chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Oral pain and ulcers. Gen myalgias and arthralgias. Fever chills, swelling, redness.
A physician report was received, concerning a female patient with approximate age of 31 years. No information regarding relevant history, concomitant disease and concomitant medications was provided. It was reported that a 29-week pregnant patient was administered nasal FLUMIST Quadrivalent (Intranasal) on 16-Dec-2015, in her doctor's office. The outcome of the pregnancy was reported to be a Non-healthy baby. The report was considered to be non-serious by reporter. Summary of follow-up information received by Medimmune on 18-Feb-2016 from the physician: The outcome of the pregnancy was reported to be a Non-healthy baby.
devel redness, tenderness, & swelling lt deltoid the next day of vax;each day area increased w/inc pain;seen in ER 18FEB96 w/pain lt arm, fever 100.5;tx w/IV ancef & given cephalexin;seen again 19FEB96 w/inc area of erythema;
he missed his second dose and is now past 42 days mark.; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (he missed his second dose and is now past 42 days mark.) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (he missed his second dose and is now past 42 days mark.). At the time of the report, PRODUCT DOSE OMISSION ISSUE (he missed his second dose and is now past 42 days mark.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication information was not reported. Treatment information as not reported.
About 5 min. after receiving TDAP vaccine , Pt complained of feeling dizzy, seeing stars, sweating, and Nausea. Pt was taken to an examination room and was asked to lie down. Vital signs BP 107/64, P 74, R 20 and o2 was 97%Provider was notified to assess pt. pt rested for half an hour and vital signs were once again checked BP 102/65, P 74, RR 18. Pt reported that he felt fine , once again was reassessed before  leaving.
This spontaneous case, initially received from a pharmacist on 24-Sep-2018, concerning a 57-year-old, adult patient of an unspecified gender. The patient's medical history and concomitant medications were not available. Since 03-Sep-2018, the refrigerator's temperature fluctuated above 47F and FLUCELVAX QIVc vaccine exposed to temperatures in the range of 47F to 50.9F, (explicitly coded as incorrect product storage). On 13-Sep-2018, the patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location, batch number and expiry date: not reported] which underwent temperature excursion (explicitly coded as drug administration error). The patient did not experienced any adverse drug reaction after the vaccination. The reporter assessed the case as non-serious. This case 201804100 cross-linked to original case 201804076 due to the same reporter. Non-significant follow-up received from the reporter on 14-Nov-2018: Added Med info number (SEQ18-04086) in the additional information tab. No changes were made in the narrative.
Knot to left upper arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Knot to left upper arm) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025B21A and 047A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-May-2021, the patient experienced VACCINATION SITE SWELLING (Knot to left upper arm). At the time of the report, VACCINATION SITE SWELLING (Knot to left upper arm) outcome was unknown.            No concomitant medications were provided. No treatment medications were provided.
fever 100 & elevating; screaming cry-several hrs contacted ER-warm baths;
After 2nd does , Pt POTS were in full swing, dizziness, unsteady on feet, fog headed, fatigue ,
I started having a cough, a sore throat, shortness of breath, and tiredness. The sore throat lasted only a few days, but the cough went on for a while. I experienced chest cold symptoms. I tested on February 4, 2023, and it was positive. I called my doctor and they prescribed Paxlovid. I also started using my Symbicort and Albuterol.
not feeling well; stomach bug and  not feeling well.; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ABDOMINAL DISCOMFORT (non-serious) with onset 19Apr2021, outcome "unknown", described as "stomach bug and  not feeling well."; MALAISE (non-serious), outcome "unknown", described as "not feeling well". Patient stated that these events were not due to the first vaccine as she had no issues. Patient would like to reschedule second dose.   No follow-up attempts are possible. Information on lot/batch number cannot be obtained. No further information is expected.
5/6/2000 Treated at ER for gouge on finger. On 5/7/2000 felt light headed but otherwise no serious problem. On 5/8/2000 morning had an episode of vomiting and extreme weakness. The weakness dissipated by 5/10/00 and pt recovered.
Headache/nausea; extreme fatigue; muscle soreness; hoarseness; tired eyes.
