chrisvoncsefalvay/vaers-outcomes huggingface dataset:
full auto immune disease; Lyme's disease; lot of aches and pains; Initial information received on 24-Oct-2019 regarding an unsolicited valid serious case received from a consumer/non-hcp.  This case involves a 63 years old female patient (going to be 65 in January and reaction was to last year flu vaccine) who experienced full auto immune disease (autoimmune disorder) and lyme's disease (lyme's disease), while she received vaccines VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX) and INFLUENZA VACCINE (INFLUENZA VACCINE).  The patient medical history, concomitant therapy, medical treatment(s), and family history were not provided.  Patient has had autoimmune reaction to influenza vaccine administered prior to last year as well.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route. On an unknown date, the patient received a dose  dose of suspect SHINGRIX not produced by Sanofi Pasteur lot number not reported via unknown route.  On an unknown date, The patient developed a serious full auto immune disease (autoimmune disorder) and lyme's disease (lyme disease) with lot of aches and pains (pain) Unknown latency following the administration of INFLUENZA VACCINE and SHINGRIX. These events were assessed as medically significant.  No lab test reported.  Final diagnosis was lyme's disease and full auto immune disease.   It was not reported if the patient received a corrective treatment.  The patient outcome is reported as Unknown for the events.  Information on the batch number was requested.; Sender's Comments: Patient experienced unspecified autoimmune disorder and Lyme's disease after vaccination. Time to onset is compatible with the role of the vaccine. However, further information including patient's concomitant medications, laboratory investigations excluding other etiology would be needed to fully assess this case. Lyme's disease is an infectious disease and cannot be causally associated with the vaccine; it can be a confounding factor for the occurrence of autoimmune disorder as well. Based on available information the role of vaccine cannot be assessed.
Muscle pain in both arms/shoulders, headache for 3 days, fatigue, stomach aches for 3 days (since 4/21/21)
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 59-year-old female patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunization; paracetamol (TYLENOL), (Batch/Lot number: unknown) for headache. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer"), for COVID-19 immunization. The following information was reported: VOMITING (non-serious), outcome "unknown", described as "I couldn't keep nothing down"; PYREXIA (non-serious), outcome "unknown", described as "Just a little fever". The action taken for paracetamol was unknown. Additional information: The patient stated, that she had the vaccine, the booster on Thursday and now  got up this morning and  had a headache and then she had something to eat, now she take some Tylenol then after that she couldn't keep nothing down and tonight trying to pushup or trying to take some 'crackers' and I want to take some Tylenol for regular headache and she think 'cracker' they made it came back right up. She just a headache and right now, just a little fever with the headache and that's it. She wanted to have a talk to nurses around as she I haven't talked to anybody. She want to know to find out what to do or what. Other medical conditions: The patient stated that she don't have diabetes. Concomitant medications: The patient stated she was trying to take Tylenol. So, she was going to get some food down. Treatment for Adverse events included ice on her head because she do know it get some greater. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Pt received 1st ANTHRAX, TYPHOID VICPs, and TWINRIX at 1350 pm. Immediately following, pt started feeling woozy, sweaty, nauseous, started seeing black and felt shaky. Pt sat and then assisted helping patient lay supine with knees bent. After a few minutes, patient felt better. Pt did state he hadn't eaten all day. Gave him a honey bun and water as well.
On 3/25/10 patient was given ZOSTAVAX instead of VARIVAX. This was discovered on 3/26/10 when a physical count of vaccine indicated we were minus one ZOSTAVAX and plus one VARIVAX. There was no adverse event associated with MENACTRA.
Had vaccine in left arm on Wednesday January 6,2021. On Thursday January 14, 2021 I noticed my armpit is swollen like maybe a gland is swollen in the same arm as vaccination was given which would be the left arm
Discharge Provider: MD Primary Care Provider at Discharge: MD  Admission Date: 8/2/2022 Discharge Date:  08/08/2022  PRESENTING PROBLEM: COVID-19 [U07.1]   HOSPITAL COURSE: 96-year-old female admitted to Hospital with weakness and fever.  In the emergency room she was found to be COVID positive.  Additionally she was hypoxemic and was given remdesivir as well as started on oral dexamethasone.  Her blood and urine cultures also ultimately grew E coli.  She was started on IV Rocephin and given positive blood cultures repeat cultures were done which were no growth at discharge.  She was transition from oral Rocephin to orally Cipro prior to discharge to complete 14 days of antibiotic for her bacteremia.  She otherwise noted to have significant weakness and was seen by PT and OT on a regular basis with steady improvement.  Given her general weakness does felt having her move to assisted living would be beneficial and arrangements were made for her to transition to assisted living.  She has a history of fairly frequent bladder infections and was started on vitamin-C 500 mg twice daily in an attempt to reduce the frequency of her bladder infections.  At discharge she had 3 days left of oral dexamethasone to complete and was given prescription for this.  She otherwise seem to do remarkably well despite her COVID and sepsis diagnosis.   Given that she is moving to the Atrium her family requested that she be followed there by Health Geriatrics and home health.  Arrangements were made for home health PT OT to follow the patient post discharge.
