chrisvoncsefalvay/vaers-outcomes huggingface dataset:
had a minor attack of vertigo; This is a spontaneous report from a contactable consumer. This consumer reported similar events for three patients. This is the third of three reports.  A patient of unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot and expiry were not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced had a minor attack of vertigo (hospitalization) on an unspecified date. The outcome of the event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021402492 same drug, different patient, similar AE;US-PFIZER INC-2021400449 same drug, different patient, similar AE
Doses administered past the published expiry; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry). On 07-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Doses administered past the published expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were provided.  The vials were stored in the freezer and taken out of the freezer and placed in the refrigerator on the date of administration. The vials did not undergo any temperature excursions.
Experienced arm pain; Fever; headache; muscle pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  An adult male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), as dose number unknown, single (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed, Unknown Manufacturer), for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "Experienced arm pain"; PYREXIA (non-serious), outcome "recovered", described as "Fever"; HEADACHE (non-serious), outcome "not recovered"; MYALGIA (non-serious), outcome "recovered", described as "muscle pain". Additional Information: Male, late 40's, DOB not available, received the Pfizer bivalent vaccine and flu vaccine at the same time. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
48 hrs after 3rd Pfizer vaccine, I had positional vertigo for 4+ days. Eyes are still a little disoriented, but symptoms are mostly resolved
Hard, swollen injection site, with rash that extended down to elbow. Severe headache, fever, nausea, chest pains and feeling of lump in throat. Developed chronic tinnitus which still persists.
Report of adverse event was described by Patient to staff on 6/13 via audio chat. Patient reports receiving a pfizer booster on March 4th at health's Clinic at Town Center. She received the vaccine in her left arm. No significant events were noted on site at the clinic. Patient reported pain that started the evening of her vaccination in her arm, neck, and back describing it as "Frozen Shoulder". She noted bilateral swelling under her arms that was red and raised. Patient reports having this assessed by a provider in which it was confirmed to be frozen shoulder. The symptoms have disturbed her sleep and work. She reports missing 10 work days due to her symptoms. She states that she had no issues prior to the vaccination. She reports that she will complete a VAERS report of her event. Patient reports this is still painful "10/10 pain".  The VAR was pulled from records and it indicates that Patient received a vaccination at Town Center on 3/4/2022.
Extreme fatigue, pain in back, right arm, back of legs, headache, low fever (100.2F)
Chronic infections; Sinus problems; This spontaneous case was reported by a pharmacist and describes the occurrence of INFECTION (Chronic infections) and SINUS DISORDER (Sinus problems) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 020B21A) for COVID-19 vaccination.     No Medical History was provided by the reporter.    On 03-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Apr-2021, the patient experienced INFECTION (Chronic infections) and SINUS DISORDER (Sinus problems). At the time of the report, INFECTION (Chronic infections) had resolved and SINUS DISORDER (Sinus problems) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2021: Follow up Appended
Developed hives on day of immunization. Hives were still present on follow up on 12/5/08. No respiratory symptoms.
25 y/o female received TDAP -> postpartum 7 days. Developed rash on (R) arm -> spread to entire body over next 24-48 hours. No resp distress or other systemic rxn - rash appears dry - like rxn.
This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical histories and concomitant medications were not reported. On 30-MAR-2016, the patient received improperly stored VARIVAX lot # L035128, expiration date: 14-SEP-2017 (exact dose, route of administration and anatomical location were not provided). There were no adverse effects reported. Administered dose of vaccine experienced the temperature excursion of 9 degrees Fahrenheit for 1 hour. There was no previous temperature excursion. This is one of the several reports from the same reporter. Additional information has been requested.
within few hours, extreme chills next morning-chills, body aches, headache, fatigue-took tylenol this lasted for days. by day 7 it got better. but then developed sinus congestion, sneezing-blocked sinuses causing loss of taste/smell.
Started to get headache/stomach bloating & pain/sweating & fever. Began on 10/25/10, but became severe on 10/29/10 & patient went to the ER. ER diagnosed pancreatitis & treated with antibiotics & got better. ER doctor did tell the patient that it was most likely not a reaction to the vaccine since he recieved the inactivated flu vaccine.
Information has been received from a pharmacist concerning an 82 year old female patient who "about 3 weeks ago" on approximately 06-MAY-2008 was vaccinated with a dose of ZOSTAVAX. The patient developed a rash "7 days later" on approximately 12-MAY-2008. The patient went to the emergency room (time not specified) and was diagnosed with shingles. No product quality complaint was involved.
