chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Do not know what flu vaccine patient received. Patient received vaccine outside of the Health System. who presents to the emergency department for spasms. Patient has been following with a neurologist at Hospital for what she states is involuntary contractors of the right hand and right foot that started on 12/30/22. She states the episodes range between 20-30 seconds in duration, 20-30 episodes per day most noted when waking and when standing. She states the intensity will vary. Patient states she has underwent MRI and multiple evaluations for these symptoms. She does report proceeding reaction after receiving the influenza vaccine on 12/8/22. Patient states her MRI showed lesions on the spine and was instructed for a second opinion here at University. Patient does report intermittent abnormal gait which she states is from the right leg cramping and tingling. Denies any acute numbness. Patient has received 2 rounds of steroids up to this time.
Severe rash on the face and the back. Started in early morning and had resolved by noon. Advised patient to take benadryl and if not better or getting worse within 4 hours to be seen by a physician.
Information has been received from a physician concerning an 8 year old male on 19-DEC-2000, 18-NOV-2006 and 23-NOV-2009 was vaccinated with the first, second and third dose of MMR respectively (route, site and lot number not reported). On 15-DEC-2009, the patient experienced mumps (the date diagnosed was reported as 06-DEC-2009). The patient was afebrile and had left side parotitis. On 23-NOV-2009, the first blood work was done which revealed serum IgM 0.62 and serum IgG 2.9. On 06-DEC-2009, the second blood work was done which revealed serum IgM 0.38, serum IgG 3.89 and serum amylase 546. The outcome for mumps was not reported. Follow up information has been received and indicated that the 8 year old male patient (also reported as 6 year old) was vaccinated with his first dose of MMR II on 19-DEC-200 and with his second dose of MMR II on 18-NOV-2006. On 01-DEC-2009 (previously reported as 06-DEC-2009) the patient experienced mumps. The patient was diagnosed on 04-DEC-2009, signs and symptoms included afebrile, L parotitis, (both sides) cheeks pain. Diagnostic laboratory tests performed on 04-DEC-2009 included: IgM: 1:40:00; IgG: 3.66 and serum amylase: 646. This is one of several reports from the same source. No further information is available.
This spontaneous report as received from a doctor pharmacist concerning a 65 years old female patient who was vaccinated once with a 0.5 ml expired dose of PNEUMOVAX23 with lot # (669579/0595AA), IM in deltoid on 09-OCT-2012. The patient had not experienced any adverse effects. Additional information has been requested.
Patient accidently received anthrax vaccine 5 months sooner than he was suppose to, no reported adverse effects up to this point 11/15/01.
administered  past the expiration date; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered  past the expiration date) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered  past the expiration date). On 19-Oct-2021, EXPIRED PRODUCT ADMINISTERED (administered  past the expiration date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant medications was reported. No treatment drug details was reported.   This case was linked to MOD-2021-359738 (Patient Link).
Chronic Spontaneous Urticaria (hives) and Dermatographia Large rashes covering both thighs, and bumps in random areas on palms, soles of feet, arms, chest, back, and lower legs. Treatment with antihistamines (diphenhydramine and loratadine taken at separate times) both are effective at reducing symptoms.  Patient was also tired for day following vaccination
Initial report received from a healthcare professional on 03 October 2012. A 43-year-old female patient, whose medical history is none and concomitant medication was not reported, received an intradermal dose 1 of FLUZONE ID (Lot number UT4472AA anatomical site of vaccine was not reported) on 01 October 2012. It was reported at the time of vaccination the patient had stiff neck and general malaise. On 02 October 2012, 1 day after vaccination patient experienced swelling and redness at the injection site that extended up to the right shoulder and neck area. At the time of this report patient reported the neck pain was stabbing and was referred to physician. No laboratory investigations were performed. Corrective medications were not reported. The patient's outcome was reported at as unknown. Documents held by sender: none. Follow-up information received from a healthcare professional on 19 December 2012: It was reported that after discussing reaction with employee it was discovered that she had hiked in the woods and fell. Her symptoms were not related to her vaccination. There were other personal reason she stated these symptoms were from the vaccine not the fall.
