chrisvoncsefalvay/vaers-outcomes huggingface dataset:
8:30 pm started with HA, then body aches and muscle aches, by 11:30 I had a temperature of 104.6 this lasted until Sunday morning, temp went down to 102.  I was alternating ibuprofen and Tylenol every four hours.  My skin hurt to the touch along with the cold sweats.  By Sunday my arm started to welt up. It started by my shoulder and went to the middle of my arm.  I called doctor. and they wanted me to start taking Benadryl. 2 pills twice that day.  She said I should a difference in the swelling.  After the second dose, my welt started to spread, down past my elbow and around my inner arm very hot to the touch and red red red in color. HA was getting worse and body and muscle aches continued.  Talked to my doctor and facility doctor again and was put on 2 asteroids and an antibiotic. They they think that I have some kind of infection in my arm.  Cellulitis  - my fever went to 99.9 by Monday, very fatigued
This spontaneous report was received from a physician, via company representatives and from a support services director, concerning to a patient of unknown age and gender. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On 04-JUN-2014 the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23 0.5 ml (lot number and expiration date: K004016 and 08-MAR-2015 respectively; strength, and route of administration were not provided). Nonetheless, no adverse effects were reported. On an unspecified dates, PNEUMOVAX 23 vaccine had two temperature excursions; one of 16 hours with a lowest recorded temperature of 34 F (1.111111111 Celsius) and other one of 536 hours with a lowest recorded temperature of 33 F (0.555555556). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". This is one  of the several reports received from the same reporter. Additional information has been requested.
I am sending this because I suspect the administration of my vaccine was improper.  Here is how it played out. The area on my arm was cleaned, I felt a prick, I looked at my arm and the administrator had grabbed a cotton ball to catch blood and a clear liquid. She put a bandage on my arm and that was it.  Very quick, no pressure.  Now I?m not sure I received a full dose and am wondering if I should get the second shot??  I had no adverse effects afterwards.
Patient woke up with red spots/sores on tongue (likened to "burnt spots when you drink something too hot"), and they continue to persist.  Patient has had trouble eating or drinking, as that increases the burning/tingling feeling.
No patients experienced any adverse effects; Improperly stored dose of ROTATEQ; This spontaneous report was received from a physician concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concomitant medications, or drug reactions/allergies.     On 04-MAY-2020, the patient was vaccinated with an improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) vial (product storage error), by oral route (lot # 1660693, has been verified to be a valid lot number; expiration date 19-MAR-2021) as prophylaxis (dosage schedule and strength were not reported).   The administered dose of the vaccine experienced a multiple temperature excursions below highest temperature above 47 Fahrenheit degrees  to 66.6 Fahrenheit degrees for 2 hours and lowest temperature below 36 Fahrenheit degrees to 33.6 Fahrenheit degrees  for 45 minutes as recorded by a data logger. There was no previous temperature excursion. There was no adverse effect reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2006USA001703:
Information has been received on 13-AUG-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. A physician recommended and/or administered the ZOSTAVAX to the patient for the long-term prevention of shingles and zoster-related injuries. On or about 18-JUL-2016, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a pharmacy for routine adult health maintenance and the intended purpose of the long-term prevention of shingles and zoster-related injuries. The vaccine did not prevent shingles or zoster-related injuries as intended. On or about 04-OCT-2016, the patient was treated by a physician for multiple crusted lesions and was diagnosed with herpes zoster. The patient was prescribed valacyclovir hydrochloride (VALTREX) and lidocaine (LIDODERM) for management of her painful symptoms and chronic pain. As a direct and proximate result of the ZOSTAVAX, and/or despite receiving the ZOSTAVAX for the long-term prevention of shingles and zoster-related injuries, the patient suffered and continues to suffer painful and ongoing injuries and damages and required and continues to require extensive medical care and treatment. As a further proximate result of ZOSTAVAX the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. Additional information has been requested.
