chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous reprot was received from a Healthcare worker refers to an unspecified patients of unknown demographics. It was reported that on an unknown date since December 2014 the patients were vaccinated with improperly stored GARDASIL (dose, route, lot # and frequency unspecified). No concomitant medications were reported. Healthcare worker stated that on an unknown date, some complaints may have been made with regards to sore arms but that's nothing out of the ordinary. Healthcare worker could not provide information regarding any specific patient(s) who may have experienced the symptom. She stated that they "always" received complaints regarding sore arms after administration of vaccines. No further information was provided. The outcome of sore arm and incorrect product storage was unknown. Causality assessment for the event sore arm not reported. There was no product quality complaint involved. This is one of several reports received from the same source. Additional information has been requested.
pt recvd vax; noc following vax, fever 102.3; irritability w/ high pitched cry; 3 days later fever still 100;
Admitted to hospital on 7/31/2021 with SOB, cough and loss of taste and smell. Blood sugar 370 with no known history of diabetes. He had known exposures to Covid 19.  Treatment recommendations indicated: remdesivir  -Dexamethasone per the protocol which is 10 mg daily for 3 days followed by 6 mg daily for 7 days -Dose of every 200 mg x 1 followed by 100 mg x 4 days. Submitter does not have access to further follow up information on this client. Please contact hospital indicated for further medical records.
Neuropathy - peripheral nerve paresthesias. Leukopenia - hypoplasia neutrophils on bone marrow examination.
Child break out in hive after MMR and Varirex, the right thigh swell up and swollen where MMR was administered. Gave Benadryl 2.5 ml po x1 , no respiratory distress, Pul O2 100 %,  Observe for 30 minutes in office. Child is stable will start him on 3 days course of predinsone and RTC follow up on Sunday.
Approximately a few hours after my 2nd booster shot I experienced the following symptoms: I had swollen ankles and I did not take any medications for treatment but just elevated my legs to help ease the swelling. It was gone by the time I woke up. I did consult with my doctor and he advised to sleep on it but if it's still swollen in the morning that I should come in.
911 was called by covid hotline nurse, stayed on the line with dispatch and the individual until paramedics arrived patient was alert and coherent able to answer questions appropriately. reported throat swelling and difficulties swallowing. 911 called spoke to dispatch, EMS in route to her home. stayed on the line until paramedics arrived.
Initial misuse report received from a nurse on 14 November 2013. The 3-year-old patient had received FLUZONE 0.25 ml instead of the age appropriate 0.5 ml dose. No adverse event was reported. List of documents held by sender: none.
No adverse effects reported; the patient received dose of PNEUMOVAX 23 that was improperly stored; This spontaneous report was received from a nurse regarding a 59-year-old patient with unknown gender. The patient's medical history, concomitant medications, concurrent conditions and drug reactions/allergies were not reported. On 07-OCT-2019, the patient received first dose of improperly stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) vial, lot # R031812 and expiration date: 26-SEP-2020 (dose and anatomical location were unknown) intramuscularly for prophylaxis (product storage error). The temperature excursions were reported as 28.2 Fahrenheit for 22 hours and 32 minutes, 28.6 Fahrenheit for 6 hours and 54 minutes, 28.8 Fahrenheit for 23 hours and 2 minutes, 30.4 Fahrenheit for 6 hours and 36 minutes and 51.6 Fahrenheit for 1 hour and 3 minutes. There was no previous temperature excursion. A digital data logger was involved. No adverse effects reported. No product complaints (PQC) were involved.
Within about 15 minutes after the vaccine I felt light headed, but at no point felt like I was going to pass out. Even today about 20 hours later I feel a little off. Stomach ache and a little nauseous.
Vaccine administered 16 days after first puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered 16 days after first puncture) in an 81-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered 16 days after first puncture). On 18-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine administered 16 days after first puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Follow up contains no new information.
