chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received on 31-OCT-2018 from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2011, a healthcare provider administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). On or about 17-JAN-2015 and 11-FEB-2015, the patient was treated by a registered nurse at a military hospital for herpes zoster and post herpetic neuralgia. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to 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 including 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 (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Patient felt faint within 2 minutes after receiving vaccine. Symptoms included sweating and nausea. EMS was called.
The patient was given the Boostrix vaccine initially then the Gardasil 9.  Right after receiving the Gardasil 9 the patient became silent and start falling into her chair.  I immediately placed the patient onto the floor and the patient had a slight black out and then was able to hear breathing and pulse.
Pt states he received both of his covid vaccines at the administration facility. His second covid vaccine was on or about May 3, 2021. His left shoulder has been painful since and continues to cause pain. Denies previous injuries.
problem with her left side, having weakness since she had a stroke/when she took the 2nd shot, it's been bothering her through the weekend/ left side weakness worsened; problem with her left side, having weakness since she had a stroke/when she took the 2nd shot, it's been bothering her through the weekend/ left side weakness worsened; dragging her feet; trouble standing up; feels like a stroke in her leg; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number unknown), intramuscular, administered in the left arm on 24Mar2021 at 12:30 as a single dose for COVID-19 immunization.  Medical history included stroke on Dec2015 and Feb2016 and ongoing left side, having weakness since she had a stroke. The patient's mother had a really bad stroke on an unspecified date in her 80's. The patient's concomitant medications were not reported.  The patient previously received the first dose of BNt162B2 (lot number: EN6208) on 03Mar2021 for COVID-19 immunization and had a sore right arm. It was reported that on 26Mar2021, the patient was dragging her feet and having trouble standing up. This occurred after her second shot. She has had a problem with her left side, having weakness since she had a stroke at the age 62 years. She worked through it and it was fine. But when she took the 2nd shot, it's been bothering her through the weekend. Her left side weakness worsened. She described the feeling like the stroke. Her doctor said when she gets sick, it could mimic her stroke symptoms. She added it is worse in the morning when she tries to get up. The patient added that her leg is affected, and feels like a stroke in her leg on Mar2021. She had no treatment for her experience and doesn't know if there is a treatment for what she is experiencing. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Vaccine was given too soon from 1st dose (1st dose administered 2/16/22, 2nd dose administered 3/2/22)
Patient received 2nd dose of Pfizer vaccine at 2:00PM and called back to the pharmacy around 4:00PM with complaints of a rash. Patient did not complain of any other symptoms besides the rash and informed us that the rash/hives appeared only on her arms. The pharmacy advised the patient to take benadryl and continue to monitor her symptoms and to seek medical attention if symptoms worsen or do not improve.
This case was reported by a physician via call center representative and described the occurrence of fever in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced fever and joint pain. On an unknown date, the outcome of the fever and joint pain were unknown. It was unknown if the reporter considered the fever and joint pain to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The age group was not provided, but was selected adult as per the vaccine indication. Caller heard from the physician that he had seen three patients who after receiving 1st dose of SHINGRIX, experienced low grade fever and joint aches. This case linked with cases US2018157973 and US2018157978, reported by the same reporter.
The patient says his left shoulder area has been hurting with pain since 10/4/2014. He just told me today 12/12/2014. He said the area where the shot was given does not have a lump or discoloration and does not hurt to touch. He said the worst pain is when he sleeps on it or putting on a shirt. The patient will check with his doctor 12/19/14.
