chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of mouth broke out in a 62-year-old female patient who received SHINGRIX for prophylaxis. On 16th July 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced mouth broke out, blistering of mouth, gingival blister, feeling abnormal, injection site pain and fever. On an unknown date, the outcome of the mouth broke out, blistering of mouth, feeling abnormal, injection site pain and fever were recovered/resolved and the outcome of the gingival blister was unknown. It was unknown if the reporter considered the mouth broke out, blistering of mouth, gingival blister, feeling abnormal, injection site pain and fever to be related to SHINGRIX. Additional details were provided as follows: The caller reported that the inside of her mouth and gums broke out in blisters like oral herpes after receiving SHINGRIX. She also felt feverish and felt like crap for about 2 weeks. The injection site was also very sore.
Approximately 5 days after vaccination patient became extremely fatigued and short of breath. Patient went to the local ER, and was transferred to a hospital with a high level of care where she was diagnosed with a pulmonary embolism. Per the patient, the hospital could not find a reason to explain the PE other than recent vaccination.
Moderna vaccine booster was administered on 11/5/2021 with an expiration date of 10/11/2021. Inquiry has been submitted to Moderna requesting validation of vaccine potency.  A response from Moderna is expected to be received between 8-10 business days.  Expiration date is currently not printed on the vaccine vial or carton and vaccine expiration date listed is 12/31/2069.  To find the expiration date, ?look up expiration date? tool is to be used from Vial Expiration Date Lookup | Moderna COVID-19 Vaccine (EUA) (modernatx.com). Patient contacted on 12/4/2021 and no adverse effects reported.
Received the second dose twice; He received 0.25 ml twice, according to the nurse; This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT DOSE ADMINISTERED (Received the second dose twice) and WRONG DOSE (He received 0.25 ml twice, according to the nurse) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On 08-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Nov-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 0.25 mL twice. On 05-Nov-2021, the patient experienced INCORRECT DOSE ADMINISTERED (Received the second dose twice) and WRONG DOSE (He received 0.25 ml twice, according to the nurse). On 05-Nov-2021, INCORRECT DOSE ADMINISTERED (Received the second dose twice) and WRONG DOSE (He received 0.25 ml twice, according to the nurse) had resolved.      No Concomitant medications were reported. No Treatment information was reported.
This spontaneous report as received from a nurse practitioner refers to a female patient of unknown age. The patient was vaccinated with 0.5 ml GARDASIL (lot # unspecified) on an unknown date. No other co-suspects were reported. No concomitant medications were reported. The patient experienced an unspecified adverse event with her supraclavicular lymph node about a week after getting GARDASIL. The patient also was experiencing an unspecified concomitant illness at that time. X-rays and complete blood count were performed (no results were reported). No treatment information was reported. The outcome of the events were unknown. The patient had sought unspecified medical attention. Additional information is not expected.
A report has been received from a Physician concerning a 2 year old, male subject, who had been receiving FLUMIST QUADRIVALENT (intranasal). FLUMIST QUADRIVALENT (intranasal) started on 08-Sep-2014. The patient administered expired FLUMIST QUADRIVALENT which started on 08-Sep-2014. The outcome of the event of administered expired FLUMIST QUADRIVALENT is unknown. The report was considered to be non-serious.
This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (slept a lot), MYALGIA (achy all over the body/still experiencing achiness in her lower extremities, achiness in legs/achiness in knees/achiness in back) and FATIGUE (very tired, still tired) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer vaccine (Dose 1 Pfizer, lot/batch - EM9810) on 06-Feb-2021, Pfizer vaccine (Dose 2 Pfizer and lot/batch - EN6203) on 27-Feb-2021. Past adverse reactions to the above products included No adverse event with Pfizer vaccine and Pfizer vaccine. Concomitant products included METFORMIN, LEVOTHYROXINE and ATORVASTATIN for an unknown indication.    On 29-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Nov-2021, the patient experienced SOMNOLENCE (slept a lot), MYALGIA (achy all over the body/still experiencing achiness in her lower extremities, achiness in legs/achiness in knees/achiness in back) and FATIGUE (very tired, still tired). At the time of the report, SOMNOLENCE (slept a lot) outcome was unknown and MYALGIA (achy all over the body/still experiencing achiness in her lower extremities, achiness in legs/achiness in knees/achiness in back) and FATIGUE (very tired, still tired) had not resolved.            Treatment information was not provided.  Patient received first and second dose Pfizer's vaccine and decided to take Moderna as booster.
