chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from the registered nurse on 02-JAN-2014. It was reported that GARDSIL vaccines were stored improper temperatures and were administered to overall number of 132 patients. This report refers to one of the patients involved: a patient of unspecified age and gender, who had administered dose of GARDSIL on 09-AUG-2013 (lot # H011350, Expiration Date: 21-FEB-2015). No adverse event was reproted. This is one of the reports from the same source. Additional information is not expected.
Started hearing loud humming/tinny sound in my head (not really in my ears). Would intensify in the morning and late afternoon. It is a persistent high pitched noise.
This spontaneous report was received from a nurse practitioner, via a company representative, referring to a 14 year old female patient. Information about concurrent conditions was not reported. The patient did not have pertinent medical history nor drug reactions/allergies.  On 13-OCT-2015 the patient was vaccinated with the first dose of GARDASIL, (dose, route of administration, lot # and expiration date were not provided). The patient was not taking any concomitant medication. On 13-OCT-2015, 15 min after the vaccination with GARDASIL, the patient experienced dizziness, tonic clonic movements, "fainted" and hit her head. The reporter also stated that the fall resulted in a two inch laceration on the patient's head. The treatment consisted in having the patient under observation and lay the patient in a supine position until the dizziness subsided. Laboratory diagnostics were not performed. The outcome of dizziness was reported as recovered, on 13-OCT-2015. The outcome of tonic clonic movements, syncope, head injury, fall and laceration was unknown. Additional information has been requested.
Muscle fasciculations; Feels tired; Lost 15 pounds; This spontaneous case was reported by a consumer and describes the occurrence of WEIGHT DECREASED (Lost 15 pounds), MUSCLE CONTRACTIONS INVOLUNTARY (Muscle fasciculations) and FATIGUE (Feels tired) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 024H20A) for COVID-19 vaccination. Concomitant products included OMEPRAZOLE and LOSARTAN for an unknown indication.On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Apr-2021, the patient experienced MUSCLE CONTRACTIONS INVOLUNTARY (Muscle fasciculations). In April 2021, the patient experienced WEIGHT DECREASED (Lost 15 pounds) and FATIGUE (Feels tired). At the time of the report, WEIGHT DECREASED (Lost 15 pounds) and FATIGUE (Feels tired) outcome was unknown and MUSCLE CONTRACTIONS INVOLUNTARY (Muscle fasciculations) had not resolved. Patient was taking acupuncture treatment. Reporter mentioned that patient saw that the biceps in both arms were twitching and it progressed to his forearms and wrists then to his torso and thighs and ankles. This was very prevalent especially the one in his extremities. He lost 15 pounds and he feels tried. He consulted his primary care physician and was told that these were muscle fasciculations. patient underwent 5 sessions with an acupuncturist but this did not resolve the condition.
symptoms came back after five days headache muscle aches fatigue hands and feet are cold feel warm but no fever joint pain
No adverse effects reported; received improperly stored VARIVAX; This spontaneous report was received from lead medical assistant refers to a 4 year old patient of unknown gender. The patient's medical history, concurrent conditions, historical drugs and drug reactions/allergies were not reported. Concomitant medication included sterile diluent. On 19-APR-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) lot # R023503 and expiry date 16-AUG-2020 (strength, dose, unit, route, anatomical location were not reported) for prophylaxis (product storage error). The vaccine was reconstituted with properly stored sterile diluent. The administered doses of the vaccines experienced temperature excursion from above 6 degree Fahrenheit (F) to 14 degree F (7.5 degree F) for five minutes. No previous temperature excursion was reported. The call was due to digital data logger. No adverse effects were reported. No product quality complaint (PQC) was involved.  This is one of several reports received from the same reporter.
Was given shot on upper left arm.  Since then, I have had pain in upper arm around bicep/tricep shoulder area.
Urticaria face, trunk and extremities, no wheezing no stridor. Normal blood pressure.
Client immunized w/ Td immunization clinic immediately after injection client had syncopal episode lasting a few seconds client moved to laying position w/feet elevated. O2 mask at 15 per liter. Skin warm to touch ice packs applied to axillary and chest. At which per patient ---->
Information has been received from a 41 year old female registered nurse with asthma and unspecified allergies. In June 2004, the nurse was vaccinated with Pneumococcal 23v polysaccharide vaccine. Concomitant therapy included an unspecified therapy Naacort fexofenadine hydrochloride + pseudoephedrine hydrochloride Allergra D, Fluticasone propionate Flovent, and lansoprazole Prevacid. In June 04, the nurse developed arm swelling when she received the Pneumococcal 23v polysaccharide vaccine. The nurse reported that the entire arm was swollen. The swelling was relieved by ice and diphenhydramine hydrochloride Benadryl. The nurse sought unspecified medical attention. At the time of this report, the patient had recovered from the event date unknown. Additional information has been requested.
