chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient experienced arm pain since flu vaccine administration. Has been taking Ibuprofen with little relief. Doesn't have full range of motion in arm, sensitive to touch. Scheduled appointment with doctor to discuss
Woke up Sunday morning with extremely swollen lip. Made virtual doctors appointment with picture of lip.  They said get to ER immediately bc i was having an allergic reaction to my blood pressure medicine Lisinopril even though i have been on it for almost 20 years.   When i got to unspecified Hospital they started me on an IV but the swelling would not go down.  They said they had to admit me for the night to continue  steroid treatments.   The doctors were not sure if  it was related to the Moderna shot i had 8 days prior.  I went to my primary care doctor who put me on a different BP med but was very sure it was from the shot.  After one day at unspecified hospital all the swelling was down and i was released .
Persistent right shoulder pain near site of injection. Pain began during injection and persisted since then. Pain is worse when extending or abducting arms 90 degrees and when throwing ball or doing push ups.
This spontaneous report as received from a pharmacist via company representative refers to a patient of unknown age and unknown gender. The patient's medical history and concomitant medication were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (lot#, expiry date not specified). On an unknown date after vaccination (reported as which lasted for 6 weeks now), the patient developed rash. The outcome of rash was unknown. Causality assessment was not provided. This was one of two reports received from the same reporter. Additional information has been requested.
Started feeling ?queasy?.  After a few hours had dry heaves.  Still later had a fever of 100.  This happened on Saturday after having the shot on Friday night.  Sunday a.m. my temp was 99 and I just felt lethargic.  However, I had a large red patch at the injection site - as I did following the first injection.  This has itched very much.  I had felt fine since Monday until today when I have had some stomach cramping.
The patient received a pediatric dose of Hepatitis A for her second dose.  The patient was contacted by telephone and returned to the clinic for an adult dose of Hepatitis A to complete her series.
10/8/22 Pt admitted to the hospital with generalized weakness and fatigue; found to be positive for COVID; desired hospice; hospice process began; 10/14/22 pt had a prolapsed ostomy, still functioning, no intervention needed; also pt fell and fractured right acetabulum; orthopedics recommended wheelchair x 4-6 wks; 10/16/22 creatinine worsened; pt aware the outcome is not good; transitioned his status to DNR comfort measures; 10/17/22 hospice in hospital took over and pt passed away in the hospital
The vaccine expiration date was identified to expire on June 22, 2021, but the manufacturer expiration date was February 25, 2021.  Based on the information learned, ok the following steps: ? Contacted Moderna for guidance and based on Moderna data, the Moderna Medical Information team provided the following information:  o ?The vaccine administered on March 4, 2021 through March 10, 2021 from lot number 025J20-2A maintained the activity necessary to protect against the SARS-CoV-2 (COVID-19) virus at time of administration.?  ? Contacted a county medical director and based on this information from Moderna, no re-vaccination is needed.
high fever of up to 104.6 ten days after MMR injection, rash, lethargic, irritable, poor appetite and restlessness during sleep
24jul90 and 22aug90 pt vax hepta B vax's. after both vax pt ex redness, swelling and itchiness around inject site.  lasted for 5-6days
This spontaneous report as received from a consumer refers to her daughter, a 34 year old female patient. The patient's pertinent medical history and drug reactions allergies were not specified by the reporter. On 23-JUL-2015 the patient was vaccinated with MMR II (Lot # K026366, exp. date was not reported) (dose, frequency and route were not provided), VAQTA (Lot # and exp. date were not reported) (dose, frequency and route were not provided), DTaP (unspecified) (dose, frequency and route were not provided), tetanus toxoid and typhoid vaccine (unspecified) (dose, frequency and route were not provided). Concomitant therapies were not reported. The patient's mother stated on 24-JUL-2015 her daughter developed a red patch on her arm which was warm to touch. Her arm felt like dead weight (limb discomfort), she had diarrhea, pain and stomach cramps (abdominal pain upper). The patient went back to the doctor who prescribed her an unspecified antibiotic. Because she did not improve, she sought medical attention and went to an emergency room. Lab diagnostics studies performed were not specified by the reporter. Later, she was diagnosed with cellulitis and was informed that she would need another unspecified medication, but she was not admitted to the hospital. She was recovering but was still not well. No product quality complaint was involved. The outcome of limb discomfort, diarrhoea, abdominal pain upper, pain, cellulitis and skin warm was reported as recovering. The patient's mother did not assess the causal relationship between MMR II, DTaP (unspecified), tetanus toxoid and typhoid vaccine (unspecified) and the events. This is one of two reports received from the same reporter. Additional information has been requested.
no adverse effect; Administration of one dose of an expired vaccine; This spontaneous report was received from a registered nurse referring to a 25 year old female patient. The patient's relevant medical history, drug reactions/allergies and concomitant medication were not reported.   On 03-JUN-2019, the patient was vaccinated with an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot number: N019923, expiration date: 28-APR-2019) intramuscularly, for prophylaxis (strength and dosage schedule were not reported). The vaccine was stored in the correct storage temperature range and no adverse effects were reported.