Initial unsolicited report received from nurse on 19-Jan-2017. This case involves a 17-month-old female patient who was vaccinated with a dose of DAPTACEL (Batch number: C5148AA and expiry date: 09 Feb 2019) and ACTHIB (Batch number: UI645AA and expiry date: 21 Jul 2017) both intramuscularly in right thigh on 21-Nov-2016. Patient do not had any illness at time of vaccination and pre-existing physician diagnosed allergies, birth defects, medical conditions. Concomitant medication was not reported. On 21 Nov 2016, five days following the vaccination, the patient developed an abcess on right leg about 4 cm in diameter, redness and swelling to that area. On an unspecified date, patient was seen in emergency room where patient was treated and released. On an unspecified date Lab data investigation performed it includes I&D (Incision and Drainage): crystalized material. Corrective treatment was not reported. On an unspecified date, patient was recovered from events. List of documents held by sender: none.
New Tinnitus. I did not have Tinnitus or hearing loss prior to my Covid 19 inoculation. Since my Booster 3 weeks ago it's louder than ever.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with the improperly stored doses of VARIVAX (lot # L041207 with expiration date 20-OCT-2017, lot # M002061 with expiration date 12-JAN-2018; dose and route of administration were not reported). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
This child had a red, swollen quarter sized area on his left up per arm at the injection site.
Felt immediate pain across shoulders and back of neck and like shot was given in both arms at the same time. Since vaccinated, has experienced bilateral swelling in both hands and fingers. Pain goes all the way down to calf in leg, like it follows the sciatic nerve. Per patient, follows fibromyalgia route pain. States pain is debilitating.
3 week post vaccination patient is complaining of all over body/joints aches & pain states pain is 8 out of 10. Also states he has an implant in left knee & can barely bend knee - MD said to take ibu still in pain 10/7/12.
This spontaneous report was received from a nurse and refers to multiple unspecified number of patients of unknown demographics. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ (lot # M012495, expiration date: 09-OCT-2017; dose and route were not provided). The vaccine was exposed to a temperature of 34 degrees Fahrenheit  for total cumulative time frame of 8 hours. There was no previous temperature excursion. Data logger was not involved. No adverse effects were reported. Additional information has been requested.
Developed a lump in her left leg. It is at most 1/2 cm round. This was noticed by mom 6/24/03. Pt received shots 6/20/03. Tx - observation.
Pfizer-BioNTech COVID-19 first dose, 1/23/2021, little reaction. second dose, 2/13/2021: headache one day later, disorientation/foggy mind 2 days after, then cleared up, muscle pain was short-lived, moderate chills, feeling unwell with weakness, restless leg syndrome (managed since 2004 with medications) returned 10 days after second shot.
This spontaneous report as received from a nurse refers to a 22 months 9 days old female patient. No concurrent condition, medical history or allergy/drug reactions were reported. On an unspecified date, the patient was vaccinated with improperly stored (exposed to 52.8 Fahrenheit for a total of 105 hours) PEDVAXHIB injection, lot # K016965, exp. date: 20-JUL-2017 (dose, strength and route unspecified). No concomitant medications were reported. No adverse experiences have been reported so far. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of several reports received from the same reporter. Additional information is not expected, no contact details were provided.
Mom states pt continued w/cough, expectoration of mucous & difficulty in breathing; MD dx viral synd probably viral pneumonia;
pt recvd vax;exp pain at inject site p/ 3 dose of vax;approx 7 mo later exp hand swelling,soreness & polyarthralgia;also exp viral synd type sxs;chills, fever, & aching; tx w/ prednisone;sxs resolved 2-4 days;all arthritis nl;
rash on the outside of left chin and outside of right chin. Rash on left hip followed by a rash on right hip. spreading on arms.; Rash blotches on right torso which spread over breast; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EM9809) via an unspecified route of administration in the left arm on 18Feb2021 at 08:15 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included blood pressure high. Concomitant medications included metoprolol (MANUFACTURER UNKNOWN), sertraline hydrochloride (ZOLOFT) and enalapril (MANUFACTURER UNKNOWN) all from an unknown date, for an unknown indication, unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EL9263) via an unspecified route of administration in the left arm on 28Jan2021 at 08:15 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. It was unknown, if the patient received any other vaccines within four weeks prior to the vaccination. On 01Mar2021, the patient experienced rash on the outside of left chin and right chin, rash blotches on right torso which spread over breast, rash on left hip followed by a rash on right hip and spreading on arms. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events which included treatment with some kind of fungal cream, pepcid ac and zyrtec. The clinical outcome of the events of rash on the outside of left chin and right chin, rash blotches on right torso which spread over breast, rash on left hip followed by a rash on right hip and spreading on arms were not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Have had a marked increase in volume of my tinnitus since shortly after being vaccinated. No treatment for this and it has been ongoing for over 4 months.