pneumonia; Information has been received from a lawyer regarding a case in litigation referring to a patient (pt) of unknown age or gender. The pt's concurrent conditions, medical history and concomitant medications were not reported. On or about 02-FEB-2016 (at approximately 66 years old), the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dosage regimen, route of administration, anatomical location, lot number and expiration date were not provided) at a pharmacy for the long-term prevention of shingles and zoster-related conditions. Subsequently, the pt was treated by health care providers for the following injury resulting from the zoster vaccine live (ZOSTAVAX) use: pneumonia. The outcome of the claimed event was not provided, and causal relationship was reported as related to zoster vaccine live (ZOSTAVAX).  Upon internal review, pneumonia was determined to be medically significant event.
leaking when administered; leaking issue; Product Complaint; This case was reported by a nurse via call center representative and described the occurrence of incomplete dose administered in a patient who received DTPa (Reduced antigen) (Boostrix) (batch number 22MS7, expiry date 1st April 2024) for prophylaxis. This case was associated with a product complaint.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced incomplete dose administered, syringe connection issue and pharmaceutical product complaint. On an unknown date, the outcome of the incomplete dose administered, syringe connection issue and pharmaceutical product complaint were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 1-Jul-2022  Reporter's comment: The nurse from the clinic reported that 3 doses of Boostrix were leaking from the connection hub when administered to 3 different patients. The reporter was unable to confirm what type needle was attached to the syringe for the administration but stated that the luer lock device appeared to be attached crooked.  The content questions were asked as  where did the vaccine leak,  at the luer lock connection hub.  The syringe was not pre-assembled with needle some time before administration.  The size of gauge needle was uncertain.  The reporter will call back with additional information when she returns to the office.  The reporter believed it was 22G. Product quality complaint was filed. No blister and/or carton damaged.  No luer lock was damaged.  The needle used to administer was discarded in sharps container but the reporter will return an unused needle of the same type that was used during administration.  The reporter reported that she had emailed in pictures and might be attached to parent case.  The reporter was unable to provide GlaxoSmithKline Direct Account or Wholesaler information and will call back with information.  The reporter did not have specific patient identifiers.  No further information provided.  The consent to contact patient's health care professional unable to be obtained. Additional supportive information: The vaccine was leaking from the connection hub when administered to the patient which led to incomplete dose administered and syringe connection issue. The case was 3 of 3 linked cases. Follow-up request was raised for the patient's gender.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR104307:Same reporter US-GLAXOSMITHKLINE-US2022103828:Same reporter
Initial report was received 17 May 2008 from a health care professional. A 22-year-old female patient had received an intramuscular right deltoid injection of MENACTRA, lot number U2568AA and an intramuscular left deltoid injection of GARDASIL (manufacturer Merck), lot number 1967U and on the evening of vaccination, she developed a low grade temperature, general weakness, headache, stiff neck, nausea and her face appeared flushed. At the time of vaccination, the patient had a history of mild asthma and seasonal allergies but no concurrent illnesses. Concomitant therapies included and Albuterol inhaler prn. According to the reporter, the patient had a temperature of 98.6 degrees Fahrenheit at the time of the report. The patient had not recovered from the event. Follow up information was received on 19 August 2008 from a health care professional. The patient fully recovered from all of the events within 48 hours of onset. No other information was provided.
I have been getting migraines since the vaccine.  I get 3-5 every week and I NEVER had them before.  They especially occur when pushing like going to the bathroom.
Neurologic symptoms; tingling sensation in B/L hands for 2 weeks. Getting worse in severity. Pt is already taking 400mg Gabapentin.
Swollen lymph nodes; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen lymph nodes) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     Concurrent medical conditions included Blood pressure high. Concomitant products included POTASSIUM for an unknown indication.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, the patient experienced LYMPHADENOPATHY (Swollen lymph nodes). At the time of the report, LYMPHADENOPATHY (Swollen lymph nodes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
10pm: shaking and feeling extremely cold 12pm: after shaking for hours, became nauseous and experienced dizziness, followed by a syncopal episode, followed by a cold sweat
This case was reported by a physician via call center representative and described the occurrence of flu like symptoms in a patient who received Flu Seasonal TIV Dresden. On an unknown date, the patient received Seasonal Influenza vaccine at an unknown dose. On an unknown date, an unknown time after receiving Seasonal Influenza vaccine, the patient experienced flu like symptoms and respiratory symptom. On and unknown date, the outcome of the flu like symptoms and respiratory symptom were unknown. It was unknown if the reporter considered the flu like symptoms and respiratory symptom to be related to Seasonal Influenza vaccine. Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that 2 to 3 patients who have presented to her clinic experienced flu like symptoms after receiving the flu shot. The symptoms were described as respiratory in nature. The patient required emergency room visit. This case was one of the 3 cases, reported by the same reporter.
