chrisvoncsefalvay/vaers-outcomes huggingface dataset:
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 62-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 11Feb2021 as dose 1, single (Lot number: EN5318), in right arm, on 02Mar2021 as dose 2, single (Lot number: En6502), in left arm and on 17Nov2021 as dose 3 (booster), single (Lot number: Fh8020) at the age of 61 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset Jun2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of vaccination failure, covid-19.  Clinical Course: Known allergies: None known. It was reported that the patient received Paxlovid (Lot Number: GA6765) from 13Jun2022 to 17Jun2022 as treatment of COVID-19. With paxlovid the patient experienced a bad, metallic taste and a couple of diarrhea instances.  No follow-up attempts are possible. No further information is expected.
Pt (R) arm was swollen, inflamed, red and warm from about elbow to shoulder.
Patient presented to emergency department for increasing trouble breathing on 4/23/2021. She was previously diagnosed with COVID-19 infection on 3/3/2021. She was admitted to a different facility from 4/8/2021 to 4/20/2021 for management of COVID-19 infection where she also tested positive for COVID-19.  She was admitted for further management of COVID-19 infection. Her symptoms did not improve and she was placed on comfort measures on 5/4/2021. Patient expired on 5/5/2021 due to complications from COVID-19 infection.
This spontaneous report was received from a physician via a company representative concerning to a patient of unknown age and gender. No concurrent conditions, medical history or concomitant medication were reported. On 07-DEC-2015, the patient was vaccinated with an improperly stored single dose of PNEUMOVAX 23 0.5 ml, which had a lot # of L014458 and an expiration date of 11-FEB-2017 (route and anatomical location of administration were not reported). The sum of hours in excursion was 8 hours and the lowest recorded temperature reported was 34 Fahrenheit (F) (1.111111111 Celsius (C)). The storage criteria  and the storage type were reported as "Refrigerator(R)". The vaccine status was reported as "in excursion". No adverse effects were reported nor product Quality Complaint (PQC) was involved. This is one of several cases received from the same reporter. Additional information has been requested.
Decreased sensation left side of face including left ear - mild numbness  but no weakness, resolving but still slightly present Mild numbness left hand/forearm, no weakness - resolving, slightly present Soreness left shoulder - still  sore.
sick with symptoms that remarkably mirrored those of the flu; Initial information received on 11-Nov-2020 regarding an unsolicited valid non-serious case received from a consumer via social media.  This case involves patient (unknown demographics) who experienced sick with symptoms that remarkably mirrored those of the flu (influenza), while he/she received vaccine INFLUENZA VACCINE.  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious sick with symptoms that remarkably mirrored those of the flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.   It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was reported as unknown.  There will be no information available on the batch number for this case.
-Pt received COVID19 vaccine on 1/8/2021 in the morning.  -Pt was initially observed for 30 minutes, given hx of anaphylaxis to Iodine.  -Pt initially had no symptoms - no itchiness, itchy or watery eyes, rash, difficulty swallowing, itchy throat, swelling, chest pain, shortness of breath, N/V.   -She came back a few hours later with one right chest wall hive and few hives on her left arm.  -No respiratory symptoms. No other symptoms besides those few hives.  -Pt was evaluated by myself and Nurse.  -Pt was observed for another 30 minutes & given Benadryal IM 25mg.  -Pt also took 2 500mg Tylenol.  -Pt felt better and was then discharged
Approximately 10 hours (4 am) after injection I woke up cold so put on sweats and tried to go back to sleep. Woke up around 6 am feeling very tired and still cold. One hour later felt a severe tingling sensation over my entire body, then started shivering and very cold. Shivers lasted an hour as I was wrapped up in several  blankets. Temperature of 101-102 remained for 10-12 hours. Fever broke and I sweated through my clothes 2-3 times for the next 6 hours. 24 hours after my initial reaction I feel normal, but tired.
Premature rupture of membranes at 34w3d gestation. Treatment= antibiotics, betamethasone injection, labor induction
This spontaneous report as received from a physician refers to a patient of unknown age. On 29-MAY-2014 the patient was vaccinated with unspecified dose of RECOMBIVAX HB (dose, route, lot# number not reported) that had been improperly stored. No adverse effects reported. This is one of several reports received from the same reporter. Additional information is not expected.