Initial information received on 27-Jul-2018 regarding an unsolicited valid non-serious case received from a consumer/non-hcp. This case involves a 4 years old male patient who inadvertently received two doses of ADACEL and IPOL on 25-Jul-2018 and again on 27-Jul-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 25-Jul-2018, the patient received a dose of suspect IPV (VERO) lot number not reported via unknown route in left leg administration site. On 27-Jul-2018 he also received a dose of the same vaccine with an unknown batch number via unknown route in right arm administration site. On 25-Jul-2018, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported via unknown route in the left leg. On 27-Jul-2018 he also received a dose of the same vaccine with an unknown batch number via unknown route in right arm. It was a case of actual medication error due to extra dose administered. It was unknown if the patient experienced any adverse event or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: None.
Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A, 031M20A and 044A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 01-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Unknown      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications was not reported. Treatment medications was not reported.
pink eye; This is a spontaneous report received from a contactable consumer. This 63-year-old female contactable consumer (patient) reported for herself that she received second dose of BNT162B2 (BNT162B2, solution for injection, Lot no: unknown) on 26Mar2021 at 09:30 AM, via an unknown route of administration on left arm as single dose for covid-19 immunization. The patient relevant medical history included Thyroid issues. The patient previously received first dose on 05Mar2021 at 09:45PM on left arm via an unknown route of administration. In Public Health Clinic facility the most recent COVID-19 vaccine was administered. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. List of the medications the patient received concomitantly within 2 weeks of vaccination included Amoxicillin, Prilosec. The patient was not diagnosed with COVID-19. Since the vaccination, the patient has been not tested for COVID-19. The patient was unaware of allergies to medications, food, or other products. On 27Mar2021 (14 hours 30 min after the vaccination), the patient experienced pink eye. The treatment for the event included eye drops. The outcome of the event pink eye was not recovered.   No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Pt was on COUMADIN when he got his shot and already had some bruising on his arm. Pt did not report symptoms to us until 1/18/10. He had seen his regular MD and MD said he had a bad hematoma but did not really treat the pt except for lowering his COUMADIN dose. MD said dose was too high.
First adverse event was a severe headache. About 12 hours later, experienced chills and muscle aches. 24 hours later , experienced severe pain in both sides of jaw and ears, along with hip pain.
Pt stated she experienced hives, initially on the left arm within 24 hour of adminitration. She woke up this morning 48-72 hours after administration and there were hives on both arms and over her body.
EPILEPSY HAS INCREASED/EPILEPTIC SEIZURE; This spontaneous report received from a patient via social media via company representative concerned a patient of unspecified age, sex, race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions included: epilepsy. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose and start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient reported that her epilepsy had increased and had an epileptic seizure recently that had caused compression fractures. It was also reported that the patient could not get the booster shot. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of epilepsy has increased/epileptic seizure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211046186-COVID-19 VACCINE AD26.COV2.S-Epilepsy has increased/ epileptic seizure. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
Pt. received TDaP and TWINRIX on 5-4-17 returned to clinic on 5-31-17 for unrelated tx. Stated arm was painful and pain went to neck after approx. 15 days. F/u with pt on 6-1-17 pt. states pain resolved.
Headache starting from the temples running along the side of my head to the base of my skull within 15 minutes of vaccine; 100-102 degree fever starting that evening and still happening as of 6:02pm of 08/12/2021; diarrhea within 1 hour of vaccine until approximately 2pm 08/11/2021; hot and cold sweats all day and through the night and still happening as of this report; exhaustion and muscle fatigue within an hour of vaccine and still continuing; mental fugue within an hour of the vaccine and still continuing; extreme tightness in arm (worse than a DTAP vaccine) to include a dime sized lump about 3 inches below the injection site within a couple of hours from the vaccine that lasted until approximately 10am 08/11/2021; shortness of breath and slight tightness of chest within an hour of vaccine and slowly getting better or feeling somewhat normal as of this report; difficulty sleeping due to fever and hot/cold sweats; loss of appetite due to all of the above.