Excruciating internal pain, 2 hrs after receiving vaccination. Can't use hand to lift. Arm went limp initially.
Symptoms of pain and swelling at around 5pm on 9/21/2020. Took Ibuprofen of 400mg. Applied ice pack at around 8pm on 9/21/20. Redness and burning sensation developed on 9/22/2020.
PATIENT WAS 7 MONTHS OLD AND WAS GIVEN TWO VACCINES THAT SHOULD NOT HAVE BEEN GIVEN UNTIL AGE ONE.
Customer experienced arm pain and immobility.  Having difficulty using arm and sleeping.  as of 11/5/21 .  As of 11/5/21 she may or may not follow up with her PCP
Redness; itchiness; Injection site is also swollen & it feels warm.; Feels warm; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness), PRURITUS (itchiness), VACCINATION SITE SWELLING (Injection site is also swollen & it feels warm.) and VACCINATION SITE WARMTH (Feels warm) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No medical history was reported by the reporter.     On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Mar-2021, the patient experienced ERYTHEMA (Redness), PRURITUS (itchiness), VACCINATION SITE SWELLING (Injection site is also swollen & it feels warm.) and VACCINATION SITE WARMTH (Feels warm). At the time of the report, ERYTHEMA (Redness), PRURITUS (itchiness), VACCINATION SITE SWELLING (Injection site is also swollen & it feels warm.) and VACCINATION SITE WARMTH (Feels warm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient said that the person that administered the injection gave it to her in fatty part of the arm.  No concomitant information was reported.  No treatment information was reported.
Patient is a resident, pt received 2nd bivalent booster today. RN unaware that pt received initial bivalent pfizer vaccine on 10/14/22 because this information was not written on CDC vaccine card or provided by supervisor of facility. Pt tolerated vaccine well, monitored for 15 minutes, no signs or symptoms of any adverse reactions at that time. Facility will continue to monitor and will notify local health department for any future adverse reactions.
Pfizer BioNTech COVID-19 Vaccine EUA: COVID-19 case resulting in Hospitalization / Death. Patient received Pfizer Vaccines on 2/7/2021, 2/28/2021, and 8/25/2021. Patient received bamlanivimab/etesevimab on 12/23/2021. Patient received at hospital - as a transfer from outside hospital for continued care of acute hypoxic respiratory failure due to COVID-19. Patient received oxygen supplementation, dexamethasone, and remdesivir. Patient's respiratory status continued to decompensate and patient was transitioned to comfort care. Patient expired on 1/8/2022 at 1520.
Patient developed a 4cm x 4cm erythematous, indurated lesion at injection site.
Pain at site of injection, headache, chills and fever, muscle aches, fatigue. Symptoms began within 6 hours of injection and continued for about 20 hours.
Injection arm became very sore at around 1 PM, around four hours after the injection of dose two. Around 6 PM, began noticing overall body soreness and fatigue. A headache began soon after, and remained throughout the night. I barely slept because my arm and shoulder hurt so bad, and I also was sweating and shivering. I woke up many times.   At 8am on 06/24 I woke up with a severe headache and nausea. My injection arm and shoulder was very sore. My body overall ached, joints and muscles. I almost called into work but decided to go.   I took 500mg of acetaminophen at 10:25am.  At 10:30am at work, I was still very sore and noticed I was mildly disoriented. My coworkers commented on my look of fatigue.  Around 1pm, my disorientation and fatigue began to alleviate somewhat, and my headache had resolved by that time.  Currently it is 8:51pm. I worked the whole day at work, though it was difficult with the body aches and exhaustion. I have a mild headache, general fatigue and soreness, and my  injection arm is still very sore.
Arm pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm pain) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Arm pain). At the time of the report, VACCINATION SITE PAIN (Arm pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No treatment medications were reported.
Pt turned age 5; Pt received Pfizer dose 3 monovalent 6 mo-4 y vaccine on 11/21/22. No adverse reactions.
This spontaneous report as received from a pharmacist via a company representative refers to a patient of unknown demographics who was hospitalized. No concurrent conditions or medical history were provided. On 15-SEP-2014, the patient was vaccinated with a dose of ZOSTAVAX injection (dose, frequency, route of administration, indication, lot# and expiry date unspecified). It was reported that the vaccine was administered two weeks after expiration. No concomitant medications were reported. The patient did not experience any adverse events after administration of the expired ZOSTAVAX. The patient received ZOSTAVAX while at hospital, for an unspecified time. Additional information has been requested.