Patient received a vaccine that was stored beyond the 30 days recommended in the refrigerated state. This event was reported to the manufacturer. The manufacturer tested the lot number in question. Data revealed that the vaccine administered did not maintain activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration. Regulatory authority consulted with the regulatory authority and recommended repeating this dose in question. Patient was sent a letter to inform them of the need to repeat the dose in question. Medical facility is working with the regulatory authority on a compliance improvement plan and has been reinstated vaccination privileges.
Temperature of 101 approximately 60 hours after injection with flu-like symptoms, gone after 24 hours
This spontaneous report as received from a nurse, refers to unspecified patients of unknown demography. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, since 02-JUN-2015, unspecified number of patients were vaccinated with improperly stored VAQTA injection (lot #K019560, expiration date: 02-JUN-2017) (strength, dose and route unspecified). No concomitant medications were reported. No adverse effect had been observed or reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Follow up information has been received on 13-JUL-2015, that all telephone attempts to obtain follow-up information have been unsuccessful. Follow up information was received on 20-JUN-2015 with additional information on 21-JUN-2015. The patient was approximately 2 years old. The patient demographics were updated. On 17-JUN-2015 the patient was vaccinated with improperly stored VAQTA (lot # K019560, expiration date: 02-JUN-2017) (strength, dose and route unspecified). Additional information has been requested. Patient, suspect therapy and narrative were updated.
Approx  10 days after vaccine administration (May 2021), patient experienced acute onset significant vomiting and diarrhea. 2 days later had acute onset of significant dysarthria with some dysphagia that have persisted without significant change since that time. No other reported neurologic symptoms. Neuro exam with hyperreflexia in lower extremities, 2 beats of clonus RLE, noted dysarthria. Normal CN exam otherwise with no weakness or deviation of tongue.  patient denies any prior head injury. Normal neuro exam otherwise. She has been undergoing speech/swallow therapy and occupational therapy with some mild improvement.
Email received 12/29/17 from patient: Sent: Friday, December 29, 2017 1:25 PM Subject: flu vaccine reaction I heard you may be the person to talk to? I had a fairly severe reaction to my flu shot I received this year. I filled out an EMS report and left a message for employee health to call me but never heard back from them. Within an hour of my flu shot I developed significant blurred vision and confusion and went on to develop some intense joint pain with fatigue later that day and into the night. I normally do not have neurological problems and I have perfect vision at baseline. My questions are as follows: 1. What is the lot number of the flu vaccination I received and what are the specific additives? 2. Are there other people who received the flu vaccination this year that had adverse side effects similar to myself? 3. Who is responsible for reporting this adverse reaction to the CDC or other pertinent agencies? 4. What are the recommendations for future flu shots based on my reaction to this one? Thank you for your time and attention to this matter. Follow up email received 1/3/18: I never had any tests or ER visits done.  I did fill out an SAS report and also contacted my primary care providers office to report event in case they wanted to see me.  The best I can tell, I am recovered with the exception that I've been experiencing more joint pain than I can recall in the past but I'm not sure if that is related or just coincidence.
This spontaneous report was received from a currently 79 year old male patient refering himself. On an unknown date the patient was vaccinated with ZOSTAVAX (dose, units, route of administration, anatomical location, lot number were not reported). On an unknown date, reported as some time afterwards, the patient developed shingles and mentioned that has experienced blisters and forgetfulness. On an unknown date, lung test (unspecified) was performed and showed everything was negative. The patient sought medical attention (unspecified). The outcome of events was not reported. The relatedness between events and ZOSTAVAX was not reported. Additional information has been requested.