Fever 39°c, serious headache, extreme fatigue, body pain, nausea, swollen arm
My left arm became very sore the day of the second injection. The soreness, over the next week began to spread into my shoulder joint and up the left side of my neck. These aches subsided, but the next week the pain spread to my left elbow and left bicep. About a week later, the pain I experience is in my left arm bicep. When I reach behind me with my left arm, over my head, or reach for something on the floor I experience a shooting pain in my left bicep, akin to hitting a "funny bone" on a hard surface. This pain continues to this day, now over 2 months after receiving the 2nd Moderna covid shot. I've easily lost about 40% of the use of my left arm, due to the excruciating pain I feel when I make instinctive movements with my left arm, (reaching into the back seat of the car, taking a dish off a high shelf, etc.)
Patient is post-menopausal. Experienced 3 days of heavy menstrual flow.
1MAY96 pt recv vax & devel blistered red spots on lt foot;12MAY96 diff carrying luggage & being slow-also having diff walking;to MD found multilevel degenerative spondylosis & herniated disc-did not improve w/surgery;EMG consistent w/GBS
Arthralgia, myalgia, dizziness, flu-like symptoms, anorexia, fatigue, malaise, nausea, sweating-onset approx 24 hours after vaccine administration
Numbness in feet, legs, hands, and the right side of face, as well as blurry vision and disorientation occurred two to three days after an updated booster shot.
I have an autoimmune disorder and when I eat gluten my stomach swells causing severe abdominal pains and vaccine triggered my autoimmune disorder (Celiac disease). I had not had any gluten for over six weeks because I simply cannot have any. I'm  really tired all the time. My doctor ordered blood work and the results came back abnormally low. My doctor is looking at running more tests because the vaccine caused a lot of inflammation and he wants to further investigate. My lymph nodes also were swollen with the 2nd dosage of the vaccine. I am unable to eat and have lost 10 pounds.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Circular little bumps around injection site), VACCINATION SITE DISCOMFORT (Injection site discomfort), VACCINATION SITE PRURITUS (Itchiness at injection site) and VACCINATION SITE URTICARIA (Hives round injection site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and PARACETAMOL (TYLENOL) 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 03-Mar-2021, the patient experienced VACCINATION SITE MASS (Circular little bumps around injection site), VACCINATION SITE DISCOMFORT (Injection site discomfort), VACCINATION SITE PRURITUS (Itchiness at injection site) and VACCINATION SITE URTICARIA (Hives round injection site). At the time of the report, VACCINATION SITE MASS (Circular little bumps around injection site), VACCINATION SITE DISCOMFORT (Injection site discomfort), VACCINATION SITE PRURITUS (Itchiness at injection site) and VACCINATION SITE URTICARIA (Hives round injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Swollen lymph node above collarbone on the side of vaccination.; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 20May2021 at 09:00 (at the age of 41-year-old) as a single dose for COVID-19 immunisation. medical history was reported as none. The patient did not have allergies to medications, food, or other products. Concomitant medications included loratadine (CLARITIN 10MG), saccharomyces boulardii (FLORASTOR) and magnesium (MANUFACTURER UNKNOWN), all used for unknown indication from unspecified dates, unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.On 27May2021 at 11:00, the patient experienced swollen lymph node above collarbone on the side of vaccination. No therapeutic measures were taken as a result of the event. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the event swollen lymph node was not recovered at the time of the report.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Headache at base of head/neck.  Feeling extremely cold.  Shivering and shaking uncontrollably, teeth chattering lasting over 1 hour.  Temp (after ibuprofen) = 98.8F
She got her vaccine, really didn't have any reactions right away.  Then about #4 that she started having loose stools that turned into watery diarrhea, everything was going right through her.  She would get cramping in her abdomen and would have to go immediately and then throughout the day.  She was concerned due to possibly getting weakness.  This went on for 2 1/2 weeks or so, then slowed down to loose stools, and now back to the liquid stools again.    She called the pharmacy as she is a NP, and is otherwise not sick but her stomach is inflamed and having the digestive issues.   No fever, has energy to work, but just has to have a bathroom close by.
Headache; has been in bed; body is sore; Diarrhea; Wheezing; Nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08Dec2021 13:15 (Lot number: 3313OBA) at the age of 54 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing), notes: Verbatim: Asthma; "Hypertension" (unspecified if ongoing), notes: Verbatim: Blood pressure high. There were no concomitant medications. The following information was reported: HEADACHE (non-serious) with onset 09Dec2021, outcome "not recovered", described as "Headache"; BED REST (non-serious) with onset 09Dec2021, outcome "not recovered", described as "has been in bed"; PAIN (non-serious) with onset 09Dec2021, outcome "not recovered", described as "body is sore"; DIARRHOEA (non-serious) with onset 09Dec2021, outcome "not recovered", described as "Diarrhea"; WHEEZING (non-serious) with onset 09Dec2021, outcome "not recovered", described as "Wheezing"; NAUSEA (non-serious) with onset 09Dec2021, outcome "not recovered", described as "Nausea". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.
