chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 01-MAR-2014, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster the very virus the ZOSTAVAX vaccine was intended to prevent. Later in July 2014 the patient was treated by a physician for a vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving ZOSTAVAX, for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered  and  will  continue to  suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Patient presented to emergency department from acute care facility on 11/28/2021 due to fatigue and exposure to COVID-19. He was confirmed to have COVID-19 infection and admitted for management. He was treated with dexamethasone and supplemental oxygen. His condition worsened and was changed to comfort measures only. Patient expired on 12/4/2021.
patient inadvertently received doses of both VARIVAX and PROQUAD; patient inadvertently received doses of both VARIVAX and PROQUAD; patient inadvertently received doses of both VARIVAX and PROQUAD; This spontaneous report as received from an office manager refers to a 12-month-old. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 07-FEB-2020 the patient received doses of both varicella virus vaccine live (oka/merck)(VARIVAX)  and varicella (oka-merck) virus vaccine live(PROQUAD) for prophylaxis (dose, route of administration, lot number and expiration date were not reported). Suspect therapy included: included sterile diluent(STERILE DILUENT).
Approximately 3.5 inch firm, red, lump.  Warm to touch and painful on right arm.
cold and Pharmacist noticed that it was half frozen; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of product storage error in a female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) (batch number C2PH4, expiry date 30-JUN-2024) for prophylaxis.   On 21-SEP-2023, the patient received Fluarix Quadrivalent 2022-2023 season. On an unknown date, an unknown time after receiving Fluarix Quadrivalent 2022-2023 season, the patient experienced product storage error (Verbatim: cold and Pharmacist noticed that it was half frozen).  The outcome of the product storage error was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 22-SEP-2023 The pharmacist reported that while administering Fluarix the patient said it was cold and Pharmacist noticed that it was half frozen, which led to Product storage error. The reporter consented to follow up.
1st dose. on 2 day fever, fatigue, headache 2nd dose on 2 day fever, fatigue, nausea, pain, inability to get around, for about a week. Went to doctor several times with chest pain, high blood pressure which was previously low. Had heart stints, 2 put in. Eyesight became a problem.  Clot Arteries 2 stints- 95% blocked CONSTANT Diarrhea Dr. said if I hadn't come when I di
Upon walking onto the tennis court and the open space all of a sudden I felt that if I took one more step I would fall off a  precipice. There was no dizziness - nothing seemed spinning around. This has continued since then whenever I am in a large open space.
flu like symphtoms; localized reaction; This case was reported by a nurse via sales rep and described the occurrence of influenza-like symptoms in an unspecified number of patients who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, less than a day after receiving Bexsero, the patient experienced influenza-like symptoms and local reaction. On an unknown date, the outcome of the influenza-like symptoms and local reaction were unknown.   It was unknown if the reporter considered the influenza-like symptoms and local reaction to be related to Bexsero.  Additional details were provided as follows: This case was reported by the Registered Nurses (RN). The age at vaccination was not reported. The patients experienced severe localized reactions as well as flu like symptoms for the first 24 to 48 hours. The reporter stated that when they were first providing Bexsero, they received a lot more calls, because they were not educating parents and patients about the side effects. This case has been linked with cases US2019AMR113762, US2019AMR113769, reported by the same reporter. The RN did not agree to be followed up.
This spontaneous report as received from a nurse refers to a patient of unknown age. The patient was vaccinated a dose of VARIVAX (Merck) (0.5 ml one dose, Subcutaneous, lot # not reported) between 9 AM and 10 AM on 29-AUG-2012 and was inadvertently given an extra dose of VARIVAX (Merck) (lot # and dose not reported) at 4:25 PM on the same day on 29-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. At the report time the outcome of event was unknown. It was unknown if the patient sought medical attention. Additional information is not expected.
Patient stopped breathing when napping - no foul play, no obstruction or suffication.  Autopsy diagnosed SIDS as cause of death.
Arm reaction after the first vaccination; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Arm reaction after the first vaccination) in a  patient of an unknown age and gender 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Arm reaction after the first vaccination). At the time of the report, VACCINATION COMPLICATION (Arm reaction after the first vaccination) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-190727 (Patient Link).
wiped out the day afterwards; tired; uncomfortable; sleepy; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (uncomfortable), SOMNOLENCE (sleepy), FATIGUE (wiped out the day afterwards) and FATIGUE (tired) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced DISCOMFORT (uncomfortable), SOMNOLENCE (sleepy) and FATIGUE (tired). On 25-Feb-2021, the patient experienced FATIGUE (wiped out the day afterwards). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DISCOMFORT (uncomfortable), SOMNOLENCE (sleepy), FATIGUE (wiped out the day afterwards) and FATIGUE (tired) outcome was unknown.            Concomitant medication was not provided
Fever, chills, bodyaches, congestion, dry cough, nausea, headache
Felt sick.  Didn't feel like eating.  Went to bed with fever and chills.  Had fever and chills all night.  Felt sick for days.  Had a headache and felt weak.  Developed a cough.