Patient states the entire weekend unable to think cleary, delayed thought process; hard time forming words; Elevated blood pressure; Patient states the entire weekend unable to think cleary, delayed thought process; dont feel like myself; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A 61-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Feb2023 at 10:15 as dose 4 (booster), single (Lot number: GL0087) at the age of 61 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE; Unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE; Unknown manufacturer), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE; Unknown manufacturer), for COVID-19 Immunization. The following information was reported: BLOOD PRESSURE INCREASED (non-serious) with onset 11Feb2023, outcome "unknown", described as "Elevated blood pressure"; MENTAL IMPAIRMENT (medically significant), BRADYPHRENIA (non-serious) all with onset 11Feb2023, outcome "unknown" and all described as "Patient states the entire weekend unable to think cleary, delayed thought process"; FEELING ABNORMAL (non-serious) with onset 11Feb2023, outcome "unknown", described as "dont feel like myself"; APHASIA (non-serious) with onset 11Feb2023, outcome "unknown", described as "hard time forming words". The events "patient states the entire weekend unable to think cleary, delayed thought process", "hard time forming words", "elevated blood pressure" and "dont feel like myself" required emergency room visit. The patient underwent the following laboratory tests and procedures: Blood pressure measurement: (unspecified date) Elevated; SARS-CoV-2 test: (14Feb2023) Pending, notes: Nasal Swab. It was unknown if therapeutic measures were taken as a result of mental impairment, aphasia, blood pressure increased, bradyphrenia, feeling abnormal.  Additional information: Other medications patient received in two weeks were Blood Pressure Medications. Prior to vaccination, was the patient was not diagnosed with COVID-19. Patient stated "the entire weekend unable to think cleary, delayed thought process, hard time forming words, do not feel like myself. Elevated blood pressure". Adverse event start date was reported as 11Feb2023 12:00 AM.; Sender's Comments: Based on the available information in the case, the causal association between the events and the suspect drug BNT162B2 cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Started with very sore shoulder after injection. The next morning felt sick, but that resolved. Arm then got very red and hot and continued that way for 3 days before she called back in to report it on Friday. She had been taking Tylenol.  Followed up with her on Monday morning and she stated it was getting better, but redness had moved down her arm a little bit. She called into clinic and left message for her primary care provider.
flu like reaction; not feel good; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like reaction) and MALAISE (not feel good) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 2001 and 006B21A) for COVID-19 vaccination.     The patient's past medical history included Open heart surgery since an unknown date and Angina attack.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like reaction) and MALAISE (not feel good). On 26-Feb-2021, INFLUENZA LIKE ILLNESS (flu like reaction) and MALAISE (not feel good) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   concomitant medication was not reported. treatment information was not reported   This case was linked to US-MODERNATX, INC.-MOD-2021-057879 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-057879:Case for second dose
Site: Bruising at Injection Site-Mild, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Medium
About 1 week after 2nd shot I had a shingles like rash on my chest and neck. I had the rash for about 2 weeks. I had a smaller reaction after the first shot in March but thought I had a poison oak infection. After the second shot I realized the shot caused the rash.
WORSE CHEST PAIN; This spontaneous report received from a patient concerned a 61 year old male. 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 not reported, batch number: 1808982, expiry: UNKNOWN) dose was not reported, administered on 07-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-AUG-2021, the patient experienced worse chest pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from worse chest pain. This report was non-serious.