Pt.'s Mother states that after receiving the 1st dose of Phizer 12/10/2021, started experiencing symptoms 12/14/2021 of developing a rash on both legs and behind the arms. Hive-like rash appearance with itchiness and "stinging" pain. Primary visit scheduled for 12/20/2021.
Temp of 100.3 for about 12 hours, sleeping all day , couldn't seem to stay awake.  Temp of 97.7 on 01/15/2021 and feeling fine.
Dizziness, Headache, Angina, SOB, VERTIGO Narrative:
Patient stated that both hands and feet went completely numb.  He has complete mobility and strength in all four extremities.  Around 2-9-10 he consulted a Dr. who did an MRI.  The MRI showed no problems with discs or spine.  He was referred to a Neurologist.  He saw this Dr. on approx. 3-10-10.  Several tests were conducted and this Dr. diagnosed pt. with Neuropathy caused by the H1N1 vaccination.  Patient is currently being treated with Lyrica.  He has a follow-up appt. with the Neurologist in April.
Immediately, I was sore at the injection spot and pain increased to the point where I could no longer use or even move my arm. Less than six hours in, headache set in, along with vomiting.  Around 10 hours after injection, fever, chills, cold sweats and severe body aches began and lasted approximately 36 hours. Fatigue set in sometime during day two and continues to linger six days later.
patient received a dose that was expired; not kept at an adequate temperature; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received a dose that was expired) and PRODUCT TEMPERATURE EXCURSION ISSUE (not kept at an adequate temperature) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received a dose that was expired) and PRODUCT TEMPERATURE EXCURSION ISSUE (not kept at an adequate temperature). On 29-Apr-2021, EXPIRED PRODUCT ADMINISTERED (patient received a dose that was expired) and PRODUCT TEMPERATURE EXCURSION ISSUE (not kept at an adequate temperature) had resolved.        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 medications were reported.  No treatment information was provided.
Complained that left arm painful with small red papules at side and both legs hurt.  Also complained of cough, sore throat, headached and fatigue.  Had fever of 103.
Loss of Weight, Anxiety, Memory Impairment (brain fog) incontinence, and irregular menstrual cycles.  The symptoms resulted in her being unable to perform daily living skills such as dressing and undressing, toileting, and sleeping through the night.  She was suspended from her pre-vocational work sites which she had attended since 2016.
She received PNEUMOV AX 23 in 2004 when she was diagnosed with asthma then Prevnar 13 in 2015 and PNEUMOV AX 23 again in 2017.; This spontaneous report was received from a vaccine account representative and  refers to a 52-years-old female patient. The patient's concurrent conditions included asthma. The patient's  medical history, concomitant therapies, drugs reactions or allergies were not provided.  On unspecified date in 2004,  the patient, who was a pharmacist, was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX 23)(dose, route of administration, lot # and expiration date were not provided) for prophylaxis. On unspecified date in 2015, the patient was vaccinated with pneumococcal 4 6b 9v 14 18c 19f 23f conj vaccine (crm197)(PREVNAR 13)(dose, route of administration, lot # and expiration date were not provided) for prophylaxis and again, on unspecified date in 2017, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX 23 )(dose, route of administration, lot # and expiration date were not provided).
