoms resolved. It was noted that the patient had not eaten much prior to receiving the vaccine. The patient sought unspecified medical attention on an unspecified date and the patient's outcome was not reported. Additional information has been requested.
My tongue has turned dark gray/black... Not sure of the exact day it turned gray, but it has been this way for 2 plus weeks...
About 5 minutes after 2nd Pfizer dose, pt complained about his right cheek/face feeling tingly/numb. I gave pt Benadryl 25mg and I kept monitoring for change. His mom reported to store to check up on him and 911 was called and arrived about 20 after start of adverse events. There was never any worsening of his event or improvement. Rescue took his vitals (all normal )and advised giving another Benadryl 25mg incase.  Pt refused going in ambulance to hospital and no Epi-pen was administered. Mom took home pt and advised to monitor the situation for the night, call 911 or report to ER if anything worsens.
A 17 year old patient was administered Flublok, no AE; Initial information was received on 22-Jan-2021 regarding an unsolicited valid non-serious case from a Nurse.  This case involves a 17 year old male patient who was administered 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot UJ455AA, expiry date: 17-Mar-2021, pre-filled syringe) once via intramuscular route in the left deltoid for prophylactic vaccination on 08-OCT-2020 (Product administered to patient of inappropriate age).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  The patient had no other vaccines.   It was a case of an actual medication error due to Inappropriate age at vaccine administration (latency same day).  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
2/5/21 @ 4:30 pm began feeling body aches. Developed chills, fever, clenched muscles, headache by 8:00 pm.  2/6/21 chills and clenched muscles remained, supraclavicular lymphnode right side swollen considerably, revert to the touch. 2/7/21 only lymphnode swelling remains 2/8/21 lymphnode swelling decreasing, new symptom of comprehensive neck stiffness. Began at 9:00 am and is growing increasingly stiff for movement in any direction.
Patient received an expired Pentacel. Health dept was called and provider made aware. Patient to return to office for redose. No acute reaction or adverse signs/symptoms reported.
Dx Diarrhea  ? Cough  ? Nasal Congestion  ? Nausea
On the day of vaccine, pt was difficult to wake up, lethargic with a fever of 101. On day 2, pt had shallow breathing and was lethergic, difficult to awaken with a fever of 101. Right leg had a large lump.
New onset headache a few days after that did improve prior to second dose. Headaches recurred after second dose and more severe. Has not improved much since second dose. She also gets nausea, vomiting, photophobia. HA consistent with migraines. No prior history of migraines.
No taste; I am kind of frustrated I can't taste anything; No taste; I am kind of frustrated I can't taste anything; Lips swelled up; Blisters; This is a spontaneous report from a contactable consumer (patient). An 86-years-old patient of unspecified gender received second dose of (solution for injection; Lot number and expiration date were not reported) via an unspecified route of administration, on 30Mar2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced (since had second shot) frustrated, completely no taste and lips swelled up and follow blisters. The symptoms were mild which appeared 10 minutes after vaccination. As such, it was acute. The outcome of blisters was recovered whereas of other events it was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Injection site is hot, red and swollen. Noted bruising shortly after injection No fever, numbness or tingling in arm.
Tinnitus in both ears began after first dose of Moderna vaccine. It has been continuous, low buzzing sound, and has not improved.  I am planning to, but have not yet sought medical care.
Feeling very weak; heart palpitations; heart would skip a beat; This is a spontaneous report from a contactable consumer (patient).  A 74-year-old male patient received the first dose (dose 1) of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9265) via an unspecified route of administration in the left arm on 04Feb2021 09:15 AM at a single dose for COVID-19 immunization. The patient had no medical history and no known allergies. The patient had unspecified concomitant medications (other medications in two weeks). He had no other vaccine in four weeks. On 05Feb2021 01:00 AM, the patient was feeling very weak and heart palpitations. He felt so weak that he had to retire to bed for rest. Periodically, he still felt weak and his heart would skip a beat since 05Feb2021 01:00 AM. He had been to his doctor and the emergency room of the hospital (doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care). Everything checked out okay; however, they had him on a 30 day heart monitor (heart monitor for 30 days). It was noted that the patient had the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EN6201) in the left arm on 27Feb2021. The patient had no COVID prior to vaccination and has not had COVID tested post vaccination. The outcome of the events was recovering.
High fever x3 days; Migraine; Back and hip pain; No prior adverse vaccine reactions, fully recovered after 5 days
lhe patient was administered an improperly stored dose of PROQUAD; This spontaneous report was received from a medical assistant and refers to a patient of an unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On an 08-SEP-2020, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), rHA, lot # S031706 has been verified to be a valid lot number, expiration date 06-APR-2021 (exact dose, route of administration and anatomical location were not provided) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (STERILE DILUENT). Administered dose of vaccine experienced the temperature excursion of -11  degrees Celsiust (C) for 5 hours and 20 minutes. Data logger was not involved. There were no previous excursions reported.
sore throat, cough, stuffy nose, congestion. starting 1/2/22
Pt recv vax on 7/28/98; on 8/26/98 pt exp SIDS
Fever, pneumonia, empyema and + blood culture. The discharge summary states, "pneumonia, and anemia-hemolytic."