on feb o4,2021 in the morning, i had severe pain in my left arm under the shot, it remins, i cannot lift my arm. i took tylonol, motrin and it did nothing. today i stared taking tramadol, it is the most severe pain i have ever expererence .the pain is off the chart, worst than  knee replacement and open heart surgery.  my question, was this a batch
so dizzy; Chills; Fever; bedridden for two days; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS, CHILLS, PYREXIA, and BEDRIDDEN in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included VITAMINS for an unknown indication.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS, CHILLS, PYREXIA, and BEDRIDDEN. The patient was treated with TYLENOL at a dose of UNK dosage form. At the time of the report, DIZZINESS, CHILLS, PYREXIA, and BEDRIDDEN outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Guillain-Barre Syndrome. First onset of weakness, 10/30/2009. Pt hospitalized for GBS on 11/26/2009, discharged 12/08/2009. Case reported to California Emerging Infections Program by consulting neurologist on 12/10/2009.  12/22/09 ED and hospital records received. Multiple visits and admissions. Service dates 11/26/09 to 12/15/09 Assessment: Hypotension, pneumonia, acute kidney insufficiency. Guillain-Barre syndrome. Patient was evaluated for leg and arm weakness 10/29/09. November 2009 c/o constipation. Cough, fever, hypotensive. Erythematous rash to arms. Abdominal pain. Leg pain. Tachycardic. Low O2 saturation. Obese. Cushingoid appearance. 12/15/09 Diffuse atrophy and weakness upper and lower extremities. Bifacial weakness. Reflexes diminshed, absent at the ankles. Vibratory sense and joint position sense reduced lower extremities.
small amount of blood was noted at injection site; Initial information received on 12-Oct-2022 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a 78 years old female patient who experienced small amount of blood was noted at injection site while receiving vaccine influenza quadrival a-b high dose hv vaccine [fluzone high-dose quadrivalent].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 11-Oct-2022, the patient received a  dose of suspect quadrival a-b high dose hv vaccine  at dose of 0.7ml lot UJ895AB Expiration Date: 30-jun-2023  via intramuscular route in the deltoid nos.  On 11-Oct-2022 the patient developed a non-serious small amount of blood was noted at injection site (injection site haemorrhage)(latency same day) following the administration of quadrival a-b high dose hv vaccine.  It was reported  "A small amount of blood was noted at injection site post-injection and a bandage was applied. This morning she called to report an orange substance on the band-aid".  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (small amount of blood was noted at injection site).  At time of reporting, the outcome was Unknown for the event small amount of blood was noted at injection site.
FEELING COLD; SHIVERING; FEVER; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown, and batch number: UNKNOWN expiry: UNKNOWN) .5 ml, administered on 10-MAR-2021 to Left Arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 10-MAR-2021, the subject experienced feeling cold. On 10-MAR-2021, the subject experienced shivering. On 10-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feeling cold, shivering, and fever. This report was non-serious.
I was told to wait 30 min instead of 15 because I've had allergic reactions before, and to let them know if I was having side effects. After 5 min I had a headache and 5-10 min later I was very nauseous. I let the EMT's know and the asked me questions to make sure I could breath ok and wasn't going into anaphylactic shock (I could breath fine). After 30 min I left and threw up on my way home and 3-4 more times after I got home. I took ibuprofen for my headache and took a nap, an hour or so later I woke up and had hives all over my arms and some on my neck and back. I called the advice nurse on my insurance card and she directed me to Teledoc (they do video/phone app's) to make a Dr. appointment. I made my app for 4/23/21. Even though my hives were pretty much all cleared up by then(2 days later) I still wanted to ask the Dr. If I should get the second shot or look into another vaccine. He told me to not get the second Pfizer dose and it was up to me if I wanted to get another one like the Moderna or J&J one. He said I was 50-60% immune instead of the full 95% and that was better than nothing. I'm glad I got the vaccine but will not be getting any more in the future.
I had my vaccination 09/09/2022. On 10/08/2022 I started to feel like I had a cold coming on with sniffles and a sore throat. I tested COVID-19 Positive on 10/09/2022. I was put on Paxlovid for 5 days. I still presently have a little bit of a cough on 12/13/2022.