The mother brought the male child in to the office for a vaccine without seeing the provider, the medical assistant asked the parent which vaccine is she wanting for the child. The mother replied Dtap, the medical assistant was new to this profession and did not question the age and gave the child this vaccine. The child really should have been given a Tdap, the mother was contacted and now I am reporting this vaccine mishap to you. Wrong vaccine. Patient was not seen by provider before vaccine.
After administration, patient was advised to wait 20-30 minutes for any adverse reactions. Mother and patient failed to wait, then received call at 10:53 AM by mother informing a medical assistant that her daughter was starting swell in bilateral arms and face with tingly/itchy sensation and throbbing sensation in face. Mother also mentioned patient was having unusual behavior. Pt arrived at 10:55 AM. Brought into an exam room with redness in face and hands/arms. Then began to C/O swelling in throat and SOB. Another medical assistant examined patient, physician was brought in for examination with approval to administer EPI 0.3 mg. Patient agreed and administered, during injection dispatch was contact to send EMS for pt to be taken to ER for evaluation. Physician then order Diphenhydramine 50 mg IM, administered in left deltoid. EMS arrived and taken to ER.
On Friday 10/21 around 6pm I had really mild chills and body aches. The following day 10/22 the mild chills and body aches were still there but I had a headache. It was similar to the same headache that I had while I had COVID-19 and the other booster. I took Ibuprofen for it. It helped a little bit, but I could tell then it wore off. The chills and body aches were still there but they came and went. That evening I had a tickle in my throat. Sunday morning, I could tell that the headache was reducing. I had a very intense sore throat. It hurt to swallow saliva. I did more ibuprofen and an oral spray. I continued that every 3-4 hours every day. The sore throat was the main symptom all day on Sunday. That night I had this single cough, I felt that postnasal drip. At 11pm I took a home COVID-19 test, and it came back negative. On Monday that sore throat was present but improving. That afternoon the sore throat was the same, but I started feeling tired and achy. The runny nose started. I took more Ibuprofen at night right before bed to help me sleep through the night. I did another home COVID-19 test because the symptoms were picking up and it was negative. That night is when the cough started, and it was waking me up. I took Tessalon Perles to stop it so I could sleep. That Tuesday the headache and sore throat resolved. The runny nose and cough were still persistent. The cough was productive. I had a lot of heaviness in my chest, and I felt it staring to thicken up in my sinuses. I took another Tessalon Perles for the cough. I took an Advil cold and sinus, but I was taking Mucinex. I think it was what was keeping the fever at bay. It also explains why the congestion was getting worse. Tuesday afternoon, the Advil wore off and my symptoms hit me like a ton of bricks. I was very lethargic, achy, congestion, dull headache, coughing. I was also having chest soreness from coughing.  I thought I had the flu because the test was coming back negative. I slept that night, but it was horrible, I had a lot of sweats and chills. I had to change twice through the night. My temperature got up to 102 degrees on Tuesday night. I was very lethargic after sleeping for 12 hours Tuesday night. My temperature was reading low 99 degrees. I took Mucinex and Zinc on Wednesday. the symptoms on Wednesday remained the same, after I took a nap, it felt like my fever broke. However, I still had a lot of nasal congestion. I had a doctors appt that day. My blood pressure was slightly high. My pulse ox was 95. It's usually hard to get a pulse ox because of my Raynaud's. They took my history did a rapid and OCR COVID-19 that were positive. They did flu and strep that are still pending. They prescribed Flonase, Tessalon Perles, Mucinex D. I'm still waiting on one prescription. I took more Mucinex DM , ibuprofen, and Tessalon Perles. the cough has continued but is not as bad now. My symptoms today are a little more mild and less severe than Tuesday. The cough is still there just less frequent. I can't hear every well because there is a lot of fluid ins my ears.
Debilitating  headache, rise in body temperature, trouble sleeping, sever fatigue, red rash at injection site.
- VACCINATED 11/4/19, PAIN ARRIVED AND CONSISTENT THE NEXT DAY. MORE PAIN CONTINUED 14 DAYS LATER, SAW MD. CURRENTLY IN PT. STATE SHOT WAS PREVIOUSLY IN DELTOID, CONCERN WITH ROTATOR CUFF + BICEP - IN PHYSICAL THERAPY.