Fluzone High- Dose was given instead of Fluarix Quadrivalent.
Patient experiencing pain in right shoulder, beginning with shot.  He has had steroid injection, used bio freeze  and is in physical therapy.
0.25 ml was admininstred instead of 0.5 ml. No adverse reaction reported
No additional adverse effect reported; Patient received a dose of improperly stored Rotateq; This spontaneous report has been received from a registered nurse referring to a patient of unknown age, gender and race. The patient's pertinent concurrent condition, medical history, drug reactions or allergies and concomitant therapies were not reported.  On 06-NOV-2019, the patient started therapy with Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) administered orally (indication, dose, frequency, batch/lot number and expiration date were not reported).   On 06-MAR-2020, the patient was vaccinated with one dose of improperly stored rotavirus vaccine, Live, Oral, Pentavalent (ROTATEQ) (product storage error), administered orally, lot number 1660942, which was verified to be a valid lot number, expiration date reported and upon internal validation established as 06-FEB-2021, as prophylaxis (dose and frequency scheme were not reported). No additional adverse effect was reported. The administered vaccine experienced multiple temperature excursion below to 2 degrees Celsius (C) at 1.28 C. The time frame was reported as 2 hours and 30 hours. In addition, no previous temperature excursion was reported. Digital data logger was involved.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On or about 01-MAY-2017, the patient was inoculated with the ZOSTAVAX vaccine, at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles (lot number, dosage and route of administration not provided). The ZOSTAVAX did not prevent shingles as intended, and on an unknown date, the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. The patient was treated at a hospital for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
sore arm; heat feeling "warm throughout her body"; tachycardia shot up to 130 BPs for 20 mins; alter sensation in her tongue; her voice had mild hoarseness; period palpitations over the next 12 hours or so; looked pale; not feeling well; headache; This spontaneous case was reported by a physician and describes the occurrence of   in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     Concomitant products included PREDNISONE.    On 08-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jan-2021, Heart rate: 130 bps 130 bps.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   On 08-Jan-2021, the patient experienced heat feeling "warm feeling through out her body" similar to IV contrast for an MRI. Tachycardia shot up to 130BPS for 20 minutes at the same time alter sensation in her tongue and her voice had "mild hoarseness" then the tachycardia came back to normal over the next hour. She had period palpitations over the next 12 hours or so. Headache started that evening on 08-Jan-2021 and she looked "pale". The patient was just not feeling well. On 09-Jan-2021, morning just had sore arm but overall the patient felt great. The patient was on tapering course of prednisone for IBU. Concomitant medications were not provided. Treatment information was not reported.
pt recv vax 16OCT97 & same day exp localized redness & itching two hr p/vax;17OCT97 24hr p/vax pt exp cellulitis;pt recovered;
Short of breath for a few weeks. MD prescribed prednisone 20mg thinking it was related to my polyserositis but I did not respond. On 4/19, I was referred for a CT scan, which diagnosed pulmonary emboli on both lungs.
Bell's palsy; This is a spontaneous report from a contactable consumer (patient). This male patient (Age: 61 Unit: Unspecified) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 01Mar2021 as single dose for covid-19 immunisation. The medical history and concomitant medications were not reported. On 10Mar2021 the patient got bell's palsy. The doctors put him on prednisone and an antiviral. They told him it was ok to take ibuprofen (ADVIL) which he did and the second vaccine was scheduled for 26Mar2021. The patient took ibuprofen up until the morning before his second vaccine. He then heard can't take ibuprofen because it reduced the efficacy of the vaccine. The outcome of the event was unknown.  Follow-up attempts are completed. Information on the lot/batch number cannot be obtained.