SORE IN  ARM AT THE INJECTION SITE; This spontaneous report received from a patient concerned a 64 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included non alcohol user, and non smoker, and other pre-existing medical conditions included the patient had no drug or non-drug allergies. the patient did not have any history of drug abuse or illicit drug use. the patient previously had vitamins. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1802072, and batch number: 1802072/1402072 expiry: UNKNOWN) dose was not reported, administered on 09-MAR-2021 for prophylactic vaccination. Concomitant medications included paracetamol.  On 09-MAR-2021, the subject experienced sore in arm at the injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore in arm at the injection site on 09-MAR-2021. This report was non-serious. This case, from the same reporter is linked to 20210319996.
severe headache, shakiness, weakness, fever, aches, nausea, and vomiting
States got vaccine on 4/2/10. That eve (L) upper arm was getting sore. The next am (L) deltoid was very swollen and painful. Developed nausea and vomiting. ON 4/4/10 had nausea but no vomiting and the swelling was starting to go down. No redness noted. On 4/15/10 area on deltoid was red/ warm and measured 13.5 cm x 7.5 cm et was warm to touch. Red area increased sl. from the am to mid afternoon. Deltoid area cont. to be firm to the touch cont. to be nauseated but no vomiting.
Kidney stone right kidney on 2 15.2022, kidney stone left kidney on 3.11.2022 Presently, we don't know cause of kidney stones  so  reporting this as informative and not so much consideration for a direct cause and effect.
Pt went to clinic reporting unresolved arm/neck/back pain that continued x 3 weeks after receiving  vaccination.
covid vaccine breakthrough case  dose 1 Moderna 3/11/21  040A21A dose 2 Moderna 4/8/21  045A21A
The pharmacist on duty drew up the Moderna Pediatric 6yr to 11yr was given instead of the Moderna Bivalent dosing. No adverse reactions at this time.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 15-AUG-2014, the patient was vaccinated with expired dose of PNEUMOVAX23  injection (lot # J006921, expiry date: 09-AUG-2014) inadvertently, dose 1, 0.5 ml. On 15-AUG-2014, 1 day after onset of therapy the patient experienced expired vaccine used. The outcome of expired vaccine used in unknown. The reporter considered expired vaccine used to be not related PNEUMOVAX23. Dose was supported. No adverse experience reported. No product quality complaint. No further information provided. Additional information has been requested.
24 hrs p/vax were administered pt devel inc temp 103 & leg cramping; this episode lasted 24 hrs then pt was fine;
I was traveling and returned Saturday July 16, 2022, and I started with symptoms Friday July 22, I took a home test on July 23 and it came out Positive. I felt congestion, weakness, cough and chills, no fever (my body does not respond to fever, I have never had). I called my rheumatologist and she told me that she told me to go to the emergency room to get the antibodies and I went to the hospital and they gave me the treatment. I have continued with congestion, despite having the antibodies, on Friday July 29 I took the test again and it came out positive; So I called my doctor again to see if I could get out of isolation and he said yes, but at work they didn't allow me. I relapsed again and visited the doctor again because I had developed Bronchitis, this was Wednesday, July 27, and they gave me an antibiotic for 3 days and a cough suppressant for 6 days. But since I did not improve, the doctor gave me Molnupiravir and Cortisone again to deflate the Bronchi.
9/8/2017 child had fever of 100.4 slight very light rash, 9/9/17 no fever, child playing normally rash still very light barely noticeable per foster mom. 9/10/17 rash more red and over trunk, extremities and face fever 99.7. Took child to after hours clinic diagnosed with 5th disease. 9/11/17 child taken to Dr with rash, low grade temp, Dr & Dr diagnosed child with measles, based on symptoms, no testing performed. 9/12/17 spoke to mom child has no fever and rash almost resolved but has some itching.
Chills; Headache; Nausea; Fever; This is a spontaneous report from a contactable consumer (patient) via Covid-19 Adverse Event Self-Reporting Solution . A 16-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 10Mar2021 13:00 (lot number: EN6205; expiry date: unknown) at the age of 16-years-old, dose 2, single for Covid-19 immunisation. The patient had no relevant medical history and had no known allergies. Concomitant medication included fluoxetine hydrochloride (PROZAC) taken for an unspecified indication, start and stop date were not reported. The patient was not diagnosed with Covid-19 prior vaccination. The patient was not pregnant at the time of vaccination. The vaccine was administered in Public Health Clinic/Veterans Administration facility. The patient did not receive other vaccines in four weeks. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on 19Feb2021 at 14:30 (lot number: EL9266; expiry date: unknown) at the age of 16-years-old in left arm, for Covid-19 immunisation. On 11Mar2021 at 02:15 AM, the patient experienced chills, headache, nausea and fever. The patient did not receive treatment for the events. The patient recovered from the events on unspecified date. The patient has not been tested for Covid-19 post vaccination.   No follow-up attempts are possible. No further information is expected.