2 days after receiving vaccines, patient developed underarm swelling on the left side.  She self administered acetaminophen and applied a cold compress for the swelling and discomfort.  She spoke to her physician and will discuss at her next appointment, which happens to be tomorrow. However, as of the time of this report, she has not been evaluated by her physician.  She stated that, today, she sees improvement.
pt recv vax 16OCT97 & 2AM 17OCT97 began w/diarrhea & vomiting;severe diarrhea lasted until 7AM;for the next 6 days did not feel good;sl h/a excessively tired, listless, ached, stomachache;then all sx abated;itching around inj site;
feeling a little tired; This is a spontaneous report from a contactable consumer. This 74-year-old (at the time of vaccination) male consumer reported that he received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19, solution for injection) via an unspecified route of administration on 23Feb2021 at single dose for covid-19 immunisation. Patient's medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 for covid-19 immunisation. Patient received second dose of COVID-19 vaccine on 23Feb2021 and reports feeling a little tired on an unknown date in Feb2021. Event took place after use of product. The outcome of event was unknown.  No follow-up attempts are possible; information about batch/ lot number cannot be obtained.
I felt dizzy immediately and unbalanced. I was walking into walls when I got home. I had a fever of 106 degrees for days on end. It felt like I had covid all over again. I was laid up on the couch for six days after being given the vaccine. It was horrible.
Hospitalized (still admitted at this time);  COVID-19 positive (9.2.21);  fully vaccinated  Admitted 9.2.21 - still hospitalized.  SUBJECTIVE: This is a 57 y.o. patient with a past medical history significant for recent DVT/PE, asthma, and recent Bartholin gland cyst who presented to ED for admission as directed by healthcare provider 2/2 leukocytosis concerning for new ALL.  She admits that she spoke with the doctor today regarding her illness, and she is "ready to do this."  She admits that her leg swelling and pain have improved greatly since starting her Eliquis.  She denies dyspnea although she does report that she has fatigue, particularly with exertion.  Pt admits that she has been having neck pain with severe headaches lately.  These headaches begin at the base of her skull and radiate "up over the top of my head."  Caffeine has been helpful for these headaches.  Additionally, pt states that she had an episode of diarrhea today.  She admits to being regular at home but her schedule is disrupted on weekends when family is around and she experiences, "Monday cleanouts." Oncology History: Patient in Hospital for DVT/PE when she was found to have WBC 76, 87% blasts.  Peripheral smear 8/31 consistent with acute leukemia and flow cytometry 9/1 positive for B-ALL.  Patient directly admitted to BW ED 9/3 for new B-ALL.  ASSESSMENT / PLAN:   New B-ALL - WBC 76 at on 8/31, 87% blasts - Peripheral smear 8/31 consistent with acute leukemia - Flow cytometry 9/1 positive for B-ALL - Repeat peripheral smear and flow cytometry pending - BMBx pending - EKG 9/1 NSR - CXR pending - Panorex pending - LDH 502, uric acid pending - ECHO 9/1 with LVEF 61%, mild mitral regurgitation, ascending aorta dilated at 4.5 cm - Fibrinogen elevated, D-dimer pending - HIV, hepatitis panel pending - Hydrea 1 gm TID started - Allopurinol 300 mg daily  Recent DVT/PE, dx 8/29/21 - Hx PE 2016 s/p back surgery - US BLE 8/29 with LLE DVT - CTA thorax 8/29 with right-sided PE - Pt started on Eliquis 8/29, cont - Trops neg - ECHO as above Recent Bartholin gland cyst - I&D by OB/Gyn 8/25 - Cultures sent Asthma - Cont home bronchodilators DVT proph - On Eliquis
8-9 days after the vaccine, I developed very itchy bumps on my left foot and base of toes that went between toes, and then behind my right knee.  I had never previously had an issue with this type of problem.  It has been a few days since the reaction began and does not seem to be spreading.