This is a spontaneous report from a contactable consumer reporting for herself. A 70-years-old Caucasian female patient received the first dose of PREVNAR 13, via an unspecified route of administration on 29Oct2017 at single dose in upper right arm for immunisation. Medical history included hypertension, thyroid disorder and gastrooesophageal reflux disease. Concomitant medication included oral metoprolol succinate (TOPROL XL, tablet, 50 mg) 50 mg for hypertension, oral triamterene (TRIAMTERENE, tablet, 37.5 mg), 37.5 mg every other day, for hypertension, oral thyroid (ARMOUR THYROID, tablet, 1 g) 1 g, once a day for thyroid disorder, oral pantoprazole (unknown manufacturer, tablet, 40 mg) 40 mg daily, oral progesterone (unknown manufacturer, 100 mg, capsules capsule) 100 mg, daily as hormone therapy. The patient experienced rash underneath breast on 30Oct2017 with outcome of not recovered, it just won't go away and it hurts with the vengeance and dermatitis both on an unspecified date in 2017 with outcome of unknown. The patient thought that Rash was a yeast infection but turned out it was not. So the patient treated rash by applying on it Nystatin cream 30 g twice daily, Vusion Ointment 50 g, twice a day, Hydrocortisone 0.2 percent twice daily for 4 days, Hydrocortisone 0.5 percent one time a day, Eucrisa and Ketoconazole Cream 2 percent, twice a day but none of these creams have worked. The patient took also a tablet of fluconazole just once, as she reported that's all you required if you have a yeast infection apparently. But then she took them also two weeks after. Furthermore she orally took a dose pack of Methylprednisolone, Methylprednisolone 4 mg dose pack 21 tablets. The patient did a biopsy in 2017 to make sure it was not something weird, it just said dermatitis.
sibling recv vax & pt exp zoster along the left T10 & T11 dermatome (umbilicus/midline to posterior flank) which was described as erythematous patches wrapping around the flank w/extensive blistering;
Information has been received from a licensed practical nurse concerning a 31 month old female who on 08/01/2000 was vaccinated with the first dose of varicella virus vaccine live, SC. On 02/23/2002, the pt developed chicken pox with a moderate rash of approximately 50 lesions. In follow-up, it was reported that the pt "broke out with chicken pox with brother (14 days later)." It was reported that the pt's brother also developed chicken pox post vaccination with varicella virus vaccine live (WAES0202USA02699).
Face bumps appeared next to both temples on the face; Patient received the 2nd dose, 17 days after the 1st dose; This is a spontaneous report from a contactable consumer (patient). A 51-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection), on 04Mar2021 13:00 (lot number: EN6202) as dose 1, single; then on 21Mar2021 13:00 (lot number: EN6206) as dose 2, single - both via an unspecified route of administration, administered in the right arm at the age of 51-years-old for COVID-19 immunization. The patient has no relevant medical history. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 21Mar2021, the patient received the 2nd dose, 17 days after the 1st dose. On 25Mar2021 14:00, the patient developed face bumps which appeared next to both temples on the face. They continued to grow in size and the patient was unable to get rid of them. Doctors say told the patient that the vaccine resulted in biofilm to emerge on her face. It still has not gone away, through multiple injections. The patient stated that she needs help to remove this. The event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care, prolongation of existing hospitalization, and disability or permanent damage. Treatment for the event included Hylenex Recombitant (hyaluronidase) and Kenalog. The outcome of the event was not recovered.  Follow-up attempts are completed. No further information is expected.
1 hour after receiving vaccine became dizzy. It passed within an hour. Following day had severe lower burning back pain..  it resolved  following day. The next day Feb 11, was severely nauseated all day. Feb 12 nausea resolved. Feb 18 nausea returned. Stomach upset for over 2 weeks then began to resolve. Called Dr . He rec delay 2nd vaccine 1-2 weeks.. Saw Dr  on  March 8 to discuss 2nd vaccine. Had 2nd vaccine March 11. Same symptoms again but much milder.  Also had fatigue for weeks after 1st vaccine and again after 2nd vaccine. .
on 6/9/21 at 8:25am Patient began feeling dizzy and as if she needed to throw up. Client was escorted to the restroom by the nursing staff, where Patient threw up.  After being escorted back to the sitting area  vitals Patient were taken and she remained sited for an additional  10 min where she recovered and departed with her spouse.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 31Mar2021 at 16:00 as dose number unknown, single (Lot number: Er8733) at the age of 59 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Topical lidocaine, reaction(s): "Known allergies: Topical Lidocaine", notes: Known allergies: Topical Lidocaine. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (2022) Negative, notes: COVID symptoms returned and tested positive after testing negative and had no symptoms; (2022) Positive, notes: COVID symptoms returned and tested positive after testing negative and had no symptoms. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Serious, Seriousness criteria-Results in death, Seriousness criteria-Life threatening, Seriousness criteria-Caused/prolonged hospitalization, Seriousness criteria-Disabling/Incapacitating, Seriousness criteria-Congenital anomaly/birth defect reported as No. Other medication in 2weeks reported as Yes. Anti viral details: product: COVID 19 Treatment, brand: Pavlovid, treatment start date: 20Jun2022, treatment stop date: 25Jun2022. Adverse event reported as COVID symptoms returned and tested positive after testing negative and had no symptoms.  No follow-up attempts are possible. No further information is expected.