No adverse event; During this administration the syringe and the needle became disconnected and the majority of vaccine leaked out; During this administration the syringe and the needle became disconnected and the majority of vaccine leaked out; This spontaneous case was reported by a pharmacist and describes the occurrence of DEVICE CONNECTION ISSUE (During this administration the syringe and the needle became disconnected and the majority of vaccine leaked out), ACCIDENTAL UNDERDOSE (During this administration the syringe and the needle became disconnected and the majority of vaccine leaked out) and NO ADVERSE EVENT (No adverse event) in a 25-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 053D22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-Oct-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 24-Oct-2022, the patient experienced DEVICE CONNECTION ISSUE (During this administration the syringe and the needle became disconnected and the majority of vaccine leaked out) and ACCIDENTAL UNDERDOSE (During this administration the syringe and the needle became disconnected and the majority of vaccine leaked out). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, DEVICE CONNECTION ISSUE (During this administration the syringe and the needle became disconnected and the majority of vaccine leaked out), ACCIDENTAL UNDERDOSE (During this administration the syringe and the needle became disconnected and the majority of vaccine leaked out) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for DEVICE CONNECTION ISSUE (During this administration the syringe and the needle became disconnected and the majority of vaccine leaked out) and ACCIDENTAL UNDERDOSE (During this administration the syringe and the needle became disconnected and the majority of vaccine leaked out).    No concomitant medications was reported.  There were no reported symptoms.  No additional doses, medications, or treatments had been administered to the patient up to that point.
temperature excursion with no reported adverse event; 1 dose of IPOL vaccine was already given after the excursion, with no reported adverse event; Initial information received on 10-Aug-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 9 years old male patient who was administered vaccine IPV (vero) [IPOL] post temperature excursion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, tetanus vaccine toxoid (TD) for; and HIB Vaccine (HIB) for Immunisation.  On 25-Jul-2023, the patient received 0.5 mL dose 3 of suspect IPV (vero), Suspension for injection (batch number: V1B891M) via intramuscular route in the right deltoid for Immunization post temperature excursion (poor quality product administered) (same day latency) (product storage error) (unknown latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event temperature excursion with no reported adverse event and was Unknown for the event 1 dose of ipol vaccine was already given after the excursion, with no reported adverse event.  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 the guidelines. 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.
Patient received covid vaccine in February and was immunosuppressed on methotrexate and Remicade. She tested positive for COVID and received pharmaceuticals in ER on 05/10/2021. Patient has mild fatigue and shortness of breath.
Information has been received from a physician, referring to a 67 year old female patient. The patient did not have any known medical history, concurrent conditions or was on any concomitant therapy. On 27-SEP-2017, the patient was vaccinated with a dose of PNEUMOVAX 23 lot # M026317 with expiration date on 11-JAN-2018 (strength, anatomical location, administration route were not reported) for prophylaxis. On an unspecified date in September 2017 (reported as "within 12 hours after vaccination"), the patient experienced fever, nausea, headache and could not get out of bed for three days. On 30-SEP-2017, the patient took an unspecified antihistamine. The outcome of the fever, nausea and headache was reported as recovering (reported as "was improving but was not recovered") and the causality between the vaccination with PNEUMOVAX 23 and the aforementioned events was not reported. The reporting physician considered the events of fever, nausea and headache to be serious due to significant disability or incapacity because the patient could not get out of bed for three days.
No adverse event; drug exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a physician and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (drug exposure during pregnancy) and NO ADVERSE EVENT (No adverse event) in a 36-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3031283) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 vaccination: Moderna (Dose 1, lot number 011J20A) on 24-Dec-2020, Moderna (Dose 2, lot number 032L20A) on 21-Jan-2021, Moderna (Dose 3, lot number 939903) on 26-Nov-2021, Moderna (Dose 4 and lot number 016H22A. Patient got COVID-19 on 21-Dec-2022.) on 21-Nov-2022; for Product used for unknown indication: flu vaccine on 22-Sep-2023. Past adverse reactions to the above products included COVID-19 with Moderna; and No adverse event with Moderna, Moderna, Moderna and flu vaccine.    On 28-Sep-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 28-Sep-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (drug exposure during pregnancy). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (drug exposure during pregnancy) had resolved and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for MATERNAL EXPOSURE DURING PREGNANCY (drug exposure during pregnancy).    Concomitant and treatment medications were not reported.  Company comment: This spontaneous case concerns a 36-year-old, female patient with no gynecological medical history information reported, who experienced the unexpected non serious event of maternal exposure during pregnancy. The event occurred on the same day after receiving the fifth dose of SPIKEVAX 2023-2024 PFS. Date of patient's last menstrual period, expected delivery date, and gestational age at time of exposure were not provided. No further information about the event was provided. The benefit-risk relationship of SPIKEVAX 2023-2024 PFS is not affected by this report.