Shot immediately burned on injection. Later that day arm felt warm and swollen slightly at injection site.  Upon waking up  on 16 October 2021 my right arm at injection site is sore, red, itchy, hot to touch, swollen and distended outward with a knot at the injection site. I immediately notified facility and will make an appointment to see my Primary Care Doctor.  I did not have this reaction at all with dose 1&2.
Dx Bacterial and Viral Pharyngitis, onset 2 days after Influenza Vaccine
Sleepy. Runny nose and tearing eyes since day of vaccine. Red, itchy, scaly condition above and below both eyes after 2 days.
Patient presented with (L) arm - injection sight being red & swollen with a hard nodule. Also patient has broken out w/ blisters externally on lips (primarily (L) side which are painful.
This spontaneous report as received from a physician via a company representative refers to a patient of unknown age and gender. There was no information about patient's concomitant medications and pertinent medical history reported. On an unknown date, approximately in 2014 (also reported as about a year ago), the patient aspirated after an unspecified dose of ROTATEQ (route, lot # and expiration date not reported). The outcome of the event was not reported. The relatedness between the event and ROTATEQ was not reported. This is one of several reports received from the same reporter. Additional information has been requested.
left arm swelling; FEVER; FLU LIKE SYMPTOMS; itchy injection site; swollen injection site; Lump red area around the injection site; This spontaneous case was reported by a patient and describes the occurrence of PERIPHERAL SWELLING (left arm swelling), PYREXIA (FEVER), INFLUENZA LIKE ILLNESS (FLU LIKE SYMPTOMS), INJECTION SITE PRURITUS (itchy injection site) and INJECTION SITE SWELLING (swollen injection site) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (no medical history provided).   On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Feb-2021, the patient experienced PERIPHERAL SWELLING (left arm swelling), PYREXIA (FEVER), INFLUENZA LIKE ILLNESS (FLU LIKE SYMPTOMS), INJECTION SITE PRURITUS (itchy injection site), INJECTION SITE SWELLING (swollen injection site) and INJECTION SITE ERYTHEMA (Lump red area around the injection site). At the time of the report, PERIPHERAL SWELLING (left arm swelling), PYREXIA (FEVER), INFLUENZA LIKE ILLNESS (FLU LIKE SYMPTOMS), INJECTION SITE PRURITUS (itchy injection site), INJECTION SITE SWELLING (swollen injection site) and INJECTION SITE ERYTHEMA (Lump red area around the injection site) outcome was unknown.            no treatment and concomitant provided   This case was linked to MOD-2021-016241 (Patient Link).
I used a new needle after drawing up dose of flu serum as pt. mom said she had had a local reaction in previous years. The child complained of redness and swelling to mother Friday evening. Site is red, puffy, warm to touch with a hardness to center of red area. Mother placed warm/damp towels to pt. arm with verbalize comfort.
I am not sure if this issue was related to the vaccine abs no doctor has indicated as such, but felt I should report it as the VSAFE system does not ask about birth outcomes, only how I was doing as the mother.   My baby was healthy at her 20 week ultrasound, but was found at the 36 week ultrasound to have had a brain hemorrhage believed to have happened in the month prior to the ultrasound. This means it would have occurred shortly after I received the vaccine.  The doctors timeframe was based on the level of clotting seen in subsequent ultrasounds.
Nine days after injection the site became red, firm, and hot. As the redness was spreading, my doctor concluded that it was an injection site infection and I am now taking a 7 day course of Keflex 500mg.
Been sick ever since I've got the shot.  Upper respitory effects. Coughing up phlegm. Sore throat . Low grade fever. Fatigue. Dizzyness.
monitoring RN noticed the pt pale and diaphoretic. brought pt back to extended observation room via ambulation. pt was placed on a cart in partial Trendelenburg . vitals 76/44 HR 52. 5 min post 91/49 HR 59 pt requested sips of 7 up and tolerated well. 10 min post report 102/57 HR 67 and "feeling better". 25 min post recovery room 113/62 HR 70. Pt released 30 min post vaccine pt ambulating out of the facility and declined any further treatment
Chills, body aches, nauseas, sore throat, fever (101.3), stomach pain, and headache. Took Tylenol and mortin
Pt received her doses for twinrin backwards. She received her 2nd dose 5 months after her first dose and 4 weeks after her 2nd dose.