5 days after my second vaccine, all of a sudden I felt shooting pain on the top of my head. I was sitting on the couch doing nothing when this happened. I took 2 Motrin?s right away. The next day the pain got worse and traveled to my whole left side of my head to the base of my skull, and I?ve had this pain ever since. I was taking Motrin?s and Tylenol, but on May 9th at night, I woke up with a lot of pain on my left side of my head. I went to the ER, they did a head CT and didn?t find anything. They gave me a cocktail of headache medicine through IV. The pain came back in the morning. My doctor prescribed me 6 days dosage of prednisone and muscle relaxer. I finished them and felt better for a while, but it slowly came back. It?s been very stressful having this constant pain on my head, neck, and I feel it?s now traveled to my shoulder. Everything feels very tight all the time, my I always have the pain on my head.
Febrile seizure of approximately one (1) minute duration the day after receiving routine immunizations for one year olds. Seen in local ER and released. As directed, parents gave Tylenol and Motrin afterwards.
This spontaneous report as received from a licensed practical nurse refers to a patient of unknown age and unknown gender. The patient pertinent medical history was not reported. On 04-APR-2014, the patient was vaccinated with VARIVAX (Merck) (dose strength and route was not reported) (lot # J007954 and expiry date: 27-JUN-2015) which was improperly stored. Primary reporter was reporting excursion of 6 F since 01-JUN-2013 (confirmed date) affecting VARIVAX (Merck), nurse also reported that products were not stored in an overall average support range of -58 degree F and 5 degree F. No adverse effects reported. No product quality complaint (PQC) was reported for VARIVAX (Merck). This is one of the several reports from the same reporter. Additional information has been requested.
I had the shot in May and it is now August. I typically have a moderate flow, mostly painless menstrual cycle of about 3 to 4 days. After receiving the vaccine I have had an extremely high flow, extremely painful menstrual cycle of at least 7 days with 4 of those days being highly painful. I also had what I can describe as a heart flutter where the heartbeat is abnormal for a few seconds. It isn't painful, but highly concerning and has occurred maybe once a week or every other week.
Loud, chronic ear tinnitus; chronic tingling tongue and skin; chronic tingling tongue and skin; keep disrupt healthy sleep; headaches; loss of sleep; loss of sleep and quality of life; exhausted; nerve damage issue; This is a spontaneous report from a contactable consumer reported for self. This 42-year-old female non pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1, administered in Arm Left on 06Apr2021 at age of 42 years old (Lot Number: EW0175) as DOSE 1, SINGLE for covid-19 immunisation. None pregnant at time of vaccination. Medical history included Chronic spine, knee, wrist, and shoulder issues/pain. Degenerative disc disease in spine and Intolerant to dairy. Prior to vaccination, the patient did not diagnose with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No any other medications the patient received within 2 weeks of vaccination. On 06Apr2021, she experienced Loud, chronic ear tinnitus which was Disability. Chronic tingling tongue and skin. Never had these symptoms prior to Pfizer covid vaccination. These side effects keep disrupt healthy sleep and cause headaches. Concerned as to what the long term side effects will be from loss of sleep and quality of life. She was exhausted. Concerned if this is a nerve damage issue. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Tested positive for Covid after the 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for Covid after the 1st dose) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     Concurrent medical conditions included RA. Concomitant products included PREDNISONE and METHOTREXATE for RA, PARACETAMOL (TYLENOL) and VITAMINS NOS for an unknown indication.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced COVID-19 (Tested positive for Covid after the 1st dose). At the time of the report, COVID-19 (Tested positive for Covid after the 1st dose) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Feb-2021, SARS-CoV-2 test: positive (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.   Reporter did not allow further contact
Pt rec'd 1st PREVNAR 13 in (R) thigh 3/27/14. Pt was fussy with decreased flexs x 48 hrs. Mom left band aid in place x 4 days. When bandaid removed she noted a square-shaped area of blisters where the nonadhesive portion of bandaid covered vaccice site. Appeared to be contact dermatitis.