No Adverse Event; 14 year old female patient received the Moderna vaccine in error on 21 June at another facility; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (14 year old female patient received the Moderna vaccine in error on 21 June at another facility) and NO ADVERSE EVENT (No Adverse Event) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 21-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jun-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (14 year old female patient received the Moderna vaccine in error on 21 June at another facility). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (14 year old female patient received the Moderna vaccine in error on 21 June at another facility) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (14 year old female patient received the Moderna vaccine in error on 21 June at another facility).    Concomitant medications were not reported.  The 14 years patient had received the Moderna vaccine in error at another facility. Moderna was not approved for children under 18 years of age. Facility that administered the vaccine told the patient to start over with Pfizer. So the patient received the first dose of Pfizer.  No treatment information was provided by the reporter.  This case was identified as part of retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Vaccine was frozen rather than refrigerated. patient was given dose. no symptoms reported. revaccination offered.
Dizziness, flashes.  Water 30 min following. Assessed by paramedics.
pt recv vax 2JUN95 & 13JUN95 pt exp swelling & redness on arm @ inj site & swollen lymph node on the arm; very itchy;
Headache, severe pain at injection site, joint pain, chills, severe fatigue, feeling tired, muscle and body aches, and pounding headache . Narrative:
A lot of pain at the injection site; This is a spontaneous report from a contactable physician pharmacist a Pfizer sales representative.  A patient of an unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) on an unspecified date, at 0.5 ml, single dose, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient experienced a lot of pain at the injection site. Clinical outcome of the adverse event was unknown at time of this report.   No follow-up attempts are needed, information about lot number cannot be obtained.
48hr post vax devel temp & extreme irritability lasting until 17APr;T105 highest temp;
Left arm sore, numb, tingling to hand. Bad headache. Body aches.
Information has been received from an office manager referring to an unspecified number of patients of unknown age and gender. On unspecified dates, the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (lot # L018500, expiration date 13-APR-2017, dose and route not provided). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Vaccination at about, 1:00PM, started feeling bad about 10:00PM, went to bed and then woke up at about 1:00a.m. - fever, chills, palpitations, malaise until about 6:00a.m., fever and malaise through the next day. Reddened injection site for 5 days about 2 inches diameter. Continued to feel bad for 5-7 days, Injection site took about 7 days to clear up completely. Almost had to go to emergency room on night after injections but finally started getting better after TYLENOL and BENADRYL about 7:00 a.m.
13APR92 230PM pt recvd vax mom states w/in 1 hr post vax pt had fever of 104-cont w/ fever 104 in site of APAP; also c/o h/a, nausea, vomit; pt seen by MD;
1555 -2nd dose of pfizer vaccine administered to patient. Site Left Deltoid, Route IM, (NDC 59267-1000-1 (PFIZER COVID-19 VACCINE (EUA)) Lot # FC3183, Manufacturer Pfizer, Inc., Expiration 08-31-2021 1558-patient reports feeling dizzy, chest feels heavy and becomes flushed. Legs elevated, patient fanned per MA.  Provider at bedside- BP taken: 172/91, HR 131. Patient transferred by wheelchair to an exam room and onto exam table. Rash noted to be forming on either side of patients' mouth. 1605-BP 179/111, HR 160s. 1607-epipen administered to L thigh per CRNP. Crash cart brought to bedside. 20g IV started in R AC per CRNP. NS started w/o. Oxygen applied via NRB on 10L. Patient placed on AED. Translator at bedside with patient. Patient non verbal- following commands. EMS called. Patient noted to be having intermittent fasciculations to L side of mouth. 1618-BP 169/85, HR 117 Patient still states still feels dizzy. Oxygen 100%, No airway compromise. 1625-EMS at bedside- Report given per CRNP to Fire and Rescue. BP 158/80, HR 106, IV slowed to KVO- 200 ml bolus given. FSBS completed-107. Patient states she is feeling better. Denies any chest pressure. States CP has resolved completely. 1638-EMS at bedside with stretcher for transport to ED. 1650-Report given to EMS- Fire and rescue transferred patient from bed to stretcher-packaged, Demographics printed for patient and given for transport. Patient stable when leaving.