Boostrix administered  IV; This case was reported by a pharmacist via call center representative and described the occurrence of intramuscular formulation administered by other route in a 63-year-old male patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 23rd October 2022, the patient received Boostrix (intravenous). On 23rd October 2022, unknown after receiving Boostrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.   Additional Information: GSK receipt date: 27-Oct-2022 Reporter's comment: The adverse event contains all reported information. The reporter unable to provide any additional information at this time. The reporter gave consented for safety team follow-up. Additional supportive information: The patient received Bostrix via intravenous route, which led to Intramuscular formulation administered by other route.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination.     No Medical History information was reported.  On 27-Oct-2021 at 11:00 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 27-Oct-2021 at 11:00 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 75.27.  Concomitant product use was not provided by the reporter.  Batch number 035C21A underwent temperature excursion on 27-Oct-2021 with temperature 29 and 32 degrees Fahrenheit from 09:00 AM to 10:00 AM. This vial was moved to fridge on 29-Sep-2021 and 05-Oct-2021, beyond use date for the vial was reported as 29-Oct-2021 and 04-Nov-2021. Product moved to clinic on 27-Oct-2021.  Vial was in cooler storage and was not in frozen storage during high-pace COVID-19 vaccination at around 2021. Vials were only punctured right before administration. Vaccines were not frozen at time of administration. It was reported that each time a vial was put into a cooler, sometimes there was a period of 1 hour or 1 hour and a half approximately, when temperature data logger registered a temperature of 34- or 35-degree Fahrenheit. Temperature recordings were taken using a traceable temperature monitor at every hour.  Treatment information was not provided.   This case was linked to MOD-2022-566976 (Patient Link).
Pt. received 4 month vaccines on 1-31-11. Developed bilious emesis, lethargy on 2-1-11 and was found to have an intussusception and Meckels diverticulum. Mass was resected and reduced successfully.
Tingling in legs, progressed to weakness, hospitalized and treated for Guillain Barre Syndrome at Hospital (treated with IVIG).  Still has intermittent weakness in the lower extremities.
About six and a half hours after receiving the second COVID-19 Vaccine EUA I became extremely tired. The extreme tiredness lasted 24 hours and then went away.
December 15,2021 I started having issues with my ear. I went to the doctor on February 21, 2022. He prescribed ofloxacin, two drops in both ears 5 times a day for 5 days. I did it actually for 7 days. In a couple of days if felt okay. Then the itchy and moist feeling came back and I went back to the doctor on April 5 and saw a PA. She prescribed tobramycin, 1-2 drops every 2-4 hours a day for 7 days. She also prescribed clotrimazole, 1 drop 3-4 times daily for 14 days. I finished that up last week, my ears are still itchy, not totally resolved. I have good days and bad days. There are days it feels so dry and itchy, feels like a lot of moisture inside. Today doesn't feel like as much moisture. My next option is to go to an ENT.
Patient received a dose of Moderna Covid vaccine that was past the 12 hour expiration time.
pt recv vax & exp urticaria, was moaning & had a poor appetite & an ear infect; 16 days later pt recovered;
Vaccine administered 2days after expiration date on vaccine. Vaccine expiration 04/29/2023. Vaccine given on 05/01/2023
Patient reported prior to receiving vaccine that she occasionally gets lightheaded after vaccines but has tolerate many vaccines recently. The only time she reported syncope was during childhood, so we chose to administer vaccine but monitor closely. She reported no symptoms immediately after receiving the Shingrix, so I asked if she wanted to remain seated in the consultation room or move to a seat in our waiting room. She elected to go sit in our waiting room for about 10 minutes. Then, she mentioned to us that she was feeling a bit lightheaded, so I walked over next to her. She then fainted while sitting upright. She did not fall out of the chair. Her breathing became irregular, so I requested a staff member call EMS. I located a pulse and continued to attempt to wake her up. After approximately 30-45 seconds she awoke to full consciousness and began speaking normally. She said she was nauseous and vomitted. EMS arrived and she was feeling well. They walked her out to her car.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old male patient received BNT162b2 (BNT162B2), in Mar2021 as dose number unknown, single (Batch/Lot number: unknown) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetes type 2" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Treatment included nirmatrelvir/ritonavir (PAXLOVID).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
WHOLE BODY WAS SORE; TERRIBLE HEADACHE; VERY NAUSEOUS; COLD; ARM WAS SORE; ARM FELT VERY HEAVY; SHIVERING; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 08-AUG-2021 for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On 08-AUG-2021, the patient experienced cold. On 08-AUG-2021, the patient experienced arm was sore. On 08-AUG-2021, the patient experienced arm felt very heavy. On 08-AUG-2021, the patient experienced shivering. On 09-AUG-2021, the patient experienced whole body was sore. On 09-AUG-2021, the patient experienced terrible headache. On 09-AUG-2021, the patient experienced very nauseous. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from arm was sore, and terrible headache, and the outcome of arm felt very heavy, cold, shivering, whole body was sore and very nauseous was not reported. This report was non-serious.
Patient admitted for respiratory distress, Patient required up to 4L of nasal cannula. Patient received Lovenox 40 mg  daily subQ.