I started developing symptoms around February 10th with a cough, slight headache, and tiredness. That continued for about a week or so. On the 14th  I took an at home test and was positive for COVID19. I contacted my Doctor and he prescribed Paxlovid and a cough medication. I felt better within a few days. It was pretty mild, I was never sick in bed, but I still have a slight cough.
Hives - mostly around eyes & face but also on trunk she was also on AMOXIL (started 12/21/11) no wheezing or cough or fevers, on 12/29/11 AMOXIL stopped. CLARITIN & ORAPRED started.
fainted briefly, pallor - happened within a couple minutes of receiving vaccine.  patient recovered within 10-15 minutes, sat with ice packs, had a glass of water, and a granola bar.
55F with HTN, obesity, preDM, covid vaccinated with J&J, admitted for severe COVID pna.  Required ICU stay for iNO (9/24-9/26) though never needed intubation.  Also s/p 5 days of remdesevir (9/21-9/25) and 2 doses of tocilizumab (9/22 and 9/23) as well as high dose steroid taper.    Improved with the above, able to wean to 2L NC at rest and 3-4L with exertion. Will need a few more days of steroids to complete taper (6 mg on 10/1/21, 3 mg on 10/2/21-10/4/21, then stop).    Notably - had mild transaminitis - suspect 2/2 underlying NASH.  HgbA1C worsened to 6.6.    Otherwise stable thru hospitalization.   Ok to de-isolate (from COVID standpoint) on 10/11/21.
A non-serious spontaneous report of ears blocked, head cold and sore throat has been received from a non-health professional concerning an adult female, subsequent to FLUMIST. Neither the patient's past medical history nor concomitant medications were reported. The patient received FLUMIST on an unknown date. The patient experienced ears blocked, head cold and sore throat after receiving FLUMIST. The outcome of ears blocked, head cold and sore throat was unknown.
patients got doses after the 30-day beyond use date; patients got doses after the 30-day beyond use date; no adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients got doses after the 30-day beyond use date), PRODUCT STORAGE ERROR (patients got doses after the 30-day beyond use date) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 023H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients got doses after the 30-day beyond use date), PRODUCT STORAGE ERROR (patients got doses after the 30-day beyond use date) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patients got doses after the 30-day beyond use date), PRODUCT STORAGE ERROR (patients got doses after the 30-day beyond use date) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (patients got doses after the 30-day beyond use date) and PRODUCT STORAGE ERROR (patients got doses after the 30-day beyond use date).    The case contains the information of 11th out of 14 patients who had received the vaccine as described by the reporter.  No concomitant drug information was provided.  It was unknown if the patient had received any other vaccine 4 weeks prior to COVID-19 vaccine.   It was reported that the pharmacist had received the vaccine order on 15Nov2022 and accidently put the expiration date as 10 weeks instead of 30 days. 14 patients got the vaccine beyond use date and the reporter was enquiring the patients need to be re-vaccinated.  The size of the vial was reported as 2.5ml and vial was initially stored in refrigerator on 15Nov2022.  The doses were administered on 16Dec2022, 28Dec2022, 4Jan2023, 7Jan2023, 9Jan2023, 11Jan2023, 13Jan2023, and 18Jan2023. It was confirmed that the vial had not undergone any temperature excursion issue.  No treatment medication information was provided by the reporter.   This case was linked to MODERNATX, INC.-MOD-2023-706920 (E2B Linked Report). Sender's Comments:  MODERNATX, INC.-MOD-2023-706920: MASTER CASE.
This is a spontaneous report from a contactable physician. A 17 year-old male patient received TRUMENBA, (lot R45078, expiry date Sep2017, NDC 0005-0100-10) at 0.5 ml single intramuscular in the left deltoid on 08Nov2016 for immunisation.  The patient medical history and concomitant medications were not reported. On 08Nov2016 at 7 pm the patient experienced swelling and pain at site of injection (left deltoid). Due to pain and swelling at the site of injection the patient was given MOTRIN and the mother applied heating pad to the area. On 09Nov2016 at 8 am the patient also experienced headaches, inability to move left arm fully, and had persistent pain and swelling at left deltoid. These side effects continued for 3 days and the patient recovered after that on 12Nov2016.
MEDICATION ERROR; This spontaneous report received from a health care professional concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included bnt 162 for prophylactic vaccination. On an unspecified date, the patient experienced medication error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of medication error was not reported. This report was non-serious.
General fatigue day of injection which resolved by morning. On day 6 after vaccination I developed a large well demarcated rash with warmth and swelling around the injection site. This has now mostly resolved this morning.