This case was reported by a consumer via call center representative and described the occurrence of heart rate increased in a 80-year-old male patient who received SHINGRIX for prophylaxis. On 3rd November 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In November 2018, 14 days after receiving SHINGRIX, the patient experienced heart rate increased. In December 2018, the patient experienced swelling of legs, water retention and hyperesthesia. The patient was treated with diuretics nos (Diuretic). On an unknown date, the outcome of the heart rate increased was recovered/resolved and the outcome of the swelling of legs, water retention and hyperesthesia were not recovered/not resolved. It was unknown if the reporter considered the heart rate increased, swelling of legs, water retention and hyperesthesia to be related to SHINGRIX. Additional details were provided as follows: The patient recevied SHINGRIX vaccine on left arm. It was reported that, two weeks after the vaccination, the patient experienced increased heart rate. In the beginning of December 2018, the patient began to experience swelling and water retention in both legs and had increased sensitivity at the tips of all of his fingers. The patient was kept on diuretic three weeks ago and had lost 8lbs of fluid. The reporter had consented to follow up and gave permission for his physician to be contacted.
Information has been received from a 69 year old physician with hypertension who "a year ago", in approximately February 2006, was vaccinated with a second dose of Varivax. Concomitant therapy included unspecified medication for hypertension. It was reported that the patient was vaccinated when he "was younger" with a first dose of Varivax. He did not seroconvert after the first vaccination. After vaccination with the second dose the patient developed a rash. The rash ranged from pin size to 10 - 12 cm in diameter. The rash had remained constant but changed in degrees. At times the rash lessened then returned. There were also areas of scarring related to the rash. The patient was seen by two dermatologist and was diagnosed with nummular eczema. He continued to use LIDEX, triamcinome cream (steroid cream), ultraviolet therapy 1-2 times a week, and CUTAR baths at home 2 times per week. Three months after the second dose the patient had another titer and still had not seroconverted. At the time of the report the patient had not yet recovered. There was no product quality complaint involved. The patient's nummular eczema was considered to be an other important medical event. Additional information has been requested.
After patient received her injection, the vaccinator realized that there was no liquid in her remaining syringes. Likely all 10 syringes had been empty to begin with and only air had been injected into patient's arm. This was quickly realized and the patient was called back to the clinic and had a vaccine administered to her.
Patient had blood sugar readings in the excess of 400 mg/dL and was feeling ill, she fainted and was transported to the hospital.
Severe vertigo and nausea and tinnitus  with any movement, waxed and waned for ten days. Worse when lying down flat. Nothing seemed to improve dizziness.  Zofran helped with nausea. Called primary care said these symptoms could last up to 5 days. On day 7 called primary care called again, Md out of office that week, nurse spoke with MD and he advised to use Flonase and prescribed  Meclizine  Which was used for last 2 days. 10th day symptoms starting  to improve. Only slight dizziness now.
Headache, Myalgia, Arthralgia, Fever, NauseaVomiting, chills, left axilla sore, "burning" Narrative:
Patient received expired Moderna vaccine, verified with pharmacy and Moderna that vaccine was good and no adverse reaction to patient after receiving.