Moderna Covid -19 Vaccine EUA Soreness, swelling, redness, and fever in left arm below injection site to elbow - lasted about 6 days.  Headache , joint and muscle aches, chills, and fatigue for just under 30 hours.
First injection of Garadsil was given to my daughter on July 21, 2009.  A few weeks later her hair has begun to fall out severely.  She has not had any change to her diet, no new medications, no new hair care products, in the past year.  9/4/09 Received vaccine & PCP medical records. Records reveal patient experienced general good health on 7/21/09.  RTC on 8/18/09 w/hair loss.
Throat swelling, Lip swelling, Shortness of breath, Chest tightness, Rash on both forearms, Pain in area by heart, pain in both breasts and ovary areas, headaches. Family Dr prescribed hydroxychloroquine, steroid and zinc. Continued throat swelling, chest tightness, pains in breasts, ovary areas and heart.
chills; headache; fever; arm pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), HEADACHE (headache), PYREXIA (fever) and VACCINATION SITE PAIN (arm pain at the injection site) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Cholesterol, Hypertension and Diabetes. Previously administered products included for an unreported indication: ZOSTER. Concomitant products included PRAVASTATIN, DAPAGLIFLOZIN PROPANEDIOL MONOHYDRATE (FARXIGA), LISINOPRIL and SEMAGLUTIDE (OZEMPIC) for an unknown indication.   On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Jan-2021, the patient experienced CHILLS (chills), HEADACHE (headache), PYREXIA (fever) and VACCINATION SITE PAIN (arm pain at the injection site). On 16-Jan-2021, CHILLS (chills), HEADACHE (headache), PYREXIA (fever) and VACCINATION SITE PAIN (arm pain at the injection site) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient took 2 tablets of ibuprofen for treatment.; 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.
This spontaneous report was received from a 68 year old female patient, regarding herself. Pertinent medical history was reported as atrial fibrillation, cardiac ablation, blood pressure and blood cholesterol. On 04-APR-2015 the patient received a one time injection of ZOSTAVAX in the left arm for the prevention of shingles. Concomitant therapies included hydrochlorothiazide, DIOVAN HCT, VYTORIN, metoprolol succinate, vitamin d (unspecified), XARELTO and NEXIUM. On 06-APR-2015, patient started to experience itching, soreness, pain and a red rash at site of injection. On an unknown date, blood work was performed, results of which were unspecified. As of yet, the patient did not sought medical attention. Outcome of the events were unknown. Causality assessment was not provided. Additional information has been requested.
Pain in lower left abdominal region - intermittent stabbing pain beginning the evening of the vaccination (2/7/2021) and continuing through the morning of  2/10/2021 (the time of this writing)
In April, 2023, I felt like I had something going on in my chest. I began to have a dry, hacking cough. I got really tired and left work early. I went to urgent care on Tuesday, April 25, 2023. I was prescribed steroids and an inhaler. I was diagnosed with bronchitis based on a physical exam and evidence of wheezing.
I have had headaches in the front right side of my head and the back right side of my head for the past 5 1/2 weeks, since April 18, 2019 when I got the 2nd dose of shingrix 50 Mcg/0.5 ml inj. I feel weak. I feel tired, fatigue, upset stomach. In my opinion, the shingrix vaccine is not a safe vaccine! Too many side effects! I will never get it again!
I developed lymphedemia after a double masectomy,  I have a lymphedemia pump and sleeves to help keep the lymphedimia under control as there is no cure.  After these injections have not been able to get the swelling down.  I am now seeing a doctor of physical therapy who specializes in lymphedemia.  See her three times a week.  She continues to do wrappings and lymphedemia massages trying to get the swelling under control again.
Patient c/o shortness of breath and L chest tightness 4 days after getting 1st COVID vaccine, more tired than usual when weight lifting and hiking.
Headache, Myalgia, chils, fatigue, armpit/head aches Narrative:
2 Red Area-, itching, burning-the size of a golf ball, the other the size of a quarter- Located at the front of my neck  I had vaccine on 12/30/20  at 1:30 pm, and woke up on 01/01/21 at 7am with the red areas.