Itchy at the injection site; sore rump near the deltoid; pain in the neck; fever of 100F; swollen lymph nodes; redness at the injection site; rash at the injection site; intense pain; Sore arm; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (intense pain), PAIN IN EXTREMITY (Sore arm), FATIGUE (Fatigue), INJECTION SITE PRURITUS (Itchy at the injection site) and TENDERNESS (sore rump near the deltoid) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported).    On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2020, the patient experienced INJECTION SITE PAIN (intense pain), PAIN IN EXTREMITY (Sore arm) and FATIGUE (Fatigue). On 04-Jan-2021, the patient experienced INJECTION SITE PRURITUS (Itchy at the injection site), TENDERNESS (sore rump near the deltoid), NECK PAIN (pain in the neck), PYREXIA (fever of 100F), LYMPHADENOPATHY (swollen lymph nodes), INJECTION SITE ERYTHEMA (redness at the injection site) and INJECTION SITE RASH (rash at the injection site). At the time of the report, INJECTION SITE PAIN (intense pain), PAIN IN EXTREMITY (Sore arm), FATIGUE (Fatigue), INJECTION SITE PRURITUS (Itchy at the injection site), TENDERNESS (sore rump near the deltoid), NECK PAIN (pain in the neck), PYREXIA (fever of 100F), LYMPHADENOPATHY (swollen lymph nodes), INJECTION SITE ERYTHEMA (redness at the injection site) and INJECTION SITE RASH (rash at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       treatment include zyrtec
Vaccine administered 13:49, adverse event started 13:50. Patient had dizziness, light headedness. Patient reports did not have breakfast or lunch and did not sleep well. BP 89/60 -- >108-- >59 -- > 113/74, HR 84 -- >71-- >76, O2 sat = 100%. Provided patient hydration, emotional support, patient stable & released from vaccination site.
102 fever Cough Nausea and vomiting Body aches Chills Insomnia
I got it, went into one eye.; shingles on my head, not bad; This case was reported by a consumer via interactive digital media and described the occurrence of ophthalmic herpes zoster in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and an unknown time after starting Valtrex, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant) and shingles. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the ophthalmic herpes zoster and shingles were unknown.   It was unknown if the reporter considered the ophthalmic herpes zoster and shingles to be related to Shingles vaccine.     Additional Information: GSK Receipt date: 27-FEB-2023 Reporter's Comment:  This case was reported by a patient via interactive digital media. The patient had the first shingles shot, so when she/he got it on the left side of her/his head it was not as bad as it could had been. The patient went to doctor first thing got an antiviral Valtrex and had to go to many visits to eye doctors because it went into one eye.  The patient understands the new vaccine was 98.9 percent effective so recommend it, you did not even want to deal with a mild case. Additional Supportive Information: The follow-up could not be possible as no contact details were available.
The first week the injection site was red, hot and painful.  Once the rash went away and a month later, I still experience pain and weakness in the left arm
Day of vaccination: muscle aches, dizziness. Next day headache, sweating, shortness of breath. Patient went to ER. She was given steroids and other medications. She recovered and left ER in 2 hours.
Pain Lymph node under the Left Arm; Pain in forearms; Sore left Arm Pit; Headache; Sore Left Arm at the injection Site; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of LYMPH NODE PAIN (Pain Lymph node under the Left Arm), PAIN IN EXTREMITY (Pain in forearms), AXILLARY PAIN (Sore left Arm Pit), HEADACHE (Headache) and VACCINATION SITE PAIN (Sore Left Arm at the injection Site) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, the patient experienced HEADACHE (Headache) and VACCINATION SITE PAIN (Sore Left Arm at the injection Site). On 14-Mar-2021, the patient experienced LYMPH NODE PAIN (Pain Lymph node under the Left Arm), PAIN IN EXTREMITY (Pain in forearms) and AXILLARY PAIN (Sore left Arm Pit). On 11-Mar-2021, HEADACHE (Headache) and VACCINATION SITE PAIN (Sore Left Arm at the injection Site) had resolved. On 15-Mar-2021, LYMPH NODE PAIN (Pain Lymph node under the Left Arm) and AXILLARY PAIN (Sore left Arm Pit) had resolved. At the time of the report, PAIN IN EXTREMITY (Pain in forearms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medicines were reported.  No treatment information were reported
Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 35-year-old female patient (gravida 1, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 028L20A) for COVID-19 vaccination.     Concurrent medical conditions included Drug allergy (Allergic to Percocet), Hypothyroidism since 2005 and Allergy to antibiotic (Allergic to Augmentin). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) and THYROID (ARMOUR THYROID) for an unknown indication.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 03-Oct-2020 and the estimated date of delivery was 10-Jul-2021. On 13-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fourteenth week of the pregnancy.  On 13-Jan-2021, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Nov-2020, Pregnancy test: positive (Positive) Positive.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       The number of previous pregnancies included one full term birth on 29-May-2019. Positive pregnancy date was 01-Nov-2020
This spontaneous report as received from a nurse refers to a patient of unknown age. On an unknown date the patient was vaccinated with GARDASIL (dosing information was not provided). On an unknown date, post vaccination with GARDASIL, the patient experienced syncope. The nurse asked if she needed to report syncope as an adverse event, if it is listed in the prescribing information. The outcome of syncope is unknown. Additional information is not expected.