Weakness  and lightheadedness about 15 minutes after vaccination. Pt had some slight difficulty breathing but self resolved. EMS on site provided first aid at paramedic level. Pt was observed for 30 minutes before symptoms resolved. Pt advised seeking further treatment but felt okay to complete refusal of transport. Medical Control familiar with vaccination clinic called and advised on situation and agreed on treatment plan.
Observed patient, lying face down on the floor, skin cool and clammy and slight jerking movements in upper extremities.  Patient able to respond to verbal commands such as gripping nurse's hand and movement of legs without difficulty.  Assisted to medical examination table.  Blood pressure 80/60 pulse 78 respirations 24 even and unlabored.  Patient responding verbally oriented to the correct time, place and person.  No noticeable bruises.  10:15 emergency team arrived B/P 110/60.  Patient refused to go to emergency room.  Released in the care of family members.
After the second shot, I have zerodesire for coffee.; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0187) via an unspecified route of administration in the right arm on 26May2021 at 09:00 (at the age of 46-year-old) as a single dose for COVID-19 immunisation. Medical history included asthma, and some mild food allergies. Concomitant medications were not reported. Patient previously received first dose BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, lot number: EW0173) in the left arm on 05May2021 at 09:00 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28May2021, after the second shot of vaccination, patient experienced zero desire for coffee, clear head after the patient has a cup of coffee every morning. The patient felt like he was addicted to coffee (guess caffeine). The patient cannot remember, the last time he did not have coffee for the day. It has probably been 5+ years since have the patient not had coffee. Patient tried drinking a cup after one week, and it is not the same. Doesn't the coffee/caffeine create some reward pathway (addiction?) or what-not in the brain? How is it that the vaccine broke this response? The vaccine changed something (in brain)! It is very strange to have ZERO urge for coffee after needing it for so long. No therapeutic measures were taken as a result of reported events. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event zero desire for coffee was unknown at the time of this report.   No follow-up attempts are needed. No further information is expected.
Moments after receiving the vaccination, the patient temporarily lost consciousness. I was able to keep the patient from any harm and with the mom, monitored the patient for many minutes as the patient returned to normalcy. patient was given granola and water and monitored for a half hour.
Elevated blood pressure, which is coming down but 10 days later is still not normal;  Sore arm (lasted 2 days- ice pack helped).
Reaction began with large red bump, size of mothers fist, per mother. Area was hard and red with red lines up shoulder. Child complained of pain and would not move arm. Arm affected was the right arm. Parent called doctor, childs pediatrician for directions. Prescribed prednisone, Benadryl and ibuprofen. Information obtained over phone. Did not visualize reaction. Information from mother.
Heplisav-B Has Been Out of Temperature Range; Initial Report Received on 11-May-2022  An office front desk clerk reported that 5-10 patients (age, gender, race or ethnicity of patients were unknown) received HEPLISAV-B (hepatitis B vaccine) that was out of temperature range.  On an unspecified date, patient 3 received a dose of HEPLISAV-B. Details of administration was not provided.   On 11-May-2022, an office front desk clerk reported that the HEPLISAV-B vaccine (Lot # 935845 and NDC # 4352-8003-05) has been out of temperature range since Dec-2021, with an average temperature of 11-12°C. This "affected 5-10 patients", but they had no information on them at time of report.   No further information was provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient through other manufacturer (Pfizer) concerned a 27 year old, female The patient's height, and weight were not reported. The patient's concurrent conditions included: drug allergy with codiene and propofol, and the patient was not pregnant at the time of reporting and the patient stated she was taking other medication or products within 2 weeks of starting covid-19 treatment (Paxlovid). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of administration, batch number were not reported, expiry: unknown) dose, start therapy date were not reported, 1 total administered to right arm for prophylactic vaccination. The batch number was not reported and has been requested.  The patient additionally received non-company suspect vaccine Moderna Covid-19 vaccine (elasomeran) (dose number in series 2) (form of administration, route of administration, batch number were not reported, expiry: unknown) dose, start therapy date were not reported, 1 total, administered to right arm for prophylactic vaccination. Concomitant medications included amoxicillin trihydrate/clavulanate potassium, carbidopa monohydrate/levodopa, levomefolic acid, and sapropterin dihydrochloride. On 13-JUN-2022, the patient was treated with non-company suspect drug Paxlovid (route of administration not reported, batch number: FY0319 and expiry were not reported) dose and frequency were not reported for covid-19 treatment and last administered on 17-JUN-2022. On JUN-2022, after non company suspect drug paxlovid treatment (for covid-19) laboratory data included: COVID-19 virus test Negative.  