Numbness in tops of feet that spread up into calves. Tingling, numbness and burning. Doesn't limit movement. Just caused irritation and worry.
My 1st vaccination went without a hitch, my second vaccination was horrible.  3 or 4 days after the vaccination I started getting really achy in my hands   By the end of the week I started getting pain in joints that I never had pain in before, such as my elbows, knees and wrists. Along with the pain , my hands began to swell so large that  I appeared to have little bowling balls at the end of my wrists . The pain was excruciating and I was unable to use my hands. This swelling lasted about 5 months. the pain continues to this day. with now RA in my ankles knees and wrists. Additional medication was added w/o much effect. Unfortunately  My Dr was on vacation for the month of May and I suffered until her return.
Heart palpitations started at 11:44 am. Lasted 30 seconds and stopped. Would begin again periodically and stop.   Second day came shortness of breath with minor exertion and exercise.
swollen lymph nodes, really bad that they hurt so bad under my armpit and every day it hurts like really bad; painful lymph nodes; This is a spontaneous report from a contactable consumer (patient). A 63-year-old patient of an unspecified gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 27Mar2021 (Lot Number: EP6955) at the age of 63-year-old as a single dose and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in Arm Left on 17Apr2021 (Lot Number: ER8731) at the age of 63-year-old as a single dose for covid-19 immunisation. The patient has no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and not any other medications the patient received within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. On 27Mar2021 12:00, patient had very painful lymph nodes started immediately after the received first dose vaccine. Patient constantly feel the pain and it is interfering with patients life. Patient had a horrible swollen lymph nodes, really bad that they hurt so bad under the armpit and every day it hurts like really bad. The patient underwent lab tests on 06Jun2021 which included COVID test, Nasal Swab was negative. The outcome of event painful lymph nodes was not recovered with no treatment received and event swollen lymph nodes, really bad that they hurt so bad under my armpit and every day it hurts like really bad was unknown.
About 5 days after the shot, I was still having a lot of fatigue, but I developed severe headaches, like someone was sticking a knife in my head, and I was having bouts of light headedness.  I am a person who never has headaches.   Because the issue of the blood clots came about with the J&J, I ended up, because of the severe headeaches  had to have a brain MRI to rule out the blood clots.  I did not have any.  But the headaches were very much a problem and the light headedness.  I had to leave area for the summer, and now came to another area.  I still was not feeling right.  The bad headaches subsided, but I was till getting the lightheadedness with a slight headache after almost every day.  II also had a full blood panel done on April 8.  It is showing my thyroid is low and now have to be on Thyroid medication.  I just had full blood work done in March, and all my blood work was normal.  I also have noticed that my arthritis in my hands is exacerbated.  And sometimes my feet go numb when I am riding my horse.  And in the morning, my arms and legs ache.  My  BP was a little elevated as well. I never have had high blood pressure.     I am 63 years old and have always had great health.   Since I had the covid shot,  I have had nothing but problems.   If I had to do it over again, I WOULD NOT have gotten the shot.  I only got it because my daughter was having a baby and insisted even though I had the virus back in October.
This is a spontaneous case, initially received from other non-health professional on 05-Dec-2018, concerning an elderly male patient (reported as over 65-year-old). On an unspecified date, the patient was administered INN Flu Vaccine Seasonal (dose, route of administration, anatomical location, batch number, expiry date, trade name and manufacturer: not reported) for influenza prophylaxis. On an unspecified date after vaccination, the patient developed red circular spot at the site of injection. On an unspecified date, the patient had recovered from the event. The reporter assessed the case as non-serious. Non-significant follow up was received from the Medical Information team on 04-Feb-2019: This case was considered as lost to follow up as the attempt to reach the reporter was not successful. Medical information reference number (SEQ19-00008) was added in the additional information tab. No changes were done in the narrative. Reporter's Comments: An elderly male patient developed red circular spot at the site of injection, on an unspecified date after administration of INN Flu Vaccine Seasonal. The causality of the event was unassessable due to lack of onset latency.