Patient reports she got shingles from the vaccination  (L) upper thigh near groin area. She saw her MD who confirmed it and treated her. Hives extended to (L) knee. VALTREX then Gabapentin 100 mg 3@ hs and in AM LIDODERM patches 50mg adhesive, uses 2 patches Hydro/AP5 50mg pm
Moderna COVID-19 Vaccine Vaccine Lot Number: 033F21A FluLaval Quadrivalent Vaccine Lot Number: 579C9 client got flu shot and felt faint. had covid vaccine in medical tent on cot. has had syncopal episodes post vaccine and blood draw in past. stayed in medical tent for 40mins. drank 2 bottles of water. RN Felt faint after getting flu vaccine, but then given COVID vaccine (in tent). No hx of HTN, HT DZ or allergies or diabetes. given additional 2 (6 oz bottles of h20) and crackers. lungs were CTA no swelling, hives or n/v or abd pain. Anxiety, hot and sweaty, felt faint but did not faint. no problem breathing, swelling or hives or abdominal or chest pain. Pt wanted to drive self and wanted to return to work despite asking him to have wife drive him and take pm off from work.  12:10 110/79 p76 r16 97% sitting 12:20 112/74 p60 r16 96% lying 12:30 110/54 p55 r16 95% lying 12:30 111/73 p64 r16 97% standing 12:35 110/74 p66 r16 98% standing
bruising at injection site; faced turned red; face flushed; bled; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE HAEMORRHAGE (bled), VACCINATION SITE BRUISING (bruising at injection site), ERYTHEMA (faced turned red) and FLUSHING (face flushed) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017b21a) for COVID-19 vaccination.     Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.   On 08-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, the patient experienced VACCINATION SITE HAEMORRHAGE (bled), ERYTHEMA (faced turned red) and FLUSHING (face flushed). On 08-Apr-2021, the patient experienced VACCINATION SITE BRUISING (bruising at injection site). On 06-Apr-2021, ERYTHEMA (faced turned red) and FLUSHING (face flushed) had resolved. On 08-Apr-2021, VACCINATION SITE HAEMORRHAGE (bled) had resolved. At the time of the report, VACCINATION SITE BRUISING (bruising at injection site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 in response to the events was not Applicable. treatment information not provided   Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Follow up received on 10-MAY-2021, contains non significant information such as, added contact details.
Initial report received on 30 July 2012 from the Investigator participating in the post-marketing study under the reference number M5A16. A case of pertussis disease in a three-year-old female subject was identified by the investigator based on review of data from the Electronic Disease Surveillance (EDS) electronic database. The subject had received 3 doses of PENTACEL; lot number C3242AA received on 20 January 2009, lot number C3276AA received on 23 March 2009, lot number C3276AA received on 22 May 2009 and one dose of DAPTACEL, lot number C3380AA received on 08 June 2010 (routes and sites of administration not reported). The subject developed cold-like symptoms with cough on 18 June 2012, approximately 24 months after the last dose. On 25 June 2012, the subject developed a paroxysmal cough without a whoop. The subject also experienced sleep disturbance. Chest x-ray findings were negative for pneumonia. Corrective treatments consisted of Azithromycin starting on 19 July 2012 for five days. The subject was not hospitalized. At the time of final contact on 19 July 2012, the subject's cough was still persisting. The duration of the cough was reported at that time as 31 days. According to the investigator, this case was epidemiologically linked to a laboratory confirmed case and was outbreak related. Investigator causality assessment is not required as per protocol. Documents held by sender: None.
Site: Bruising at Injection Site-Mild, Site: Itching at Injection Site-Mild, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Additional Details: extremity itching and injection site pain
Patient received first Moderna mRNA vaccine 2/20/2021, second Moderna vaccine 3/20/21.  Severe flulike symptoms after Moderna vaccine intermittently over 1 day.  3/23/2021 chest pain hospitalized severe pericarditis 750 mL.  Also cardiac Cath Lab one of his blood vessels 80% occluded (I do not currently have hospital report) coronary artery stented.  Failed Plavix of in-stent thrombosis and myocardial infarction recatheterization fixed thrombotic stent.  Following couple weeks has had recurrent pericarditis requiring several hospitalization recurrent chest pain including recently requiring pericardial window.