I received the Moderna Covid 19 Vaccination four days ago.  This morning I began to sweat, then I  suddenly had intense nausea, followed by  stomach pains.  This was followed by a bout  of diarrhea for a a couple of hours.  I didn't eat anything out of the ordinary.   The diarrhea has subsided, but my stomach is still bothering me.  I'm also very tired, achy and out of it.  My doctor said to report this as a potential side effect.
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 24-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 19Jan2021 as dose 1, single (Lot number: EL1283), in left arm, on 09Feb2021 as dose 2, single (Lot number: EM9810), in left arm and on 25Sep2021 as dose 3 (booster), single (Lot number: EW0178) at the age of 24 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Pots" (unspecified if ongoing), notes: POTS; "Known allergies: Latex" (unspecified if ongoing), notes: Known allergies: Latex. There were no concomitant medications. The following information was reported: SUSPECTED COVID-19 (medically significant), outcome "not recovered", DRUG INEFFECTIVE (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of suspected covid-19.  Additional information: It was reported that no other medication were received in 2 weeks.  Follow-up attempts are completed. No further information is expected.
Administration of a 3rd dose of PEDVAX HIB/ /the dose were administered at 2, 4 and 6 months.; No additional AE reported; This spontaneous report has been received from a registered nurse regarding a 6-month-old patient of unknown gender. The patient's medical history, drug allergies, previously drug reactions, concurrent conditions and concomitant medications were not reported.  On unspecified dates, at 2 and 4 months old, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAHIB) for prophylaxis (strengths, doses, routes of administration, and anatomical locations were not reported). On an unknown date, at 6 months old, the patient was vaccinated with the third (3rd) dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAHIB) (strength, dose, route of administration, and anatomical location not reported) (product administered to patient of inappropriate age) (conflicting information as it was also reported that the reporter can not confirmed if the dose was administered).  No additional adverse events reported (no adverse event).
1st dose / on April-26-2021 / 2nd dose / (Aug-13-2021); This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 96-year-old female patient who received HAB (Twinrix) (batch number 57E3G, expiry date 20th February 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (1st dose received on 26th April 2021).   On 13th August 2021, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 13th August 2021, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long 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 details were provided as follows: The pharmacist reported that, the patient received 2nd dose of Twinrix later than the recommended time interval, which led to lengthening of vaccination schedule. The reporter consented to follow up.
DEMENTIA, UNSPECIFIED SEVERITY, DUE TO EPILEPSY W OTHER BEHAVIORAL DISTURBANCE
Red, Very swollen injection site, including axillary area, fluid filled.  Injection site very close to shoulder joint.
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients. On an unknown date an unspecified number of patients may have received improperly stored VARIVAX (Merck) (dose, frequency, lot number not provided) and PROQUAD (Merck) (dose, frequency, lot number not provided). The VARIVAX (Merck) and PROQUAD were improperly stared from January of 2012 to present 25-MAR-2013. No adverse event reported. Additional information has been requested.
Had syncopal episode after administration of HPV vaccine.  Laid down and received juice and crackers, and was at baseline within 20 minutes.