Itchy, red, swollen, warm, size of an orange, took ibuprofen, lasted 4 days
Patient a physician called on 7/14/10 about reaction to vaccine given on 7/9/10.  On 7/10/10 at 9:30 am started with flu-like symptoms and a sore left arm at site of vaccination.  By 1:00pm had fever 101.5, chills, body aches and felt much worse.  Took Advil at 4:00pm with fever, chills, loss of appetite and one episode of vomiting.  Alternated Advil and Tylenol for the rest of 7/10/10 and 7/11/10.  Fever ended 7/11/10 at 5:30am with sweating.  At that time noted that left upper arm was firm, red, hot to touch and painful in a 4 inch by 6 inch area and arm was swollen about 1 1/2 inches outward.  Continued with no appetite and pain with movement on 7/11/10.  Patient had affected arm checked by a fellow physician on 7/12 who diagnosed cellulitis and patient started on a course of Cipro.  Left arm improved by later 7/12 and today 7/14 area on left arm is now 1 inch in diameter, much improved reported by patient.
This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with ROTATEQ lot # M004726, expiration date: 19-OCT-2017, orally (strength, dose, route of administration and frequency were not reported) for prophylaxis, which was improperly stored at 32 and 36 Farenheit degrees for an unknown time. This excursion was detected due to a digital data logger, however no previous temperature excursion was reported.  No adverse effect was reported. This is one of several reports received from  the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA013134: US-009507513-1701USA010177: US-009507513-1701USA013137: US-009507513-1701USA013138: US-009507513-1701USA013132: US-009507513-1701USA013135: US-009507513-1701USA013133: US-009507513-1701USA013136:
Bleeding from injection site.  Concern that the injection was done in the wrong place (it was not done in our office.)  Severe muscle pain and joint pain,  with moderate widespread pain, especially chest wall pain, persisting > 5 weeks so far.
This spontaneous report was received from a registered nurse and refers to a 40 year old female patient. The patient's concurrent conditions and medical history were not reported. On 23-DEC-2016, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(manufacturer unknown) lot # M018436 with expiration date of 13-APR-2018 (dose, route and frequency were not reported) reconstituted with properly stored sterile diluent (DILUENT MRK) for prophylaxis. No adverse effects were reported. It was stated that the vaccine underwent a temperature excursion of 6 degrees Fahrenheit to 14 degrees Fahrenheit for 87 days. It was reported that there was no need to repeat vaccine. No previous temperature excursion. The call was not because of a "data logger". There was no Product Quality Complaint (PQC) involved in this case. No further information was provided. This is one of the several reports received from the same reporter.
Vestibular disorder; Had to start walking with a cane; This spontaneous case was reported by a consumer and describes the occurrence of VESTIBULAR DISORDER (Vestibular disorder) and WALKING AID USER (Had to start walking with a cane) in a 91-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 616M20A, 039K20A and 052E21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VESTIBULAR DISORDER (Vestibular disorder) (seriousness criterion disability) and WALKING AID USER (Had to start walking with a cane) (seriousness criterion disability). At the time of the report, VESTIBULAR DISORDER (Vestibular disorder) and WALKING AID USER (Had to start walking with a cane) outcome was unknown.            No concomitant medication reported. No treatment information was provided.  Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. It's unclear if this immunocompromised patient had an underlying vestibular disorder, which got exaggerated per the source document. Further information would be requested.   This case was linked to MOD-2021-306534 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. It's unclear if this immunocompromised patient had an underlying vestibular disorder, which got exaggerated per the source document. Further information would be requested.
About 12 hrs after vaccine, I started having chills and running a fever.  My fever spiked to 103+ with severe chills all night.  The next day I still had minor chills with fevers ranging from 99 to 103.  The same symptoms lasted through the second day with lessening severity.  By third day I was fine.  But two days later, I noticed an itching on my back right side and thought it was bug bites because I was working in the yard.  By that night I noticed the "bites" were angry red and continued itching.  I attempted throughout the next day to alleviate the itch with creams, etc. but by Tuesday, one week exactly following the vaccine, I decided to go to immediate care.  I was diagnosed with Shingles, and not but bites.
Vaccinated on 10/3/06.  Began having chills and fever on 10/09.  Improved on 10/10 during the evening.  On morning of 10/11 experienced symptoms of fever, vomiting, and diarrhea. 10/12:  Symptoms once again stopped.  Lingering fatigue with no other symptoms.