No additional AE reported; assistant accidently pushed the plunger and reports that a few drops of VARIVAX sprayed into her eye; assistant accidently pushed the plunger and reports that a few drops of VARIVAX sprayed into her eye; a medical assistant was preparing a dose of VARIVAX to administer when the needle came off the syringe; This spontaneous report was received from a nurse referring to a female patient (medical assistant) of unknown age. The patient's concurrent conditions, medical history, concomitant medications, and drug reactions/allergies were not reported.     On 06-APR-2022, the patient was preparing a dose of varicella virus vaccine live (oka/merck) (VARIVAX) to administer when the needle came off the syringe. The reporter stated that when the needle came off the syringe, the patient accidently pushed the plunger and a few drops of varicella virus vaccine live (oka/merck) (VARIVAX) sprayed into her eye. No adverse events were reported.
Infant developed seizures (facial grimacing) and arm movements within a week of administration of DTaP.
1. "Blood blisters in mouth".  They disappear in a few days but re-appear periodically. 2.  "Memory issues".  Started 3-4 months after shot.  Got better and haven't reoccurred. 3. Extreme fatigue. Started 3-4 months after shot and still present. 4.  Joints in hands hurt.  Started 6 months after shot and still present. 5.  Enlarged lymph nodes in neck.  Reoccur periodically. 6. Sinus blockage &/or drainage and sore throat.  Occurs periodically. 7. Canker sores in mouth and throat. Had oral herpes as a child. 8. Ringing in ears.  Present now.
Unmixed/undiluted pediatric Pfizer vaccine (0.2mL) administered to the patient. No adverse event reported yet.
11/22/12 itch on back, "hard around arm with Y.F. vax. No rash, erythema or induration. 1/7/13 hyperalgesic at injection site, abdomen, back, thigh "feels like sunburn". Crawly sensation. No motor symptoms. Improved on Gabapentin - is now weaning off Gabapentin.
This spontaneous report as received from a pharmacist refers to a 50 year old female patient with drug allergy to BIAXIN, Doxycycline and CECLOR. On 19-APR-2016, the patient was vaccinated with ZOSTAVAX with lot # L034726 and expiration date 09-DEC-2016 (unspecified dose and route), in the left deltoid. There were no concomitant medications. The pharmacist reported that since 25-APR-2016, the patient had had a swollen gland in her left axillary area, as well as another swollen gland on the left side of her neck (Lymphadenopathy). There were no laboratory diagnostic studies performed and no treatment was given for the adverse event. At the reporting time, the patient was not recovered from Lymphadenopathy. The causality assessment was not provided. Additional information has been requested.
PATIENT RECEIVED PFIZER FOR 2ND DOSE BUT MODERNA FOR 1ST DOSE.  MODERNA INFO LOT:002C21A
[Pfizer COVID-19 Vaccine] use for Emergency use Authorization (EUA): acute ischemic stroke 12/7/2021 after covid booster shot (pfizer) 10/6/2021
In one week -out of the blue, I started with tinitus, neuropathy, and anxiety.  I was perfectly healthy prior.  I ended up being admitted into the ER because the neuropthy worsened and my leg went numb so I thought I was having a stroke.  I have had scans and MRI's of my back and  brain and all have shown nothing. Two weeks later, I was at a hospital and fainted. This has been a nightmare.
Caused severe dementia symptoms for an active elderly female. Female was able to live independently and take care of every day activities, such as bills, cooking, cleaning, driving, grocery shopping, e.t.c.  After vaccination, elderly female had symptoms of rapid dementia. Female needed constant supervision daily and was no longer independent. After 6 weeks, elderly female is able to continue every day activities with minimal supervision.