Fall Narrative:  Patient required lift assistance from EMS. Patient states he had general weakness for awhile after receiving the first vaccination. Patient elected to receive the second vaccination as he had several falls that predated the administration of the first vaccination and had been receiving ongoing PT for severe deconditioning r/r morbid obesity. Fall occurred approximately 10 hours post vaccine administration.
Patient states she started to develop a bumpy, chickenpox-like rash on her lower extremities two days after vaccination. Within two weeks she developed another rash on her arm and side. She saw Dr. and he diagnosed this rash as shingles.
Patient had headache with the first dose of PFIZER COVID-19 vaccine at 02/27/2021 then experienced pain in the the eye ball (right side) after the second dose at 03/17/2021  the pain giving the patient sensitivity for lights as well as blurred vision.
Large red rashes below injection sites, specifically large below the left arm with both shots. Itchy, inflamed, sore.
This spontaneous report as received from a nurse refers to a 14 year old patient of unknown gender. Medical history and concurrent conditions were not reported. On 25-FEB-2015, the patient was vaccinated with an improperly stored GARDASIL dose 1, lot # K005881, expiration date 14-JAN-2017 (dose and route were not reported). No adverse event reported. No co-suspect and concomitant therapies were reported. This is one of several reports from the same source. Additional information is not expected. All follow up requested to complete the case were received.
Breakthrough COVID-19 case. Hospitalized on unknown date for unknown duration. Death 5/7/2021. From Records COD = SEPTIC SHOCK, MULTISYSTEM ORGAN FAILURE, BOWEL PERFORATION. place of death: HOSPITAL-INPATIENT; certified by: PRONOUNCING AND CERTIFYING PHYSICIAN; occupation: MAINTENANCE, HEAT AND AIR CONDITION
This case was reported by a pharmacist via call center representative and described the occurrence of injection site itching in a 71-year-old female patient who received SHINGRIX (batch number 3Z4KL, expiry date 30th January 2020). On 2nd March 2018 13:46, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In March 2018, less than a day after receiving SHINGRIX, the patient experienced injection site itching, injection site swelling and injection site erythema. On an unknown date, the outcome of the injection site itching, injection site swelling and injection site erythema were recovered/resolved. The reporter considered the injection site itching, injection site swelling and injection site erythema to be possibly related to SHINGRIX. Additional details were provided as follows: The patient was administered SHINGRIX in the left deltoid. On 6th March 2018, all symptoms were started.
Patient passed out, fell over out of chair, hit his head, then had a seizure. 911 was called. Patient refused to go to the hospital. Incident happened about 5 minutes after vaccine was given.
I started getting a Migraine , but then in the middle of the night I woke up with severe Lower Back Pain , Joint pain in my shoulders , elbows , and hands bilaterally. Currently My fever is running 100.5-101 F and that?s with taking Tylenol . I still have constant severe low back pain and fatigue . I just feel sick .
Pt reported feeling a cold sweat followed by dizziness, clinical staff assisted him giving water and snack,Pt continued to feel dizzy and was assisted to the floor into recovery position until picked up by medical observartion staff.  PT was transported by stretcher and monitored . Pt claims to begin feeling better and was released on his on charge at 09:50 am. Vitals as follows: 09:31 BP 109/73 HR 63 RR 20 Sp02 !00% Lying 09:38 BP 113/73 HR 62 RR 18 Spo2 100% sitting  09:46 BP 107/71 HR 58 RR 18 Sp02 100% standing
Tested positive on 12/28.  No fever but had bad cough and nasal congestion.  Worst of symptoms lasted about a week, diminishing symptoms about another week.
VOMITING; TEETH PAIN; SINUS PAIN; CHILLS; FEVER; NAUSEA; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included shellfish allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 15-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 15-MAR-2021, the subject experienced fever. On 15-MAR-2021, the subject experienced chills. On 15-MAR-2021, the subject experienced nausea. On 15-MAR-2021, the subject experienced vomiting. On 15-MAR-2021, the subject experienced teeth pain. On 15-MAR-2021, the subject experienced sinus pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The patient was recovering from fever, chills, nausea, vomiting, teeth pain, and sinus pain. This report was non-serious.
Patient showed signs of favoring his legs on the evening Wednesday Sept. 12th.  By Thursday morning patient would not move his legs at all and cried as if in severe pain.  I took him to see Dr. and we were sent to the emergency room for x-rays and blood work.  We went back to the doctor that afternoon and because it could not be determined whether patient was having a reaction to the Varicella virus or a bacterial infection he was given a shot of an antibiotic for safety.  He was taken back to the hospital the next day for more blood work.  It was determined the following day, after a negative blood culture for bacteria, that he had toxic synovitis.  I believe it was due to a reaction to the Varicella virus.