This spontaneous report was received from a physician via company representatives, referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history and concomitant medications were not reported. On 09-JUN-2015, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (Lot No. J007946; expiration date 16-APR-2016), "TF 5mcg/0.5mL Te" (route of administration and anatomical location were not reported). On an unspecified dates, the RECOMBIVAX HB had six temperature excursions:80 hours (Lowest recorded temperature was 30F (-1.111111111 Celsius); 24 hours (Highest recorded temperature was 48 F (8.888888889 Celsius); 168 hours (Highest 49 F(9.44444444 Celsius); 1172 hours (Lowest recorded temperature was -3 (-3 Celsius); hours (Highest recorded temperature was 59 F (15 Celsius); 416 hours (Highest recorded temperature was 47 F (8.333333333 Celsius). No adverse effects reported. The vaccine status was reported as "in excursion". The vaccine storage criteria and the storage type of excursion were reported as "Refrigerator(R)". No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
6AM 7JAn had sz-mom called 911 & took pt to hosp through ER; still in hosp; has ear infect & URI;
Very sore arm. Started on my shoulder, moved to the rest of my left arm after I was working for about half an hour. I took two ibuprofen and it all stopped aside from soreness around the injection point. Which is still a little sore now at 11:10.  I also had some dizziness around 3:30 pm (2+ hours after receiving the shot)
adult VAQT A and it was administered to three 15 month old patients; Physicians's office accidently ordered adult VAQTA; adult VAQT A and it was administered to three 15 month old patients; no adverse reactions were reported; This spontaneous report as received from an unspecified reporter concerning a 15-month-old patient. There was no information about the patient's medical history, concurrent conditions or concomitant medication.  The practice accidently ordered adult hepatitis a vaccine, inactivated (VAQTA) instead of pediatric dose (Product prescribing error).    On an unknown date, the patient was vaccinated with an adult dose of hepatitis a vaccine, inactivated (VAQTA) instead of pediatric dose  for prophylaxis (dose,  route of administration, lot number and expiration date were not reported) (Product administered to patient of inappropriate age, Accidental overdose) .  No adverse reactions were reported per caller.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2105USA002492: US-009507513-2105USA004309:
Asthma flared up; Sneezing; Congestion; Shortness of Breath; headache; This spontaneous case was reported by a patient and describes the occurrence of ASTHMA (Asthma flared up), SNEEZING (Sneezing), NASAL CONGESTION (Congestion), DYSPNOEA (Shortness of Breath) and HEADACHE (headache) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy (allergic to oak) and Pollen allergy.    On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ASTHMA (Asthma flared up), SNEEZING (Sneezing), NASAL CONGESTION (Congestion), DYSPNOEA (Shortness of Breath) and HEADACHE (headache). At the time of the report, ASTHMA (Asthma flared up), SNEEZING (Sneezing), NASAL CONGESTION (Congestion), DYSPNOEA (Shortness of Breath) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 04-May-2021: Non significant follow up received on 04-MAY-2021, no new information
Vomited 3 times 3/13/13 and diarrhea during the day.  No fever and still eating.  No vomiting 3/14/13 but loose stools.  Alert and otherwise child is doing well per parent.
morning p/vax pt awakened & told mom didn't feel well;pt stated exp n/v, severe h/a, fever, very sore arm w/ redness;mom called clinic & was instructed to take pt to MD;to MD who stated pt had an allerg rxn to Td;t99, red nickel size area;
warts on my feet are completely gone after taking the 2nd dose of the Moderna Covid-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (warts on my feet are completely gone after taking the 2nd dose of the Moderna Covid-19 vaccine) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B21A and 025H21A) for COVID-19 vaccination.     Concurrent medical conditions included Plantar warts (Had warts 5-8 yrs, predominantly on right foot.1 inch cluster of warts that went across the entire width of his right foot, including the great toe. Minimal involvement to left foot.) since 30-Jun-2005 and Blood pressure high. Concomitant products included SIMVASTATIN for an unknown indication.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Jun-2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (warts on my feet are completely gone after taking the 2nd dose of the Moderna Covid-19 vaccine). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (warts on my feet are completely gone after taking the 2nd dose of the Moderna Covid-19 vaccine) outcome was unknown.            Patient got positive adverse event which cured Plantar Warts. The patient reports that, he previously tried the over-the-counter medicines, but nothing had worked. He also tried wrapping duct tape around his foot and also wrapped electrical tape around his foot for 4-5 weeks at a time, without successful removal of warts.  Concomitant medication also reported some blood pressure medications. No treatment medication reported by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: Follow up information received. The patient medical history, product dose details and concomitant medication were updated.
guillan barre-patient is currently in a medical ICU. 60-day follow up on 01/22/04: "The pt has not recovered from the adverse events. Pt has still not regained the ability to breath on his own, and still cannot more his lower extremities. Pt can move upper extremities, but not on a constant basis.  He is still in our medical intensive care unit and will be transferred to a long term care facility in the near future." Discharge summaries state vomit, abdominal pain, pneumonia, asthenia, paresthesia, facial paralysis, speech disorder, fever, heart arrest, apnea;  Corneal ulcer, conjunctivitis, keratitis, rsh, ventricular tachycardia. msv