Pediatric patient given ZOSTAVAX in place of VZV as booster dose. No adverse reaction as of 10/18/13. No adverse reaction as of 10/21/13.
Injection given around 10:00am.  No side effects, whatsoever.  Started to feel soreness at site of injection around 6 hours later.  Self administered ibuprofen.  I woke up around 11:30pm to extreme chills, aches, and shaking.  Oral temperature of 100.9.  Self administered Tylenol .  Almost unbearable teeth chattering (thought my teeth were going to break), whole body chills (shaking the entire bed, woke up my husband from shivering, almost convulsing).  Fever kept going up until it peaked at 101.9.  At some point it broke.  Woke up again around 5:30am, same symptoms as above, add to the list, nausea and vomiting. Fever to 101.7. I took Ibuprofen this time and it went down sooner.  Returned about 5 hours later.  No chills or teeth chattering, but severe lethargy all day.  No appetite, sense of smell diminished again.  Nausea gone.  No fever again until 12:00 Sunday morning.  Ibuprofen diminished it.  Fever was 101.2. Sunday was better.  More energy, less sleepy.  No fever until 4:30 pm.  More appetite.  Sunday afternoon I began to show a red rectangle about 1"x2" over the injection site.  It's warm to the touch.  It's currently still there, and now itches.   Have had no more fever, but am still extremely tired.
VACCINE WAS ADMINISTERED ON 12/1/2022,   PAST BUD DATE OF 11/29/22
Local rash immediately after vaccine. Red hive like appearance. Began to resolve 15 minutes later. Medicated with Benadryl and monitored closely for 30 minutes.
This spontaneous report as received from a healthcare worker refers to a 16 year old patient of unknown gender. The patient's medical history and current conditions were not provided. On 15-JUN-2015, the patient was vaccinated with a dose of improperly stored GARDASIL (strength, dose and route were not provided) lot # K007828 expiration date 02-MAR-2017. Concomitant medication was not reported. No adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
One day after: all over soreness and malaise similar to flu. Today, extreme tiredness.
pt recv vax 11JUL95 & 25MAR97 pt was irritable & had a stomach ache;27MAR97 pt devel a rash consisting of 40 water-filled blisters & a fever;
COVID-19 symptoms started on 06/06/22; antigen positive test on 06/06/22 Symptoms were fever, cough, sinuses and nose were slammed shut and I couldn't breathe through nose at all. That lasted even after other symptoms went away on the 13th. It felt like sinuses were completely blocked. On 06/04/22 my temperature was 98.3 and my normal temperature is 97.4/97.5. 06/06/22 my temperature was 99.0 and then on 06/07/22 it ranged from 98.3-99.4. It started out in the morning and would fluctuate. 06/07/22 was also the last day I had a temperature and the highest was 99.4 and nothing after. I had a little bit of brain fog and I wasn't quite as achy but I did have some body aches and it was scary not to breathe through my nose and it lingered on way before fever and other symptoms were gone. The thing I've noticed is I feel a lot more fatigued, and I haven't bounced back as quickly and normally I walk 2-3 miles a day and it's been a struggle walking again and I can only walk a mile and a half. I was exhausted today after 2 1/2 miles. No loss of taste or smell. I did call PCP and did a telehealth visit and was prescribed an antibiotic and I took a couple of doses and decided not to take anymore and took vitamin C, D, and zinc.
Severe localized reaction to SC injection. Itching, induration traveling up the arm from the injection site by several inches.
a dose of the Moderna Covid-19 vaccine administered to a pediatric patient; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (a dose of the Moderna Covid-19 vaccine administered to a pediatric patient) in a 17-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (a dose of the Moderna Covid-19 vaccine administered to a pediatric patient). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (a dose of the Moderna Covid-19 vaccine administered to a pediatric patient) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment drugs were reported.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow up received on 26-MAY-2021 and does not contain any new information
6 hours after vaccination had extreme pain 7/10. Also developed limited movement in arm/shoulder that has lasted over 5 days.