Muscle bulges; Muscle tumor; This case was reported by a pharmacist via call center representative and described the occurrence of muscle mass in a 77-year-old male patient who received Herpes zoster (Shingrix) (batch number 7D9C3, expiry date 25th September 2021) for prophylaxis.   On 15th July 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than a month after receiving Shingrix, the patient experienced muscle mass and muscle neoplasm. On an unknown date, the outcome of the muscle mass and muscle neoplasm were not recovered/not resolved.   It was unknown if the reporter considered the muscle mass and muscle neoplasm to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Shingrix in the left arm. The pharmacist reported that, shortly after the vaccination, the patient developed two bulges in their muscle. An ultrasound was preformed which showed no liquid. There was one underneath the shoulder bone and one to the back of the arm, and almost looks like tumors, big muscle tumors. The patient develpoed muscle bulges shortly after the vaccination, but not right away, and are ongoing. The reporter consented to follow up.
This case was reported by a consumer via other manufacturer and described the occurrence of Autism in a male patient who received PEDIARIX. On an unknown date, the patient received the 2nd dose of PEDIARIX (unknown). On an unknown date, unknown after receiving PEDIARIX, the patient experienced Autism (serious criteria GSK medically significant). On an unknown date, the outcome of the Autism was unknown. It was unknown if the reporter considered the Autism to be related to PEDIARIX.
Mastitis; the patient was lactating; the patient was lactating; This is a spontaneous report from a contactable pharmacist (patient). An adult female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 02Feb2021 (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunisation. The patient was not pregnant at time of vaccination. Medical history and concomitant medication were not reported. The patient had no other vaccine in four weeks and has not had COVID tested post vaccination. The patient experienced mastitis after both doses on 02Feb2021. The patient was lactating. The outcome of event was recovered on unspecified date. The event was treated with Dicloxacillin.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the temporal association, there was a reasonable possibility that the vaccination with BNT162B2 played a contributory role in triggering the onset of mastitis in this patient who was lactating. 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.
SEVERE ACHING IN MUSCLES AND JOINTS.  FEVER UP TO 102 X 2 DAYS.  POINT TENDERNESS TO ENTIRE BODY.  COULD NOT WALK FOR 6 HOURS (MUSCLE WEAKNESS), CONFUSION, DIZZYNESS, HEADACHE, ABDOMINAL PAIN, CHEST PAIN, SHORTNESS OF BREATH.
HEADACHES, SEVERE FATIGUE, SKIN DISCOLORATION, MUSCLE WEAKNESS, SEVERE ANEMIA, FACE PUFFINESS, EDEMA, VERTIGO, HAIR LOSS, VISION CHANGES, MEMORY LOSS, SEVERE MOBILITY ISSUES, STOMACH DISCOMFORT, ESOPHAGUS TIGHTENING. GONE THROUGH IMMUNOSUPPRESSANTS, CELLCEPT, PLAQUENIL, RITUXAN TWICE, PLASMAPHERESIS EVER SINCE.
Narrative: COVID infection following COVID vaccine series 03/17 ,Pfizer, dose #1 04/08, Pfizer, dose #2 08/16 COVID swab, result, result: detected 08/16 SARS-COV-2 LINEAGE result: B.1.617.2 08/16 SARS-COV-2 CLADE result: 21A 08/17 pt cc: chills, cough, Diarrhea, fatigue, myalgias, dyspnea exposure; unknown
Pain and pressure in the right breast plate and shoulder blade. Hurts worse when I take a deep breath, bend over or move in certain ways.
Swelling, redness, sore, warmth at injection site and then bruising at injection site. Still slighty swollen today. Saw MD at clinic for follow-up who told pt. her reaction was not unusual. The size was about 6 inches when it was at its largest.
Extreme abdominal pains cyclic and consistent; diarrhea; headaches; nausea; body aches; lethargic; small amount of vomiting over the duration of 4 days and continuing.
choreoathetosis & cervical/facial motor  tics onset 2 days p/vax & resolved in 2wk;recurred following 2nd vaccine dose;
About 2 Hours after receiving vaccine slight headache Then bout 4 hours later, Severe Headache that has lasted 4 days so far. Poor response to usual medications taken for Headache. Today, @ 1700 still Headache when I think it is better, Moves to a different part of my head. Had to miss work today due to Headache .
Moderate to severe hives, relieved by antihistamine; severe itching, redness and swelling at injection site for 24 hours.
fever 100.6,  nausea, injection site pain, joint pain, tired, chills, headache,muscle pain, sweating alot, sick dizzy & weak
Pt recvd measles vax on 18APR91 approx 10 days post vax pt devel generalized pruritic rash which was felt to be vax related; @ time of report, pt had recovered;
Enlarged left axillary lymph node, mild tenderness (discovered today [10/5/21], not yet resolved)