PATIENT FELT VERY LIGHTHEADED, FELT TEMPORARY LOSS OF HEARING AND FELT CLOSE TO FAINTING.
Information has been received from a certified nurse midwife concerning a 20 year old female with a history of syncope after unspecified vaccinations and anaesthesia who on 07-MAR-2008 was vaccinated IM with a first dose of GARDASIL (lot # 659665/1486U). Concomitant therapy included ORTHO TRI-CYCLEN. On 07-MAR-2008, right after vaccination, "she turned white, her eyes rolled back and her arms became stiff as if she was having a seizure." The nurse brought in smelling salt and the patient "came back." The nurse did not let the patient leave the office for 2 hours. Later that day, the patient's mother took her to the emergency department to check for any neurological problems and everything came back normal. The patient was not admitted. At the time of the report, the patient had improved. Upon internal review, "she turned white, her eyes rolled back and her arms became stiff as if she was having a seizure" was considered to be an other important medical event. Additional information has been requested.
pt recv vax 630AM ambulating to BR w/assistance became unresponsive-assisted to floor by CNA-color pale diaphoretic;
Patient called on day 3 post immunization stating that she experienced redness and swelling at injection site progressing from time of injection through current time.  Swelling progressed to diameter of tennis ball by her estimation.   Swollen area was tender and warm to the touch.   Reaction was not able to be viewed at pharmacy at the time of this report.
hearing loss within 13 days both ears, went for a hearing examination  to Dr.  on May 18th  and bilateral loss of hearing with a stuffy ears which has not gone away. I had never seen him before but he said it was very unusual to have both ears lose hearing the same. Nothing wrong with my ears.
After 5 minutes into getting the vaccine, the 17 year old female patient felt like blacking out, dizzy, nauseous and looked extremely pale. She attempted to go to the restroom with fathers help, but did not make it far before she started to vomit. After vomiting, she felt better and remained sitting for another 15 minutes before she left.  Reached out to her several hours later and patient is doing  well.
The evening of 1/29/21, hives (small red itchy bumps) started on the side of my right knee and then spread to upper thigh.  The morning of 1/31/21 the hives had spread to my right forearm and left thigh.   The morning of 2/1/21 the complete front side on my right leg and shin are covered in hives.  The hives are gone from my forearm and only a few remain on my left thigh.  I have taken benedryl over the counter.
Pt given HIB titer 21DEC90 aprox 1230PM pt died 22DEC90 738 HRS.F/U 19Apr91 Autopsy rept-Acute respiratory failure,SIDS.Petechial hemorrhages of pleurae,epicardium & thymus.Pulmonary/cerebral edema &congestion.Congestion of abdo viscera.
Subsequent to receiving one dose of varicella virus vaccine live the pt developed chickenpox with a fever of 101F. Approximately 48 hours post onset the chickenpox began to scab over and the pt recovered.
Patient presented vaccine card with two Pfizer doses documented. RN checked vaccine card. Pfizer booster dose administered by RN. Patient requested new card. When copying information for new card from the system, staff noticed that patient had previously received two doses of Moderna rather than Pfizer. Patient has had no ill effects at this time from vaccine.
During the evening of his vaccination he started having chills with severe shaking associated with fever. Presented to ED on 2/28/21. Fever was 104F. Disoriented on presentation, CRP of 18, mildly elevated troponin, persistent hypotension, headache. Received fluids and Rocephin. Admitted to ICU 2/28/21. Discharged 3/1/21. Final Diagnosis- hyperpyrexia, hypotension, related to immunologic reaction from second Pfizer COVID vaccine. Cannot rule out septic shock from RLL pneumonia and pleural effusion. Hx of COVID 19 myocarditis, chronic systolic CHF and cardiomyopathy EF of 45%, with current mildly elevated troponin. Mild hyponatremia, lactic acidosis. Acute encephalopathy related to hyperpyrexia.
neuropathic pain; viral exanthems due to herpes zoster/recurrent shingles outbreak; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of an unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 13-APR-2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route of administration not specified) for prevention of shingles (herpes zoster). On an unspecified date (reported as shortly after receiving zoster vaccine live (ZOSTAVAX)) , the patient suffered from a burning rash and was diagnosed with viral exanthems due to herpes zoster. The patient had recurrent shingles outbreak and neuropathic pain resulting from shingles. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms resulted in physical limitations not present prior to using the product and the patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the product, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of Zoster Vaccine Live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The outcome of the events was reported as not recovered. The reporter considered herpes zoster and neuropathic pain to be related to Zoster Vaccine Live ( ZOSTAVAX).  The events of herpes zoster and neuropathic pain were considered to be disabling.  Additional information has been requested.
After Administering a series of vaccination, the child had an allergic reaction. The Physician Assistant on duty, evaluated the patient and gave him treatmant. the child was Complaining of Shortness of breath, difficulty breathing, and Angioedema.