Received an expired dose of Kinrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a patient who received DTPa-IPV (Kinrix) (expiry date 15-JAN-2022) for prophylaxis.   On 16-FEB-2022, the patient received Kinrix. On 16-FEB-2022, an unknown time after receiving Kinrix, the patient experienced expired vaccine used (Verbatim: Received an expired dose of Kinrix). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt date: 04-MAY-2023 The reporter did consent to follow up. The patient received an expired dose of kinrix vaccine, which led to expired vaccine used.
10 days post vaccine, vaccination area swelled and became itchy and hot to touch, these symptoms lasted two days
Information has been received from a physician concerning his daughter who on an unknown date was vaccinated with a dose of GARDASIL and the warts in her feet went away. No further information is available.
I woke up with severe chills from 4am-10am and then had fever of 103 plus that afternoon, could barely get up out of bed, nausea, weakness, dizziness. Aches all over my body and joints especially, intense headache, pain at injection site. The next night, same thing, woke up at 5am with chills and fever of 103 plus and all the other symptoms the second day. I was in so much pain I considered going to the doctor but could barely move. Tylenol did not touch it. I was delirious. The third night/day the fever finally had broken but I was still super weak and tired. The next day I was better. Anyway, if I had the option I would not take the vaccine again because of these side effects.
doses administered after more than 1 temperature excursion; doses administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021 at 9:22 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021 at 9:22 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant products were not provided. It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F. Vaccine was stored in Cooler 1 on 20-Apr-2021. The excursion time on initial supply was 9A and 10A, temperature was 34 and 37, total 184 doses were given for the day, vaccine was not frozen prior to administration. Vaccine moved to fridge on 09-Mar-2021 and moved to clinic on 20-Mar-2021. 19 vials were sent to the clinic. BUD date was 08-Apr-2021. Vials only punctured right before administration. On 20 Mar 2021, the temperature excursion duration At 9 AM: 34, 10 AM: 30, 11 AM: 41, 12 AM: 45, 1PM : 44, 2 PM : 44, 3 PM: 44, 4PM: 44, 5PM: 43  Treatment medications were not reported.
Client had FLUZONE vaccine 11/19/08 - states she started later that evening she started with fever severe aches dizziness, labored breathing - heart rate 96 - states went to sleep and felt ok the next day. Client did not report this until today 12/08/08. Did not go physician. 1st FLUZONE vaccine.
I woke up with a very sore throat and a lot of congestion. It took until that evening until I took a at home COVID test which came back positive. I was coughing continuously for 3-5 minutes intermittently. My pulse ox reading was dipping to 95% when I coughed, it was up to 120% most of the time. Headache and nausea and a lot of fatigue. For the past week I've mainly been sleeping and taking Tylenol to keep the low grade fever down and monitoring my oxygen and heart rate. Now it's just slight brain fog and fatigue, I no longer have a fever or congested.
Swollen lymph nodes.; This is a spontaneous report from a Non-contactable consumer.   A 67-year-old female patient received second dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EH9899) on 28Dec2020 at 01:15 p.m. via an unspecified route of administration, on left arm at single dose for COVID-19 immunization. Relevant medical history included allergy to penicillin. Concomitant medications were not reported. On 29Dec2020 the patient experienced swollen lymph nodes. At the time of the reporting the patient had not recovered from the event.   No follow-up attempts are possible. No further information is expected.
Headache, Myalgia, Fever, Soreness/swelling in injection site ,arm heaviness, body aches , chills Narrative:
Flu symptoms: fever, aches, congestion, runny nose, sore throat, symptoms persisted for 7 days. Vaccine caused what it was meant to prevent.