On 21-JUN-2022, three days after non company suspect drug paxlovid treatment symptoms returned despite of isolation, the patient had suspected covid-19 infection (dose number in series 2) and suspected clinical vaccination failure (dose number in series 1). On same day laboratory data included: COVID-19 virus test Positive (strong). The action taken with covid-19 vaccine ad26.cov2.s, and elasomeran was not applicable. The patient was recovering from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint, and reference number requested.; Sender's Comments: V0: 20220706776-covid-19 vaccine ad26.cov2.s-suspected clinical vaccination failure. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Has not received the 2nd vaccine; PAIN IN ARM; it was red and looked infected; she had a blister the size of her hand; looked infected; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BLISTER (she had a blister the size of her hand), INFECTION (looked infected), PRODUCT DOSE OMISSION ISSUE (Has not received the 2nd vaccine), INJECTION SITE PAIN (PAIN IN ARM) and INJECTION SITE ERYTHEMA (it was red and looked infected) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L2004) for COVID-19 vaccination.     Concurrent medical conditions included Multiple allergies (Multiple food allergies to shrimp, pineapple, mango, and papaya).    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jan-2021, the patient experienced BLISTER (she had a blister the size of her hand), INFECTION (looked infected), INJECTION SITE PAIN (PAIN IN ARM) and INJECTION SITE ERYTHEMA (it was red and looked infected). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Has not received the 2nd vaccine). At the time of the report, BLISTER (she had a blister the size of her hand), INFECTION (looked infected), PRODUCT DOSE OMISSION ISSUE (Has not received the 2nd vaccine), INJECTION SITE PAIN (PAIN IN ARM) and INJECTION SITE ERYTHEMA (it was red and looked infected) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment reported as blister was drained in the Emergency Room. No concomitant medications reported.
Patient described excessive pain at injection sites and in the left arm in general (that is, the whole arm).
itchy throat, mouth, and around skin mouth, mild rash around mouth, inflammation of throat, sent to the ER, tachycardia, O2 95% on room air at first reading in ER waiting area. Was given IV push of Pepcid, Benadryl, solo-medrol, and atarax.  Monitored in ER for a few hours.
p/an inject pt devel a tender bump @ the inject site; aspiration of the lesion revealed pus which was culture pos; the lesion was incised & drained;
Dizziness, tongue felt numb. BP 154/77 (pulse 85), O2 sat 99%. Benadryl 25 mg and Epipen given.
All day 4/2 had shortness of breath and pharyngitis.  Around 5PM became dizzy, had short blackout, followed by confusion/stumbling/inability to speak.  In the E.R. was checked for stroke - diagnosed T.I.A.   Heart was found to be in A-Fib.  Next day heart had converted to A-Flutter and I was discharged with script for Eliquis.  Returned to hospital 6/23 for cardiac ablation and by 7/1 had returned to normal sinus rhythm  (Even with all this -- took second vaccination on 4/29.)  History: I had a syncopy episode in 2014 and as a result was given numerous cardiac stress tests and heart was found to be "Strong and trouble free."
Severe swelling and redness around injection site, fever, skin very hot to touch around injection site, crying when touched, also green stools for 3 days following vaccination.
Weight gain; This spontaneous case was reported by a physician and describes the occurrence of SARS-COV-2 ANTIBODY TEST NEGATIVE (Covid-19 antibody test negative) and WEIGHT INCREASED (Weight gain) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Alcohol use. Concurrent medical conditions included CLL, Drug allergy, Blood pressure high and Weight gain. Concomitant products included OLMESARTAN for Blood pressure high, IBRUTINIB (IMBRUVICA) from 20-Jan-2019 to 08-Mar-2021 and VENETOCLAX from an unknown date to 08-Mar-2021 for CLL.   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. On 24-Apr-2021, the patient experienced SARS-COV-2 ANTIBODY TEST NEGATIVE (Covid-19 antibody test negative). On an unknown date, the patient experienced WEIGHT INCREASED (Weight gain). At the time of the report, SARS-COV-2 ANTIBODY TEST NEGATIVE (Covid-19 antibody test negative) and WEIGHT INCREASED (Weight gain) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Apr-2021, SARS-CoV-2 antibody test: Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Reporter did not allow further contact
Patient experience heart palpitations and was experiencing anxiety before and during vaccination. After sitting for 30 minutes after getting the vaccine patient felt more calm.
2 days after Vaccine c/o Stomach Pains, chills and vomiting X 1 day, reported to us on 4/30/2007
Headache lasting 8 days, ongoing. Experienced a metallic taste for 6 days.