This spontaneous report as received from a medical assistant, referring to an unspecified number of patients of unknown genders and ages. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On an unknown date, the patients were vaccinated with improperly stored dose of VARIVAX with Lot # reported as M039318 with an expiration date of 20-SEP-2018, lot # M034586 with an expiration date of 27-JUL-2018 and lot # 7/27/18 with an expiration date of 7-SEP-2018 (strength, dose and route of administration were not reported) for prophylaxis, however no adverse effects were reported. It was reported that the vaccines were exposed to temperature of - 14 centigrade degrees (°C) to - 10 °C for a time frame of 1 hour and 4 minutes. The temperature excursion was recorded by a data logger and no previous excursions were reported for the vaccines. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1704USA008784:
started with diarrhea 6/30, some vomiting 7/1, diarrhea off and on, called 7/5 with still some diarrhea
This spontaneous report as received from a physician refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On 18-NOV-2015, the patient was vaccinated with a dose of improperly stored PROQUAD lot # L011080, expiry date 01-OCT-2016, (dose, strength, route of administration were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report was received from a nurse and refers to a 7-month-old patient. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On 03-MAY-2018, the patient was vaccinated with a dose of M-M-R II injection, lot # M045400 with expiration date on 14-NOV-2018 (dose and route of administration were not reported) and, on the same day, with a dose of VARIVAX injection, lot # reported as N008826 with expiration date on 16-MAR-2019 (dose and route of administration were not reported). No adverse effects were reported.
Seizures lasting for 10 days. The first 3 days experienced 1 per day. The next 4 days experienced multiple. Ended up at hospital. Treated there in neurology. The next three days experienced one per day. Then they stopped. And I felt completely back to normal. Resumed normal exercise and daily activities.
Got PREVENAR 13 shot on 23Oct2017. 24Oct2017 thru 27Oct2017 very ill-mild fever, chills, no appetite, extreme exhaustion, cold sores in nose and on lip and face, severe headache, nausea, site of injection red, swollen, painful entire arm. Lot S35324. Was not able to get out of bed for 3 days. Lost work days.
I received the first dose of the Modera covid vaccine on 12/24/2020. Initially I had tenderness at the injection site. On 1/3/2021 it was discovered that had "massive lymph node enlargement" in my right axillary and breast region. At 32 years old, everyone took this very seriously and I started a FULL work up after being told "this is acting like either breast cancer or lymphoma".
This spontaneous report was received from a healthcare worker (also reported as nurse) refers to a patient of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On 08-DEC-2014, the patient was vaccinated with a dose of oral, ROTATEQ, (strength, dose, route and anatomical location were not reported), (lot # J011336, expiration date: 14-MAY-2015), which was incorrect stored since 02-DEC-2014. No adverse effects were reported and no product quality complaint (PQC) was filled. This is one of several reports received from the same reporter. Additional information has been requested.
Received shot Tuesday July 6. On Thursday July 8 at 11pm I woke up with a terrible case of itching .  I got up looked in the mirror and found five to six red bumps (size from a head of an eraser to a quarter (coin) in the area of my waist to 4 inches above my knee.  I put on Cortisone cream 1% and the itching stopped.  Went back to bed and a hour later was woke up with more bumps itching put on cream this went on the rest of the night.  Got up around 3am Friday and they were all gone.  I had no problems until 4pm Friday and the bumps came back.  Friday night was like Thursday night.  Saturday got up all gone,  I went to Urgent Care and saw a Dr.  who told me I was one out of a hand full to react this way to the shot.  He told me to continue with the cream and take 12.5 mg of Benadryl.  Saturday at 4pm a few bumps appeared so I put the cream on them and took the  Benadryl.  I was not woken up by the bumps all Saturday night.  Got up Sunday all gone.  Sunday, Monday and Tuesday evening I took the Benadryl with no bumps. Last night Wednesday July 14 I did not take the Benadryl and had no problems.   Tuesday I did see my Primary Care Doctor about whether I should receive the second shot.  I said this is all to new to give me an answer told me to contact CDC for an answer.   Should I receive the Second Shot as scheduled on August 3
Chills, fatigue, aches, red large and hard spot around injection area.  Unresolved as of report.
Skin eruptions all over my body.  They are itchy and irritating.  They are little red spots, some of them puss filled.  I took prednisone pills with no result so was give cortisone shot.  Still no relief.   This has been going on since a week following the second vaccine shot.   There have been no changes that I can recall in foods I eat or cleaning products I use or other things that might affect the skin.  The only new thing seems to be the vaccine.